Paracetamol cinfa 1 g comprimidos efg

Leaflet: information for the user

paracetamol cinfa1 gfilm-coated tablets EFG

Read this leaflet carefully before you start to take 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, 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. See section 4.

Contents of the pack and additional information

paracetamol cinfa 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 over 15 years oldand weighing more than 50 kg.

Do not take paracetamol cinfa

• 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 cinfa.

• Do not take more than the recommended dose in the section 3, “How to take paracetamol cinfa”.
• Avoid using this medication with other medications that contain paracetamol, for example, medications for the flu and cold, 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 g/24 hours of paracetamol.
• Patients with kidney diseases due to the paracetamol content of 1 g cannot take this medication. Patients with 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 when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in high-dose treatments with paracetamol.
• Inform your doctor before taking this medication if you are an asthmatic patient sensitive to acetylsalicylic acid.
• Paracetamol can cause severe skin reactions, such asacute generalized pustular psoriasis (PEAG), Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), which can be fatal. Patients should be informed about the signs of severe skin reactions, and the use of the medication should be interrupted at the first sign of skin eruption or any other sign of hypersensitivity.
• 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 suffer from chronic malnutrition, alcoholism, or if you 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, somnolence, feeling unwell (nausea) and vomiting.

Children and adolescents

Due to the paracetamol dose, this medication should not be used in children or adolescents under 15 years (and weight under 50 kg). Ask your doctor or pharmacist about the available presentations that allow for proper dosing of these patients.

Interference with analytical tests

Inform your doctor that you are taking this medication if you are to undergo any analytical test (including blood, urine, etc.), as it may alter the results.

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

Other medications and paracetamol cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

In particular, if you are taking any of the following medications, as it may be necessary to modify the dose of some of them or interrupt treatment:

• Medication to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medications for treating epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for treating tuberculosis: (isoniazid, rifampicin).
• Medications for treating depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications used to lower blood cholesterol levels (colestiramine).
• Medications used to increase urine elimination (diuretics of the loop, such as those in the furosemide group).
• 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.

Inform your doctor or pharmacist if you are taking:

flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (denominated metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Paracetamol cinfa with food, drinks, and alcohol

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

Taking this medication with food does not affect its efficacy.

Pregnancy and breastfeeding

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

Paracetamol passes into breast milk, so breastfeeding women 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.

This medication is taken orally.

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

The recommended dose is:

Adults and adolescents over 15 years (and weight over 50 Kg)

The recommended dose is 1 or half a tablet (1 g-500 mg of paracetamol) as needed. Doses should be spaced at least 4 hours apart. No more than 4 tablets (4 g) should be taken in 24 hours.

Senior patients

Your doctor will indicate the frequency and if necessary, reduce the dose.

Patients with liver disease

They should take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose. They should not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease

Before taking this medication, they must consult their doctor. They should take a maximum of half a tablet (500 milligrams) per dose. According to their disease, their doctor will indicate if they should take their medication with a minimum interval of 6 or 8 hours.

They should not take more than 2 grams in 24 hours, divided into several doses, not exceeding 500 milligrams per dose in any case.

Use in children and adolescents

Do not use in children under 15 years

The tablet can be divided into equal doses.

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

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.

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, the doctor should be consulted and the clinical situation reevaluated.

If you take more paracetamol cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately 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.

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

When an overdose has been taken, the treatment of the overdose is more effective if it is initiated within 4 hours of the medication ingestion.

Patients undergoing barbiturate treatment or chronic alcoholics, an overdose of paracetamol may be more toxic to them than to the rest of the patients.

If you forgot to take paracetamol cinfa

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 cinfa

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The possible adverse effects are:

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

Very rare adverse effects (may affect up to 1 in 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.

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

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

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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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 that appears 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 medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of paracetamol cinfa

The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.

The other components are:cornstarchpregelatinized without gluten, stearic acid, povidone, crospovidone, microcrystalline cellulose(E-460)and magnesium stearate of vegetable origin.

Appearance of the product and contents of the packaging

paracetamol cinfa1 gtablets EFG are presented in the form of oblong, biconvex, scored and white tablets for oral administration.

They are presented in packaging of 20 or 40 tablets, conditioned in PVC-PVDC/ALU blisters.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas, Spain

FERRER INTERNACIONAL, S.A.

Joan Buscallá, 1-9

08173 Sant Cugat del Valles, Spain

PHARMALOOP S.L.

C/Bolivia, Nº 15, Pol. Ind Azque

Alcalá de Henares, 28806 Madrid

Spain

Last review date of this leaflet:February 2025

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

You can access detailed and updated information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70310/P_70310.html

QR code to:https://cima.aemps.es/cima/dochtml/p/70310/P_70310.html