CETAMYL

500 MG · poudre pour solution buvable · box 12 sachets

PARACETAMOL

Reference dated : 2017-12-18. Confirm price and availability with a pharmacist.

Public price

14,30 MAD

Composition and presentation

CETAMYL — PARACETAMOL. Listed presentation: 500 MG · POUDRE POUR SOLUTION BUVABLE · 1 BOITE 12 SACHET.

Full clinical reference

Additional sections are available in French. Read the original document; the information concerns the French reference product.

Uses

Symptomatic treatment of mild to moderate pain and/or fever.

Adults and children from 27 kg (approximately 8 years).

Pregnancy and breastfeeding

Pregnancy

A vast amount of data concerning pregnant women demonstrates the absence of any malformation or any fetal/neonatal toxicity.

Epidemiological studies dedicated to the neurodevelopment of children exposed to paracetamol in utero produce inconclusive results.

If it proves necessary from a clinical point of view, paracetamol can be used during pregnancy; however, it should be used at the lowest effective dose, for the shortest possible duration and at the lowest possible frequency.

Breastfeeding

After administration, paracetamol is eliminated in small amounts in breast milk. At therapeutic doses, the administration of this medicine is possible during breastfeeding.

Fertility

Due to the potential mechanism of action on cyclo-oxygenases and prostaglandin synthesis, paracetamol could alter fertility in women, through an effect on ovulation reversible upon discontinuation of treatment.

Effects on male fertility were observed in one study in animals. The relevance of these effects in humans is unknown.

Driving

Paracetamol has no effect or a negligible effect on the ability to drive vehicles and use machines.

Adverse effects

Adverse effects are classified by system-organ class. Their frequencies are defined as follows:

· very frequent (≥ 1/10),

· frequent (≥ 1/100 to < 1/10),

· uncommon (≥ 1/1 000 to < 1/100),

· rare (≥ 1/10 000 to < 1/1 000),

· very rare (< 1/10 000),

· frequency unknown (cannot be estimated based on available data).

System organ class	Rare ( ≥ 1/10 000 to < 1/1 000)	Very rare (< 1/10 000)	Frequency unknown
Hematological and lymphatic system disorders		Thrombocytopenia, Leucopenia, Neutropenia
Immune system disorders	Hypersensitivity reactions 1		Anaphylactic reaction (including hypotension) 1 Anaphylactic shock 1 Angioedema (Quincke's edema) 1
Respiratory, thoracic and mediastinal disorders			Bronchospasm (cases of bronchospasm have been identified with paracetamol, mostly in asthmatic patients sensitive to aspirin or other non-steroidal anti-inflammatory drugs)
Metabolism and nutrition disorders			Pyroglutamic acidosis in patients with factors predisposing to glutathione depletion, High anion gap metabolic acidosis
Gastrointestinal disorders	Diarrhoea, Abdominal pain
Hepatobiliary disorders			Increase in liver enzymes
Skin and subcutaneous tissue disorders	Erythema 1 Urticaria 1 Skin rash 1 Purpura 2	Serious skin reactions 1	Fixed pigment erythema
1 Their occurrence requires immediate and permanent discontinuation of this medicinal product and related medicinal products. 2 The occurrence of this effect requires immediate discontinuation of this medicinal product. The medicinal product may only be reintroduced on medical advice.

Description of selected adverse effects

High anion gap metabolic acidosis

Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors taking paracetamol (see section 4.4). Pyroglutamic acidosis may occur in these patients due to low glutathione levels.

Reporting of suspected adverse effects

Reporting suspected adverse effects following authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/

Read the French reference

Hospital price

8,90 MAD

Type

Generic

Therapeutic class

ANALGESIQUE ANTIPYRETIQUE

References and update dates

CNOPS Referentiel des medicaments · 2017-12-18

Product and price reference

This information is informational and must be confirmed by a pharmacist or doctor. Do not change medicine or dosage based only on this page.

Price history

Reference price recorded since 2017-12-18: 14,30 MAD

Same ingredient, strength and form

This grouping does not establish interchangeability.

DOLIPRANE

500 MG · poudre pour solution buvable · box 12 sachets

14,40 MAD

Other strengths and forms

Routes and instructions may differ.