Paracetamol Alter 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Paracetamol Alter 1 g tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

1. What Paracetamol Alter is and what it is used for

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

This medicine is used for the symptomatic treatment of mild to moderate pain and fever in adults and adolescents aged 15 years and older, weighing over 50 kg.

2. What you need to know before taking Paracetamol Alter

Do not take Paracetamol Alter

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol Alter.

• Do not take more medicine than the recommended dose stated in section 3, How to take Paracetamol Alter 1 g tablets.
• The simultaneous use of this medicine with other medicines containing paracetamol (e.g. cold and flu remedies) should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should take care not to take more than 2 grams of paracetamol in 24 hours.
• Patients with kidney, liver, heart or lung disease, or those with anemia, should consult their doctor before taking this medicine.
• If you are being treated with medicines for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatment.
• Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
• If you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic), be aware that a serious condition called metabolic acidosis (an imbalance in blood and body fluids) has been reported in patients under these circumstances when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children

For children under 15 years of age, consult your doctor or pharmacist, as other dosage forms are available that are suitable for this patient group.

Other medicines and Paracetamol Alter

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

In particular, if you are taking any of the following medicines, your dose may need to be adjusted or treatment interrupted:

• Medicines to prevent blood clots: Oral anticoagulants (acenocumarol, 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 seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: (cholestyramine)
• Medicines used to increase urine output (loop diuretics such as furosemide)
• Medicines used in the treatment of gout: (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with laboratory tests:

If you are due to have any laboratory tests (including blood or urine tests), inform your doctor that you are taking/using this medicine, as it may affect test results.

Taking Paracetamol Alter with food, drinks and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

Taking this medicine with food does not affect its effectiveness.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

If necessary, paracetamol may be used during pregnancy. You should use the lowest dose possible that relieves pain or fever and use it for the shortest possible time. Contact your doctor if pain or fever does not subside or if you need to take the medicine more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medicine.

Driving and operating machinery

The effect of paracetamol on the ability to drive and operate machinery is none or negligible.

3. How to take Paracetamol Alter

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

Remember to take your medicine. Paracetamol Alter is taken orally.

Depending on your preference, the tablets may be taken whole or split in half, with a glass of liquid, preferably water.

Recommended dose:

Adults and adolescents over 15 years of age:

1 tablet (1 g of paracetamol) every 6–8 hours, 3 or 4 times daily.

Do not exceed 1 g of paracetamol per dose under any circumstances. Do not take more than 4 g of paracetamol in 24 hours, divided into 4 doses.

Patients with liver disease: Before taking this medicine, you must consult your doctor. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not take more than 2 tablets of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: Before taking this medicine, you must consult your doctor.

Take a maximum of 500 milligrams per dose.

Due to the dosage (1 g of paracetamol), this medicine is not indicated for this patient group.

This medicine is taken orally.

The tablets should be swallowed whole or split in half, with a glass of liquid, preferably water.

The tablets are scored, which allows them to be split in half. The score line is provided solely to assist splitting the tablet if you have difficulty swallowing it whole. Do not split the tablet to administer 500 mg doses, as other presentations containing this amount of active ingredient are available.

Always use the lowest effective dose.

High daily doses of paracetamol should be avoided over prolonged periods, as this increases the risk of adverse effects such as liver damage.

This medicine should only be administered when pain or fever occurs. Treatment should be discontinued as symptoms resolve.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, discontinue treatment and consult your doctor.

If you take more Paracetamol Alter than you should

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.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and inflammation of the pancreas (pancreatitis).

If you have taken an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

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

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamol Alter

Do not take a double dose to make up for a missed dose. Simply take the missed dose as soon as you remember, then take the next doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

Like all medicines, Paracetamol Alter can have adverse effects, although not everyone will experience them.

Rare adverse effects (occurring in between 1 and 10 out of every 10,000 people) include: malaise, low blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in fewer than 1 in 10,000 people) include: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with serious illness who are using paracetamol (see section 2).

Very rare cases of severe skin reactions have been reported.

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

Reporting of adverse effects:

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

5. Storage of Paracetamol Alter

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

This medicine does not require any special storage conditions.

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

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

6. Contents of the pack and other information

Composition of Paracetamol Alter

• The active substance is paracetamol.
• The other components are: pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose and vegetable-source magnesium stearate.

Appearance of the product and contents of the pack

Paracetamol Alter is presented as oral tablets, in packs of 20 and 40 tablets. The tablets are scored, allowing them to be divided into halves to facilitate swallowing.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter S.A
C/ Mateo Inurria 30
28036 Madrid

Manufacturer

Toll Manufacturing Services S.L
Aragoneses, 2
28108 Alcobendas (Madrid)

or

Farmalider, S.A.
Aragoneses, 2
28108 Alcobendas (Madrid)

Date of the most recent review of this leaflet: February 2025

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