Paracetamol Cinfa 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

paracetamol cinfa 1 g 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 adverse 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 adverse effects
5. How to store paracetamol cinfa

Pack contents and additional 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 symptomatic treatment of mild to moderate pain and fever in adults and adolescents over 15 years of age and weighing more than 50 kg.

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 than the recommended dose stated in section 3, “How to take paracetamol cinfa”.
• Concomitant 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.
• Chronic alcoholics should take care not to exceed 2 g of paracetamol in 24 hours.
• Patients with kidney disease cannot take this medicine due to its 1 g paracetamol content. Patients with liver, heart or lung disease, or those with anaemia, should consult their doctor before taking this medicine.
• If you are being treated with any medication for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatment.
• Inform your doctor before taking this medicine if you are an asthmatic patient sensitive to acetylsalicylic acid.
• Paracetamol may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), which may be fatal. Patients should be informed about the signs of serious skin reactions, and the medicine should be discontinued at the first sign of skin rash or any other symptom of hypersensitivity.
• 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 suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

Due to the paracetamol dose, this medicine should not be used in children or adolescents under 15 years of age (and weighing less than 50 kg). Ask your doctor or pharmacist about available formulations that allow appropriate dosing for these patients.

Interference with laboratory tests

If you are due to have any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

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

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.

In particular, if you are taking any of the following medicines, it may be necessary to adjust the dose or discontinue treatment:

• 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 levels (cholestyramine).
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used in the treatment of gout (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.

Also inform your doctor or pharmacist if you are taking:

flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap), which requires urgent treatment (see section 2).

Taking paracetamol cinfa with food, drinks and alcohol

Taking 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.

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

Paracetamol passes into breast milk, so breastfeeding women should consult their 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 or none.

3. How to take paracetamol cinfa

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

This medicine is taken orally.

Depending on your preference, the tablets may be taken whole or split in half, with a glass of liquid, preferably water.

The recommended dose is:

Adults and adolescents over 15 years of age (and weighing more than 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. Do not take more than 4 tablets (4 g) in 24 hours.

Elderly patients

Your doctor will determine the dosing frequency and whether the dose needs to be reduced.

Patients with liver disease

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

Patients with kidney disease

Must consult their doctor before taking this medicine. Maximum dose per administration is half a tablet (500 milligrams). Depending on the severity of their condition, their doctor will indicate whether the medicine should be taken with a minimum interval of 6 or 8 hours.

They must not take more than 2 grams in 24 hours, divided into several doses, and must not exceed 500 milligrams per dose under any circumstances.

Use in children and adolescents

Do not use in children under 15 years of age.

The tablet may be divided into equal doses.

This medicine should be taken only when symptoms such as pain or fever occur. As symptoms subside, treatment should be discontinued.

Prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, consult your doctor and reevaluate the clinical situation.

If you take more paracetamol cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount ingested.

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

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

Treatment for overdose is most effective when started within 4 hours of ingestion of the medicine.

Patients undergoing treatment with barbiturates or chronic alcoholics may experience greater toxicity from a paracetamol overdose than other patients.

If you forget to take paracetamol cinfa

Do not take a double dose to make up for missed doses. Simply take the missed dose as soon as you remember, and take subsequent doses at the recommended intervals (at least 4 hours apart).

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 will experience them.

The possible adverse effects are:

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

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

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

Frequency not known (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 are using paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging following EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and unused medicines. 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 1 g of paracetamol.

The other components are: pregelatinized maize starch without gluten, stearic acid, povidone, crospovidone, microcrystalline cellulose (E-460), and vegetable-source magnesium stearate.

Appearance of the product and contents of the pack

paracetamol cinfa 1 g tablets EFG are presented as oblong, biconvex, scored, white tablets for oral administration.

They are available in packs of 20 or 40 tablets, packed in PVC-PVDC/ALU blisters.

Only certain 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

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial 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 Vallès, Spain

PHARMALOOP S.L.

C/Bolivia, No. 15, Pol. Ind Azque

Alcalá de Henares, 28806 Madrid

Spain

Date of the most recent review of this package leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (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/70310/P_70310.html

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