Each tablet contains 50 mg of sumatriptan (as succinate).
The tablet can be divided into equal halves.
Excipients/Inactive Ingredients: The other ingredients are: Tablet core: lactose monohydrate, croscarmellose sodium, colloidal anhydrous silica, microcrystalline cellulose and magnesium stearate.
Tablet coating: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 3000 and glycerol triacetate. The 50 mg tablets also contain iron oxides red, yellow and black (E172).
Sumatriptan belongs to the group of antimigraine preparations. The active substance of Sumatriptan Teva is sumatriptan, a 5-HT1 receptor agonist.
Migraine headaches are thought to result from the dilatation of blood vessels. Sumatriptan constricts these blood vessels, thus relieving the migraine headache.
Sumatriptan Teva is used to treat migraine attacks with or without aura (a warning sensation that usually involves visual distortions, such as light flashes, zigzag lines, stars, or waves).
Always take Sumatriptan Teva exactly as told by the doctor. Check with the doctor or pharmacist if unsure.
Sumatriptan Teva must not be taken to prevent migraine attacks, because it is intended to treat migraine attacks. Sumatriptan Teva must be taken as soon as possible after the migraine headache appears; however, it is equally effective when taken at a later stage of the attack.
The usual dose for adults is 50 mg. For some patients, 100 mg may be necessary. If Sumatriptan Teva does not bring immediate relief, it is not beneficial to take more tablets for this attack. Sumatriptan Teva can be used for the next attack. If, after the first dose, the migraine goes away but then returns, another tablet may be taken, provided it is at least two hours since the first tablet was taken.
Do not take more than 300 mg (six 50 mg tablets, or three 100 mg tablets) in 24 hours. The use of Sumatriptan Teva in children, adolescents and patients over 65 years is not recommended. For patients with mild to moderate liver impairment, low doses of 25-50 mg should be considered. Swallow the tablet whole with some water.
Overdose symptoms are the same as those listed in Side Effects. If too many tablets have been taken, contact a doctor or hospital.
Do not take Sumatriptan Teva: if allergic (hypersensitive) to sumatriptan or any of the other ingredients of Sumatriptan Teva; if with a history of heart attack; if with any heart disease; if with symptoms that might indicate heart disease, such as temporary chest pain or a sensation of pressure in the chest; if with a history of stroke or transient ischaemic attack (TIA, a minor form of stroke that lasts less than 24 hours); if with blood circulation problems in the legs that cause cramp-like pains when walking (peripheral vascular disease); if with significantly high blood pressure, or if blood pressure is high despite medication; if with severe liver problems; if using or have recently used medicines containing ergotamine or ergotamine derivatives (including methysergide); if using or have recently used medicines to treat depression that belong to the group known as monoamine oxidase (MAO) inhibitors.
Take special care with Sumatriptan Teva: Before Sumatriptan Teva is prescribed, the physician will establish whether the headache is caused by migraine and not by any other condition.
Contact the doctor before starting to use this medicine if any of the following is applicable: If there are problems with the liver or kidneys.
If epilepsy has been diagnosed, or any other disease that reduces the threshold for epileptic fits.
If allergic to antibacterial medicines that belong to the group of sulphonamides.
If with controlled high blood pressure. As is in a small number of cases, sumatriptan has been seen to increase blood pressure.
If taking selective serotonin reuptake inhibitors (SSRIs). Hyperreflexia and lack of coordination has been observed after concomitant use of selective serotonin reuptake inhibitors and sumatriptan.
If experiencing pain and/or tightness in the chest or throat. These effects are usually short-lasting. If they, however, persist and are concerning, or they become severe, contact the doctor immediately for advice.
If experiencing chronic daily headaches. Taking Sumatriptan Teva too often may namely result in developing a chronic headache. In such cases, contact the doctor as taking Sumatriptan Teva may have to be stopped.
If considered to be at risk of developing heart disease (e.g. diabetic, heavy smoker or undergoing nicotine replacement therapy), and particularly if post-menopausal woman or man over 40 years with these risk factors, the doctor should check the heart function before prescribing Sumatriptan Teva. In very rare cases, serious heart conditions have occurred after taking Sumatriptan Teva, even if no signs of any heart disease were found. Contact the doctor for advice if there are any concerns.
Important information about some of the ingredients of Sumatriptan Teva: Sumatriptan Teva contains the sugar lactose. If informed to have an intolerance to some sugars by the doctor, contact the doctor before taking this medicinal product.
Driving and using machines: Migraine itself or its treatment with Sumatriptan Teva may cause drowsiness. Do not drive or operate machinery if affected.
Pregnancy: Ask the doctor or pharmacist for advice before taking this medicine.
There is only limited information regarding the safety of Sumatriptan Teva in human pregnancy. Up to now, these data do not indicate that there is an increased risk for malformations. It is recommended that Sumatriptan Teva is not taken during pregnancy, unless instructed by the doctor to do so.
Breast-feeding: Ask the doctor or pharmacist for advice about taking this medicine whilst breast-feeding.
Sumatriptan Teva is excreted into breast milk. The exposure of the baby can be minimised by avoiding breast-feeding for 12 hours after administration of Sumatriptan Teva, during which time any breast milk expressed should be discarded.
Like all medicines, Sumatriptan Teva can cause side effects, although not everybody gets them.
The following side effects are possible with the following frequencies: Common: 1 to 10 of every 100 patients may have these: Drowsiness, dizziness, tingling; Temporary increase in blood pressure (arising soon after treatment), flushing; Feeling sick (nausea) or being sick (vomiting); Sensation of tension [generally transient (temporary), but may be strong and may appear in any part of the body, including chest and throat]; Pain, sensation of heat, pressure, tightness or anxiety [may be strong and may appear in any part of the body, including chest and throat]; Feeling of weakness, tiredness.
Very rare: Fewer than 1 in every 10,000 patients may have these: Allergic reactions of the skin [skin rash such as red spots or hives (skin lumps)]; Anaphylaxis (strong allergic reactions such as swelling of eyelids, face or lips and sudden wheeziness, fluttering or tightness in the chest) [if any strong allergic reaction appears, stop taking Sumatriptan Teva and contact the doctor immediately]; Nystagmus (involuntary back and forth movement of the eyeball), scotoma (dark spots in the field of vision), tremor and dystonia (involuntary muscle contractions); Fits [usually in people with a history of epilepsy]; Visual disturbances (flickering, diplopia, reduced vision, loss of vision including permanent defect), although these may be caused by the migraine attack itself; Racing heart, slow heartbeat, palpitations, irregular heartbeat, and serious complications of the coronary artery, heart attack, transient ischaemic ECG changes; Decrease in blood pressure, which is a disease characterised by signs of paleness or a blue tinge to the skin and/or pain of the fingers, toes, ears, nose or jaw in response to cold or stress (Raynaud's phenomenon); Inflammation of the colon (part of the intestine), which may present as lower left-sided stomachache and bloody diarrhoea; Neck stiffness.
If a blood test is performed to check the liver function, Sumatriptan Teva may affect the results.
If any of the side effects gets serious, or if noticing any side effects not previously listed, tell the doctor or pharmacist.
Certain medicines may influence the effectiveness of Sumatriptan Teva, and Sumatriptan Teva may influence the effectiveness of other medicines. Contact the doctor if taking: other medicines against migraine, such as ergotamine or similar medicines; medicines to treat depression (MAO inhibitors or serotonin reuptake inhibitors); medicines to treat manic/depressive (bipolar) disorders, such as lithium.
During concomitant use of sumatriptan and herbal preparations containing St. John's Wort (Hypericum perforatum), side effects may become more common.
Tell the doctor or pharmacist if taking or have recently taken any other medicines, including medicines obtained without a prescription.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
This medicinal product does not require any special storage conditions.
N02CC01 - sumatriptan ; Belongs to the class of selective serotonin (5HT1) agonists preparations. Used to relieve migraine.
Sumatriptan Teva FC tab 50 mg
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