Paracetamol Alter 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Paracetamol Alter 650 mg tablets EFG

Read this entire leaflet carefully before you start taking this medicine, because 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 adverse 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 with a body weight above 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.
• Avoid taking this medicine together with other medicines containing paracetamol, such as cold and flu remedies, because 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 exceed 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 effectiveness and increase the hepatotoxic potential of paracetamol, especially with high-dose paracetamol regimens.
• 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 abnormality 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 concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

This medicine must not be used in children under 15 years of age or weighing less than 50 kg.

Other medicines and Paracetamol Alter

Inform your doctor or pharmacist if you are currently 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, dosage adjustments or discontinuation of treatment may be necessary:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
• Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for tuberculosis (isoniazid, rifampicin)
• Medicines for depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels (cholestyramine)
• Medicines used to increase urine elimination (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 for treating high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (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 and urine tests), inform your doctor that you are taking/using this medicine, as it may alter test results.

Taking Paracetamol Alter with food, drinks, and alcohol

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

Taking this medicine with food does not affect its efficacy.

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 the pain or fever, and use it for the shortest time possible. Contact your doctor if pain or fever does not improve or if you need to take the medicine more frequently.

Breast-feeding

Consult your doctor or pharmacist before taking any medicine.

Paracetamol passes into breast milk, so women who are breast-feeding should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The effect of paracetamol on the ability to drive and use machines is none or negligible.

3. How to take Paracetamol Alter

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

The recommended dose is:

Adults and adolescents over 15 years of age (weight >50 kg): take 1 tablet every 4–6 hours as needed.

Do not take more than 4 g (6 tablets) in 24 hours.

Patients with liver disease: you must consult your doctor before taking this medicine. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.

Do not take more than 3 tablets in 24 hours, divided into 3 doses.

Chronic alcoholics: you should take care not to exceed 2 grams of paracetamol in 24 hours.

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

Take a maximum of 500 milligrams per dose. Due to the dosage (650 milligrams of paracetamol), this medicine is not indicated for this patient group.

This medicine is for oral use.

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

The tablets are scored. The tablet may be divided into equal doses.

Always use the lowest effective dose.

The prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.

Administration of this medicine should only occur when pain or fever is present. As these symptoms subside, treatment should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you must stop 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 ingested an overdose, you should go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until after 3 days following the overdose, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours after ingestion of 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 missed doses. Simply take the missed dose as soon as you remember, then take the following doses at the recommended intervals (at least 4 hours apart).

If you stop treatment with paracetamol

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 out of every 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). Very rare cases of serious skin reactions have been reported.

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 severe illness who use paracetamol (see section 2).

Paracetamol may damage the liver 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 System for Pharmacovigilance of 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 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE 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 container and additional information

Composition of Paracetamol Alter

• The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.
• The other components are: pregelatinized maize starch, stearic acid, povidone, crospovidone, microcrystalline cellulose and magnesium stearate.

Appearance of the product and contents of the pack

Paracetamol Alter is presented as tablets for oral administration, in packs of 40 tablets. The tablets are oblong, biconvex, white in colour and scored, allowing them to be divided into equal doses.

Marketing Authorization Holder

Laboratorios Alter S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Toll Manufacturing Services S.L.

C/ Aragoneses 2

28108 Alcobendas, Madrid

Spain

or

Farmalider, S.A.

C/ Aragoneses 2

28108 Alcobendas, Madrid

Spain

or

Pharmex Advanced Laboratories, S.L.

Ctra. A-431, Km. 19

14720 Almodóvar del Río, Córdoba

Spain

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

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