IMIGRAN 6 mg injectable solution

2. What you need to know before you use Imigran

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 (ischaemic heart disease) or chest pain (angina), or have had a heart attack
• if you have circulation problems in your legsthat cause pain when you walk (peripheral vascular disease)
• if you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA)
• if you have high blood pressure. You can use Imigran if your blood pressure is mildly elevated and is being treated
• if you have liver disease, consult your doctor. If the liver disease is severe, Imigran is not suitable for you
• with migraine medicines, including those that contain ergotamine, or similar medicines such as methysergide (see section 2 Do not use Imigran)
• with antidepressants called MAOIs(monoamine oxidase inhibitors), or if you have taken these medicines in the last two weeks.

If any of these apply to you

Tell your doctor and do not use Imigran.

Warnings and precautions

Talk to your doctor or pharmacist before you start using Imigran.

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

• if you are a man over 40 years old
• 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.

On very rare occasions, people have developed serious heart problems after using Imigran, even though they had no signs of heart disease before. If any of the above applies to you, it may mean that you have a greater risk of developing heart disease, so

Tell 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.

Tell your doctor to monitor you more closely.

If you have high blood pressure

Imigran may not be suitable for you:

Tell your doctor or pharmacist before using Imigran.

If you have kidney or liver disease

Tell your doctor or pharmacist before using Imigran.

If you are allergic to antibiotics called sulphonamides

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

Tell your doctor or pharmacist before using Imigran.

If you are taking antidepressants called SSRIs(Selective Serotonin Reuptake Inhibitors) or SNRIs(Serotonin and Noradrenaline Reuptake Inhibitors)

Tell your doctor or pharmacist before using Imigran.See also below, Other medicines and Imigran.

If you use Imigran frequently

Using Imigran too often may make your headaches worse.

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

If you feel pain or pressure in your chest after using Imigran

These effects may get worse but usually pass quickly. If they do not pass quickly or get worse:

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

Other medicines and Imigran

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any herbal remedies or medicines that you have bought without a prescription.

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

• ergotaminewhich is also used to treat migraine,or similar medicines such as methysergide (see section 2 Do not use Imigran). Do not use Imigran at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran. Do not take any other medicine that contains ergotamine or ergotamine-like compounds until at least 6 hours after using Imigran
• other triptans/5-HT1 receptor agonists(such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine, (see section 2 Do not use Imigran). Do not use Imigran at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran. Do not take another triptan/5-HT1 receptor agonist for at least 24 hours after using Imigran
• SSRIs(Selective Serotonin Reuptake Inhibitors) or SNRIs(Serotonin and Noradrenaline Reuptake Inhibitors) used to treat depression. Using Imigran with these medicines can cause serotonin syndrome (a set of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heart rate and agitation). Tell your doctor immediately if you are affected in this way
• MAOIs(monoamine oxidase inhibitors) used to treat depression. 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 have side effects if you take herbal remedies containing St John’s Wort while you are using Imigran.

Fertility, pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advicebefore taking this medicine. There is limited information on the safety of Imigran in pregnant women, although up to now there is no evidence that it increases the risk of birth defects. Your doctor will weigh up the benefits and risks of using Imigran during pregnancy.

Do not breastfeed for 12 hours after taking Imigran. If you express breast 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 experience these effects, do not drive or use machines because it can be dangerous.

Imigran contains sodium

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

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

3. How to use Imigran

Follow exactly the instructions of administration of this medicine given by your doctor. If you are not sure, talk to your doctor or pharmacist.

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

Remember to use your medicine.

Your doctor will tell you how long to use Imigran. Do not stop using it before then.

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

It is not recommended to administer to children, adolescents under 18 years or elderly patients.

The recommended dose in adults for migraine or cluster headache symptoms is a single injection (6 mg) subcutaneously, just under the skin. Your doctor will show you where to administer the injection, usually in the thigh or buttock. Do not inject directly into a vein. Some people start to feel better within 15 minutes of using Imigran.

If you do not feel better after taking a dose, do not use a second dose of sumatriptan for the same migraine or cluster headache attack. However, you can take your usual painkiller, as long as it does not contain ergotamine or dihydroergotamine.

If you feel better after the first dose but the symptoms come back, 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, case and a cartridge that contains two syringes, as shown in the following figure:

The auto-injector can only be used when it is loaded with a syringe.

Contents of the case

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

1. Check that the cartridge is correctly placed, i.e. when you see the blue buttons through the holes in the case.

To use the auto-injector

1. Open the case.

Remove the seal from one of the two syringes that contains the cartridge.

1. Open the cap of the corresponding syringe.

1. Remove the auto-injector from the case.

1. Firmly insert the auto-injector into the cartridge and turn the auto-injector clockwise until it cannot be turned any further.

1. Firmly pull the loaded auto-injector outwards. It may be a bit difficult to do this.

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

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

1. Carefully remove the auto-injector.

Be careful, you will see the needle.

1. Immediately return the used syringe to the cartridge, pushing the auto-injector downwards inside it until it reaches the end. Then, turn the auto-injector anti-clockwise until it comes out of the cartridge.

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

1. Return the auto-injector to its place in the case, pushing it downwards. You will hear a click when the auto-injector is in place.

If you use more Imigran than you should:

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Imigran can cause adverse effects, although not all people suffer from them. Some of these symptoms may be caused by the migraine itself.

Allergic Reactions: Seek Medical Attention Immediately

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

• Signs of allergy include rash, hives (itching and rash); wheezing (whistling in the chest); swollen eyelids, face, or lips, complete collapse.

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

? Never use it again.Contact your doctor immediately.

Very Common Adverse Effects

(affect more than 1 in 10people)

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

Common Adverse Effects

(affect up to 1 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 may be intense but usually disappear quickly.

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

?Seek urgent medical attention. In a small number of people, these symptoms can be caused by heart attacks.

Other common adverse effects include:

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

Very Rare Adverse Effects

(affect up to 1 in 10,000people)

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

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

• Seizures/attacks, tremors, muscle spasms, stiffness of the neck.
• 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).
• Heart problems, in which the heart may beat faster, slower, or with changes in rhythm, chest pain (angina) or heart attack.
• Pallor, bluish 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 if you have inflammation (such as rheumatism or colon inflammation), you may experience pain or worsening of pain at the site of the injury or inflammation.
• Pain in the joints.
• Anxiety.
• Difficulty swallowing.
• Excessive sweating.

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

Reporting Adverse Effects:

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

5. Storage of Imigran

Keep this medicine out of sight and reach of children.

Do not store above 30°C. Store in the original packaging to protect it from light.

Do not use this medicine after 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 thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 injectable preparations.

Appearance of the Product and Package Contents

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 pouch with 2 pre-filled syringes and a self-injector device.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

GlaxoSmithKline S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

GlaxoSmithKline Manufacturing S.p.A.Strada Provinciale Asolana, 90

43056 San Polo di Torrile

Parma

Italy

Date of the Last Revision of this Prospectus:September 2020.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/