Paracetamol Tecnimede 500 mg comprimidos recubiertos con película

Contents of the leaflet

1. Introduction
2. What is Paracetamol Tecnimede and what is it used for
3. What you need to know before taking Paracetamol Tecnimede
4. How to take Paracetamol Tecnimede
5. Possible side effects
6. Storage of Paracetamol Tecnimede
7. Package contents and additional information

Introduction

Leaflet: Information for the User

Paracetamol Tecnimede 500 mg film-coated tablets

Read the entire 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 leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this 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 leaflet. See section 4.
• If your condition worsens or if the fever persists after 3 days of treatment or the pain for 5 days, you should consult your doctor.

Contents of the Leaflet

1. What is Paracetamol Tecnimede and what is it used for
2. What you need to know before taking Paracetamol Tecnimede
3. How to take Paracetamol Tecnimede
4. Possible side effects
5. Storage of Paracetamol Tecnimede
6. Package contents and additional information

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

Paracetamol is effective in reducing pain and fever.

This medication is used in adults and adolescents from 12 years old (with a body weight over 33 kg) for the symptomatic relief of occasional mild or moderate pain and febrile conditions.

You should consult a doctor if your condition worsens or if the fever persists after 3 days of treatment or the pain for 5 days.

2. What you need to know before taking Paracetamol Tecnimede

Do not take Paracetamol Tecnimede

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

Do not take more medication than recommended in section 3, as serious liver damage may occur.

Warnings and precautions

During treatment with Paracetamol Tecnimede, inform your doctor immediately:

If you have severe diseases, such as severe renal insufficiency 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 disease called metabolic acidosis (an anomaly in the 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.

Consult your doctor or pharmacist before starting to take paracetamol.

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 the use of the medication should be discontinued at the first sign of skin rash or any other sign of hypersensitivity.

The total dose of paracetamol should not exceed 3 g per day.

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

The simultaneous use of this medication with other medications that contain 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 that contains paracetamol without consulting your doctor. If an overdose occurs, seek medical attention immediately.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsen or other symptoms appear, the clinical situation should be evaluated by your doctor. This medication should not be used for self-medication of high fever (over 39°C), fever lasting more than 3 days, or recurrent fever, unless indicated by your doctor, as these situations may require medical evaluation and treatment.

The administration of paracetamol doses higher than recommended implies a very serious risk of liver injury. Medications containing paracetamol should not be taken for more than a few days or in high doses unless indicated by your doctor.

Prolonged use of analgesics or inadequate use of high doses can cause headaches, which should not be treated with higher doses of the medication; consult "If you take more than you should).

Children and adolescents

Due to the amount of paracetamol it contains, children (under 12 years old or weighing less than 33 kg) cannot take this medication.

Other medications and Paracetamol Tecnimede

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

In particular, if you are using any of the following medications, it may be necessary to modify the dose of one of them or interrupt treatment:

• 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 the blood: colestyramine
• 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 (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol
• Salicylamide, a medication 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 anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with analytical tests

If you are going to have any analytical tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results. Paracetamol may alter the values of analytical determinations of uric acid and glucose.

Taking Paracetamol Tecnimede with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages per day) may cause liver damage.

Taking this medication with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

Paracetamol can be used during pregnancy if necessary. 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

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medication.

Fertility

No harmful effects on fertility have been reported with the normal use of paracetamol.

Driving and using machines

The influence of this medication on the ability to drive and use machines is zero or insignificant.

3. How to take Paracetamol Tecnimede

Follow the administration instructions for this medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adolescents from 12 to 18 years old (33-50 kg)

• Between 33 kg and 40 kg of weight: Take 1 tablet every 4-6 hours, as needed, up to a maximum of 4 tablets per day.
• Between 41 kg and 50 kg of weight: Take 1 tablet every 4-6 hours, as needed, up to a maximum of 5 tablets per day.

Adults (body weight over 50 kg)

Take 1 tablet, if necessary, every 4-6 hours, as needed, up to a maximum of 6 tablets per day.Do not take more than 3 grams in 24 hours.

Patient with liver disease

Consult your doctor before taking this medication.

They should take the prescribed amount of medication by their doctor with a minimum interval between each intake of 8 hours.

They should not take more than 2 grams (4 tablets) of paracetamol in 24 hours.

Patient with kidney disease

Consult your doctor before taking this medication.

Patients with moderate to severe kidney disease should take a maximum of 500 mg of paracetamol per intake. According to their disease, their doctor will indicate if they should take their medication with a minimum interval of 6 or 8 hours.

How to take

This medication is taken orally.

The tablets should be swallowed whole or broken in half, with the help of some liquid, preferably water.

The tablets are scored, which allows them to be broken in half. The tablet can be divided into equal doses.

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

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

The administration of this medication is subject to the appearance of pain or fever. As they disappear, treatment should be discontinued. The medication should be used for the shortest possible time.

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

If you take more Paracetamol Tecnimede than you should

You should consult your doctor or pharmacist immediately.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

If you have taken an overdose, you should go to a medical center immediately, due to the risk of liver failure, even if you do not notice symptoms, as they often do not manifest until 3 days after taking the overdose, even in cases of severe poisoning.

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

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Paracetamol Tecnimede

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

If you forget to take a dose, take the forgotten dose as soon as you remember, taking the following doses with the indicated separation between intakes (at least 4 hours).

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

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

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

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

Frequency unknown: cannot be estimated with the available data:

• Headache induced by analgesic abuse
• A serious 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 a rash or peeling of the skin, or ulcers in the mouth.

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

-You experience bruising or bleeding without explanation.

These reactions are rare.

Paracetamol may damage the liver when taken in high doses or in prolonged treatments.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this 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 Paracetamol Tecnimede

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

Do not use this medication after the expiration date that appears after CAD on the packaging and blister. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Tecnimede

The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.

The other components (excipients) are:

Core of the tablet: pregelatinized cornstarch, magnesium stearate

Coating of the tablet: hypromellose, macrogol, propylene glycol, talc, and titanium dioxide (E171).

Appearance of the product and package contents:

White to off-white film-coated tablets with a capsule shape, oval, approximately 16.50 mm x 8.25 mm, smooth on one side and scored on the other.

The tablet can be divided into equal doses.

The medication is packaged in a blister pack (PVC/Alu) with 20 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 last revision of this leaflet: January 2025

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