SUMATRIPTAN SUN 6 mg/0.5 ml INJECTABLE SOLUTION

Introduction

Patient Information: Summary of Product Characteristics

Sumatriptan SUN 6 mg/0.5 ml Solution for Injection EFG

Read the entire summary of product characteristics carefully before starting to use this medication, as it contains important information for you.

• Keep this summary of product characteristics, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this summary of product characteristics. See section 4.

Contents of the Summary of Product Characteristics

1. What is Sumatriptan SUN and what is it used for
2. What you need to know before taking Sumatriptan SUN
3. How to take Sumatriptan SUN
4. Possible side effects
5. Storage of Sumatriptan SUN
6. Package contents and additional information

1. What is Sumatriptan SUN and what is it used for

The active ingredient of Sumatriptan SUN is sumatriptan. It belongs to a group of medications called 5-HT1 receptor agonists.

Sumatriptan is used to treat migraine attacks and a rare condition called cluster headache. Migraine symptoms can be caused by the temporary dilation of blood vessels in the head. This medication reduces such dilation.

2. What you need to know before taking Sumatriptan SUN

Do not take Sumatriptan SUN:

• if you are allergic to sumatriptan or any other component of this medication (listed in section 6)
• if you have had a heart attack or suffered from 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 called mini-stroke)
• if you have severe liver problems
• if you have significantly high or uncontrolled blood pressure
• with other medications containing ergotamine or similar medications, such as ergotamine tartrate or methysergide, or with triptans or 5-HT receptor agonists
• with MAOIs (monoamine oxidase inhibitors) or if you have used MAOIs in the last two weeks

Warnings and precautions

Consult your doctor or pharmacist before taking Sumatriptan 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 in postmenopausal women and men over 40 years old, who should have their heart and blood vessels checked before taking this medication)
• if you are at high risk of developing heart disease due to family history, diabetes, high blood cholesterol, or if you are a habitual smoker or overweight
• if you are allergic to certain antibiotics (sulfonamides); people allergic to sulfonamides may have an allergic reaction to sumatriptan
• if you are taking certain medications for depression, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), or lithium (a medication used to treat manic-depressive disorders). You may develop serotonin syndrome (including mental 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 Sumatriptan SUN and will teach you how to use the injector

As with other antimigraine treatments, abuse can worsen migraine and make it more frequent

Sumatriptan SUN should only be used in cases of clear diagnosis of migraines or cluster headaches

Using Sumatriptan SUN with other medications

Before taking Sumatriptan SUN, inform your doctor:

• if you are taking medications for migraines that contain ergotamine or ergotamine derivatives, such as ergotamine tartrate or methysergide (if so, you should stop taking them at least 24 hours before using Sumatriptan SUN)
• if you are taking any prescribed medication for depression, such as monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs) (e.g., citalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline), or if you have taken an MAOI in the last two weeks
• if you are taking lithium (a medication for manic-depressive disorders)
• 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 these medications with Sumatriptan SUN may increase the risk of side effects

Inform your doctor or pharmacist if you are using, have recently used, 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 plan to become pregnant
• if you are breastfeeding. You may still be advised to use Sumatriptan SUN while breastfeeding. Breastfeeding should be suspended for 12 hours after using the medication, and the breast milk produced during this period should be discarded

Driving and using machines

This medication, like migraines, can cause drowsiness. If you experience these effects, avoid driving or using machines, as it may be dangerous

Sumatriptan SUN contains sodium

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

3. How to take Sumatriptan SUN

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again

Sumatriptan SUN is usually injected into the thigh

Read the section "How to use the pre-filled pen" carefully, which can be found at the end of this summary of product characteristics. The pre-filled pen will inject a dose of Sumatriptan SUN under the skin quickly and painlessly. The injection must notbe administered in any way other than as described in the summary of product characteristics

Do notinject Sumatriptan SUN into a vein

Do notuse Sumatriptan SUN to prevent an attack

For migraines:

Use a pre-filled 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 relieved but then returns, you can use a second pre-filled pen, provided that at least 1 hour has passed since the first injection. Do notuse more than TWO injections in 24 hours

If the injection does not relieve your migraine, you can take pain medications, provided they do not contain ergotamine or its derivatives. Wait at least 6 hours after administering Sumatriptan SUN before taking any medication that contains ergotamine or its derivatives

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

For cluster headaches:

Use ONE pre-filled pen for each attack. It should be used at the first sign of a cluster headache (although it will be equally effective if used at any time during an attack). Do notuse 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 old)

Sumatriptan injectable should not be used in children and adolescents under 18 years old

Use in elderly patients (over 65 years old)

There is limited experience with the use of sumatriptan injectable in patients over 65 years old, so it is not normally prescribed for this age group

If you use more Sumatriptan SUN than you should

Using more Sumatriptan SUN than prescribed may make you feel unwell

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

If you have any further questions about the use of this medication, ask your doctor or pharmacist

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them

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

• transient pain at the injection site
• tingling/burning, redness, inflammation, bruising, and bleeding at the injection site

Common (may affect up to 1 in 10 people)

• flushing (redness of the face for a few minutes), dizziness, feeling of weakness, fatigue, drowsiness
• temporary increases in blood pressure shortly after treatment
• feeling of nausea and vomiting not due to the migraine attack
• 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 problems that spread to the arms, inform your doctor immediately, as there have been reports of such problems being caused by a heart attack
• shortness of breath
• muscle pain (myalgia)

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

• changes in liver function: 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

Frequency not known (cannot be estimated from available data)

• allergic reactions, which can range from skin reactions such as rash, hives to anaphylactic reactions such as collapse
• seizures, tremors, muscle contractions, involuntary eye movements
• vision disorders, 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 feelings of weakness, especially when standing up
• slowing or acceleration of heart rate, palpitations (feeling of rapid heartbeat), changes in heart rhythm
• Raynaud's syndrome, which can 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 or stress
• heart attack
• chest pain (angina)
• ischemic colitis with symptoms such as abdominal pain, rectal bleeding, and fever
• diarrhea
• stiffness of the neck
• joint pain
• anxiety and sweating
• If you have had a recent injury or 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 experience any of the following side effects, consult your doctor immediatelyand do notuse more Sumatriptan SUN unless advised by your doctor:

• wheezing (whistling when breathing), palpitations, or chest tightness, swelling of the face, mouth, lips, or eyelids, skin rashes, red spots, or hives, which can be signs of an allergic reaction
• seizures (usually in patients with a history of epilepsy)
• inflammation of the colon (part of the intestine) that can cause lower abdominal pain and/or bloody diarrhea
• Raynaud's syndrome, which can 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 or stress
• chest pain (angina)
• heart attack

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this summary of product characteristics. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication

5. Storage of Sumatriptan SUN

Keep this medication out of sight and reach of children

Do not use this medication after the expiration date stated 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 notice particles in the solution

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment

6. Package contents and additional information

Composition of Sumatriptan SUN

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

Appearance of the product and package contents

The pre-filled pen contains a clear, colorless to pale yellow injectable solution.

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Sun Pharma Laboratories, S.L.

Rambla de Catalunya 53-55

08007-Barcelona

Spain

Tel: +34 93 342 78 90

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: 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/. -----------------------------------------------------------------------------------------------------------------------

Drawing 1

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

Drawing 2

Drawing 3

1. Remove (without twisting)
2. White needle cap
3. Safety shield of the needle

Drawing 4

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

1. Safety shield of the needle extended
2. Safety shield of the needle fully retracted

Drawing 5

1. Press
2. Release
3. Click
4. Blue control window
5. Safety shield 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 shield of the needle lowered)