Termalgine 500 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the patient
Introduction
Package leaflet: information for the patient
Termalgin 500 mg film-coated 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 or pharmacist.
- Keep this leaflet, as you may need to refer to it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 5 days in adults (3 days in children or adolescents), or if fever persists for more than 3 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 side effects
- How to store Termalgin
- Contents of the pack and other information
1. What Termalgin is and what it is used for
This medicine belongs to the group of medicines called analgesics and antipyretics. It is indicated for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle spasms), or back pain (lumbago), and for febrile conditions in adults and children aged 10 years and older weighing more than 33 kg.
2. What you need to know before taking Termalgin
Do not take Termalgin:
If you are allergic (hypersensitive) to paracetamol, or to any of the other components of the medicine.
Warnings and precautions:
Do not take more than the recommended dose stated in section 3 of this leaflet (How to take Termalgin). The simultaneous use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
You should consult your doctor or pharmacist before taking this medicine:
- If you have asthma and are sensitive to acetylsalicylic acid.
- 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.
In chronic alcoholics, care should be taken not to exceed 2 g of paracetamol per day (4 tablets).
If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, as using both simultaneously may reduce the effectiveness of paracetamol and increase its toxicity, especially with high-dose paracetamol treatment.
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 in these situations 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.
Taking too much paracetamol can cause severe liver damage.
Children
The use of this medicine is not recommended in children under 8 years of age. Consult your doctor or pharmacist, as other formulations with doses appropriate for this patient group are available.
Interference with diagnostic tests:
If you are scheduled to undergo any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests. Paracetamol may affect measurements of blood uric acid and glucose levels.
Taking Termalgin with other medicines:
Inform your doctor or pharmacist if you are using or have recently used any other medicines, even those obtained without a prescription. Paracetamol may interact with the following medicines:
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Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
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Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
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Medicines for tuberculosis: (isoniazid, rifampicin)
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Medicines for depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
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Medicines to lower blood cholesterol levels: (cholestyramine)
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Medicines used to increase urine elimination (loop diuretics such as furosemide)
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Medicines used in the treatment of gout: (probenecid and sulfinpyrazone)
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Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
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Medicines used for high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol
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Do not use with other analgesics (medicines that relieve pain) without consulting your doctor.
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Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder (called metabolic acidosis) that requires urgent treatment (see section 2)
As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking another medicine. In patients taking oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.
Taking Termalgin with food, drinks, and alcohol:
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Taking this medicine with food does not affect its efficacy.
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
If necessary, Termalgin may be used during pregnancy. You should 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 improve or if you need to take the medicine more frequently.
Breastfeeding
Consult your doctor or pharmacist before using any medicine. Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine. Try to use the lowest effective dose for the shortest possible time.
Driving and using machines
No effects affecting the ability to drive or operate machinery have been reported.
3. How to take Termalgin
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Do not exceed the recommended dose, and always use the lowest effective dose needed to relieve your symptoms.
This medicine is for oral use.
Tablets should be swallowed whole, split, or crushed, with a glass of liquid, preferably water.
The tablet's score line allows it to be divided into equal doses.
Recommended dose:
Adults and adolescents over 15 years of age: 1 or 2 tablets 3–4 times daily, depending on symptom intensity. Doses should be spaced at least 4 hours apart. Do not take more than 6 tablets (3 g) in 24 hours.
Use in children and adolescents: It is essential to follow dosage recommendations based on body weight. The age ranges corresponding to weight are provided for informational purposes only.
- Do not exceed a total daily dose of 60 mg/kg, administered as divided doses of 10–15 mg/kg per day.
- In children under 12 years of age, do not continue treatment for more than 3 days without consulting your doctor.
- Children weighing 33–40 kg (aged 10–12 years): half or one tablet per dose, depending on symptom severity, every 6 hours, up to a maximum of 4 tablets per day.
- Children weighing 41–50 kg (aged 12–15 years): one tablet per dose every 6 or 4 hours, up to a maximum of 5 tablets per day.
Children weighing 26–33 kg (aged 8–10 years): may take half a tablet every 4–6 hours, up to a maximum of 3 tablets per day. Other medicines with doses adapted for these children are available; please consult your pharmacist.
Patients with liver disease: You must consult your doctor before taking this medicine. Take only the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not take more than 2 grams or 4 tablets of 500 mg paracetamol in 24 hours.
Patients with kidney disease: You must consult your doctor before taking this medicine. Take a maximum of 500 milligrams per dose.
Elderly patients: You should consult your doctor.
This medicine should only be taken when pain or fever occurs. As symptoms improve, treatment should be discontinued.
Avoid using high daily doses of paracetamol for prolonged periods, as this increases the risk of adverse effects, such as liver damage.
If pain persists for more than 5 days (3 days in children or adolescents), if fever lasts more than 3 days, or if pain or fever worsen or new symptoms appear, stop treatment and consult your doctor.
When doses lower than 500 mg of paracetamol per administration are required, it is recommended to use other paracetamol formulations better suited to the required dosage. Ask your doctor or pharmacist for advice.
If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
If you take more Termalgin than you should:
If you have taken more paracetamol than recommended, contact your doctor or the Poison Information Service immediately (telephone 915 620 420). In case of overdose, seek immediate medical attention due to the risk of liver failure, even if no symptoms are present, as symptoms often do not appear until three days after the overdose—even in severe cases. Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
Treatment for overdose is most effective when started within 4 hours of taking the medicine.
Patients undergoing treatment with barbiturates or those with chronic alcoholism may be more susceptible to paracetamol overdose.
If you forget to take Termalgin:
Do not take a double dose to make up for missed doses. Simply take the missed dose as soon as you remember, then continue with your next dose at the recommended interval (at least 4 hours apart).
If you stop treatment with Termalgin:
If you have any questions about using this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Possible adverse effects
Like all medicines, Termalgin may cause adverse effects, although not everyone experiences them.
This medicine may cause the following adverse effects:
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Rare (may affect up to 1 in 1,000 people): malaise, low blood pressure (hypotension), and increased blood transaminase levels.
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Very rare (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine. Some cases of serious skin reactions have been reported, including allergic dermatitis (such as skin rash, angioedema, and Stevens-Johnson syndrome), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia, thrombocytopenia), 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).
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Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).
Stop taking this medicine and contact a doctor immediately if:
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You experience allergic reactions such as skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face.
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You develop a skin rash or peeling, or mouth ulcers.
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You have previously experienced breathing problems with aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), and have a similar reaction with this medicine.
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You experience unexplained bruising or bleeding.
These reactions are rare.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 reach and sight of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the container (after EXP.). The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers 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.
The other components are:
Core: pregelatinized corn starch, calcium carbonate, alginic acid, crospovidone, povidone, magnesium stearate, colloidal anhydrous silica.
Coating: Opadry White YS-1-7003 and carnauba wax.
Appearance of the product and contents of the pack:
Termalgin are capsule-shaped, film-coated tablets, white or almost white, with the letter P within a circle engraved on one side and “-” on both sides of the score line on the other side.
It is presented in cardboard packs containing Al/PVC blisters with 12 tablets, 24 tablets, or 500 tablets (Hospital Pack).
Only certain pack sizes may be marketed.
Marketing Authorization Holder:
Haleon Spain, S.A.
C/Severo Ochoa No. 2, 28760, PTM, Tres Cantos, Madrid.
Manufacturer:
Haleon Ireland Dungarvan Ltd
Knockbrack, Dungarvan, Ireland.
or
Haleon Italy Manufacturing S.r.l.
Via Nettunense, 90, Aprilia (LT), 04011, Italy
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/