Paracetamol Tarbis Farma 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Tarbis Farma 1 g tablets EFG

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Contents of the leaflet

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

1. What Paracetamol Tarbis Farma is and what it is used for

Paracetamol Tarbis Farma belongs to a group of medicines called analgesics and antipyretics. Paracetamol is indicated for the treatment of symptoms of moderate pain and fever.

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 starting to take this medicine.

Do not take more than the recommended dose stated 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 have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.

If you are being treated with medications for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially when high doses of paracetamol are used.

In chronic alcoholics, do not exceed 2 g of paracetamol in 24 hours.

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

If you have serious 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), be aware that a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these circumstances when paracetamol is used at regular doses for prolonged periods 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.

Children

For children under 15 years of age, consult your doctor or pharmacist, as other formulations with doses appropriate for this patient group are available.

Taking Paracetamol Tarbis Farma with other medicines

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:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for tuberculosis: (isoniazid, rifampicin)
• Medicines for depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: (cholestyramine)
• Medicines used to increase urine elimination (loop 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 (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.

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

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking another medicine. In patients taking oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Inform your doctor or pharmacist if you are taking:

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

Interference with laboratory tests:

If you are scheduled to undergo any laboratory tests (including blood and urine tests, skin tests using 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 drink:

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

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 if pain or fever do not improve or if you need to take the medicine more frequently.

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 paracetamol on the ability to drive and operate machinery is none or negligible.

3. How to take Paracetamol Tarbis Farma

Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Remember to take your medicine. Paracetamol Tarbis Farma is taken orally.

Depending on your preference, the tablets may be taken whole or split in half, with 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 of age: The usual dose is 1 tablet (1 g of paracetamol) 3 times a day. Do not exceed 1 g per dose. If necessary, 1 g may be taken every 6–8 hours, up to 3 times a day. Do not exceed 3 g in 24 hours, divided into several doses.

Patients with liver disease: You must consult your doctor before taking this medicine. You should take only the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not take more than 2 g of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: You must consult your doctor before taking this medicine.

Take a maximum of 500 milligrams per dose.

Due to the dosage (1 g of paracetamol), this medicine is not indicated for this patient group.

Elderly patients: You should consult your doctor.

Use in children

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

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

When doses lower than 1 g of paracetamol per dose are required, other paracetamol formulations suitable for the required dosage should be used.

If you take more Paracetamol Tarbis Farma than you should

Contact 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), stating the name of the medicine and the amount ingested.

If you have taken an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after 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 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 the toxicity of a paracetamol overdose.

If you forget to take Paracetamol Tarbis Farma

Do not take a double dose to make up for a missed dose. Simply take the missed dose as soon as you remember, then take the following doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

Like all medicines, Paracetamol Tarbis Farma can cause adverse effects, although not everyone will experience them.

Rare adverse effects (occurring in up to 1 in 1,000 people) are: malaise, low blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in up to 1 in 10,000 people) are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Paracetamol may cause liver damage when taken at high doses or during prolonged treatment. Very rare cases of serious skin reactions have been reported.

Adverse effects with unknown frequency (cannot be estimated from the available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via 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 Tarbis Farma

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the container (after EXP.). The expiry date refers to the last day of the month indicated.

"Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point* at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment."*

6. Contents of the pack and other information

Composition of Paracetamol Tarbis Farma

• The active substance is paracetamol.
• The other components are: pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose and vegetable-source magnesium stearate.

Appearance of the product and contents of the pack

Paracetamol Tarbis Farma is presented as tablets for oral administration, in packs of 20 and 40 tablets. The tablets are scored, allowing them to be split in half to facilitate swallowing.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: February 2025

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