Imigran

Package Leaflet: Information for the User

Imigran, 20 mg/0.1 ml, nasal spray, solution
Sumatriptan

Read the package leaflet carefully before using 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 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 is Imigran and what is it used for

Imigran is used to treat migraine attacks with or without aura. Imigran should only be used after the symptoms of a migraine attack have appeared. It should not be used as a preventive measure.
The nasal spray solution is intended for patients who experience nausea and vomiting along with pain or to achieve rapid pain relief.
The effect of the medicine starts 15 minutes after nasal administration.

2. Important information before using Imigran

When not to use Imigran

• if the patient has been diagnosed with an allergy (hypersensitivity) to sumatriptan or any of the other ingredients of this medicine (listed in section 6),
• if the patient has 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 the patient has been diagnosed with severe liver failure,
• if the patient has been diagnosed with moderate or severe hypertension or uncontrolled mild hypertension,
• if the patient is taking ergotamine or its derivatives, including methysergide (vasoconstrictor medicines used to treat migraine) or any other triptan or 5-HT receptor agonist (medicines used to treat migraine),
• if the patient is taking or has taken within the last 2 weeks monoamine oxidase inhibitor (MAOI) antidepressants (medicines used to treat nervous system diseases, mainly 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 attack,
• shortness of breath, pain or feeling of pressure in the chest (which may radiate to the jaw or arms) of unknown cause,
• heart disease risk factors (men over 40, postmenopausal women, overweight people, diabetes, high cholesterol, 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 there may be a transient increase in blood pressure and peripheral vascular resistance.

When sumatriptan is used concomitantly with 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 improper functioning of the part of the nervous system responsible for involuntary functions, including gastrointestinal disorders, circulatory disorders, excessive sweating, and excessive salivation) and neuromuscular disorders.
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 is clinically justified, the patient should be under medical supervision.
When sumatriptan is used concomitantly with products containing 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 an increase in headache frequency 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 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

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 using Imigran, the patient should 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 medicine containing ergotamine, another triptan, or other 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 stopping treatment with these medicines.
When sumatriptan is used concomitantly with products containing St. John's Wort (Hypericum perforatum), side effects may occur more frequently.
When sumatriptan is used in combination with 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Sumatriptan passes into breast milk. Within 12 hours of taking Imigran, breastfeeding should be avoided.

Driving and using machines

As a result of a migraine attack or after using Imigran, drowsiness may occur. In such cases, the patient should not drive or operate machinery.

3. How to use Imigran

This medicine should be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
It should not be used as a preventive measure.
The medicine should be taken as soon as possible after the first symptoms of migraine appear, but the medicine can be administered at any stage of the pain attack and is equally effective.
The patient should not take a higher dose than recommended.
Adults (18 years and older)
The single dose of Imigran nasal spray is 20 mg (the contents of one dose unit) and is administered into one nostril. However, due to individual variability in migraine attacks and sumatriptan absorption, a dose of 10 mg may be effective in some patients.
If the symptoms of the migraine attack do not disappear after the first dose, taking a second dose during the same attack is not justified. In such cases, the patient can use paracetamol, acetylsalicylic acid, or another non-steroidal anti-inflammatory drug.
Sumatriptan can be used during subsequent attacks.
If the patient responded to the first dose but the symptoms recurred, a second dose can be administered, but not earlier than 2 hours after the first dose.
The patient should not take more than two doses of Imigran nasal spray within 24 hours (with a minimum 2-hour interval between doses).

Instructions for use

The dose unit (container with nasal spray tip) consists of the following parts:
Fig. 1: Scheme of the dose unit
Nasal spray tip:this is the part of the dose unit that should be inserted into the nostril. The spray is released through a small hole in its upper part.

Body:this is the part of the dose unit that is held.
Blue actuator:when the actuator is pressed, the medicine is released from the dose unit.

WARNING!

The actuator works only once.

Do not press the actuator until the tip of the dose unit is inserted into the nostril, otherwise the entire dose of the medicine will be lost.

To use Imigran nasal spray correctly, follow the instructions below.

Remove the dose unit from the foil packaging immediately before use.

Fig.2

• Take a comfortable position, preferably sitting.
• Clear your nose, especially if you have a cold.

Fig.3

• Open the foil packaging and remove the dose unit.
• Hold the dose unit carefully, as shown in the picture.
• Do not press the blue actuator yet.

Fig.4

• Close one nostril by gently pressing with your finger.
• Breathe calmly through your mouth.

Fig.5

• Insert the tip of the dose unit into the other nostril, about 1 cm deep.
• Now, keep your head straight (avoid tilting it back) and close your mouth.
• Slowly inhale through your nose and press the blue actuator with your thumb.
• When pressing the actuator, you may feel a slight resistance and hear a clicking sound.
• After administering the medicine, continue to keep your head straight. Breathe slowly, inhaling through your nose and exhaling through your mouth for the next 10-20 seconds.
• You may experience a feeling of moisture in your nose, as well as a mild taste of the medicine. This is a normal symptom that will pass quickly. The dose unit is now empty. Dispose of it in the trash.

Using a higher dose of Imigran than recommended

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

4. Possible side effects

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

Very common side effects

May affect more than 1 in 10 people taking Imigran:
Taste disturbances or unpleasant taste

Common side effects

May affect up to 1 in 10 people taking Imigran:
pain, numbness, tingling, feeling 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 contact their doctor immediately. The patient should not take another dose of Imigran before consulting their doctor.
Other common side effects may include:
mild, transient irritation or burning sensation in the nose or throat, nasal bleeding, unpleasant taste
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 stop using the medicine and contact their doctor immediately:
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 (blood pressure drop, weakness, fainting)
seizures
rash in the form of red spots or hives
abdominal pain and (or) intense rectal bleeding.
Other side effects with unknown frequency may include:
tremors
dystonia (muscle tone disorder)
vision disorders such as nystagmus, scotoma, flickering lights, double vision, changes in the visual field, loss of vision, including permanent visual field defects (vision disorders may be a component of a migraine attack)
slow or rapid heartbeat or feeling of irregular and (or) strong heartbeat
hypotension (excessive decrease in blood pressure)
change in normal finger and toe color
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 injury site or inflammatory condition may occur
difficulty swallowing
feeling of anxiety
In case of the above symptoms, there is no need to stop using the medicine, but the patient should inform their doctor about them during the next visit. In case of persistent discoloration of the hands or feet, the patient should stop using the medicine and contact their doctor immediately.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. 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

The medicine should be stored out of sight and reach of children.
Store in 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 month.
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. The dose unit (container with nasal spray tip) contains a single dose of the medicine, i.e., 20 mg of sumatriptan in 0.1 ml of solution.
• The other ingredients of the medicine 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 dose units in blisters in a cardboard box.

Marketing authorization 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
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:January 2025