Sumatriptan Teva ⋆ instructions for use ⋆ tablets for migraine

Sumatriptan Teva

Release form

Tablets 50 mg , film-coated, pink with a yellowish tint to pink, oval in shape with a scoring line on both sides. On one side there is an engraving “50”.

Tablets 100 mg , film-coated, white or almost white, oval in shape; on one side there is an engraving “100”; on a cross section, the core is white or almost white.

Compound

Tablets 50 mg

Active ingredient : sumatriptan succinate (70 mg, equivalent to 50 mg sumatriptan).
Excipients : lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.
Film shell: Opadry II 33G28707 white (hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol-3000, triacetin).

Tablets 100 mg

Active ingredient : sumatriptan succinate (140 mg, equivalent to 100 mg sumatriptan).
Excipients : lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.
Film shell: Opadry II 33G23092 peach (hypromellose (E 464), titanium dioxide (E 171), lactose monohydrate, macrogol-3000, triacetin, red iron oxide dye (E 172), yellow iron oxide dye (E 172), iron dye black oxide (E 172)).

Production

Teva Pharmaceutical Enterprises Ltd (Israel);
Teva Pharmaceutical Works Private Limited Company (Hungary)

Package

2, 6, 12 or 30 tablets in a blister. Blister in a cardboard box.

Pharmacological group

Serotonergic agent. Antimigraine drug.

Action

A drug with antimigraine activity. Selective 5-HT1 serotonin receptor agonist. Selective stimulation of these receptors leads to a narrowing of the dilated blood vessels of the brain and stops the migraine attack. Sumatriptan activates the sensitivity of trigeminal nerve receptors, preventing the release of pain mediators. Eliminates migraine-related nausea and photophobia.

Sumatriptan - description of the substance

The therapeutic effect usually occurs 30 minutes after oral administration. The greatest effect is observed when used at the height of an attack.

Indications

Relief of migraine attacks with or without aura, including menstrually associated migraine.

Sumatriptan should only be taken if the diagnosis of migraine is certain. Sumatriptan is not intended for the prevention of migraine.

Application and dosage

Orally (swallow the tablet whole with water).

The initial single dose is 50 mg; if necessary, the dose can be increased to 100 mg. The maximum daily dose when taken orally is 300 mg.

Sumatriptan should be used once per migraine attack and as soon as possible after the onset of the attack, but the drug is effective at any stage of the attack. If there is no effect from the first dose, the diagnosis should be clarified.

To control subsequent attacks, after symptoms have subsided and returned, a second dose may be taken over the next 24 hours, at least 2 hours apart.

Contraindications and restrictions

Hypersensitivity to any of the components of the drug.
Hemiplegic, basilar or ophthalmoplegic forms of migraine.
Coronary heart disease, angina pectoris, myocardial infarction, arterial hypertension, occlusive diseases of peripheral vessels, risk factors for diseases of the cardiovascular system.
Stroke or transient cerebrovascular accident (including history).
Severe liver and/or kidney failure.
Taking other serotonergic drugs (triptans, ergotamine), lithium salts, serotonin reuptake inhibitors and MAO inhibitors.
Lactose intolerance, glucose/galactose malabsorption syndrome, congenital lactase deficiency.
Ages under 18 and over 65 years of age (efficacy and safety have not been established).

with caution for epilepsy and any decrease in the threshold of convulsive readiness; controlled arterial hypertension; dysfunction of the liver and/or kidneys; hypersensitivity to sulfonamides; pregnancy and lactation (avoid breastfeeding for 12 hours after taking the drug).

special instructions

With migraine, as well as during therapy with sumatriptan, drowsiness may develop. Therefore, during the period of use of sumatriptan, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage

Store out of the reach of children at a temperature not exceeding 25°C. Shelf life: 3 years.

Recipe

Dispensed by prescription.

Sumatriptan-Teva

Sumatriptan should only be prescribed if the diagnosis of migraine is beyond doubt.

Sumatriptan should not be used for prophylactic purposes.

Sumatriptan is contraindicated for use in hemiplegic, basilar and ophthalmoplegic forms of migraine. As with other drugs used to treat acute migraine attacks, other types of neurological pathology must be excluded before treating a headache attack in patients with previously undiagnosed migraine or in patients with atypical migraine. It should be noted that patients with migraine have an increased risk of developing certain cerebrovascular events (eg, stroke or transient ischemic attack).

Taking sumatriptan may be associated with transient symptoms such as pain and tightness in the chest, spreading to the neck area; symptoms may be intense. If there is reason to believe that these symptoms are a manifestation of coronary artery disease, it is necessary to conduct an appropriate diagnostic examination.

Sumatriptan should not be used in patients at risk of cardiovascular pathology without prior examination to exclude it (such patients include postmenopausal women, men over the age of 40 years and patients with risk factors for the development of coronary artery disease). However, the examination does not always reveal heart disease in every patient. In very rare cases, serious cardiovascular adverse reactions may occur in patients without a history of cardiovascular disease.

Sumatriptan should be used with caution in patients with controlled hypertension, as transient increases in blood pressure and peripheral vascular resistance have been observed in a small number of patients.

There are rare reports from post-marketing surveillance of the development of serogonin syndrome (including mental disorders, autonomic lability and neuromuscular disorders) as a result of the simultaneous use of SSRIs and sumatriptan. The development of serotonin syndrome has also been reported during concomitant use of triptans with SSRIs.

If the patient is indicated for simultaneous use of drugs from the SSRI and/or SNRI group. The patient's condition should be carefully monitored.

Concomitant use of any triptan (5-HHT1 agonist) with sumatriptan is not recommended.

Sumatriptan should be used with caution in patients in whom the absorption, metabolism, or elimination of sumatriptan may be significantly altered (for example, patients with impaired renal or hepatic function).

Sumatriptan should be used with caution in patients with a history of seizures or other risk factors for lowering the seizure threshold.

In patients with known hypersensitivity to sulfonamides, taking sumatriptan may cause allergic reactions that range from skin manifestations of hypersensitivity to anaphylaxis. Cross-sensitivity data are limited, but caution should be exercised when using sumatriptan in such patients.

Overuse of medications intended to treat migraine attacks is associated with increased headaches in sensitive patients (drug overuse headache). In this case, the possibility of discontinuing the drug should be considered.

Do not exceed the recommended dose of sumatriptan.

SUMATRIPTAN-TEVA film-coated tablets 100 mg No. 2

Sumatriptan is not intended for the prevention of migraine. Sumatriptan should only be taken if the diagnosis of migraine is certain. Sumatriptan should be used as soon as possible after the onset of a migraine attack, but the drug is equally effective at any stage of the attack. If there is no effect from the first dose, the diagnosis should be clarified. When using sumatriptan to relieve headaches in patients with previously undiagnosed migraine or migraine with atypical symptoms, other potentially dangerous neurological diseases should be excluded. It must be borne in mind that patients with migraine are at risk of developing cerebrovascular complications (including stroke or transient cerebrovascular accident). Sumatriptan should be taken with caution in case of epilepsy and any other conditions accompanied by a decrease in the seizure threshold. In case of simultaneous use with SSRIs/SNRIs, the patient's condition should be carefully monitored (see section "Interaction with other drugs"). Before using sumatriptan, patients should exclude the presence of cardiovascular disease, especially in patients at risk. These patients include postmenopausal women, men over 40 years of age, and patients with risk factors for coronary artery disease. The examination does not always reveal cardiovascular disease in some patients. In very rare cases, transient side effects such as chest pain and tightness may occur after taking sumatriptan. The pain can be intense and radiate to the neck (pharynx). If there is reason to believe that these symptoms may be a manifestation of coronary artery disease, it is necessary to stop taking the drug and perform a diagnostic examination. Treatment with sumatriptan should be carried out with caution in patients with controlled arterial hypertension, since in some cases an increase in blood pressure and peripheral vascular resistance may be observed. Sumatriptan-Teva should be used with caution in patients with diseases that may significantly alter the absorption, metabolism or excretion of sumatriptan, for example, impaired renal or hepatic function. In patients with hypersensitivity to sulfonamides, when using sumatriptan, allergic reactions may develop, which range from skin manifestations to anaphylactic shock. Cross-sensitivity data are limited, but caution is warranted when administering sumatriptan to these patients. Overuse of medications intended to treat migraine attacks is associated with increased headaches in sensitive patients (drug overuse headache). In this case, the possibility of discontinuing the drug should be considered. Effect on the ability to drive vehicles and control equipment During migraine, as well as during therapy with sumatriptan, drowsiness may develop. Therefore, during the period of use of sumatriptan, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Sumatriptan-Teva, 2 pcs., 100 mg, film-coated tablets

Sumatriptan-Teva tablet p/o 50 mg N2 (Teva)

Sumatriptan is not intended for the prevention of migraine. Sumatriptan should only be taken if the diagnosis of migraine is certain. Sumatriptan should be used as soon as possible after the onset of a migraine attack, but the drug is equally effective at any stage of the attack. If there is no effect from the first dose, the diagnosis should be clarified. When using sumatriptan to relieve headaches in patients with previously undiagnosed migraine or migraine with atypical symptoms, other potentially dangerous neurological diseases should be excluded. It must be borne in mind that patients with migraine are at risk of developing cerebrovascular complications (including stroke or transient cerebrovascular accident). Sumatriptan should be taken with caution in case of epilepsy and any other conditions accompanied by a decrease in the seizure threshold. In case of simultaneous use with SSRIs/SNRIs, the patient's condition should be carefully monitored (see section "Interaction with other drugs"). Before using sumatriptan, patients should exclude the presence of cardiovascular disease, especially in patients at risk. These patients include postmenopausal women, men over 40 years of age, and patients with risk factors for coronary artery disease. The examination does not always reveal cardiovascular disease in some patients. In very rare cases, transient side effects such as chest pain and tightness may occur after taking sumatriptan. The pain can be intense and radiate to the neck (pharynx). If there is reason to believe that these symptoms may be a manifestation of coronary artery disease, it is necessary to stop taking the drug and perform a diagnostic examination. Treatment with sumatriptan should be carried out with caution in patients with controlled arterial hypertension, since in some cases an increase in blood pressure and peripheral vascular resistance may be observed. Sumatriptan should be used with caution in patients with diseases that may significantly alter the absorption, metabolism or excretion of sumatriptan, such as impaired renal or hepatic function. In patients with hypersensitivity to sulfonamides, when using sumatriptan, allergic reactions may develop, which range from skin manifestations to anaphylactic shock. Cross-sensitivity data are limited, but caution is warranted when administering sumatriptan to these patients. Overuse of medications intended to treat migraine attacks is associated with increased headaches in sensitive patients (drug overuse headache). In this case, the possibility of discontinuing the drug should be considered.