Leaflet: information for the user

Termalgin 500 mg tablets

Paracetamol

Read this leaflet carefully before you start taking this medicine, as it contains important information for you

Follow exactly the administration instructions for this medicine contained in this leaflet or those given by your doctor, pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult your doctor if your fever worsens or persists after 3 days of treatment or if your pain lasts for 5 days.

Paracetamol is effective in reducing pain and fever.

This medication is used in adults and adolescents 12 years of age and older for symptomatic relief of occasional mild to moderate pain, such as headache, toothache, muscle pain (muscle cramps) or back pain (lumbago), as well as in febrile states.

Consult a doctor if the fever worsens or persists after 3 days of treatment or if the pain lasts for 5 days.

Do not take Termalgin

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Termalgin.

• Do not take more of the medication than recommended in section 3, "How to take Termalgin," as it may cause serious liver damage.

- Avoid taking this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not take more than one medication containing paracetamol without consulting your doctor

• Chronic alcoholics should be careful not to take more than 2 grams (4 tablets) of paracetamol in 24 hours.
• Patients with kidney, liver, heart, or lung diseases, and patients with anemia, should consult their doctor before taking this medication.
• When taking medication for epilepsy, consult your doctor before taking this medication, as it may reduce the effectiveness and increase the hepatotoxicity of paracetamol, especially at high doses.
• Patients with asthma sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• Consult your doctor or pharmacist before taking this medication:
• If you have any liver, kidney, heart, or lung disease, or anemia (decreased hemoglobin levels in the blood, due or not due to a decrease in red blood cells).
• If you have dehydration, underweight, or chronic malnutrition.
• If you are taking warfarin or other oral anticoagulants.
• If you regularly consume alcohol.
• As it may be necessary not to take this medication or limit the amount of paracetamol you take.

Inform your doctor immediately if you experience any of the following during treatment with this medication:

if you have severe diseases, such as severe kidney failure 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 severe 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Interference with analytical tests

Inform your doctor if you are to undergo any analytical tests (including blood, urine, etc.) as this medication may alter the results.

Children

Due to the amount of paracetamol it contains, children (under 12 years) cannot take this medication

Termalgin with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

• Medication to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
• Medications for treating epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for treating tuberculosis: isoniazid, rifampicin
• Medications for treating depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications used to lower cholesterol levels in the blood: cholestyramine
• Medications used to increase urine elimination (diuretics of the loop, such as furosemide)
• Medications used to treat gout: probenecid and sulfinpyrazone
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): propranolol
• flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment (see section 2)

Termalgin with food, drinks, and alcohol

The taking of this medication with food does not affect its effectiveness.

Pregnancy and breastfeeding

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If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

In case of need, Termalgin 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 medication more frequently.

Paracetamol passes into breast milk, so women breastfeeding should consult their doctor or pharmacist before taking this medication.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adolescents 12 years to 18 years (43 – 65 kg):

Take 1 tablet every 4 – 6 hours, as needed, up to a maximum of 5 tablets per day.

Adults:

Take 1 - 2 tablets, if necessary, every 4 - 6 hours, as needed, up to a maximum of 6 tablets per day. Do not take more than 3 grams in 24 hours.

Patients with liver diseases:

Before taking this medication, they must consult their doctor.

They must take the prescribed amount of medication with a minimum interval of 8 hours between each dose.

They must not take more than 2 grams (4 tablets) of paracetamol in 24 hours.

Patients with kidney diseases:

Before taking this medication, they must consult their doctor. Take a maximum of 500 mg per dose.

According to their disease, their doctor will indicate if they should take their medication with a minimum interval of 6 or 8 hours.

How to take

This medication is administered orally.

The tablets must be swallowed whole or broken with the help of a liquid. Do not exceed the established dose, and always take the lower effective dose.

The use of this medication is subject to the appearance of pain or fever. As these disappear, treatment should be suspended. The medication should be used for the shortest possible time.

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.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or other symptoms appear, treatment should be interrupted and the doctor consulted.

Use in children and adolescents

This medication is for exclusive use in adults and adolescents from 12 years old. Children and adolescents under 12 years old cannot take this medication.

If you take more Termalgin than you should

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

If you have taken an overdose, you must go immediately to a medical center, due to the risk of liver failure, even if you do not notice the symptoms, as they often do not appear until 3 days after the overdose, even in cases of severe intoxication.

The treatment of an overdose is more effective if it is initiated within 4 hours of the overdose of the medication. Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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

If you forgot to take Termalgin

Do not take a double dose to compensate for the missed doses.

Like all medicines, Termalgin may cause side effects, although not everyone will experience them.

The possible side effects of Termalgin are:

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

Very rare side effects, which may affect up to 1 in 10,000 people: kidney diseases, cloudy urine, Severe skin reactions have been reported, including allergic dermatitis (including skin rash, angioedema, and Stevens-Johnson syndrome), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Liver function alteration. Paracetamol can damage the liver when taken in high doses or prolonged treatment. Bronchial spasm in patients allergic to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

Unknown frequency (cannot be estimated with available data): headache induced by analgesic abuse, A severe disease that can make the blood more acidic (designated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Stop taking this medicine and talk to a doctor immediately if:

-You experience allergic reactions such as skin rash or itching, sometimes with breathing problems or swelling of the lips, tongue, throat, or face.

-You suffer from a skin rash or peeling, or ulcers in the mouth.

-You have previously experienced breathing problems with aspirin or NSAIDs, and experience a similar reaction with this medicine.

-You experience bruising or unexplained bleeding.

These reactions are rare.

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

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects that do not appear in this leaflet.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No special conditions for conservation are required.

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

Do not use this medication after the expiration date that appears on the packaging afterExpiration Date. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Termalgin

The active principle is paracetamol.

The other components (excipients) are: talc (E-553b), povidone (E-1201), cornstarch, anhydrous colloidal silica (E-551), microcrystalline cellulose (E-460i) and stearic acid (E-570).

Appearance of Termalgin and content of the packaging

White, round, biconvex, scored tablets.

It is presented in packaging of 20 or 40 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

Haleon Spain, S.A.

Parque Tecnológico de Madrid, Calle de Severo Ochoa, 228760 Tres Cantos, Madrid - Spain

Responsible for manufacturing

LUSOMEDICAMENTA SOCIEDADE TECNICA FARMACÉUTICA S.A

ESTRADA CONSIGLIERI PEDROSO 69-B

(QUELUZ DE BAIXO BARCARENA) - 2730-055 – Portugal

Date of the last review of this leaflet:January 2025

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/