Paracetamol Teva-Rimafar 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Teva-Rimafar 650 mg tablets EFG

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

Follow exactly the instructions for use of this medicine as described in this leaflet or as directed 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You must consult a doctor if fever worsens or does not improve after 3 days, or if pain persists beyond 5 days.

Contents of the leaflet:

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

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

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

This medicine is used for the symptomatic treatment of mild to moderate occasional pain and fever.

2. What you need to know before taking Paracetamol Teva-Rimafar

Do not take Paracetamol Teva-Rimafar

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

Warnings and precautions

Consult your doctor or pharmacist before taking Paracetamol Teva-Rimafar

• Do not take more medicine than the recommended dose stated in section 3, How to take Paracetamol Teva-Rimafar.
• The simultaneous use of this medicine with other medicines containing paracetamol (e.g. cold and flu remedies) should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• In patients with asthma who are sensitive to acetylsalicylic acid, you should 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), you should consult your doctor before taking this medicine.
• In chronic alcoholics, care should be taken not to exceed 2 g/day of paracetamol.

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 the 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, feeling unwell (nausea), and vomiting.

Interference with laboratory tests:

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

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

Other medicines and Paracetamol Teva-Rimafar

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

Paracetamol may interact with the following medicines:

• Antibiotics (chloramphenicol)
• Oral anticoagulants (used to treat thromboembolic disorders)
• Contraceptives
• Antiepileptics (used to treat epileptic seizures)
• Diuretics (used to increase urine elimination)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring 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 spasms or contractions of the stomach, intestine, and bladder)
• Zidovudine (used to treat HIV infections)
• Cholestyramine (used to lower blood cholesterol levels)

Do not use with other analgesics (medicines that reduce 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 receiving treatment with another medicine. In the case of treatment with oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Taking Paracetamol Teva-Rimafar with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

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

If necessary, paracetamol 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 or midwife if pain or fever do not improve or if you need to take the medicine more frequently.

Pregnancy

If you are pregnant or think you might be, consult your doctor before taking this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

If necessary, paracetamol 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 or midwife if pain or fever do not improve or if you need to take the medicine more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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 this medicine on the ability to drive and use machines is none or negligible.

3. How to take Paracetamol Teva-Rimafar

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist.

If in doubt, consult your doctor or pharmacist again.

This medicine is taken orally. According to your preference, the tablets may be taken whole or split in half with water, milk, or fruit juice.

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

Recommended dose:

Adults and adolescents over 15 years of age

1 tablet every 4–6 hours as needed, do not take more than 3 g (4 tablets) in 24 hours.

Children and adolescents:

Dosages based on body weight must be respected. The age range corresponding to body 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.

• Between 22 and 25 kg (ages 6 to 10): half a tablet per dose every 6 hours, up to a maximum of 2 tablets in 24 hours.

• Between 26 and 40 kg (ages 8 to 13): half a tablet per dose every 4 hours, up to a maximum of 3 tablets in 24 hours.

• Between 41 and 50 kg (ages 12 to 15): 1 tablet per dose every 6 hours, up to a maximum of 4 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, discontinue 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 3 tablets of 650 mg paracetamol in 24 hours.

Patients with kidney disease:

Before taking this medicine, you must consult your doctor.

Take a maximum of 500 milligrams of paracetamol per dose.

Due to the dosage (650 mg of paracetamol), this product is not recommended for this patient group.

Elderly patients:

Your doctor will advise you on the most appropriate treatment for you.

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

When lower doses than 650 mg of paracetamol per administration are required, other formulations of paracetamol adapted to the required dosage should be used.

If you take more Paracetamol Teva-Rimafar than you should:

If you have taken more paracetamol than you should, or have accidentally ingested the entire contents of the package, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.

If an overdose has occurred, you must go immediately to a medical center even if there are no symptoms, as symptoms often do not appear until three days after the overdose, even in cases of severe poisoning.

Symptoms of overdose may include: nausea, dizziness, vomiting, anorexia, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Liver and kidney damage may subsequently develop. Severe overdoses can lead to death.

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

Patients undergoing treatment with barbiturates or those suffering from chronic alcoholism may be more susceptible to paracetamol overdose.

If you forget to take Paracetamol Teva-Rimafar

Do not take a double dose to make up for a missed dose. Simply take the missed dose when you remember, then take the next 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 experiences them.

The adverse effects observed are described below according to their frequency of occurrence:

Rare adverse effects (may affect up to 1 in 1,000 people), very rare adverse effects (may affect up to 1 in 10,000 people), not known (cannot be estimated from the available data)

The following adverse effects have been observed:

General disorders and administration site conditions

Rare: Malaise

Immune system disorders

Not known: 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).

Not known: Liver damage

Metabolism and nutrition disorders

Very rare: Hypoglycaemia (reduced glucose blood levels).

Not known: A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

Blood and lymphatic system disorders

Very rare: Leucopenia, neutropenia (decrease in white blood cells in blood), haemolytic anaemia (decrease in red blood cells in blood).

Not known: Thrombocytopenia (reduction in blood platelets), agranulocytosis

Vascular disorders

Rare: Hypotension (decrease in blood pressure).

Renal and urinary disorders

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

Skin and subcutaneous tissue disorders

Not known: Exanthema

Serious 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 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-Rimafar

Keep out of sight and reach of children.

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to properly 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-Rimafar

• The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.
• The other components are: pregelatinized corn starch, povidone, stearic acid,

crospovidone, microcrystalline cellulose and vegetable-source magnesium stearate.

Appearance of the product and contents of the pack

The tablets are oblong, white in colour, and scored on one side.

Each pack contains 20 tablets in an aluminium-PVC-PVDC blister pack.

Marketing Authorization Holder

Teva Pharma, S.L.U.

c/ Anabel Segura, 11, Edificio Albatros B, 1st floor, Alcobendas

28108 Madrid (Spain)

Manufacturer

Toll Manufacturing Services S.L

C/ Aragoneses, 2

28108, Alcobendas

Madrid (Spain)

or

LABORATORIOS PEREZ GIMENEZ, S.A.

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

Crta. A-431, Km 19

14720, Almodovar del Río

Córdoba (Spain)

or

FROSST IBERICA, S.A.

Vía Complutense, 140

28805, Alcalá de Henares

Madrid (Spain)

or

SAG Manufacturing S.L.U

Crta. N-I, Km 36 ()

28750, San Agustín de Guadalix

Madrid (Spain)

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

Other sources of information

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