Cipladon Effeverscent Granules 1000

Šalis: Tanzanija

kalba: anglų

Šaltinis: Tanzania Medicinces & Medical Devices Authority

Veiklioji medžiaga:

paracetamol

Prieinama:

Cipla Limited, INDIA

ATC kodas:

Other analgesics and antipyretics

INN (Tarptautinis Pavadinimas):

paracetamol

Dozė:

1000

Vaisto forma:

Effeverscent Granules

Pagaminta:

Cipla Limited, INDIA

Produkto santrauka:

Physical description: White to off white colored flat bevelled tablets plain on both sides; Local technical representative: JD PHARMACY LIMITED (6943)

Autorizacija statusas:

Registered/Compliant

Leidimo data:

2019-08-02

Prekės savybės

Summary of Product Characteristics
1. Name of the medicinal product
Cipladon (Paracetamol 1000 mg effervescent tablets)
2. Qualitative and quantitative composition
Each effervescent tablet contains 100 mg of paracetamol.
Excipients with known effects:
NNN
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Effervescent tablet.
White to off white colored flat bevelled tablets plain on both sides
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of mild to moderate pain and/or fever in adults and adolescents aged 12
years and above.
4.2 Posology and method of administration
Posology
Paediatric population
Dose depends on body weight and age. A single dose ranges from 10 to 15 mg/kg bodyweight.
The maximum total daily dose is 60 mg/kg body weight for total daily dose.
• Children below 12 years of age: this product is not recommended in children aged less than 12
years.
• Adolescents of 12 to 15 years of age: one tablet at a time, every 4-6 hours as needed, the
maximum being 4 tablets per day (paracetamol 2000 mg per 24 hours).
• Adolescents of 16 to 18 years and weighing more than 50 kg: as adults.’
Adults
For adults and adolescents (aged 16 years and older) weighing more than 50 kg the usual single
dose is 1-2 tablets at a time, to be repeated every 6 hours as needed, the maximum being 8
tablets per day (paracetamol 4000 mg per 24 hours).
For adults and adolescents (aged 16 years and older) and weighing less than 50 kg the
recommended single dose is 1 tablet. The daily effective dose of paracetamol should not exceed
60 mg/kg/day (upto maximum 2g/day).
Renal impairment