Prospect: information for the user

Paracetamol Tevagen 1000 mg tablets EFG

paracetamol

Read this prospect carefullybefore starting to take this medicinebecause it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, or pharmacist
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, or pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1. What isParacetamol Tevagenand for what it is used

2. What you need to know before starting to takeParacetamol Tevagen

3. How to takeParacetamol Tevagen

4. Possible adverse effects

5. Storage ofParacetamol Tevagen

6. Contents of the package and additional information

Paracetamol belongs to a group of medicines called analgesics and antipyretics.

It is indicated for the treatment of symptoms of pain and fever.

Do not take Paracetamol Tevagen

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paracetamol Tevagen..

• No take more doses than recommended in section 3. Cómo tomar Paracetamol Galenicum Health.
• In patients with asthma sensitive to acetylsalicylic acid, consult your doctor before taking this medication.
• If you have any kidney, liver, heart, or lung disease, or anemia (decrease in hemoglobin levels in the blood, either due to a decrease in red blood cells), consult your doctor before taking this medication.
• When undergoing treatment with any medication for epilepsy, consult your doctor before taking this medication, as when used together, it decreases the efficacy and increases the hepatotoxicity of paracetamol, especially in high-dose paracetamol treatments.
• In chronic alcoholics, be careful not to take more than 2 g in 24 hours of paracetamol.
• If the pain persists for more than 5 days, fever for more than 3 days, or the pain or fever worsen or other symptoms appear, consult your doctor and reevaluate the clinical situation.
• In children under 15 years, consult your doctor or pharmacist, as there are other presentations with doses adapted to this group of patients.

Inform your doctor immediately during treatment with paracetamol if:

• Si 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 respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Other medications and Paracetamol Tevagen

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Paracetamol may interact with the following medications:

• Blood clot prevention medication: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, metharbital, primidone, carbamazepine)
• Medications for treating tuberculosis: (isoniazid, rifampicin)
• Medications for treating depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower blood cholesterol levels: (colestiramine)
• Medications used to increase urine elimination (diuretics such as furosemide)
• Medications used to treat gout (probencid 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.

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

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

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

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/using this medication, as it may alter the results of these tests.

Taking Paracetamol Tevagen with food, drinks, and alcohol

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

The taking of this medication with food does not affect the efficacy of the medication.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before taking this medication.

The consumption of medications during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

Small amounts of paracetamol may appear in breast milk, so it is recommended to consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

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

Paracetamol Tevagen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially "sodium-free".

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

Paracetamol should be taken orally.

The recommended dose is:

Adults and children over 15 years old: the usual dose is 1 tablet (1000 mg of paracetamol) 3 times a day. Doses should be spaced at least 4 hours apart. No more than 4 tablets (4 g) should be taken in 24 hours:

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 of 8 hours between each dose.

They should not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

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

Due to the dose, 1000 mg of paracetamol, it is not indicated for this group of patients.

Older adults: they should consult their doctor.

Use in children:Not to be used in children under 15 years old.

If it is estimated that the action of Paracetamol is too strong or too weak, inform your doctor or pharmacist. When requiring the administration of doses lower than 1000 milligrams of paracetamol per dose, other presentations of paracetamol should be used that adapt to the required dosage.

If you take more Paracetamol Tevagen 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 ingested an overdose, you should go to a medical center immediately, even if you do not notice the symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

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 chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Paracetamol Tevagen

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 spacing between doses (at least 4 hours).

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Rare adverse effects that may occur (between 1 and 10 of every 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects that may occur (in fewer than 1 of every 10,000 people) are: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Rarely, severe skin reactions have been reported.

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

Unknown adverse effects (cannot be estimated from available data): A severe disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 about the safety of this medication.

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Paracetamol Tevagen:

Each tablet contains 1000 mg of paracetamol as the active ingredient.

The other components (excipients) are sodium carboxymethylcellulose type A (from potato), purified water, pregelatinized cornstarch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).

Appearance of the product and content of the packaging:

Paracetamol Tevagen is presented in oral tablets.

The tablets are oblong, biconvex, white in color, with a notch on one face and marked with PC on the other face.

Packaging of 20 and 40 tablets and clinical packaging of 500 tablets, conditioned in PVC/PVdC/Aluminum blisters.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible for manufacturing

SAG Manufacturing S.L.U

Crta.N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.U

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Last review date of this leaflet: January 2025

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/