Imigran

Package Leaflet: Information for the User

Imigran, 50 mg, coated tablets

Imigran, 100 mg, coated tablets

Sumatriptan

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

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor.
• 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 package leaflet, they should tell their doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What Imigran is and what it is used for
• 2. Important information before taking Imigran
• 3. How to take Imigran
• 4. Possible side effects
• 5. How to store Imigran
• 6. Package contents and other information

1. What Imigran is and what it is used for

Imigran is used for the acute treatment of migraine attacks with or without aura. Imigran should only be taken after the onset of migraine symptoms. It should not be taken as a preventive measure.

2. Important information before taking Imigran

When not to take Imigran

• if the patient is allergic (hypersensitive) to sumatriptan or any of the other ingredients of this medicine (listed in section 6),
• if the patient has: symptoms of ischemic heart disease, Prinzmetal's angina (a type of ischemic heart disease), peripheral vascular disease, a history of myocardial infarction, stroke, or transient cerebral ischemic attack,
• if the patient has severe liver impairment,
• if the patient has moderate or severe hypertension or uncontrolled mild hypertension,
• if the patient is taking ergotamine or its derivatives, including methysergide (vasoconstrictor medicines used to treat migraine), or any other triptan or 5-HT receptor agonist (medicines used to treat migraine),
• if the patient is taking or has taken within the last 2 weeks monoamine oxidase inhibitor (MAOI) antidepressants (medicines used to treat depression and other mental health conditions).

Warnings and precautions

Before starting treatment with Imigran, the patient should tell their doctor if they have:

• headache, but migraine has not been previously diagnosed,
• headache that is different from the usual migraine headache,
• shortness of breath, pain, or feeling of pressure in the chest (which may radiate to the jaw or arms) of unknown cause,
• heart disease risk factors (men over 40, postmenopausal women, overweight, diabetes, high cholesterol, smokers, family history of heart disease),
• liver or kidney function disorders,
• history of seizures or predisposition to seizures,
• allergy to sulfonamide medicines, as sumatriptan may cause allergic reactions ranging from skin changes to anaphylactic shock,
• mild controlled hypertension, as a transient increase in blood pressure and peripheral vascular resistance may occur.

During concomitant use of sumatriptan and selective serotonin reuptake inhibitors (SSRIs) (antidepressants), serotonin syndrome has been rarely reported, including changes in mental status, autonomic dysfunction (symptoms related to abnormal functioning of the part of the nervous system responsible for involuntary functions, such as gastrointestinal and circulatory disorders, excessive sweating, and excessive salivation), and neuromuscular dysfunction. Serotonin syndrome has also been reported during concomitant use of triptans and SSRIs or serotonin-norepinephrine reuptake inhibitors (SNRIs) (antidepressants). If concomitant treatment with sumatriptan and an SSRI or SNRI is clinically justified, the patient should be under medical supervision.

Children and adolescents

Imigran is not recommended for use in children and adolescents.

Elderly patients

Imigran is not recommended for use in elderly patients (over 65 years of age).

Imigran and other medicines

The patient should tell their doctor about all medicines they are currently taking or plan to take.

After taking Imigran, the patient should not take any ergotamine or its derivatives for 6 hours, and any triptans or 5-HT receptor agonists for 24 hours. After taking any ergotamine or its derivatives, or any other triptan or 5-HT receptor agonist, the patient should not take Imigran for at least 24 hours.

The patient should not take Imigran with MAOIs or within 2 weeks of stopping treatment with MAOIs.

During concomitant use of sumatriptan and St. John's Wort (Hypericum perforatum) products, side effects may occur more frequently.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Sumatriptan passes into breast milk. Therefore, during the 12 hours after taking Imigran, breastfeeding should be avoided.

Driving and using machines

Due to migraine or after taking Imigran, drowsiness may occur. In such cases, the patient should not drive or operate machinery.

Imigran contains lactose

Imigran 50 mg coated tablets contain 70 mg of lactose monohydrate and 140 mg of lactose anhydrous per tablet.

Imigran 100 mg coated tablets contain 140 mg of lactose monohydrate per tablet.

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

Imigran contains sodium

Imigran 50 mg and 100 mg coated tablets contain less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Imigran

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.

Imigran should only be taken after the onset of migraine symptoms, not as a preventive measure. The tablets should be swallowed whole with water.

The patient should not take more than the recommended dose.

The usual dose of Imigran is 50 mg, taken as soon as possible after the first symptoms of migraine appear. However, the medicine is equally effective when taken at any stage of the migraine attack. Some patients may require a 100 mg dose - they should follow their doctor's advice.

If the migraine symptoms do not improve after taking the first dose, taking a second dose during the same attack is not recommended. In such cases, the patient can take paracetamol, acetylsalicylic acid, or another non-steroidal anti-inflammatory drug (NSAID).

If the migraine symptoms recur, the patient can take another dose of Imigran, but not earlier than 2 hours after the first dose.

The patient should not take more than 300 mg in 24 hours.

Overdose of Imigran

In case of overdose, the patient should immediately consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Imigran can cause side effects, although not everybody gets them.

Common side effects

May affect up to 1 in 10 people taking Imigran:

pain, numbness, tingling, heat, or cold sensation, heaviness, tension in various parts of the body, including the chest and throat.

These symptoms may be severe but are usually transient and short-lived. If the symptoms persist and worsen, the patient should immediately consult their doctor. The patient should not take another dose of Imigran before consulting their doctor.

Other common side effects may include:

dizziness

fatigue

drowsiness

weakness

transient increase in blood pressure shortly after administration

flushing

shortness of breath

nausea and vomiting

muscle pain

Very rare side effects

May affect up to 1 in 10,000 people taking Imigran:

liver function changes (if liver function tests are performed, the doctor should be informed about Imigran use, as it may affect the test results).

Side effects with unknown frequency

Frequency cannot be estimated from the available data:

In case of any of the following symptoms, the patient should stop taking Imigran and consult their doctor immediately:

severe chest pain radiating to the jaw and arms

sudden wheezing or chest tightness

swelling of the eyelids, face, or lips

anaphylactic shock (blood pressure drop, weakness, fainting)

seizures

rash with red spots or hives

abdominal pain and/or intense rectal bleeding.

Other side effects with unknown frequency may include:

tremor

dystonia (muscle tone disorder)

visual disturbances such as nystagmus, scotoma, flickering lights, double vision, changes in the visual field, loss of vision, including permanent vision loss (visual disturbances may be a component of migraine)

slow or rapid heart rate or feeling of irregular or forceful heartbeat

hypotension (excessive decrease in blood pressure)

change in normal finger or toe color

joint pain

stiff neck

excessive sweating

diarrhea

in patients who have recently had trauma or have an inflammatory condition (such as rheumatism or colitis), pain or worsening of pain at the site of trauma or inflammation may occur

difficulty swallowing

feeling of anxiety

In case of the above symptoms, there is no need to stop taking Imigran, but the patient should inform their doctor during the next visit. In case of persistent finger or toe discoloration, the patient should stop taking Imigran and consult their doctor immediately.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the package leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can also be reported to the marketing authorization holder.

5. How to store Imigran

The medicine should be stored out of sight and reach of children.

Store in a temperature below 30°C.

Do not use this medicine after the expiry date stated on the package after EXP.

The expiry date refers to the last day of the month.

The batch number is stated on the package as "Lot".

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Imigran contains

• The active substance is sumatriptan in the form of sumatriptan succinate. Each coated tablet contains 50 mg or 100 mg of sumatriptan in the form of sumatriptan succinate.
• The other ingredients are: Imigran 50 mg coated tablets: lactose monohydrate, lactose anhydrous, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Coating: Opadry Pink YS-1-1441-G (hypromellose, titanium dioxide (E171), triacetin, iron oxide red (E172)). Imigran 100 mg coated tablets: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Coating: Opadry White OY-S-7393 or hypromellose, Opaspray White M-1-7120

What Imigran looks like and contents of the package

Imigran 50 mg coated tablets: pink, biconvex, film-coated tablets in the shape of a capsule.

Imigran 100 mg coated tablets: white to off-white, biconvex, film-coated tablets in the shape of a capsule.

The package contains:

2 tablets - 1 blister pack of 2 tablets

6 tablets - 1 blister pack of 6 tablets

6 tablets - 3 blister packs of 2 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

D24 YK11

Ireland

Manufacturer

Delpharm Poznań Spółka Akcyjna

ul. Grunwaldzka 189

60-322 Poznań

To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:

GSK Services Sp. z o.o.

ul. Rzymowskiego 53

02-697 Warsaw

tel. +48 22 576 90 00

Date of last revision of the package leaflet:January 2025