Migtan

Package leaflet: Information for the user

MIGTAN, 50 mg, coated tablets
MIGTAN, 100 mg, coated tablets
Sumatriptanum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What MIGTAN is and what it is used for
2. What you need to know 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 headache.
Migraine symptoms may be caused by temporary dilation of blood vessels in the head.
This medicine reduces the dilation of blood vessels, thereby helping to relieve headache and other migraine symptoms such as discomfort (nausea or vomiting), and sensitivity to light and sound.
This medicine works only after a migraine attack has started. It does not prevent migraine attacks.
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 disorders of sugar intolerance (hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome)
• if the patient currently has or has ever had heart disease, including myocardial infarction, angina pectoris (chest pain during exertion), Prinzmetal's angina (chest pain at rest), or if the patient has ever experienced heart-related symptoms such as shortness of breath or chest tightness
• if the patient has circulation problems in the hands and feet (peripheral vascular disease)
• if the patient has had a stroke, also described as a "haemorrhagic stroke" or cerebrovascular accident (CVA)
• if the patient has experienced transient ischaemic attacks (TIA), i.e. temporary disturbances in blood supply to the brain causing minor or no lasting symptoms
• if the patient has hypertension
• if the patient has severe liver function disorders
• if the patient is taking medications containing ergotamine or ergotamine derivatives (anti-migraine drugs such as methysergide) or other triptans (5-hydroxytryptamine type 1 (5-HT₁) receptor agonists, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan). These medicines must not be used concomitantly with MIGTAN (see section "MIGTAN and other medicines")
• if the patient is currently taking monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide used in the treatment of depression or selegiline used in the treatment of Parkinson's disease). Sumatriptan must not be used within two weeks of stopping treatment with MAOIs (see also section "MIGTAN and other medicines").

If in doubt whether any of the above contraindications apply, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting MIGTAN, discuss it with your doctor, pharmacist, or nurse.

Before starting treatment with MIGTAN, inform your doctor if:

• the patient has diabetes, particularly relevant in postmenopausal women or men over 40 years of age. The doctor should examine the patient beforehand
• the patient is a habitual smoker or uses nicotine-containing products (patches or chewing gum), particularly relevant in men over 40 years of age or postmenopausal women. The doctor should examine the patient beforehand
• the patient has ever had a seizure (convulsion) or has predisposition to seizures (convulsions); sumatriptan may provoke a seizure. MIGTAN may increase the risk of seizures
• the patient has impaired liver or kidney function. The prescribing doctor may adjust the dose accordingly
• the patient is allergic (hypersensitive) to certain antibiotics (sulfonamides). Taking sumatriptan may cause an allergic reaction. Caution is advised
• the patient is using herbal products containing St John's wort (Hypericum perforatum). Adverse effects may occur more frequently.

If any of the above warnings apply, inform the doctor so that they can perform a thorough assessment of the patient's health status.

This medicine should only be used in patients with a clear diagnosis of migraine and after excluding other causes. Some forms of migraine cannot be treated with sumatriptan.

After taking this medicine, the patient may experience chest pain or tightness for a short period. These symptoms may be intense and radiate towards the throat. Very rarely, this may be due to the medicine's effect on the heart. Therefore, if these symptoms do not resolve, contact a doctor.

Overuse of this medicine may lead to chronic daily headache or worsening of headache. In such cases, consult a doctor. Discontinuation of treatment with this medicine may be necessary to improve the patient's condition.

MIGTAN and other medicines

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.

Drug interactions mean that medicines taken at the same time may affect each other's efficacy and/or adverse effects. The following notes may also apply to medicines the patient has taken at any time in the past or plans to take in the near future.

• Medicines containing ergotamine (anti-migraine drugs) or other triptans. These medicines must not be used simultaneously with 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 medicines containing other triptans.
• Monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide used in the treatment of depression or selegiline used in the treatment of Parkinson's disease). MIGTAN must not be taken within two weeks after stopping treatment with MAOIs.
• Concurrent use of triptans with antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) may lead to serotonin syndrome (a group of symptoms such as agitation, confusion, profuse sweating, hallucinations, increased reflexes, muscle spasms, shivering, rapid heartbeat, and tremor). If these symptoms occur, the patient should inform their doctor.
• Concurrent use of sumatriptan and lithium (used in the treatment of bipolar disorder) increases the risk of serotonin syndrome.

Note that the medicines listed above may be marketed under different names, often brand names. Only the active substance name or pharmacological group is mentioned in this section, not the brand name. Always carefully read the information on the active substance or therapeutic group provided on the packaging and in the leaflet of any medicines being used.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before taking this medicine. Data on the safety of sumatriptan use during pregnancy are limited; however, no increased frequency of congenital malformations in children has been observed so far. The treating doctor will discuss with the patient whether she should use MIGTAN during pregnancy.
• Breastfeeding is not recommended for 12 hours after taking MIGTAN. Do not feed the infant with milk expressed during this period.
• Some breastfeeding women have reported breast and/or nipple pain after using sumatriptan. The pain is usually transient and resolves within 3 to 12 hours.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

No studies on the effect of sumatriptan on the ability to drive or operate machinery have been conducted. Drowsiness may occur due to migraine or treatment with sumatriptan. This may affect the ability to drive or operate machinery.

MIGTAN contains lactose

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

3. How to take MIGTAN

This medicine should always be taken as directed by a physician or pharmacist.
If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults:
The usual dose of MIGTAN is 50 mg taken once. In some patients, a dose of 100 mg may be required – follow the doctor's instructions.
Use in children (under 12 years of age) and adolescents (12 to 17 years of age):
Use of this medicine is not recommended in children and adolescents.
Elderly persons (over 65 years of age):
Use of this medicine is not recommended in this age group.
Method of administration:
Swallow the tablet whole (with water) as soon as possible after the onset of a migraine attack.
Do not chew or crush the tablets.
Timing of administration:
If symptoms do not improve after the first dose, do not take a second dose during the same migraine attack. If another attack occurs, MIGTAN may be taken again.
If symptoms initially subside after the first dose but return later, a second dose may be taken within 24 hours, but not earlier than 2 hours after the first dose.
Do not take more than 300 mg of MIGTAN within 24 hours.
Do not exceed the recommended dose.
Taking more than the recommended dose of MIGTAN
If more than the recommended dose of MIGTAN has been taken, contact a doctor or pharmacist immediately.
Adverse reactions listed in section "Possible side effects" may occur.
Missed dose of MIGTAN
Do not take a double dose to make up for a missed dose.
Discontinuation of MIGTAN
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Common (may affect up to 1 in 10 people):

• Dizziness, drowsiness or feeling of warmth, sensory disturbances
• Transient increase in blood pressure occurring shortly after taking the medicine, sudden flushing of the face
• Shortness of breath
• Nausea, vomiting
• Feeling of heaviness, tightness, pain or pressure in any part of the body, including 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 1,000 people):

• Chest pain

Very rare (may affect up to 1 in 10,000 people):

• Abnormal liver function test results

Adverse reactions with unknown frequency:

• Allergic reactions/hypersensitivity reactions – from skin reactions to rarely occurring anaphylactic reaction (sudden drop in blood pressure, pale skin, restlessness, weak and rapid pulse, moist skin, disturbances of consciousness). If you suspect that MIGTAN is causing an allergic reaction, you must stop taking the medicine and contact your doctor immediately.
• Seizures
• Tremor
• Movement disorders involving abnormal movements or assuming abnormal body positions (dystonia)
• Visual disturbances, e.g. double vision, flickering, sometimes loss of vision with persistent visual impairment. Visual disturbances may also occur as a result of migraine attack itself.
• Slow heartbeat, rapid heartbeat, irregular heartbeat, palpitations
• Reduced blood flow to upper and lower limbs, leading to paleness or blueness of fingers and toes
• Angina pectoris (chest pain often provoked by exertion), myocardial infarction, or spasm of blood vessels of the heart, transient ischaemic changes on ECG. If chest pain or shortness of breath occurs after taking this medicine, you should contact your doctor and must not take further doses of the medicine.
• Spasm of intestinal blood vessels, which may cause intestinal damage. Abdominal pain or bloody diarrhoea may occur. If these symptoms occur, you should contact your doctor and must not take further doses of this medicine.
• Diarrhoea
• Decreased blood pressure
• Neck stiffness
• Joint pain
• Anxiety
• Excessive sweating

Not known: frequency cannot be estimated from the available data:

• In patients who have recently suffered trauma or who have an inflammatory condition (such as rheumatism or inflammatory bowel disease), pain or worsening of pain at the site of injury or inflammation may occur
• Difficulty swallowing

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store MIGTAN

Keep in the original packaging to protect from light.
Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package 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, pregelatinized maize starch, microcrystalline cellulose (Avicel PH 200), sodium croscarmellose, magnesium stearate.
  Tablet coating: hypromellose 15 cps, titanium dioxide (E 171), talc, polyethylene glycol 6000.
  Colourants: 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-coloured, biconvex, film-coated tablets, capsule-shaped.
MIGTAN 100 mg: white, biconvex, film-coated tablets, capsule-shaped.
MIGTAN 50 mg and 100 mg tablets are available in blisters containing 2, 4 or 6 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturers:
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

This medicinal product is authorised in 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