Patient Information Leaflet

Sumatriptán SUN 6 mg/0.5 ml Injectable Solution EFG

Read this leaflet carefully before you start using 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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.

Table of Contents

1. What Sumatriptán SUN is and what it is used for
2. What you need to know before using Sumatriptán SUN
3. How to use Sumatriptán SUN
4. Possible side effects
5. Storage of Sumatriptán SUN
6. Contents of the pack and additional information

The active ingredient of Sumatriptán SUN is sumatriptan. It belongs to the group of medicines called 5-HT1 receptor agonists.

Sumatriptán is used in the treatment of migraine attacks and for the treatment of a rare disease called cluster headache.The symptoms of migraine may be caused by the transient dilation of blood vessels in the head. This medicine reduces said dilation.

Do not use Sumatriptán SUN:

• if you are allergic to sumatriptán or to any of the other components of this medication (listed in section 6)
• if you have ever had heart attacks or have suffered from any heart disease
• if you have circulation problems in your legs and/or arms
• if you have a history of stroke or transient ischemic attacks (also known as TIA)
• if you have severe liver problems
• if you have significantly high or uncontrolled blood pressure
• with other medications that contain ergotamine or similar medications such as methysergide or triptans or 5-HT receptor agonists
• with monoamine oxidase inhibitors (MAOIs) or if you have used MAOIs in the last two weeks

Warnings and precautions

Consult your doctor or pharmacist before starting to use Sumatriptán SUN

• if you have any of the following conditions: heart disease, such as heart failure, angina or coronary thrombosis (heart attack), high blood pressure, liver or kidney disease, epilepsy or brain problems (especially postmenopausal women and men over 40 years old should have their heart and blood vessels checked before taking this medication)
• if you have a high risk of developing heart disease due to family history, diabetes, high cholesterol in the blood; if you are a habitual smoker or if you are overweight
• if you are allergic to certain antibiotics (sulfonamides); people allergic to sulfonamides may have allergic reactions to sumatriptán
• if you are taking certain medications for depression called selective serotonin reuptake inhibitors (SSRIs) or norepinephrine reuptake inhibitors (SNRIs) or lithium (a medication used to treat manic/depressive disorders (bipolar)). You may develop serotonin syndrome (including confusion, increased heart rate, tremors, sweating, and muscle twitches). Consult your doctor if you notice any of these symptoms

Despite this, your doctor may advise you to take Sumatriptán SUN and will teach you how to use the injector

Like other migraine treatments, abuse can make the migraine worse and can make the migraine more frequent

Sumatriptán SUN should only be used in cases of clear diagnosis of migraine or cluster headache

Use of Sumatriptán SUN with other medications

Before taking Sumatriptán SUN, inform your doctor:

• if you are taking migraine medications that contain ergotamine or ergotamine derivatives, such as ergotamine tartrate or methysergide maleate (if so, you should stop taking them at least 24 hours before using Sumatriptán SUN)
• if you are taking any prescribed medication for depression, such as monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs) (for example, citalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline) or if you have taken an MAOI in the last two weeks
• if you have been prescribed medications for weight loss or to treat epilepsy
• if you are taking herbal remedies such as St. John's Wort (Hypericum perforatum). Taking this type of medication with Sumatriptán SUN may increase the risk of adverse effects

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using this medication:

• if you are pregnant, think you may be pregnant or intend to become pregnant
• if you are breastfeeding. Your doctor may recommend using Sumatriptán SUN. Breastfeeding should be suspended for 12 hours after using the medication and during this period, the breast milk produced should be discarded

Driving and operating machinery

This medication, like migraine, can cause drowsiness. If you experience these effects, avoid driving or operating machinery as it may be hazardous

Sumatriptán SUN contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per dose, making it essentially "sodium-free"

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

Sumatriptán SUN is usually injected in the thigh.

Read carefully the section “How to use the preloaded pen” located at the end of this leaflet. The preloaded pen will inject a dose of Sumatriptán SUN under the skin quickly and painlessly. The injectionSHOULD NOTbe administered in any other way than described in the leaflet.

DO NOTinject Sumatriptán SUN into a vein.

DO NOTuse Sumatriptán SUN to prevent an attack.

For migraine:

Use a preloaded pen at the first sign of a migraine attack (although it will be equally effective if used at any time during an attack).If after the first dose the migraine is alleviated but then reappears, you may use a second preloaded pen, provided that at least 1 hour has elapsed since the first injection. DO NOT use more than TWO injections in 24 hours.

If the injection does not alleviate your migraine, you may take pain medications, provided they do not containergotamine or its derivatives. Wait at least 6 hours after administration of Sumatriptán SUN before taking any medication that contains ergotamine or its derivatives.

If the symptoms of the migraine do not improve after a first dose,do not administer a second dose for the same attack. Sumatriptán SUN may be used in the next attack.

For cluster headache (cluster headache):

Use ONE preloaded pen for each attack.It should be used at the first sign of cluster headache (although it will be equally effective if used at any time during an attack).DO NOT use more than TWO injections in 24 hours and make sure to leave at least 1 hour between two doses.

Use in children and adolescents (under 18 years)

Sumatriptán injectable should not be used in children and adolescents under 18 years.

Use in elderly people (over 65 years)

There is little experience with the use of sumatriptán injectable in patients over 65 years, so it is usually not prescribed for this age group.

If you use more Sumatriptán SUN than you should

Using more Sumatriptán SUN than prescribed may make you feel sick.

In case of overdose or accidental administration, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount administered

If you have any other questions about the use of this medication,askyour doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Very common (may affect more than 1 in 10 people)(may affect more than 1 in 10 people)

• Transient pain at the injection site
• Itching/burning, redness, inflammation, bruising, and bleeding at the injection site.

Common (may affect up to 1 in 10 people)

• Flush (face redness for a few minutes), dizziness, feeling of weakness, fatigue, drowsiness
• Temporary increases in blood pressure shortly after treatment
• Feeling of dizziness (nausea) and feeling of discomfort (vomiting) not due to migraine crisis
• Pain, unusual sensations such as tingling, numbness, feeling of heat or cold, feeling of heaviness, pressure, or tension. These symptoms usually pass quickly but can be intense and can occur anywhere in the body, including the chest and throat. If these effects continue or are particularly severe, especially chest pain or heart pain that radiates to the arms, notify your doctorimmediatelyas there have been reports that such problems are caused by a heart attack.
• Feeling of suffocation
• Muscle pain (myalgia).

Very rare (may affect up to 1 in 10,000 people)

• Liver function changes: If you have any blood tests to monitor your liver function and have used sumatriptan, inform your doctor or nurse as it may affect the results.

Unknown frequency (cannot be estimated from available data)

• Allergic reactions that can range from skin reactions such as skin rash, urticaria to anaphylactic reactions such as collapse
• Seizures, tremors, muscle contractions, involuntary eye movements
• Vision disturbances including blinking, double vision, and reduced vision. There have been cases where permanent vision defects have occurred.
• Decreases in blood pressure that can lead to feeling of weakness especially when standing up
• Slowing or speeding of heart rate, palpitations (feeling of rapid heartbeats), changes in heart rhythm
• Raynaud's syndrome that can manifest as paleness, blue discoloration of the skin, and/or pain in the fingers of the hands and feet, ear, nose, or jaw in response to cold exposure or stress
• Heart attack
• Chest pain (angina)
• Ischemic colitis with the following symptoms: abdominal pain, rectal bleeding, and fever
• Diarrhea
• Stiffness of the neck
• Joint pain
• Anxiety and sweating.
• 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.
• Difficulty swallowing.

If you show any of the following side effects, consult your doctorimmediatelyanddo notuse more Sumatriptan unless it is with your doctor's consent:

• Acute onset of wheezing, palpitations, or chest tightness, swelling of the face, mouth, lips, or eyelids, skin rash, red patches, or urticaria (skin bumps), which may be signs of an allergic reaction
• Seizures (usually in patients with a history of epilepsy)
• Colitis (inflammation of the colon) that may cause abdominal pain and/or diarrhea with blood
• Raynaud's syndrome that may manifest as paleness, blue discoloration of the skin, and/or pain in the fingers of the hands and feet, ear, nose, and/or jaw in response to cold exposure or stress
• Chest pain (angina)
• Heart attack.

Reporting of 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 prospectus. 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 usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe particles in the solution.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Sumatriptan SUN

• The active ingredient is sumatriptan. Each pre-filled pen contains 6 mg of sumatriptan assumatriptan succinate.
• The other components are sodium chloride and water for injection.

Appearance of the product and contents of the pack

The pre-filled pen contains a transparent, colourless to pale yellow injectable solution.

Each pack contains 1, 2 or 6 pre-filled pens.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Sun Pharma Laboratories, S.L.

Rambla de Catalunya 53-55

08007-Barcelona

Spain

Phone: +34 93 342 78 90

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Last update of the summary of product characteristics: September 2020

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.-----------------------------------------------------------------------------------------------------------------------

Drawing 1

1. White needle cap
2. Viewing window
3. Cartridge
4. Blue activation button

Drawing 2

Drawing 3

1. Remove (without turning)
2. White needle cap
3. Safety guard of the needle

Drawing 4

1. Safety guard of the needle aligned with the tip of the cartridge

1. Safety guard of the needle out
2. Safety guard of the needle fully retracted

Drawing 5

1. Press
2. Release
3. Click
4. Viewing window blue
5. Safety guard of the needle lowers to protect the needle
6. Click

Drawing 6

1. Before use (with white needle cap)
2. Before use (without white needle cap)

After use (safety guard of the needle down)