PARACETAMOL TEVA-RIMAFAR 650 mg TABLETS

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

Do not take Paracetamol Teva-Rimafar

• if you are allergic to paracetamol or any of the other components of this medication

(including those listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Paracetamol Teva-Rimafar.

• Do not take more medication than recommended in section 3. How to take Paracetamol Teva-Rimafar.
• The simultaneous use of this medication with other medications containing paracetamol, such as flu and cold medications, should be avoided, as high doses can lead to liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.
• In patients with asthma who are sensitive to acetylsalicylic acid, consultation with the doctor is necessary

before taking this medication.

• If you have kidney, liver, heart, or lung disease, or have anemia (decreased hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), you should consult your doctor before taking this medication.
• In chronic alcoholics, caution should be exercised not to take more than 2 g/day of paracetamol.

During treatment with paracetamol, inform your doctor immediately if:

• If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Interference with Laboratory Tests:

If you are going to undergo any laboratory tests (including blood, urine, 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.

Other Medications and Paracetamol Teva-Rimafar

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

Paracetamol may interact with the following medications:

• Antibiotics (chloramphenicol)
• Oral anticoagulants (used to treat thromboembolic diseases)
• Contraceptives
• Antiepileptics (used to treat epileptic seizures)
• Diuretics (used to increase urine elimination)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires 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 stomach, intestine, and bladder spasms or contractions)

Food, Beverages, and Alcohol

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

Pregnancy, Breastfeeding, and Fertility

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

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

Pregnancy

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

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

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

3. How to Take Paracetamol Teva-Rimafar

Follow the administration instructions for this medication indicated by your doctor or pharmacist exactly.

In case of doubt, consult your doctor or pharmacist again.

This medication should be taken orally. According to your preferences, the tablets can be swallowed directly or broken in half with water, milk, or fruit juice.

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

The recommended dose is:

Adults and adolescents over 15 years

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

Children and adolescents:

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

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• Between 22 and 25 kg in weight (from 6 to 10 years): half a tablet per dose, every 6 hours, up to a maximum of 2 tablets in 24 hours.
• Between 26 and 40 kg in weight (from 8 to 13 years): half a tablet per dose, every 4 hours, up to a maximum of 3 tablets in 24 hours.
• Between 41 and 50 kg in weight (from 12 to 15 years): 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 during prolonged periods, as the risk of side 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.

Patient with liver disease:

Before taking this medication, they must consult their doctor. They should take the prescribed amount of medication 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.

Patient with kidney disease:

Before taking this medication, they must consult their doctor.

Take a maximum of 500 milligrams of paracetamol per dose.

Due to the dose, 650 mg of paracetamol, it is not recommended for this group of patients.

Elderly patients

Your doctor will indicate the most suitable treatment for you.

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

When lower doses of paracetamol are required per dose, other presentations of paracetamol that adapt 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 contents of the package, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If an overdose has been taken, you should go to a medical center immediately, even if there are no symptoms, as they often do not appear until three days after taking 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. Later, liver and kidney damage can develop. Severe overdoses can cause death.

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

Patient taking barbiturates or suffering from chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forget to take Paracetamol Teva-Rimafar

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

4. Possible Side Effects

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

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

Rare side effects (may affect up to 1 in 1,000 people), very rare side effects (may affect up to 1 in 10,000 people), unknown (cannot be estimated from available data)

The following side effects have been observed.

General Disorders and Administration Site Conditions

Rare:Discomfort

Immune System Disorders

Unknown: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).

Unknown:Liver damage

Metabolic and Nutrition Disorders

Very Rare:Hypoglycemia (reduced glucose levels in the blood).

Unknown:A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Blood and Lymphatic System Disorders

Very Rare:Leukopenia, neutropenia (decreased white blood cells in the blood), hemolytic anemia (decreased red blood cells in the blood).

Unknown:Thrombocytopenia (reduced platelets in the blood), agranulocytosis

Vascular Disorders

Rare:Hypotension (decreased blood pressure).

Renal and Urinary Disorders

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

Skin and Subcutaneous Tissue Disorders

Unknown: Exanthema

Severe skin reactions have been reported in very rare cases (medications that induce Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and generalized pustular exanthema (AGEP).

Reporting Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects 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-Rimafar

Keep out of sight and reach of children.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your 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-Rimafar

• The active ingredient is paracetamol. Each tablet contains 650 mg of paracetamol.
• The other components are: pregelatinized cornstarch, povidone, stearic acid, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the Product and Package Contents

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

Each package contains 20 tablets packaged in aluminum-PVC-PVDC blisters.

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Madrid (Spain)

Manufacturer

Toll Manufacturing Services S.L.

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 Last Revision of this Package Leaflet: January 2025

Other Sources of Information

"Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"