Leaflet: information for the user

Abacat granulated for oral solution

Paracetamol / Phenylephrine bitartrate / Chlorphenamine maleate

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor, or pharmacist.

- Keep this leaflet, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet.

- You should consult your doctor if you worsen or do not improve or if the fever persists for more than 3 days or the pain for more than 5 days.

1.What isAbacatand for what it is used

2.What you need to know before starting to takeAbacat

3.How to takeAbacat

4.Possible side effects

5.Storage ofAbacat

6.Contents of the package and additional information

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

Paracetamol is an analgesic that reduces pain and fever. Chlorphenamine is an antihistamine that relieves nasal secretion and phenylephrine acts by reducing nasal congestion.

It is indicated in adults for the relief of symptoms of colds and flu that are accompanied by fever or mild to moderate pain, congestion and nasal secretion.

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

Do not take Abacat

-If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).

- If you have high blood pressure.

- If you have hyperthyroidism.

- If you have diabetes mellitus.

- If you have tachycardia (rapid heartbeats).

- If you are being treated with any monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease).

- If you are being treated with sympathomimetic medications (medications used to treat asthma or medications to increase heart rate).

- If you are being treated with beta-blocker medications (medications for the heart or to treat blood vessel diseases) (see: Taking Abacat with other medications).

- If you have glaucoma (high eye pressure).

- If you have severe heart or blood vessel disease (such as coronary disease or angina pectoris).

- If you have severe liver or kidney disease.

Patients under 18 years old cannot take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

- Do not take more medication than recommended in section 3: How to take Abacat.

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

- While taking this medication, do not take other medications that contain paracetamol, as it may cause liver damage.

- You should consult your doctor before taking this medication:

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

- Patients with asthma who are sensitive to acetylsalicylic acid.

- Patients who are sensitive (allergic) to antihistamines, as they may be sensitive to other antihistamines (such as chlorphenamine).

- Patients who are being treated with medications for: benign prostatic hyperplasia, bronchial asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer disease, pyloric obstruction, thyroid diseases, patients sensitive to the sedative effects of some medications.

If you are being treated with tricyclic antidepressants or medications with similar effects and experience gastrointestinal problems, stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (intestinal motility stops).

Children and adolescents

Patients under 18 years old cannot take this medication.

Taking Abacat with other medications

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

Particularly, if you are using any of the following medications, as it may be necessary to modify the dose of some of them or discontinue treatment:

- Medications for epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

- Medications for tuberculosis: (isoniazid, rifampicin).

- Medications for seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.

- Medications used to prevent blood clotting: Oral anticoagulants (acenocoumarol, warfarin).

- Medications used to increase urine production: Diuretics of the loop type (such as furosemide) or other diuretics that cause potassium loss (such as diuretics for hypertension or others).

- Medications used to prevent nausea and vomiting: Metoclopramide and domperidone.

- Medications used to treat gout: Probenecid and sulfinpyrazone.

- Medications used to treat high blood pressure and heart rhythm disorders: Propranolol.

- Medications used to lower cholesterol levels in the blood: Cholestyramine.

- Medications used to treat depression, Parkinson's disease, or other diseases: Monoamine oxidase inhibitors (MAOIs). You should separate the intake of Abacat and these medications by at least 15 days.

- Medications used to treat migraines; medications taken for childbirth; medications taken to treat high blood pressure or other diseases (alpha-blocker medications).

- Alpha and beta-blocker medications (labetalol and carvedilol) used for the heart or to treat blood vessel diseases.

- Medications used to treat depression, such as tricyclic antidepressants and tetracyclic antidepressants.

- Medications used for general anesthesia.

- Medications used to lower blood pressure.

- Medications used for the heart, such as cardiac glycosides and antiarrhythmics.

- Medications containing thyroid hormones (used to treat thyroid diseases).

- Medications used for heart or digestive diseases, such as atropine sulfate.

- Medications that cause central nervous system depression, such as those used for insomnia or anxiety.

- Ototoxic medications (that can damage the ear).

- Photosensitizing medications (that can cause light allergy).

- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, and when using the maximum daily doses of paracetamol.

Interference with laboratory tests:

If you are to undergo any laboratory test (including blood, urine, etc...), inform your doctor that you are taking this medication, as it may alter the results.

Taking Abacat with food, drinks, and alcohol

While taking this medication, do not consume alcoholic beverages, as it may potentiate the appearance of adverse effects of this medication.

Additionally, the use of medications containing paracetamol by patients who regularly consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, etc... per day) may cause liver damage.

Abacat can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

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

This medication should not be taken by mothers during breastfeeding, as it may cause adverse effects in the baby.

Driving and operating machinery

This medication may cause drowsiness. If you experience drowsiness during treatment with this medication, avoid driving vehicles or operating machinery.

Abacat contains mannitol (E-421).

This medication may cause a mild laxative effect due to the presence of mannitol.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults 18 years and older: 1 tablet every 6-8 hours as needed (3 or 4 tablets per day). Do not take more than 4 tablets in 24 hours.

Patients with liver or kidney disease:Should consult a doctor (see section 2- What you need to know before starting to take Abacat).

Use in children

This medication is contraindicated in children under 18 years.

Use in older adults

Older adults should not use this medication without consulting a doctor because they may be especially affected by some medication side effects such as slow heart rate (bradycardia) or reduced cardiac output, due to phenylephrine and chlorphenamine. They may also be more likely to experience 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 packet completely in a little liquid, preferably half a glass of water and then drink.

Always take the smallest effective dose.

The use of this medication is subject to the appearance of symptoms. As these symptoms disappear, you should discontinue treatment.

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

If you take more Abacat than you should

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

The symptoms of overdose may be: 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 somnolence), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (this last one especially in children). Dryness of the mouth, nose, or throat. You may also notice effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, decreased urine output, metabolic acidosis (decreased blood alkalinity reserve). In cases of prolonged use, a decrease in blood volume may occur.

The treatment of an overdose is more effective if it is started within 4 hours of taking the overdose of the medication.

Patients on barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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

Like all medicines, Abacat may cause side effects, although not everyone will experience them.

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

-The side effects that may appear most frequently are: Mild drowsiness, dizziness, muscle weakness: these side effects may disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and paresthesias, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medication is taken with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucosities, sweating, blurred vision, or other visual disturbances.

• The side effects that may appear with low frequency (rare) are:

Discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in lung volume) and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (usually with high doses, and is more frequent in the elderly and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other side effects that may appear with low frequency are: chest tightness, lung noises, rapid or irregular heartbeats (usually with overdose), liver disorders (which may present with stomach or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) with related chlorphenamine medications. 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 fatigue; low or high blood pressure, edema (swelling), ear alterations, impotence, menstrual alterations.

• The side effects that may appear with very low frequency (very rare) are:

Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Very rarely, severe skin reactions have been reported.

Paracetamol may damage the liver when taken in high doses or with prolonged treatment.

• The side effects whose frequency of appearance is unknown are: Anxiety, irritability, weakness, high blood pressure (hypertension, usually with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (bradycardia), reduction in peripheral blood vessel diameter (vasoconstriction), reduction in heart function that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, pallor, goosebumps, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolic disorder), coldness in the extremities (legs or arms), flushing, sensation of fainting (hypotension). With high doses, vomiting, palpitations, psychotic states with hallucinations may occur; with prolonged use, a decrease in blood volume may occur.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use Abacat after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

Composition of Abacat

Each blister pack contains:

- As active ingredients: 1 g of paracetamol, 15.58 mg of phenylephrine bitartrate (equivalent to 8.21 mg of phenylephrine) and 4 mg of chlorphenamine maleate (equivalent to 2.8 mg of chlorphenamine).

- The other components (excipients) are: Mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange flavor (containing maltodextrin, a cornstarch derivative) and povidone.

Appearance of the product and content of the packaging

Abacat is an oral granule solution of white or light yellow color and orange flavor, presented in blister packs that are packaged in cardboard containers with 10 blister packs.

Holder of the marketing authorization

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Laboratorios Alcalá Farma, S.L.

Ctra. M-300, Km. 29,920.

28802 Alcalá de Henares (Madrid)

Spain

Last review date of this leaflet: November 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/