Leaflet: information for the user

Paracetamol Cinfa 650 mg tablets EFG

Read this 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, 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.

1. What isParacetamol Cinfaand what it is used for

2. What you need to know before starting to takeParacetamol Cinfa

3. How to takeParacetamol Cinfa

4. Possible side effects

5. Storage ofParacetamol Cinfa

6. Contents of the pack and additional information

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

It is indicated for the treatment of mild to moderate pain symptoms and fever. You should consult a doctor if the pain worsens or does not improve after 5 days, or the fever after 3 days.

Do not take Paracetamol Cinfa

• If you are allergic to paracetamol, propacetamol hydrochloride or any of the other ingredients of this medicine (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 section 3. “How to take Paracetamol Cinfa”.
• In patients with asthma sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have liver, kidney, heart or lung disease, or anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells), consult your doctor before taking this medicine.
• If you are being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in high-dose paracetamol treatments.
• In chronic alcoholics, be careful not to take more than 3 tablets of 650 mg of paracetamol in 24 hours.
• If the pain persists for more than 5 days, fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, consult your doctor and re-evaluate the clinical situation.
• 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 malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious 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 difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

In children and adolescents under 15 years, consult your doctor or pharmacist, as there are other presentations with doses adapted to this group of patients.

Other medicines and Paracetamol Cinfa

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

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, 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 cholesterol levels in the blood (colestiramine).
• Medicines used to increase urine elimination (diuretics of the loop, such as furosemide).
• Medicines used to treat gout (probencid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.

Also inform your doctor or pharmacist if you are taking:

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

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

As a general rule for any medicine, it is recommended to inform your doctor or pharmacist systematically if you are being treated with another medicine. In the case of treatment with oral anticoagulants, Paracetamol Cinfa can be administered occasionally as the preferred analgesic.

Interference with analytical tests

If you are to undergo any analytical test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Paracetamol Cinfa with food, drinks and alcohol

The taking of this medicine with food does not affect the efficacy of the same.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Paracetamol Cinfa can be used during pregnancy if necessary. 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 do not decrease or if you need to take the medicine more frequently.

Breastfeeding

Small amounts of paracetamol may appear in breast milk, so it is recommended to consult your doctor or pharmacist before taking this medicine.

Driving and operating machinery

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

Paracetamol Cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

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

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

According to your preference, the tablets can be swallowed whole or broken in half with the help of a liquid, preferably water.

The tablet can be divided into equal doses.

The recommended dose is:

Adults and adolescents over 15 years old: the recommended dose is 1 tablet (650 mg of paracetamol) every 4 or 6 hours. Doses should be spaced at least 4 hours apart. No more than 6 tablets should be taken in 24 hours.

Patients with liver disease: before taking this medication, they must consult their doctor. 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 3 tablets of 650 mg of paracetamol in 24 hours.

Patients with kidney disease: before taking this medication, they must consult their doctor. Take a maximum of 500 mg per dose.

Due to the dose, 650 mg of paracetamol, the medication is not indicated for this group of patients.

Older adults: they should consult their doctor.

Use in children and adolescents: Do not use in children under 15 years old.

If it is estimated that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Paracetamol Cinfa than you should

You should consult your doctor or pharmacist immediately.

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 of the overdose, even in cases of severe poisoning.

The treatment of an 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.

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.

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 spacing between doses (at least 4 hours).

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

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.

Adverse effects of 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 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 at 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 650 mg of paracetamol.
• The other components (excipients) are: sodium carboxymethylcellulose (type A) (from potato), purified water, pregelatinized cornstarch, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).

Appearance of the product and contents of the packaging

The tablets are oblong, biconvex, white in color, with a notch on one face and marked with “PB” on the other face.

The packaging is of 20, 40, or 500 (clinical packaging) tablets, conditioned in PVC/PVDC/Aluminum blisters.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible for manufacturing:

SAG Manufacturing S.L.U.

N-I Highway, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50,

Esplugues de Llobregat

08950 Barcelona

Spain

or

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – 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 the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84215/P_84215.html

QR code to:https://cima.aemps.es/cima/dochtml/p/84215/P_84215.html