Properties
What is it?
Composition: 1 tablet contains: Active substances: Passiflora (Passiflorae herba) dry extract 300mg; Doxylamine hydrogen succinate 3.75mg; Excipients: Glycine, microcrystalline cellulose, copovidone, crospovidone, pregelatinized starch, colloidal anhydrous silica, magnesium stearate, Opadry II Blue coating (polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc, indigotine (E132), brilliant blue (E133), iron black oxide (E172). Indications: Periodic and transient insomnia. Contraindications: Hypersensitivity to the preparation; pregnancy and lactation; narrow-angle glaucoma in the patient's history or family history; urethral and prostatic disorders with risk of urinary retention. Method of administration and dosage: Take orally. The recommended dose is 1 tablet, which can be increased to 2 tablets if necessary. The preparation is taken 30 minutes before bedtime. Dose reduction is recommended in elderly patients and patients with kidney or liver failure. Duration of treatment - up to 10 days. If symptoms do not subside, consult a doctor. If insomnia persists for more than 5 days, consult a doctor about the advisability of further use of the preparation. Use during pregnancy and lactation: Do not use during pregnancy and lactation. Children: The efficacy and safety of the preparation in children under 15 years of age have not been established, therefore its use in this category of patients is not recommended. Effect on ability to drive and operate machinery: Attention should be paid to the risk of daytime sleepiness, which may develop when taking this preparation, especially in individuals who drive or operate machinery. Interaction with other medicines: Medicines with a central inhibitory effect enhance the effect of this preparation. Simultaneous use with benzodiazepines is not recommended. The patient should avoid simultaneous intake with disulfiram. Alcoholic beverages should not be consumed during treatment with the preparation. Doxylamine combinations with the following preparations should be considered: atropine and atropine-like preparations (imipramine antidepressants, anticholinergic antiparkinsonian drugs, atropine antispasmodics, disopyramide, phenothiazine neuroleptics) due to the occurrence of side effects such as urinary retention, constipation, dry mouth. Other antidepressants affecting the central nervous system, morphine derivatives (analgesics; preparations used for cough and substitution therapy), neuroleptics; barbiturates; benzodiazepines, anxiolytics; sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine); sedative H1-antihistamines; centrally acting antihypertensive drugs, and others (baclofen, pizotifen, thalidomide) due to potentiation of central nervous system depression. Description: Tablets are round and biconvex, coated with a film coating of light blue to blue color, with a specific odor. Two layers are visible in cross-section. Dosage form: 10 tablets in a blister; 3 blisters in a cardboard box with instructions for medical use. Storage conditions: Store in the original packaging at a temperature not exceeding 25C, out of reach of children. Shelf life: 2 years. Dosage form: Tablets, film-coated. Dispensing category: Pharmaceutical product group - III group, available without a prescription. Manufacturer LLC "Pharma Start", Ukraine, Kyiv.