ALDIREK 10 mg

Generic drug of the therapeutic class: Allergology
active ingredients: Cetirizine
laboratory: Actavis Group Ptc Ehf

Indication

In adults and children 6 years and older:

· Cetirizine is indicated for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

· Cetirizine is indicated for the treatment of symptoms of chronic idiopathic urticaria.

Medical advice is recommended for chronic idiopathic urticaria.

Dosage ALDIREK 10 mg Breakable film-coated tablet Box of 7

Dosage

Children from 6 to 12 years: 5 mg twice a day (half a tablet twice a day).

Adults and adolescents over 12 years of age: 10 mg once daily (one tablet).

The tablet should be swallowed with a drink.

Elderly: There is no need to adjust the dosage in elderly patients with normal renal function.

Moderate to severe renal impairment: The available data do not allow documentation of benefit / risk in renal failure.

Due to its essentially renal elimination (see section 5.2 ), and if it can not be used as an alternative treatment, cetirizine will be administered in these situations by adjusting the dosage and the spacing between catches as a function of clearance. renal according to the table below.

The creatinine clearance (CL _cr ) can be estimated (in ml / min) from the measurement of serum creatinine (in mg / dl) according to the following formula:

CL _cr = [140- age (year)] x weight (kg) x (0.85 for women)

72 x serum creatinine (mg / dl)

Dosage adjustment in patients with renal impairment:

In children with renal impairment, the dosage will be adjusted individually according to the renal clearance, age and body weight of the patient.

Hepatic impairment: no dose adjustment is necessary in patients with isolated hepatic impairment.

In patients with hepatic impairment associated with renal impairment, a dose adjustment is recommended (see section "Moderate to severe renal impairment" above).

Against indications

· Known hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to piperazine derivatives.

· Severe renal insufficiency with creatinine clearance less than 10 ml / min.

Aldirek side effects

Minor adverse effects on the central nervous system including somnolence, fatigue, dizziness and headache were observed in clinical trials with cetirizine at the recommended dose. In a few cases, a paradoxical effect of stimulation of the central nervous system has been observed.

Despite its selective antagonistic effect on peripheral H1 receptors and the relatively low anticholinergic activity, isolated cases of voiding difficulties, accommodation problems and dryness of the mouth have been reported.

Cases of abnormal hepatic function with increased liver enzymes associated with increased bilirubin have been reported. In most cases, abnormalities decreased with cessation of treatment with cetirizine dihydrochloride.

Clinical tests

More than 3, 200 subjects exposed to cetirizine were included in double-blind controlled clinical trials or in pharmaco-clinical trials comparing cetirizine to the recommended 10 mg daily dose with placebo or other antihistamines of which quantified tolerance data are available.

In this population as a whole, adverse events reported in placebo-controlled trials with an incidence of 1.0% or greater were:

Drowsiness was statistically more frequent than placebo, but mild to moderate in most cases. Objective tests, validated by other studies, have shown, in the healthy young volunteer, that the usual daily activities are not assigned to the recommended daily dose.

Adverse reactions reported with an incidence of 1% or more in children aged 6 months to 12 years included in placebo-controlled clinical trials or in pharmaco-clinical studies are:

Adverse reactions reported since marketing

In addition to the undesirable effects reported in clinical trials and listed above, isolated cases of adverse events have been reported since the product was marketed. For these less frequently reported adverse events, frequency estimation (uncommon: 1/1000 and <1/100, rare: 1/10000 and <1/1000, very rare <1/10000) is based on marketing data.

Hematologic and lymphatic system disorders:

Very rare: thrombocytopenia

Affection of the immune system:

Rare: hypersensitivity

Very rare: anaphylactic shock

Psychiatric disorders:

Uncommon: agitation

Rare: aggression, confusion, depression, hallucination, insomnia

Very rare: tic

Nervous system disorders:

Uncommon: paresthesia

Rare: convulsions, abnormal movements

Very rare: dysgeusia, syncope, tremors, dystonia, dyskinesia

Eye disorders:

Very rare: accommodation disorders, blurred vision, oculogyric crisis

Heart conditions:

Rare: tachycardia

Gastrointestinal disorders:

Uncommon: diarrhea

Hepatobiliary disorders:

Rare: abnormal liver function (increased liver enzymes: transaminases, alkaline phosphatase, gamma-GT and bilirubin)

Skin and subcutaneous tissue disorders:

Uncommon: pruritus, rash

Rare: urticaria

Very rare: angioneurotic edema, fixed pigmented erythema

Renal and urinary disorders

Very rare: dysuria, enuresis

General disorders and administration site defects:

Uncommon: asthenia, malaise

Rare: edema

Investigations:

Rare: weight gain.