IMIGRAN 20 mg NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

Imigran 20 mg Nasal Spray Solution

Sumatriptan

Read all of this leaflet carefully before you start using 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 is Imigran and what is it used for
2. What you need to know before you use Imigran
3. How to use Imigran
4. Possible side effects
5. Storing Imigran
6. Contents of the pack and other information

1. What is Imigran and what is it used for

Each Imigran 20 mg nasal spray contains a single doseof sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HT1receptor agonists).

Imigran 20 mg is used to treat migraine headaches.

The symptoms of migraine can be caused by temporary widening of the blood vessels in the head. It is thought that Imigran 20 mg works by reversing this widening of the blood vessels. This helps to remove the headache and relieve other symptoms of migraine attacks, such as nausea and vomiting and sensitivity to light and sound.

2. What you need to know before you use Imigran

Do not use Imigran 20 mg

• 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 mini-stroke(also known as a transient ischaemic attack or TIA)
• if you have high blood pressure.You can use Imigran 20 mg if your blood pressure is mildly elevated and is being treated
• if you have severe liver disease
• with other migraine medicines,including those that contain ergotamine, or medicines that are similar to ergotamine, such as methysergide, or any triptan/5-HT1 receptor agonist (medicines used to treat migraine)
• with monoamine oxidase inhibitors (MAOIs),or if you have taken MAOIs in the last 2 weeks.

If any of these apply to you:

Tell your doctor, and do not use Imigran 20 mg.

Be especially careful with Imigran 20 mg

Tell your doctor or pharmacist before you start using Imigran 20 mg.

If you have any extra risk factors

• if you smoke heavilyor are using nicotine replacement therapy, and especially
• if you are a man over 40 years old,or
• if you are a woman who has started the menopause.

On very rare occasions, people have developed serious heart problems after using Imigran 20 mg, even though they had no signs of heart disease before. If any of the above points apply to you, it may mean that you have a greater risk of developing heart disease, so:

Tell your doctor so that they can check your heart functionbefore they prescribe Imigran 20 mg 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 so that they can monitor you more closely.

If you have liver or kidney disease

Tell your doctor so that they can monitor you more closely.

If you are allergic to an antibiotic called sulfonamides

If this is the case, you may also be allergic to Imigran 20 mg.If you know you are allergic to antibiotics but are not sure if it is a sulfonamide:

Tell your doctor or pharmacist before you use Imigran 20 mg.

If you are taking antidepressants called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors)

Tell your doctor or pharmacist before you use Imigran 20 mg.See also Other medicines and Imigran 20 mgbelow.

If you use Imigran 20 mg frequently

Using Imigran 20 mg too often may make your headaches worse.

Tell your doctor if this happens to you.Your doctor may recommend that you stop using Imigran 20 mg.

If you feel pain or tightness in your chest after using Imigran 20 mg

These effects may be intense 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 on these possible side effects.

Other medicines and Imigran 20 mg

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

Some medicines must not be taken with Imigran 20 mg and others may cause adverse effects if taken with Imigran 20 mg. Tell your doctor if you are taking any of the following medicines:

• Ergotamine,which is also used to treat migraine ormedicines similar to ergotamine, such as methysergide (see section 2 Do not use Imigran 20 mg). Do not use Imigran 20 mg at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran 20 mg. Do not take any other medicine that contains ergotamine or ergotamine-like compounds for at least 6 hours after using Imigran 20 mg.
• Other triptans/5-HT1receptor agonists(such as naratriptan, rizatriptan, zolmitriptan), which are also used to treat migraine(see section 2 Do not use Imigran 20 mg). Do not use Imigran 20 mg at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran 20 mg. Do not take another triptan/5-HT1 receptor agonist for at least 24 hours after using Imigran 20 mg.
• SSRIs (selective serotonin reuptake inhibitors)orSNRIs (serotonin and noradrenaline reuptake inhibitors)used to treat depression. Using Imigran 20 mg 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 20 mg if you have taken MAOIs in the last 2 weeks.
• St John’s Wort (Hypericum perforatum). It is more likely that you will experience side effects if you take herbal remedies containing St John’s Wort while you are using Imigran 20 mg.

Pregnancy and breast-feeding

Tell your doctor or pharmacist before using any medicine.

• If you are pregnant or breast-feeding,think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. There is limited experience with the use of Imigran 20 mg 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 potential benefits and risks of using Imigran 20 mg during pregnancy.
• Do not breast-feed for 12 hours after using Imigran 20 mg.If you express breast milk during this time, discard the milk and do not give it to your baby.

Driving and using machines

Migraine symptoms or the medicine may cause you to feel drowsy. If this happens, do not drive or use machines.

3. How to use Imigran

Only use Imigran 20 mg after your migraine headache has started.

Do not use Imigran 20 mg to prevent a migraine attack.

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor or pharmacist again.

There is a step-by-step guideto using the nasal spray at the end of the leaflet (see section 6).

How much to use

Adults aged 18 and over

• The usual dose for adults aged between 18 and 65 yearsis a single spray of Imigran 20 mg into one nostril.

For some people, a 10 mg spray into one nostril is sufficient.

Do not use more than two sprays in 24 hours.

Adolescents aged 12 to 17 years

• The usual dose for adolescents aged 12 to 17 yearsis a single 10 mg spray into one nostril.

Children under 12 years

• Imigran 20 mg is not recommended forchildren under 12 years.

Elderly (over 65 years of age)

• Imigran 20 mg is not recommended forpeople over 65 years of age.

When to use Imigran 20 mg

• It is best to use Imigran 20 mg as soon as you feel the migraine coming on,although you can use it at any time during an attack.

If your symptoms come back

• You can use a second spray of Imigran 20 mg after 2 hours, but do not use more than two sprays in 24 hours.

If the first spray has no effect

• Do not use a second spray,or any other Imigran preparation for the same attack.

If Imigran 20 mg does not give you relief:

Talk to your doctor or pharmacist for advice.

If you use more Imigran 20 mg than you should

• Do not use more than two sprays of Imigran 20 mg in 24 hours

Using too much Imigran 20 mg can make you ill. If you have used more than two sprays in 24 hours:

Contact your doctor for advice.

In case of overdose, contact your doctor or pharmacist or call the National Poison Information Service on 111 immediately, stating the name of the medicine and the amount you have taken.

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

4. Possible side effects

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

Some of these symptoms may be caused by the migraine itself.

Side effects reported in adults have also been observed in adolescents. These include very rare cases of heart attacks.

Allergic reactions: get medical help immediately

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

• Signs of allergy include rash, itching, hives (itchy rash); wheezing (puffing of the cheeks); swelling of the eyelids, face or lips, collapse.

If you notice any of these symptoms soon after using Imigran 20 mg:

Do not use it again.Contact your doctor immediately.

Very common side effects

(affect more than 1 in 10people)

• Unpleasant taste.

Common side effects

(affect up to 1 in 10people)

• Pain, heaviness, pressure, tightness or pain in the chest, throat or other parts of the body, or unusual sensations, including numbness, tingling and warmth or cold. These effects may be intense but usually pass quickly.

If these effects continue or get worse(especially chest pain):

Get medical help urgently.In a small number of people, these symptoms can be caused by heart attacks.

Other common side effects include:

• Irritation or burning sensation in the nose or throat, nosebleeds.
• Nausea or vomiting, although this may be due to the migraine itself.
• Tiredness or drowsiness.
• Dizziness, feeling of weakness or flushing.
• Temporary increase in blood pressure.
• Difficulty breathing.
• Muscle pain.

Very rare side effects

(affect up to 1 in 10,000people)

• Changes in liver function. Tell your doctor or nurse that you are taking Imigran 20 mg if you are going to have a blood test to check your liver function.

Some patients may experience any of the following side effects, but the frequency is unknown

• Seizures/fits, tremors, muscle spasm, stiffness of the neck.
• Visual disturbances such as flickering, 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 beats more quickly, more slowly or with changes in rhythm, chest pain (angina)or heart attack.
• Pallor, bluish discolouration and/or pain of the fingers of the hands, fingers of the feet, ears, nose or jaw in response to cold or stress (Raynaud’s phenomenon).
• Feeling of weakness (may cause low blood pressure).
• Pain in the lower left side of the abdomen and bloody diarrhoea (ischaemic colitis).
• Diarrhoea.
• If you have had a recent injury or if you have inflammation (such as arthritis or inflammation of the bowel),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.

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. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Imigran

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

Keep this medicine in the outer carton in order to protect from light.

Do not store above 30°C.

Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton after EXP.The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste.Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Container Contents and Additional Information

Composition of Imigran 20 mg

The active ingredient issumatriptan (20 mg).

The other components arepotassium dihydrogen phosphate, anhydrous sodium phosphate dibasic, sulfuric acid, sodium hydroxide, and purified water.

Appearance of the Product and Container Contents

This medication comes in a preloaded spray device and contains sumatriptan in 0.1 ml of colored yellow solution.

Imigran 20 mg is packaged in a box containing individually sealed nasal spray devices in blisters. They are available in packs of 1, 2, or 6 preloaded nasal spray devices, although not all pack sizes are available in your country. Each spray device contains a dose of Imigran 20 mg.

Only some pack sizes may be marketed.

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

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

• Imigran nasal spray:Austria, Denmark, Finland, Germany, Italy, Netherlands, Spain, Sweden, and United Kingdom (Northern Ireland).
• Imitrex nasal spray:Belgium and Luxembourg.

Date of the Last Revision of this Leaflet:October 2021.

Follow the Imigran 20 mg Guide Step by Step

Do not open the blister until you are about to use the spray device.Each spray device is sealed in a blister to keep it safe and clean. If you carry a spray device without the blister, or in an open blister, it may not work properly when you need it.

Each spray device contains only one dose of Imigran 20 mg.

Do not press the plunger too soon or you will lose the dose.

Imigran 20 mg consists of three parts:

How to Use the Nasal Spray Device

1. Remove the nasal spray device fromthe blister packaging only before immediate use.
2. Get into a comfortable position, preferably sitting down.
3. If you feel that your nose is blocked or you have a cold, blow your nose.
4. Hold the nasal spray devicegently with your fingers and thumb as shown in Figure A.

Do not press the blue plunger yet.

1. Close one nostrilby firmly pressing one side of your nose with your finger. It does not matter which nostril you choose.

1. Insert the nasal spray device applicatorinto the other nostril, as far as it feels comfortable – about 1 cm or half an inch (Figure B).

Breathe out gently through your mouth.

Keep your head upright and close your mouth.

1. Start breathing in gently through your nose.

While breathing in:

Press the blue plunger firmly with your thumb.

The plunger may be a bit stuck, and you may hear a click. Hold your breath while inhaling (Figure C).

1. Remove the nasal spray deviceand remove the finger from the side of your nose.

Keep your head upright for 10-20 seconds,breathing gently in through your nose and out through your mouth. This helps the medication stay in your nose.

You may notice that your nose feels moist inside and you may taste a slight characteristic taste after using the nasal spray device – this is normal and will pass soon.

1. Your nasal spray device is now empty.Dispose of it safely and hygienically.

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