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Donormil 15 mg effervescent (20 tablets)


Brands:: UPSA (France)


The instruction for medical use of DONORMIL medicine the Trade name Donormil Mezhdunarodnoye the unlicensed name Docsilamin Lekarstvennaya the Tablet form sparkling 15 mg Structure One tablet contains active agent – a docsilamin succinate of 15 mg, excipients: Natrii hydrocarbonas, anhydrous citric acid, sodium hydrophosphate anhydrous, sodium sulfate anhydrous, Natrium benzoicum, macrogoal 6000. The description of the Tablet of white color, cylindrical, flat, with slanted edges and risky for division on one party, soluble in water with sparkling reaction, chips are admissible. Pharmacotherapeutic group Antihistaminic drugs of systemic action. Aminoalkilny ethers. Docsilamin. The ATX R06AA09 code the Pharmacological Pharmacokinetics Maximum Concentration properties (Cmax) in blood plasma is reached on average in 1 hour (Tmax) after reception of a docsilamin of succinate. Plasma elimination half-life (T½) averages 10 hours. Docsilamina succinate is partially metabolized in a liver by demethylation and N-acetylation. Various metabolites which are formed as a result of disintegration of a molecule are quantitatively little significant as 60% of the accepted dose are found in urine in the form of an invariable docsilamin. Docsilamin’s pharmacodynamics succinate – H1 blocker – histamine receptors of a class of ethanolamines, having sedative and atropinopodobny effects. Reduces backfilling time and also improves duration and sleep quality. Duration of action is 6-8 hours. Indications – periodic and tranzitorny insomnia. A route of administration and doses the Recommended dose makes 7.5-15 mg a day, that is ½ – 1 tablets a day. The pill is taken inside in 15-30 minutes prior to a dream, having dissolved in a glass of water. If necessary, the dose can be increased up to 30 mg a day, that is 2 tablets a day. With a renal or liver failure it is recommended to adult to reduce a dose. Treatment duration – 2-5 days. If insomnia does not pass in 5 days‚ treatment has to be reconsidered. Side effects – Anticholinergic effects: a constipation, an ischuria, dryness in a mouth, disorders of vision (illegibility of sight, turbidity of sight, a hallucination, disorder of vision), a cardiopalmus, confusion of consciousness. – A rhabdomyolysis, increase in a kreatinfosfokinaza (KFK) in blood. – Drowsiness in the afternoon which emergence demands a dose decline. Also the first generation of H1 of antihistaminic drugs, as we know, can cause sedation, cognitive disturbances and disturbances of a psychomotor system. Contraindications – hypersensitivity to antihistaminic drugs, the active ingredient or excipient which is a part of drug – closed-angle glaucoma in the family anamnesis or the anamnesis of the patient – uretroprostatichesky disturbances with risk of an ischuria – the breastfeeding period – the children’s age up to 15 years Medicinal interactions of the Combination which are not recommended Alcohol enhances sedation of the majority of H1 antihistamines. It is necessary to avoid consumption of alcoholic drinks and medicines which contain alcohol. Sodium Oxubatum strengthens oppression of the central nervous system. Combinations which it is necessary to take into account Atropine and other atropinopodobny medicines (imipraminovy antidepressants, the majority of H1 of antihistaminic atropin, anticholinergic protivoparkinsonichesky drugs, atropinic antispasmodics, Disopyramidum, fenotiazinovy neuroleptics, clozapine) are caused by such side effects as an ischuria, a constipation, dryness in a mouth. Other sedative drugs (morphine derivatives (soothing and means which are applied to treatment of cough and replacement therapy), neuroleptics, barbiturates, benzodiazepines, meprobamate, tranquilizers, hypnotic drugs, sedative antidepressants (amitriptyline, docsepin, mianserin, mirtazapin, trimipramin), sedative H1 – antihistamines, antihypertensive drugs of the central action, others: Baclofenum, thalidomide), strengthen oppression of the central nervous system. Special instructions the tablet Donormila contains 563 mg of sodium that patients who adhere to a diet with the low content of sodium should take into account at daily reception in case of appointment. Docsilamina succinate as all hypnotic drugs or sedatives, can aggravate a syndrome of a night apnoea (increase in quantity and duration of apnoeas). Elderly patients of H1 – antihistamines have to be applied with care at elderly patients in connection with risk of cognitive disturbances, a sedation and/or feeling of dizziness which can lead to falling (for example when people get up at night) is frequent with serious consequences for this category of patients. Elderly patients with a renal or liver failure At increase in concentration in plasma and reduction of plasmatic clearance it is recommended to reduce a dosage. Pregnancy Considering available data, use of a docsilamin is possible during pregnancy, irrespective of term. In case of use at the end of pregnancy, it is necessary to take into account atropinopodobny and sedative properties of this molecule at observation of the newborn. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Should pay attention to risk of emergence of day drowsiness at the persons running motor transport and working with mechanisms at administration of drug. The combination to other sedatives, sodium Oxubatum, alcoholic beverages or medicines containing alcohol is not recommended or has to be taken into account in case of driving or potentially dangerous mechanisms. If duration of a dream is insufficient, there is a risk of strengthening of disturbances of vigilance. Overdose Symptoms: drowsiness, excitement, expansion of pupils, accommodation paralysis, dryness in a mouth, face reddening and necks, a hyperthermia, sinus tachycardia. The delirium, hallucinations and athetotic movements are more often observed at children, they sometimes foretell appearance of spasms or even a coma which are rare complications of severe poisoning. Acute poisoning docsilaminy sometimes causes a rhabdomyolysis which can be complicated by an acute renal failure. This muscular damage is not an exception that demands systematic determination of activity of a kreatinfosfokinaza (KFK). Treatment: symptomatic treatment. At an early stage of treatment the intake of activated carbon is recommended (50 g for adults, 1 g/kg of body weight for children). The form of release and packing On 10 tablets sparkling on 15 mg place in a white propylene tuba with the polyethylene cover containing desiccant. On 2 tubas together with the instruction for medical use in the Kazakh and Russian languages place in a cardboard box. To Store storage conditions in the place protected from moisture at a temperature not over 25 ºС. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription UPSA SAS Producer, 979, de Pirene’s avenue, 47520 Le the Passage, France the Owner of the registration certificate of UPSA SAS, 3 Rue Joseph Monie, 92500 Ryuey-Malmezon, France. The name and the address of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers, responsible for post-registration observation of safety of medicine Representative office of JSC Delta Medikel Promoushnz AG (Switzerland), 050040. Almaty, Bostandyksky district, Bayzakov St., 280

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