Leaflet: information for the user

Paracetamol Teva Group 1 g tablets EFG

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, pharmacist or nurse.

This medicine can be purchased without a prescription. Nevertheless, for the best results, it should be used with care.

• 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult your doctor if the fever worsens or persists after 3 days of treatment or the pain lasts for more than 5 days.

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

Paracetamol is used for the treatment of moderate intensity pain and febrile states in adults and adolescents 16 years of age and older (or a body weight of 50 kg or more)

Do not take Paracetamol Teva Group:

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

Be particularly careful with Paracetamol Teva Group:

- Do not take more of the medicine than recommended in the section 3. How to take Paracetamol Teva Group.

- Avoid using this medicine with other medicines that contain paracetamol, for example, cold and flu medicines, as high doses can cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.

- If you are an asthmatic sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.

- If you have kidney, liver, heart, or lung disease, or anemia (a decrease in the hemoglobin level in the blood, due or not due to a decrease in red blood cells), consult your doctor before taking this medicine.

- If you are being treated with a medicine for epilepsy, consult your doctor before taking this medicine, as when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in high-dose treatments with paracetamol.

- In chronic alcoholics, 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 if the pain or fever worsen or other symptoms appear, consult your doctor and reevaluate the clinical situation.

- In adolescents under 16 years, consult your doctor or pharmacist as there are other presentations with doses adapted to this group of patients.

During treatment with paracetamol, inform your doctor immediately if:

• If 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 chronic malnutrition, 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 medicines and Paracetamol Teva Group

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

Paracetamol may interact with the following medicines:

- Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)

- Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)

- Medicines to treat tuberculosis: (isoniazid, rifampicin)

- Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)

- Medicines to lower cholesterol levels in the blood: (cholestyramine)

- Medicines used to increase urine elimination (diuretics such as furosemide)

- Medicines used to treat gout (probencid and sulfinpyrazone)

- Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone

- Medicines 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 (denominated metabolic acidosis) that must be treated urgently (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 inform your doctor or pharmacist systematically if you are being treated with another medicine. In the case of treatment with oral anticoagulants, paracetamol may be administered occasionally as the preferred analgesic.

Interference with analytical tests:

If you are to undergo any analytical test (including blood, 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 regularly consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, etc. per day) may cause liver damage.

The taking of this medicine with food does not affect its efficacy.

Pregnancy and Breastfeeding:

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

This medicine may 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 do not decrease or if you need to take the medicine more frequently.

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

Driving and operating machinery:

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

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

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

The usual dose is:

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

It is recommended to avoid high daily doses of paracetamol for prolonged periods of time as it increases the risk of adverse effects such as liver damage.

If the pain persists for more than 5 days, fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, you should interrupt treatment and consult your doctor.

Patients with liver disease:Before taking this medication, you must consult your doctor. You should take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each dose.

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

Patients with kidney disease:Before taking this medication, you must consult your 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.

Older adults:You should consult your doctor.

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

If it is estimated that the action of paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses than 1 g of paracetamol per dose are required, other paracetamol presentations should be used that adapt to the required dosing.

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

If you forgot to take Paracetamol Teva Group

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 have adverse effects, although not all people may 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 for prolonged periods.

Unknown adverse effects (cannot be estimated from available data): A severe disease that can make the blood more acidic (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 Medicines 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 trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paracetamol Teva Group:

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

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

Appearance of the product and contents of the packaging:

Paracetamol Teva Group 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. The tablet can be divided into two equal halves.

In packs of 10 tablets, conditioned in PVC/PVDC/Aluminum blisters.

Marketing Authorization Holder:

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible for Manufacturing:

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 medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

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 for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/