Paracetamol is effective in reducing pain and fever.

This medicine is used in adults and adolescents from 14 years of age for the symptomatic relief of occasional mild or moderate pain, such as headache, dental, muscular (contractures) or back (lumbago), as well as in feverish states.

You should see a doctor if the fever worsens or if the fever persists after 3 days of treatment or the pain for 5 days.

Do not take Termalgin

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

Warnings and cautions

Consult your doctor, pharmacist or nurse before taking Termalgin

• Do not take more amount of medicine than recommended in section 3. How to take Termalgin
• Simultaneous use of this medicine with other medicines containing paracetamol, for example medicines for flu and colds, should be avoided, as high doses can lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should be careful not to take more than 2 grams (3 tablets) in 24 hours of paracetamol.
• Patients with kidney, liver, heart or lung diseases and patients with anemia should consult a doctor before taking this medicine.
• When you are being treated with any medication to treat epilepsy, you should consult your doctor before taking this medication, because when used at the same time, the effectiveness is decreased and the hepatotoxicity of paracetamol is enhanced, especially in high dose treatments. paracetamol
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

Interference with analytical tests

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

Children and adolescents

Due to the amount of paracetamol in this medicine, children and adolescents under the age of 14 cannot take this medicine.

Taking Termalgin with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines, even those obtained without a prescription.

In particular, if you are using any of the following medicines, as it may be necessary to modify the dose of some of them or to interrupt treatment:

• Medicine to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
• Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Drugs to treat tuberculosis: isoniazid, rifampicin
• Medicines to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: cholestyramine
• Medicines used to increase urine output (loop diuretics such as those of the furosemide group)
• 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 disturbances (cardiac arrhythmias): propranolol.

Taking Termalgin with food, drink and alcohol

Taking this medicine with food does not affect its effectiveness.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If necessary, Termalgin can 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 subside or if you need to take the medicine more often.

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 this medicine on the ability to drive and use machines is nil or negligible.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 14 years to 18 years :

Take 1 tablet every 4 - 6 hours, as needed, up to a maximum of 4 tablets per day. Do not take more than 3 grams of paracetamol in 24 hours.

Patients with liver diseases :

Before taking this medicine you have to consult your doctor.

They should take the amount of medicine prescribed by their doctor with a minimum interval between each taking of 8 hours.

They should not take more than 2 grams (3 tablets) of paracetamol in 24 hours, divided into 3 doses.

Patients with kidney disease :

Before taking this medicine you have to consult your doctor.

Due to the dose, 650 mg of paracetamol, these patients should not take this medicine.

How to drink

This medicine is administered orally.

The tablets should be swallowed whole or broken with the help of some liquid.

Always take the lowest dose that is effective.

The taking of this medicine is subject to the appearance of pain or fever. As these disappear, treatment should be stopped.

The use of high daily doses of paracetamol for prolonged periods of time should be avoided as the risk of suffering adverse effects such as liver damage is increased.

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

Use in children and adolescents

This medicine is for use only in adults and adolescents from 14 years of age. Children and adolescents under 14 years of age cannot take this medicine.

If you take more Termalgin than you should

Overdose symptoms may be: 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 center immediately even if you do not notice the symptoms, since these often do not appear until 3 days after taking the overdose, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours of taking the drug overdose.

Patients taking barbiturates or chronic alcoholics may be more susceptible to toxicity from a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone: 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Termalgin

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

Like all medicines, Termalgin can cause side effects, although not everyone gets them.

The possible adverse effects of Termalgin are:

Rare side effects, may affect up to 1 in 1,000 people : malaise, hypotension (drop in blood pressure), and increased levels of transaminases in the blood.

Very rare side effects, may affect up to 1 in 10,000 people: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia) and hypoglycaemia (low blood sugar).

Unknown frequency (cannot be estimated from the available data): headache induced by analgesic abuse

Paracetamol can damage the liver when taken in high doses or in long-term treatments.

If you experience side effects, consult your doctor, pharmacist or nurse, even if it is about side effects that are not listed in this leaflet.

Keep this medicine out of the sight and reach of children.

It does not require any special storage conditions.

Do not use this medicine after the expiry date on the container after expiration. The expiration date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

Composition of Termalgin

The active substance is paracetamol.

• The other ingredients (excipients) are talc (E-553b), povidone (E-1201), corn starch, pregelatinized corn starch, colloidal anhydrous silica (E-551), microcrystalline cellulose (E-460i) and stearic acid ( E-570).

What the product looks like and contents of the pack

Termalgin 650 mg tablets are available as white, oblong, scored tablets, in packs of 20 tablets.

Marketing authorization holder

GLAXOSMITHKLINE CONSUMER HEALTHCARE SA

Madrid Technology Park, Calle de Severo Ochoa, 2

28760 Tres Cantos, Madrid - Spain

Responsible for manufacturing

LUSOMEDICAMENTA Sociedade Técnica Farmacêutica, SA,

Estrada Consiglieri Pedroso, 69-B, Queluz

2730-055 Barcarena

Portugal

Date of the last revision of this leaflet: July 2019

Detailed and updated information on this drug is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/