Imigran Fdt

Package Leaflet: Information for the User

Imigran FDT, 50 mg, coated tablets / oral suspension tablets

Imigran FDT, 100 mg, coated tablets / oral suspension 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Imigran FDT and what is it used for

Imigran FDT contains the active substance sumatriptan. Sumatriptan acts on specific receptors in blood vessels in the area supplied by the carotid artery, selectively constricting these vessels. Sumatriptan also inhibits the activity of the trigeminal nerve. Both mechanisms are responsible for the anti-migraine effect of the medicine.
Imigran FDT is used to treat migraine attacks with or without aura. Imigran FDT should only be used after the onset of migraine attack symptoms. It should not be used as a preventive measure.

2. Important information before taking Imigran FDT

When not to take Imigran FDT

• if you are allergic (hypersensitive) to sumatriptan or any of the other ingredients of this medicine (listed in section 6).
• if you have been diagnosed with: symptoms of coronary heart disease, Prinzmetal's angina (a type of coronary heart disease), peripheral vascular disease, previous myocardial infarction, stroke, or transient cerebral ischemic attack,
• if you have severe liver impairment,
• if you have moderate or severe hypertension or uncontrolled mild hypertension,
• if you are taking ergotamine or its derivatives, including methysergide (vasoconstrictor medicines used, among others, to treat migraines) or any other triptan or 5-HT receptor agonist (medicines used to treat migraines),
• if you are taking or have taken monoamine oxidase inhibitors (MAOIs) (medicines used to treat nervous system diseases, mainly depression) within the last 2 weeks.

Warnings and precautions

Before starting treatment with Imigran FDT, tell your doctor if you have:
headache, but migraine has not been previously diagnosed in you,
headache that is different from the one that usually occurs during a migraine attack,
shortness of breath, pain, or feeling of pressure in the chest (which may radiate to the jaw or shoulders) of unknown cause,
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 of varying severity after sumatriptan administration: 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 (medicines used to treat depression), serotonin syndrome has been rarely reported, including changes in mental state, autonomic disorders (disorders related to the malfunction of the part of the nervous system responsible for involuntary functions, e.g., gastrointestinal disorders, circulatory disorders, excessive sweating, excessive salivation) and neuromuscular disorders. Serotonin syndrome has also been reported during concomitant use of triptan and serotonin-norepinephrine reuptake inhibitors (medicines used to treat depression). If concomitant treatment with sumatriptan and a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor is clinically justified, the patient should be under medical supervision.
During concomitant use of sumatriptan and St. John's Wort (Hypericum perforatum) products, adverse reactions 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 each 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 FDT is not recommended for use in children and adolescents.

Elderly patients

Imigran FDT is not recommended for use in elderly patients (over 65 years old).

Imigran FDT and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
After taking Imigran FDT, do not take any medicines containing ergotamine or its derivatives for 6 hours, and triptans or other 5-HT receptor agonists for 24 hours. On the other hand, after taking any ergotamine-containing medicine, another triptan, or other 5-HT receptor agonist, do not take Imigran FDT for at least 24 hours.
Do not take Imigran FDT at the same time as MAOIs and for 2 weeks after stopping treatment with these medicines.
During concomitant use of sumatriptan and St. John's Wort (Hypericum perforatum) products, adverse reactions may occur more frequently.
During concomitant use of sumatriptan and selective serotonin reuptake inhibitors, serotonin syndrome has been rarely reported (including changes in mental state, autonomic disorders, and neuromuscular disorders). Serotonin syndrome has also been reported during concomitant use of triptans and serotonin-norepinephrine reuptake inhibitors (see Warnings and precautions).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Sumatriptan passes into breast milk. Therefore, during the 12 hours after taking Imigran FDT, it is recommended to avoid breastfeeding.

Driving and using machines

Due to a migraine attack or after taking Imigran FDT, drowsiness may occur. In such cases, do not drive or operate machinery.

Imigran FDT contains sodium

Imigran FDT, 50 mg, coated tablets / oral suspension tablets, and Imigran FDT, 100 mg, coated tablets / oral suspension 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 FDT

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Imigran FDT should only be used after the onset of migraine attack symptoms, it should not be used as a preventive measure.
Do not exceed the recommended dose.
Swallow the tablets whole with water. If you have difficulty swallowing, the tablet can be dissolved in a small amount of water before administration. The medicine prepared in this way has a bitter taste.
The usual dose of Imigran FDT 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 pain. Some patients may require a dose of 100 mg - follow your doctor's instructions.
If the symptoms of the migraine attack do not disappear after taking the first dose, taking a second dose during the same attack is not recommended. In such cases, you can use paracetamol, acetylsalicylic acid, or another non-steroidal anti-inflammatory medicine.
In the event of a recurrence of symptoms, you can take further doses of Imigran FDT, but not earlier than 2 hours after the first dose.
Do not take more than 300 mg in 24 hours.

Overdose of Imigran FDT

In case of overdose, contact your doctor or pharmacist immediately.

4. Possible side effects

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

Common side effects

May affect up to 1 in 10 people taking Imigran FDT:
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 transient and usually short-lived. If the symptoms persist and worsen, contact your doctor immediately. Do not take further doses of Imigran FDT before consulting your 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 FDT:
liver function changes (in case of liver function tests, inform your doctor that you are taking Imigran FDT, as it may affect the results of these tests).

Side effects of unknown frequency

Frequency cannot be estimated from the available data:
If you experience any of the following symptoms, stop taking the medicine and contact your doctor immediately:
very severe chest pain radiating to the jaw and upper limbs
sudden wheezing or feeling of pressure in the chest
swelling of the eyelids, face, or lips
anaphylactic shock (drop in blood pressure, weakness, fainting)
seizures
rash in the form of red spots or hives
abdominal pain and (or) intense bleeding from the rectum.
Other side effects of unknown frequency may include:
tremors
dystonia (muscle tone disorder)
vision disorders such as nystagmus, scotoma, flickering light, double vision, changes in the field of vision, loss of vision, including permanent vision loss (vision disorders may be a component of a migraine attack)
slow or accelerated heart rate or feeling of irregular and (or) strong 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.
If you experience any of these symptoms, there is no need to stop taking the medicine, but inform your doctor about them during your next visit. If persistent discoloration of the hands or feet occurs, stop taking the medicine and contact your doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Imigran FDT

Keep the medicine out of the sight and reach of children.
Store in a temperature not exceeding 30°C.
Do not use 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. Ask your 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 FDT contains

• The active substance of Imigran FDT is sumatriptan in the form of sumatriptan succinate. Each coated tablet/oral suspension tablet contains 50 mg or 100 mg of sumatriptan in the form of sumatriptan succinate.
• The other ingredients are:

Imigran FDT 50 mg: calcium hydrogen phosphate, microcrystalline cellulose, sodium hydrogen carbonate, sodium croscarmellose, magnesium stearate. Coating composition: Opadry Pink YS-1-1441G (hypromellose E464, titanium dioxide E171, triacetin, iron oxide red E172).
Imigran FDT 100 mg: calcium hydrogen phosphate, microcrystalline cellulose, sodium hydrogen carbonate, sodium croscarmellose, magnesium stearate. Coating composition: Opadry White OY-S-7322 (hypromellose E464, titanium dioxide E171, triacetin)

What Imigran FDT looks like and contents of the pack

Imigran FDT, 50 mg: pink, biconvex, triangular coated tablets/oral suspension tablets with the inscription "GS 1YM" on one side and "50" on the other side.
Imigran FDT, 100 mg: white, biconvex, triangular coated tablets/oral suspension tablets with the inscription "GS YE7" on one side and "100" on the other side.
The pack contains 2, 4, 6, or 12 tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Manufacturer

Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
To obtain more detailed information, please 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:June 2022