TERMALGIN 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Termalgin 500 mg Film-Coated Tablets

Paracetamol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package 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 or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms 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.

Contents of the Package Leaflet:

1. What Termalgin is and what it is 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. Package Contents and Additional Information

1. What Termalgin is and what it is used for

This medication belongs to the group of medications called analgesics and antipyretics. It is indicated for the symptomatic relief of occasional mild or moderate pain, such as headache, toothache, muscle pain (cramps) or back pain (lumbago), and febrile states in adults and children over 10 years old and 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 any of the other components of the medication.

Warnings and Precautions:

Do not take more than the recommended dose in section 3 of this package leaflet (How to take Termalgin). The simultaneous use of this medication with other medications containing paracetamol, such as flu and cold medications, should be avoided, as high doses can lead to liver damage. Do not use more than one medication containing 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 if you have anemia (decreased hemoglobin level in the blood, due to or not due to a decrease 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 medication or to limit the amount of paracetamol you take.

In chronic alcoholics, it is recommended not to take more than 2 grams per day of paracetamol (4 tablets).

When being treated with any medication for epilepsy, you should consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and its toxicity increased, especially with high doses of paracetamol.

During treatment with this medication, 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 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 breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Taking too much paracetamol can cause serious liver damage.

Children

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

Interference with Laboratory Tests:

If you are going to have any laboratory tests (including blood tests, urine tests, 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 uric acid and glucose measurements in blood.

Taking 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:

-Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)

-Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)

-Medications to treat tuberculosis: (isoniazid, rifampicin)

-Medications to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)

-Medications to lower cholesterol levels in blood: (cholestyramine)

-Medications used to increase urine elimination (loop diuretics such as furosemide)

-Medications used to treat gout (probenecid and sulfinpyrazone)

-Medications used to prevent nausea and vomiting: Metoclopramide and domperidone

-Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.

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

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

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Taking Termalgin with Food, Drinks, and Alcohol:

Taking this medication with food does not affect its efficacy.

Pregnancy

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

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 medication more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medication. Small amounts of paracetamol may appear in breast milk; therefore, it is recommended to 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 Using Machines

No effects have been described that alter the ability to drive or operate machinery.

3. How to Take Termalgin

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. 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 should be administered orally.

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

The score line 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. The doses should be spaced at least 4 hours apart. Do not take more than 6 tablets (3 grams) in 24 hours.

Use in Children and Adolescents:It is necessary to respect the dosages defined according to weight. The child's age is given for informational purposes.

-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 in weight (from 10 to 12 years old): half or one tablet per dose, depending on the intensity of the symptoms, every 6 hours, up to a maximum of 4 tablets per day.
• Between 41 and 50 kg in weight (from 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 in weight (from 8 to 10 years old) can take half a tabletevery 4-6 hours, up to a maximum of 3 tablets per day. There are other medications available with doses suitable for these children; consult your pharmacist.

Patients with liver disease: before taking this medication, they must consult their doctor. They should take the amount of medication prescribed by their doctor, with a minimum interval between each dose of 8 hours. 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.

Elderly patients: 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 suspended.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of side effects such as liver damage increases.

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, you should interrupt treatment and consult your doctor.

When lower doses of paracetamol are required, it is recommended to use other presentations of paracetamol that adapt to the required dosage; ask your doctor or pharmacist.

If you think the effect 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 Toxicology Information Service (telephone 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 taking the overdose, even in cases of severe poisoning. The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

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

Patients being treated with barbiturates or 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 make up for forgotten doses; simply take the forgotten dose when you remember, taking the next doses with the indicated spacing between doses (at least 4 hours).

If you stop taking Termalgin:

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

4. Possible Side Effects

Possible Side Effects

Like all medications, Termalgincan cause side effects, although not everyone experiences them.

This medication can cause the following side effects:

-Rare (may affect up to1 in 1,000 people): discomfort, low blood pressure (hypotension), and increased levels of transaminases in blood.

-Very rare (may affect up to1 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, leukopenia, neutropenia, hemolytic anemia, thrombocytopenia), and hypoglycemia (low blood sugar) have been reported. Liver function disorder. Paracetamol can damage the liver when taken in high doses or in prolonged treatments. Bronchospasm in patients allergic to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

-Frequency not known (cannot be estimated from available data): 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 medication 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 ulcers in the mouth.

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

-You experience unexplained bruising or bleeding.

These reactions are rare.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Termalgin

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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Termalgin Composition:

The active ingredient is paracetamol.

The other ingredients are:

Core: pregelatinized corn starch, 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 Package Contents:

Termalgin are film-coated tablets in capsule shape, white or off-white in color, with the letter P surrounded by a circle engraved on one face and "-" on both sides of the score line 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 Packaging).

Only some package sizes may be marketed.

Marketing Authorization Holder:

Haleon Spain, S.A.

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

Manufacturer:

GlaxoSmithKline Dungarvan Ltd

Knockbrack - Dungarvan, Ireland.

or

Haleon Italy Manufacturing S.r.l.,

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

Date of the Last Revision of this Package Leaflet: January 2025.

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