PARACETAMOL TARBIS FARMA 650 mg TABLETS

2. What you need to know before taking Paracetamol Tarbis Farma

Do not take Paracetamol Tarbis Farma:

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

Warnings and Precautions:

Consult your doctor before starting to take this medication.

Do not take more than the recommended dose in section 3, How to take Paracetamol Tarbis Farma. To do this, check that you are not taking other medications that contain paracetamol, such as cold medications.

Asthmatic patients sensitive to acetylsalicylic acid should inform their doctor before taking this medication.

If you have liver, kidney, 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.

Paracetamol should be administered with caution in patients with chronic malnutrition or dehydration.

If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the 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.

In chronic alcoholics, caution should be taken not to take more than 2 g/day of paracetamol.

Children and Adolescents

Due to the dose of paracetamol, this medication should not be used in children weighing less than 21 kg (under 6 years old).

In children and adolescents under 15 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 Tarbis Farma:

Tell 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:

• Antibiotics (chloramphenicol)
• Anticoagulants (used to treat thromboembolic diseases)
• Antiepileptics (used to treat epileptic seizures)
• Contraceptives
• Diuretics (used to increase urine elimination)
• 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)
• Zidovudine (used to treat HIV infections)
• Colestyramine (used to decrease blood cholesterol levels)

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.

Tell your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a serious risk of alteration of the blood and fluids (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with analytical tests:

If you are going to have any analytical tests (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 Tarbis Farma with Food, Drinks, and Alcohol:

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

Taking this medication with food does not affect its efficacy.

Pregnancy and Breastfeeding

Pregnancy:

Consult your doctor or pharmacist before using any medication.

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.

If necessary, it 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.

Breastfeeding:

Consult your doctor or pharmacist before using any medication.

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 nil or insignificant.

3. How to Take Paracetamol Tarbis Farma

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medication is administered orally. According to your preferences, the tablets can be taken directly or broken in half with water, milk, or fruit juice. The tablet can be divided into equal doses.

Consult your doctor or pharmacist if you have doubts.

The recommended dose is:

Adults and adolescents over 15 years old and weighing more than 50 kg: 1 tablet every 4-6 hours, up to a maximum of 6 tablets per day.

Children: 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 21 and 25 kg in weight (6 to 10 years old): half a tablet per dose, every 6 hours, up to a maximum of 2 tablets per day.
• Between 26 and 40 kg in weight (8 to 13 years old): half a tablet per dose, every 4 hours, up to a maximum of 3 tablets per day.
• Between 41 and 50 kg in weight (12 to 15 years old): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.

Patients with liver disease: 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.

Patients with kidney disease:

Take a maximum of 500 milligrams per dose.

Due to the dose of paracetamol (650 mg), these patients cannot take this medication.

Elderly patients: Your doctor will indicate the frequency and if the dose needs to be reduced.

If it is estimated that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

When lower doses of paracetamol (less than 650 mg) are required per dose, other presentations of paracetamol that adapt to the required dosage should be used. Consult your doctor or pharmacist.

If you take more Paracetamol Tarbis Farma than you should:

If you have taken paracetamol more than you should, consult your doctor, pharmacist, or the Toxicology Information Service (telephone 915 620 420), indicating the medication and the amount taken.

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: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

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

Patients treated with barbiturates or who have chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forget to take Paracetamol Tarbis Farma:

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 gets them.

Paracetamol may cause the following side effects:

Rare side effects that may occur (in 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 (in 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 for prolonged treatments.

Side effects with unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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 Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Paracetamol Tarbis Farma

No special storage conditions are required.

Keep this medication out of sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. 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 Tarbis Farma:

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

Appearance of the Product and Package Contents

Paracetamol Tarbis Farma are oblong, scored, and white tablets. They are available in packages of 20 and 40 tablets, packaged in PVC/PVDC/Aluminum blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Manufacturer:

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid), Spain

Pharmex Advanced Laboratories, S.L.

Ctra. A-431 Km. 19,

14720 Almodóvar del Río (Córdoba), Spain

Date of the Last Revision of this Package Leaflet:February 2025