Paracetamol Teva Group 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Teva Group 650 mg tablets

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

Follow exactly the instructions for administration of this medicine contained in this leaflet or those given by your doctor or pharmacist.

• 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 a doctor if fever worsens or does not improve after 3 days, or after 5 days in case of pain.

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.

This medicine is used for the symptomatic treatment of mild to moderate pain and fever in adults and adolescents over 12 years of age (weighing at least 41 kg).

Half a tablet may be used in children aged 6 to 11 years (weighing at least 21 kg).

You should consult a doctor if your symptoms worsen or do not improve, pain after 5 days, or fever after 3 days.

2. What you need to know before taking Paracetamol Teva Group

Do not take Paracetamol Teva Group:

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

Warnings and precautions:

• Do not take more than the recommended dose stated 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 take an overdose, seek immediate medical attention (see "If you take more Paracetamol Teva Group than you should").

Consult your doctor, pharmacist, or nurse before starting to take paracetamol:

• If you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic drinks per day);
• If you have kidney problems;
• If you have glucose-6-phosphate dehydrogenase deficiency;
• If you have anorexia, bulimia, cachexia, or chronic malnutrition;
• If you are dehydrated or have hypovolemia;
• If you are taking medication for epilepsy, you should consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatments (see below in this section “Other medicines and Paracetamol Teva Group”);
• If you have Gilbert’s disease (also known as Meulengracht’s disease);
• If you have heart problems, respiratory failure, or anemia; in these cases, treatment should be under medical supervision and only for short periods;
• If you have asthma and are sensitive to acetylsalicylic acid;
• If you have any kidney, liver, heart, or lung disease, or have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells).

You should consult your doctor if you require treatment for more than 3 days, or if pain or fever worsen or new symptoms appear.

During treatment with paracetamol, inform your doctor immediately if:

• You have serious illnesses 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 breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

For children under 12 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.

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 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 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) requiring urgent 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 another medicine. In the case of treatment with oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Interference with laboratory tests:

If you are undergoing any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Paracetamol may alter the analytical values of uric acid and glucose measurements.

Taking Paracetamol Teva Group with food, drinks, and alcohol:

The use of 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 effectiveness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

If necessary, Paracetamol Teva Group may be used during pregnancy. Use the lowest possible dose that relieves 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.

Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

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 use machines is negligible or none.

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 exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt,
ask your doctor, pharmacist, or nurse.

The score line allows the tablet to be divided into two equal doses.

The tablets are taken orally.

The recommended dose is:

Adults and adolescents over 15 years of age

1 tablet every 4–6 hours as needed, not exceeding 3 g of paracetamol (4 tablets) in 24 hours.

Children and adolescents

It is necessary to follow the dosage regimens based on body weight. The age range corresponding to each weight category 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.

• Between 21 and 32 kg body weight (approximately 6 to 10 years of age): half a tablet per dose (325 mg paracetamol), every 6 hours, up to a maximum of 2 tablets in 24 hours.
  • Between 33 and 40 kg body weight (approximately 10 to 11 years of age): half a tablet per dose (325 mg paracetamol), every 4 hours, up to a maximum of 3 tablets in 24 hours.
  • Between 41 and 50 kg body weight (approximately 12 to 15 years of age): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.

The half-tablet dose (325 mg paracetamol) is particularly suitable for treating children weighing between 21 and 32 kg (approximately from 6 to 10 years of age). For more precise dose adjustment in children (under 12 years of age), other paracetamol formulations are available.

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, treatment should be discontinued and medical advice sought.

Patients with liver disease

Must consult their doctor before taking this medicine. They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses.

They must not take more than 3 tablets of 650 mg paracetamol in 24 hours.

Patients with kidney disease

Must consult their doctor before taking this medicine.

Maximum dose per administration is 500 milligrams.

In patients with moderate or severe renal impairment, half a tablet may be administered.

For patients with renal insufficiency, other more appropriate formulations of the medicine are available.

Elderly patients

Must consult their doctor.

If you take more Paracetamol Teva Group than you should:

You must 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 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 for overdose is most effective if started within 4 hours of ingestion.

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

In case of overdose or accidental ingestion, contact your doctor 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 missed doses. Simply take the missed dose as soon as you remember, and take subsequent 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) are: malaise, low blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in up to 1 in 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 in 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 critically ill patients 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 refers to the last day of the month indicated.

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

6. Contents of the container and other information

Composition of Paracetamol Teva Group:

The active substance is Paracetamol. Each tablet contains 650 mg of paracetamol.

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

Appearance of Paracetamol Teva Group and contents of the container:

Oblong, biconvex, white tablets, with a score line on one side and marked "PB" on the other side.

Pack sizes of 20 tablets, presented in PVC/PVdC/Aluminum blisters.

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

Galenicum Health, S.L.U.
Sant Gabriel, 50, Esplugues de Llobregat
08950 Barcelona
Spain

For further information about this medicinal product, 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 medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85893/P_85893.html