50 mg film-coated tablet
What Sumatriptan Apofri is and what it is used for
Sumatriptan Apofri belongs to a group of medicines called triptans, which are used to treat migraine headaches.
Migraine symptoms can be caused by a temporary dilation of the blood vessels in the head. This medicine reduces the dilation of these blood vessels. This helps the headache disappear and relieves other migraine symptoms such as nausea, vomiting, and sensitivity to light and sound.
Sumatriptan Apofri is used to treat migraine attacks with or without aura (a premonition that usually consists of visual disturbances such as flashes, zigzag lines, stars, or waves).
Sumatriptan Apofri 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 Apofri is not intended for the treatment of other types of headache, e.g. tension headache.
Sumatriptan contained in Sumatriptan Apofri 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 using Sumatriptan Apofri
Sumatriptan Apofri 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 unilateral,
- 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.
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.
Do not use Sumatriptan Apofri
- if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).
- if you have or have had heart problems, such as a heart attack, angina (chest pain brought on by exercise or exertion), Prinzmetal’s angina (chest pain that comes on at rest), or have had heart-related symptoms such as shortness of breath or tightness in the chest
- if you have problems with blood circulation in the hands and feet ( peripheral vascular disease)
- if you have had a stroke (“stroke”) or bleeding in the brain ( cerebrovascular disease) or if you have had a transient disturbance of the blood supply to the brain ( TIA )
- if you have high blood pressure
- if you have severely impaired liver function
- if you are taking medicines containing ergotamine or ergotamine derivatives (migraine medicines such as methysergide) or triptans (5‑hydroxytryptamine (5‑HT 1 ), receptor agonists such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan or zolmitriptan) These must not be taken at the same time as Sumatriptan Apofri (see also “Other medicines and Sumatriptan Apofri”).
- if you are currently taking monoamine oxidase inhibitors (MAOIs) (eg moclobemide for depression or selegiline for Parkinson’s disease ) Sumatriptan Apofri must not be used within two weeks of stopping treatment with MAOIs. See also “Other medicines and Sumatriptan Apofri” below.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sumatriptan Apofri.
Before you start using Sumatriptan Apofri, talk to your doctor if you:
- Have diabetes, especially if you are a postmenopausal woman or a man over 40. A medical examination should take place before treatment begins.
- Are a heavy smoker or use products containing nicotine ( patches or gum ), especially if you are a man over 40 or a woman who has passed menopause. A medical examination should take place before treatment begins.
- Have had seizures/convulsions or are prone to seizures/convulsions. Sumatriptan Apofri may increase the risk of seizures.
- Has reduced liver or kidney function. The doctor may adjust your dose.
- Are allergic (hypersensitive) to certain antibiotics ( sulfonamides ). In this case, you may also be allergic to Sumatriptan Apofri. If you know that you are allergic to an antibiotic (even if you are not sure that it is a sulfonamide), consult your doctor or pharmacist before using this medicine.
This medicine may only be used if you have been diagnosed with a “migraine” and other factors have been ruled out. Some forms of migraine cannot be treated with sumatriptan.
After taking this medicine, you may feel pain in your chest and a feeling of pressure for a short time. These symptoms can be quite intense and radiate up to the throat. In very rare cases this can be caused by effects on the heart. Therefore, you should contact a doctor if the symptoms do not disappear.
Overuse of this medication may cause chronic, daily headaches or worsening headaches. It may be necessary to discontinue treatment with Sumatriptan Apofri. Consult your doctor if this is right for you.
Other medicines and Sumatriptan Apofri
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Interaction means that medicines used at the same time can affect each other’s effects and/or side effects. The following may also apply to medicines that you have used in the past or will use shortly.
- Medicines containing ergotamine (migraine medicine) or other triptans. These must not be taken at the same time as Sumatriptan Apofri (see also “Do not take Sumatriptan Apofri”):
- After taking medicines containing ergotamine, you should wait at least 24 hours before taking Sumatriptan Apofri.
- After you have taken Sumatriptan Apofri, you should wait at least 6 hours before taking medicines containing ergotamine and at least 24 hours before taking medicines containing other triptans.
- Monoamine oxidase inhibitors (MAOIs) (eg moclobemide for depression or selegiline for Parkinson’s disease ).
- You must not take Sumatriptan Apofri within two weeks of stopping using MAOIs.
- Use of triptans together with antidepressants such as selective serotonin reuptake inhibitors ( SSRIs ) and serotonin and norepinephrine reuptake inhibitors ( SNRIs ) may cause serotonin syndrome (a collection of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle twitching, tremors, palpitations, and tremors). If you get these symptoms, tell your doctor.
- There is a risk that the simultaneous use of sumatriptan and lithium (for manic/depressive (bipolar) disorders) may cause serotonin syndrome.
- With the simultaneous use of natural remedies containing St. John’s wort ( Hypericum perforatum ), side effects may occur more often.
Pregnancy, breastfeeding, and fertility
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.
Sumatriptan Apofri should only be used during pregnancy under the prescription of a doctor. Sumatriptan Apofri should only be used during pregnancy if the positive effects for the mother are greater than the potential risk to the fetus.
Sumatriptan passes into breast milk. Avoid breastfeeding for 12 hours after taking Sumatriptan Apofri to reduce the amount of medicine the baby gets. During this time, the breast milk should be pumped out and thrown away.
Driving ability and use of machinery
No studies on the ability to drive and use machines have been performed.
Drowsiness may occur as a result of migraine or its treatment with sumatriptan and this may affect the ability to drive and use machines.
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 a doctor or pharmacist if you are unsure.
Sumatriptan Apofri contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicinal product contains less than 1 mmol (23 mg) sodium per film-coated tablet, i.e. is almost “sodium-free”.
How to use Sumatriptan Apofri
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 Apofri should be taken at the first sign of a migraine attack, but can also be taken during an ongoing attack.
- Sumatriptan Apofri should not be used preventively (prophylactically).
- Do not take more than 2 tablets per 24-hour period.
- Do not take more than 2 tablets during the same migraine attack.
Adults (18-65 years):
The usual dose for adults is 1 tablet of 50 mg for migraine attacks. No more than 2 tablets in 24 hours.
Take the tablet with water, preferably as soon as possible after the migraine attack starts. The tablets must not be chewed or crushed.
Children and young people:
Sumatriptan Apofri is not recommended for children and adolescents under the age of 18.
Elderly people (over the age of 65):
Sumatriptan Apofri is not recommended for adults over 65 years of age.
If the migraine symptoms are relieved after the first dose (1 tablet) but later return, another 1 tablet can be taken. You must wait at least 2 hours after taking the first dose before you can take the second dose.
If the migraine symptoms are not relieved after the first dose and the medication is not effective, do not take another dose during the same migraine attack. The next time you get a migraine, you can try Sumatriptan Apofri again.
You must contact a doctor if symptoms worsen or do not improve within 3 days.
Sumatriptan Apofri 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 Apofri does not provide any relief, it may mean that you do not have a migraine. Talk to your doctor.
Use for children and adolescents
Sumatriptan Apofri is not recommended for children and adolescents under the age of 18.
If you have used too much Sumatriptan Apofri
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.
Side effects such as those mentioned under “Potential side effects” may occur.
If you forget to use Sumatriptan Apofri
Do not take a double dose to make up for a missed dose.
If you stop using Sumatriptan Apofri
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 Apofri and contact your doctor immediately if you experience any of the following side effects:
- Severe allergic reaction (so-called anaphylactic reaction ) with symptoms such as swelling of the face, tongue, or throat; difficulty swallowing; hives and breathing difficulties, and drop in blood pressure.
- Seizures (usually in people who have or have had epilepsy ).
- Vascular spasm (pain in the chest, often brought on by exertion), heart attack, or spasm in the blood vessels of the heart.
- Inflammation in the large intestine due to reduced blood flow in the intestine. This is a serious condition that can manifest as acute cramping stomach pains and diarrhea.
The above side effects have been reported but occur in an unknown number of users.
Other side effects that may occur:
Common (affects more than 1 in 100 users):
- Dizziness, drowsiness or feeling of warmth, sensory disturbance
- Transient increase in blood pressure et soon after treatment, flushing
- Shortness of breath
- Nausea, vomiting
- A feeling of heaviness, tightness, pain, or pressure in any part of the body including the throat or chest, muscle pain ( myalgia )
- Pain, heat, or cold sensation
- Weakness and tiredness (exhaustion)
Uncommon (affects less than 1 in 100 users):
- Drowsiness (sleepiness)
Very rare (affects less than 1 in 10,000 users):
- Impaired liver function
Has been reported (occurring in an unknown number of users):
- Allergic skin reaction with itching
- Movement disorder that can cause abnormal movements or abnormal posture ( dystonia )
- Impaired vision, e.g. double vision, flickering, and sometimes loss of vision with permanent visual impairment. Visual disturbances can also occur as a result of the migraine attack itself.
- Slow heartbeats, fast heartbeats, organ-bound heartbeats, palpitations. Transient ischemic EKG changes, seen during EKG examination.
- Reduced blood flow to the arms and legs, resulting in pale or bluish fingers and toes
- 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
- Drop in blood pressure
- Stiff neck
- Joint pain
- Increased sweating
How to store Sumatriptan Apofri
Store in the original packaging. Light sensitive.
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after Exp or EXP. The expiration date is the last day of the specified month.
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
The active substance is sumatriptan succinate corresponding to 50 mg of sumatriptan per tablet.
Other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized maize starch, croscarmellose sodium, magnesium stearate (E470b).
Coating: hypromellose (E464), titanium dioxide (E171), talc (E553b), red iron oxide (E172), yellow iron oxide (E172), macrogol
Appearance and package sizes of the medicine
Sumatriptan Apofri 50 mg film-coated tablets are peach-colored, capsule-shaped, biconvex tablets, 10.6 x 4.4 mm and are available in blister packs of 2 tablets.
Marketing Authorisation Holder
182 12 Danderyd
Evolan Pharma AB
182 33 Danderyd