50 mg film-coated tablets
sumatriptan
What Sumatriptan Mylan is and what it is used for
Sumatriptan Mylan contains the active substance sumatriptan succinate.
Sumatriptan Mylan is a medicine used to treat migraine attacks with or without aura (a premonition usually consisting of visual disturbances such as flashes, zigzag lines, stars, or waves).
Sumatriptan Mylan 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 Mylan is not intended for the treatment of other types of headache, such as tension-type headaches.
What you need to know before you take Sumatriptan Mylan
Sumatriptan Mylan should only be used by you who have been diagnosed with migraine confirmed by a doctor.
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 with normal physical activity (eg walking or climbing stairs)
- Affects your ability to concentrate and your daily tasks
Migraine can be accompanied by other symptoms such as:
- Nausea, sensitivity to light and sound
- Aura symptoms, for example, visual field loss, zigzag patterns or flashes in the visual field, and less often numbness or speech difficulties.
Consult a doctor or pharmacist if you are unsure or need more information.
Do not use Sumatriptan Mylan:
- if you are allergic to sumatriptan or any other ingredient in this medicine. (listed in section 6)
- if you are allergic to a type of antibiotic called ‘sulfonamides’ (such as trimethoprim and sulfamethoxazole).
- if you have or have had any heart disease (for example, spasm of the coronary arteries with chest pain) or if you have had a heart attack.
- if you have peripheral vascular disease (narrowing of blood vessels that supply blood to the arms and legs).
- if you have had a stroke or symptoms of a stroke that lasted only a short time and from which you fully recovered (so-called TIA, transient ischemic attack).
- if you have severely impaired liver function.
- if you suffer from unusual forms of migraine associated with disturbances in the functioning of the brain or eyes.
- if you have moderately high or very high blood pressure or slightly high blood pressure that is not under control.
- if you are using, or in the last 24 hours have used, medicines containing ergotamine or ergotamine derivatives for migraine (including methysergide), see under Other medicines and Sumatriptan Mylan for more information.
- if you are taking, or in the last 24 hours have taken, any other triptans (such as naratriptan, zolmitriptan, rizatriptan, almotriptan, or eletriptan). See under Other medicines and Sumatriptan Mylan for more information
- if you use or in the last two weeks have used monoamine oxidase inhibitors (so-called MAO inhibitors ) for depression or Parkinson’s disease
Warnings and precautions
Sumatriptan Mylan may cause pain or tightness in the chest and throat.
After taking Sumatriptan Mylan, you may feel pain or tightness in the chest and throat. If these symptoms do not disappear quickly, contact your doctor immediately.
Tell your doctor or pharmacist if any of the following apply to you:
- if you have risk factors for heart disease such as diabetes, are heavy smoker, or use nicotine replacement preparations, your doctor should do additional checks. This is especially important if you are past menopause or are male and over 40 and have these risk factors.
- if you are being treated for high blood pressure that is under control
- if you have impaired liver or kidney function.
- if you have previously had convulsions or epileptic seizures.
- you are using antidepressant medicines called selective serotonin reuptake inhibitors ( SSRIs ) or selective serotonin-norepinephrine reuptake inhibitors ( SNRIs ) to treat depression.
If you use Sumatriptan Mylan regularly
Using Sumatriptan Mylan too often can cause or worsen headaches. This can also occur if you need to use other medications regularly against migraines, such as painkillers. Talk to your doctor or pharmacist if this applies to you.
Other medicines and Sumatriptan Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking:
- medicines against depression called selective serotonin reuptake inhibitors ( SSRIs ) e.g. fluoxetine, or serotonin-norepinephrine reuptake inhibitors ( SNRIs ) e.g. venlafaxine or duloxetine (which can also be used for some urinary tract problems). Concomitant use of Sumatriptan Mylan with these medicines may cause serotonin syndrome (a collection of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle twitching, tremors, palpitations, and tremors). Talk to a doctor immediately if you are affected in this way.
- lithium (a medicine used in the treatment of major depression or manic depression, a disorder with alternating periods of low mood and hyperactivity) or severe types of headache known as Horton’s headache.
- medicines for the treatment of depression or Parkinson’s disease, so-called monoamine oxidase inhibitors ( MAO inhibitors ). Do not take Sumatriptan Mylan if you have taken MAO inhibitors in the last 2 weeks.
- herbal medicines containing St. John’s wort.
If you are taking or have taken other migraine medicines
If you have been taking other migraine medicines, such as ergotamine or ergot inhibitor (eg methysergide) or other triptans (such as naratriptan, zolmitriptan, rizatriptan, almotriptan, or eletriptan), you should wait at least 24 hours before taking sumatriptan. If you have taken sumatriptan, wait at least 6 hours before taking ergotamine or ergotamine derivatives (eg methysergide) and wait at least 24 hours before taking any other type of triptan medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If the medicine is used during breastfeeding, you should be aware that sumatriptan passes into breast milk. Avoid breastfeeding for 12 hours after taking Sumatriptan Mylan to reduce the amount of medicine the baby gets. During this time, breast milk should be pumped out and thrown away.
Driving ability and use of machinery
This medicine, or a migraine attack, can make you drowsy, dizzy, or weak. Avoid driving or using machines if you feel drowsy, dizzy, or weak.
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 a doctor or pharmacist if you are unsure.
Sumatriptan Mylan contains lactose and sodium
This medicine contains lactose. If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is almost ‘sodium-free’.
Contact a doctor, nurse, or pharmacist if there is anything you are unsure about.
How to take Sumatriptan Mylan
Always use Sumatriptan Mylan as directed in this leaflet. Ask your doctor or pharmacist if you are unsure.
- Take the medicine as soon as possible at the first sign of a migraine attack. However, you can take the medicine at any time during an attack.
- This medicine should not be used for preventive purposes.
- Swallow the tablets with a glass of water.
- Do not take more than 2 tablets in 24 hours.
- Do not take more than 2 tablets during the same migraine attack.
Adults
The recommended dose is one 50 mg tablet. In some cases, 100 mg may be needed. If the first tablet helped, but the headache returns, you can take another dose after at least two hours.
If the first dose of Sumatriptan Mylan has no effect, do not take a second dose of the same migraine medicine. A pain-relieving drug such as paracetamol or NSAID, eg acetylsalicylic acid or ibuprofen, can be taken instead. The next time you get a migraine, you can try Sumatriptan Mylan again.
You must contact a doctor if symptoms worsen or do not improve within 3 days.
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 Mylan.
Sumatriptan Mylan 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 Mylan does not provide any relief, it may mean that you do not have a migraine. Talk to your doctor.
Elderly patients (over 65 years)
Sumatriptan Mylan is not recommended.
Children and young people (under 18 years)
Sumatriptan Mylan should not be given to children and adolescents.
Patients with liver problems
If you have mild to moderate liver problems, you may need to take a lower dose. Contact a doctor or pharmacist.
If you have taken too much Sumatriptan Mylan:
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 go to the hospital, take the medicine package and any remaining tablets with you.
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.
Stop taking Sumatriptan and contact your doctor or hospital immediately if you experience:
Frequency not known (cannot be estimated from available data)
- allergic reactions including serious reactions, so-called anaphylactic reactions (such as skin reactions which may include severe itchy rash and swelling of the skin, swelling of the tongue or throat, difficulty breathing, and drop in blood pressure)
- heart attack (you may notice tingling in the jaw and down the left arm, severe chest pain, and difficulty breathing)
- epileptic seizures or convulsions (usually in people who have or have had epilepsy )
- inflammation of the large intestine (which can be felt as stomach pain with bloody diarrhea)
Other side effects ar
Common (may affect up to 1 in 10 users):
- short-term increase in blood pressure soon after taking the tablets,
- tingling or numbness in the hands or feet, reduced sensation
- dizziness, fatigue, drowsiness,
- the feeling of weakness,
- flushing ( flush ),
- nausea and vomiting (this can also be caused by the migraine attack itself), feeling of heaviness, pain, feeling of heat and cold, and pressure or tightness in various parts of the body including the chest and throat (see section: Warnings and precautions),
- breathing difficulties, shortness of breath,
- muscle pain
Very rare (may affect up to 1 in 10,000 users):
- small changes in liver function tests (which can be seen in blood tests).
Frequency not known (cannot be estimated from available data):
- loss of muscle control, tremors,
- visual disturbances and vision loss including persistent vision problems (visual disturbances can also occur during a migraine attack),
- slower or faster heartbeat, changes in heart rhythm (these can be seen in EKG tests done by your doctor to study the electrical activity of the heart),
- palpitation,
- sudden intense chest pains,
- low blood pressure, pale and numb fingers, and toes (Raynaud’s phenomenon),
- diarrhea,
- neck stiffness,
- joint pain,
- concern,
- increased sweating
- Difficulty swallowing
- 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.
How to store Sumatriptan Mylan
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Use before the expiry date stated on the carton and blister card after “EXP”. The expiry date is the last day of the month indicated.
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 succinate equivalent to 50 mg of sumatriptan.
Other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, titanium dioxide (E171), polydextrose, hypromellose, glycerol triacetate, and macrogol. The film coating also contains red iron oxide (E172) and yellow iron oxide (E172). See section 2, “Sumatriptan Mylan contains lactose and sodium”.
Appearance and package sizes of the medicine
Sumatriptan Mylan 50 mg tablets are pink, round, film-coated tablets marked “SU 50” on one side and “G” on the other.
Sumatriptan Mylan is available in blister packs of 2 tablets.
Marketing Authorisation Holder:
Mylan AB
Box 23033
104 35 Stockholm
Manufacturer
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan. BV
Krijgsman 201186 DM, Amstelveen
Netherlands
Mylan Hungary Kft
H-2900 Come room
Mylan út.1
Hungary