Package Insert: Information for the Patient

Paracetamol Alter 650 mg Tablets EFG

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Paracetamolbelongs 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.
• Avoid using 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.
• When taking medication for epilepsy, consult your doctor before taking this medication, as it may decrease the effectiveness and increase the hepatotoxicity of paracetamol, especially with high doses of paracetamol.
• Patients with asthma who are sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• If you have severe diseases, such as severe kidney failure 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

This medication should not be used in children under 15 years old or weighing less than 50 kg.

Other medications and Paracetamol Alter

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

Particularly, if you are using any of the following medications, as it may be necessary to modify 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 and heart rhythm disorders (arrhythmias): Propranolol.

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid alteration (called 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. 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 breastfeeding 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 this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents over 15 years (weight>50 kg): take1 tablet every 4-6 hours, as needed.

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

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

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

Chronic alcoholics:You should be careful not to take more than 2 grams of paracetamol in 24 hours.

Patients with kidney diseases: before taking this medicationyou must consult your doctor.

Take a maximum of 500 milligrams per dose.Due to the dose,650 milligramsof paracetamol, the medication is not indicated for this group of patients.

This medication is taken orally.

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

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

Always use the smallest effective dose.

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

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, you should interrupt treatment and consult your doctor.

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), abdominal pain and pancreatitis inflammation.

If you have ingested an overdose, you should 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).

If you interrupt treatment with paracetamol

If you have any other doubt about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may 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). Rarely, severe skin reactions have been reported.

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).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does 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 about 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.

Medications should not be disposed of through drains or in the 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. Each tablet contains 650 mg of paracetamol.
• The other components are: cornstarch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and content of the packaging

Paracetamol Alter is presented in the form of oral tablets, in packaging of 40 tablets. The tablets are oblong, biconvex, white in color, and have a groove, allowing them to be divided into equal doses.

Holder of the marketing authorization

Laboratorios Alter S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet:February 2025

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