PARACETAMOL TEVA 1 g TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol Teva 1 g tablets EFG

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

Keep this leaflet, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, do not pass it on to others, it may harm them, even if their symptoms are the same as yours.

if they have the same symptoms as you.

• If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Paracetamol Teva and what is it used for
2. What you need to know before taking Paracetamol Teva
3. How to take Paracetamol Teva
4. Possible side effects
5. Storage of Paracetamol Teva
6. Contents of the pack and further information

1. What is Paracetamol Teva and what is it used for

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

This medicine is indicated for the treatment of symptoms of mild to moderate pain and fever.

2. What you need to know before taking Paracetamol Teva

Do not take Paracetamol Teva

• if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).

If you have liver disease.

• If you have liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol Teva

• Do not take more than the recommended dose.
• If you have kidney, liver, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood), you should consult your doctor before taking this medicine.

if you have kidney disease, you should consult your doctor before taking this medicine.

• In chronic alcoholics, caution should be exercised not to take more than 2 g/day of paracetamol.

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, treatment should be discontinued and a doctor consulted.

• In children under 12 years of age, consult your doctor or pharmacist, as there are other formulations with doses suitable for 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 damage to organs), or if you have malnutrition, chronic alcoholism, or if you 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 unwell (nausea) and vomiting.

Interference with laboratory tests:

If you are going to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Paracetamol may alter the values of analytical determinations of uric acid and glucose

Taking Paracetamol Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Paracetamol may interact with the following medicines:

• Antibiotics (chloramphenicol)
• Anticoagulants (used to treat thromboembolic diseases)
• Oral contraceptives
• Antiepileptics (used to treat epileptic seizures)
• Diuretics (used to increase urine elimination)
• Flucloxacillin (antibiotics), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

• Isoniazid (used to treat tuberculosis)
• Lamotrigine (used to treat epilepsy)
• Probenecid (used to treat gout)
• Propranolol (used to treat hypertension, cardiac arrhythmias)
• Rifampicin (used to treat tuberculosis)
• Anticholinergics (used to relieve stomach, intestine, and bladder spasms or contractions)

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.

Taking Paracetamol Teva with food, drinks, and alcohol

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In case of need, Paracetamol 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 or midwife if the pain or fever does not decrease or if you need to take the medicine more frequently.

Pregnancy

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The use of medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Epidemiological studies in pregnant women have not shown undesirable effects due to the use of paracetamol in the recommended doses, but patients should follow their doctor's advice regarding its use.

Breastfeeding

Consult your doctor or pharmacist before using any medicine. Small amounts of paracetamol may appear in breast milk, so it is recommended that you 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 zero or insignificant.

3. How to take Paracetamol Teva

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

The recommended dose is:

Adults and adolescents over 15 years (over 50 kg body weight):

The recommended dose is half to 1 tablet (1 g of paracetamol) 3 or 4 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g of paracetamol) in 24 hours.

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 between each dose of 8 hours. They should not take more than 2 tablets of 1 g of paracetamol in 24 hours.

Patient with kidney disease:

Before taking this medicine, they must consult their doctor.

They can take a maximum of half a tablet (500 mg of paracetamol) per dose.

Elderly patient:

They should consult their doctor

Use in children and adolescents

Adolescents over 12 years (>42 kg):

The recommended dose is half a tablet (500 mg of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 2 and a half tablets (2.5 g of paracetamol) in 24 hours.

Do not use in children (under 12 years).

Paracetamol Teva should be taken orally. According to your preferences, the tablets can be swallowed directly or broken in half with water, milk, or fruit juice.

The tablet can be divided into equal doses.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Paracetamol Teva than you should

If you have taken more Paracetamol than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they often do not appear until 3 days after taking the overdose, even in cases of severe poisoning.

The symptoms of overdose may be: nausea, dizziness, vomiting, anorexia, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Later, liver and kidney damage can develop. Severe overdoses can cause death.

Treatment of overdose is most effective if started within 4 hours of taking the medicine.

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamol Teva

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

4. Possible side effects

Like all medicines, Paracetamol Teva can cause side effects, although not everybody gets them.

The side effects observed are described below according to their frequency:

Rare side effects (may affect up to 1 in 1,000 people), very rare side effects (may affect up to 1 in 10,000 people), unknown frequency (cannot be estimated from the available data)

The following side effects have been observed.

General disorders and administration site conditions

Rare:Malaise

Immune system disorders

Unknown:Allergic reactions (hypersensitivity) ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction).

Hepatobiliary disorders

Rare:Increased levels of hepatic transaminases (liver enzymes).

Very rare:Hepatotoxicity (liver toxicity) and jaundice (yellowing of the skin and mucous membranes).

Unknown:Liver damage

Metabolic and nutrition disorders

Very rare:Hypoglycemia (reduced glucose levels in the blood).

Unknown:A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Blood and lymphatic system disorders

Very rare:Leukopenia, neutropenia (reduced white blood cell count), hemolytic anemia (reduced red blood cell count).

Unknown:Thrombocytopenia (reduced platelet count), agranulocytosis

Vascular disorders

Rare:Hypotension (reduced blood pressure).

Renal and urinary disorders

Very rare:Sterile pyuria (cloudy urine), adverse renal effects.

Skin and subcutaneous tissue disorders

Unknown: Exanthema

Severe skin reactions have been reported in very rare cases (medicines that induce Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Teva 1 g tablets EFG

• The active substance is paracetamol. Each tablet contains 1 g of paracetamol.
• The other ingredients are: pregelatinized starch (from corn), stearic acid, povidone, crospovidone, microcrystalline cellulose, and magnesium stearate of vegetable origin.

Appearance of the product and pack contents

Paracetamol Teva 1 g tablets are presented in the form of oblong tablets, white in color, and scored on one side.

Each pack contains 20 or 40 tablets packaged in aluminum-PVC-PVDC blisters.

Marketing authorization holder

Teva Pharma, S.L.U.

c/ Anabel Segura, 11, Edificio Albatros B, 1ª planta, Alcobendas

28108 Madrid (Spain)

Manufacturer

FROSST IBERICA, S.A.

Vía Complutense, 140 (Alcalá de Henares (Madrid)

28805 – Spain

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

Alcobendas (Madrid)

28108 - Spain

Pharmex Advanced Laboratories, S.L..

Pol. Ind. Los Mochos. Polígono 8- Parcela 20.

Crta. A-431, Km 19 (Almodovar del Río) - Córdoba

14720- Spain

SAG MANUFACTURING S.L.U

Crta N-I, Km 36 (San Agustín de Guadalix)

28750, Madrid

Spain

Date of last revision of this leaflet: January 2025

Other sources of information

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