What Sumatriptan Bluefish is and what it is used for
Sumatriptan Bluefish belongs to the drug group triptans.
Sumatriptan Bluefish is 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 Bluefish 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.
Migraine symptoms are probably caused by a temporary dilation of the blood vessels in the head. Sumatriptan Bluefish is thought to reduce the dilation of these blood vessels. This contributes to the headache as well as other migraine symptoms, such as nausea, vomiting, and sensitivity to light and sound disappearing or being alleviated.
Sumatriptan Bluefish only works when a migraine attack has started. It does not stop an attack.
You must not use sumatriptan to prevent a migraine attack.
Sumatriptan Bluefish is not intended for the treatment of other types of headaches, such as tension-type headaches.
The sumatriptan contained in Sumatriptan Bluefish may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Sumatriptan Bluefish
Sumatriptan Bluefish 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 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 Bluefish
- if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).
- if you have had heart problems, e.g. heart attack, angina (chest pain during exercise or exertion), angina (chest pain that occurs 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 (so-called peripheral vascular disease).
- if you have had a stroke/cerebral infarction, so-called stroke, or brain hemorrhage.
- if you have had symptoms of a stroke known as a TIA, transient ischemic attack, i.e. temporary obstruction in the blood supply to the brain.
- if you have severely impaired liver function.
- if you have high blood pressure.
- if you take medicines containing ergotamine or ergotamine derivatives (migraine medicines such as methysergide) or other triptans (5-hydroxytryptamine 1 ( 5-HT 1 ) – receptor agonists ) such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan or zolmitriptan and others. These must not be used at the same time as Sumatriptan Bluefish (see also “Use of other medicines”).
- if you are currently taking monoamine oxidase inhibitors (so-called MAO inhibitors ), for example, moclobemide for depression or selegiline for Parkinson’s disease. Sumatriptan should not be used within two weeks of ending treatment with MAO inhibitors. See also “Use of other medicines” below.
Warnings and precautions
Before treatment with Sumatriptan Bluefish, tell your doctor if:
- you are a heavy smoker or use other nicotine products ( patches or nicotine gum), especially if you are a woman and have undergone menopause or are a man and over 40 years old. A medical examination should take place before the treatment is started.
- you have liver or kidney failure. The dose may need to be adjusted.
- you have ever had seizures/convulsions or are prone to seizures/convulsions? Sumatriptan can induce seizures/convulsions. Sumatriptan Bluefish may increase the risk of seizures.
- you are hypersensitive to certain antibiotics (sulfa drugs). If you have had an allergic reaction after starting to take sumatriptan, Caution should be observed.
- you use herbal remedies that contain St. John’s wort ( Hypericum perforatum ). Side effects may occur with greater frequency.
Sumatriptan Bluefish may only be used if you have been diagnosed with “migraine” and other factors have been ruled out. Some forms of migraine cannot be treated with sumatriptan. If the headache is not at all similar to your usual headache, you should not take Sumatriptan Bluefish without first consulting a doctor.
When taking Sumatriptan Bluefish, you may sometimes briefly feel pain and pressure in your chest. This can be a relatively intense feeling that can radiate up to the throat. In very rare cases, this may be due to the heart being affected. If the symptoms do not go away, you must contact your doctor.
Overuse of Sumatriptan Bluefish can cause chronic, daily headaches or worsening headaches. Consult your doctor if this is right for you.
Other medicines and Sumatriptan Bluefish
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
An interaction means that different medicines used at the same time can affect each other’s effects and/or side effects. This may also affect medicines that you have taken or will take shortly.
This should be especially taken into account when using:
- medicines containing ergotamine (for migraines ) or other triptans. These must not be used at the same time as Sumatriptan Bluefish (see also “Do not use Sumatriptan Bluefish”). When you have taken medicines containing ergotamine or other triptans, it is inappropriate to take Sumatriptan Bluefish for 24 hours. After taking Sumatriptan Bluefish, it is inappropriate to take medicines containing ergotamine for 6 hours and at least 24 hours for medicines containing other triptans.
- MAO inhibitors (eg moclobemide for depression or selegiline for Parkinson’s disease ). Sumatriptan Bluefish must not be used for two weeks after you stop using MAO inhibitors.
- use of triptans together with selective serotonin reuptake inhibitors ( SSRIs ) and serotonin-norepinephrine reuptake inhibitors ( SNRIs ) may cause serotonin syndrome (a combination of symptoms that may include confusion, hallucination, restlessness, sweating and muscle cramps, and tremors). If you experience these symptoms, consult a doctor.
- there is a risk that the simultaneous use of sumatriptan with lithium (used in the treatment of manic-depressive (bipolar) disorder) may cause serotonin syndrome.
Please note that the above-mentioned medicines may have other names, for example, brand names. In this section, only the drug or the active substance of the drug group is stated and not the brand name. Always carefully check the active substance or the drug’s treatment group on the package and the information in the package leaflet of the drug you are already using.
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 taking this medicine.
Sumatriptan should only be used during pregnancy under the prescription of a doctor. Sumatriptan should only be used during pregnancy if the positive effects for the mother are greater than the potential risk to the fetus and no other forms of treatment are available.
Sumatriptan passes into breast milk. Avoid breastfeeding for 12 hours after taking Sumatriptan Bluefish 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
Drowsiness can occur as a result of migraines or due to treatment with Sumatriptan Bluefish. This may affect your ability to drive or 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 Bluefish contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 50 mg tablet, i.e. it is almost ‘sodium-free’.
How to take Sumatriptan Bluefish
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.
- The tablets should be swallowed whole with water as soon as possible after the first sign of a migraine attack, but can also be taken during an ongoing attack.
- Sumatriptan Bluefish 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 usual dose for adults is 1 tablet for migraine attacks. Maximum 2 tablets per day.
Use in children and adolescents:
Sumatriptan Bluefish is not suitable for children under 18 years of age.
Elderly (over 65 years)
Sumatriptan Bluefish is unsuitable for this age group.
Duration of treatment
You must not take a second dose for the same attack if the symptoms do not decrease after the first dose. In a subsequent attack, you can take Sumatriptan Bluefish again.
If symptoms subside after the first dose but then return, you can take a second dose within 24 hours provided you wait at least two hours between doses.
If the migraine symptoms are not relieved after the first tablet and the medicine does not have an effect, do not take additional tablets during the same migraine attack. The next time you get a migraine, you can try Sumatriptan Bluefish again.
The recommended dose must not be exceeded.
Sumatriptan Bluefish 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.
You must contact a doctor if symptoms worsen or do not improve within 3 days.
If you find that Sumatriptan Bluefish 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 Bluefish
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 forget to take Sumatriptan Bluefish
Do not take a double dose to make up for a missed dose.
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.
The most serious side effects: seek medical attention immediately.
The following side effects have occurred, but their exact frequency is unknown.
- Allergic/hypersensitivity reactions vary from skin reactions to rare cases of anaphylaxis (severe drop in blood pressure, pallor, restlessness, weak and rapid pulse, clammy skin, impaired consciousness).
- Vascular spasm (chest pain, often with exertion), heart attack or spasm in the blood vessels of the heart, temporary ischemic ECG changes. Chest pain or shortness of breath after taking Sumatriptan Bluefish.
- Spasms in the intestinal blood vessels can cause damage to the intestine. You may have stomach pains or bloody diarrhea.
If you get any of these symptoms after using Sumatriptan Bluefish, stop taking the medicine and see a doctor immediately.
Other side effects:
Common (may affect up to 1 in 10 users):
- Dizziness, drowsiness, heat, sensory disturbances
- Temporary increase in blood pressure early after treatment, flushing
- Shortness of breath
- Nausea. Vomiting
- Heaviness, tightness, pain, or pressure in any part of the body, including the neck or chest. Myalgia
- The sensation of pain, the sensation of heat and cold
- The feeling of weakness and fatigue
Very rare (may affect up to 1 in 10,000 users):
- Disturbances in liver function tests
Has been reported (occurring in an unknown number of users):
- Muscle tension
- Impaired vision, e.g. double vision, flickering vision, and sometimes loss of vision in case of permanent deterioration. However, the migraine attack itself can cause visual disturbances.
- Slow, fast, or irregular heart rate, palpitations.
- Decreased blood flow to the arms and legs causing white or blotchy fingers and toes.
- Vascular spasm (chest pain, often with exertion), heart attack or spasm in the blood vessels of the heart, temporary ischemic ECG changes. If you experience chest pain or breathing difficulties after taking Sumatriptan Bluefish, contact your doctor and do not take any more tablets.
- Drop in blood pressure
- Stiff neck
- Joint pain
- 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
If you experience side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this information.
How to store Sumatriptan Bluefish
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton after “Exp. dat.”. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use Sumatriptan Bluefish if you notice any visible signs of deterioration of the tablet.
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. One tablet contains 50 mg of sumatriptan.
- Other ingredients are croscarmellose sodium (E468), polysorbate 80 (E433), anhydrous calcium hydrogen phosphate (E450), microcrystalline cellulose (E460), sodium bicarbonate (E500), and magnesium stearate (E470b).
Appearance and package sizes of the medicine
Appearance: white, capsule-shaped, biconvex uncoated tablets with “C” debossed on one side and “33” on the other side.
Package size: 2 tablets in blister pack (over the counter).
Prescription pack sizes: 3, 4, 6, 8, 12, 18, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.