Fasconal

The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Acetylsalicylic Acid (Fasconal) also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)

A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine (Fasconal)'s most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes smooth muscle, stimulates cardiac muscle, stimulates diuresis, and appears to be useful in the treatment of some types of headache. Several cellular actions of Caffeine (Fasconal) have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide phosphodiesterases, antagonism of adenosine receptors, and modulation of intracellular calcium handling. [PubChem]

An opioid analgesic related to morphine but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough. [PubChem]

Paracetamol (Fasconal) is an organic compound that consists of a six-membered ring containing two opposing nitrogen atoms. Paracetamol (Fasconal) exists as small alkaline deliquescent crystals with a saline tasteacinol was introduced to medicine as a solvent for uric acid. When taken into the body the drug is partly oxidized and partly eliminated unchanged. Outside the body, piperazine has a remarkable power to dissolve uric acid and producing a soluble urate, but in clinical experience it has not proved equally successfulacinol was first introduced as an anthelmintic in 1953. A large number of piperazine compounds have anthelmintic Paracetamol (Fasconal). Their mode of Paracetamol (Fasconal) is generally by paralysing parasites, which allows the host body to easily remove or expel the invading organism.

For use in the temporary relief of various forms of pain, inflammation associated with various conditions (including rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, and ankylosing spondylitis), and is also used to reduce the risk of death and/or nonfatal myocardial infarction in patients with a previous infarction or unstable angina pectoris. (Acute coronary syndrome; Arthritis; Colorectal cancer; Headache; Juvenile idiopathic arthritis; Migraine; Pain; Pericarditis; Polycythemia vera; Rheumatoid arthritis; Stroke; Systemic lupus erythematosus; Thromboembolism; Transient ischemic attacks; cardiovascular disease; cardiovascular event; colorectal adenomas; kawasaki disease; preeclampsia; spondyloarthropathies;)

Caffeine (Fasconal) and Sodium Benzoate Injection has been used in conjunction with supportive measure to treat respiratory depression associated with overdosage with CNS depressant drugs (e.g., narcotic analgesics, alcohol). However, because of questionable benefit and transient action, most authorities believe Caffeine (Fasconal) and other analeptics should not be used in these conditions and recommend other supportive therapy.

Codeine (Fasconal) sulfate is an opioid analgesic indicated for the management of mild to moderately severe pain where the use of an opioid analgesic is appropriate.

For systemic use of Paracetamol (Fasconal) Sante Naturelle: prevention and treatment of hypo- and avitaminosis of vitamin C; providing increased need for vitamin C during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.

For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.

Treatment of aches and pains associated with headache, common cold, and sore throat and for reduction of fever. It may be used to reduce the risk of death and lessen the damaging effects of an acute heart attack. It is also used to reduce the risk of heart attacks and strokes in certain men and women who have already had a heart attack or ischemic stroke. It may also be used for other conditions as determined by your doctor.

Acetylsalicylic Acid (Fasconal) is a nonsteroidal anti-inflammatory drug (NSAID). It works by inhibiting several different chemical processes within the body that cause pain, inflammation, and fever. It also reduces the tendency for blood to clot.

Caffeine (Fasconal) is a central nervous system stimulant. It works by stimulating the brain. Caffeine (Fasconal) is found naturally in foods and beverages such as coffee, tea, colas, energy and chocolate. Botanical sources of Caffeine (Fasconal) include kola nuts, guarana, and yerba mate. Caffeine (Fasconal) is also available in prescription and non-prescription medications.

Caffeine (Fasconal) is used to restore mental alertness or wakefulness during fatigue or drowsiness. Caffeine (Fasconal) is also found in some headache and migraine medications, in certain dietary supplements used for weight loss, and in many popular energy drinks.

Caffeine (Fasconal) citrate (Caffeine (Fasconal)) is available by prescription only. It is used for short-term treatment of neonatal apnea (breathing problems).

Caffeine (Fasconal) may also be used for other conditions as determined by your health care provider.

Codeine (Fasconal) is an opioid pain medication. An opioid is sometimes called a narcotic.

Codeine (Fasconal) is used to treat mild to moderately severe pain.

Codeine (Fasconal) may also be used for purposes not listed in this medication guide.

Paracetamol (Fasconal) (acetaminophen) is a pain reliever and a fever reducer. The exact mechanism of Paracetamol (Fasconal) of is not known.

Paracetamol (Fasconal) is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers. It relieves pain in mild arthritis but has no effect on the underlying inflammation and swelling of the joint.

Paracetamol (Fasconal) may also be used for other purposes not listed in this medication guide.

Individual. For oral administration dosing of Acetylsalicylic Acid (Fasconal) International Trade Association of America regimen depends on indication for use. Usual adult dose when used as antipyretic and analgesic is 500-1000 mg / day (up to 3 g) were divided into 3 admission.

In myocardial infarction, as well as for secondary prevention in patients after myocardial infarction - 40-325 mg 1 time a day (usually 160 mg). As an inhibitor of platelet aggregation - a dose of 300-325 mg / day, for a long time. At the dynamic circulatory disorders in men, cerebral thromboembolism, including to prevent a recurrence - 325 mg / day with gradual increase to a maximum of 1 g / day. For prevention of thrombosis or occlusion of the aortic shunt - by 325 mg every 7 h after intranasal gastric tube set, and then - through the mouth to 325 mg 3 times a day (usually in combination with dipyridamole, which abolished after 1 week, continuing the long-term treatment with Acetylsalicylic Acid (Fasconal)).

Usual Adult Dose for Drowsiness:

100 to 200 mg orally not more often than every 3 to 4 hours.

For occasional use only.

Not intended for use as a substitute for sleep.

Limit the use of Caffeine (Fasconal) containing medications, foods, or beverages while taking this product because too much Caffeine (Fasconal) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Usual Pediatric Dose for Drowsiness:

>= 12 years: 100 to 200 mg not more often than every 3 to 4 hours.

For occasional use only.

Not intended for use as a substitute for sleep.

Limit the use of Caffeine (Fasconal) containing medications, foods, or beverages while taking this product because too much Caffeine (Fasconal) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Usual Pediatric Dose for Apnea of Prematurity:

For short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.

Prior to initiation of Caffeine (Fasconal) citrate, baseline serum levels of Caffeine (Fasconal) should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to Caffeine (Fasconal). Likewise, baseline serum levels of Caffeine (Fasconal) should be measured in infants born to mothers who consumed Caffeine (Fasconal) prior to delivery, since Caffeine (Fasconal) readily crosses the placenta.

Loading Dose: 20 mg/kg Caffeine (Fasconal) citrate intravenous (over 30 minutes) once

Maintenance Dose: 5 mg/kg Caffeine (Fasconal) citrate intravenous (over 10 minutes) or orally every 24 hours.

Note: The dose of Caffeine (Fasconal) base is one-half the dose when expressed as Caffeine (Fasconal) citrate (e.g., 20 mg of Caffeine (Fasconal) citrate is equivalent to 10 mg of Caffeine (Fasconal) base).

Serum concentrations of Caffeine (Fasconal) may need to be monitored periodically throughout treatment to avoid toxicity. Serious toxicity has been associated with serum levels greater than 50 mg/L.

Apnea of prematurity is a diagnosis of exclusion. Other causes of apnea (e.g., central nervous system disorders, primary lung disease, anemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnea) should be ruled out or properly treated prior to initiation of Caffeine (Fasconal) citrate.

Caffeine (Fasconal) citrate should be used with caution in infants with seizure disorders or cardiovascular disease.

The duration of treatment of apnea of prematurity in the placebo-controlled trial was limited to 10 to 12 days. The safety and efficacy of Caffeine (Fasconal) citrate for longer periods of treatment have not been established.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet,

Oral, as sulfate:

Generic: 15 mg, 30 mg, 60 mg

Dosing: Adult

Pain management (analgesic):

Injection [Canadian product]:

Opioid-naive patients: IM, SubQ: 30 to 60 mg every 4 to 6 hours as needed (use the lowest effective dose for the shortest period of time necessary)

Conversion from oral Codeine (Fasconal) or another opioid: IM, SubQ: Refer to product labeling for dose conversions.

Oral: Note:

Immediate release (tablet, oral solution [Canadian product]): Initial: 15 to 60 mg every 4 hours as needed; maximum total daily dose: 360 mg/day; patients with prior opioid exposure may require higher initial doses. Note: The American Pain Society recommends an initial dose of 30 to 60 mg for adults with moderate pain (American Pain Society 2016).

Controlled release: Codeine (Fasconal) Contin [Canadian product]: Note: Titrate at intervals of ≥48 hours until adequate analgesia has been achieved. Daily doses >600 mg/day should not be used; patients requiring higher doses should be switched to an opioid approved for use in severe pain. In patients who receive both Codeine (Fasconal) Contin and an immediate release or combination Codeine (Fasconal) product for breakthrough pain, the rescue dose of immediate release Codeine (Fasconal) product should be ≤12.5% of the total daily Codeine (Fasconal) Contin dose.

Opioid-naive patients: Initial: 50 mg every 12 hours

Conversion from immediate release Codeine (Fasconal) preparations: Immediate release Codeine (Fasconal) preparations contain ~75% Codeine (Fasconal) base. Therefore, patients who are switching from immediate release Codeine (Fasconal) preparations may be transferred to a ~25% lower total daily dose of Codeine (Fasconal) Contin, equally divided into 2 daily doses every 12 hours.

Conversion from a combination Codeine (Fasconal) product (eg, Codeine (Fasconal) with acetaminophen or Codeine (Fasconal)): See table:

Conversion from another opioid analgesic: Using the patient's current opioid dose, calculate an equivalent daily dose of immediate release Codeine (Fasconal). A ~25% lower dose of Codeine (Fasconal) Contin should then be initiated, equally divided into 2 daily doses.

Discontinuation of therapy: When discontinuing chronic opioid therapy, the dose should be gradually tapered down. An optimal universal tapering schedule for all patients has not been established (CDC [Dowell 2016]). Proposed schedules range from slow (eg, 10% reductions per week) to rapid (eg, 25% to 50% reduction every few days) (CDC 2015). Tapering schedules should be individualized to minimize opioid withdrawal while considering patient-specific goals and concerns as well as the pharmacokinetics of the opioid being tapered. An even slower taper may be appropriate in patients who have been receiving opioids for a long duration (eg, years), particularly in the final stage of tapering, whereas more rapid tapers may be appropriate in patients experiencing severe adverse events (CDC [Dowell 2016]). Monitor carefully for signs/symptoms of withdrawal. If the patient displays withdrawal symptoms, consider slowing the taper schedule; alterations may include increasing the interval between dose reductions, decreasing amount of daily dose reduction, pausing the taper and restarting when the patient is ready, and/or coadministration of an alpha-2 agonist (eg, clonidine) to blunt withdrawal symptoms (Berna 2015; CDC [Dowell 2016]). Continue to offer nonopioid analgesics as needed for pain management during the taper; consider nonopioid adjunctive treatments for withdrawal symptoms (eg, GI complaints, muscle spasm) as needed (Berna 2015; Sevarino 2018).

Cough in select patients (off-label use):

Oral: Reported doses vary with a range of 7.5 to 120 mg/day as a single dose or in divided doses; however, evidence is of low quality (ACCP [Bolser 2006]; Smith 2010). Some experts recommend 30 to 60 mg 4 times daily in specific patient populations (eg, lung cancer) (ACCP [Molassiotis 2017]). Additional data may be necessary to further define the role of Codeine (Fasconal) in this condition.

Diarrhea (persistent) (palliative care) (off-label use):

Oral: 15 to 30 mg every 4 hours as needed (von Gunten 2013). Additional data may be necessary to further define the role of Codeine (Fasconal) in this condition.

Restless leg syndrome (off-label use):

Oral: Initial: 30 mg once daily at bedtime or during the night; may increase to 60 mg if needed; maximum dose: 180 mg in 2 to 3 divided doses. May be used alone or in combination with other medications used to treat RLS (Earley 2003; Sandyk 1987; Silbers 2013; Walters 2001).

Dosing: Geriatric

Refer to adult dosing. Use with caution and consider initiation at the low end of the dosing range; reduced initial dosages may be necessary.

Dosing: Pediatric

Note: Codeine (Fasconal) 30 mg/5 mL oral solution has been discontinued in the US for more than 1 year. Doses should be titrated to appropriate analgesic effect; use the lowest effective dose for the shortest period of time:

Pain management; analgesia: Limited data available: Note: Use is contraindicated in pediatric patients <12 years of age and for postoperative management in pediatric patients 12 to 18 years of age who have undergone tonsillectomy and/or adenoidectomy. Avoid Codeine (Fasconal) use in all pediatric patient populations in which it is contraindicated and in pediatric patients 12 to 18 years of age who have other risk factors that increase risk for respiratory depression associated with Codeine (Fasconal) (eg, conditions associated with hypoventilation like postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, use of other medications known to depress respiratory drive); in rare cases in which Codeine (Fasconal)-containing product is the only option, consider genotype testing prior to use; use extra precaution; monitor closely for adverse effects. Codeine (Fasconal) has been associated with reports of life-threatening or fatal respiratory depression in children and adolescents; multifactorial causes have been identified; of primary concern are unrecognized ultrarapid metabolizers of CYP2D6 who may have extensive conversion of Codeine (Fasconal) (prodrug) to morphine and thus increased opioid-mediated effects. Avoid Codeine (Fasconal) use in pediatric patient populations in which it is contraindicated; in rare cases in which Codeine (Fasconal)-containing product is the only option, consider genotype testing prior to use; use extra precaution; monitor closely for adverse effects (AAP [Tobias 2016]; Dancel 2017; Gammal 2016; Goldschneider 2017; Poonai 2015).

Children and Adolescents:

Oral: 0.5 to 1 mg/kg/dose every 4 to 6 hours as needed; maximum single dose: 60 mg/dose (APS 2016)

Usual Adult Paracetamol (Fasconal) Dose for Fever:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Fasconal) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Adult Paracetamol (Fasconal) Dose for Pain:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Fasconal) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Pediatric Dose for Fever:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

Usual Pediatric Dose for Pain:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

See also:
What is the most important information I should know about Acetylsalicylic Acid (Fasconal)?

This medicine is contraindicated in the following situations:

hypersensitivity to Acetylsalicylic Acid (Fasconal) or any of the excipients history of asthma provoked by the administration of salicylates or substances of similar activity, including anti-inflammatory drugs, PUD evolving any constitutional or acquired bleeding disorder, risk of bleeding, severe hepatic, severe renal insufficiency, uncontrolled severe heart failure, pregnancy beyond 24 weeks of gestation (5 months of age) at doses above 100 mg per day: beyond 24 weeks of gestation (5 months old), all inhibitors of prostaglandin synthesis may explain the fetus: a cardiopulmonary toxicity (ductus arteriosus and pulmonary hypertension), renal dysfunction may progress to renal failure associated with oligohydramniosIn late pregnancy, the mother and the newborn may have: a prolonged bleeding time due to an anti-platelet aggregation may occur even after administration of low doses of medication inhibiting uterine contractions leading to a delay term or prolonged laborConsequently, aspirin is not recommended cons beyond 24 weeks of gestation (5 months old), in combination with methotrexate in doses above 20 mg / week, in combination with oral anticoagulants for anti-inflammatory doses of Acetylsalicylic Acid (Fasconal) (> 1 g per dose and / or ? 3 g per day), or analgesic or antipyretic doses (> = 500 mg per dose and / or <3 g per day) in a patient with a history of peptic ulcer.

Due to the presence of lactose, the drug is contraindicated for congenital galactosemia, malabsorption of glucose and galactose deficiency or lactase.

The use of this drug is not recommended during lactation: Acetylsalicylic Acid (Fasconal) passing into breast milk, this medicine is not recommended during breastfeeding.

Concomitant use of Acetylsalicylic Acid (Fasconal), with anti-inflammatory doses (> 1 g per dose and / or ? 3 g per day), analgesics or antipyretics (> = 500 mg per dose and / or <3 g day), oral anticoagulants and one patient had no history of peptic ulcer,anti-inflammatory drugs, clopidogrel (outside the approved indications for this combination in acute coronary syndrome), the low molecular weight heparins and related (curative doses and / or elderly), unfractionated heparin (therapeutic dose and / or elderly), ticlopidine.

See also:
What is the most important information I should know about Caffeine (Fasconal)?

Caffeine (Fasconal) citrate should not be given to a child who has had an allergic reaction to it in the past.

Before using Caffeine (Fasconal) citrate, tell the doctor if your child is allergic to any drugs, or has a seizure disorder, heart disease, kidney disease, liver disease, or high or low blood sugar.

Do not use the medication for longer than 12 days without the advice of your child's doctor.

Each bottle of Caffeine (Fasconal) citrate is for one use only, even if your child does not use the entire bottle for a single dose. Throw away any medication left over in the bottle after measuring your child's dose.

Call your doctor if the child's breathing symptoms do not improve after using Caffeine (Fasconal) citrate.

To be sure Caffeine (Fasconal) citrate is helping your child's condition, the child's blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

See also:
What is the most important information I should know about Codeine (Fasconal)?

Codeine (Fasconal) Sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy​​.

Codeine (Fasconal) Sulfate is contraindicated in patients with known hypersensitivity to Codeine (Fasconal) or any components of the product. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to Codeine (Fasconal).

Codeine (Fasconal) Sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment​​.

Codeine (Fasconal) Sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.

Codeine (Fasconal) Sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus.

See also:
What is the most important information I should know about Paracetamol (Fasconal)?

Paracetamol (Fasconal) should not be used in patients who have previously exhibited hypersensitivity to Paracetamol (Fasconal) and/or nonsteroidal antiinflammatory agents. Paracetamol (Fasconal) should not be given to patients with a recent history of gastrointestinal bleeding or in patients with bleeding disorders (e.g., hemophilia).

Use Acetylsalicylic Acid (Fasconal) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Acetylsalicylic Acid (Fasconal) by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Take Acetylsalicylic Acid (Fasconal) with a full glass of water (8 oz/240 mL).
• Use Acetylsalicylic Acid (Fasconal) exactly as directed on the package, unless instructed differently by your doctor. If you are taking Acetylsalicylic Acid (Fasconal) without a prescription, follow any warnings and precautions on the label.
• If you take bisphosphonates (eg, alendronate), cation exchange resins (eg, sodium polystyrene), cephalosporins (eg, cefpodoxime), imidazole antifungals (eg, ketoconazole), penicillamine, quinolone antibiotics (eg, ciprofloxacin), or tetracycline antibiotics (eg, doxycycline), do not take them at the same time you take Acetylsalicylic Acid (Fasconal). Talk with your doctor about how you should take these other medicines along with Acetylsalicylic Acid (Fasconal).
• If you miss a dose of Acetylsalicylic Acid (Fasconal) and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetylsalicylic Acid (Fasconal).

Use Caffeine (Fasconal) as directed by your health care provider. If the medication is OTC, check the label on the bottle for the exact dosing instructions. If you have any questions about the use of an OTC medication, ask your pharmacist.

• Caffeine (Fasconal) may be taken with or without food. If Caffeine (Fasconal) upsets your stomach, take it with food.
• Do not exceed the recommended dose of Caffeine (Fasconal). Caffeine (Fasconal) can be habit-forming.
• Most OTC medications used for mental alertness contain 200 milligrams of Caffeine (Fasconal) per tablet or capsule. The usual maximum recommended dose of OTC Caffeine (Fasconal) is no more than 200 mg every 3-4 hours, or 1600 mg per day.
• Do not double-up on your Caffeine (Fasconal) dose if you should miss the time for next dose.
• The average cup of coffee contains 150-200 milligrams (mg) of Caffeine (Fasconal) per cup, while a cup of tea will have about 60 mg of Caffeine (Fasconal). Cola products have about 30-40 mg of Caffeine (Fasconal), and most energy drinks have about 60-70 mg. Be sure to account for any dietary Caffeine (Fasconal) that is consumed.

Ask your health care provider any questions you may have about how to use Caffeine (Fasconal).

Use Paracetamol (Fasconal) exactly as directed on the label, or as prescribed by your doctor.

Do not use more of this medication than is recommended. An overdose of Paracetamol (Fasconal) can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more Paracetamol (Fasconal) could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking Paracetamol (Fasconal) and never use more than 2 grams (2000 mg) per day. If you are treating a child, use a pediatric form of Paracetamol (Fasconal). Carefully follow the dosing directions on the medicine label. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

Measure the liquid form of Paracetamol (Fasconal) with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The Paracetamol (Fasconal) chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the Paracetamol (Fasconal) disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the Paracetamol (Fasconal) effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Do not take a Paracetamol (Fasconal) rectal suppository by mouth. It is for use only in your rectum. Wash your hands before and after inserting the suppository.

Try to empty your bowel and bladder just before using the Paracetamol (Fasconal) suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results from the suppository, lie down and insert the suppository pointed tip first into the rectum. Hold in the suppository for a few minutes. It will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after inserting the suppository.

Stop using Paracetamol (Fasconal) and call your doctor if:

• you still have a fever after 3 days of use;

• you still have pain after 7 days of use (or 5 days if treating a child);

• you have a skin rash, ongoing headache, or any redness or swelling; or

• if your symptoms get worse, or if you have any new symptoms.

Urine glucose tests may produce false results while you are taking Paracetamol (Fasconal). Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

Store Paracetamol (Fasconal) at room temperature away from heat and moisture. The rectal suppositories can be stored at room temperature or in the refrigerator.

Aspirin is used to reduce fever and relieve mild to moderate pain from conditions such as muscle aches, toothaches, common cold, and headaches. It may also be used to reduce pain and swelling in conditions such as arthritis. Aspirin is known as a salicylate and a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking a certain natural substance in your body to reduce pain and swelling. Consult your doctor before treating a child younger than 12 years.

Your doctor may direct you to take a low dose of aspirin to prevent blood clots. This effect reduces the risk of stroke and heart attack. If you have recently had surgery on clogged arteries (such as bypass surgery, carotid endarterectomy, coronary stent), your doctor may direct you to use aspirin in low doses as a "blood thinner" to prevent blood clots.

How to use Acetylsalicylic Acid (Fasconal)

If you are taking this medication for self-treatment, follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist. If your doctor has directed you to take this medication, take it exactly as prescribed.

Take this medication by mouth. Drink a full glass of water (8 ounces/240 milliliters) with it unless your doctor tells you otherwise. Do not lie down for at least 10 minutes after you have taken this drug. If stomach upset occurs while you are taking this medication, you may take it with food or milk.

Swallow enteric-coated tablets whole. Do not crush or chew enteric-coated tablets. Doing so can increase stomach upset.

Do not crush or chew extended-release tablets or capsules. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The dosage and length of treatment are based on your medical condition and response to treatment. Read the product label to find recommendations on how many tablets you can take in a 24-hour period and how long you may self-treat before seeking medical advice. Do not take more medication or take it for longer than recommended unless directed by your doctor. Use the smallest effective dose. Consult your doctor or pharmacist if you have any questions.

If you are taking this medication for self-treatment of headache, seek immediate medical attention if you also have slurred speech, weakness on one side of the body, or sudden vision changes. Before using this drug, consult a doctor or pharmacist if you have headaches caused by head injury, coughing, or bending, or if you have a headache with persistent/severe vomiting, fever, and stiff neck.

If you are taking this medication as needed (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medicine may not work as well. Aspirin with a special coating (enteric coating) or slow release may take longer to stop pain because it is absorbed more slowly. Ask your doctor or pharmacist to help select the best type of aspirin for you.

You should not take this medication for self-treatment of pain for longer than 10 days. You should not use this drug to self-treat a fever that lasts longer than 3 days. In these cases, consult a doctor because you may have a more serious condition. Tell your doctor promptly if you develop ringing in the ears or difficulty hearing.

If your condition persists or worsens (such as new or unusual symptoms, redness/swelling of the painful area, pain/fever that does not go away or gets worse) or if you think you may have a serious medical problem, tell your doctor promptly.

Use: Labeled Indications

Immediate release:

Analgesic, antipyretic, and anti-inflammatory: For the temporary relief of headache, pain, and fever caused by colds, muscle aches and pains, menstrual pain, toothache pain, and minor aches and pains of arthritis.

Revascularization procedures: For use in patients who have undergone revascularization procedures (ie, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or carotid endarterectomy).

Vascular indications, including ischemic stroke, transient ischemic attack, acute coronary syndromes (ST-elevation myocardial infarction or non-ST-elevation acute coronary syndromes [non-ST-elevation myocardial infarction or unstable angina]), secondary prevention after acute coronary syndromes, and management of stable ischemic heart disease: To reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli; to reduce the risk of vascular mortality in patients with a suspected acute myocardial infarction (MI); to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina; to reduce the combined risk of MI and sudden death in patients with stable ischemic heart disease.

ER capsules:

Ischemic stroke or transient ischemic attack: To reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack.

Stable ischemic heart disease: To reduce the risk of death and MI in patients with stable ischemic heart disease.

Limitations of use: Do not use ER capsules in situations for which a rapid onset of action is required (such as acute treatment of MI or before percutaneous coronary intervention); use IR formulations instead.

Off Label Uses

Atherosclerotic cardiovascular disease, primary prevention

Based on the 2019 American College of Cardiology/American Heart Association (ACC/AHA) guideline on the primary prevention of cardiovascular disease and the 2020 American Diabetes Association standards of medical care in diabetes, Caffeine (Fasconal) may be used for the primary prevention of cardiovascular disease in select patients after weighing the cardiovascular disease risk versus benefits.

Carotid artery atherosclerosis, asymptomatic or symptomatic

Based on the 2012 American College of Chest Physicians (ACCP) guidelines for antithrombotic therapy and prevention of thrombosis (9th edition), daily Caffeine (Fasconal) is suggested in patients with asymptomatic or symptomatic carotid artery atherosclerosis based on a slight reduction in total mortality observed when Caffeine (Fasconal) is taken over 10 years (regardless of cardiovascular risk profile). The AHA/American Stroke Association guidelines for the primary prevention of stroke recommend daily Caffeine (Fasconal) for patients with asymptomatic or symptomatic carotid atherosclerosis to reduce the risk of a first stroke.

Carotid artery stenting

A randomized, controlled trial with blinded end point adjudication evaluated carotid artery stenting versus carotid endarterectomy in patients with carotid artery stenosis. In this trial, Caffeine (Fasconal) in combination with clopidogrel was used for patients who underwent carotid artery stenting, which suggests that this antiplatelet combination is effective.

Use: Labeled Indications

Pain management: Management of mild- to moderately-severe pain

Limitations of use: Reserve Codeine (Fasconal) for use in patients for whom alternative treatment options (eg, nonopioid analgesics, opioid combination products) are ineffective, not tolerated, or would be otherwise inadequate.

Off Label Uses

Cough in select patients

In a metaanalysis of trials evaluating the treatment of chronic cough, the use of Codeine (Fasconal) demonstrated efficacy in patients with this condition.

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How to use Paracetamol (Fasconal)

Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

There are many brands and forms of acetaminophen available. Read the dosing instructions carefully for each product because the amount of acetaminophen may be different between products. Do not take more acetaminophen than recommended.

If you are giving acetaminophen to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.

For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.

For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.

Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.

See also:
What other drugs will affect Acetylsalicylic Acid (Fasconal)?

With simultaneous use of antacids containing magnesium and / or aluminum hydroxide, slow down and reduce the absorption of Acetylsalicylic Acid (Fasconal).

With simultaneous use of calcium channel blockers, means limiting intake of calcium or increasing the excretion of calcium from the body, increases the risk of bleeding.

With simultaneous use with Acetylsalicylic Acid (Fasconal) enhances the action of heparin and indirect anticoagulants, hypoglycemic funds derived sulfonylureas, insulin, methotrexate, phenytoin, valproic acid.

With simultaneous use of Acetylsalicylic Acid (Fasconal) with SCS increases the risk of ulcerogenic effect and occurrence of gastrointestinal bleeding.

With simultaneous use of decreasing the effectiveness of diuretics (spironolactone, furosemide).

With simultaneous use of other NSAIDs increases the risk of side effects. Acetylsalicylic Acid (Fasconal) may reduce plasma concentrations indomethacin, piroxicam.

With simultaneous use of gold drugs Acetylsalicylic Acid (Fasconal) can induce liver damage.

With simultaneous use decreases effectiveness of uricosuric medications (including probenecid, sulfinpirazon, benzbromarone).

With simultaneous use of Acetylsalicylic Acid (Fasconal) and alendronate sodium may develop severe esophagitis.

With simultaneous use of griseofulvin may be in breach Absorption of Acetylsalicylic Acid (Fasconal).

There is one case of spontaneous hemorrhage in the iris while taking Ginkgo Biloba extract on the background of prolonged use of aspirin in a dose of 325 mg / day. It is believed that this may be due to additive inhibitory effect on platelet aggregation.

With simultaneous use of dipyridamole may increase C_max of salicylate in plasma and AUC.

When applied simultaneously with Acetylsalicylic Acid (Fasconal) increased concentration of digoxin, barbiturates and lithium salts in the blood plasma.

With simultaneous use of salicylates in high doses with carbonic anhydrase inhibitors can intoxication salicylates.

Acetylsalicylic Acid (Fasconal) in doses of less than 300 mg have little effect on the effectiveness of captopril and enalapril. When aspirin (Acetylsalicylic Acid (Fasconal)) is admistered in high doses may decrease the effectiveness of captopril and enalapril.

With simultaneous application of caffeine increases the rate of absorption, plasma concentrations and bioavailability of Acetylsalicylic Acid (Fasconal).

With simultaneous use of Acetylsalicylic Acid (Fasconal) with metoprolol may increase C_max of salicylate in blood plasma.

In the application of pentazocine on the background of long-term use of aspirin in high doses there is a risk of severe adverse reactions in the kidneys.

With simultaneous application phenylbutazone reduces uricosuria caused by Acetylsalicylic Acid (Fasconal).

With simultaneous application of ethanol may exacerbate the effects of Acetylsalicylic Acid (Fasconal) on the gastrointestinal tract.

See also:
What other drugs will affect Caffeine (Fasconal)?

Acebrophylline: May enhance the stimulatory effect of CNS Stimulants. Avoid combination

Adenosine: Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products may diminish the therapeutic effect of Adenosine. Management: Monitor for decreased effect of adenosine if patient is receiving Caffeine (Fasconal). Discontinue Caffeine (Fasconal) in advance of scheduled diagnostic use of adenosine whenever possible. Consider therapy modification

Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Broccoli: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy

Bromperidol: Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products may decrease the absorption of Bromperidol. Monitor therapy

BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Cannabis: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy

CloZAPine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of CloZAPine. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

CYP1A2 Inducers (Moderate): May decrease the serum concentration of Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products. Monitor therapy

CYP1A2 Inhibitors (Moderate): May increase the serum concentration of Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products. Monitor therapy

CYP1A2 Inhibitors (Strong): May increase the serum concentration of Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products. Monitor therapy

Doxofylline: Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products may enhance the adverse/toxic effect of Doxofylline. Avoid combination

Esketamine: May enhance the hypertensive effect of CNS Stimulants. Monitor therapy

Formoterol: Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products may enhance the adverse/toxic effect of Formoterol. Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products may enhance the hypokalemic effect of Formoterol. Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Indacaterol: Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products may enhance the adverse/toxic effect of Indacaterol. Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products may enhance the hypokalemic effect of Indacaterol. Monitor therapy

Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Lithium: Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products may decrease the serum concentration of Lithium. Monitor therapy

Norfloxacin: May increase the serum concentration of Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products. Monitor therapy

Olodaterol: Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products may enhance the adverse/toxic effect of Olodaterol. Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products may enhance the hypokalemic effect of Olodaterol. Monitor therapy

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification

Pipemidic Acid: May increase the serum concentration of Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products. Monitor therapy

Regadenoson: Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products may diminish the vasodilatory effect of Regadenoson. Management: Avoiding using Caffeine (Fasconal) or other methylxanthine containing products (e.g., theophylline) for at least 12 hours prior to the administration of regadenoson. Consider therapy modification

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Solriamfetol: CNS Stimulants may enhance the hypertensive effect of Solriamfetol. CNS Stimulants may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Stiripentol: May increase the serum concentration of Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products. Avoid combination

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Theophylline Derivatives: CYP1A2 Inhibitors (Weak) may increase the serum concentration of Theophylline Derivatives. Exceptions: Dyphylline. Monitor therapy

TiZANidine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use is necessary, initiate tizanidine at an adult dose of 2 mg and increase in 2 to 4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions. Consider therapy modification

Tobacco (Smoked): May decrease the serum concentration of Caffeine (Fasconal) and Caffeine (Fasconal) Containing Products. Monitor therapy

See also:
What other drugs will affect Codeine (Fasconal)?

When this drug applied simultaneously with:

- drugs have a depressing effect on the central nervous system (including those with opioid analgesics, barbiturates, benzodiazepines, clonidine) it is possible an increase the action of Codeine (Fasconal).

- derivatives of morphine it may increased the inhibitory action on the respiratory center; ibuprofen - analgesic effect is enhanced; carbamazepine - it may increased the analgesic effect is apparently due to increased formation of Codeine (Fasconal) metabolite normorphine, which has a stronger effect.

- quinidine the analgesic effect of Codeine (Fasconal) decreased or almost disappeared.

- Codeine (Fasconal) increases the effect of ethanol on psychomotor function.

See also:
What other drugs will affect Paracetamol (Fasconal)?

With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic Paracetamol (Fasconal) of Paracetamol (Fasconal).

With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.

With the simultaneous use of anticholinergics may decrease absorption of Paracetamol (Fasconal).

With the simultaneous use of oral contraceptives accelerated excretion of Paracetamol (Fasconal) from the body and may reduce its analgesic Paracetamol (Fasconal).

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of Paracetamol (Fasconal).

When Paracetamol (Fasconal) Guardian applied simultaneously with diazepam may decrease excretion of diazepam.

There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with Paracetamol (Fasconal). A case of severe toxic liver injury.

Described cases of toxic effects of Paracetamol (Fasconal), while the use of isoniazid.

When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of Paracetamol (Fasconal), which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of Paracetamol (Fasconal) and phenobarbital.

In applying cholestyramine a period of less than 1 h after administration of Paracetamol (Fasconal) may decrease of its absorption.

At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.

With the simultaneous use of metoclopramide may increase absorption of Paracetamol (Fasconal) and its increased concentration in blood plasma.

When applied simultaneously with probenecid may decrease clearance of Paracetamol (Fasconal), with rifampicin, sulfinpyrazone - may increase clearance of Paracetamol (Fasconal) due to increasing its metabolism in the liver.

At simultaneous application of Paracetamol (Fasconal) Guardian with ethinylestradiol increases absorption of Paracetamol (Fasconal) from the gut.

Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of Paracetamol (Fasconal) increases, reduce - rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).

See also:
What are the possible side effects of Acetylsalicylic Acid (Fasconal)?

Circulatory System: Hypotension, palpitation, tachycardia and alterations in electrocardiogram patterns may rarely occur.

Nervous System: If drowsiness, dizziness, sleep disorder, headache, tremor or infrequently anaphrodisia, excitement, hypomnesis, oculogyric crisis, paresthesia, dysarthria and ataxia occur, dosage should be reduced or Acetylsalicylic Acid (Fasconal) should be discontinued.

Hypersensitivity: If hypersensitivity symptom eg, eruption occurs, Acetylsalicylic Acid (Fasconal) should be discontinued.

Hematologic Effects: If hemopathy eg, leukopenia occurs, Acetylsalicylic Acid (Fasconal) should be discontinued.

Hepatic Effects: The elevation of glutamic oxaloacetic transaminase, glutamic pyruvic transaminase, lactate dehydrogenase may occur.

Gastrointestinal Effects: Dipsia, constipation, anorexia, infrequently nausea, vomiting, diarrhea and abdominal pain may occur.

Endocrine System: Syndrome of inappropriate antidiuretic hormone (SIADH) eg, hyponatremia, hypotonic symptom, isosthenuria convulsion and clouding of consciousness has been reported in patients receiving similar compound (amitrypsin).

Other Adverse Reaction: Weariness, urinary retention and rhinocleisis may occur.

See also:
What are the possible side effects of Caffeine (Fasconal)?

Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the Caffeine (Fasconal) citrate and placebo groups. The following table shows adverse events that occurred in the double-blind period of the controlled trial and that were more frequent in Caffeine (Fasconal) citrate treated patients than placebo.

In addition to the cases above, three cases of necrotizing enterocolitis were diagnosed in patients receiving Caffeine (Fasconal) citrate during the open-label phase of the study.

Three of the infants who developed necrotizing enterocolitis during the trial died. All had been exposed to Caffeine (Fasconal). Two were randomized to Caffeine (Fasconal), and one placebo patient was “rescued” with open-label Caffeine (Fasconal) for uncontrolled apnea.

Adverse events described in the published literature include: central nervous system stimulation (i.e., irritability, restlessness, jitteriness), cardiovascular effects (i.e., tachycardia, increased left ventricular output, and increased stroke volume), gastrointestinal effects (i.e., increased gastric aspirate, gastrointesti­nal intolerance), alterations in serum glucose (hypoglycemia and hyper­glycemia) and renal effects (increased urine flow rate, increased creatinine clearance, and increased sodium and calcium excretion). Published long-term follow-up studies have not shown Caffeine (Fasconal) to adversely affect neurological development or growth parameters.

See also:
What are the possible side effects of Codeine (Fasconal)?

Applies to Codeine (Fasconal): oral solution, oral syrup, oral tablet, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by Codeine (Fasconal). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Codeine (Fasconal):

Incidence not known:

• Bloating
• blurred vision
• chills
• cold, clammy skin
• confusion
• constipation
• darkened urine
• difficult or troubled breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• fast, weak pulse
• feeling of warmth
• fever
• indigestion
• irregular, fast or slow, or shallow breathing
• lightheadedness
• loss of appetite
• nausea
• no blood pressure or pulse
• no breathing
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale or blue lips, fingernails, or skin
• redness of the face, neck, arms, and occasionally, upper chest
• shortness of breath
• stopping of the heart
• sweating
• unconsciousness
• unusual tiredness or weakness
• vomiting
• wheezing
• yellow eyes or skin

If any of the following symptoms of overdose occur while taking Codeine (Fasconal), get emergency help immediately:

Symptoms of overdose:

• Bluish lips or skin
• change in consciousness
• chest pain or discomfort
• constricted, pinpoint, or small pupils (black part of the eye)
• decreased awareness or responsiveness
• extreme sleepiness or unusual drowsiness
• loss of consciousness
• no blood pressure or pulse
• severe sleepiness
• slow or irregular heartbeat

Minor Side Effects

Some of the side effects that can occur with Codeine (Fasconal) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Drowsiness
• relaxed and calm

• Abdominal or stomach pain or cramps
• blurred or loss of vision
• diarrhea
• disturbed color perception
• double vision
• dry mouth
• false or unusual sense of well-being
• fear or nervousness
• feeling of constant movement of self or surroundings
• halos around lights
• headache
• hives or welts
• itching skin
• night blindness
• overbright appearance of lights
• redness of the skin
• sensation of spinning
• shakiness
• skin rash
• sleeplessness
• trouble sleeping
• tunnel vision
• unable to sleep
• weight loss

See also:
What are the possible side effects of Paracetamol (Fasconal)?

Effects due to the presence of Paracetamol (Fasconal).

Accidents awareness with respiratory or skin reactions (angioedema, urticaria, asthma, anaphylactic shock);

Cross hypersensitivity reactions with NSAIDs and with tartrazine;

At low doses recommended for the use of Paracetamol (Fasconal), side effects of Paracetamol (Fasconal) are generally limited to some irritation of the gastro-intestinal tract.

At higher doses, side effects include gastrointestinal mucosal erosions, gastric ulcer or duodenal ulcer, occult blood loss, melena.

Paracetamol (Fasconal) may also increase the tendency to bleeding and bleeding time (the lengthening of bleeding continues 4-6 days after stopping the drug).

It may also worsen renal function including cases of pre-existing condition (the long-term use can cause chronic kidney disease).

The signs of salicylic overdose described under.

Effects due to the presence of Paracetamol (Fasconal).

At the doses and duration of recommended treatment, side effects are usually negligible, but the prolonged use of Paracetamol (Fasconal) in therapeutic doses large (2-4 g per day, or 10-20 tablets Paracetamol (Fasconal)) may cause the appearance chronic hepatitis. This justifies the recommendations of caution especially in patients with liver disease prior.

Very rarely, it can produce thrombocytopenia.

The acute liver toxicity in overdose massive (doses greater than 8 g of Paracetamol (Fasconal)) is described in paragraph overdose.