PARACETAMOL TEVA GROUP 650 mg TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Teva Group 650 mg Tablets

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your fever worsens or does not improve after 3 days or 5 days in the case of pain.

Contents of the Package 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. Storage of Paracetamol Teva Group
6. Package Contents and Additional Information

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

Paracetamol belongs to the group of medications called analgesics and antipyretics.

This medication is used for the symptomatic treatment of mild to moderate pain and febrile states in adults and adolescents over 12 years old (from 41 kg of body weight).

Half a tablet can be used in children from 6 to 11 years old (from 21 kg of body weight).

You should consult a doctor if the pain worsens or does not improve after 5 days, or if the fever worsens or does not improve 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 any of the other components of this medication (listed in section 6).

Warnings and Precautions:

• Do not take more than the recommended dose in section 3. How to take Paracetamol Teva Group.
• Avoid simultaneous use of this medication with other medications that contain paracetamol, such as flu medications, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

If you overdose, seek medical attention immediately (see "If you take more Paracetamol Teva Group than you should").

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

"Other Medications and Paracetamol Teva Group");

You should consult your doctor if you need treatment for more than 3 days, or if the pain or fever worsens or other symptoms appear.

During treatment with paracetamol, inform your doctor immediately if:

Children and Adolescents

In children under 12 years old, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

Other Medications and Paracetamol Teva Group

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

Paracetamol may interact with the following medications:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications to treat tuberculosis: (isoniazid, rifampicin)
• Medications to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with Analytical Tests:

If you are going to have any analytical test (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medication, 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 Group with Food, Drinks, and Alcohol:

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

Taking this medication with food does not affect its efficacy.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

In case of necessity, Paracetamol Teva Group 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 if the pain or fever does not decrease or if you need to take the medication more frequently.

Taking medications during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Small amounts of paracetamol may appear in breast milk, so it is recommended that you consult your doctor or pharmacist before taking this medication.

Driving and Using Machines:

The influence of paracetamol on the ability to drive and use machines is null or insignificant.

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

3. How to Take Paracetamol Teva Group

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt,

ask your doctor, pharmacist, or nurse.

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

The tablets are administered orally.

The recommended dose is:

Adults and Adolescents over 15 years old

1 tablet every 4-6 hours, as needed, do not take more than 3 grams of paracetamol (4 tablets) in 24 hours.

Children and Adolescents

It is necessary to respect the dosages defined according to weight.The age of the child according to weight is given for informational purposes.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is

divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

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

The dose of half a tablet (325 mg of paracetamol) is especially suitable for the treatment of children between 21 and 32 kg of body weight (approximately from 6 years old to 10 years old). For a more precise adjustment of the dose in children (under 12 years old), there are other presentations of paracetamol available.

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

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, you should discontinue treatment and consult your doctor.

Patients with Liver Disease

Before taking 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 3 tablets of 650 mg of paracetamol in 24 hours.

Patients with Kidney Disease

Before taking this medication, they must consult their doctor.

Take a maximum of 500 milligrams per dose.

In people with moderate or severe renal impairment, half a tablet can be administered.

For people with renal impairment, there are other presentations of the medication that are more suitable.

Elderly Patients

They should consult their doctor.

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 symptoms, as they often do not manifest until 3 days after ingestion, even in cases of severe poisoning. Treatment of overdose is more effective if started within 4 hours after ingestion of the medication.

Patients being treated with barbiturates 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 call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Paracetamol Teva Group

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

Very rare side effects that may occur (up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

Paracetamol can damage the liver when taken in high doses or in prolonged treatments.

Unknown side effects (cannot be estimated from available data): a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol Teva Group

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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol Teva Group:

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

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

Appearance of Paracetamol Teva Group and Package Contents:

Oblong, biconvex tablets, white in color, with a score line on one face and marked with PB on the other face.

Packaging of 20 tablets, packaged in PVC/PVdC/Aluminum blisters.

Marketing Authorization Holder

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Date of the last revision of this package leaflet:January 2025

Detailed and updated information about this medication 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 updated information about this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85893/P_85893.html