ABEZEN 1 G FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Abezen 1 g Film-Coated Tablets

Paracetamol

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if they have the same symptoms as you.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Abezen and what is it used for

Paracetamol belongs to a group of medicines called analgesics and antipyretics.

This medicine is used in adults and adolescents over 15 years old (and weighing over 50 kg) for the treatment of symptoms of moderate pain and fever.

2. What you need to know before taking Abezen

Do not take Abezen

• if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Do not take more than the recommended dose in section 3. How to take Abezen. Check that you are not taking other medicines that contain paracetamol at the same time.

In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.

Talk to your doctor or pharmacist before starting to take this medicine:

• if you have any liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells),
• if you have Gilbert's syndrome (mild jaundice), if you are dehydrated, or if you have chronic malnutrition.
• when you are being treated with any medicine for epilepsy, as paracetamol may decrease its effectiveness and increase its toxicity to the liver, especially in high-dose treatments (see below in this section, Other medicines and Abezen).

• In chronic alcoholics, do not take more than 2 g of paracetamol in 24 hours.
• If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, consult your doctor and reassess the clinical situation.

In case of overdose or accidental ingestion, seek immediate medical attention (see If you take more Abezen than you should).

Children and adolescents

In children and adolescents under 15 years old, consult your doctor or pharmacist, as there are other presentations with paracetamol doses adapted to these patients.

During treatment with Abezen, inform your doctor immediately if:

• You have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Interference with laboratory tests

If you are going to have any laboratory tests (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Paracetamol may alter the values of uric acid and glucose determinations.

Other medicines and Abezen

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin),
• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine),
• Medicines to treat tuberculosis: (isoniazid, rifampicin),
• Medicines to treat depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants),
• Medicines to lower cholesterol levels in the blood: (cholestyramine),
• Medicines used to increase urine elimination (loop diuretics such as furosemide),
• Medicines used to treat gout (probenecid and sulfinpyrazone),
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone,
• Medicines used to treat high blood pressure and heart rhythm disorders (arrhythmias): propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Do not use with other pain relievers (medicines that reduce pain) without consulting your doctor.

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Taking Abezen with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day: beer, wine, liquor, etc.) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The use of medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Small amounts of paracetamol may appear in breast milk, so it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible or non-existent.

3. How to take Abezen

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Method of administration:

For oral administration.

According to your preferences, the tablets can be taken directly or broken in half, with water, milk, or fruit juice. The score line is only for breaking the tablet if you find it difficult to swallow whole.

The recommended dose is:

Adults and adolescents over 15 years old (and weighing over 50 kg):One tablet (1 g of paracetamol) 3 times a day, every 6-8 hours. The doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g) in 24 hours.

Patient with liver disease: Before taking this medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval between each dose of 8 hours. They should not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patient with kidney disease: Before taking this medicine, they must consult their doctor. Due to the dose of paracetamol (1 gram), the medicine should not be used in patients with moderate or severe kidney disease.

Use in children and adolescents

Do not use in children or adolescents under 15 years old.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

When lower doses of paracetamol are required (less than 1 g per dose), other presentations of paracetamol should be used.

If you take more Abezen than you should

Consult your doctor or pharmacist immediately, even if you feel well.

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 taken.

If you have taken an overdose, go immediately to a medical center, even if you do not notice symptoms, as they often do 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.

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

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Abezen

Do not take a double dose to make up for forgotten doses. Simply take the forgotten dose when you remember, taking the next doses with the indicated spacing between them (at least 4 hours).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects that may occur (up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Paracetamol may damage the liver when taken in high doses or for prolonged periods.

Side effects of unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Very rare cases of severe skin reactions have been reported.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abezen

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Abezen

• The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.
• The other ingredients are: pregelatinized maize starch, magnesium stearate, hypromellose, polyethylene glycol 6000, propylene glycol, titanium dioxide, talc.

Appearance of the product and pack contents

White or almost white, oblong, film-coated tablets, scored on one side and smooth on the other, packaged in transparent PVC/Aluminum blisters; available in packs of 20 and 40 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

UXA FARMA, S.A.

Avda. J.V. Foix 62

08034 Barcelona.

Spain

Manufacturer:

Netpharmalab Consulting Services

Carretera de Fuencarral 22

Alcobendas 28108 Madrid

Spain

Date of last revision of this package leaflet:January 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/