Leaflet: information for the user

Paracetamol Teva Group 500 mg tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.

This medicine can be obtained 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.

1. What isParacetamol Teva Groupand what it is used for

2. What you need to know before starting to takeParacetamol Teva Group

3. How to takeParacetamol Teva Group

4. Possible side effects

5. Storage ofParacetamol Teva Group

6. Contents of the pack and additional information

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

Paracetamol is used for the treatment of mild to moderate pain and febrile states in adults and children aged 12 years and above (or with a body weight of 40 kg or more).

Do not take Paracetamol Teva Group:

If you are allergic (hypersensitive) to paracetamol, or to any of the other components 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, medicines for flu and cold, as high doses may cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.

- In patients with asthma sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.

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

- When you are being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as when used together, it reduces the effectiveness and increases the hepatotoxicity of paracetamol, especially in treatments with high doses of paracetamol.

- In chronic alcoholics, be careful not to take more than 4 tablets of 500 mg or 2 g per day of paracetamol.

- 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 children under 10 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:

• 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 medicines and Paracetamol Teva Group:

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

Paracetamol may interact with the following medicines:

- Blood clot prevention medicine: oral anticoagulants (acenocoumarol, warfarin)

- Epilepsy treatment medicines: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)

- Tuberculosis treatment medicines: isoniazid, rifampicin

- Depression and convulsions treatment medicines: barbiturates (used as hypnotics, sedatives, and anticonvulsants)

- Cholesterol-lowering medicines in the blood: cholestyramine

- Diuretics of the asa group, such as furosemide

- Gout treatment medicines: probenecid and sulfinpyrazone

- Nausea and vomiting prevention medicines: metoclopramide and domperidone

- High blood pressure and heart rhythm alteration treatment medicines: propranolol

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

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

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

Interference with analytical tests:

If you are to undergo any analytical test (including blood, urine, skin tests that use allergens, etc…), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Paracetamol Teva Group with food, drinks, and alcohol:

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

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

Pregnancy and Lactation:

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

Paracetamol Teva Group 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 machines:

The influence of paracetamol on the ability to drive and operate machines 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 normal dose is:

Adults and children 12 years of age or older, or a body weight of 40 kg or more:

Take 1 tablet every 4-6 hours as needed, up to a maximum of 6 tablets per day. Do not take more than 3 grams of paracetamol in 24 hours.The doses should be spaced at least 4 hours apart.

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, the fever for more than 3 days, or the pain or fever worsen or other symptoms appear, you should discontinue treatment and consult your doctor.

Children: It is necessaryto respect the dosages defined according to weight. The child's age according to weight is given for information purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is divided into 4 or 6 doses per day, that is15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

Children weighing between 33 and 40 kg:1 tablet per dose, every 6 hours,up to a maximum of 4 tablets per day.

Between 41 and 50 kg of weight:1 tablet per dose, every 4-6 hours,up to a maximum of 6 tablets per day.

Patients with liver disease: Beforetaking 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 or 4 tablets of 500 mg of paracetamol in 24 hours.

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

Older adults:

They must consult their doctor.

Use in children and adolescents:

Do not use in children under 12 years of age

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 less than 500 mg of paracetamol per dose, other presentations of paracetamol should be used that adapt to the required dosage.

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 on 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 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 produce adverse effects, although not all people will experience them.

Rare adverse effects that may occur (in up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and elevated levels of transaminases in the blood.

Very rare adverse effects that may occur (in up to 1 in 10,000 people) are: kidney disease, 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 prolonged treatment.

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 not listed 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 on 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. 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:

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

The other components are: potato starch glycolate sodium (Type A), purified water, pregelatinized cornstarch, povidone K30 (E1201), stearic acid (E570) and crospovidone (E1202).

Appearance of the product and contents of the packaging:

Paracetamol Teva Group is presented

in tablets for oral administration.

The tablets arebiconvex, white in color, and round in shape.

The packaging is of 20 tablets, packaged in PVC/PVDC/Aluminum blister.

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/