Sumatriptan-Vertex, 100 mg 2 pcs

An agonist of serotonin 5-HT1 receptors.

A drug with antimigraine activity

Indications

– migraine attack with or without aura.

Pharmacological effect

Serotonin 5-HT1 receptor agonist.

Drug with antimigraine activity

Special instructions

Do not use to prevent a migraine attack.

Patients at risk for the cardiovascular system should not begin therapy without prior examination (postmenopausal women, men over 40 years of age, persons with risk factors for coronary artery disease).

Before prescribing sumatriptan to patients with newly diagnosed or atypical migraine, other potentially dangerous neurological diseases should be excluded. Chest pain and tightness may occur after taking sumatriptan. The pain can be intense and radiate to the neck. If there is reason to believe that these symptoms are a manifestation of coronary artery disease, it is necessary to conduct an appropriate examination.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Sumatriptan

Composition

Film-coated tablets 1 tab. sumatriptan 100 mg

Contraindications

– hemiplegic, basilar or ophthalmoplegic forms of migraine;

— IHD or the presence of symptoms suggesting its presence;

– history of myocardial infarction;

– pharmacologically uncontrolled arterial hypertension;

– occlusive diseases of peripheral vessels;

— stroke or transient cerebrovascular accident (including history);

– severe dysfunction of the liver and kidneys;

– simultaneous administration with ergotamine or its derivatives and within 24 hours after their administration;

– use while taking monoamine oxidase inhibitors or earlier than 2 weeks after discontinuation of these drugs;

– age under 18 and over 65 years (efficacy and safety have not been established);

– pregnancy;

– breastfeeding (breastfeeding is possible no earlier than 24 hours after taking the drug;

– congenital galactosemia, glucose/galactose malabsorption syndrome, congenital lactose deficiency;

– hypersensitivity to any of the components of the drug.

With caution: epilepsy (including any conditions with a reduced epileptic threshold), pharmacologically controlled arterial hypertension, impaired liver or kidney function, hypersensitivity to sulfonamides (administration of sumatriptan can cause allergic reactions, the severity of which varies from skin manifestations to anaphylaxis).

Side Effects

The frequency of adverse reactions listed below was determined according to the following: very often – more than 1/10; often – from more than 1/100 to less than 1/10; sometimes – from more than 1/1000 to less than 1/100; rarely – from more than 1/10,000 to less than 1/1000; very rarely – from less than 1/10,000, including isolated cases.

From the nervous system: often – dizziness, drowsiness, sensory disturbances, including parasthesia and decreased sensitivity.

From the cardiovascular system: often – a transient increase in blood pressure (observed soon after taking the drug), “hot flashes”.

From the respiratory system and organs of the cell group: often – dyspnea, mild, transient irritation of the mucous membrane or a burning sensation in the nasal cavity or throat, nosebleeds.

From the gastrointestinal tract: often – nausea, vomiting.

From the musculoskeletal system and connective tissue: often – a feeling of heaviness (usually transient, can be intense and occur in any part of the body, including the chest and throat).

General and local reactions: often – pain, a feeling of cold or heat, a feeling of pressure or tightness (usually transient, can be intense and occur in any part of the body, including the chest and throat), weakness, fatigue (usually mild or moderate, transient).

Laboratory indicators: very rarely – minor deviations in liver test results.

Post-marketing surveillance

From the immune system: very rarely – hypersensitivity reactions, including skin manifestations, as well as anaphylaxis.

From the nervous system: very rarely – seizures (in some cases observed in patients with a history of seizures or with concomitant conditions predisposing to seizures; in some patients no risk factors were identified), tremor, dystonia, nystagmus, scotoma.

On the part of the visual organs: very rarely – flickering, diplopia, decreased visual acuity, blindness (usually transient). However, visual disturbances can be caused by the migraine attack itself.

From the cardiovascular system: very rarely – bradycardia, tachycardia, flutter, arrhythmias, transient changes on the ECG, coronary vasospasm, angina pectoris, myocardial infarction, hypotension, Raynaud’s syndrome.

From the gastrointestinal tract: very rarely – ischemic colitis, dysphagia, feeling of discomfort in the abdomen.

Interaction

When administered simultaneously with ergotamine and ergotamine-containing drugs, prolonged vasospasm is possible.

There may be an interaction between sumatriptan and MAO inhibitors (decreased metabolism of sumatriptan, increased its concentration).

With the simultaneous use of sumatriptan and drugs from the group of selective serotonin reuptake inhibitors, the development of weakness, hyperreflexia and impaired coordination of movements is possible.

There was no interaction of sumatriptan with propranolol, flunirizine, pizotifen and ethanol.

Overdose

Symptoms: when taken orally up to 400 mg, no other adverse reactions are observed other than those listed above.

Treatment: gastric lavage, observation of the patient for 10 hours, symptomatic therapy.

Manufacturer

Vertex, Russia