Paracetamol Teva Group 500 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Teva Group 500 mg tablets EFG

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

Follow exactly the instructions for taking this medicine provided in this leaflet or those given by your doctor, pharmacist, or nurse.

This medicine is available without a prescription. However, to obtain the best results, it must be used carefully.

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

Contents of the leaflet

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

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

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

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

2. What you need to know before starting to take Paracetamol Teva Group

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).

Take special care with Paracetamol Teva Group:

• Do not take more medicine than the recommended dose stated in section 3, How to take Paracetamol Teva Group.
• Avoid taking this medicine together with other medicines containing paracetamol, such as cold and flu remedies, because high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• If you are an asthmatic patient sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have liver, kidney, heart, or lung disease, or suffer from anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
• If you are being treated with antiepileptic medicines, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxic potential of paracetamol, especially with high-dose paracetamol regimens.
• In chronic alcoholics, caution should be taken not to exceed 4 tablets of 500 mg or 2 g per day of paracetamol.
• If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, consult your doctor and reassess your clinical condition.
• For children under 10 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.

During treatment with paracetamol, inform your doctor immediately if:

• You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Other medicines and Paracetamol Teva Group:

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
• Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for tuberculosis: isoniazid, rifampicin
• Medicines for depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: colestyramine
• Medicines used to increase urine output (loop diuretics such as furosemide)
• Medicines used to treat gout: probenecid and sulfinpyrazone
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring 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 advisable to systematically inform your doctor or pharmacist if you are taking another medicine. In patients treated with oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Interference with diagnostic tests:

If you are due to have any diagnostic tests (including blood and urine analyses, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of such tests.

Taking Paracetamol Teva Group with food, drinks and alcohol:

Using paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks per day: beer, wine, spirits, etc.) 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.

Paracetamol Teva Group may be used during pregnancy if necessary. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible duration. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.

Small amounts of paracetamol may pass into breast milk; therefore, 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 none or negligible.

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

3. How to take Paracetamol Teva Group

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

The usual dose is:

Adults and children aged 12 years and older, or body weight above 40 kg:

Take 1 tablet every 4–6 hours as needed, up to a maximum of 6 tablets per day. Do not exceed 3 grams of paracetamol in 24 hours. Doses should be spaced at least 4 hours apart.

High daily doses of paracetamol should be avoided for prolonged periods, as this increases the risk of adverse effects such as liver damage.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you should stop treatment and consult your doctor.

Children: It is necessary to follow the dosage recommendations based on body weight. The age of the child in relation to weight is provided for informational purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 doses per day, i.e., 15 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.
• Children weighing between 41 and 50 kg: 1 tablet per dose every 4–6 hours, up to a maximum of 6 tablets per day.

Patients with liver disease: You must consult your doctor before taking this medicine.
You should take only the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.
Do not exceed 2 grams or 4 tablets of 500 mg paracetamol in 24 hours.

Patients with kidney disease: You must consult your doctor before taking this medicine. Take a maximum of 500 mg per dose.

Elderly patients: You should consult your doctor.

Use in children and adolescents:

Do not use in children under 12 years of age.

If you feel that the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist.

When doses lower than 500 mg of paracetamol per dose are required, other formulations of paracetamol better suited to the required dosage should be used.

If you take more Paracetamol Teva Group than you should:

You should contact your doctor or pharmacist immediately.

Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

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

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

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 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 the missed dose. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Rare adverse effects (occurring in up to 1 in 1,000 people) include: malaise, low blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in up to 1 in 10,000 people) include: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Very rare cases of serious skin reactions have been reported.

Paracetamol may damage the liver when taken at high doses or during prolonged treatment.

Adverse effects not known (frequency cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of any unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Teva Group:

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

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

Appearance of the product and contents of the pack:

Paracetamol Teva Group is presented as tablets for oral administration.

The tablets are biconvex, white, and round in shape.

Pack sizes of 20 tablets, packaged in PVC/PVDC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva B.V.,
Swensweg 5,
2031GA Haarlem,
The 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

Further information about this medicinal product is available upon request from 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)

Date of the most recent revision of this leaflet: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/