Termalgin 650 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Termalgin 650 mg tablets
Paracetamol
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for administration of this medicine provided 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult your doctor if your condition worsens or if fever persists after 3 days of treatment or pain after 5 days.
Leaflet contents:
- What Termalgin is and what it is used for
- What you need to know before taking Termalgin
- How to take Termalgin
- Possible adverse effects
- How to store Termalgin
- Contents of the pack and other information
1. What Termalgin is and what it is used for
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 mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle spasms), or back pain (lumbago), as well as for febrile conditions.
You should consult a doctor if symptoms worsen or if fever persists for more than 3 days of treatment or pain for more than 5 days.
2. What you need to know before taking Termalgin
Do not take Termalgin
- if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take Termalgin.
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Do not take more medicine than the recommended dose stated in section 3, How to take Termalgin, as serious liver damage may occur.
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The simultaneous use of this medicine with other medicines containing paracetamol (e.g. cold and flu remedies) should be avoided, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
- Chronic alcoholics should take care not to exceed 2 grams (4 tablets) of paracetamol in 24 hours.
- Patients with kidney, liver, heart, or lung disease, or those with anemia, should consult their doctor before taking this medicine.
- If you are being treated with medication for epilepsy, you must consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
- Asthmatic patients who are 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 liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells).
- If you are dehydrated, underweight, or suffer from chronic malnutrition.
- If you are taking warfarin or other oral anticoagulants.
- If you regularly consume alcohol.
- As it may be necessary to avoid taking this medicine or to limit the amount of paracetamol you take.
During treatment with this medicine, inform your doctor immediately if:
- You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
Interference with laboratory tests
If you are due to have any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.
Children
Due to the amount of paracetamol it contains, this medicine must not be given to children under 12 years of age.
Taking Termalgin with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
In particular, if you are taking any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:
- Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
- Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
- Medicines for tuberculosis: isoniazid, rifampicin
- Medicines for 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 furosemide)
- Medicines used in the treatment of 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 disorders (cardiac arrhythmias): propranolol
- flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2)
Taking Termalgin with food, drinks, and alcohol
The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, liquor, etc., per day) may cause liver damage. |
Taking this medicine with food does not affect its effectiveness.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Termalgin may be used during pregnancy if necessary. Use the lowest possible dose that relieves pain or fever, and take it for the shortest possible duration. Contact your doctor if pain or fever do not subside, or if you need to take the medicine more frequently.
Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.
Driving and operating machinery
This medicine has no or negligible influence on the ability to drive or operate machinery.
3. How to take Termalgin
Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents aged 14 to 18 years:
Take 1 tablet every 4 to 6 hours as needed, up to a maximum of 4 tablets per day. Do not exceed 3 grams of paracetamol in 24 hours.
Patients with liver disease:
You must consult your doctor before taking this medicine.
You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.
You should not take more than 2 grams (3 tablets) of paracetamol in 24 hours, divided into 3 doses.
Patients with kidney disease:
You must consult your doctor before taking this medicine.
Due to the dose of 650 mg of paracetamol, these patients should not take this medicine.
How to take
This medicine is administered orally.
Tablets should be swallowed whole or split with the help of a liquid. Do not exceed the recommended dose, and always take the lowest effective dose. The medicine should be used for the shortest possible time.
This medicine should only be taken when pain or fever occurs. As these symptoms subside, treatment should be discontinued.
Prolonged use of high daily doses of paracetamol should be avoided, as it 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 new symptoms appear, you must stop treatment and consult your doctor.
Use in children and adolescents
This medicine is intended for use only in adults and adolescents aged 14 years and older. Children and adolescents under 14 years of age must not take this medicine.
If you take more Termalgin than you should
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 must immediately go to a medical center due to the risk of liver failure, even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.
Treatment of overdose is most effective if started within 4 hours of taking the overdose.
Patients receiving treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.
In case of overdose or accidental ingestion, seek immediate medical attention or call the Toxicology Information Service (telephone: 91 562 04 20), stating the medicine and the amount ingested.
If you forget to take Termalgin
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, Termalgin may produce adverse effects, although not everyone experiences them.
Possible adverse effects of Termalgin are:
Rare adverse effects, may affect up to 1 in 1,000 people: malaise, hypotension (low blood pressure), and increased blood transaminase levels.
Very rare adverse effects, may affect up to 1 in 10,000 people: kidney disorders, cloudy urine. There have been reports of some cases of serious skin reactions, allergic dermatitis (including skin rash, angioedema, and Stevens-Johnson syndrome), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Impaired liver function. Paracetamol may cause liver damage when taken in high doses or during prolonged treatment. Bronchospasm in patients allergic to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).
Frequency unknown (cannot be estimated from the available data): headache caused by analgesic overuse, a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).
Stop taking this medicine and speak to a doctor immediately if:
-You experience allergic reactions such as skin rash or itching, sometimes with breathing difficulties or swelling of the lips, tongue, throat, or face.
-You develop a skin rash or peeling, or mouth ulcers.
-You have previously experienced breathing problems with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), and have a similar reaction with this medicine.
-You experience unexplained bruising or bleeding.
These reactions are rare.
Paracetamol may cause liver damage when taken in high doses or during prolonged treatment.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es . By reporting adverse 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 expiry date stated on the packaging after Expiry. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Termalgin
The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.
- The other components (excipients) are talc (E-553b), povidone (E-1201), corn starch, pregelatinized corn starch, anhydrous colloidal silica (E-551), microcrystalline cellulose (E-460i), and stearic acid (E-570).
Appearance of Termalgin and contents of the pack
White, oblong, scored tablets, packed 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 the most recent revision of this leaflet: January 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/