Leaflet: information for the user

Paracetamol Tarbis Farma 650 mg tablets EFG

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Paracetamol Tarbis Farma

3. How to take Paracetamol Tarbis Farma

4. Possible side effects

5. Storage of Paracetamol Tarbis Farma

6. Contents of the pack and additional information

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 states.

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. Check that you are not taking other medications that contain paracetamol, such as cold medications, at the same time.

Patients with asthma who are sensitive to acetylsalicylic acid should inform their doctor before taking this medication.

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

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

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

Children and adolescents:

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

In children and adolescents under 15 years, consult your doctor or pharmacist, as there are other presentations with doses that are adapted to this group of patients.

Other medications and Paracetamol Tarbis Farma:

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Paracetamol may interact with the following medications:

• Antibiotics (cloranfenicol)
• Anticoagulants (used for the treatment of thromboembolic diseases)
• Antiepileptics (used for the treatment of epileptic seizures)
• Contraceptives
• Diuretics (used to increase urine elimination)
• Isoniazid (used for the treatment of tuberculosis)
• Lamotrigine (used for the treatment of epilepsy)
• Probenecid (used for the treatment of gout)
• Propanolol (used for the treatment of hypertension, cardiac arrhythmias)
• Rifampicin (used for the treatment of tuberculosis)
• Anticholinergics (used for the relief of spasms or contractions of the stomach, intestines, and bladder)
• Zidovudine (used for the treatment of HIV infections)
• Colestiramida (used to reduce blood cholesterol levels)

Do not use with other analgesics (pain medications) without consulting your doctor.

As a general rule for any medication, it is recommended to inform your doctor or pharmacist systematically if you are being treated with another medication. In the case of oral anticoagulants, paracetamol can be administered occasionally as a pain medication of choice.

Inform your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Interference with analytical tests:

If you are to undergo any analytical test (including blood, urine, skin tests using 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.

Paracetamol Tarbis Farma intake with food, drinks, and alcohol:

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

The intake of 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 consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Lactation:

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery:

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is administered orally. According to your preference, the tablets can be taken directly or divided 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 and weighing over 50 kg: 1 tablet every 4-6 hours,up to a maximum of 6 tablets per day.

Children:it is necessaryto respect the dosages defined according to weight. The child's age according to weight is given for information purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/Kg/day, which is 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 of weight (6 to 10 years):halftablet per dose, every 6 hours,up to a maximum of 2 tablets per day.

- Between 26 and 40 kg of weight (8 to 13 years):halftablet per dose, every 4 hours,up to a maximum of 3 tablets per day.

- Between 41 and 50 kg of weight (12 to 15 years): 1 tablet per dose, every 6 hours,up to a maximum of 4 tablets per day.

Patients with liver disease:They should take the amount of medication prescribed by their doctor 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 paracetamol dose (650 mg), these patients cannot take this medication.

Older patients:your doctor will indicate the frequency and if necessary reduce the dose

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

When requiring the administration of doses lower than 650 mg of paracetamol per dose, other presentations of paracetamol that adapt to the required dosing 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 Toxicological Information Service immediately, 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 the overdose, even in cases of severe intoxication.

The symptoms of an overdose can be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), and abdominal pain.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the medication.

Patients undergoing barbiturate treatment or those suffering from chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forgot to take Paracetamol Tarbis Farma:

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated interval (at least 4 hours).

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Paracetamol may produce the following adverse effects:

Rare adverse 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 adverse effects that may occur (in up to 1 in 10,000 people) are: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Rarely, severe skin reactions have been reported. Paracetamol can damage the liver when taken in high doses or prolonged treatments.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not require special storage conditions.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Paracetamol Tarbis Farma:

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

Appearance of the product and content of the packaging

Paracetamol Tarbis Farma are oblong, scored and white tablets. They are presented in packaging of 20 and 40 tablets conditioned in PVC/PVDC/Aluminum blisters.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Responsible for manufacturing:

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 review of this leaflet:April 2017