PARACETAMOL TARBIS FARMA 1 g TABLETS

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

Do not take Paracetamol Tarbis Farma

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

Warnings and Precautions

Consult your doctor or pharmacist before taking this medicine.

Do not take more than the recommended dose in section 3. How to take Paracetamol Tarbis Farma.

In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.

If you have liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), consult your doctor before taking this medicine.

When being treated with any medication for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.

In chronic alcoholics, do not take more than 2 g of paracetamol in 24 hours.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, consult your doctor and reassess the clinical situation.

If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are 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 respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children

In children under 15 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

Taking Paracetamol Tarbis Farma with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or may take any other medicine.

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 convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower cholesterol levels in the blood: (cholestyramine)
• Medicines used to increase urine elimination (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 and heart rhythm disorders (arrhythmias): Propranolol.

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

As a general rule for any medicine, it is recommended to inform your doctor or pharmacist if you are being treated with another medicine. 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 laboratory tests:

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

Taking Paracetamol Tarbis Farma with food and drinks:

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 medicine with food does not affect its efficacy.

Pregnancy and Breastfeeding

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

If necessary, it can be used during pregnancy. You should use the lowest possible dose that reduces the 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 medicine more frequently.

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

Driving and Using Machines

The influence of paracetamol on the ability to drive and use machines is negligible or nonexistent.

3. How to take Paracetamol Tarbis Farma

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Remember to take your medicine. Paracetamol Tarbis Farma should be taken orally.

According to your preferences, the tablets can be swallowed directly or broken in half, with the help of a glass of liquid, preferably water.

Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

Adults and adolescents over 15 years: the usual dose is 1 tablet (1 g of paracetamol) 3 times a day. Do not exceed 1 gram per dose, if necessary, you can take 1 gram every 6-8 hours, 3 times a day. Do not take more than 3 g in 24 hours, divided into several doses.

Patients with liver disease: before taking this medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval between each dose of 8 hours. They should not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: before taking this medicine, they must consult their doctor.

Take a maximum of 500 milligrams per dose.

Due to the dose, 1 gram of paracetamol, the medicine is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Use in Children

Do not use in adolescents and children under 15 years of age.

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

When a dose lower than 1 g of paracetamol per dose is required, other presentations of paracetamol that are suitable for the required dosage should be used.

If you take more Paracetamol Tarbis Farma than you should

Consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you have ingested an overdose, go immediately to a medical center, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of overdose is more effective if started within 4 hours after ingestion of the medicine.

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

If you forget to take Paracetamol Tarbis Farma

Do not take a double dose to make up for the 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 medicines, Paracetamol Tarbis Farma can cause side effects, although not everyone gets 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). Paracetamol may damage the liver when taken in high doses or for prolonged periods. Very rare cases of severe skin reactions have been reported.

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).

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are 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 medicine.

5. Storage of Paracetamol Tarbis Farma

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date stated on the packaging (after EXP.). The expiration date is the last day of the month indicated.

“Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment”

6. Package Contents and Additional Information

Composition of Paracetamol Tarbis Farma

• The active ingredient is paracetamol.
• The other ingredients are: pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the Product and Package Contents

Paracetamol Tarbis Farma is presented in the form of tablets for oral administration, in packages of 20 and 40 tablets. The tablets are scored, which allows them to be broken in half to facilitate swallowing.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Manufacturer

Toll Manufacturing Services, S.L.

C/ Aragoneses,

2 28108 Alcobendas - Madrid Spain

Or

Pharmaloop, S.L.

C/Bolivia, nº 15

Pol. Ind. Azque

28806 – Alcalá de Henares – Madrid Spain

Or

Pharmex Advanced Laboratories, S.L

Ctra. A-431 Km. 19

Almodóvar del Río,

14720 Córdoba

Spain

Date of the Last Revision of this Package Leaflet February 2025

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