Paracetamol Tecnimede 1 g film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Tecnimede 1 g film-coated tablets

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Always follow exactly the instructions for taking this medicine as contained in this leaflet or as given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further 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.
• If your condition worsens or if fever persists beyond 3 days of treatment or pain beyond 5 days, you should consult your doctor.

Contents of the leaflet

1. What Paracetamol Tecnimede is and what it is used for
2. What you need to know before taking Paracetamol Tecnimede
3. How to take Paracetamol Tecnimede
4. Possible adverse effects
5. How to store Paracetamol Tecnimede
6. Contents of the pack and other information

1. What Paracetamol Tecnimede is and what it is used for

Paracetamol is effective in reducing pain and fever.

This medicine is used in adults (body weight over 50 kg) for the symptomatic relief of mild to moderate occasional pain and feverish 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 Paracetamol Tecnimede

Do not take Paracetamol Tecnimede

If you are allergic to paracetamol or to any of the other components of this medicine (listed in section 6).

Do not take more medicine than the recommended dose stated in section 3. How to take Paracetamol Tecnimede, as serious liver damage may occur.

Warnings and precautions

Consult your doctor or pharmacist before starting to take paracetamol.

• if you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic drinks per day);
• if you have kidney problems;
• if you have glucose-6-phosphate dehydrogenase deficiency;
• if you have anorexia, bulimia, cachexia, or chronic malnutrition;
• if you are dehydrated or have hypovolemia;
• if you are taking a medicine to treat epilepsy, you should consult your doctor before taking this medicine, as its concurrent use may reduce effectiveness and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatments (see further below in this section);
• if you have Gilbert's disease (also known as Meulengracht's disease);
• if you have heart failure, respiratory failure, or anemia; in these situations, administration should be under medical supervision and only for short periods;
• if you have asthma and are sensitive to acetylsalicylic acid.

Paracetamol may cause serious skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the medicine must be stopped at the first sign of a skin rash or any other sign of hypersensitivity.

During treatment with Paracetamol Tecnimede, 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 concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

The total daily dose of paracetamol must not exceed 3 g.

Chronic alcoholics should be careful not to take more than 2 grams of paracetamol in 24 hours.

Concurrent use of this medicine with other medicines containing paracetamol, such as 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. If an overdose occurs, seek medical attention immediately.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, your clinical condition should be evaluated by your doctor. This medicine should not be used for self-treatment of high fever (over 39°C), fever lasting more than 3 days, or recurrent fever, unless directed by your doctor, as these conditions may require medical evaluation and treatment.

Taking paracetamol doses higher than recommended involves a very high risk of severe liver injury. Medicines containing paracetamol should not be taken for longer than a few days or in high doses unless directed by your doctor.

Prolonged use of analgesics or inappropriate use of high doses may cause headaches, which should not be treated with higher doses of the medicine (see "If you take more than you should").

Children and adolescents

Due to the amount of paracetamol it contains, this medicine must not be used in individuals under 18 years of age or weighing less than 50 kg.

Other medicines and Paracetamol Tecnimede

Inform your doctor or pharmacist if you are currently 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, a dose adjustment or discontinuation of treatment may be necessary:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
• Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines to treat tuberculosis: isoniazid, rifampicin
• Medicines to treat 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 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
• Salicylamide, a medicine used to treat fever and pain, may prolong the elimination half-life of paracetamol.
• Zidovudine (used in the treatment of HIV infections)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2)

Interference with laboratory tests

If you are scheduled for any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results. Paracetamol may affect the analytical values of uric acid and glucose measurements.

Taking Paracetamol Tecnimede with food, drinks, and alcohol

Using paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

Paracetamol may be used during pregnancy if necessary. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever does not improve or if you need to take the medicine more frequently.

Breastfeeding

Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Fertility

No harmful effects on fertility are known with normal use of paracetamol.

Driving and using machines

The influence of this medicine on the ability to drive and operate machinery is negligible or none.

3. How to take Paracetamol Tecnimede

Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults (body weight over 50 kg)

Take 1 tablet every 6–8 hours as needed, up to a maximum of 3 tablets per day.

Patients with liver disease

Consult your doctor before taking this medicine.

They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses.

They must not take more than 2 grams (2 tablets) of paracetamol in 24 hours.

Patients with kidney disease

Consult your doctor before taking this medicine.

Patients with moderate to severe renal disease should take a maximum of 500 mg of paracetamol per dose. Depending on their condition, their doctor will indicate whether they should take the medicine with a minimum interval of 6 or 8 hours between doses.

Due to the dosage (1 gram of paracetamol), this medicine is not indicated for this patient group.

How to take

This medicine is taken orally.

The tablets should be swallowed whole or split in half, with a liquid, preferably water.

The tablets are scored, allowing them to be split in half. The tablet can be divided into equal doses.

Do not exceed the recommended dose and always use the lowest effective dose.

Prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.

This medicine should only be administered when pain or fever occurs. As these symptoms subside, treatment should be discontinued. The medicine should be used for the shortest time possible.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment should be stopped and a doctor consulted.

If you take more Paracetamol Tecnimede than you should

Contact your doctor or pharmacist immediately.

Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

If an overdose has occurred, seek immediate medical attention due to the risk of liver failure, even if no symptoms are present, as symptoms 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 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Paracetamol Tecnimede

Do not take a double dose to make up for missed doses.

If you forget to take a dose, take it as soon as you remember, then take the following doses at the recommended intervals (at least 6 hours apart).

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects that may occur in adults and adolescents are:

Rare adverse effects: may affect up to 1 in 1,000 people:

• Malaise,
• hypotension (low blood pressure),
• increased levels of transaminases in the blood.

Very rare adverse effects: may affect up to 1 in 10,000 people:

• Kidney disorders,
• cloudy urine,
• allergic dermatitis (including skin rash, angioedema, and Stevens-Johnson syndrome),
• jaundice (yellowing of the skin),
• blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).
• Very rare cases of severe skin reactions have been reported. Bronchospasm in patients allergic to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

Frequency not known: 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 difficulty breathing 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 can damage the liver 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, 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 through 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 Paracetamol Tecnimede

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

Do not use this medicine after the expiry date stated after EXP on the packaging and on the blister. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Tecnimede

The active substance is paracetamol. Each tablet contains 1 g of paracetamol.

The other components (excipients) are:

Core of the tablet: pregelatinized corn starch, magnesium stearate

Tablet coating: hypromellose, macrogol, propylene glycol, talc and titanium dioxide (E171).

Appearance of the medicinal product and contents of the container:

Film-coated tablets, capsule-shaped, white to off-white, oval, approximately 21.00 mm x 10.00 mm, smooth on one side and scored on the other.

The tablet can be divided into equal doses.

The medicine is packaged in blisters (PVC/Alu) containing 10 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega.

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2

Abrunheira, 2710-089 Sintra

Portugal

Tecnimede – Sociedade Técnico-Medicinal S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Date of the most recent review of this leaflet: January 2025

Detailed 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/