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 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 leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Imigran and what is it used for

Imigran is used for the acute treatment of migraine attacks with or without aura. Imigran should only be taken after the symptoms of a migraine attack have appeared. It should not be taken preventively.

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 been diagnosed with: symptoms of ischemic heart disease, Prinzmetal's angina (a type of ischemic heart disease), peripheral vascular disease, previous 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 in the treatment of migraine) or any other triptan or 5-HT receptor agonist (medicines used in the treatment of migraine),
• if the patient is taking or has taken in the last 2 weeks monoamine oxidase inhibitors (MAOIs) (medicines used in the treatment of depression).

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 in the patient,
• 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 shoulders) for no known reason,
• heart disease risk factors (men over 40 years old, postmenopausal women, overweight people, diabetics, high cholesterol levels, smokers, family history of heart disease),
• liver or kidney function disorders,
• history of seizures or predisposition to seizures,
• allergy to sulfonamide medicines, as there is a possibility of allergic reactions to sumatriptan, 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) (medicines used in the treatment of depression), serotonin syndrome has been rarely reported, including changes in mental status, autonomic dysfunction (disorders related to the part of the nervous system that controls involuntary functions, such as gastrointestinal and circulatory disorders, excessive sweating, and salivation), and neuromuscular dysfunction. Serotonin syndrome has also been reported during concomitant use of triptans and SSRIs or serotonin-norepinephrine reuptake inhibitors (SNRIs) (medicines used in the treatment of depression). If concomitant treatment with sumatriptan and an SSRI or SNRI is clinically justified, the patient should be under medical supervision.

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

Overuse of medicines for the acute treatment of migraine attacks, including triptans and painkillers, may be associated with worsening of headaches in sensitive patients (medication overuse headache, MOH). In every patient who experiences an increase in frequency or severity of migraine during treatment, the doctor should consider the diagnosis of medication overuse headache. In these patients, it may be necessary to discontinue treatment.

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 old).

Imigran and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they 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.

Imigran should not be taken concomitantly with MAOIs or within 2 weeks of discontinuing treatment with MAOIs.

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

During concomitant use of sumatriptan and SSRIs, serotonin syndrome has been rarely reported (including changes in mental status, autonomic dysfunction, and neuromuscular dysfunction). Serotonin syndrome has also been reported during concomitant use of triptans and SSRIs or SNRIs (see Warnings and precautions).

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 a migraine attack 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 anhydrous lactose 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. In case of doubts, the patient should consult their doctor or pharmacist.

Imigran should only be taken after the symptoms of a migraine attack have appeared, and not preventively. The tablets should be swallowed whole with water.

The patient should not take a higher dose than recommended.

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 headache. Some patients may require a 100 mg dose - they should follow their doctor's advice.

If the symptoms of a migraine attack 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 medicine.

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

Within 24 hours, the patient should not take a dose higher than 300 mg.

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, sensation of heat or cold, 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 (in case of liver function tests, the patient should inform their doctor about taking Imigran, 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 immediately stop taking the medicine and consult their doctor:

very severe chest pain radiating to the jaw and arms

sudden wheezing or tightness in the chest

swelling of the eyelids, face, or lips

anaphylactic shock (drop in blood pressure, 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 visual field defects (visual disturbances may be a component of a migraine attack)

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

hypotension (excessive decrease in blood pressure)

change in normal skin color of fingers and toes

joint pain

stiffness of the neck

excessive sweating

diarrhea

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

difficulty swallowing

feeling of anxiety

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

Reporting side effects

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

By reporting side effects, it is possible to gather more information on the safety of the medicine.

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 packaging after EXP.

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

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

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

6. Contents of the pack and other information

What Imigran contains

• The active substance of Imigran 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 of the medicine 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 pack

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 pack 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 leaflet:January 2025