Abacavir granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Abacat granules for oral solution

Paracetamol / Phenylephrine bitartrate / Chlorpheniramine maleate

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

Follow exactly the instructions for use provided 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 further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
• You should consult your doctor if your condition worsens, does not improve, or if fever persists for more than 3 days or pain for more than 5 days.

Leaflet contents:

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

1. What Abacat is and what it is used for

It is a combination of three active substances: paracetamol, chlorpheniramine, and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever. Chlorpheniramine is an antihistamine that relieves nasal discharge, and phenylephrine acts to reduce nasal congestion.

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

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

2. What you need to know before 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 (hypertension).
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeat).
• If you are being treated with monoamine oxidase inhibitor (MAOI) medicines (such as certain antidepressants or medicines used to treat Parkinson's disease).
• If you are being treated with sympathomimetic medicines (medicines used to treat asthma or medicines that increase heart rate).
• If you are being treated with beta-blockers (medicines for heart conditions or to treat artery diseases) (see: Taking Abacat with other medicines).
• If you have glaucoma (high eye pressure).
• If you have a serious heart or artery disease (such as coronary artery disease or angina pectoris).
• If you have a severe liver or kidney disease.

Children under 18 years of age must not take this medicine.

Warnings and precautions

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

• Do not take more medicine than recommended in section 3: How to take Abacat.

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

• While taking this medicine, you must not take other products containing paracetamol, as this could lead to a paracetamol overdose that may damage the liver.

• The following patients should consult their doctor before taking this medicine:

• 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 an antihistamine, as they may also be sensitive to other antihistamines (such as chlorpheniramine).

• Patients who are being treated with medicines for: prostate enlargement, bronchial asthma, very slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), peptic ulcer (stenosing peptic ulcer), pyloroduodenal obstruction (between the stomach and intestine), thyroid disorders, or patients sensitive to the sedative effects of certain medicines.

If you are taking tricyclic antidepressants or medicines with similar effects and develop gastrointestinal problems, you must stop taking this medicine and consult your doctor immediately, as you may develop paralytic ileus (normal intestinal movements stop).

Children and adolescents

Patients under 18 years of age must not take this medicine.

Taking Abacat with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, if you are using any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:

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

• Medicines to treat tuberculosis: (isoniazid, rifampicin).

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

• Medicines to prevent blood clots: 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 used to treat hypertension or others).

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

• Medicines used to treat gout (probenecid and sulfinpyrazone).

• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (propranolol).

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

• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Abacat and these medicines must be taken at least 15 days apart.

• Medicines used to treat migraine; medicines taken during childbirth; medicines used to treat blood pressure or other conditions (alpha-adrenergic blocking agents).

• Alpha- and beta-adrenergic blocking agents (labetalol and carvedilol) used for heart conditions or artery diseases.

• Medicines used to treat depression, such as tricyclic and tetracyclic antidepressants.

• Medicines used for general anesthesia.

• Antihypertensive medicines used to lower blood pressure.

• Medicines used for heart conditions, such as cardiac glycosides and antiarrhythmics.

• Medicines containing thyroid hormones (used to treat thyroid disorders).

• Medicines used for heart diseases or digestive disorders such as atropine sulfate.

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

• Ototoxic medicines (those that have the adverse effect of damaging the ear).

• Photosensitizing medicines (those that cause light allergy as an adverse effect).

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that requires urgent treatment and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or when maximum daily doses of paracetamol are used.

Interference with laboratory tests:

If you are scheduled for any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Abacat with food, drinks, and alcohol

While being treated with this medicine, you must not drink alcoholic beverages, as they may increase the risk of adverse effects of this medicine.

In addition, using medicines containing paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

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

Breastfeeding mothers must not take this medicine, as it may cause adverse effects in the infant.

Driving and using machines

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

Abacat contains mannitol (E-421).

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

3. How to take Abacat

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults from 18 years of age: 1 sachet every 6–8 hours as needed (3 or 4 sachets per day). Do not take more than 4 sachets in 24 hours.

Patients with liver or kidney disease: Must consult their doctor (see section 2 – What you need to know before taking Abacat).

Use in children

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

Use in elderly people

Elderly individuals should not take this medicine without consulting a doctor, as they may be especially sensitive to certain adverse effects of the medicine such as slow heart rate (bradycardia) or reduced cardiac output due to phenylephrine and chlorphenamine. They may also be more likely to experience adverse effects such as sedation, confusion, hypotension, or agitation, and may be more sensitive to effects such as dry mouth and urinary retention.

How to take

Abacat is taken orally.

Dissolve the entire contents of the sachet in a small amount of liquid, preferably half a glass of water, and then drink.

Always take the lowest effective dose.

This medicine should only be taken when symptoms appear. As symptoms improve, treatment should be discontinued.

If fever persists beyond 3 days of treatment, or pain or other symptoms beyond 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 must go immediately to a medical center even if you do not feel symptoms, as symptoms often do not appear until 3 days after the overdose has been ingested, even in cases of severe poisoning.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (which may be a sign of high blood pressure), seizures, insomnia (or extreme drowsiness), clumsiness, feeling faint, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (the latter especially in children). Dry mouth, nose, or throat. You may also experience effects such as high blood pressure, arrhythmias (rapid or irregular heartbeat), palpitations, reduced urine output, metabolic acidosis (decreased alkaline reserve in the blood). With prolonged use, a reduction in blood volume may occur.

Treatment of overdose is most effective if started within 4 hours after the overdose has been taken.

Patients undergoing treatment 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 Toxicology Information Service (Telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Abacat may cause adverse effects, although not everyone experiences them.

During the period of use of paracetamol, phenylephrine, and chlorpheniramine, the following adverse effects have been reported, although their frequency has not been accurately established:

• The adverse effects that may occur more frequently are: Mild drowsiness, dizziness, muscle weakness: these adverse effects may disappear after 2–3 days of treatment. Difficulty moving the face, clumsiness, tremor, disturbances in sensation and tingling, dry mouth, loss of appetite, disturbances in taste or smell, gastrointestinal discomfort (which may decrease if the medicine is taken with food), nausea, vomiting, diarrhoea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus, sweating, blurred vision or other visual disturbances.

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

Malaise, drop in blood pressure (hypotension), and increased blood levels of transaminases. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary edema (increased fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitation (generally with high doses, and more common in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, and even seizures. Other adverse effects that may occur infrequently are: chest tightness, lung noises, rapid or irregular heartbeat (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 heartbeat, itching, swelling of eyelids or around the eyes, face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to drugs related to chlorpheniramine. Blood disorders (changes in blood cell counts, such as agranulocytosis, leucopenia, aplastic anaemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear disturbances, impotence, menstrual disorders.

• Adverse effects that may occur very infrequently (very rare) are:

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

Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.

• Adverse effects for which frequency of occurrence is unknown are: Anxiety, irritability, weakness, increased blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeat (severe bradycardia), reduction in blood vessel diameter (peripheral vasoconstriction), reduced cardiac performance especially affecting elderly patients and those with poor cerebral or coronary circulation, possible onset or worsening of heart disease, urinary retention, pallor, piloerection (hair standing on end), increased blood sugar (hyperglycaemia), decreased potassium levels in blood, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, feeling of faintness (hypotension). At high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, reduction in blood volume may occur.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abacat

Keep out of the sight and reach of children.

Do not use Abacat after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the package and other information

Composition of Abacat

Each sachet contains:

• Active substances: 1 g of paracetamol, 15.58 mg of phenylephrine bitartrate (equivalent to 8.21 mg of phenylephrine) and 4 mg of chlorpheniramine maleate (equivalent to 2.8 mg of chlorpheniramine).
• Other components (excipients): Mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange flavour (containing maltodextrin, which is a derivative of maize starch) and povidone.

Appearance of the medicine and contents of the pack

Abacat is a white or yellowish-white granulate for oral solution with an orange flavour, presented in sachets packed in cardboard packs containing 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 most recent revision of this leaflet: November 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS):

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