Termalgin 500 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Termalgin 500 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 use of this medicine as described in this leaflet or as directed 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 reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult your doctor if you worsen or if fever persists beyond 3 days of treatment, or pain beyond 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 side 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 12 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 beyond 3 days of treatment or pain beyond 5 days.
2. What you need to know before starting to take Termalgin
Do not take Termalgin
- if you are allergic to paracetamol or to 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.
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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, 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 known as metabolic acidosis (an imbalance 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 difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
Interference with diagnostic 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, your dose may need to be adjusted or treatment interrupted:
- 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: colestyramine
- 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 (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol
- flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (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
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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 time. Contact your doctor if pain or fever do not improve, or if you need to take the medicine more frequently.
Paracetamol passes into breast milk; therefore, breastfeeding women should consult their doctor or pharmacist before taking this medicine.
Driving and operating machinery
The effect of this medicine on the ability to drive and operate machinery is none or negligible.
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:
Adolescents aged 12 to 18 years (weighing 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 every 4 – 6 hours as needed, up to a maximum of 6 tablets per day. Do not exceed 3 grams in 24 hours.
Patients with liver disease:
Before taking this medicine, you must consult your doctor.
You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.
You must not take more than 2 grams (4 tablets) of paracetamol in 24 hours.
Patients with kidney disease:
Before taking this medicine, you must consult your doctor. Take a maximum of 500 mg per dose.
Depending on your condition, your doctor will advise whether you should take the medicine with a minimum interval of 6 or 8 hours.
How to take
This medicine is administered orally.
The tablets should be swallowed whole or split with the help of a liquid. Do not exceed the recommended dose, and always use the lowest effective dose.
This medicine should be taken only when pain or fever occurs. As these symptoms subside, treatment should be discontinued. The medicine should be used for the shortest possible duration.
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, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, discontinue treatment and consult your doctor.
Use in children and adolescents
This medicine is intended for use only in adults and adolescents aged 12 years and older. Children and adolescents under 12 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 seek immediate medical attention due to the risk of liver failure, even if you do not experience symptoms, as these often do not appear until 3 days after the overdose, even in cases of severe poisoning.
Treatment for overdose is most effective if started within 4 hours of ingesting the overdose. Patients undergoing 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 name of 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 cause adverse effects, although not everyone experiences them.
The possible adverse effects of Termalgin are:
Uncommon adverse effects, may affect up to 1 in 1,000 people: malaise, hypotension (low blood pressure), and increased levels of transaminases in blood.
Very rare adverse effects, 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), and hypoglycaemia (low blood sugar). Liver function impairment. 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 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 previously had breathing problems with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), and experience 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 can 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
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Expiry . The expiry date is 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 you are 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 (excipients) are: talc (E-553b), povidone (E-1201), corn starch, colloidal anhydrous silica (E-551), microcrystalline cellulose (E-460i) and stearic acid (E-570).
Appearance of Termalgin and contents of the pack
White, round, biconvex, scored tablets.
Available in packs of 20 or 40 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Haleon Spain, S.A.
Paseo de la Castellana, 259D, 32nd floor - 28046 – Madrid – Spain
Manufacturer
LUSOMEDICAMENTA SOCIEDADE TECNICA FARMACÊUTICA S.A
ESTRADA CONSIGLIERI PEDROSO 69-B
(QUELUZ DE BAIXO BARCARENA) - 2730-055 – Portugal
Date of the most recent review 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 Medical Devices (AEMPS) http://www.aemps.gob.es/