Package leaflet: Information for the user

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

Keep this leaflet for future reference.
If you have any questions, consult your doctor.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are similar.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Imigran is and what it is used for
Important information before taking Imigran
How to take Imigran
Possible side effects
How to store Imigran
Contents of the pack 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 be taken only after the onset of migraine attack symptoms. It should not be used prophylactically.

2. Important information before using Imigran

When not to use 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 ischaemic heart disease, Prinzmetal's angina (a type of ischaemic heart disease), peripheral vascular disease, history of myocardial infarction, stroke or transient ischaemic attack,
if the patient has been diagnosed with severe hepatic insufficiency,
if the patient has been diagnosed with moderate or severe arterial hypertension or mild uncontrolled hypertension,
if the patient is currently taking medicines containing ergotamine or its derivatives, including methysergide (vasoconstrictive medicines used, among others, in the treatment of migraine) or any other medicine from the group of triptans or other 5-HT receptor agonists (medicines used in the treatment of migraine),
if the patient is taking or has taken within the previous 2 weeks antidepressant medicines from the group of MAO inhibitors (medicines used in neurological disorders, mainly in the treatment of depression).

Warnings and precautions
Before starting treatment with Imigran, inform your doctor if the patient has:

headache, but migraine has not previously been diagnosed,
headache different from the usual migraine attack,
shortness of breath, chest pain or pressure (which may radiate to the jaw or shoulders) of unknown cause,
risk factors for heart disease (men over 40 years of age, postmenopausal women, overweight individuals, diabetes, high cholesterol levels, smokers, family history of heart disease),
impaired liver or kidney function,
history of seizures or increased susceptibility to their occurrence,
allergy to sulphonamide drugs, as after administration of sumatriptan, there is a possibility of allergic reactions of varying severity: from skin rashes to anaphylactic shock,
mild controlled hypertension, as transient increase in blood pressure and peripheral vascular resistance may occur.

Rare cases of serotonin syndrome have been reported when sumatriptan was used concomitantly with selective serotonin reuptake inhibitors (medicines used in the treatment of depression), including changes in mental status, autonomic disturbances (symptoms related to abnormal functioning of the part of the nervous system responsible for involuntary bodily functions, e.g. gastrointestinal disturbances, circulatory disorders, excessive sweating, hypersalivation) and neuromuscular disturbances. Serotonin syndrome has also been reported with concomitant use of triptans and serotonin-norepinephrine reuptake inhibitors. If concomitant treatment with sumatriptan and a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor (medicines used in the treatment of depression) is clinically justified, the patient should remain under medical supervision.
When sumatriptan is used concomitantly with products containing St. John's wort (Hypericum perforatum), adverse reactions may occur more frequently.
Overuse of medications for acute treatment of migraine attacks, including triptans and analgesics, may be associated with increased frequency or severity of headaches in susceptible patients (medication-overuse headache - MOH). In any patient experiencing increased frequency or severity of migraine during treatment, the physician should consider the diagnosis of medication-overuse headache. In such patients, discontinuation of treatment may be necessary.

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
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
After administration of Imigran, no medicines containing ergotamine or its derivatives should be used for 6 hours, and no medicines from the triptan group or other 5-HT receptor agonists for 24 hours. Conversely, after taking any medicine containing ergotamine, another triptan or other 5-HT receptor agonist, Imigran must not be used for at least 24 hours.
Imigran should not be used concomitantly with MAO inhibitors or within two weeks after discontinuation of such medicines.
When sumatriptan is used concomitantly with products containing St. John's wort (Hypericum perforatum), adverse reactions may occur more frequently.
Rare cases of serotonin syndrome (including changes in mental status, autonomic disturbances and neuromuscular disturbances) have been reported during concomitant use of sumatriptan and selective serotonin reuptake inhibitors. Serotonin syndrome has also been reported during concomitant use of triptans and serotonin-norepinephrine reuptake inhibitors (see: Warnings and precautions).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Sumatriptan passes into breast milk. Therefore, breastfeeding should be avoided for 12 hours after taking Imigran.
Some breastfeeding women have reported breast pain and/or nipple pain after taking sumatriptan. The pain is usually transient and resolves within 3 to 12 hours.

Driving and operating machinery
Somnolence may occur as a result of a migraine attack or after taking Imigran. In such cases, driving vehicles or operating machinery should be avoided.

Imigran contains lactose
Imigran 50 mg film-coated tablets contain 70 mg of monohydrate lactose and 140 mg of anhydrous lactose per tablet.
Imigran 100 mg film-coated tablets contain 140 mg of monohydrate lactose per tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

3. How to use Imigran

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult the doctor or pharmacist.
Imigran should be used only after the onset of migraine attack symptoms; it should not be used preventively. Tablets should be swallowed whole with water.
Do 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 administered at any stage of the headache attack. Some patients may require a dose of 100 mg – follow the doctor's instructions.
If migraine symptoms do not subside after the first dose, taking a second dose during the same attack is not recommended. In such a case, treatment with paracetamol, acetylsalicylic acid, or another non-steroidal anti-inflammatory drug may be used.
If symptoms recur, further doses of Imigran may be taken, but not earlier than two hours after the first dose.
Do not exceed 300 mg within 24 hours.
Taking a higher than recommended dose of Imigran
If an overdose is taken, contact a doctor or pharmacist immediately.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Common adverse reactions
May occur in 1 to 10 out of 100 patients taking Imigran:
pain, numbness, tingling, heaviness, warmth or cold sensations, tightness, or pressure in various parts of the body, including the chest and throat.
These symptoms may be intense but are transient and usually short-lived. If symptoms persist or worsen, contact your doctor immediately. Do not take further doses of Imigran before consulting your doctor.

Other common adverse reactions may also occur:
dizziness
fatigue
drowsiness
weakness
transient increase in blood pressure shortly after administration of the medicine
skin flushing
shortness of breath
nausea and vomiting
muscle pain

Rare adverse reactions
May occur less frequently than in 1 out of 1,000 patients taking Imigran:
chest pain

Very rare adverse reactions
May occur less frequently than in 1 out of 10,000 patients taking Imigran:
liver function abnormalities (if liver function tests are performed, inform the doctor that you are taking Imigran, as it may affect test results).

Adverse reactions with unknown frequency
Frequency cannot be estimated from available data:
If any of the following symptoms occur, stop using the medicine immediately and contact your doctor:
very severe chest pain radiating to the jaw and upper limbs
sudden wheezing or chest tightness
swelling of the eyelids, face, or lips
anaphylactic shock (drop in blood pressure, weakness, fainting)
seizures
rash with red spots or hives
abdominal pain in the lower part of the abdomen and (or) intense rectal bleeding

Other adverse reactions with unknown frequency may also occur:
tremor
dystonia (abnormal muscle tone)
visual disturbances such as nystagmus, scotoma, flickering lights, double vision, changes in visual field, vision loss, including permanent visual defects (visual disturbances may be part of a migraine attack)
slowed or rapid heartbeat or sensation of irregular and (or) forceful heartbeat
hypotension (excessive lowering of blood pressure)
changes in normal skin color of fingers and toes
joint pain
neck stiffness
excessive sweating
diarrhea
in patients who have recently experienced trauma or who 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
feelings of anxiety

If any of the above symptoms occur, there is no need to discontinue the medicine immediately; however, inform your doctor during your next visit. If persistent bluish discoloration of the hands or feet occurs, discontinue the medicine and contact your doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Imigran

Keep the medicine out of sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month. The abbreviation 'Lot' on the packaging
indicates the batch number.
Medicines must 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 Imigran contains

The active substance is sumatriptan in the form of sumatriptan succinate. Each coated tablet contains 50 mg or 100 mg of sumatriptan as sumatriptan succinate.
The other ingredients are:

Imigran 50 mg coated tablets: monohydrate lactose, anhydrous lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
Coating composition: Opadry Pink YS-1-1441-G (hypromellose, titanium dioxide (E171), triacetin, red iron oxide (E172)).
Imigran 100 mg coated tablets: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
Coating composition: 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, capsule-shaped, biconvex coated tablets.
Imigran 100 mg coated tablets: white to off-white, capsule-shaped, biconvex coated tablets.
Pack contents:
2 tablets – 1 blister containing 2 tablets
6 tablets – 1 blister containing 6 tablets
6 tablets – 3 blisters containing 2 tablets each.
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
Poland

For further information, contact the representative of the Marketing Authorization Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
tel. + 48 22 576 90 00