50 mg film-coated tablets
sumatriptan
What Sumatriptan Teva is and what it is used for
- Sumatriptan Teva belongs to the group of drugs for migraine. The active substance in Sumatriptan Teva film-coated tablets is sumatriptan, a 5-HT 1 – receptor agonist.
- Migraines are thought to be caused by a dilation of the blood vessels. Sumatriptan Teva constricts these blood vessels and thereby relieves a migraine.
- Sumatriptan Teva is used to treat migraine attacks with or without aura (a premonition, usually consisting of visual disturbances such as flashes of light, zigzag lines, stars, or waves).
Sumatriptan Teva should only be used when you have signs or symptoms of a migraine attack. Migraine headaches are usually of moderate to severe intensity, unilateral (but can switch sides between attacks), and have a pulsating character. Symptoms such as nausea, sometimes vomiting, and significant sensitivity to light and sound are common in migraines.
Sumatriptan Teva is not intended for the treatment of other types of headache, e.g. tension headache.
The sumatriptan contained in Sumatriptan Teva may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Sumatriptan Teva
Sumatriptan Teva should only be used by you who know you have migraines.
You probably have a migraine if you have recurring headaches such as:
- has a pulsating character and is one-sided
- has moderate to the strong intensity and lasts for 4-72 hours
- worsens during normal physical activity (eg walking or climbing stairs), affects your ability to concentrate and your daily activities.
Migraines can be accompanied by other symptoms such as:
- nausea, sensitivity to light and sound
- aura symptoms (e.g. visual field loss, zigzag patterns or flashes in the visual field et), and more rarely numbness or speech difficulties.
Consult a doctor or pharmacist if you are unsure or need more information.
Do not take Sumatriptan Teva
- if you are allergic (hypersensitive) to sumatriptan or any of the other ingredients of this medicine (listed in section 6)
- if you have had a heart attack
- if you suffer from any heart disease
- if you have symptoms that may indicate heart diseases, such as transient chest pain or a feeling of pressure on the chest
- if you have had a stroke or transient ischemic attack ( TIA, a mild form of stroke that lasts less than 24 hours )
- if you have problems with blood circulation in your legs that cause cramp-like pain when you walk ( peripheral vascular disease)
- if you have significantly elevated blood pressure, or if your blood pressure is high despite medication
- if you have severe liver problems
- if you are using or have recently used medicines containing ergotamine or ergotamine derivatives (including methysergide) or any triptan or 5-HT1 agonist (eg naratriptan or zolmitriptan)
- if you are using or have recently used medicines for the treatment of depression that belongs to the group of monoamine oxidase inhibitors ( MAO inhibitors ).
If you suspect that you may have any of these problems, or if you are in doubt, contact your doctor before taking Sumatriptan Teva.
Warnings and precautions
Consult your doctor before starting to use Sumatriptan Teva
- if you know you have liver or kidney problems
- if you have been diagnosed with epilepsy or any other disease that lowers the threshold for epileptic seizures
- if you know that you are allergic to antibacterial drugs that belong to the sulfonamide group
- if your blood pressure is well controlled with drug treatment, as sumatriptan has been seen in rare cases to increase blood pressure it
- if you are taking selective serotonin reuptake inhibitors ( SSRIs ) or serotonin-norepinephrine reuptake inhibitors ( SNRIs ). Increased reflex irritability and impaired coordination have been observed after concomitant use of selective serotonin reuptake inhibitors and sumatriptan
- if you have pain and/or tightness in your chest or throat. These effects are usually short-lived. However, if they persist and worry you, or if they become severe, you should contact your doctor immediately for advice
- if you have chronic headaches daily. If you take Sumatriptan Teva too often, it can lead to the development of chronic headaches. In this case, you should contact your doctor as you may need to stop taking Sumatriptan Teva
- if you are considered to be at risk of developing heart disease (e.g. if you have diabetes, are a heavy smoker, or take nicotine replacement products), especially if you are a postmenopausal woman or a man over 40 with these risk factors, your doctor should examine your heart function before he/she prescribing Sumatriptan Teva. In very rare cases, serious heart disease has occurred after taking Sumatriptan Teva, even though there were no signs of heart disease. Contact your doctor for advice if you are concerned.
- if you simultaneously use sumatriptan and (traditional) herbal medicines containing St. John’s wort (Hypericum perforatum), side effects may occur to an increased extent.
Sumatriptan Teva should only be used for guaranteed migraine. If the headache is not at all like your usual headache, you should not take sumatriptan without first consulting a doctor.
After taking Sumatriptan Teva, you may experience short-term chest pain and a feeling of tightness, which may be intense and radiate up to the throat. In very rare cases, this may be due to cardiac involvement. Therefore, contact a doctor immediately if the symptoms do not disappear quickly.
Overconsumption of sumatriptan can cause chronic, daily headaches or worsening headaches. Consult your doctor if you think it has affected you. It may be necessary to stop treatment with Sumatriptan Teva to correct the problem.
Other medicines and Sumatriptan Teva
Some medicines can affect the effect of Sumatriptan Teva, and Sumatriptan Teva can affect the effectiveness of other medicines. Contact your doctor if you are taking:
- other migraine medicines, for example, ergotamine or similar medicines or any triptan or 5-HT1 agonist (eg naratriptan or zolmitriptan);
- medicines for the treatment of depression ( MAOIs, serotonin reuptake inhibitors, or serotonin-norepinephrine reuptake inhibitors);
- medicines to treat manic-depressive (bipolar) disease, such as lithium.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
Pregnancy:
- Consult a doctor or pharmacist before taking this medicine.
- There is only limited information on the safety of sumatriptan use during human pregnancy. So far, these data do not indicate an increased risk of malformations. You are advised not to take Sumatriptan Teva during pregnancy unless otherwise instructed by your doctor.
Breast-feeding:
- Consult a doctor or pharmacist before taking this medicine while breastfeeding.
- Sumatriptan is excreted in breast milk. You can reduce the amount of medicine your child gets by avoiding breastfeeding for 12 hours after taking Sumatriptan Teva. During this time, all expressed milk must be discarded.
Driving ability and use of machinery
Both the migraine attack and the treatment with Sumatriptan Teva can cause drowsiness. Do not drive or operate machinery if you are affected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Sumatriptan Teva contains lactose and sodium
Sumatriptan Teva contains lactose
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
Sumatriptan Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is almost ¨sodium-free¨.
How to take Sumatriptan Teva
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
- Sumatriptan Teva should be taken at the first sign of a migraine attack, but can also be taken during an ongoing attack.
- Sumatriptan Teva should not be used preventively (prophylactically).
- Do not take more than 2 tablets in 24 hours.
- Do not take more than 2 tablets during the same migraine attack.
- The tablets should be swallowed whole with water. If you have difficulty swallowing the tablet, you can break it apart and take it in two parts.
The recommended dose for adults is 50 mg. Some patients may need 100 mg. Do not take more than 100 mg (two 50 mg tablets) in 24 hours.
If the migraine symptoms are relieved after the first dose but then return, you can take another tablet, provided that at least two hours have passed since you took the last tablet. If Sumatriptan Teva does not provide immediate relief, it is not worth taking more tablets for the same attack. Sumatriptan Teva can be used in the next attack.
Use for children and adolescents
Use of Sumatriptan Teva in children, adolescents, and patients over 65 is not recommended.
Do not take other medicines containing triptans (including other medicines containing sumatriptan, zolmitriptan, rizatriptan, naratriptan, eletriptan, almotriptan) or other medicines containing ergotamine or ergotamine derivatives (including methysergide) together with Sumatriptan Teva.
Sumatriptan Teva should only be used to relieve migraine symptoms. Do not take the medicine to try to prevent a seizure. Do not take the medicine until you are sure that it is a migraine and not a regular headache.
If you feel that Sumatriptan Teva does not provide any relief, it may mean that you do not have a migraine. Talk to your doctor.
If you have taken too much Sumatriptan Teva
Symptoms of overdose are the same as those listed in section 4 ‘Possible side effects. If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor if you need to discuss these.
The following side effects are possible with the following frequencies:
Common: may affect up to 1 in 10 users
- with drowsiness, dizziness, and tingling.
- temporary increased blood pressure (immediately after medication), flushing.
- nausea or vomiting.
- the feeling of tightness. This is usually transient but can be intense and appear anywhere on the body, including the chest and neck. Muscle pain
- , feeling of heat or cold, feeling of pressure or tightness. These symptoms can be intense and appear anywhere on the body, including the chest and neck.
- respiratory distress
- feelings of weakness, and fatigue.
Very rare: may affect up to 1 in 10,000 users
- if you have a blood test to check your liver function, Sumatriptan Teva may affect the test results.
The following side effects are possible for some patients, but it is not known (occurring in an unknown number of users) how often they occur:
- allergic skin reactions: rashes in the form of red spots or hives
- anaphylactic state (severe allergic reaction such as swollen eyelids, face, or lips and sudden shortness of breath, and tightness in the chest).
If a severe allergic reaction occurs, stop taking Sumatriptan Teva and contact a doctor immediately. - nystagmus (involuntary movements of the eye back and forth), scotoma (dark spots in the field of vision, etc.); tremors, and dystonia (involuntary muscle contractions).
- seizures – usually in people who have previously had epilepsy.
- visual disturbances (flickering, double vision, visual impairment, vision loss including permanent damage), but these can also be caused by the migraine attack itself.
- fast pulse, slow pulse, palpitations, irregular heart rhythm and serious complications in the coronary arteries of the heart, myocardial infarction, and transient ischemic ECG changes.
- lowering of blood pressure et, Raynaud’s phenomenon, which is a disease characterized by pale or bluish skin and/or pain in the fingers, toes, ears, nose, or jaws when cold or stressed.
- inflammation of the colon, which can manifest as left-sided pain in the lower abdomen and bloody diarrhea (ischemic colitis ).
- diarrhea
- joint pain
- concern
- neck stiffness
- increased sweating
- If you have recently injured yourself or if you have inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening pain at the site of the injury or inflammation.
- difficulty swallowing.
How to store Sumatriptan Teva
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister after Ex.Date. / EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is sumatriptan.
50 mg: One tablet contains 50 mg of sumatriptan (as succinate).
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, glycerol triacetate, red, yellow, and black iron oxide (E172).
Appearance and package sizes of the medicine
50 mg: Sumatriptan Teva 50 mg are peach to pink, oblong film-coated tablets debossed with “5” and “0” on one side and scored on both sides.
The tablet can be divided into two equal doses.
50 mg: The product is available in pack sizes of 2 (non-prescription), 3, 4, 6, 12, 18, 24, 30 and 50 tablets.
Not all pack sizes may be marketed.
Manufacturer
Pharmachemie BV
Swensen 5
Postbus 552
2003 RN Haarlem – The Netherlands
Teva Pharmaceutical Works Private Limited Company
Pallagi Street 13, Debrecen, H 4042
Hungary