PARACETAMOL TEVA GROUP 1 g TABLETS

2. What you need to know before taking Paracetamol Teva Group

Do not take Paracetamol Teva Group:

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

Be careful with Paracetamol Teva Group:

• Do not take more medicine than recommended in section 3. How to take Paracetamol Teva Group.
• The simultaneous use of this medicine with other medicines containing paracetamol should be avoided, for example, medicines for flu and colds, as high doses can lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• In asthmatic patients sensitive to acetylsalicylic acid, consult your doctor before taking this medicine
• If you have any kidney, liver, heart, or lung disease, or if you have anemia (decrease in hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), you should consult your doctor before taking this medicine.
• When being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially in high-dose treatments.
• In chronic alcoholics, they should be careful not to take more than 2 grams of paracetamol in 24 hours.
• 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, consult your doctor and reevaluate the clinical situation.
• In adolescents under 16 years old, consult your doctor or pharmacist, as there are other presentations with doses that adapt to this group of patients.

During treatment with paracetamol, inform your doctor immediately if:

• If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in 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 medicines and Paracetamol Teva Group

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

Paracetamol may interact with the following medicines:

• Medicine to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for treating tuberculosis: (isoniazid, rifampicin)
• Medicines for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines for lowering cholesterol levels in blood: (cholestyramine)
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used for treating gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used for treating 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 should receive urgent treatment (see section 2).

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

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. 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 test (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Paracetamol Teva Group 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 medicine with food does not affect its efficacy.

Pregnancy and Breastfeeding:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

In case of need, this medicine can be used during pregnancy. 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 medicine more frequently.

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

Driving and using machines:

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

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

3. How to take Paracetamol Teva Group

Follow these instructions unless your doctor has given you different instructions. Remember to take your medicine. Paracetamol should be taken orally.

The normal dose is:

Adults and adolescents over 16 years old: the usual dose is 1 tablet (1 g of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 3 grams (3 tablets) in 24 hours.

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

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, you should stop treatment and consult your doctor.

Patient with liver disease: before taking this medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval of 8 hours between each dose.

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

Patient with kidney disease: before taking this medicine, they must consult their doctor. Take a maximum of 500 mg per dose.

Due to the dose, 1 g of paracetamol is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Use in children and adolescents: Do not use in children and adolescents under 16 years old.

If you think the action of paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses of paracetamol are required, other presentations of paracetamol that adapt to the required dosage should be used

If you take more Paracetamol Teva Group 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 ingested an overdose, you should 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 more effective if started within 4 hours after taking the medicine.

Patient treated with 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 (phone 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Paracetamol Teva Group

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 separation between doses (at least 4 hours).

4. Possible side effects

Like all medicines, this medicine can have side effects, although not everyone gets them.

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

Very rare side effects that may occur (in less than 1 in every 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

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

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Teva Group

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the package after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Teva Group:

Each tablet contains 1 g of paracetamol as the active ingredient.

The other components (excipients) are potato starch glycolate (Type A), purified water, pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).

Appearance of the product and package contents:

Paracetamol Teva Group is presented in oral tablets.

The tablets are oblong, biconvex, white, with a score line on one face and marked with PC on the other face. The tablet can be divided into two equal halves.

In packages of 10 tablets, packaged in PVC/PVDC/Aluminum blisters.

Marketing Authorization Holder:

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer:

Galenicum Health, S.L.U

Sant Gabriel, 50

Esplugues de Llobregat, 08950,

Barcelona – Spain

or

SAG Manufacturing S.L.U

Crta. N-I, Km 36

28750 San Agustin de Guadalix,

Madrid – Spain

You can request more information about this medicine 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 package leaflet: January 2025

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