Patient Information Leaflet

Termalgin 500 mg Film-Coated Tablets

Paracetamol

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

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

- 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

- You should consult a doctor if you worsen or do not improve after 5 days in adults (3 days for children or adolescents), or if the fever persists for more than 3 days.

1.What is Termalgin and what it is used for

2.What you need to know before starting to take Termalgin

3.How to take Termalgin

4.Possible side effects

5.Storage of Termalgin

6.Contents of the pack and additional information

This medication belongs to a group of medications called analgesics and antipyretics. It is indicated for the symptomatic relief of occasional mild to moderate pain, such as headache, dental pain, muscle pain (muscle spasms) or back pain (lumbago) and febrile states in adults and children aged 10 years and above and weighing more than 33 kg.

Do not take Termalgin:

If you are allergic (hypersensitive) to paracetamol, or to any of the other components of the medication.

Warnings and precautions:

Do not take more than the recommended dose as stated in section 3 of this leaflet (How to take Termalgin). Avoid using this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

You should consult your doctor or pharmacist before taking this medication:

• If you are asthmatic and sensitive to acetylsalicylic acid.
• If you have any liver, kidney, heart, or lung disease, or have anemia (a decrease in the hemoglobin level 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 to limit the amount of paracetamol you take.

In chronic alcoholics, be careful not to take more than 2 g per day of paracetamol (4 tablets).

When taking this medication with any medication for treating epilepsy, consult your doctor before taking this medication, as when used together, the efficacy is decreased and the toxicity of paracetamol is increased, especially in high-dose treatments of paracetamol.

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

You have severe diseases, such as severe renal insufficiency 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.

Taking too much paracetamol can cause severe liver damage.

Children

This medication is not recommended for use in children under 8 years old. Consult your doctor or pharmacist as there are other presentations with doses adapted to this group of patients.

Interference with analytical tests:

If you are to undergo any analytical test (including blood, urine, skin tests using allergens, etc...) inform your doctor that you are taking this medication, as it may alter the results of these tests. Paracetamol may alter the values of uric acid and glucose in blood measurements.

Termalgin with other medications:

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription. Paracetamol may interact with the following medications:

-Blood thinners: Oral anticoagulants (acenocoumarol, warfarin)

-Epilepsy medications: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)

-Tuberculosis medications: (isoniazid, rifampicin)

-Depression and seizure medications: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)

-Cholesterol-lowering medications: (cholestyramine)

-Diuretics (furosemide group)

-Gout medications: (probencid and sulfinpyrazone)

-Nausea and vomiting medications: Metoclopramide and domperidone

-High blood pressure and arrhythmia medications: Propranolol.

-Do not use with other analgesics (pain medications) without consulting your doctor.

-Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment (see section 2)

As a general rule for any medication, it is recommended to inform your doctor or pharmacist if you are taking another medication. In the case of oral anticoagulants, this medication can be used occasionally as the preferred analgesic.

Termalgin with food, drinks, and alcohol:

The taking of this medication with food does not affect its efficacy

Pregnancy

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

This medication can be used during pregnancy if necessary. 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.

Lactation

Consult your doctor or pharmacist before using any medication. Small amounts of paracetamol may appear in breast milk, so consult your doctor or pharmacist before taking this medication.Try to use the smallest amount that is effective, for the shortest possible time.

Driving and operating machinery

No effects have been described that modify the ability to drive and operate machinery.

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

Do not exceed the established dose and always use the minimum effective dose to alleviate your symptoms.

This medication must be taken orally.

The tablets should be swallowed whole, broken, or crushed, with the help of a liquid, preferably water.

The groove on the tablets allows the tablet to be divided into equal doses.

The recommended dose is:

Adults and adolescents over 15 years old: 1 or 2 tablets 3-4 times a day, depending on the intensity of the symptoms. 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 necessaryto respect the dosages defined according to weight. The child's age according to weight is given for information purposes only.

-Do not exceed the total dose of 60 mg/kg in divided doses of 10-15 mg/kg per day

-In children under 12 years old, do not continue treatment for more than 3 days without consulting your doctor.

-Children between 33 and 40 kg of weight (10 to 12 years old): half or one tablet per dose according to the intensity of the symptoms, every 6 hours,up to a maximum of 4 tablets per day.

-Between 41 and 50 kg of weight (12 to 15 years old): 1 tablet per dose, every 6 or 4 hours,up to a maximum of 5 tablets per day.

Children between 26 and 33 kg of weight (8 to 10 years old): can takehalf a tabletevery 4-6 hours,up to a maximum of 3 tablets per day.There are other medications available with dosages adapted to these children; consult your pharmacist.

Patients with liver disease:before taking this medication, they must consult their doctor. They should take the prescribed amount of medication with a minimum interval of 8 hours between each dose. They should not take more than 2 grams or 4 tablets of 500 mg of paracetamol in 24 hours.

Patients with kidney disease:before taking this medication, they must consult their doctor. Take a maximum of 500 milligrams per dose.

Patients of advanced age:they should consult their doctor.

The administration of the medication is subject to the appearance of pain or fever. As these disappear, the medication should be discontinued.

It should be avoided to use high daily doses of paracetamol for prolonged periods of time, as this increases the risk of suffering adverse effects such as liver damage.

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

When requiring the administration of doses lower than 500 mg of paracetamol per dose, it is recommended to use other paracetamol presentations that adapt to the required dosage, ask your doctor or pharmacist.

If you estimate that the action of this medication 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 you should, consult your doctor or the Toxicological Information Service (phone 915 620 420) immediately. If you have taken an overdose, you should go to a medical center immediately, due to the risk of liver failure, even if there are no symptoms, as they often do not appear until three days after the overdose, even in cases of severe intoxication. The symptoms of an overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the medication.

Patients undergoing treatment with barbiturates or those suffering from chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forget to take Termalgin:

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated interval (at least 4 hours).

If you interrupt the treatment with Termalgin:

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Possible Adverse Effects

Like all medications,Termalginmay cause adverse effects, although not everyone will experience them.

This medication may cause the following adverse effects:

-Rare (may affectup to1 in 1,000 people): Discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

-Very rare (may affectup to1 in 10,000 people): Kidney diseases, cloudy urine. Severe skin reactions, including allergic dermatitis (including skin rash, angioedema, and Stevens-Johnson syndrome), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia, thrombocytopenia), and hypoglycemia (low blood sugar). Liver function impairment. Paracetamol may damage the liver when taken in high doses or for prolonged periods. Bronchial spasm in patients allergic to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs).

-Unknown frequency (cannot be estimated from available data): A severe disease that may cause the blood to become more acidic (designated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Stop taking this medication and speak with a doctor immediately if:

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

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

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

-You experience bruising or unexplained bleeding.

These reactions are rare.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store below 30°C.

Do not use this medication after the expiration date shown on the packaging (after CAD.). 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 packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Termalgin:

The active ingredient is paracetamol.

The other components are:

Core: pregelatinized cornstarch, calcium carbonate, alginic acid, crospovidone, povidone, magnesium stearate, anhydrous colloidal silica. Coating: opadry white YS-1-7003 and carnauba wax.

Appearance of the product and content of the packaging:

Termalgin are coated tablets in capsule form, white or off-white in color, with the letter P encircled engraved on one face and “-“ on both sides of the groove on the other face.

It is presented in a cardboard box containing an aluminum/PVC blister pack containing 12 tablets, 24 tablets, or 500 tablets (Clinical Pack).

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization:

Haleon Spain, S.A.

C/Severo Ochoa Nº 2, 28760, PTM, Tres Cantos Madrid.

Responsible for manufacturing:

GlaxoSmithKline Dungarvan Ltd

Knockbrack- Dungarvan. Ireland.

or

Haleon Italy Manufacturing S.r.l.,

Via Nettunense, 90, Aprilia (LT), 04011, Italy

Date of the last review of this leaflet: January 2025.

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