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 all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Imigran FDT is and what it is used for
• 2. Before you take 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 Imigran FDT is and what it is used for

Imigran FDT contains the active substance sumatriptan. Sumatriptan works by reversing the dilation of blood vessels in the brain, which is believed to be the cause of migraine headaches. Imigran FDT is used to treat migraine attacks with or without aura.

2. Before you take Imigran FDT

Do not take Imigran FDT

• if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6),
• if you have had a heart attack or have angina, or have had a stroke or a transient ischaemic attack (TIA),
• if you have severe liver disease,
• if you have severe high blood pressure or mild high blood pressure that is not controlled,
• if you are taking other triptans or ergotamine, or if you have taken these in the last 24 hours,
• if you are taking MAO inhibitors (a type of medicine used to treat depression) or have taken them in the last 2 weeks.

Warnings and precautions

Before taking Imigran FDT, tell your doctor if you:

• have a headache that is different from your usual migraine headache,
• have had a heart problem or have any risk factors for heart disease (e.g. high blood pressure, high cholesterol, smoking, obesity, diabetes, family history of heart disease),
• have liver or kidney disease,
• have had seizures or fits in the past or have a condition that increases your risk of seizures (e.g. epilepsy),
• are allergic to sulfonamides (a type of antibiotic),
• have mild controlled high blood pressure.

When taking sumatriptan and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) at the same time, there is a risk of serotonin syndrome, which can be life-threatening. If you are taking these medicines, your doctor will monitor you closely.

Children and adolescents

Imigran FDT should not be used in children and adolescents under 18 years of age.

Elderly

Imigran FDT should not be used in patients over 65 years of age.

Other medicines and Imigran FDT

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal remedies and non-prescription medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Imigran FDT may cause drowsiness. If this happens, do not drive or use machines.

Imigran FDT contains sodium

Imigran FDT contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Imigran FDT

Always take Imigran FDT exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Take Imigran FDT as soon as possible after the symptoms of a migraine attack start.

Do not take more than the recommended dose.

Swallow the tablet whole with water. If you have difficulty swallowing, you can dissolve the tablet in a small amount of water.

The usual dose is 50 mg, taken as soon as possible after the symptoms of a migraine attack start. Some patients may need to take 100 mg. Follow your doctor's advice.

If your symptoms come back, you can take a second dose, but not sooner than 2 hours after the first dose.

Do not take more than 300 mg in 24 hours.

If you take more Imigran FDT than you should

Contact your doctor or pharmacist immediately.

4. Possible side effects

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

Common side effects

May affect up to 1 in 10 people:

• pain, tingling, numbness, or warmth or cold sensations in the skin
• dizziness
• fatigue
• sleepiness
• weakness
• transient increase in blood pressure
• flushing
• nausea and vomiting
• muscle pain

Rare side effects

May affect up to 1 in 1,000 people:

• abnormal liver function tests

Side effects with unknown frequency

Cannot be estimated from the available data:

• severe chest pain radiating to the jaw and arms
• shortness of breath or tightness in the chest
• swelling of the face, lips, or tongue
• anaphylaxis (a severe, life-threatening allergic reaction)
• seizures
• rash or hives
• abdominal pain or rectal bleeding

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Imigran FDT

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use after the expiry date stated on the pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

6. Contents of the pack and other information

What Imigran FDT contains

• The active substance is sumatriptan.
• The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose, sodium hydrogen carbonate, croscarmellose sodium, magnesium stearate.

What Imigran FDT looks like and contents of the pack

Imigran FDT 50 mg: pink, triangular, biconvex, film-coated tablets, engraved with "GS 1YM" on one side and "50" on the other side.

Imigran FDT 100 mg: white, triangular, biconvex, film-coated tablets, engraved with "GS YE7" on one side and "100" on the other side.

Pack sizes: 2, 4, 6, or 12 tablets in blisters, in a cardboard box.

Marketing authorisation holder

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

Manufacturer

Delpharm Poznań Spółka Akcyjna, ul. Grunwaldzka 189, 60-322 Poznań, Poland

Date of last revision: June 2022