Leaflet: information for the user

Paracetamol Tecnimede 500 mg film-coated tablets

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

Follow exactly the administration instructions of 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.
• If your fever worsens or persists after 3 days of treatment or your pain lasts for 5 days, consult your doctor.

Paracetamol is effective in reducing pain and fever.

This medication is used in adults and adolescents 12 years and older (body weight greater than 33 kg) for symptomatic relief of occasional mild or moderate pain and febrile states.

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

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 of the medication than recommended in the section3. How to take Paracetamol Tecnimede, as it may cause severe liver damage.

Warnings and precautions

Inform your doctor immediately during treatment with Paracetamol Tecnimede:

If you have serious illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from chronic malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious illness 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.

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 beverages per day);
• If you have kidney problems;
• If you have a deficiency of glucose-6-phosphate dehydrogenase;
• If you have anorexia, bulimia, cachexia, or chronic malnutrition;
• If you suffer from dehydration or hypovolemia;
• If you are taking a medication to treat epilepsy, consult your doctor before taking this medication, as when used together, it decreases the effectiveness and increases the hepatotoxicity of paracetamol, especially in high-dose treatments (see more 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 done under close supervision and only for short periods;
• If you have asthma and are sensitive to acetylsalicylic acid

Paracetamol can cause severe skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Inform patients about the signs of severe skin reactions and discontinue use of the medication 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.

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.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 if the pain or fever worsens 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), prolonged fever, or recurrent fever, unless your doctor indicates it, as these situations may require medical evaluation and treatment.

The administration of paracetamol doses higher than recommended involves a high risk of severe liver damage. Medications containing paracetamol should not be taken for more than a few days or at high doses unless your doctor indicates it.

Prolonged use of analgesics or the inappropriate use of high doses may 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 used recently, 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, as 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, metharbital, primidone, carbamazepine)
• Medications to treat tuberculosis: isoniazid, rifampicin
• Medications to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower blood cholesterol levels: cholestyramine
• Medications used to increase urine elimination (diuretics such as the furosemide group)
• 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 (arrhythmias): propranolol
• Salicylamide, a medication to treat fever and pain, may prolong the elimination half-life of paracetamol.
• Zidovudine (used to treat HIV infections).
• Flucloxacillin (antibiotic), due to a high risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with analytical tests

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

Paracetamol Tecnimede with food, drinks, and alcohol

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

The use of 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Paracetamol 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.

Breastfeeding

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

Fertility

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

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

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

The recommended dose is:

Adolescents from 12 years to 18 years (33 – 50 kg)

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

Adults (body weight above 50 kg)

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

Patients with liver diseases

Consult your doctor before taking this medication.

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

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

Patients with kidney diseases

Consult your doctor before taking this medication.

Patients with moderate to severe renal disease should take a maximum of 500 mg of paracetamol per dose.According to your disease, your doctor will indicate if you should take your 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 andalways use the smallest effective dose.

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

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

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, yellowish discoloration 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 the symptoms, as they often do not appear until 3 days after taking the overdose, even in cases of severe intoxication.

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

Patients undergoing barbiturate treatment 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Paracetamol Tecnimede

Do not take a double dose to compensate for the missed doses

If you forgot to take a dose, take the missed dose as soon as you remember, taking the next doses with the indicated interval (at least 4 hours).

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

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

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

• Kidney diseases,
• cloudy urine,
• allergic dermatitis (including skin rash, angioedema, and Stevens-Johnson syndrome),
• jaundice (yellow discoloration of the skin),
• blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).
• Severe skin reactions have been reported very rarely.Bronchospasm in patients allergic to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs).

Unknown frequency: cannot be estimated with the available data:

• Headache induced by analgesic abuse
• A severe disease that can make the blood more acidic (designated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Stop taking this medicine and talk to a doctor immediately if:

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

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

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

-You experience bruising or bleeding without explanation.

These reactions are rare.

Paracetamol can damage the liver when taken in high doses or prolonged treatment

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

Reporting of side effects

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

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 disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the 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 Paracetamol Tecnimede

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

The other components (excipients) are:

Tablet core: pregelatinized cornstarch, magnesium stearate

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

Appearance of the product and content of the packaging:

Coated tablets with a film coating in the shape of a white to off-white capsule, oval in shape, 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 (PVC/Alu) with 20 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega.

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: January 2025

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