PARACETAMOL CINFA 650 mg TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Cinfa 650 mg Tablets EFG

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Paracetamol Cinfa is and what it is used for
2. What you need to know before taking Paracetamol Cinfa
3. How to take Paracetamol Cinfa
4. Possible side effects
5. Storage of Paracetamol Cinfa
6. Contents of the pack and further information

1. What Paracetamol Cinfa is and what it is used for

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

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

2. What you need to know before taking Paracetamol Cinfa

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, you should consult your doctor before taking this medicine.
• If you have any liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells), you should consult your doctor before taking this medicine.
• When being treated with any medicine for epilepsy, you should consult your doctor before taking this medicine, as the efficacy of paracetamol may be reduced and hepatotoxicity may be increased when used at the same time, especially in high-dose paracetamol treatments.
• In chronic alcoholics, you should be cautious not to take more than 3 tablets of 650 mg of paracetamol in 24 hours.
• If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, you should consult your doctor and reassess the clinical situation.
• If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

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

Other medicines and Paracetamol Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medicines for treating epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for treating tuberculosis (isoniazid, rifampicin).
• Medicines for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower cholesterol levels in the blood (cholestyramine).
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medicines used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.

Tell your doctor or pharmacist if you are taking:

- flucloxacillin (antibiotic), due to a serious risk of alteration of the blood and fluids (called metabolic acidosis with high anion imbalance) that should 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 systematically inform your doctor or pharmacist if you are being treated with another medicine. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with analytical tests

If you are going to have any analytical tests (including blood tests, urine tests, skin tests that use allergens, etc.), tell your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Paracetamol Cinfa with food, drinks, and alcohol

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

In case of necessity, Paracetamol Cinfa 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 medicine more frequently.

Breastfeeding

Small amounts of paracetamol may appear in breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is negligible.

Paracetamol Cinfa contains sodium

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

3. How to take Paracetamol Cinfa

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

Remember to take your medicine. Paracetamol should be taken orally.

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

The tablet can be divided into equal doses.

The recommended dose is:

Adults and adolescents over 15 years: the recommended dose is 1 tablet (650 mg of paracetamol) every 4 or 6 hours. The doses should be spaced at least 4 hours apart. Do not take more than 6 tablets in 24 hours.

Patient with liver disease: before taking this medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval of 8 hours between each dose.

Do not take more than 3 tablets of 650 mg of paracetamol in 24 hours.

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

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

Elderly patients: should consult their doctor.

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

If you think that the action of this medicine is too strong or too weak, tell 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, yellowing of the skin and eyes (jaundice), and abdominal pain.

If you have taken 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 taking the overdose, even in cases of severe poisoning.

Treatment of overdose is more effective if started within 4 hours of taking the medicine.

Patient taking barbiturates 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Paracetamol Cinfa

Do not take a double dose to make up for forgotten doses; simply take the forgotten dose when you remember, taking the next doses with the indicated spacing between doses (at least 4 hours).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side 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 side effects (may affect up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

Side effects of unknown frequency (cannot be estimated from the available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Cinfa

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 which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Cinfa

• The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.
• The other ingredients (excipients) are: sodium carboxymethyl starch (type A) (potato), purified water, pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).

Appearance of the product and contents of the pack

The tablets are oblong, biconvex, white, with a score line on one face and marked with "PB" on the other face.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer:

SAG Manufacturing S.L.U.

Ctra. N-I, 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

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this package leaflet:February 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the package leaflet and packaging with your mobile phone (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