Medicinal Products

DOXYLAMINE CRISTERS 15 mg

Generic drug of Donormyl
Therapeutic Class: Diagnostic Products or Other Therapeutic Products
Active ingredients: Doxylamine
laboratory: Cristers

Divisible coated tablet
tube of 10
All forms

Indication

Occasional insomnia in adults.

RESERVED FOR THE ADULT.

Dosage DOXYLAMINE CRISTERS 15 mg film-coated tablets scored tube of 10

Occasional insomnia in adults.

RESERVED FOR THE ADULT.

Against indications

· Known hypersensitivity to antihistamines, the active substance or any of the excipients listed under Composition,

· Personal or family history of acute glaucoma due to closure of the iridocorneal angle,

· Urethroprostatic disorders at risk of urinary retention,

· Child under 15 years old.

Adverse effects Doxylamine Cristers

· Anticholinergic effects: constipation, urinary retention, dry mouth, visual disturbances (accommodation disorders, blurred vision, hallucinations, visual impairment), heart palpitations, confusion.

· Rhabdomyolysis, increased blood creatine phosphokinase (CPK).

· Daytime sleepiness, which requires a reduction in dosage.

In addition, the first generation of antihistamines H 1 are known to cause sedation, cognitive disorders and psychomotor performance disorders.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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