Paracetamol Cinfa 650 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

paracetamol cinfa 650 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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. How to store paracetamol cinfa

6. Contents of the pack and other information

1. What paracetamol cinfa is and what it is used for

paracetamol cinfa belongs to a group of medicines called analgesics and antipyretics.

This medicine is used for the occasional treatment of mild to moderate pain and fever.

2. What you need to know before taking paracetamol cinfa

Do not take paracetamol cinfa

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

Warnings and precautions

Consult your doctor or pharmacist before taking paracetamol cinfa.

• Do not take more medicine than the recommended dose stated in section 3, How to take paracetamol cinfa.
• The simultaneous use of this medicine with other medicines containing paracetamol (e.g. cold and flu remedies) should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have liver, kidney, heart, or lung disease, anaemia (reduced haemoglobin levels in the blood, with or without reduced red blood cells), or suffer from chronic malnutrition or dehydration, consult your doctor before taking this medicine.
• If you are being treated with medicines for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxic potential of paracetamol, especially with high-dose paracetamol regimens.
• In chronic alcoholics, caution should be taken not to exceed 3 tablets of 650 mg paracetamol in 24 hours.
• If you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic), be aware that a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

This medicine should not be used in children under 6 years of age (weighing less than 22 kg), as it does not allow for administration of doses lower than 325 mg of paracetamol.

For children and adolescents under 15 years of age, consult your doctor or pharmacist, as other formulations with paracetamol doses adapted to these patients may be available.

Interference with laboratory tests

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

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

Other medicines and paracetamol cinfa

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

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for tuberculosis: isoniazid, rifampicin.
• Medicines for depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower blood cholesterol: colestyramine.
• Medicines used to increase urine output (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 (hypertension) and heart rhythm disorders (cardiac 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 requires urgent treatment (see section 2).

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

Paracetamol may occasionally be administered as the analgesic of choice in patients undergoing treatment with oral anticoagulants.

Taking paracetamol cinfa with food, drinks and alcohol

Using paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day: beer, wine, spirits) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

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

If necessary, paracetamol may be used during pregnancy. Use the lowest effective dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever does not subside or if you need to take the medicine more frequently.

Paracetamol passes into breast milk, so women who are breastfeeding should consult their doctor before using this medicine.

Driving and using machines

The effect of paracetamol on the ability to drive and operate machinery is negligible or none.

paracetamol cinfa contains hydrogenated castor oil.

This medicine may cause stomach discomfort and diarrhoea because it contains hydrogenated castor oil.

paracetamol cinfa contains sodium.

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

3. How to take paracetamol cinfa

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

The recommended dose is:

Adults and adolescents over 15 years of age (and weighing more than 50 kg)

The recommended dose for adults is half to 1 tablet (325 mg to 650 mg of paracetamol) every 4–6 hours. Do not take more than 4 and a half tablets (approximately 3 g) in any 24-hour period.

The minimum interval between doses must not be less than 4 hours.

For adults with low body weight (40 kg or less), pediatric dosing recommendations may apply, although other formulations with paracetamol doses adapted for these patients are available. Please consult your doctor or pharmacist.

High daily doses of paracetamol should be avoided during prolonged periods, as this increases the risk of adverse effects such as liver damage.

Patients with kidney or liver disease

Must consult their doctor.

Elderly patients

Must consult their doctor.

Use in children and adolescents

It is necessary to respect the doses based on body weight. The child's age corresponding to weight is provided for informational purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 doses per day, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

Children under 6 years of age

Must consult their doctor, as other formulations with doses adapted for these patients are available.

Children weighing more than 22 kg up to 33 kg (approximately 6 to 9 years of age)

Half a tablet (325 mg) of paracetamol every 4–6 hours, according to the child's weight, up to a maximum of 2–3 tablets (1,300 mg–1,950 mg of paracetamol) every 24 hours, depending on the patient's weight. The time interval between each dose and the maximum daily dose will depend on the patient's weight.

Children weighing more than 33 kg up to 43 kg (approximately 10–12 years of age)

From half a tablet (325 mg of paracetamol) every 4 hours to 1 tablet every 6 hours, depending on the patient's weight. The maximum dose will be 3–4 tablets of paracetamol (1,950 mg–2,600 mg of paracetamol) every 24 hours, depending on the patient's weight.

Adolescents weighing more than 43 kg (from 13 years of age)

1 tablet (650 mg of paracetamol) every 4–6 hours, not exceeding 4 tablets every 24 hours (2,600 mg of paracetamol).

If pain persists for more than 5 days (more than 3 days in children), or for sore throat beyond 2 days, or if fever lasts more than 3 days, or if pain or fever worsens or new symptoms appear, treatment must be discontinued and a doctor consulted.

Method of administration

The tablets should be taken orally with a glass of water.

The tablet may be divided into equal doses.

For rapid pain relief, take the medicine without food.

If you feel that the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist.

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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

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

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of overdose is most effective if started within 4 hours after ingestion of the medicine.

Treatment includes:

• Gastric lavage.
• Oral administration of activated charcoal.
• Hemodialysis.
• Administration of acetylcysteine at appropriate doses.

Patients receiving treatment with barbiturates (a type of sedative medicine) or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take paracetamol cinfa

Do not take a double dose to make up for forgotten doses.

Take the missed dose as soon as you remember, and take the following doses at the recommended intervals (4–6 hours).

If you stop taking paracetamol cinfa

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Rare adverse effects (may affect up to 1 in 1,000 patients): malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (may affect up to 1 in 10,000 patients): kidney disorders, cloudy urine, severe skin reactions, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Adverse effects with unknown frequency (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 special storage conditions.

Do not use this medicine after the expiry date 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 drains or in household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of paracetamol cinfa

• The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.
• The other components are:
  • Tablet core: colloidal anhydrous silica, maize starch, microcrystalline cellulose (E-460), magnesium stearate (E-470b), sodium carboxymethylstarch (type A) (from potato), hydrogenated castor oil, povidone (E-1201).
  • Tablet coating: macrogol 6000, hypromellose 606 and hypromellose 615 (E-464).

Appearance of the product and contents of the pack

paracetamol cinfa 650 mg film-coated tablets EFG are oblong, film-coated, biconvex tablets, white in colour, with a score line on one side and a code on the other.

They are presented in PVC-PVDC/ALU blisters. Each pack contains 20, 40 or 500 (hospital pack) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 - Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

or

GALENICUM HEALTH, S.L.

Avda. de Cornella 144, 7th floor - 1st Edificio LEKLA,

Esplugues de Llobregat, 08950 Barcelona, Spain

Date of the most recent revision of this summary: February 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68066/P_68066.html

QR code link: https://cima.aemps.es/cima/dochtml/p/68066/P_68066.html