Doliprane 1000 mg tablets

Each tablet contains 1000 mg of paracetamol

Therapeutic indications:
Doliprane is indicated for the symptomatic treatment of clinical conditions requiring an analgesic and/or an antipyretic such as:

• Symptomatology associated with flu or hyperthermia related to infection
• Fever reaction to vaccination
• Headaches and migraines
• Toothache, earache, period, traumatic, muscle, joints or osteoarthritic pain
• Analgesic before and after surgical procedures

Posology:
Doliprane is for oral administration adults aged 18 and above.
The usual dosage for Doliprane is I tablet, 2 to 4 times a day.
Administration can be repeated at 4 - 8 hour intervals, depending on the clinical situation.
Maximum daily dose is 4 tablets (i.e., 4 g paracetamol/day).

Method of administration:
The tablets can be taken whole.
Administration after the meals can delay the start of action.
Unless prescribed by the doctor, medicines containing paracetamol should not be taken for more than a few days or in high doses.

Contraindications:
- hypersensitivity to the active substance or to any of the excipients
- serious hepatic disease.

Special warnings and precautions for use:
In therapeutic doses paracetamol is relatively nontoxic. However, allergic reactions may occur, including anaphylaxis.

Cases of hepatic necrosis in patients receiving high doses of paracetamol have been reported.

In the following situations the medicinal product should only be used with particular caution (i.e., with adjustment of doses or intervals of administration) and under medical supervision:

• hepatic insufficiency (e.g., due to chronic alcohol abuse hepatitis)
• renal insufficiency
• Gilbert's disease

Precaution in the administration of paracetamol is recommended for patients with severe renal impairment, severe liver disease or severe hemolytic anemia.

Paracetamol must be used with caution in situation dehydration or malnutrition.

The maximum dose of 4 tablets per day in adults should not be exceeded unless expressly stated by a doctor.

Long-term use of this medicine can cause renal alterations.

Prolonged use of analgesics or inappropriate use of high doses, can cause headaches which should not be treated with increased doses of the medicine.

The medicine should not be used for more than 10 days in adults unless prescribed by the doctor.

In situations of high fever (above 39°C), lasting more than 3 days or recurrent fever, paracetamol should not be used unless prescribed by the doctor, as these situations may indicate a serious illness requiring medical assessment and treatment.

During treatment with Doliprane, do not take other medicines containing paracetamol.

Fertility, pregnancy, and lactation:
There is epidemiological clinical evidence on the safety of paracetamol administration during pregnancy.

However, paracetamol should only be used during pregnancy after a careful risk-benefit assessment.
A large amount of data on pregnant women indicates neither malformities, nor feto/neonatal toxicity.
Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results.

If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Paracetamol is excreted in breast milk, but in clinically insignificant amounts. After a single dose of 650 mg, an average concentration of 11 μg/ml was measured in breast milk.
Since no adverse effects on the infant have been established, as a rule during paracetamol treatment, interruption of breastfeeding is not necessary.

Effects on to drive and use machines:
Paracetamol does not interfere with the ability to drive or use machinery. However, it should be taken into account that during treatment with paracetamol, slight drowsiness and dizziness may be observed as side effects.

Undesirable effects:
Paracetamol is generally very well tolerated when given at the recommended therapeutic doses.
Central nervous system diseases: Common: light drowsiness.
Gastrointestinal diseases: Frequent: nausea, vomiting.

• Always read the full prescribing information.
• Healthcare professionals are asked to report any suspected adverse reactions to pharmacovigilance center (EPVC) at PV.followup@edaegypt.gov.eg, Hotline: 15301, Website: www.edaegypt.gov.eg.
• Doliprane tablets 1000 mg. Egyptian Drug Authority (EDA) leaflet approval date: 04/01/2021.