Gelocatil 650 mg 20 tablets

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1. What Gelocatil 650 mg Tablets is and what it is used for

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of occasional mild to moderate pain, such as headache, dental pain, muscle pain (contractures) or back pain (lumbago) and in febrile states.

Gelocatil is indicated for adults and adolescents over 14 years of age.

2. Before taking Gelocatil

Do not take Gelocatil if:

- you are allergic (hypersensitive) to paracetamol or any of the other ingredients of Gelocatil.

Take special care with Gelocatil:

- Do not take more of the medicine than recommended in section 3. How to take Gelocatil.

- Simultaneous use of this medicine with other medicines containing paracetamol, e.g. cold and flu medicines, should be avoided, as high doses may result in liver damage. Do not use more than one medicine containing paracetamol without consulting a doctor.

- Chronic alcoholics should be careful not to take more than 2 grams of paracetamol in 24 hours.

- Patients with kidney, liver, heart or lung disease and patients with anaemia should consult a doctor before taking this medicine.

- When being treated with a medicine to treat epilepsy, a doctor should be consulted before taking this medicine, because when they are used at the same time, the efficacy is reduced and the hepatotoxicity of paracetamol is enhanced, especially in treatments with high doses of paracetamol.

- Asthmatic patients sensitive to acetylsalicylic acid should consult a doctor before taking this medicine.

Use of other medicines:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, if you are using any of the following medicines, as the dosage of some of them may need to be changed or the treatment discontinued:

- Medicine to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).

- Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

- Medicines to treat tuberculosis (isoniazid, rifampicin).

- Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives and anticonvulsants).

- Medicines used to lower blood cholesterol levels: (cholestyramine)

- Medicines used to increase urine output (loop diuretics such as those in the furosemide group).

- Medicines used for 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 disturbances (cardiac arrhythmias): Propranolol.

Interference with laboratory tests:

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

Taking Gelocatil with food and drink:

The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks: beer, wine, liquor,... per day) may cause liver damage.

Taking this medicine with food does not affect the efficacy of the medicine.

Use in children:

- Do not use in adolescents under 14 years of age.

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

IMPORTANT FOR WOMEN

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The use of medicines during pregnancy may be dangerous to the embryo or foetus and should be monitored by your doctor.

If necessary, Gelocatil 650mg Tablets may 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 often.

Breast-feeding:

Consult your doctor or pharmacist before using any medicine.

Paracetamol passes into breast milk, so breast-feeding women should consult their doctor or pharmacist before taking this medicine.

Driving and using machines:

There is no or negligible influence of paracetamol on the ability to drive and use machines.

Gelocatil contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e. essentially "sodium-free".

3. How to take Gelocatil

Follow these instructions unless your doctor has given you different instructions. Consult your doctor or pharmacist if you are in any doubt.

The usual dose is:

Adults and adolescents over 14 years of age (weight 64-65 kg): take 1 tablet every 4 - 6 hours, as needed. Do not take more than 3 grams (4 tablets) in 24 hours.

Patients with liver disease: Before taking this medicine, you should consult your doctor.

They should take the amount of medicine prescribed by their doctor with an interval of at least 8 hours between each dose.

They should not take more than 3 tablets in 24 hours, divided into 3 doses.

Patients with kidney disease: consult your doctor before taking this medicine.

Take a maximum of 500 milligrams per dose.

Because of the dose, 650 milligrams of paracetamol, the medicine is not suitable for this group of patients.

This medicine is taken by mouth.

The tablets should be swallowed whole or broken in half, with a glass of liquid, preferably water.

The tablets are slotted, which allows them to be broken in half. The slit is only used to break the tablet if you find it difficult to swallow it whole.

Always use the lowest effective dose.

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

Administration of this medicine is contingent on the onset of pain or fever. As soon as these disappear, treatment should be stopped.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or other symptoms appear, you should stop treatment and consult your doctor.

If you take more Gelocatil than you should:

You should consult your doctor or pharmacist immediately.

Symptoms of overdose may include: 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 centre immediately even if you do not notice symptoms, as symptoms often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

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

Patients on barbiturates or chronic alcoholics may be more susceptible to toxicity from an overdose of paracetamol.

In case of overdose or accidental ingestion, seek immediate medical attention or call the Poisons Information Service (telephone 91 562 04 20), indicating the medicinal product and the quantity taken.

4. Possible side effects

Like all medicines, Gelocatil can have side effects, although not everybody gets them.

Rare side effects that may occur (between 1 and 10 in 10,000 people) include: malaise, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (in less than 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, haemolytic anaemia) and hypoglycaemia (low blood sugar). Serious skin reactions have been reported very rarely.

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

Reporting side effects

If you experience any side effects, please tell your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects you can help to provide more information on the safety of this medicine.

5. Storage of Gelocatil 650 mg Tablets

Keep out of the reach and sight of children.

This medicine does not require special storage conditions.

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

Medicines should not be flushed down the drain or thrown away. Please dispose of unneeded medicines and containers at the SIGRE Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unneeded medicine containers and medicines. In this way, you will help to protect the environment.

6. Package contents and additional information

Composition of Gelocatil:

Each tablet contains 650 milligrams of paracetamol, as the active substance.

The other ingredients (excipients) are magnesium stearate, povidone, colloidal anhydrous silica, potato starch and pregelatinised maize starch.

Appearance of the product and contents of the pack:

Gelocatil is presented as tablets for oral administration.

The tablets are oblong, grooved on one side and white in colour.