Paracetamol Teva Group 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Teva Group 1 g 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 as directed by your doctor, pharmacist, or nurse.

This medicine is available without a prescription. However, to achieve 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 adverse 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 longer 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 moderate pain and febrile conditions in adults and adolescents aged 16 years and older (or with a body weight above 50 kg).

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 to any of the other components of this medicine (listed in section 6)

Take special care with Paracetamol Teva Group:

• Do not take more medicine than recommended in section 3, How to take Paracetamol Teva Group.
• Avoid using this medicine together with other medicines containing paracetamol, such as cold and flu remedies, as 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 kidney, liver, heart or lung disease, or have 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 medication for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
• Chronic alcoholics should take care not to exceed 2 grams of paracetamol in 24 hours.
• 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 the clinical situation.
• For adolescents under 16 years of age, consult your doctor or pharmacist, as other formulations with appropriate doses are available for this patient group.

During treatment with paracetamol, inform your doctor immediately if:

• You have serious medical 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 under these conditions 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

Inform 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: (cholestyramine)
• 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) — alteration of blood and fluids (metabolic acidosis with high anion gap imbalance) — which requires urgent medical treatment (see section 2).

Do not use with other analgesics (medicines that relieve pain) 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 any other medicine. In patients taking oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Interference with diagnostic tests:

If you are scheduled to have any diagnostic tests (including blood or urine tests, 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:

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and Breast-feeding:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If necessary, this medicine may be used during pregnancy. Use the lowest possible dose that controls pain or fever, and use it for the shortest possible time. 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 effect of paracetamol on the ability to drive and operate machinery 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 ones. Remember to take your medicine. Paracetamol should be taken orally.

The usual dose is:

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

High daily doses of paracetamol should be avoided over 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.

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

Do not take more than 2 paracetamol tablets in 24 hours, divided into 2 doses.

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

Due to the dosage, 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 of age.

If you feel that the effect 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 formulations suitable for the required dosage should be used.

If you take more Paracetamol Teva Group than you should:

You should consult 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 ingested an overdose, you must 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 of 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, go immediately to a medical center 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 when you remember, and 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 between 1 and 10 out of 10,000 people) are: malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in less than 1 out of 10,000 people) are: 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 severe skin reactions have been reported.

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

Adverse effects not known (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 through 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 which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Teva Group:

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

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

Appearance of the product and contents of the pack:

Paracetamol Teva Group is presented as oral tablets.

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

Packaged in packs of 10 tablets, presented in PVC/PVDC/Aluminium blisters.

Marketing Authorization Holder:

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

The Netherlands

Manufacturer responsible:

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

For further information on this medicine, please contact 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 review of this leaflet: January 2025

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