Translation of the instruction Mose

AMIGREN of the capsule of 50 mg, capsules of 100 mg

Instruction

On medical use of medicine

Amigren

(amigren)

Ingredients:

Active ingredient: sumatriptan;

1 capsule supports a sumatriptan of succinate in terms of sumatriptan 50 mg or 100 mg;

excipients: lactose, monohydrate; microcrystalline cellulose; sodium of a kroskarmeloz; magnesium stearate;

structure of a cover of the capsule: gelatin, titan dioxide (E 171), ponso 4R (E 124).

Dosage form.

Capsule of 50 mg No. 1, 50 of mg No. 3, 100 of mg No. 1, 100 of mg No. 3.

Pharmacotherapeutic group.

Selection agonist of 5nt1-receptors of serotonin. the medicaments used for treatment of migraine. code of automatic telephone exchange n02c c01.

Pharmacological properties.

Pharmacodynamics. sumatriptan is a selection agonist of 5nt1-receptors which does not influence other 5nt-receptors. these receptors contain, mainly, in craniocereberal blood vessels. in pilot studies it was established what sumatriptan has selection vasopressor effect on vessels in the system of carotids, but does not influence cerebral circulation. the system of carotids delivers blood in extra- and intracranial fabrics, for example a meninx. owing to expansion of these vessels the migraine develops. in addition by means of experimental data it was proved what sumatriptan brakes activity of a trifacial. these are two possible mechanisms because of which the antimigrenozny activity of a sumatriptan is shown.

Clinical effect is observed by

in 30 min. after oral administration of 100 mg of drug.

Pharmacokinetics. After oral administration sumatriptan it is quickly soaked up, reaching 70% of the maximum concentration in 45 min. After reception of 100 mg the average maximum concentration in blood plasma makes 45 ng/ml. The bioavailability after oral administration is 14%, partially owing to presistemny metabolism, partially as result of incomplete absorption. Linking with blood plasma proteins low (14-21%), the average volume of distribution – 17 l. The average general plasma clearance is about 1160 ml/min., and average renal clearance – about 260 ml/min. Not renal clearance is about 80% of the general clearance, it gives the grounds to consider what sumatriptan is removed, mainly, in the form of metabolites. The main metabolite, an indolacetic analog of a sumatriptan, is removed with urine where it contains in a type of free acid and the conjugated connection with a glucuronide. It does not render 5HT1 — and 5HT2-activities. Other metabolites are not identified. The pharmacokinetics of an oral sumatriptan significantly does not change during a migraine attack.

Pharmaceutical characteristics.

Main physical and chemical properties: solid gelatin capsules No. 1 of a cylindrical form with the hemispherical ends; the body – white color, a lid – red color.

Contents of capsules – powder of white or flavourless almost white color.

Clinical characteristics.

Indication.

For fast simplification of a state at migraine attacks, with aura or without it.

Contraindication.

Hypersensitivity to any component of drug.

Myocardial infarction in the anamnesis, coronary heart disease, Printsmetal's stenocardia, diseases of peripheral vessels or symptoms characteristic of coronary heart disease.

Stroke or the taking place disturbance of cerebral circulation in the anamnesis.

Moderate or heavy arterial hypertension and the slight not controlled arterial hypertension.

Heavy liver failure.

Accompanying use of ergotamine or its derivatives (including metizergid) (see. section "Interaction with Other Medicines and Other Types of Interactions").

Accompanying use of any agonist of triptanes/5-hydroksitriptamin-receptors (5-HT ₁ ) (see the section "Interaction with Other Medicines and Other Types of Interactions").

Competitive prescribing of monoamine oxidase inhibitors (MAO) and Amigren. Amigren it is not necessary to apply within 2 weeks after cancellation of MAO inhibitors.

Interaction with other medicines and other types of interactions.

do not have

data on interaction with propranolol, flyunariziny, pizotifeny or alcohol.

Data on combined use with the medicines containing ergotamine or other agonists of triptanes/5-HT1-receptors are limited to

. The prolonged vasospastic reactions are theoretically possible therefore such combined use is contraindicated (see the section "Contraindications").

Period of time to which it is necessary to adhere between reception of a sumatriptan and the medicines containing ergotamine or other agonists triptane / 5-HT1 — receptors is unknown to

. It depends on doses and type of the applied medicines. As these effects can be enhanced by Amigren's reception, it is necessary to adhere to a 24-hour interval between administration of medicaments containing ergotamine and other agonists of triptanes/5-HT1-receptors and Amigren's reception. Respectively the medicaments containing ergotamine and other agonists of triptanes/5-HT1-receptors cannot be applied within 6 hours after Amigren's reception.

Interaction can arise between sumatriptany and MAO inhibitors therefore their simultaneous use is contraindicated (see the section "Contraindications").

. There are messages about development of a serotoninovy syndrome at simultaneous use of triptanes and inhibitors of the return serotonin reuptake and noradrenaline (SNRI) (see the section "Features of Use").

Feature of use.

Capsule of an amigren is applied only at accurately established diagnosis of migraine.

Amigren is not applied to treatment of hemiplegic, basilar and ophthalmoplegic migraine.

As well as at use of other drugs, for stopping of attacks of migraine at patients with the diagnosis of migraine which is not established earlier and at patients with the established diagnosis, but in the presence of atypical symptoms, prior to reception of a sumatriptan it is necessary to exclude presence of other serious neurologic pathology. It should be noted that patients with migraine have the increased risk of emergence of cerebrovascular disturbances (a stroke, passing disturbance of cerebral circulation).

Use of a sumatriptan for some patients causes such tranzitorny symptoms as pain, feeling of compression in a breast that could have intensive character and extend to a throat (see the section "Side reactions"). If such symptoms indicate coronary heart disease, it is necessary to perform the corresponding cardiological examination.

Sumatriptan patients cannot appoint

with suspicion of a heart disease without preliminary survey for detection of cardiovascular pathology. Women in the post-menopausal period, men from 40 years and patients with risk factors of developing coronary heart disease treat this group. However such inspection can not always reveal presence of a heart trouble therefore in isolated cases heavy cardiological complications meet at patients with not diagnosed heart trouble. With care Amigren the patients who are under observation concerning arterial hypertension as at a small amount of patients the tranzitorny increase in level of arterial blood pressure and peripheric vascular resistance can be observed need to appoint.

by

described the isolated cases of emergence at patients of a serotoninovy syndrome (including the changed mental state, visceral instability, neuromuscular disturbances) arising after intake of selective serotonin reuptake inhibitors (SSRI) and a sumatriptan. There are messages about development of a serotoninovy syndrome at co-administration of triptanes and inhibitors of the return serotonin reuptake and noradrenaline (SNRI). If simultaneous use of Amigren and SSRI/SNRI are clinically justified, it is desirable that preliminary survey of patients was performed (see the section "Interaction with Other Medicines and Other Types of Interactions").

is not recommended to be applied at the same time sumatriptan with any triptane/5HT1-agonist.

Amigren needs to appoint

with care to patients with considerable disturbance of absorption, metabolism or removal of medicine, for example in a renal and liver failure.

Amigren should appoint

with care to patients with spasms in the anamnesis or with risk factors of reduction of the threshold of convulsive readiness.

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At patients with hypersensitivity to streptocides allergic reactions after Amigren's use can be observed. Reactions can be found in the range from skin hypersensitivity to an anaphylaxis. Presence of cross sensitivity is limited, nevertheless it is necessary to adhere to care, appointing medicament to such patients.

Recommended Amigren's doses cannot be exceeded.

Intensive treatment of bad attacks of migraine is associated with exacerbation of a headache (the headache caused by intensive treatment) at sensitive patients. Perhaps, there will be necessary a treatment termination.

Side reactions can arise more often during combined use of triptanes and medicaments from the herbs containing a grass of a St. John's wort (Hypericum perforatum).

Prolonged use of any types of anesthetics can strengthen a headache. In case of such situation or at its threat it is necessary to consult with the doctor and to stop treatment. At patients who often or daily have a headache because of regular use of medicines against a headache the diagnosis of a headache owing to abuse of anesthetics can be established.

Drug contains lactose therefore patients with the most rare hereditary forms of intolerance of a galactose, insufficiency of lactose or a syndrome of glyukozo-galaktozny malabsorption should not use drug.

Use during pregnancy or feeding by a breast.

is not recommended to be applied amigren to pregnant women. in case of need it is necessary to weigh a ratio of the expected advantage for mother and possible risk for a fruit.

With care is applied during feeding by a breast. It is not recommended to nurse the child for 24 hours after administration of drug.

Children.

is not recommended to be Applied as till this time the efficiency and safety of use of a sumatriptan for treatment of children are not established.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

Drowsiness can become a consequence of both migraine, and its treatment amigreny therefore it is necessary to avoid control of motor transport or work with other mechanisms during administration of medicament or an attack of migraine.

Route of administration and doses.

Capsule of an amigren cannot be applied for the purpose of prevention of an attack.

Amigren is recommended to apply

as soon as possible after the beginning of an attack of migraine though it is equally effective at each stage of an attack.

Recommended Amigren's dose for adults — 50 mg (1 tablet). In some cases the dose can be raised to 100 mg (2 capsules).

Amigren can be applied at new attacks of migraine, but if the first dose of medicament is inefficient, it is not necessary to use medicament repeatedly during the same attack.

If the patient reacted with

to the first dose, but symptoms are restored, the second dose can be applied within the next 24 hours, at the same time the general daily dose should not exceed 300 mg.

needs to swallow of

Capsule whole, washing down with water.

Children efficiency and safety of use of a sumatriptan for treatment of children are not established to

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Till this time therefore to children do not apply.

Patients of advanced age (age of 65 years)

Experience of use of a sumatriptan for treatment of patients are more senior than 65 years insufficiently. Though the pharmacokinetics of medicament does not differ from that at persons of younger age, additional clinical data, Amigren's appointment to elderly patients will not be obtained yet it is not recommended.

Side reactions.

from the immune system: reactions of hypersensitivity — from skin hypersensitivity to anaphylaxis cases.

from nervous system: dizziness; drowsiness; disturbance of sensitivity, including paresthesias and gipoesteziya; spasms. Though some of these cases were noted at patients with spasms or with states which can bring to them, in the anamnesis, there are cases of development of spasms in patients without any tendency to them; tremor, dystonia, nystagmus, scotoma.

from mentality: excitement.

from a cardiovascular system: tranzitorny increase in arterial blood pressure at once after administration of drug, rush of blood, bradycardia, tachycardia, heartbeat strengthening, disturbance of a rhythm, tranzitorny ischemic changes on the ECG, a spasm of coronary arteries, stenocardia, a myocardial infarction, arterial hypotension, a Raynaud's disease.

from a respiratory system: asthma.

from a digestive tract: the nausea and vomiting arising at some patients, but their communication with use of a sumatriptan it is up to the end not found out; ischemic colitis, diarrhea.

from a musculoskeletal system: heavy feeling, myalgia. The induced symptoms usually are passing, can have intensive character and influence any part of a body, including a thorax and a throat; muscle tension of a neck, arthralgia.

from organs of sight: blinking, diplopia, decrease in visual acuity, loss of sight (usually passing). However the disorder of vision can be a consequence of the attack of migraine.

from skin: hyperhidrosis.

General disorders: pain, caumesthesia or cold weather, compression or tension (the given symptoms usually are passing, can have intensive character and influence any part of a body, including a thorax and a throat); feeling of weakness, fatigue (the given symptoms, mainly, have easy or moderate temper and are passing).

Laboratory indicators: minor changes in functional hepatic tests were observed.

Overdose.

Dose, the exceeding 400 mg (orally), did not cause other side effects, except those which are stated above.

Treatment: performing the supported therapy and observation of the patient is not less than 10 hours.

Influence of a hemodialysis or peritoneal dialysis on the Amigrena level in blood plasma is not established to

.

Expiration date.

2 years.

Storage conditions.

to Store

in original packing at a temperature not over 25 ºс.

to Store

out of children's reach.

Packing.

On 1 capsule in the blister; on 1 or 3 blisters in a box.

Category of release.

According to the prescription.

Producer.

LLC astrafarm.

Location of the producer and address of the place of implementation of its activity.

Ukraine, 08132, kiyevo-svyatoshinsky district, cherry, st. Kiev, 6.