Leaflet: information for the user

Imigran 6 mg injectable solution

Sumatriptan (as sumatriptan succinate)

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribedonlyfor you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Imigran contains the active ingredient sumatriptan which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).

Imigran is used to relieve headache pain and other symptoms of a migraine attack or an acute headache attack.

The dilation of blood vessels in the head is thought to be the cause of the headache that occurs in a migraine. This medication constricts the blood vessels in the head and relieves the symptoms of a migraine.

Do not use Imigran

• if you are allergicto sumatriptan or any of the other ingredients of this medicine (listed in section 6)
• if you have heart problemssuch as narrowing of the arteries (coronary heart disease)(ischaemic heart disease)or chest pain (angina)(angina pectoris), or have had a heart attack
• if you have circulation problems in your legsthat cause pain, such as cramp when walking(peripheral vascular disease)
• if you have had a strokeor a mini-stroke (also known as transient ischaemic attack or TIA)(TIA)
• if you have high blood pressure. You can use Imigran if your blood pressure is slightly raised and you are being treated
• if you have liver disease,consult your doctor. If your liver disease is severe, Imigran is not suitable for you
• with migraine medicines,including those that contain ergotamine, or similar medicines such as methysergide or any triptan/5-HT1 receptor agonist (medicines used also for the treatment of migraine)
• with antidepressants called MAOIs(monoamine oxidase inhibitors),or if you have taken these medicines in the last two weeks

If any of these cases apply to you

?Inform your doctor, and do not use Imigran.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Imigran.

Before taking Imigran, your doctor needs to knowif you have any extra risk factors for developing heart disease:

• if you are a man over 40 years
• if you are a woman who has started the menopause
• if you smoke or are overweight

• if you have diabetes or high cholesterol
• if you have a family history of heart disease.

In very rare cases, people have developed serious heart problems after using Imigran, even though they did not have any signs of heart disease beforehand. If any of the above points apply to you, it may mean that you have a higher risk of developing heart disease, so

?Inform your doctor to check your heart functionbefore Imigran is prescribed for you.

if you have a history of fits(seizures)

Or if you have other conditions that may make you more likely to have fits – for example, a head injury or alcoholism.

?Inform your doctor to be monitored more closely..

if you have high blood pressure

Imigran may not be suitable for you:

?Inform your doctor or pharmacist before using Imigran.

if you have kidney or liver disease

?Inform your doctor or pharmacist before using Imigran.

if you are allergic to sulphonamide antibiotics

If you are, you may also be allergic toImigran. If you know you are allergic to antibiotics but are not sure if it is a sulphonamide:

?Inform your doctor or pharmacist before usingImigran.

if you are taking antidepressants called SSRIs(Selective Serotonin Reuptake Inhibitors)orSNRIs(Serotonin and Noradrenaline Reuptake Inhibitors)

?Inform your doctor or pharmacist before usingImigran. See also below,Other medicines and Imigran.

if you useImigranfrequently

Using Imigran too frequently can make your headaches worse.

?Inform your doctor if this happens to you.Your doctor may recommend that you stop using this medicine.

if you feel pain or tightness in the chest after using Imigran

These effects can intensify but usually pass quickly. If they do not pass quickly or become more severe:

?Get medical help immediately.See section 4 of this leaflet for more information about these possible side effects.

Other medicines and Imigran

Informyour doctor or pharmacist if you are taking,have taken recently or may need to take any other medicine. This includes any herbal remedies or medicines that have been bought without a prescription.

Some medicines should not be taken with Imigran and others may cause side effects if taken with Imigran.Inform your doctor if you are taking other medicines, such as:

• ergotamineis also used to treat migraine,or similar medicines such as methysergide (see section 2Do not useImigran). Do not useImigranat the same time as these medicines. Stop taking these medicines at least 24 hours before usingImigran. Do not take any other medicine that contains ergotamine or similar compounds to ergotamine for at least 6 hours after usingImigran
• other triptans/5-HT1 receptor agonists(such as naratriptan, rizatriptan, zolmitriptan),also used to treatmigraine,(see section 2Do not useImigran). Do not useImigranat the same time as these medicines. Stop taking these medicines at least 24 hours before usingImigran. Do not take another triptan/5-HT1 receptor agonist for at least 24 hours after usingImigran
• SSRIs(Selective Serotonin Reuptake Inhibitors)orSNRIs(Serotonin and Noradrenaline Reuptake Inhibitors)used to treatdepression. The use ofImigranwith these medicines may cause serotonin syndrome (a group of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heart rate and agitation). Inform your doctor immediately if you are affected in this way
• MAOIs(monoamine oxidase inhibitors)used to treatdepression. Do not use Imigran if you have taken these medicines in the last two weeks
• St John's Wort(Hypericum perforatum). It is more likely that you will experience side effects if you take herbal remedies that contain St John's Wort while usingImigran.

Fertility, pregnancy and breastfeeding

if you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine. There is limited information on the safety of Imigran in pregnant women, although so far there is no evidence that it increases the risk of birth defects. Your doctor will assess with you whether you should or should not use Imigran while pregnant.

You must not breastfeed your baby for12 hours after taking Imigran. If you express milk during this time, discard the milk and do not give it to your baby.

Driving and using machines

This medicine, like migraine, can cause drowsiness. If you notice these effects avoid driving or using machines as it may be dangerous.

Imigran contains sodium chloride

This medicine contains less than 23 mg of sodium (1 mmol) per 0.5 ml; this is, essentially “sodium-free”.

It may cause severe allergic reactions because it contains latex in the packaging.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

Only use Imigran after your migraine attack has started. Do not use Imigran to prevent a migraine attack.

Remember to use your medication.

Your doctor will indicate the duration of your treatment with Imigran. Do not stop treatment before.

Imigran must be used as soon as migraine or acute headache symptoms appear; however, it can be used at any time during an attack.

Administration to children, adolescents under 18 years, and elderly patients is not recommended.

The recommended dose in adults for migraine or acute headache symptoms is a single subcutaneous injection (6 mg) just below the skin. Your doctor will teach you where to administer the injection, usually in the thigh or buttock. Do not inject directly into a vein. Some people start to notice an improvement within 15 minutes of Imigran administration.

If no improvement is obtained after administering a dose, do not use a second dose of sumatriptan for the same migraine or acute headache attack. However, you can take your usual pain medication, as long as it does not contain ergotamine or dihydroergotamine.

If you obtain symptom improvement after the first dose, but symptoms recur, you can use a second dose of Imigran, at least one hour after the first dose.

Do not use more than 2 injections in 24 hours and leave at least one hour between each dose.

Needles and syringes can be hazardous and must be disposed of safely and hygienically.

The device consists of three parts: auto-injector, cartridge or case, and a cartridge containing two syringes, as shown in the following figure:

Theauto-injector can only be used when loaded with a syringe.

Contents of the case or cartridge

1. When opening the case or cartridge, you will see the auto-injector and the cartridge with the syringes.

1. Check that the cartridge is correctly positioned, i.e., when you see the blue buttons through the holes of the case or cartridge.

To use the auto-injector

1. Open the case or cartridge.

Remove the tamper-evident seal from one of the two syringes

that contains the cartridge.

2. Open the cap of the corresponding syringe.

3. Remove the auto-injector from the case or cartridge.

4. Insert the auto-injector firmly into the cartridge and turn the auto-injector clockwise until it cannot be turned further.

5.Push the loaded auto-injector firmly outwards. It may take a bit of effort to do so.

There is a safety button that prevents accidental injection until you are ready.

6. Press the loaded auto-injector firmly against the skin, preferably on the outer surface of the thigh or the upper outer surface of the arm (deltoid muscle), so that the gray part slides just to the blue part. To inject, press the blue button on the auto-injector and hold it firmly in place for at least five seconds (or count to ten).

7. Carefully remove the auto-injector.

Be careful as you will see the needle.

8. Immediately return the used syringe to the cartridge by pushing the auto-injector downwards into it as far as it will go. Then, turn the auto-injector counterclockwise until it comes out of the cartridge.

9. Remove the auto-injector from the cartridge; then, close the cap over the used syringe.

10. Return the auto-injector to its place in the case or cartridge by pushing it downwards. You will hear a click when the auto-injector is properly seated.

If you use more Imigran than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, Imigran can cause side effects, although not everyone will experience them. Some of these symptoms may be caused by the migraine itself.

Allergic reactions: seek medical help immediately

The following side effects have occurred in a very small number of people and their exact frequency is unknown.

• Allergic signs include rash, hives (itching and rash); wheezing (chest wheezing); swollen eyelids, face, or lips, complete collapse.

If you notice any of these symptoms shortly after using Imigran:

?Do not use it again.Immediately contact your doctor.

Very common side effects

(affect more than1 in 10people)

• Pain at the injection site.
• Itching/burning, redness, swelling, bruising, and bleeding at the injection site.

Common side effects

(affect up to1 in 10people)

• Pain, heaviness, pressure, oppression, or pain in the chest, throat, or other parts of the body, or unusual sensations, including numbness, tingling, and heat or cold. These effects can be intense, but generally disappear quickly.

If these effects persist or worsen(especially chest pain):

?Seek urgent medical help.In a reduced number of people, these symptoms may be caused by heart attacks.

Other common side effects include:

• Nausea or vomiting, although this may be due to the migraine itself.
• Tiredness or drowsiness.
• Dizziness, feeling weak, or hot flushes.
• Temporary increase in blood pressure.
• Difficulty breathing.
• Muscle pain.

Rare side effects

(affect up to1 in 10,000people)

• Liver function abnormalities. Inform your doctor or nurse that you are taking Imigran if you are to have a blood test to check liver function.

Some patients may experience any of the following side effects, but the frequency with which they occur is unknown

• Convulsions/seizures, tremors, muscle spasms, neck stiffness.
• Visual disturbances such as blinking, reduced vision, double vision, loss of vision, and in some cases, even permanent defects (although these may be due to the migraine attack itself).
• Cardiac problems, in which the heart may beat faster, slower, or with changes in rhythm, chest pain (angina) or heart attack.
• Pallor, blue skin, and/or pain in the fingers of the hands, toes, ears, nose, or jaw in response to cold or stress (Raynaud's phenomenon).
• Pain in the lower left abdomen and bloody diarrhea (ischemic colitis).
• Diarrhea.
• If you have had a recent injury or have inflammation (such as arthritis or colon inflammation), you may experience pain or worsening of pain at the injury or inflammation site.
• Joint pain.
• Anxiety.
• Difficulty swallowing.
• Excessive sweating.

If you have had a blood test to check how your liver is functioning and you have taken Imigran, inform your doctor, as it may affect the test results.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above 86°F (30°C). Store in the original packaging to protect it from light.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Imigran:

-The active ingredient is sumatriptan. Each pre-filled syringe contains 6 milligrams of sumatriptan (as sumatriptan succinate).

-The other components are sodium chloride and water for injection.

Appearance of the product and contents of the packaging

Imigran is presented in the form of a pre-filled syringe with a solution containing 6 mg of sumatriptan. Each package contains a case or box with 2 pre-filled syringes and an auto-injector device.

The needle guard of the pre-filled syringe contains natural dry latex rubber that may cause severe allergic reactions in people sensitive to latex.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

GlaxoSmithKline S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible manufacturer:

GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana, 90
43056 San Polo di Torrile
Parma
Italy

Date of the last review of this leaflet:September 2020.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/