50 mg, 100 mg film-coated tablets
sumatriptan
What Sumatriptan Accord is and what it is used for
Sumatriptan Accord belongs to a group of medicines called serotonin receptor agonists (5‑HT1).
The cause of migraine is probably an expansion of the blood vessels. Sumatriptan has a constricting effect on the dilated blood vessels and thus relieves the migraine headache.
Sumatriptan Accord is used to treat migraine attacks with or without aura (a sensation usually consisting of visual disturbances such as flashes, zigzag lines, stars, or waves).
Sumatriptan contained in Sumatriptan Accord 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 use Sumatriptan Accord
Do not use Sumatriptan Accord
- if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).
- if you have heart problems such as narrowing of your arteries (ischemic heart disease) or chest pain (angina) or if you have ever had a heart attack.
- if you have had a stroke or a transient disturbance in the blood circulation of the brain ( TIA, i.e. temporary lack of oxygen in the brain).
- if you have problems with blood circulation in the legs that cause cramp-like pain in the legs when walking (so-called peripheral vascular disease, PVD).
- if you have high blood pressure or if your blood pressure is high despite medication.
- if you have severely impaired liver function.
- if you are using or have recently used medicines containing ergotamine or similar medicinal substances such as methysergide maleate (for migraine ).
- if you use or have recently used so-called MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson’s disease ).
Warnings and precautions
The doctor must make sure before he/she prescribes Sumatriptan Accord if your headache is caused by a migraine or by some other disease. Talk to a doctor before using Sumatriptan Accord, if any of the following apply to you:
- you have symptoms of heart disease, such as chest pain or feeling of pressure across the chest and possibly up towards the neck.
- you are using antidepressants called selective serotonin reuptake inhibitors ( SSRIs ) or selective serotonin-norepinephrine reuptake inhibitors ( SNRIs ).
- your body cannot tolerate certain types of sugars
- you have impaired liver or kidney function.
- you have had seizures or any other illness that may increase the risk of seizures – such as head injury or alcoholism.
- you are allergic to sulfonamides. In this case, you may also be allergic to sumatriptan. If you know you are allergic to an antibiotic, but you are not sure if it is a sulfonamide, consult your doctor or pharmacist before using this medicine.
- you are a heavy smoker or you use nicotine replacement therapy and especially
- if you are a man over 40 or
- if you are a postmenopausal woman.
In some very rare cases, serious heart disease has occurred after the use of sumatriptan, even though no signs of heart disease have previously been observed. Consult a doctor so that the function of your heart can be examined before sumatriptan is prescribed.
After using sumatriptan, you may experience a feeling of pain or pressure in the chest. These feelings can be intense but they pass quickly. If they do not disappear quickly or if they worsen, contact the doctor immediately.
If you use sumatriptan frequently: too frequent use of sumatriptan may worsen the headache. The doctor may recommend that you stop using Sumatriptan Accord.
Other medicines and Sumatriptan Accord
Some medicines can affect the effect of Sumatriptan Accord, and Sumatriptan Accord can also affect the effectiveness of other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to herbal medicines, dietary supplements (e.g. vitamin, iron, or calcium preparations), and other medicines that you bought without a prescription. It is especially important to inform the doctor if the medicines you are using contain
- ergotamine or similar medications (against migraine ). If you have taken a medicine containing ergotamine, you should wait at least 24 hours before taking sumatriptan. Likewise, you should wait at least six hours after taking sumatriptan before taking medicines containing ergotamine.
- MAO inhibitors (eg moclobemide for depression or selegiline for Parkinson’s disease ). Sumatriptan Accord must not be used if you have used these medicines in the last two weeks.
- selective serotonin reuptake inhibitors ( SSRIs ) or selective serotonin-norepinephrine reuptake inhibitors ( SNRIs ) for depression. Concomitant use of Sumatriptan Accord and these medicines can cause serotonin syndrome with symptoms such as restlessness, confusion, sweating, hallucinations, increased reflexes, muscle twitching, tremors, increased heart rate, and tremors. If you experience such symptoms, tell your doctor immediately.
- St. John’s wort ( Hypericum perforatum ). Concomitant use of Sumatriptan Accord and herbal medicines containing St. John’s wort can increase the risk of side effects.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy:
There is only limited information regarding the safety of Sumatriptan Accord when used in pregnant women, although there is no evidence of any increased risk of birth defects to date. The doctor will discuss with you whether you need to use Sumatriptan Accord during pregnancy or not.
Breast-feeding:
Ask your doctor or pharmacist before taking any medicine. Sumatriptan is excreted in breast milk. Therefore, breastfeeding should be avoided for 24 hours after taking Sumatriptan Accord.
Driving ability and use of machinery
Drowsiness may affect a migraine patient due to a migraine attack or the treatment with Sumatriptan Accord. This should be taken into account, as sharper attention than usual is required, e.g. when driving or using machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. 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 Accord contains lactose
This medicine contains lactose. If a doctor has told you that you have an intolerance to certain types of sugars, consult a doctor before taking this medicine.
How to use Sumatriptan Accord
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure. It is best to take Sumatriptan Accord as soon as you feel a migraine attack is coming, but you can also take the preparation later during the attack. Do not try to avoid an attack with Sumatriptan Accord – use it only when the migraine symptoms have started.
Adults (18–65 years):
The recommended dose is one tablet of 50 mg Sumatriptan Accord for a migraine attack. Some patients may need 100 mg. Follow the doctor’s instructions.
Children (under 18):
Use of Sumatriptan Accord in children under 18 years of age is not recommended.
Elderly (over 65):
Use of Sumatriptan Accord is not recommended for people over 65 years of age.
Method of administration:
Swallow the tablet whole with water. Preferably take the tablet as soon as a migraine attack begins. Do not chew or crush the tablets.
If you feel that the effect of Sumatriptan Accord is too strong or too weak, contact your doctor or pharmacist.
If the first tablet has no effect
Do not take another dose during the same migraine attack even if the symptoms are not relieved after the first dose. If you have another migraine attack, you can take an additional dose of Sumatriptan Accord. If Sumatriptan Accord does not relieve your symptoms, see a doctor.
If the symptoms return
If the symptoms are relieved after the first dose of one of the medicines but later return, you can take another dose once, in some rare cases no more than twice, in 24 hours. You must wait at least two hours between doses. A daily dose of 300 mg must not be exceeded.
If you have used too much Sumatriptan Accord
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 taken too many Sumatriptan Accord tablets, contact a doctor or hospital immediately. Symptoms of overdose are the same as listed in section 4. Possible side effects.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the symptoms below can form part of the migraine attack itself.
Allergic reaction:
Frequency not known (cannot be estimated from available data):
- an allergic skin reaction: skin rash such as red dots or hives (raised redness )
- anaphylaxis (severe allergic reactions such as swelling of the eyelids, face, or lips and sudden wheezing, palpitations, or loss of consciousness).
If you get an allergic reaction , stop taking Sumatriptan Accord. Contact your doctor immediately .
Other possible side effects:
Common (may affect up to 1 in 10 patients):
- sleepiness, dizziness, unusual sensations
- breathing difficulties
- muscle pain
- transient increase in blood pressure et (immediately after treatment), flushing of the face and neck
- feeling of weakness, fatigue
- nausea or vomiting
- pain, hot flushes or feeling cold, feeling of tightness or pressure. These symptoms usually go away quickly, and they can appear anywhere on the body, including the chest and throat.
Frequency not known (cannot be estimated from available data):
- seizures (epileptic seizures), involuntary movements ( dystonia ), tremors, involuntary eye movements
- visual disturbances such as flashes, reduced vision, loss of vision (these can also be caused by the migraine attack).
- heart problems where the heart rhythm may become faster or slower or change; chest pain (angina) or heart attack
- low blood pressure , Raynaud’s syndrome (disease where fingers and toes become white and numb)
- inflammation of the large intestine (symptoms include pain in the lower abdomen on the left side, and bloody diarrhea)
- neck stiffness
- mild liver disorders have been observed occasionally
- diarrhea
- anxiety
- excessive sweating
- joint pain.
- If you have recently injured yourself or if you have an 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 Accord
- No special storage instructions.
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among 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
50 mg film-coated tablet
The active substance is:
Sumatriptan. One tablet contains 70 mg of sumatriptan succinate, which corresponds to 50 mg of sumatriptan.
Other ingredients are:
Tablet core: lactose monohydrate , hypromellose, microcrystalline cellulose, croscarmellose sodium and magnesium stearate
Film coating: hypromellose, titanium dioxide (E 171), triacetin, red iron oxide (E 172).
100 mg film-coated tablet
The active substance is:
Sumatriptan. One tablet contains 140 mg of sumatriptan succinate, which corresponds to 100 mg of sumatriptan.
Other ingredients are:
Tablet core: lactose monohydrate , hypromellose, microcrystalline cellulose, croscarmellose sodium and magnesium stearate
Film coating: hypromellose, titanium dioxide (E 171)
Appearance and package sizes of the medicine
Description of film-coated tablet 50 mg: pink, capsule-shaped, biconvex, film-coated tablet, smooth on both sides.
Description of film-coated tablet 100 mg: white to off-white, capsule-shaped, biconvex, film-coated tablet, smooth on both sides.
Sumatriptan Accord 50 mg film-coated tablets are supplied in packs of 4, 6, 12 and 18 tablets.
Sumatriptan Accord 100 mg film-coated tablets are supplied in packs of 4, 6, 12 and 18 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited,
Sage house, 319 Pinner Road,
North Harrow,
Middlesex HA1 4HF,
UK
Accord Healthcare Polska Sp.z o.o
ul. Lutomirska 50
95-200 Pabianice
Poland