Aceplas P

It is an association of 3 active ingredients, paracetamol, chlorphenamine and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever. Chlorphenamine is an antihistamine that relieves runny nose and phenylephrine works by reducing nasal congestion.

It is indicated in adults for the relief of the symptoms of colds and flu that occur with fever or mild or moderate pain, congestion and runny nose.

You should consult the doctor if it gets worse or does not improve or if the fever persists for more than 3 days or the pain for more than 5 days.

Follow exactly the instructions for taking the medicine in this leaflet or as directed by your doctor or pharmacist. If in doubt ask your doctor or pharmacist.

The recommended dose is:

Adults from 18 years: 1 sachet every 6-8 hours as needed (3 or 4 sachets a day). No more than 4 sachets can be taken in 24 hours.

Patients with liver or kidney diseases: You should consult your doctor (see Section 2 - what you need to know before you start taking Abacat).

Use in children

This drug is contraindicated in children under 18 years of age.

Use in the elderly

Elderly people cannot use this medicine without consulting their doctor because some side effects of the medicine, such as slow heartbeat (bradycardia) or reduced heart rate, due to phenylephrine and chlorphenamine, may especially affect them. You are also more likely to have side effects such as sedation, confusion, hypotension or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

How to take

Abacat is taken orally.

Dissolve the contents of the sachet completely in a little liquid, preferably half a glass of water and then drink.

Always take the lowest effective dose.

Taking this drug is subject to the appearance of symptoms. As these disappear, you should stop treatment.

If the fever is maintained after more than 3 days of treatment, pain or other symptoms more than 5 days, or the symptoms worsen or other new symptoms appear, you should consult your doctor.

If you take more Abacat than you should

If you have swallowed an overdose, you should immediately go to a medical center even if you do not notice the symptoms, since they often do not manifest until after 3 days after the overdose ingestion, even in cases of severe poisoning.

Overdose symptoms may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (may be a symptom of high blood pressure), convulsions, insomnia (or intense drowsiness), awkwardness, fainting sensation, instability, confusion, irritability, tremors, anorexia, psychosis with hallucinations (the latter especially in children). Dry mouth, nose or throat. You may also notice effects such as high blood pressure, arrhythmias (rapid or irregular heartbeat), palpitations, decreased amount of urine, metabolic acidosis (decreased alkaline reserve of the blood). In case of prolonged use, a decrease in blood volume may occur

Overdose treatment is most effective if started within 4 hours of taking the drug overdose.

Patients treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of an overdose of paracetamol.

In case of overdose or accidental ingestion, immediately go to a medical center or call the toxicological Information Service (Phone 91 562 04 20), indicating the medicine and the amount ingested.

Like all medicines, Abacat can cause side effects, although not everyone gets them.

During the period of use of paracetamol, phenylephrine and chlorphenamine, the following side effects have been reported, the frequency of which has not been accurately established:

-              The most common side effects that may occur are: Slight drowsiness, dizziness, muscle weakness: these side effects may disappear after 2-3 days of treatment. Difficulty in facial movements, awkwardness, tremor, changes in sensation and tingling, dry mouth, loss of appetite, changes in taste or smell, gastrointestinal discomfort (which may decrease if given with food), nausea, vomiting, diarrhoea, constipation, stomach pain, urine retention, dry nose and throat, thickening of the mucous membranes, sweating, blurred vision or other vision disorders.

• Side effects that may occur infrequently (rare) are:

Discomfort, decreased blood pressure (hypotension), and increased blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary oedema (increased volume of fluid in the lungs) and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (usually at high doses, and is more common in the elderly and children), which can include symptoms such as: restlessness, insomnia, nervousness and even seizures. Other side effects that may occur infrequently are: chest tightness, lung noises, rapid or irregular heartbeat (usually with overdose), liver disorders( which may occur with stomach or belly pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeat, itching, swelling of the eyelids or around the eyes, face, tongue, shortness of breath, etc.), photosensitivity (sensitization to sunlight), cross-sensitivity (allergy) to chlorphenamine-related medicinal products. Blood disorders (changes in the formula of blood cells, such as Agranulocytosis, Leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat or tiredness, low or high blood pressure, oedema (swelling), ear disorders, impotence, menstrual disorders

• Side effects that may occur very rarely (very rare) are:

Kidney disease, cloudy urine, allergic dermatitis (rash), jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia) and hypoglycemia (low blood sugar).cases of severe skin reactions have been reported very rarely.

Paracetamol can damage the liver when taken in high doses or in prolonged treatments.

• Side effects whose frequency of occurrence is not known are. With high doses may occur: vomiting, palpitations, psychotic states with hallucinations, with prolonged use may occur decrease in blood volume

Reporting of adverse effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish system of Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects you can help provide more information about the safety of this medicine.

Do not take avocado

- If you are allergic to the active substances or any of the other ingredients of this medicine (listed in Section 6).

- If you have high blood pressure.

- If you have hyperthyroidism.

- If you have diabetes mellitus.

- If you have tachycardia (rapid heartbeat).

- If you are being treated with any monoamine oxidase inhibitor (MAOI) medicines (such as some antidepressant medicines, or medicines to treat Parkinson's disease).

- If you are being treated with sympathomimetic medicines (medicines used to treat asthma, or medicines to speed up the frequency of heartbeats).

- If you are being treated with beta-blocking medicines (medicines for the heart or to treat diseases of the arteries) (see: taking Abacat with other medicines).

- If you have glaucoma (high eye pressure).

- If you have serious heart or artery disease ( such as coronary heart disease

angina).

- If you have severe liver or kidney disease.

Patients under the age of 18 can not take this medication.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking this medicine.

- No more medication should be taken than is recommended in Section 3: how to take Abacat.

- Chronic alcoholics should be careful not to take more than 2 sachets a day of Abacat.

- While you are taking this medicine you cannot take others that contain paracetamol because an overdose of paracetamol may occur that could damage the liver.

- You should consult your doctor before taking this medicine:

- Patients with kidney, liver, heart or lung diseases and patients with anaemia.

- Asthmatic patients sensitive to acetylsalicylic acid.

- Patients sensitive (allergic) to an antihistamine, because they may be sensitive to other antihistamines (such as chlorphenamine).

- Patients who are being treated with medicines to treat: prostate hypertrophy, bronchial asthma, very slow heartbeat, hypotension, cerebral arteriosclerosis, inflammation of the pancreas (pancreatitis), digestive ulcer (stenosing peptic ulcer), pyloroduodenal obstruction (between the stomach and intestine), thyroid diseases, patients sensitive to the sedative effects of some medicines.

If you are being treated with tricyclic antidepressants or medicines with similar effect and you have gastrointestinal problems, you should stop taking this medicine and immediately consult a doctor, because you may have paralytic ileus (normal movements of a part of the intestine stop).

Children and adolescents

Children under the age of 18 cannot take this medicine.

Taking other medicines and Abacat

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take any other medicines.

In particular, if you are using some of the following drugs, as it may be necessary to change the dosage of some of them or discontinuous treatment:

- Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

- Drugs to treat tuberculosis: (isoniazid, rifampicin).

- Medicines to treat seizures and depression (barbiturates), used as hypnotics, sedatives and anticonvulsants.

- Drugs to prevent the formation of blood cloths: oral anticoagulants (acenocoumarol, warfarin).

- Medicines used to increase the excretion of urine (loop diuretics such as those of the furosemide group, or others) and other diuretics that cause potassium loss (such as diuretics to treat hypertension or others).

- Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).

- Drugs used for the treatment of gout (probenecid and sulfinpyrazone).

- Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disturbances (propranolol).

- Medicines used to lower blood cholesterol levels (Cholestyramine).

- Medicines used to treat depression, Parkinson's disease or other diseases (monoamine oxidase inhibitors (MAOIs)). Abacat and these medicines should be separated for at least 15 days.

- Medicines used to treat migraine, medicines taken for childbirth, medicines taken to treat blood pressure, or other diseases (alpha-adrenergic blocking drugs).

- Alpha-and beta-adrenergic blocking drugs (labetalol and carvedilol) used for the heart or to treat diseases of the arteries.

- Drugs to treat depression of the tricyclic type and tetracyclic antidepressants.

- Drugs used for general anesthesia.

- Antihypertensive drugs used to lower blood pressure.

- Drugs used for the heart of the type of cardiac glycosides and antiarrhythmics.

- Drugs containing thyroid hormones (they are used to treat thyroid diseases).

- Drugs used for heart disease or diseases of digestion of the type of atropine sulfate.

- Drugs that cause depression on the central nervous system such as those used for insomnia or anxiety.

- Ototoxic drugs (which have an adverse effect that damage the ear). - Photosensitizing drugs (which as an adverse effect, cause allergy to light).

Interference with analytical tests:

If you are going to have any analytical tests (including blood tests, urine tests, etc)) tell your doctor that you are taking this medicine, as it may alter the results.

Taking Abacat with food, drinks and alcohol

While you are being treated with this medicine you should not drink alcoholic beverages, because it can potentiate the appearance of side effects of this medicine.

In addition, the use of drugs containing paracetamol by patients who regularly consume alcohol (3 or more alcoholic beverages: beer, wine, liquor,... may cause liver damage.

The drug can be taken with or without food.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking this medicine.

This medication should not be taken during pregnancy unless your doctor considers it strictly necessary.

This medicine can not be taken by mothers during breastfeeding, because it can cause adverse effects on the baby.

Driving and using machines

This medicine may cause drowsiness. If you experience drowsiness during treatment with this medication, avoid driving or using machines.

Avocado contains mannitol (e-421).

This drug may produce a slight laxative effect because it contains mannitol.