Medicinal Products

ALGOTROPYL 200 mg / 5 mg

Generic drug of the therapeutic class: Allergology
active ingredients: Paracetamol, Promethazine
laboratory: Biocodex

Suppository
Box of 10
All forms

Indication

Symptomatic treatment of nasal hypersecretion in acute nasopharyngeal conditions with headache and / or fever.

NB: In view of the general clinical signs of bacterial infection, a systemic antibiotic therapy should be considered.

Dosage ALGOTROPYL 200 mg / 5 mg suppository Box of 10

RESERVED FOR CHILDREN WEIGHING BETWEEN 13 AND 16 KG (ABOUT 2 TO 5 YEARS).

RECTAL PATH.

In children, it is imperative to respect the dosages defined according to the weight of the child and therefore to choose a suitable presentation. Approximate ages by weight are given for information.

The recommended daily dose of paracetamol depends on the weight of the child: it is about 60 mg / kg / day, to be divided into 4 doses, or about 15 mg / kg every 6 hours.

Due to the risk of local toxicity; the administration of a suppository is not recommended beyond 4 times a day, and the rectal treatment should be as short as possible.

In case of diarrhea, suppository administration is not recommended.

The dosage is 1 suppository 200 mg paracetamol to be renewed if necessary after 6 hours without exceeding 4 suppositories per day.

Evening intakes should be preferred because of the pronounced sedative effect of promethazine, especially at the beginning of treatment.

Renal failure:

In case of severe renal insufficiency (creatinine clearance less than 10 ml / min), the interval between two doses will be at least 8 hours.

Against indications

This medicine is CONTRAINDICATED in the following cases:

· Due to the presence of paracetamol:

o hypersensitivity to paracetamol,

o hepatocellular insufficiency;

· Due to the presence of promethazine:

o hypersensitivity to promethazine,

o antecedents of agranulocytosis,

o risk of urinary retention related to urethral disorders,

o risk of glaucoma by closing the angle,

· Recent history of proctitis, anitis or rectorrhagia.

Algotropyl side effects

Related to the presence of paracetamol:

· A few rare cases of allergic accidents are manifested by simple skin rashes with erythema or urticaria and require discontinuation of treatment;

· Very exceptional cases of thrombocytopenia have been reported.

Linked to the suppository form:

Possible rectal or anal irritation.

Linked to the presence of promethazine:

The pharmacological characteristics of the molecule cause undesirable effects of unequal intensity and are dose-related or non-dose-related (see section 5.1 Pharmacodynamic properties).

· Neurovegetative effects:

o sedation or drowsiness, more marked at the beginning of treatment;

o anticholinergic effects such as dryness of the mucous membranes, constipation, accommodation disorders, mydriasis, heart palpitations, risk of urinary retention;

o orthostatic hypotension;

o disturbances of balance, vertigo, loss of memory or concentration;

motor incoordination, tremors;

o mental confusion, hallucinations;

o more rarely and especially in infants, effects with excitation type: agitation, nervousness, insomnia;

· Awareness Reactions:

o erythema, eczema, pruritus, purpura, possibly giant urticaria,

o edema, more rarely angioedema,

o anaphylactic shock,

o photosensitization;

· Hematological disorders:

o leukopenia, neutropenia, exceptional agranulocytosis;

o thrombocytopenia,

o Hemolytic anemia.

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