Paracetamol Tarbis Farma 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Tarbis Farma 650 mg tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• 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.

Leaflet contents

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 side 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 belongs to a group of medicines called analgesics and antipyretics.

This medicine is used for the symptomatic treatment of mild to moderate pain and febrile conditions.

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

Do not take Paracetamol Tarbis Farma:

• 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 before starting to take this medicine.

Do not take more than the recommended dose indicated in section 3, How to take Paracetamol Tarbis Farma. To avoid overdose, check that you are not simultaneously taking other medicines containing paracetamol, such as cold and flu remedies.

Patients with asthma who are sensitive to acetylsalicylic acid should inform their 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, with or without a reduction in red blood cells), you should consult your doctor before taking this medicine.

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

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), be cautious. A serious condition known as metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions 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 breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

In chronic alcoholics, care should be taken not to exceed 2 g/day of paracetamol.

Children and adolescents

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

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

Other medicines and Paracetamol Tarbis Farma:

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Paracetamol may interact with the following medicines:

• Antibiotics (chloramphenicol)
• Anticoagulants (used to treat thromboembolic disorders)
• Antiepileptics (used to treat epileptic seizures)
• Oral 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 and cardiac arrhythmias)
• Rifampicin (used to treat tuberculosis)
• Anticholinergics (used to relieve spasms or contractions of the stomach, intestines, and bladder)
• Zidovudine (used to treat HIV infections)
• Cholestyramine (used to lower blood cholesterol levels)

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 receiving treatment with another medicine. In patients treated with 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 diagnostic 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 test results.

Paracetamol may alter the results of analytical tests for 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 drinks per day—beer, wine, spirits, etc.) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or think you may be pregnant, 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 if pain or fever does not subside 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 influence of paracetamol on the ability to drive and operate machinery is none or negligible.

3. How to take Paracetamol Tarbis Farma

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is administered orally. Depending on your preference, the tablets may be taken directly or split in half with water, milk, or fruit juice. The tablet can be divided into equal doses.

Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

Adults and adolescents over 15 years of age 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 follow the dosage recommendations based on body weight. The child's age according to 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 21 and 25 kg (ages 6 to 10): half a tablet per dose, every 6 hours, up to a maximum of 2 tablets per day.
• Between 26 and 40 kg (ages 8 to 13): half a tablet per dose, every 4 hours, up to a maximum of 3 tablets per day.
• Between 41 and 50 kg (ages 12 to 15): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.

Patients with liver disease: Should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses. They must not take more than 3 tablets of 650 mg of paracetamol in 24 hours.

Patients with kidney disease:

Maximum dose per administration: 500 milligrams.

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

Elderly patients: Your doctor will advise you on the appropriate dosing frequency and whether dose reduction is necessary.

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

When lower doses of paracetamol than 650 mg per administration are required, other paracetamol formulations adapted 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 more paracetamol than you should, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 915 620 420, indicating the medicine and the amount ingested.

If you have taken an overdose, 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: 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 after 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 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, and take the following doses at the recommended intervals (at least 4 hours between doses).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Paracetamol may cause the following adverse effects:

Rare adverse effects (occurring in up to 1 in 1,000 people) are: malaise, drop in 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). Very rare cases of serious skin reactions have been reported. Paracetamol can cause liver damage when taken at high doses or during prolonged treatment.

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

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 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

No special storage conditions are required.

Keep this medicine out of the 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and animal information

Composition of Paracetamol Tarbis Farma:

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

Appearance of the product and contents of the pack

Paracetamol Tarbis Farma are white, oblong, scored tablets. They are available in packs of 20 and 40 tablets, presented in PVC/PVDC/Aluminium blisters.

Only certain pack 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 most recent revision of this leaflet: February 2025