PARACETAMOL TEVAGEN 1000 mg TABLETS

2. What you need to know before starting to take Paracetamol Tevagen

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.

• Do not take more than the recommended dose in section 3. How to take Paracetamol Galenicum Health.
• In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medication.
• If you have kidney, liver, heart, or lung disease, or anemia (decreased hemoglobin levels in the blood, with or without a decrease in red blood cells), consult your doctor before taking this medication.
• When being treated with medication for epilepsy, consult your doctor before taking this medication, as the effectiveness of paracetamol may be reduced and hepatotoxicity increased, especially with high doses of paracetamol.
• In chronic alcoholics, be cautious not to take more than 2 grams of paracetamol in 24 hours.
• If the pain persists for more than 5 days, fever for more than 3 days, or the pain or fever worsens, or other symptoms appear, consult your doctor and reevaluate the clinical situation.
• In children under 15 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

During treatment with paracetamol, inform your doctor immediately 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 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 respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Other medications and Paracetamol Tevagen

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

Paracetamol may interact with the following medications:

• Medication 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: (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.

Flucloxacillin (antibiotic), due to a serious 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 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.

Interference with analytical tests

If you are going to have any analytical tests (including blood tests, urine tests, skin tests that use 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 habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor... per day) may cause liver damage.

Taking this medication with food does not affect its efficacy.

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 plan to become pregnant, consult your doctor before taking this medication.

Taking medication during pregnancy can 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 that you consult your doctor or pharmacist before taking this medication.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines 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".

3. How to take Paracetamol Tevagen

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Paracetamol should be taken orally.

The recommended dose is:

Adults and children over 15 years: the usual dose is 1 tablet (1000 mg of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 grams) in 24 hours:

Patient 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.

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

Patient 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.

Elderly patients: should consult their doctor.

Use in children: Do not use in children under 15 years of age.

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

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

Treatment of overdose is most effective if started within 4 hours of ingestion 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, go to a medical center immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Paracetamol Tevagen

Do not take a double dose to make up for forgotten doses, simply take the forgotten dose when you remember, taking the following doses with the indicated spacing between doses (at least 4 hours).

4. Possible adverse effects

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

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

Very rare adverse effects that may occur (in less than 1 out of 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), 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.

Paracetamol can damage the liver when taken in high doses or for prolonged periods.

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

Reporting adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol Tevagen

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

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 point in the pharmacy. 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

Composition of Paracetamol Tevagen:

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

The other components (excipients) are sodium carboxymethyl starch type A (derived from potatoes), purified water, pregelatinized starch (derived from corn), povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).

Appearance of the product and package contents:

Paracetamol Tevagen is presented in oral tablets.

The tablets are oblong, biconvex, white, with a score line on one side and marked with PC on the other side.

Packages of 20 and 40 tablets and clinical package of 500 tablets, packaged in PVC/PVdC/Aluminum blisters.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer

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 marketing authorization holder:

Teva Pharma, S.L.U

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

Alcobendas, 28108, Madrid (Spain)

Date of the last revision of this prospectus: 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/