Bromhexine/Loratadine/Paracetamol/Pseudoephedrine

Bromhexine hydrochloride SYRUP indicated for cough associated with wheeziness (bronchospasm) and tenacious phlegm (sputum).

Treatment of seasonal allergic rhinitis, perennial rhinitis, urticaria, allergic dermatologic disorders, angioedema and conjunctivitis. Loratadine is generally considered to be ineffective in asthma.

Acute anaphylaxis should be treated with adrenaline; loratadine and corticosteroids are given to prevent relapse.

Loratadine is also used to control the pruritus associated with skin disorders eg, atopic eczema.

For systemic use of Paracetamol 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.

Temporary relief of symptoms of upper respiratory tract disorders such as sinusitis, vasomotor rhinitis, and hay fever; temporary relief of coughs associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma when tenacious mucus and/or mucus plugs and congestion complicate these conditions.

Loratadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Loratadine is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.

Loratadine is also used to treat skin hives and itching in people with chronic skin reactions.

Loratadine may also be used for purposes not listed in this medication guide.

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

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

Pseudoephedrine (pseudoephedrine) is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pseudoephedrine is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

Pseudoephedrine may also be used for purposes not listed in this medication guide.

Unless otherwise prescribed, the following doses are recommended:

Tablet: Adults and Children >12 years: 8 mg (1 tab) thrice daily; 6-12 years: 4 mg (½ tab) thrice daily; 2-6 years: 4 mg (½ tab) twice daily.

Oral Solution:

Inhalation Solution (with aerosol apparatus): It is generally recommended to warm inhalation solution to body temperature before inhalation. Patients with bronchial asthma may be advised to commencing inhalation after they have taken their regular bronchospasmolytic therapy.

Adults: 4 mL. Children >12 years: 2 mL; 6-12 years: 1 mL; 2-6 years: 10 drops; <2 years: 5 drops. All doses to be taken twice daily.

The solution may be diluted 1:1 in physiological saline solution. In order to avoid precipitation, the solution should be inhaled immediately after mixing. The combined administration of inhalation and oral application intensifies the effect, and is especially suited for the commencement of treatment in cases where the full effect is to be reached quickly.

Syrup: Adults and Children >12 years: 5 ml (1 tsp) thrice daily.

At commencement of treatment, it may be necessary to increase the total daily dose up to 48 mg in adults.

The syrup is sugar-free and therefore suitable for diabetics and small children.

Ampoule: Severe cases, before and after surgical intervention: 1 amp SC, IM or IV (duration of injection: 2-3 min) 2-3 times daily.

Capsule: Adults: 1 cap 3 times daily.

It is recommended for the initial phase of treatment usually lasting not more than a week.

Patients being treated with Bromhexine should be notified of an expected increase in the flow of secretions.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule,

Oral:

Loratadine: 10 mg [contains brilliant blue fcf (fd&c blue #1)]

GoodSense Allergy Relief: 10 mg [contains brilliant blue fcf (fd&c blue #1)]

Generic: 10 mg

Solution,

Oral:

Childrens Loratadine: 5 mg/5 mL (120 mL) [alcohol free, dye free, sugar free; contains propylene glycol, sodium benzoate; grape flavor]

Loratadine Childrens: 5 mg/5 mL (120 mL [DSC]) [alcohol free, dye free, sugar free; contains polyethylene glycol, propylene glycol, sodium benzoate; grape flavor]

Loratadine Childrens: 5 mg/5 mL (120 mL [DSC]) [alcohol free, dye free, sugar free; contains propylene glycol, sodium benzoate; fruit flavor]

Loratadine Hives Relief: 5 mg/5 mL (120 mL [DSC]) [alcohol free, dye free, sugar free; contains propylene glycol, sodium benzoate; grape flavor]

Syrup,

Oral:

Childrens Loratadine: 5 mg/5 mL (120 mL) [fruit flavor]

Childrens Loratadine: 5 mg/5 mL (120 mL) [alcohol free, dye free; contains propylene glycol, sodium benzoate, sodium metabisulfite; grape flavor]

Loratadine: 5 mg/5 mL (60 mL [DSC], 120 mL [DSC], 150 mL [DSC]) [alcohol free, color free, dye free, sugar free; contains edetate disodium, propylene glycol, sodium benzoate; grape flavor]

Loratadine Allergy Childrens: 5 mg/5 mL (240 mL) [alcohol free, dye free, sugar free; contains edetate disodium, propylene glycol, sodium benzoate, sorbitol]

Loratadine Childrens: 5 mg/5 mL (120 mL) [alcohol free, dye free, gluten free, sugar free; contains edetate disodium, propylene glycol, sodium benzoate; grape flavor]

Loratadine Childrens: 5 mg/5 mL (10 mL) [alcohol free, dye free, sugar free; contains propylene glycol, sodium benzoate; grape flavor]

Loratadine Childrens: 5 mg/5 mL (120 mL) [sugar free; contains polyethylene glycol, propylene glycol, sodium benzoate, sodium metabisulfite; grape flavor]

Generic: 5 mg/5 mL (120 mL)

Tablet,

Oral:

Allergy: 10 mg [DSC]

Allergy Non-Drowsy: 10 mg [DSC]

Allergy Relief: 10 mg

Allergy Relief: 10 mg [contains corn starch]

Allergy Relief: 10 mg [gluten free]

Allergy Relief Loratadine: 10 mg

Loratadine: 10 mg

Loradamed: 10 mg

Generic: 10 mg

Tablet Chewable,

Oral:

Loratadine: 5 mg [contains aspartame, fd&c blue #2 aluminum lake; grape flavor]

Loratadine Childrens: 5 mg [contains aspartame]

Loratadine Childrens: 5 mg [DSC] [contains aspartame; bubble-gum flavor]

Tablet Disintegrating,

Oral:

Loratadine: 10 mg [contains aspartame]

Loratadine: 10 mg [contains aspartame; citrus flavor]

Allergy Relief: 10 mg [DSC] [contains aspartame]

Loratadine Reditabs: 5 mg, 10 mg

Triaminic Allerchews: 10 mg

Dosing: Adult

Allergic rhinitis or conjunctivitis:

Oral: 10 mg once daily or 5 mg twice daily.

OTC labeling (patient-guided therapy for symptoms of hay fever or other upper respiratory allergies):

Oral: 10 mg once daily or 5 mg twice daily; maximum dose: 10 mg/day.

Urticaria (acute and chronic spontaneous):

Oral: Initial: 10 mg once daily. If symptom control is inadequate, may increase to 10 mg twice daily. There is limited evidence for larger doses. Reevaluate necessity for continued treatment periodically (Asero 2020; Khan 2019; Zuberbier 2018).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Allergic symptoms/rhinitis:

Oral

Children 2 to <6 years:

Oral liquid or chewable tablet: 5 mg once daily

Children ≥6 years and Adolescents:

Oral liquid, capsule, tablet, or chewable tablet: 10 mg once daily

Dispersible tablet: 5 mg twice daily or 10 mg once daily

Chronic idiopathic urticaria: Limited data available (Kliegman 2011; Simons 1994):

Children 2 to 12 years: 5 mg once daily

Adolescents: 10 mg once daily

Usual Adult Paracetamol 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 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Adult Paracetamol 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 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.

Usual Adult Dose for Nasal Congestion

Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed

12-hour extended- release: 120 mg orally every 12 hours as needed

24-hour extended-release: 240 mg orally every 24 hours as needed

Maximum dose: 240 mg per day

Comment: Recommended doses should not be exceeded.

Uses:

-Temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies.

-Temporarily relieve sinus congestion and pressure.

Usual Pediatric Dose for Nasal Congestion

4 to 5 years:

Immediate release: 15 mg orally every 4 to 6 hours as needed

Maximum dose: 60 mg in 24 hours

6 to 12 years:

Immediate release: 30 mg orally every 4 to 6 hours as needed

Maximum dose: 120 mg in 24 hours

12 years or older:

Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed

12-hour extended- release: 120 mg orally every 12 hours as needed

24-hour extended-release: 240 mg orally every 24 hours as needed

Maximum dose: 240 mg in 24 hours

Comments:

-Recommended doses should not be exceeded.

-Giving more than 1 cough and cold medicine to a child could result in overdose; there are many products that have similar names and it is critical to identify the active ingredients in the product to ensure the correct dosage is being used.

Uses:

-Temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies.

-Temporarily relieve sinus congestion and pressure.

Renal Dose Adjustments

Severe renal impairment: Use caution, especially in patients with concurrent cardiovascular disease.

Liver Dose Adjustments

Severe hepatic impairment: Use caution, especially in patients with concurrent cardiovascular disease.

Precautions

On March 9, 2006, The Combat Methamphetamine Epidemic Act of 2005 was enacted which requires sellers of this drug ensure that: employees have been trained; records of the training are being maintained; sales limits are being enforced; products are being stored appropriately; and a written or electronic logbook is being maintained. The law requires that retailers place pseudoephedrine products where customers do not have direct access to such products before a sale is made. The FDA defines pseudoephedrine as an OTC drug in accordance with the monograph and FDA regulations.

The US FDA strongly recommends that over- the- counter (OTC) cough and cold products not be used in children younger than 2 years of age because serious and potentially life-threatening side effects can occur including death, convulsions, rapid heart rates, and decreased levels of consciousness. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives.

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Oral Liquid:

-Use only with enclosed measuring device or measuring devices specifically designed for measuring drugs.

Extended-release tablets:

-Swallow whole; do not divide crush, chew, or dissolve

Storage requirements:

-Protect from light

General:

-Over the counter cough and cold products can be harmful if more than the recommended amount is consumed; this may happen if more than 1 product containing the same active ingredient is used.

Patient advice:

-Patients should be instructed to pay close attention to drugs labels, particularly to the active ingredients section to ensure they are not receiving duplicate therapy.

-Adult cough and cold products should not be used for children; appropriate measuring devices should be used with liquid products.

-Patients should check with their health care provider if they are receiving concomitant medications.

-Patients should understand that over the counter cough and cold medications do not cure or shorten the duration of the common cold, these products are for the management of symptoms.

Bromhexine hydrochloride SYRUP is contra-indicated in patients with known hypersensitivity to sympathomimetic amines or any of the other ingredients; hypertrophic obstructive cardiomyopathy; and tachyarrhythmia.

Sympathomimetics, such as orciprenaline sulphate, may interact with monoamine oxidase inhibitors (MAOI), and therefore Bromhexine hydrochloride SYRUP should not be given to patients receiving such treatment or within 14 days of MAOI treatment termination.

Safety in pregnancy and lactation has not been established.

See also:
What is the most important information I should know about Loratadine?

You should not take this medication if you are allergic to loratadine or to desloratadine (Clarinex).

Ask a doctor or pharmacist before taking this medicine if you have liver or kidney disease.

Do not give this medication to a child younger than 6 years old without the advice of a doctor.

Loratadine disintegrating tablets (Loratadine Reditab) may contain phenylalanine. Talk to your doctor before using this form of loratadine if you have phenylketonuria (PKU).

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

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

See also:
What is the most important information I should know about Pseudoephedrine?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant.

Do not use pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Use Loratadine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Loratadine by mouth with or without food.
• Be sure that your hands are completely dry before you handle Loratadine. Use the tablet right away after you remove it from the tablet blister.
• To open the tablet blister, peel back the foil, then gently remove the tablet. Place the tablet on the tongue. The tablet will dissolve quickly. You may take Loratadine with or without water.
• If you miss a dose of Loratadine, 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 Loratadine.

Use paracetamol 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 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 could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking paracetamol and never use more than 2 grams (2000 mg) per day. If you are treating a child, use a pediatric form of paracetamol. 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 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 chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the paracetamol 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 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 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 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 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. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

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

Use Pseudoephedrine (24 hour) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine (24 hour) with food, water, or milk to minimize stomach irritation.
• Swallow Pseudoephedrine (24 hour) whole. Do not break, crush, or chew before swallowing.
• Do not take more than 1 tablet in 24 hours.
• If you miss a dose of Pseudoephedrine (24 hour) and 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 Pseudoephedrine (24 hour).

Bromhexine is used to treat breathing difficulties caused by excessive mucus secretions in the air passages associated with respiratory tract infections.

This medication is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergies. It is also used to relieve itching from hives.

Loratadine does not prevent hives or prevent/treat a serious allergic reaction (e.g., anaphylaxis). Therefore, if your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use loratadine in place of your epinephrine.

If you are self-treating with this medication, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist.

Do not use this medication in children younger than 6 years unless directed by the doctor.

How to use Loratadine

If you are using the over-the-counter product to self-treat, read all the directions on the product package before taking this medication. If your doctor has prescribed this medication, follow your doctor's directions and the instructions on your prescription label. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor or the product package, usually once or twice a day. Remove the tablet from its foil pack immediately before taking and place the tablet on the tongue. It will dissolve quickly. You may swallow the dissolved medication with or without water. Dosage is based on your age, condition, and response to treatment. Do not increase your dose or take this drug more often than directed. Do not take more of this medication than recommended for your age.

Tell your doctor if your allergy symptoms do not improve after 3 days of treatment or if your hives last more than 6 weeks. Seek immediate medical attention if your condition worsens or you think you have a serious medical problem (e.g., very serious allergic reaction/anaphylaxis).

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

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.

Pseudoephedrine is used for the temporary relief of stuffy nose and sinus pain/pressure caused by infection (such as the common cold, flu) or other breathing illnesses (such as hay fever, allergies, bronchitis). Pseudoephedrine is a decongestant (sympathomimetic). It works by narrowing the blood vessels to decrease swelling and congestion.

If you are self-treating with this medication, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product in children younger than 6 years unless specifically directed by the doctor. Long-acting tablets/capsules are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar decongestants. Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Your doctor may direct you to use pseudoephedrine to decrease pain and swelling in the ear or to help "open up" the ear canal when there is a change in air pressure (such as during air travel, underwater diving). Follow your doctor's directions carefully.

How to use Pseudoephedrine

If you are taking the over-the-counter product to self-treat, read all directions on the product package before taking this medication. If you have any questions, ask your doctor or pharmacist. If your doctor has prescribed this medication, take it as directed.

Take this medication by mouth with or without food, usually every 4-6 hours, as directed by the product package or by your doctor. Do not take more than 4 doses in a day. Dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or take this drug more often than directed. Do not take more of this medication than recommended for your age.

If you are using the chewable tablets, chew each tablet well and swallow. If you are using the liquid form of this medication, measure the dose carefully using a special measuring device/cup. Do not use a household spoon because you may not get the correct dose.

There are many brands and forms of pseudoephedrine available. Some tablets should be swallowed with plenty of water. Check your product package for specific directions. Read the dosing instructions carefully for each product because the amount of pseudoephedrine may be different between products. Do not take more pseudoephedrine than recommended.

Caffeine can increase the side effects of this medication. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking nonprescription products that contain caffeine.

If your symptoms do not improve after 7 days, if they worsen or return, if you develop fever, rash, or a persistent headache, or if you think you may have a serious medical problem, seek immediate medical attention.

A reduction in dose of cardiac glycosides (e.g. digitalis) and quinidine might become necessary in patients suffering from congestive cardiac failure because of the positive inotropic effect of orciprenaline sulphate.

Bromhexine hydrochloride SYRUP should not be administered concomitantly with beta-blocking agents, due to orciprenaline’s reversal of anti-hypertensive action.

The concomitant use of other sympathomimetic agents should be carefully controlled to avoid potentiation of effects.

See also:
What other drugs will affect Loratadine?

Loratadine (10 mg once daily) has been coadministered with therapeutic doses of erythromycin, cimetidine, and ketoconazole in controlled clinical pharmacology studies in adult volunteers. Although increased plasma concentrations (AUC 0-24 hrs) of loratadine and/or descarboethoxyloratadine were observed following coadministration of loratadine with each of these drugs in normal volunteers (n = 24 in each study), there were no clinically relevant changes in the safety profile of loratadine, as assessed by electrocardiographic parameters, clinical laboratory tests, vital signs, and adverse events. There were no significant effects on QT_c intervals, and no reports of sedation or syncope. No effects on plasma concentrations of cimetidine or ketoconazole were observed. Plasma concentrations (AUC 0-24 hrs) of erythromycin decreased 15% with coadministration of loratadine relative to that observed with erythromycin alone. The clinical relevance of this difference is unknown. These above findings are summarized in TABLE 1.

See also:
What other drugs will affect Paracetamol?

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

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.

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

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of paracetamol.

When Paracetamol 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. A case of severe toxic liver injury.

Described cases of toxic effects of paracetamol, while the use of isoniazid.

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

In applying cholestyramine a period of less than 1 h after administration of paracetamol 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 and its increased concentration in blood plasma.

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

At simultaneous application of Paracetamol with ethinylestradiol increases absorption of paracetamol from the gut.

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

See also:
What other drugs will affect Pseudoephedrine?

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: stimulants (such as caffeine, dextroamphetamine, methamphetamine, herbal products like ephedra/ma huang), terbutaline.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Pseudoephedrine may decrease the effectiveness of blood pressure medications (such as beta blockers, calcium channel blockers, reserpine, guanethidine, methyldopa).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain similar ingredients (decongestants such as phenylephrine). Ask your pharmacist about using those products safely.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

Bromhexine’s pharmacological action may lead to gastric irritation. A transient rise in serum aminotransferase values have been reported due to bromhexine.

Orciprenaline sulphate, as a sympathomimetic agent, may precipitate a wide range of adverse effects. Side-effects include fear; anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states. Appetite may be reduced and nausea and vomiting may occur. A rise in blood pressure which may produce cerebral haemorrhage and pulmonary oedema, tachycardia and cardiac arrhythmias, anginal pain, palpitations, and cardiac arrest. Hypotension with dizziness and fainting and flushing may occur. Other effects that may occur include difficulty in micturition and urinary retention; dyspnoea; weakness; headache; disturbances of glucose metabolism; sweating and hypersalivation. Muscle cramps or twitching or unpleasant taste may occur.

See also:
What are the possible side effects of Loratadine?

Applies to loratadine: oral fixed-combination tablets, oral orally disintegrating tablets, oral solution, oral tablets

Side effects include:

Children 2–5 years of age receiving oral solution: Diarrhea, epistaxis, pharyngitis, flu-like symptoms, fatigue, stomatitis, tooth disorder, earache, viral infection, rash.

Children 6–12 years of age receiving oral solution: Nervousness, wheezing, fatigue, hyperkinesia, abdominal pain, conjunctivitis, dysphonia, upper respiratory tract infection.

Adults and children ≥12 years of age receiving conventional or orally disintegrating tablets: Headache, somnolence, fatigue, dry mouth.

Fixed combination loratadine (the active ingredient contained in Loratadine) pseudoephedrine sulfate preparations: Insomnia, dry mouth, headache, somnolence, nervousness, dizziness, fatigue.

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

Effects due to the presence of acetylsalicylic acid.

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, side effects of aspirin 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.

Acetylsalicylic acid 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.

At the doses and duration of recommended treatment, side effects are usually negligible, but the prolonged use of paracetamol in therapeutic doses large (2-4 g per day, or 10-20 tablets Paracetamol) 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) is described in paragraph overdose.

See also:
What are the possible side effects of Pseudoephedrine?

Applies to pseudoephedrine: oral capsule, oral capsule extended release, oral capsule liquid filled, oral liquid, oral solution, oral suspension, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

Along with its needed effects, pseudoephedrine (the active ingredient contained in Pseudoephedrine) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking pseudoephedrine:

Rare

• Convulsions (seizures)
• hallucinations (seeing, hearing, or feeling things that are not there)
• irregular or slow heartbeat
• shortness of breath or troubled breathing

Symptoms of Overdose

• Convulsions (seizures)
• fast breathing
• hallucinations (seeing, hearing, or feeling things that are not there)
• increase in blood pressure
• irregular heartbeat (continuing)
• shortness of breath or troubled breathing (severe or continuing)
• slow or fast heartbeat (severe or continuing)
• unusual nervousness, restlessness, or excitement

Some side effects of pseudoephedrine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

• Nervousness
• restlessness
• trouble in sleeping

Less Common

• Difficult or painful urination
• dizziness or light-headedness
• fast or pounding heartbeat
• headache
• increased sweating
• nausea or vomiting
• trembling
• unusual paleness
• weakness

Each tablet also contains lactose, maize or potato starch, gelatine and magnesium stearate as excipients.

The oral/inhalation solution also contains tartaric acid and methyl parahydroxybenzoate as excipients.

The syrup also contains tartaric acid, benzoic acid, sodium carboxymethylcellulose, glycerol, sorbitol solution, pharma flavor and ethanol as excipients.

Each capsule also contains lactose, cornstarch and magnesium stearate as excipients.

Bromhexine HCl is N-cyclohexyl-N-methyl-(2-amino-3,5-dibromobenzyl)amine hydrochloride.

Loratadine competes with free histamine for binding at HA-receptor sites. This antagonizes the effects of histamine on HA-receptors, leading to a reduction of the negative symptoms brought on by histamine HA-receptor binding. In addition to the usual allergic symptoms, the drug also treats irritant cough and nausea, vomiting, and vertigo associated with motion sickness. Loratadine's anticholinergic action appears to be due to a central antimuscarinic effect, which also may be responsible for its antiemetic effects, although the exact mechanism is unknown. It also is used commonly to treat drug-induced extrapyramidal symptoms as well as to treat mild cases of Parkinson's disease.

Paracetamol is an organic compound that consists of a six-membered ring containing two opposing nitrogen atoms. Paracetamol 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. Their mode of Paracetamol is generally by paralysing parasites, which allows the host body to easily remove or expel the invading organism.

Pseudoephedrine has been withdrawn in Canada. In November 2000, the Food and Drug Administration (FDA) issued a public health advisory against the use of the drug.