TERMALGIN 650 mg TABLETS

Introduction

Package Leaflet: Information for the User

Termalgin 650 mg Tablets

Paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of this medicine contained in this leaflet or as indicated 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 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 persists or worsens after 5 days.

Contents of the Package Leaflet:

1. What is Termalgin and what is it used for
2. What you need to know before taking Termalgin
3. How to take Termalgin
4. Possible side effects
5. Storage of Termalgin
6. Contents of the pack and further information

1. What is Termalgin and what is it used for

Paracetamol is effective for 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, toothache, muscle pain (cramps), or back pain (lumbago), as well as in febrile states.

You should consult a doctor if your fever worsens or persists after 3 days of treatment or if your pain persists or worsens after 5 days.

2. What you need to know before taking Termalgin

Do not take Termalgin

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

Warnings and precautions

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

• Do not take more than the recommended dose of this medicine, as stated in section 3, How to take Termalgin, as serious liver damage may occur.

• Avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as flu and cold medicines, as high doses may lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor
  • Chronic alcoholics should be cautious not to take more than 2 grams (4 tablets) of paracetamol in 24 hours.
  • Patient with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medicine.
  • If you are being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be reduced and hepatotoxicity may be increased, especially with high doses of paracetamol.
  • Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
  • You should consult your doctor or pharmacist before taking this medicine:
  • If you have any liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells).
  • If you have dehydration, low weight, 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 medicine or to limit the amount of paracetamol you take.

During treatment with this medicine, inform your doctor immediately if:

• 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 severe 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.

Interference with laboratory tests

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

Children

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

Taking Termalgin with other medicines

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

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

• Medicines 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 convulsions: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to reduce cholesterol levels in the blood: cholestyramine
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• 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 and heart rhythm disorders (arrhythmias): propranolol
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking Termalgin with food, drinks, and alcohol

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 plan 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 decrease 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 this medicine on the ability to drive and use machines is negligible.

3. How to take Termalgin

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

The recommended dose is:

Adults and adolescents from 14 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.

Patient with liver disease:

Before taking this medicine, they must consult their doctor.

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

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

Patient with kidney disease:

Before taking this medicine, they must consult their doctor.

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

How to take

This medicine is administered orally.

The tablets should be swallowed whole or broken with the help of some liquid. Do not exceed the established dose and always take the lowest effective dose. The medicine should be used for the shortest possible time.

Taking this medicine is subject to the appearance of pain or fever. As they disappear, treatment should be discontinued.

Avoid using high daily doses of paracetamol for prolonged periods, as the risk of side effects such as liver damage increases.

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, discontinue treatment and consult your doctor.

Use in children and adolescents

This medicine is for use exclusively 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

Symptoms of overdose 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 immediately go to a medical center, due to the risk of liver failure, even if you do not notice symptoms, as they often do not appear until 3 days after taking the overdose, even in cases of severe poisoning.

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

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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

If you forget to take Termalgin

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

4. Possible side effects

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

Possible side effects of Termalgin are:

Rare side effects, may affect up to 1 in 1,000 people: discomfort, hypotension (low 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, Some cases of severe skin reactions, allergic dermatitis (including skin rash, angioedema, and Stevens-Johnson syndrome), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Liver function disorder. Paracetamol may damage the liver when taken in high doses or for prolonged periods. Bronchospasm in patients allergic to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

Frequency not known (cannot be estimated from the available data): headache induced by analgesic abuse, A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using 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 skin rash or peeling, or mouth ulcers.

-You have previously had breathing problems with aspirin or non-steroidal anti-inflammatory drugs, and you experience a similar reaction with this medicine.

-You experience bruising or bleeding without explanation.

These reactions are rare.

Paracetamol may damage the liver when taken in high doses or for prolonged periods.

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

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Termalgin

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after Expiration Date. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Termalgin

The active ingredient is paracetamol. Each tablet contains 650 mg of paracetamol.

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

Appearance of Termalgin and pack contents

White, oblong, scored tablets, packaged in boxes of 20 tablets.

Marketing Authorization Holder

Haleon Spain, S.A.

Paseo de la Castellana, 259D, 32nd floor - 28046 - Madrid - Spain

Manufacturer

LUSOMEDICAMENTA Sociedade Técnica Farmacêutica, S.A.,

Estrada Consiglieri Pedroso, 69-B, Queluz

2730-055 Barcarena

Portugal

Date of last revision of this leaflet:January 2025

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