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Sumamigren 2’s 100 mg coated tablets




The instruction
for medical use

of Sumamigren Torgovoye medicine a name

Mezhdunarodnoye the unlicensed

name Sumatriptan Lekarstvennaya
the Tablet form, coated 50 mg, 100 mg

One tablet contains
active agent – a sumatriptan of succinate (it is equivalent to a sumatriptan of 50 mg and 100 mg),
excipients: lactoses monohydrate, cellulose microcrystalline, sodium of a kroskarmelloz, magnesium stearate, talc, silicon dioxide colloidal anhydrous,
cover: the gipromeloza, a macrogoal 6000, talc, the titan E171 dioxide, trietit citrate, dye cochineal red E124 (for a dosage of 50 mg).

The description
of the Tablet of oblong shape, with a biconvex surface, coated light pink color, with dividing risky on the one hand (for a dosage of 50 mg).
Tablets of oblong shape, with a biconvex surface, coated white color (for a dosage of 100 mg).

Pharmacotherapeutic group
Selection agonists 5HT1 – receptors. Protivomigrenozny drugs.
The code of automatic telephone exchange N02CC01

the Pharmacological

Pharmacokinetics Later properties of administration of drug inside the maximum concentration of a sumatriptan averages 63 ng/ml (min 52 max 79) and is reached in 1 hour. As a result of biotransformation and incomplete absorption, biological availability of a sumatriptan makes about 15%.
Meal has no considerable impact on biological availability of a sumatriptan, but slightly increases tmax (approximately for 30 minutes).
Sumatriptan in small degree contacts proteins of blood plasma (14–21%). The volume of distribution is 2.4 l/kg.
Sumatriptan is mainly brought with urine (60%) in the form of inactive indolacetic acid and glyukuronat of indolacetic acid. Only 3% are removed in not changed look. 40% are removed with excrements.
Therapeutic action comes approximately in 30 minutes after administration of drug.
The liver failure
At patients with abnormal liver functions, after reception of a sumatriptan inside, can raise considerably its biological availability (about 70%).
The pharmacodynamics
Sumatriptan is selection agonist 5-hydroksitriptamin1d (5-HT1D) receptors. Activates serotonergic anti-nociceptive mechanisms of a brainstem, selectively excites 5-HT1D serotoninovy receptors of vessels of a brain (firm meninx of a basilar artery), inhibits activation of a trigeminal system and reduces accumulation of the specific stimulating protein in trifacial kernels. Weakens a pulsation of brain vessels and the headache connected with it.
Drug reduces also release of neuropeptids and other mediators of inflammation.
On adrenergic, dofaminergichesky, muskarinovy and benzodiazepine receptors has no significant impact. Does not possess direct analgetic action.

– stopping of attacks of migraine

the Route of administration and doses
it is necessary to use Drug as soon as possible after approach of an attack of migraine and at attack height.
The single dose makes 50 mg or 100 mg. The single dose depends on individual susceptibility of the patient.
In case of recurrent attacks of migraine and at noted effect after reception of the first dose it is possible to reuse drug within the next 24 hours, but no more than 300 mg a day.

Side effects
Often (≥1/10)
– dizziness, drowsiness, disturbance of sensitivity, including
paresthesia and a hypesthesia
– tranzitorny increase in arterial blood pressure soon after
administration of drug, inflows
– feeling of suffocation
– nausea, vomiting (connection with administration of drug is not established)
– feeling of compression in a thorax, a nape, a throat
– myalgias
– pain, feeling of heat, cold, tension or compression
– weakness, fatigue
Very seldom (& lt, 1/10,000)
– minor changes of functional indicators of a liver
Frequency is unknown
– hypersensitivity symptoms, from skin reactions (urticaria) prior to
exceptional cases of an acute anaphylaxis
– spasms, a tremor, dystonia, a nystagmus, scotoma
– a diplopia, change of a field of vision, decrease in visual acuity, including
irreversible decrease in visual acuity
– bradycardia, tachycardia, the strengthened heartbeat, arrhythmia, passing
changes of the ECG of ischemic type, a spasm of coronary arteries,
stenocardia, a myocardial infarction
– hypotension, Reynaud’s syndrome
– ischemic colitis, diarrhea
– stiff neck, arthralgias
– fear

the Contraindication hyperhidrosis
– hypersensitivity to a sumatriptan or other components
of drug
– coronary heart disease (stenocardia, Printsmetal’s stenocardia,
a state after the postponed heart attack) and other diseases of the cardiac
vascular system
– disturbance of cerebral circulation (brain stroke, tranzitorny
ischemia of a brain)
– disturbances of peripheric circulation
– uncontrollable hypertensia, arterial hypertension of moderate and
heavy degree
– simultaneous use with monoamine oxidase inhibitors
(Sumamigren it is possible to apply after 14 days after treatment
by monoamine oxidase inhibitors)
– simultaneous use with the medicines containing
ergotamine or its derivatives, such as, dihydroergotamine and
metisergid or other medicines from group of agonists
of receptors 5-HT1 (Sumamigren it is possible to apply after 24 hours
after treatment by drugs containing ergotamine or its
– a heavy liver failure
– epilepsy
– children’s and teenage age up to 18 years
– pregnancy and the period of a lactation
– age are more senior than 65 years

Medicinal interactions
Medicine should not be accepted with:
– the drugs containing ergotamine and its derivatives (for example, dihydroergotamine or metisergid)
– monoamine oxidase inhibitors which reduce clearance of a sumatriptan (look: Contraindications)
– selective serotonin reuptake inhibitors, for example fluoxetine, fluvoksaminy, paroksetiny, sertaliny (the weakness, hyperexcitability, lack of coordination can be noted)
– a St. John’s wort grass – possibly strengthening of serotonergic effects
– moklobemidy – increases its bioavailability
If simultaneous use of these medicines is necessary, the patient has to remain under medical control.

Special instructions
Sumamigren should be applied only if the diagnosis of migraine does not raise doubts.
Sumamigren is not shown for use for patients with hemiplegic, basilar and ophthalmoplegic migraine.
Sumamigren it is not necessary to apply at patients with high risk of development warmly – vascular diseases (for example, patients with hypertensia, a family hypercholesterolemia, diabetes, smokers, corpulent patients, women in the post-menopausal period, men are more senior than 40 years) without preliminary estimate of a functional condition of this system.
After reception Sumamigren can come tranzitorny pain and feeling of squeezing of a thorax and throat. These symptoms can testify to coronary heart disease. In case of their approach, it is recommended to cancel medicine and to conduct the corresponding researches.
Sumamigren can cause short-term increase in pressure of blood and increase in peripheric vascular resistance. Medicine should be applied very carefully at patients with a hypertension.
Sumamigren it is necessary to apply carefully in a liver or renal failure and also at patients with epilepsy in the anamnesis.
Sumamigren it is not necessary to apply in case of approach of an atypical headache as it can be a symptom of a brain stroke, bleeding or tranzitorny ischemia of a brain. Patients with migraine have an increased risk of developing these diseases.
Sumamigren can cause anaphylactic reactions, sometimes life-threatening, especially in patients with an allergy in the anamnesis.
Drug contains lactoses monohydrate therefore patients should not appoint it with rare hereditary intolerance of a galactose, deficiency of lactase like Lapp or a glucose galactose sprue.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
during the Sumamigren drug treatment drowsiness therefore it is necessary to warn the patient about the danger connected with management of vehicles and service of mechanisms can develop.

Symptoms: strengthening of severity of side effects. At overdose it is necessary to cancel drug.
Treatment: symptomatic.

The form of release and packing
On 2 or 6 tablets place in blister strip packaging from aluminum foil.
On 1 (on 2 or 6 tablets) planimetric packing together with the instruction for medical use in the state and Russian languages place in a cardboard pack.

To Store storage conditions in the dry, protected from light place at
a temperature not over 25 of 0C.
To store out of children’s reach!

A period of storage
4 years
not to use drug after expiry date.

Prescription status
According to the prescription

the Producer
the Pharmaceutical plant ‘POLFARMA’ of the joint-stock company, Poland
st. of Pelplinsk 19, 83-200 Starogard Gdanski

the Owner of the registration certificate
of JSC Khimfarm, Kazakhstan

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Khimfarm, Shymkent, REPUBLIC OF KAZAKHSTAN, Rashidov St.,/N, ph.: 560882 Phone number 7252 (561342) Fax number 7252 (561342)
to Develop the E-mail address of

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