Leaflet: information for the user

Paracetamol cinfa 650 mg film-coated tablets

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.

5.Storage of paracetamol cinfa

6.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 occasional treatment of mild to moderate pain and fever.

Do not take paracetamol cinfa

• If you are allergic to paracetamol or any of the other components 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 of the medicine than recommended in section 3 How to take paracetamol cinfa.
• Avoid using this medicine with other medicines that contain paracetamol, for example, cold and flu medicines, as high doses can cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• If you are an asthmatic sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have liver, kidney, heart, or lung disease, anemia (a decrease in the hemoglobin level in the blood, due or not to a decrease in red blood cells), or chronic malnutrition or dehydration, consult your doctor before taking this medicine.
• If you are being treated with an epilepsy medicine, 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 treatments with paracetamol.
• In chronic alcoholics, be careful not to take more than 3 tablets of 650 mg of paracetamol in 24 hours.
• 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

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

In children and adolescents under 15 years, consult your doctor or pharmacist as there may be other presentations available with paracetamol doses adapted to these patients.

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 may alter the values of uric acid and glucose determinations.

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, metharbital, 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: cholestyramine.
• Medicines used to increase urine elimination (diuretics 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.

In the case of treatment with oral anticoagulants, it can be administered occasionally as the preferred analgesic.

Paracetamol cinfa with food, drinks, and alcohol

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

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

Pregnancy and lactation

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

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 medicine more frequently.

Paracetamol passes into breast milk, so women breastfeeding should consult their doctor before using 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 hydrogenated ricin oiland.

This medicine may cause stomach discomfort and diarrhea because it contains hydrogenated ricin oil.

Paracetamol cinfa contains sodium.

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

Follow exactly the administration instructions of this medication as 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 old (and weight over 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) every 24 hours.

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

In case of adults with low weight (40 kg or less), they may follow the dosage recommendations for children, although there are other presentations with paracetamol doses adapted for these patients. Ask your doctor or pharmacist.

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

Patients with kidney or liver diseases

They should consult their doctor.

Patients of advanced age

They should consult their doctor.

Use in children and adolescents

It is necessary to respect the doses defined according to weight. The child's age according to weight is given for information purposes only.

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

Children under 6 years old

They should consult their doctor, as there are other presentations with doses adapted to these patients.

Children weighing over 22 kg, up to 33 kg (approximately 6 to 9 years old):

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 according to the patient's weight. The time interval between each administration and the maximum daily dose will depend on the patient's weight.

Children weighing over 33 kg, up to 43 kg (approximately 10-12 years old)

Half a tablet (325 mg of paracetamol) every 4 hours up 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 according to the patient's weight.

Adolescents weighing over 43 kg (from 13 years old)

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

If the pain persists for more than 5 days (more than 3 days in children) or 2 days for sore throat, fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, discontinue treatment and consult your doctor.

Administration form

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

The tablet can be divided into equal doses.

For quick relief of pain, take the medication without food.

If you estimate that the paracetamol action 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you have ingested an overdose, you should go quickly 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 intoxication.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), and abdominal pain.

The treatment of overdose is more effective if it is initiated within 4 hours of ingestion of the medication.

The treatment includes:

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

Patients undergoing barbiturate treatment (a type of sedative medication) 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 compensate for the missed doses.

Take the missed dose as soon as you remember and take the next doses with the indicated interval between doses (4-6 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.

Rare Adverse Effects(may affect up to 1 in 1,000 patients), 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 patients) are: kidney diseases, cloudy urine, severe skin reactions, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

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 treatments.

Communication of 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 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 unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. 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 are:
• • Tablet core: anhydrous colloidal silica, cornstarch, microcrystalline cellulose (E-460), magnesium stearate (E-470b), sodium carboxymethyl starch (type A) (from potato), hydrogenated ricin oil, povidone (E-1201).
  • Tablet coating: macrogol 6000, hypromellose 606 and hypromellose 615 (E-464).

Appearance of the product and contents of the packaging

Paracetamol cinfa 650 mg coated tablets EFG are oblong, coated, biconvex, white tablets with a notch on one face and a code on the other.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 - Industrial Estate Areta.

31620 Huarte (Navarra) - Spain

or

GALENICUM HEALTH, S.L.

Avda. de Cornella 144, 7th- 1st Floor Building LEKLA,

Esplugues de Llobregat, 08950 Barcelona

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/68066/P_68066.html

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