EFETAMOL 1 g TABLETS

2. What you need to know before taking EFETAMOL

Do not take EFETAMOL:

• If you are allergic (hypersensitive) to paracetamol or any of the other ingredients of EFETAMOL.
• If you have liver disease.

Tell your doctor immediately if:

• Do not take more than the recommended dose.
• If you have kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), you should consult your doctor before taking this medicine.
• In chronic alcoholics, it is recommended not to take more than 2 g/day of paracetamol.
• If the pain persists for more than 10 days, the fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, treatment should be discontinued and a doctor consulted.
• In children under 15 years of age, consult your doctor or pharmacist, as there are other formulations with doses suitable for this group of patients.
• 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 respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Paracetamol may interact with the following medicines:

• Antibiotics (chloramphenicol).
• Anticoagulants (used to treat thromboembolic diseases).
• Antiepileptics (used to treat epileptic seizures).
• Contraceptives.
• Diuretics (used to increase urine elimination).
• Isoniazid (used to treat tuberculosis).
• Lamotrigine (used to treat epilepsy).
• Probenecid (used to treat gout).
• Propranolol (used to treat hypertension, cardiac arrhythmias).
• Rifampicin (used to treat tuberculosis).
• Anticholinergics (used to relieve spasms or contractions of the stomach, intestine, and bladder).
• Zidovudine (used to treat HIV infections).
• Colestyramine (used to decrease blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (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.

Interactions with diagnostic tests:

Consult your doctor if you need to undergo a blood or urine test.

Taking EFETAMOL with food and drinks:

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

In case of necessity, it can be used during pregnancy. You should use the lowest possible dose that reduces the pain or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain or fever does not decrease or if you need to take the medicine more frequently.

Breastfeeding:

Consult your doctor or pharmacist before using any medicine.

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

Driving and using machines:

No effects have been described that alter the ability to drive and use machinery.

3. How to TAKE EFETAMOL

Follow these instructions unless your doctor has given you different instructions.

Remember to take your medicine. EFETAMOL should be taken orally. According to your preferences, the tablets can be swallowed directly or broken in half with water, milk, or fruit juice. Consult your doctor or pharmacist if you have any doubts. The normal dose is:

Adults and children over 15 years: the usual dose is 1 tablet (1 g of paracetamol) 3-4 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g) in 24 hours.

Patient with liver or kidney disease: should consult their doctor.

Elderly patients: should consult their doctor.

If you think the effect of EFETAMOL is too strong or too weak, tell your doctor or pharmacist.

When lower doses of paracetamol are required (less than 1 g per dose), other paracetamol formulations should be used that are suitable for the required dosage.

If you take more EFETAMOL than you should:

If you have taken more EFETAMOL than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.

If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they often do not appear until three days after taking the overdose, even in cases of severe poisoning. The symptoms of overdose may be: 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 of taking the medicine.

Patient taking barbiturates or suffering from chronic alcoholism may be more susceptible to paracetamol overdose.

If you forget to take EFETAMOL:

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 interval (at least 4 hours).

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

4. Possible side effects

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

EFETAMOL can cause the following side effects:

• Rare (between 1 and 10 in every 10,000 patients): discomfort and low blood pressure.
• Very rare (less than 1 in every 10,000 patients): allergic reactions (such as skin reactions), low blood sugar, blood disorders, and liver and kidney disorders.

Very rare cases of serious skin reactions have been reported.

• Frequency not known (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).

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing EFETAMOL

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions.

Do not use EFETAMOL 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 or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of EFETAMOL:

The active ingredient is paracetamol.

The other ingredients are: pregelatinized corn starch, stearic acid, and povidone.

Appearance of the product and pack contents:

EFETAMOL is presented in the form of tablets for oral administration, in packs of 20 and 40 tablets. The tablets are scored, which allows the tablet to be divided into equal doses.

Marketing authorization holder and manufacturer:

Holder:

ITALFARMACO S.A.

San Rafael 3, 28108 - Alcobendas (Madrid)

Manufacturer:

• Uriach y Cia. S.A.

Polígono Industrial Riera de Caldes

Avenida Camí Reial 51-57 – 08184-Palau-solita i Plegamans (Barcelona)

This leaflet was approved in

December 2024