ABACAT GRANULADO FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Abacat Granules for Oral Solution

Paracetamol / Phenylephrine Bitartrate / Chlorphenamine Maleate

Read all of 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 as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist even if it is a side effect not listed in this leaflet.
• You should consult your doctor if your symptoms worsen or do not improve or if the fever persists for more than 3 days or the pain for more than 5 days.

Contents of the Package Leaflet:

1. What is Abacat and what is it used for
2. What you need to know before you start taking Abacat
3. How to take Abacat
4. Possible side effects
5. Storage of Abacat
6. Contents of the pack and further information

1. What is Abacat and what is it used for

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 occur with fever or mild to moderate pain, congestion, and nasal secretion.

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

2. What you need to know before you start taking Abacat

Do not take Abacat

• If you are allergic to the active substances or to any of the other components 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 heartbeats).
• If you are being treated with a monoamine oxidase inhibitor (MAOI) (such as some antidepressant medicines or medicines for treating Parkinson's disease).
• If you are being treated with sympathomimetic medicines (medicines used for treating asthma or medicines for accelerating heart rate).
• If you are being treated with beta-blocker medicines (medicines for the heart or for treating arterial diseases) (see: Taking Abacat with other medicines).
• If you have glaucoma (high eye pressure).
• If you have any serious heart or arterial disease (such as coronary disease or angina pectoris).

or any serious liver or kidney disease.

• If you have any serious liver or kidney disease.

Patients under 18 years of age cannot take this medicine.

Warnings and precautions

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

• Do not take more than the recommended dose of the medicine (see section 3: How to take Abacat).

• Chronic alcoholics should be cautious not to take more than 2 sachets of Abacat per day.

• While taking this medicine, you cannot take other medicines that contain paracetamol because a paracetamol overdose may occur, which could damage the liver.

• The following patients should consult their doctor before taking this medicine:
• Patient with kidney, liver, heart, or lung disease, and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, because they may be sensitive to other antihistamines (such as chlorphenamine).
• Patient being treated with medicines for: prostate hypertrophy, bronchial asthma, very slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid diseases, patient sensitive to the sedative effects of some medicines.

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

Children and adolescents

Patients under 18 years of age cannot take this medicine.

Taking Abacat with other medicines

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

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medicines for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

• Medicines for treating tuberculosis: (isoniazid, rifampicin).

• Medicines for treating convulsions and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.

• Medicines for preventing blood clot formation: Oral anticoagulants (acenocoumarol, warfarin).

• Medicines used to increase urine elimination (loop diuretics such as furosemide, or others) and other diuretics that cause potassium loss (such as diuretics for treating hypertension or others).

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

• Medicines used for treating gout (probenecid and sulfinpyrazone).

• Medicines used for treating high blood pressure and heart rhythm disorders (propranolol).

• Medicines used to lower cholesterol levels in the blood (cholestyramine).

• Medicines used for treating depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). Abacat and these medicines should be taken with a minimum interval of 15 days.

• Medicines used for treating migraine; medicines taken for childbirth; medicines taken for treating blood pressure or other diseases (alpha-adrenergic blocking medicines).

• Alpha and beta-adrenergic blocking medicines (labetalol and carvedilol) used for the heart or for treating arterial diseases.

• Medicines for treating depression of the tricyclic and tetracyclic type.

• Medicines used for general anesthesia.

• Antihypertensive medicines used to lower blood pressure.

• Medicines used for the heart of the type of cardiac glycosides and antiarrhythmics.

• Medicines containing thyroid hormones (used for treating thyroid diseases).
• Medicines used for heart diseases or digestive diseases of the type of atropine sulfate.
• Medicines that produce depression of the central nervous system, such as those used for insomnia or anxiety.
• Ototoxic medicines (which have the adverse effect of damaging the ear).
• Photosensitizing medicines (which have the adverse effect of producing allergy to light).
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that should be treated urgently and may occur particularly in case of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Interference with analytical tests

If you are going to have any analytical test (including blood tests, urine tests, etc.), inform 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 take alcoholic beverages, as it may enhance the appearance of adverse effects of this medicine.

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

The medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

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

This medicine should not be taken by breastfeeding mothers, as it may produce adverse effects in the baby.

Driving and using machines

This medicine may cause drowsiness. If you experience drowsiness while taking this medicine, avoid driving vehicles or using machines.

Abacat contains mannitol (E-421).

This medicine may produce a mild laxative effect because it contains mannitol.

3. How to take Abacat

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of 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 per day). Do not take more than 4 sachets in 24 hours.

Patient with liver or kidney disease: Should consult their doctor (see section 2 - What you need to know before you start taking Abacat).

Use in children

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

Use in elderly

Elderly patients cannot use this medicine without consulting their doctor, as some adverse effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output, due to phenylephrine and chlorphenamine, may affect them especially. It is also more likely that they may experience adverse 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 smallest effective dose.

The intake of this medicine is subject to the appearance of symptoms. As they disappear, you should suspend treatment.

If the fever persists after more than 3 days of treatment, pain or other symptoms for more than 5 days, or if symptoms worsen or new symptoms appear, you should consult your 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 symptoms, as they may not appear 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 drowsiness), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dry 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 (decrease in blood alkaline reserve). In case of prolonged use, a decrease in blood volume may occur.

Treatment of overdose is most effective if started within 4 hours after taking the overdose of the medicine.

Patient being treated with barbiturates 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 medicine and the amount ingested.

4. Possible side effects

Like all medicines, Abacat can cause side effects, although not everybody gets 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 most frequent side effects that may appear 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 paresthesia, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal disorders (which may decrease if the medicine is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dry nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

• 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 fluid 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 pain 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) to medicines related to chlorphenamine. Blood disorders (changes in the blood cell formula, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear disorders, impotence, menstrual disorders.

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

Kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

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

• The side effects whose frequency of appearance is not known 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 (severe bradycardia), reduction of peripheral blood vessel caliber (peripheral vasoconstriction), reduction of heart performance that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, paleness, hair standing on end, high blood sugar (hyperglycemia), low potassium levels in the blood, metabolic acidosis (alteration of metabolism), cold in the extremities (legs or arms), flushing, feeling of fainting (hypotension). With high doses, the following effects may occur: vomiting, palpitations, psychotic states with hallucinations; in prolonged use, a decrease in blood volume may occur.

Reporting of side effects

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

5. Storage of Abacat

Keep out of sight and reach of children.

Do not use Abacat after the expiry date stated on the packaging, after CAD. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. By doing so, you will help protect the environment.

6. Container Content and Additional Information

Abacat Composition

Each sachet 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, which is a corn starch derivative) and povidone.

Product Appearance and Container Content

Abacat is a white or yellowish-white granulate for oral solution with an orange flavor, presented in sachets packaged in cardboard containers with 10 sachets.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Laboratorios Alcalá Farma, S.L.

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

28802 Alcalá de Henares (Madrid)

Spain

Date of the last revision of this prospectus: November 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

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