Package Leaflet: Information for the User
MIGTAN, 50 mg, coated tablets
MIGTAN, 100 mg, coated tablets
Sumatriptan
Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Contents of the Package Leaflet:
- 1. What MIGTAN is and what it is used for
- 2. Important information before taking MIGTAN
- 3. How to take MIGTAN
- 4. Possible side effects
- 5. How to store MIGTAN
- 6. Contents of the pack and other information
1. What MIGTAN is and what it is used for
MIGTAN belongs to a group of medicines called triptans, which are used to treat migraine headaches.
The symptoms of migraine can be caused by temporary widening of blood vessels in the head.
The medicine reduces the widening of blood vessels. This helps to relieve the headache and other symptoms of a migraine attack, such as feeling sick (nausea or vomiting) and being sensitive to light and sound.
The medicine only works after a migraine attack has started. It will not prevent a migraine attack from happening.
Do not use sumatriptan to prevent migraine attacks.
2. Important information before taking MIGTAN
When not to take MIGTAN:
Warnings and precautions
Before taking MIGTAN, discuss it with your doctor, pharmacist, or nurse.
Before taking MIGTAN, tell your doctor if:
This medicine should only be used in patients with a clear diagnosis of migraine and after other causes have been ruled out. Some types of migraine cannot be treated with sumatriptan.
After taking this medicine, you may feel tired or experience chest tightness for a short time.
These symptoms may be severe and radiate to the throat. Very rarely, this may be caused by the medicine affecting the heart. If these symptoms do not go away, tell your doctor.
MIGTAN with other medicines
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Interaction means that medicines taken at the same time can affect each other's action and/or side effects. The following notes may also apply to medicines you have taken in the past or plan to take in the future.
- Medicines containing ergotamine or other triptans. These medicines must not be taken at the same time as MIGTAN (see section "When not to take MIGTAN"). After taking ergotamine-containing medicines, wait at least 24 hours before taking MIGTAN. After taking MIGTAN, wait at least 6 hours before taking ergotamine-containing medicines and at least 24 hours before taking other triptans
- MAOIs (such as moclobemide for depression or selegiline for Parkinson's disease). Do not take MIGTAN for at least two weeks after stopping MAOIs
- Taking triptans with antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) may cause serotonin syndrome (a condition characterized by symptoms such as restlessness, confusion, sweating, hallucinations, rapid heart rate, and shivering). If you experience these symptoms, tell your doctor
- Taking sumatriptan and lithium (used to treat manic-depressive illness) may increase the risk of serotonin syndrome
Remember that the above medicines may be available under different names, often trade names. This section only lists the active substance or pharmacological group, not the trade name. Always carefully read the information on the active substance or therapeutic group provided on the packaging and in the leaflet of the medicines you are taking.
Pregnancy, breastfeeding, and fertility
- If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. There is limited experience with the use of sumatriptan during pregnancy, but no increased risk of birth defects has been seen. Your doctor will discuss with you whether you should take sumatriptan during pregnancy
- Do not breastfeed for 12 hours after taking MIGTAN. Do not give your baby breast milk for this period
Before taking any medicine, consult your doctor or pharmacist.
Driving and using machines
No studies have been conducted on the effects of sumatriptan on the ability to drive or operate machinery. Drowsiness caused by migraine or sumatriptan may occur. This may affect your ability to drive or operate machinery.
MIGTAN contains lactose
3. How to take MIGTAN
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose:
Adults:
The usual dose of MIGTAN is 50 mg, taken as a single dose. Some patients may need a 100 mg dose - follow your doctor's advice
Use in children (under 12 years) and adolescents (12-17 years):
Do not use this medicine in children and adolescents
Elderly (over 65 years):
Do not use this medicine in this age group
Method of administration:
Swallow the tablet (with water) as soon as possible after the migraine headache begins.
Do not chew or crush the tablets
Duration of treatment:
Do not take more than 300 mg of MIGTAN in 24 hours.
Do not exceed the recommended dose
Overdose of MIGTAN
Missed dose of MIGTAN
Do not take a double dose to make up for a forgotten dose
Stopping treatment with MIGTAN
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common(may affect up to 1 in 10 people):
- Dizziness, drowsiness, or feeling warm, tingling sensations
- Transient increases in blood pressure, occurring soon after administration, sudden flushing of the face
- Shortness of breath
- Nausea, vomiting
- Feeling of heaviness, pressure, pain, or tightness in any part of the body, including the throat and chest, muscle pain (myalgia)
- Pain, feeling of heat or cold
- Feeling of weakness (fatigue)
Uncommon(may affect up to 1 in 100 people):
- Drowsiness (somnolence)
- Rare(may affect up to 1 in 10,000 people):
- Abnormal liver function test results
Side effects with unknown frequency:
- Allergic reactions/hypersensitivity reactions - from skin reactions to rare anaphylactic reactions (sudden fall in blood pressure, pallor, agitation, weak and rapid pulse, sweating, confusion, and flushing). If you suspect that MIGTAN has caused an allergic reaction, stop taking the medicine and contact your doctor immediately.
- Seizures
- Tremors
- Abnormal movements or postures (dystonia)
- Visual disturbances, such as double vision, flickering, or loss of vision with permanent visual disturbance. Visual disturbances may also occur due to the migraine itself
- Slow heart rate, rapid heart rate, irregular heart rate, palpitations
- Reduced blood flow to the arms and legs, leading to pale or blue discoloration of fingers and toes
- Angina pectoris (chest pain often caused by exertion), heart attack, or coronary artery spasm. If you experience chest pain or shortness of breath after taking this medicine, contact your doctor and do not take any further doses of the medicine.
- Intestinal vasospasm, which may cause intestinal damage. Abdominal pain or bloody diarrhea may occur. If you experience these symptoms, contact your doctor and do not take any further doses of the medicine.
- Diarrhea
- Decreased blood pressure
- Stiff neck
- Joint pain
- Anxiety
- Excessive sweating
Reporting side effects
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine
5. How to store MIGTAN
Store in the original package to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment
6. Contents of the pack and other information
What MIGTAN contains
- The active substance is sumatriptan, in the form of sumatriptan succinate
- The other ingredients are: Tablet core: microcrystalline cellulose (Avicel PH 101), lactose monohydrate, maize starch, microcrystalline cellulose (Avicel PH 200), sodium croscarmellose, magnesium stearate. Tablet coating: hypromellose 15 cps, titanium dioxide (E 171), talc, macrogol 6000. Colorants: iron oxide red (E 172) and iron oxide yellow (E 172) only in 50 mg tablets
What MIGTAN looks like and contents of the pack
MIGTAN is available in two strengths: 50 mg and 100 mg.
MIGTAN, 50 mg: peach-colored, biconvex, film-coated tablets in capsule shape.
MIGTAN, 100 mg: white, biconvex, film-coated tablets in capsule shape.
MIGTAN, 50 mg and 100 mg are available in blisters containing 2, 4, or 6 film-coated tablets
Marketing authorization holder and manufacturer
Marketing authorization holder:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer:
Bausch Health Poland Sp. z o.o.,
ul. Przemysłowa 2,
35-959 Rzeszów, Poland
Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Mysłowice, Poland
PharmaS d.o.o.
Industrijska cesta 5
44317 Potok, Popovača
Croatia
Apotex Nederland B.V.
Archimedesweg 2
2333 CN Leiden
Netherlands
This medicine is authorized in the Member States of the European Economic Area under the following names:
Netherlands:
Sumatriptan Ipca 50mg filmomhulde tabletten
Sumatriptan Ipca 100mg filmomhulde tabletten
Poland:
MIGTAN, 50 mg, film-coated tablets
MIGTAN, 100 mg, film-coated tablets
Sweden:
Sumatriptan Punkt 50 mg filmdragerade tabletter
Germany:
Sumatriptan Hormosan 50mg Filmtabletten
Sumatriptan Hormosan 100mg Filmtabletten
Date of last revision of the leaflet: June 2024