Migtan

Leaflet accompanying the packaging: information for the user

MIGTAN, 50 mg, coated tablets
MIGTAN, 100 mg, coated tablets
Sumatriptan

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is MIGTAN and what is it 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 is MIGTAN and what is it 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 blood vessel dilation in the head.
The medicine reduces blood vessel dilation. This helps to relieve headache and other symptoms of a migraine attack, such as nausea or vomiting, and sensitivity to light and sound.
The medicine only works after a migraine attack has started. It will not prevent a migraine attack from occurring.
Sumatriptan should not be used to prevent migraine attacks.

2. Important information before taking MIGTAN

When not to take MIGTAN:

• if the patient is allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6)
• if the patient has intolerance to certain sugars (hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency)
• if the patient currently has or has had heart disease, including heart attack, angina pectoris (chest pain during exertion), or Prinzmetal's angina (chest pain at rest), or if the patient has had symptoms related to the heart, such as shortness of breath or chest tightness

if the patient has problems with blood circulation in the hands and feet (peripheral vascular disease)

• if the patient has had a stroke or transient ischaemic attack (TIA)
• if the patient has high blood pressure
• if the patient has severe liver function impairment
• if the patient is taking medicines containing ergotamine or ergotamine derivatives (migraine medicines such as methysergide) or other triptans (5-HT1 receptor agonists such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan, etc.). These medicines should not be taken at the same time as MIGTAN (see section "MIGTAN and other medicines")
• if the patient is taking monoamine oxidase inhibitors (MAOIs) (e.g., moclobemide used to treat depression or selegiline used to treat Parkinson's disease). Sumatriptan should not be taken within two weeks of stopping MAOIs (see also section "MIGTAN and other medicines")

In case of doubt whether the above contraindications apply to the patient, the patient should consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting to take MIGTAN, the patient should discuss it with their doctor, pharmacist, or nurse.
Before starting to take MIGTAN, the patient should tell their doctor if:

• the patient has diabetes, especially if they are a postmenopausal woman or a man over 40 years old. The doctor should examine the patient beforehand
• the patient is a heavy smoker or uses nicotine products (patches or chewing gum). This is especially important for men over 40 years old or postmenopausal women. The doctor should examine the patient beforehand
• the patient has had a seizure (convulsion) or has a history of seizure disorders; sumatriptan may cause seizures
• the patient has liver or kidney function impairment. The doctor may need to adjust the dose of the medicine
• the patient is allergic to certain antibiotics (sulfonamides). Taking sumatriptan may cause an allergic reaction. Caution is advised
• the patient is taking herbal products containing St. John's Wort (Hypericum perforatum). Adverse reactions may occur more frequently

If any of the above warnings apply to the patient, they should inform their doctor so that the doctor can assess their health condition.
This medicine should only be used in patients with a clear diagnosis of migraine and after other factors have been ruled out.
After taking this medicine, the patient may feel sleepy for a short time.
This may affect their ability to drive or use machines.

MIGTAN and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Interactions can occur when medicines are taken at the same time, affecting each other's action and/or side effects. The following notes may also apply to medicines taken in the past or planned to be taken in the near future.

• Medicines containing ergotamine (migraine medicines) or other triptans. These medicines should not be taken at the same time as MIGTAN (see section "When not to take MIGTAN"). After taking ergotamine-containing medicines, the patient should wait at least 24 hours before taking MIGTAN. After taking MIGTAN, the patient should wait at least 6 hours before taking ergotamine-containing medicines and at least 24 hours before taking other triptans.
• Monoamine oxidase inhibitors (MAOIs) (e.g., moclobemide used to treat depression or selegiline used to treat Parkinson's disease). MIGTAN should not be taken within two weeks of stopping MAOIs.
• Taking triptans with antidepressant medicines such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs) may cause serotonin syndrome (a condition characterized by symptoms such as agitation, confusion, sweating, hallucinations, increased reflexes, muscle rigidity, shivering, rapid heartbeat, and tremors). If the patient experiences these symptoms, they should inform their doctor.
• Taking sumatriptan and lithium (used to treat manic-depressive illness) may increase the risk of serotonin syndrome.

The patient should remember that the above-mentioned medicines may be available under different names, often trade names. This section only mentions the active substance or pharmacological group of the medicine, not its trade name. The patient should always carefully read the information about the active substance or therapeutic group provided on the packaging and in the leaflet of the medicines they are taking.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine. There is limited data on the safety of sumatriptan during pregnancy, but no increased risk of congenital abnormalities has been found. The doctor will discuss with the patient whether they should take sumatriptan during pregnancy.
• Breastfeeding is not recommended for 12 hours after taking MIGTAN.The patient should not breastfeed their child with milk expressed during this time.

Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

No studies have been conducted on the effects of sumatriptan on the ability to drive or use machines. Drowsiness caused by migraine or sumatriptan treatment may occur. This may affect the ability to drive or use machines.

MIGTAN contains lactose

If the patient has been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take MIGTAN

This medicine should always be taken exactly as advised by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Recommended dose:

Adults:

The usual dose of MIGTAN is 50 mg taken as a single dose. In some patients, a dose of 100 mg may be necessary – the patient should follow the doctor's advice.

Use in children (under 12 years) and adolescents (12-17 years):

This medicine is not recommended for use in children and adolescents.

Elderly patients (over 65 years):

This medicine is not recommended for use in this age group.

Method of administration:

The patient should swallow the tablet (with water) as soon as possible after the migraine attack has started.
The patient should not chew or crush the tablets.

Duration of treatment:

If the symptoms do not improve after the first dose, the patient should not take a second dose during the same attack. If the patient has another attack, they can take MIGTAN again.
If the symptoms improve after the first dose but then return, the patient can take a second dose of MIGTAN within 24 hours, provided that at least 2 hours have passed since the first dose.
The patient should not take more than 300 mg of MIGTAN in 24 hours.
The patient should not exceed the recommended dose.

Taking more than the recommended dose of MIGTAN

In case of overdose, the patient should contact their doctor or pharmacist immediately. Adverse reactions listed in section "Possible side effects" may occur.

Missing a dose of MIGTAN

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with MIGTAN

In case of further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

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 of warmth, sensation disturbances.
• Transient increase in blood pressure, occurring soon after taking the medicine, 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 drop in blood pressure, pallor, agitation, weak and rapid pulse, sweaty skin, impaired consciousness). If the patient suspects that MIGTAN has caused an allergic reaction, they should stop taking the medicine and contact their doctor immediately.
• Seizures.
• Tremors.
• Movement disorders characterized by abnormal movements or postures (dystonia).
• Visual disturbances, such as double vision, flickering, or loss of vision with permanent visual impairment. Visual disturbances may also occur due to the migraine attack itself.
• Slow heartbeat, rapid heartbeat, irregular heartbeat, palpitations.
• Reduced blood flow to the arms and legs, leading to pale or blue discoloration of the fingers and toes.
• Angina pectoris (chest pain often caused by exertion), heart attack, or coronary vasospasm. If the patient experiences chest pain or shortness of breath after taking this medicine, they should contact their doctor and not take further doses of the medicine.
• Intestinal vasospasm, which may cause intestinal damage. Abdominal pain or bloody diarrhea may occur. If the patient experiences these symptoms, they should contact their doctor and not take further doses of the medicine.
• Diarrhea.
• Decreased blood pressure.
• Stiffness of the neck.
• Joint pain.
• Anxiety.
• Excessive sweating.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
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 packaging 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What MIGTAN contains

• The active substance of the medicine 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 the shape of capsules.
MIGTAN, 100 mg: white, biconvex, film-coated tablets in the shape of capsules.
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