Sumamigren - instructions for use, doses, side effects, contraindications

For tablets 50 mg: cellulose microcrystalline - 100.00 mg, lactose monohydrate - 123,50 mg, croscarmellose sodium - 1.50 mg, magnesium stearate - 3.00 mg, talc - 1.50 mg, silicon dioxide colloid - 0.50 mg.

Sheath: hypromellose - 3.07 mg, macrogol 6000 - 1.20 mg, talc - 1.31 mg, titanium dioxide - 0.90 mg, triethyl citrate - 0.98 mg, dye crimson [Ponso 4 R] 0.040 mg.

For tablets, 100 mg: cellulose microcrystalline - 200.00 mg, lactose monohydrate - 247.00 mg, croscarmellose sodium - 3.00 mg, magnesium stearate - 6.00 mg, talc - 3.00 mg, silicon dioxide colloid - 1.00 mg.

Sheath: hypromellose - 4,10 mg, macrogol 6000 - 1,60 mg, talc - 1,80 mg, titanium dioxide -1.20 mg, triethyl citrate - 1.30 mg.

Description:Tablets of 50 mg are oblong, biconvex tablets covered with a filmy coating of light pink color, with a dividing risk on the one hand, on the fracture of white color.

Tablets of 100 mg are oblong, biconvex tablets covered with a white film membrane, on a broken white color.

Pharmacotherapeutic group:Anti-migraine means.

ATX: & nbsp

N.02.C Anti-migraine drugs

Pharmacodynamics:

A sumatriptan-specific selective agonist of vascular 5-hydroxytryptamine-1 receptors (5HT_ID), does not affect other subtypes of 5HT-serotonin receptors (5HT₂- 5HT₇). 5HT Receptors_ID are located, mainly, in the blood vessels of the brain, and their stimulation leads to narrowing of these vessels. Reduces the sensitivity of the trigeminal nerve. Both these effects can underlie the anti-migraine effect of sumatriptan. The clinical effect is usually seen 30 minutes after ingestion.

Pharmacokinetics:

After oral administration sumatriptan quickly absorbed, 70% of the maximum concentration in the plasma (C_m_Oh) is reached after 45 minutes. After taking 100 mg of C_m_Ohin blood plasma averages 54 ng / ml. Bioavailability is 14% due to intensive pre-systemic metabolism and incomplete absorption. Binding to plasma proteins is small and amounts to 14-21%. Sumatriptan Metabolized with the participation of monoamine oxidase (MAO) type A. The main metabolite is indoleacetic analogue of sumatriptan, which is excreted mainly by the kidneys, in the form of free acid and conjugate with glucuronic acid. This metabolite has no activity in relation to 5HT₁- and 5HT₂-serotonin receptors. Migraine attacks do not seem to have a significant effect on the pharmacokinetics of sumatriptan taken internally.

Indications:Coping migraine attacks with or without an aura.

Contraindications:

- Hypersensitivity to any component of the drug;

- deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;

- hemiplegic, basilar and ophthalmoplegic forms of migraine;

- ischemic heart disease (IHD) (including myocardial infarction, postinfarction cardiosclerosis, Prinzmetal angina), as well as the presence of symptoms suggesting the presence of IHD;

- Occlusal diseases of peripheral vessels;

- stroke or transient ischemic attack (including in anamnesis);

- arterial hypertension II-III severity;

- uncontrolled arterial hypertension;

- simultaneous administration with ergotamine or its derivatives (including methyl ester);

- simultaneous administration with other tryptans / agonists of the 5-HT1 receptor;

- use on the background of taking monoamine oxidase (MAO) inhibitors or earlier than 2 weeks after their withdrawal;

- severe violations of the liver and / or kidney function;

- age under 18 years old and over 65 years of age (safety and efficacy not established);

- pregnancy;

- lactation period.

Pregnancy and lactation:Sumatriptan is contraindicated in pregnancy. For the duration of treatment, breastfeeding should be discontinued.In the case of taking the drug, breastfeeding is possible no sooner than after 24 hours.

Dosing and Administration:

Inside, during meals or on an empty stomach, the drug should be swallowed whole, washed down with water. The recommended dose is 50 mg. Some patients may require a higher dose of 100 mg. If migraine symptoms do not disappear and do not decrease after the first dose, then to stop the same attack, do not take the drug again. In this case, treatment can be performed with paracetamol, acetylsalicylic acid, non-steroidal anti-inflammatory drugs. However, the drug can be used to stop subsequent migraine attacks.

If the patient feels better after the first dose, and then the symptoms resume, you can take a second dose during the next 24 h, provided that the interval between admission is at least 2 hours. The maximum daily dose of sumatriptan should not exceed 300 mg. Patients with hepatic insufficiency The recommended dose is 50 mg.

Children and teenagers (under the age of 18) Sumatriptan is not recommended for use in children and adolescents because of a lack of safety and efficacy data.

Patients of advanced age (over 65 years)

The experience with sumatriptan in patients over 65 years of age is limited. The pharmacokinetics of the drug is not significantly different from that of younger patients; however, until further clinical data are available, the use of sumatriptan in patients over the age of 65 is not recommended.

Precautions for use

Sumatriptan should be prescribed only if the diagnosis of migraine is undoubted, and it should be used as soon as possible after the onset of a migraine attack, although it is equally effective when used at any stage of an attack. The drug can not be used for preventive purposes.

Sumatriptan should be taken with caution under controlled arterial hypertension; diseases in which the absorption, metabolism or excretion of the drug may change (eg, impaired renal or hepatic function). There are very rare reports from post-marketing surveillance of the development of serotonin syndrome (including psychiatric disorders, autonomic lability and neuromuscular disorders) as a result of the concomitant use of selective serotonin reuptake inhibitors (SSRIs) and sumatriptan.Also, the development of serotonin syndrome was reported against the background of the simultaneous administration of triptans with selective serotonin and noradrenaline reuptake inhibitors (SSRIs). In the case of simultaneous prescription with drugs from the SSRI / SSRIs group, the patient's condition should be carefully monitored. Sumatriptan should be taken with caution in epilepsy and any conditions with a decrease in the threshold of convulsive readiness.

The concomitant use of other tryptans / 5-HT1 agonists with sumatriptan is not recommended.

In patients with hypersensitivity to sulfonamides, the use of sumatriptan can cause allergic reactions, the severity of which varies from skin manifestations to anaphylaxis. Data on cross-sensitivity are limited, but caution should be exercised when assigning sumatriptan to such patients. As with the use of other antimigraine drugs, when prescribing sumatriptan in patients with a previously undiagnosed migraine or in patients with atypical migraine, other potentially serious neurologic conditions should be excluded.It should be noted that patients with migraine are at increased risk of developing certain cerebrovascular complications (stroke or transient cerebral circulation disorders).

Sumatriptan should not be prescribed to patients with suspected heart disease without a prior examination to exclude cardiovascular disease. These patients include postmenopausal women, men over the age of 40, and patients with risk factors for developing coronary artery disease. Although the examination does not always allow the identification of heart disease in some patients, in very rare cases they develop side effects from the cardiovascular system. After taking sumatriptan, transient intense pains and chest tightness that can spread to the neck area may occur. If there is reason to believe that these symptoms are a manifestation of CHD, it is necessary to conduct an appropriate diagnostic examination.

Abuse of medicines intended to stop migraine attacks is associated with increased headaches in sensitive patients (headache,related to drug abuse). In this case, the possibility of drug cancellation should be considered. Do not exceed the recommended dose of sumatriptan.

Side effects:

Depending on the frequency of occurrence, the following groups of side effects are distinguished: very often: >1/10; often: >1/100, <1/10; infrequently: >1/1000, <1/100; rarely: >1/10000, <1/1000; rarely: <1/10000, including individual cases; the frequency is unknown: the frequency of development can not be estimated from the available data.

From the nervous system: often - dizziness, drowsiness, sensitivity disorders, including paresthesia and hypoesthesia; frequency unknown - convulsive attacks (in a number of cases they were observed in patients with seizures in the anamnesis or in conditions predisposing to the onset of seizures, in some patients predisposing factors were not identified), tremor, dystonia, nystagmus, scotoma; anxiety.

From the side of the organ of vision: frequency unknown - diplopia, flashing before the eyes, reduced visual acuity, partial transient or persistent loss of vision. However, it should be borne in mind that visual impairment may be associated with the very seizure of the migraine itself.

From the cardiovascular system: often - a transient increase in blood pressure (observed soon after taking sumatriptan), "hot flashes"; frequency unknown - bradycardia, tachycardia, lowering of blood pressure, heart rhythm disturbances, transient ECG changes in ischemic type, myocardial infarction, coronary artery spasm, angina pectoris, Raynaud's syndrome; a feeling of palpitations.

From the gastrointestinal tract: often - nausea, vomiting; very rarely - dysphagia, a feeling of discomfort in the abdomen; frequency unknown - ischemic colitis, diarrhea.

From the musculoskeletal system: often a feeling of heaviness (usually transient, can be intense and occur in any part of the body, including the chest and throat), myalgia; infrequently - pain in the joints; frequency unknown - rigidity of the occipital muscles, arthralgia.

From the respiratory system and chest organs: often shortness of breath; light, transient irritation of the mucosa or burning sensation in the nasal cavity or throat, nosebleeds.

Laboratory indicators: very rarely - slight changes in the activity of "liver" transaminases.

Allergic reactions: very rarely - hypersensitivity reactions vary from skin manifestations (rash, hives, itching, erythema) to cases of anaphylaxis.

From the skin and subcutaneous tissue: frequency is unknown - hyperhidrosis.

Other: often a feeling of heat or cold, pain, a feeling of constriction or heaviness (are transient and capable of appearing in any part of the body, including the chest and throat), a feeling of weakness, a feeling of fatigue, is usually mild or moderate and also transient. There may be transient intense pain and chest tightness that spreads to the neck area.

Overdose:Symptoms. Taking sumatriptan inside at a dose of more than 400 mg did not cause any side effects other than those listed above.

Treatment: In case of an overdose, patients should be monitored for at least 10 hours and, if necessary, symptomatic therapy should be performed. There is no data on the effect of hemodialysis or peritoneal dialysis on the concentration of sumatriptan in plasma.

Interaction:

No interaction of sumatriptan with propranolol, flunarizine, pizotifen and ethyl alcohol has been observed. When taken concomitantly with ergotamine or with other tryptans / receptor agonists 5-HT₁, there was a long spasm of blood vessels. Sumatriptan can be prescribed no earlier than 24 hours after taking medications containing ergotamine or other tryptans / receptor agonists 5-HT₁, on the contrary, preparations containing ergotamine can be prescribed no earlier than 6 hours after taking sumatriptan, and tryptans / receptor agonists 5-HT₁, - not earlier than 24 hours after taking sumatriptan.

Possible interaction between sumatriptan and MAO inhibitors, their simultaneous use is contraindicated.

There are very rare reports from post-marketing surveillance of the development of serotonin syndrome (including psychiatric disorders, autonomic lability and neuromuscular disorders) as a result of the concomitant use of selective serotonin reuptake inhibitors (SSRIs) and sumatriptan. Also, the development of serotonin syndrome was reported against the background of the simultaneous administration of triptans with selective serotonin and noradrenaline reuptake inhibitors (SSRIs).

Special instructions:

Sumatriptan should be prescribed only in the event that,if the diagnosis of migraine is not in doubt, then it should be used as soon as possible after the onset of a migraine attack, although it is equally effective when used at any stage of an attack. The drug can not be used for preventive purposes. Sumatriptan should be taken with caution under controlled arterial hypertension I severity, since in some cases, along with the reception, a transient increase in arterial pressure and peripheral vascular resistance was observed; diseases in which the absorption, metabolism or excretion of the drug may change (eg, impaired renal or hepatic function). There are very rare reports from post-marketing surveillance of the development of serotonin syndrome (including psychiatric disorders, autonomic lability and neuromuscular disorders) as a result of the concomitant use of selective serotonin reuptake inhibitors (SSRIs) and sumatriptan. Also, the development of serotonin syndrome was reported against the background of the simultaneous administration of triptans with selective serotonin and noradrenaline reuptake inhibitors (SSRIs).In the case of simultaneous prescription with drugs from the SSRI / SSRIs group, the patient's condition should be carefully monitored.

Sumatriptan should be taken with caution in epilepsy and the presence of other risk factors in the history, accompanied by a reduction in the threshold of convulsive readiness, because such patients may develop seizures on the background of taking sumatriptan. Concomitant use of other triptans/ receptor agonists 5HT₁ with sumatriptan is not recommended. In patients with hypersensitivity to sulfonamides, the use of sumatriptan can cause allergic reactions, the severity of which varies from skin manifestations to anaphylaxis. Cross-sensitivity data are limited, but caution should be exercised when assigning

sumatriptan to such patients. As with the use of other antimigraine drugs, when prescribing sumatriptan in patients with a previously undiagnosed migraine or in patients with atypical migraine, other potentially serious neurologic conditions should be excluded. It should be noted that in patients with migraine increased risk of certain cerebrovascular complications (stroke or transient ischemic attack). Sumatriptan should not be administered to patients at risk of cardiovascular disease without a preliminary examination in order to exclude cardiovascular pathology. Such patients include postmenopausal women, men over the age of 40, patients with risk factors for developing coronary artery disease, as well as smoking and using nicotine replacement therapy. Although the examination does not always allow the identification of heart disease in some patients, in very rare cases they develop side effects from the cardiovascular system.

After taking sumatriptan, transient intense pains and chest tightness that can spread to the neck area may occur. If there is reason to believe that these symptoms are manifestations of IHD, should stop taking the drug and conduct an appropriate diagnostic examination. Abuse of medicinal products

drugs designed to stop migraine attacks, is associated with increased headaches in sensitive patients (headache associated with drug abuse). In case of development or suspected headache associated with drug abuse, it is necessary to see a doctor. In this case, the possibility of drug cancellation should be considered.

Undesired effects can often occur It is observed during the application of triptans and herbal preparations containing St. John's wort (Hypericum perforatum).

Do not exceed the recommended dose of sumatriptan.

Effect on the ability to drive transp. cf. and fur:In patients with migraine, there may be drowsiness associated with both the disease itself and with the use of sumatriptan, so they should be especially careful when driving and working with moving mechanisms.

Form release / dosage:

Tablets, film-coated 50 mg, 100 mg.

Packaging:For 2 or 6 tablets in a foil blister, aluminum hard, lacquered, and a laminate for cold forming. 1 blister together with instructions for use are placed in a cardboard box.

Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LS-001522

Date of registration:15.09.2011

The owner of the registration certificate:Pharmaceutical factory "POLFARMA" JSCPharmaceutical factory "POLFARMA" JSC Poland

Manufacturer: & nbsp

POLPHARMA PHARMACEUTICAL WORKS, S.A. Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp04.09.2015

Illustrated instructions

Instructions

Sumamigren® (Sumamigren®)