Imigran

Package leaflet: Information for the user

Imigran, 20 mg/0.1 ml, nasal spray, solution
Sumatriptanum
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Imigran is and what it is used for

Imigran is used for the treatment of migraine attacks with or without aura. Imigran should be used only after the onset of migraine symptoms. It must not be used prophylactically.
The aqueous nasal solution is particularly intended for patients who experience nausea and vomiting along with pain, or when rapid analgesic effect is desired.
The effect of the medicine begins approximately 15 minutes after nasal administration.

2. Important information before using Imigran

When not to use Imigran

• if the patient has hypersensitivity (allergy) 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, previous myocardial infarction, stroke, or transient ischaemic attack,
• if the patient has severe hepatic insufficiency,
• if the patient has moderate or severe arterial hypertension or mild uncontrolled hypertension,
• if the patient is currently taking medicines containing ergotamine or its derivatives, including methysergide (vasoconstrictive agents 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, tell your doctor if the patient has:

• headache, but migraine has not previously been diagnosed,
• headache different from that usually occurring during a 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, individuals with overweight, diabetes, high cholesterol levels, smokers, family history of heart disease),
• impaired liver or kidney function,
• a history of seizures or a predisposition to their occurrence,
• allergy to sulphonamide drugs, because after administration of sumatriptan there is a possibility of allergic reactions of varying severity: from skin rashes to anaphylactic shock,
• mild controlled hypertension, because a transient increase in blood pressure and peripheral vascular resistance may occur.

When sumatriptan is used concomitantly with selective serotonin reuptake inhibitors (medicines used in the treatment of depression), serotonin syndrome has been rarely reported, including changes in mental status, autonomic disturbances (gastrointestinal symptoms, circulatory disturbances, excessive sweating, excessive salivation), and neuromuscular disturbances. Serotonin syndrome has also been reported during 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 worsening headaches in susceptible patients (medication-overuse headache, MOH). In every patient in whom an increase in frequency or severity of migraine occurs 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
Tell 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 triptans 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.
When sumatriptan is used concomitantly with selective serotonin reuptake inhibitors, serotonin syndrome (including changes in mental status, autonomic disturbances, and neuromuscular disturbances) has been rarely reported. 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 child, she should consult a doctor or pharmacist before using this medicine.
Sumatriptan passes into breast milk. Breastfeeding should be avoided for 12 hours after taking Imigran.
Some breastfeeding women have reported breast pain and/or nipple pain after using 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 administration of Imigran. In such cases, driving or operating machinery should not be undertaken.

3. How to use Imigran

This medicine should be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Do not use this medicine preventively.
Take the medicine as soon as possible after the first symptoms of migraine appear; however,
administration at any stage of the headache attack is equally effective.
Do not exceed the recommended dose.

Adults (18 years and older)
The single dose of Imigran nasal spray is 20 mg (the content of one dispenser), administered into one nostril. However, due to individual variability in migraine attacks and sumatriptan absorption, a 10 mg dose may be effective in some patients.

If migraine symptoms do not subside after the first dose, administering a second dose during the same attack is not recommended. In such cases, treatment with paracetamol, acetylsalicylic acid, or another non-steroidal anti-inflammatory drug may be considered.
Sumatriptan may be used during subsequent migraine attacks.

If the patient responded to the first dose but symptoms recur, a second dose may be administered, not earlier than two hours after the first dose.

Do not use more than two doses of Imigran nasal spray within 24 hours (with at least a two-hour interval between doses).

Instructions for use
The dispenser (container with a nasal spray nozzle) consists of the following parts:
Fig. 1: Diagram of the dispenser
Nasal spray nozzle: this is the part of the

dispenser that should be inserted into the nostril. The spray is released through a small opening at its upper end.
Body: this is the part you hold when using the dispenser.
Blue plunger: pressing the plunger releases the medicine from the dispenser.
WARNING!
The plunger operates only once.
Do not press the plunger until the dispenser nozzle is placed in the nostril, otherwise the entire dose of medicine will be lost.
To correctly administer Imigran nasal spray, follow the instructions below.
Remove the dispenser from the foil packaging immediately before use.

Fig. 2

• Adopt a comfortable position, preferably sitting.
• Clear the nose, especially if you have a cold.

Fig. 3

• Tear open the foil packaging and remove the dispenser.
• Hold the dispenser carefully, as shown in the picture.
• Do not press the blue plunger yet.

Fig. 4

• Gently close one nostril by pressing it with your finger.
• Breathe calmly through your mouth.

Fig. 5

• Insert the dispenser nozzle into the other nostril to a depth of about 1 cm.
• Keep your head upright (avoid tilting it backward) and close your mouth.
• While slowly inhaling through your nose, press the blue plunger with your thumb.
• While pressing the plunger, you may feel slight resistance and hear a clicking sound.
• After administering the medicine, keep your head upright. Breathe slowly, inhaling through your nose and exhaling through your mouth for the next 10–20 seconds.
• You may feel moisture in the nose and may taste the medicine slightly. This is a normal effect that will quickly disappear. The dispenser is now empty. It should be discarded in a waste container.

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

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.

Very common adverse reactions
May occur in more than 1 in 10 patients taking Imigran:
Taste disturbances or a sensation of unpleasant taste

Common adverse reactions
May occur in 1 to 10 in 100 patients taking Imigran:
Pain, numbness, tingling, prickling, hot or cold sensations, heaviness, tightness 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:
Mild, transient irritation or burning sensation in the nose or throat, nosebleeds, unpleasant taste
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

Uncommon adverse reactions
May occur in no more than 1 in 1,000 patients taking Imigran:
Chest pain

Rare adverse reactions
May occur in fewer than 1 in 10,000 patients taking Imigran:
Liver function abnormalities (if liver function tests are performed, inform your 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:
Severe chest pain radiating to the jaw and upper limbs
Sudden onset of wheezing or chest tightness
Swelling of the eyelids, face or lips
Anaphylactic shock (drop in blood pressure, weakness, fainting)
Seizures
Skin rash with red spots or hives
Pain in the lower abdomen and (or) severe rectal bleeding

Other adverse reactions with unknown frequency may also occur:
Tremor
Dystonia (muscle tone disorder)
Visual disturbances such as nystagmus, scotoma, flickering lights, double vision, visual field changes, vision loss, including permanent visual defects (visual disturbances may be part of a migraine attack)
Slowed or accelerated heartbeat or sensation of irregular and (or) strong heartbeat
Hypotension (excessive lowering of blood pressure)
Change in normal skin coloration of fingers and toes
Joint pain
Neck stiffness
Excessive sweating
Diarrhea
In a patient who has recently suffered trauma or who has an inflammatory condition (such as rheumatism or inflammatory bowel disease), pain or worsening of pain at the site of injury or inflammation may occur
Difficulty swallowing
Feeling of anxiety

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 this medicine out of sight and reach of children.
Store at a temperature between 2 °C and 30 °C. Protect from light.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Imigran contains

• The active substance in Imigran is sumatriptan. The nasal spray device (container with a nozzle for nasal aerosol administration) contains a single dose of the medicinal product, i.e. 20 mg of sumatriptan in 0.1 ml of solution.
• Other ingredients are: potassium dihydrogen phosphate, anhydrous disodium phosphate, sulfuric acid, sodium hydroxide, purified water.

What Imigran looks like and contents of the pack
The pack contains 2 spray devices in blisters within a cardboard box.
Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland
Manufacturer
GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana, 90
43056 San Polo di Torrile
Parma, Italy
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
For more detailed information, please contact the representative of the Marketing Authorisation Holder.
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
Tel: + 48 22 576 90 00