Paracetamol Zentiva 1000 mg 8 tablets pain and fever

Therapeutic indications Paracetamol Zentiva 1000 mg 8 tablets

Symptomatic treatment of mild to moderate pain and/or febrile states.

Symptomatic treatment of osteoarthritis pain.

This presentation is reserved for adults and children from 50 kg (from about 15 years).

Contraindications Paracetamol Zentiva 1000 mg 8 tablets

- Hypersensitivity to the active substance or to any of the excipients mentioned in section 6.1.

- Severe hepatocellular insufficiency.

- Children under 6 years of age because of the risk of a false start.

Precautions for use and special warnings

-Special warnings

Due to the unit dose per tablet (1000 mg), this presentation is not suitable for children under 15 years.

To avoid the risk of overdose:

- check the absence of paracetamol in the composition of other medicines,

- respect the maximum recommended doses.

Maximum recommended dose :

For information

In children under 40 kg, the total dose of paracetamol should not exceed 80 mg/kg/day (see section 4.9).

In children between 41 and 50 kg, the total dose of paracetamol should not exceed 3 g per day (see section 4.9).

In adults and children weighing more than 50 kg, the total dose of PARACETAMOL should not exceed 4 GRAMS PER DAY (see section 4.9).

Precautions for use Paracetamol Zentiva 1000 mg 8 tablets

The administration of paracetamol may exceptionally lead to liver toxicity, even at therapeutic doses, after short-term treatment and in patients without a history of liver disorders (see section 4.8).

Paracetamol should be used with caution and not exceed 3/day in the following situations (see section 4.2):

- weight < 50 kg,

- mild to moderate hepatocellular insufficiency,

- severe renal insufficiency (creatinine clearance < 30 ml/min (see section 5.2))

- chronic alcoholism,

- dehydration,

- low glutathione reserves such as chronic malnutrition, fasting, recent weight loss, elderly subject over 75 years old or over 65 years old and polypathological, chronic viral hepatitis and HIV, cystic fibrosis, familial cholemia (Gilbert disease),

- allergy to aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs).

The consumption of alcoholic beverages during treatment is not recommended.

In case of recent withdrawal from chronic alcoholism, the risk of hepatic damage is increased

In case of discovery of an acute viral hepatitis, the treatment should be stopped.

In children, the dosage should be adjusted according to weight (see section 4.2).

In a child treated with 60 mg/kg/day of paracetamol, the combination of another antipyretic is justified only in case of inefficiency.

Interactions with other drugs

Associations subject to precautions for use

+ Oral anticoagulants: warfarin and other K-vitamins (VKA)

Risk of increased effect of warfarin and other VKAs and bleeding risk if paracetamol is taken at maximum doses (4 g/d) for at least 4 days. Biological monitoring including more frequent monitoring of INR. Possible adjustment of the dosage of warfarin and other VKAs during treatment with paracetamol and after its discontinuation.

+ Chelating resins

Taking chelating resins may decrease intestinal absorption and potentially the efficacy of paracetamol taken simultaneously. Generally speaking, the resin should be taken at a distance from the paracetamol, with an interval of more than 2 hours, if possible.

+ Flucloxacillin

Risk of metabolic acidosis in patients receiving concomitant flucloxacillin treatment, especially in patients with risk factors for glutathione deficiency, such as sepsis, malnutrition, chronic alcoholism.

+ Hepatotoxic drugs

The toxicity of paracetamol may be increased in patients treated with potentially hepatotoxic drugs or drugs that induce cytochrome P450 enzymes, such as anti-epileptic drugs (such as phenobarbital, phenytoin, carbamazepine, topiramate), rifampicin, or when alcohol is taken concomitantly. The induction of metabolism leads to an important production of the hepatotoxic metabolite of paracetamol. Hepatotoxicity occurs if the amount of this metabolite exceeds the binding capacity of glutathione.

Interactions with paraclinical examinations

Paracetamol may interfere with the glucose oxidase-peroxidase test for abnormally high blood glucose levels.

Paracetamol may interfere with the determination of blood uric acid by the phosphotungstic acid method.

Use during pregnancy and lactation

Pregnancy

Animal studies have not shown any teratogenic or fetotoxic effect of paracetamol.

Clinically, epidemiological studies on a large number of pregnancies have not shown any malformative or fetotoxic effect related to the use of paracetamol at usual doses.

Therefore, paracetamol can be used during pregnancy if clinically necessary. However, it should be used at the lowest effective dose, for the shortest duration and as infrequently as possible during pregnancy.

Breastfeeding

At therapeutic doses, this drug can be administered during breastfeeding.

Fertility

Due to the potential mechanism of action on cyclo-oxygenase and prostaglandin synthesis, paracetamol may impair fertility in women, through an effect on ovulation that is reversible upon discontinuation of treatment.

Effects on male fertility were observed in an animal study. The relevance of these effects in humans is not known.

List of excipients with a known effect

Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment

Dosage Paracetamol Zentiva 1000 mg 8 tablets

Warning: this presentation contains 1000 mg (1 g) of paracetamol per tablet: do not take 2 tablets at the same time.

The usual unit dose is one 1000 mg tablet per dose, to be repeated after 6 to 8 hours. If necessary, the dose can be repeated after a minimum of 4 hours.

It is generally not necessary to exceed 3 g of paracetamol per day, i.e. 3 tablets per day.

However, in case of more intense pain, the maximum dosage can be increased to 4 g per day, i.e. 4 tablets per day.

Always respect an interval of 4 hours between doses.

Maximum recommended doses: see section 4.4.

Frequency of administration

Systematic intake avoids oscillations of pain or fever:

- in children and adolescents, they should be regularly spaced, including at night, preferably 6 hours apart, and at least 4 hours apart;

- in adults, they should be spaced at least 4 hours apart.

Renal insufficiency

In cases of severe renal impairment (creatinine clearance less than 10 ml/min), the interval between two doses should be increased to at least 8 hours.

The total dose of paracetamol should not exceed 3 g per day or 3 tablets.

Other clinical situations

The lowest effective daily dose should be considered, without exceeding 60 mg/kg/day (without exceeding 3 g/d) in the following situations

- weight < 50 kg,

- mild to moderate hepatocellular insufficiency,

- chronic alcoholism,

- dehydration,

- low glutathione reserves such as chronic malnutrition, fasting, recent weight loss, elderly subject over 75 years old or over 65 years old and polypathological, chronic viral hepatitis and HIV, cystic fibrosis, familial cholemia (Gilbert disease).

Mode of administration

Oral route.

The tablets are to be swallowed as they are with a drink (for example water, milk, fruit juice).

Symptoms and instructions in case of overdose

Due to the unit dose per tablet (1000 mg), this presentation is not suitable for children under 15 years.

To avoid the risk of overdose:

- check the absence of paracetamol in the composition of other medicines,

- respect the maximum recommended doses.

Maximum recommended dose :

For information

In children under 40 kg, the total dose of paracetamol should not exceed 80 mg/kg/day (see section 4.9).

In children between 41 and 50 kg, the total dose of paracetamol should not exceed 3 g per day (see section 4.9).

In adults and children weighing more than 50 kg, the total dose of PARACETAMOL should not exceed 4 GRAMS PER DAY

Instructions in case of missed dose(s)

If you forget to take PARACETAMOL BIOGARAN 1 g, tablet:

Do not take a double dose to make up for the dose you forgot to take.

Description of possible side effects

Like all medicines, PARACETAMOL BIOGARAN 1 g, Tablet is likely to have side effects, although not everyone is susceptible.

- In rare cases, a rash or redness of the skin or an allergic reaction may occur, which may include sudden swelling of the face and neck or sudden discomfort with a fall in blood pressure. You must immediately stop the treatment, inform your doctor and never take any medication containing paracetamol again,

- exceptionally, biological changes requiring a blood test have been observed: abnormally low levels of certain blood elements (platelets) that can result in nosebleeds or bleeding gums. In this case, consult a doctor.

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.

Storage conditions

No special storage precautions.

Active ingredients

Paracetamol....................................................................................................................... 1000 mg

For one tablet.

Other components

Povidone K30, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate.