Зомиг

Зомиг – drug with protivomigrenozny action.

Form of release and structure

Зомиг release in the form of tablets, film coated: yellow, biconvex, round, with an engraving of "Z" on one of the parties (on 2 or 3 pieces in blisters, on 1 blister in a cardboard pack).

Is a part of 1 tablet:

• Active ingredient: золмитриптан – 2,5 mg;
• Auxiliary components: anhydrous lactose – 100 mg, sodium carboxymethylstarch – 3 mg, microcrystallic cellulose – 15 mg, magnesium stearate – 1,5 mg;
• Cover: a macrogoal of 8000 - 0,2 mg, yellow dye (OY-22906) – 3,1 mg;
• Dye: a gipromelloza – 1,923 mg, a macrogoal of 400 - 0,192 mg, titanium dioxide – 0,963 mg, dye iron oxide yellow (E172) – 0,022 mg.

Indications to use

Зомиг appoint for stopping of attacks of migraine with aura or without aura.

Contraindications

• The Tranzitorny ischemic attacks or disturbances of cerebral circulation in the anamnesis;
• Syndrome of WPW or arrhythmia which are associated with other additional ways of carrying out an impulse;
• Uncontrollable arterial hypertension;
• Coronary heart disease;
• Printsmetal's stenocardia (angiospastic stenocardia);
• Simultaneous use with ergotamine either its derivatives or other agonists of 5HT1B/1D-serotoninovy receptors;
• Hypersensitivity to drug components.

There are no necessary data confirming safety and efficiency of use of drug for the patients belonging to the following categories:

• Pregnancy (purpose of Zomiga perhaps after assessment by the doctor of a ratio of advantage/risk);
• The lactation period (drug can be taken with caution);
• Age up to 18 years;
• Advanced age (drug can be taken with caution).

Route of administration and dosage

Зомиг accept inside.

For stopping of an attack of migraine drug is recommended to accept 2,5 mg in a single dose. In cases if symptoms remain or arise for 24 hours again, it is possible to accept a repeated dose, but not earlier, than in 2 hours after the first. If necessary increase in a single dose is possible twice.

As a rule, improvement of a state is shown within 1 hour after reception of Zomiga.

Efficiency of drug does not depend on through what time from the moment of the beginning of an attack the pill was taken, however it is recommended to be accepted as soon as possible from the moment of developing of a migrenozny headache.

The general daily dose of Zomiga at development of repeated attacks of migraine should not be more than 10 mg.

Patients with heavy functional disturbances of a liver are not recommended to exceed a daily dose of 5 mg.

Correction of the mode of dosing at functional disturbances of kidneys is not required.

Side effects

Зомиг, as a rule, by patients it is transferred well. Side effects have tranzitorny character, proceed in moderate or easy degree and are usually resolved independently without therapy.

During use of Zomiga there can be following disturbances (≥1% and <10% – is frequent; ≥0,01% and <0,1% – are rare; <0,01% – are very rare):

• Cardiovascular system: seldom – heartbeat, tachycardia; very seldom – a spasm of coronary vessels, stenocardia, a myocardial infarction, tranzitorny arterial hypertension (very seldom is followed by clinically significant symptoms);
• Alimentary system: often – dryness in a mouth, nausea; very seldom – hemorrhagic diarrhea, an abdominal pain, a spleen heart attack, ischemic colitis, a heart attack or ischemia of intestines;
• Central and peripheral nervous system: often – a caumesthesia, dizziness, sensitivity disturbances, an adynamy, feeling of constraint and weight in extremities, constraint in a neck, a throat and in a pectus (ischemic changes on the electrocardiogram is not followed), drowsiness, paresthesias; seldom – a headache;
• Urinary system: very seldom – a frequent urination, a polyuria;
• Musculoskeletal system: often – muscular weakness, a mialgiya;
• Allergic reactions: seldom – a Quincke's disease, anaphylactic reactions, a small tortoiseshell.

Most often adverse reactions develop for 4 hours after use of Zomiga and with reception of repeated doses do not become frequent.

Special instructions

It is not necessary to apply Zomig to prevention of attacks of migraine.

Drug has the expressed effect at migraine with aura and without aura, and also at the migraine associated with periods. Does not exert impact on its efficiency: age, sex, attack duration, existence of nausea before reception of Zomiga and use of usual medicines for prevention of attacks of migraine.

Зомиг it is possible to accept only after diagnosis. Before therapy it is necessary to exclude other probable serious neurologic states.

Today the data confirming efficiency and safety of use of Zomiga at basilar or hemiplegic migraine no.

At patients with migraine the risk of emergence of disturbances of cerebral circulation can be increased. At the patients accepting agonists of 5HT1B/1D-serotoninovy receptors the subarachnoidal, hemorrhagic and ischemic stroke, and also other disturbances of cerebral circulation were noted.

Seldom or never at use of Zomiga there were spasms of coronary vessels, a myocardial infarction or stenocardia. Patients with high degree of probability of development of coronary heart disease before therapy are recommended to conduct examination of a condition of cardiovascular system. Seldom or never serious complications can be observed at the patients who did not have in the anamnesis of instructions on diseases of cardiovascular system.

During therapy emergence of atypical feelings in heart is possible. At emergence of symptoms of coronary heart disease or stethalgias before performing the corresponding medical examination it is necessary to stop use of a zolmitriptan.

Reception of Zomiga can cause easy tranzitorny increase in arterial pressure regardless of existence of arterial hypertension in the anamnesis. Seldom or never such increase was clinically expressed.

At use of Zomiga exceptional cases of development of anaphylactoid and/or anaphylactic reactions were celebrated.

Excessive use of protivomigrenozny medicines can lead to increase in frequency of emergence of a headache that potentially demands therapy cancellation.

During control of motor transport and when performing potentially dangerous works it is necessary to consider that Zomig can cause negative side effects in the form of drowsiness.

Medicinal interaction

This, confirmatory that the concomitant use with drugs for prevention of migraine (dihydroergotamine, beta adrenoblockers, пизотифен) has any effect on undesirable effects or efficiency of Zomiga, no.

It is necessary to exclude the accompanying reception of other agonists of 5HT1B/1D-serotoninovy receptors for 12 hours after reception of Zomiga.

At simultaneous use of Zomiga with some medicines there can be following effects:

• Ergotamine: increase in probability of development of a coronary vasospasm (between cancellation of the drugs containing ergotamine and reception of Zomiga not less than 24 hours are recommended to observe a break; after use of Zomiga ergotamine can be accepted not earlier than in 6 hours);
• Monoamine oxidase inhibitors (MAO) of A type: increase in total concentration of a zolmitriptan (the maximum daily recommended dose of Zomiga for the patients receiving at the same time MAO inhibitors of A type should not exceed 5 mg);
• Cimetidinum: increase in total concentration and an elimination half-life of a zolmitriptan (the maximum daily recommended dose of Zomiga for the patients receiving at the same time Cimetidinum should not exceed 5 mg);
• CYP1A2 isoenzyme inhibitors: a possibility of interaction (the maximum daily recommended dose of Zomiga for receiving at the same time флувоксамин and antibiotics of a hinolonovy number of patients should not exceed 5 mg);
• Drugs of a St. John's Wort (Hypericum perforatum): increase in risk of development of undesirable effects.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 30 °C.

Period of validity – 2 years.