Leaflet: information for the patient

Paracetamol Alter1 gfilm-coated tablets EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

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

This medicine is used for the symptomatic treatment of mild or moderate pain and fever in adults and adolescents 15 years of age and older and weighing more than 50 kg.

Do not take Paracetamol Alter

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paracetamol Alter.

• Do not take more of the medication than recommended in section 3. How to take Paracetamol Alter 1 g tablets.
• Avoid taking this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be careful not to take more than 2 grams of paracetamol in 24 hours.
• Patients with kidney, liver, heart, or lung diseases, and patients with anemia, should consult their doctor before taking this medication.
• Patients undergoing treatment for epilepsy should consult their doctor before taking this medication, as it may reduce the effectiveness and increase the hepatotoxicity of paracetamol, especially with high doses.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have chronic malnutrition, alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children

Consult your doctor or pharmacist for children under 15 years, as there are other presentations with doses adapted to this age group.

Other medications and Paracetamol Alter

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription.

Particularly, if you are using any of the following medications, as it may be necessary to adjust the dose of some of them or discontinue treatment:

• Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications to treat tuberculosis: (isoniazid, rifampicin)
• Medications to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower blood cholesterol levels: (cholestyramine)
• Medications used to increase urine elimination (diuretics such as furosemide)
• Medications used to treat gout (probencid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid alteration (metabolic acidosis) that must be treated urgently (see section 2).

Interference with analytical tests:

If you are to undergo any analytical tests (including blood and urine tests, etc.), inform your doctor that you are taking/using this medication, as it may alter the results.

Taking Paracetamol Alter with food, drinks, and alcohol

The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages: beer, wine, liquor... per day) may cause liver damage.

The taking of this medication with food does not affect its efficacy.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medication.

In case of need, paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Paracetamol passes into breast milk, so women in the lactation period should consult their doctor or pharmacist before taking this medication.

Driving and operating machinery

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.consult your doctor or pharmacist again.

Remember to take your medication. Paracetamol Alter must be taken orally.

According to your preferences, the tablets can be taken directly or broken in half, with the help of a liquid, preferably water.

The recommended dose is:

Adults and adolescents over 15 years old

1 tablet (1 g of paracetamol) every 6-8 hours, 3 or 4 times a day.

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

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

Patients with kidney disease: before taking this medication, they must consult their doctor.

Take a maximum of 500 milligrams per dose.

Due to the dose, 1 gram of paracetamol, the medication is not indicated for this group of patients.

This medication is taken orally.

The tablets must be swallowed whole or broken in half, with the help of a liquid, preferably water.

The tablets are scored, which allows them to be broken in half. The score serves only to break the tablet if it is difficult to swallow whole, not to administer doses of 500 mg. There are other presentations available with this amount of active ingredient.

Always use the lower dose that is effective.

It should be avoided to use high daily doses of paracetamol for prolonged periods of time, as the risk of suffering adverse effects such as liver damage increases.

The administration of this medication is subject to the appearance of pain or fever. As these disappear, treatment should be suspended.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, treatment should be interrupted and the doctor consulted.

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If you take moreParacetamol Alterthan you should

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), and abdominal pain and pancreatitis inflammation.

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

The treatment of overdose is more effective if it is initiated within 4 hours of medication ingestion.

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

If you forgot to takeParacetamol Alter

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated interval (at least 4 hours).

Like all medications, Paracetamol Alter may have adverse effects, although not all people will experience them.

Rare adverse effects that may occur (between 1 and 10 of every 10,000 people), are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects that may occur (in fewer than 1 of every 10,000 people) are: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

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

Severe skin reactions have been reported very rarely.

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

Reporting of Adverse Effects:

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

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging (after CAD). The expiration date is the last day of the month indicated.

Do not dispose of medications through the drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Paracetamol Alter

• The active ingredient is paracetamol.
• The other components are: pregelatinized cornstarch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and plant-derived magnesium stearate.

Appearance of the product and contents of the packaging

Paracetamol Alter is presented in the form of oral tablets, in packaging of 20 and 40 tablets. The tablets are scored, allowing them to be split in half to facilitate swallowing.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Alter S.A

C/ Mateo Inurria 30

28036 Madrid

Responsible for manufacturing

Toll Manufacturing Services S.L

Aragoneses, 2

28108 Alcobendas (Madrid)

or

Farmalider, S.A.

Aragoneses, 2

28108 Alcobendas (Madrid)

Last review date of this leaflet:February 2025

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/