SUMATRIPTAN SUN 3 mg/0.5 mL Injectable Solution in Pre-filled Pen

Introduction

Package Leaflet: Information for the Patient

Sumatriptan SUN 3mg/0.5mlinjectable solution in a pre-filled pen

Sumatriptan

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, 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 package leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

This medication is used to treat migraine attacks. Migraine symptoms can be caused by temporary inflammation of blood vessels in the head. It is believed that this medication works by constricting these blood vessels.

2. What you need to know before taking Sumatriptan SUN

Do not use Sumatriptan SUN:

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

Warnings and precautions

Consult your doctor before starting to use Sumatriptan SUN

• if you have any of the following diseases: 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, the heart and blood vessels should be checked before taking this medication.
• if you have risk factors for developing heart disease, such as being a heavy smoker or undergoing nicotine replacement therapy, and especially if you are a postmenopausal woman or a man over 40. In very rare cases, serious heart disease has occurred after taking Sumatriptan, even without prior signs of heart disease. If you have any of these risk factors, it may mean that you have a higher risk of developing heart disease, and your heart function should be checked before using this medication.
• if you are allergic to certain antibiotics (sulfonamides); people allergic to sulfonamides may have allergic reactions to sumatriptan.
• if you are taking certain medications for depression called selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) or lithium (a medication used to treat manic/depressive disorders (bipolar)).

Despite this, your doctor may advise you to take this medication and will teach you how to use the injectable.

As with other antimigraine treatments, abuse can make migraine worse and more frequent.

This medication should only be used in cases of clear diagnosis of migraines.

Consult your doctor immediately if you experience symptoms such as mental confusion, increased heart rate, trembling, sweating, and muscle spasms. These can be signs of a serious condition called "serotonin syndrome."

Using Sumatriptan SUN with other medications

Before taking Sumatriptan SUN, inform your doctor:

• if you are taking medications for migraine 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 sumatriptan).
• if you are taking any medication prescribed 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 (bipolar)).
• 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 sumatriptan may increase the chances of experiencing side effects.

Tell 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 while breastfeeding. Breastfeeding should be stopped for 12 hours after using the medication, and the breast milk produced during this period should be discarded.

Driving and using machines

This medication can cause drowsiness. Do not drive or operate machines if you are affected.

Sumatriptan SUNcontains sodium

This medication contains less than 1 mmol (23 mg) of sodium per dose (3 mg), so it is considered essentially "sodium-free."

3. How to use 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 or upper arm.

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

Do notinject Sumatriptan SUN into a vein.

Do notuse Sumatriptan SUN to prevent an attack.

Use the pre-filled pen as soon as migraine symptoms appear (however, it will be equally effective at any time during an attack).

If your migraine disappears but your symptoms come back

If, after the first dose, the migraine is relieved but then returns, you can use a second pre-filled pen within the next 24 hours, provided that at least 1 hour has passed since the first injection. Do notuse more than TWOpre-filled pens in 24 hours.

If your migraine does not disappear

Do not administer a second dose for the same attack. This medication can be used for the next attack at any time within the next 24 hours, provided that at least 1 hour has passed since the first injection. Do not use more than two pre-filled pens in 24 hours.

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

Use in children and adolescents (under 18 years)

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

Use in elderly people (over 65 years)

There is limited experience with the use of sumatriptan injectable in patients over 65 years, 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 can make you ill.

In case of overdose, 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 experiences them.

Serious side effects

The following side effects have been reported (whose frequency is unknown)

If you experience the following side effects, contact your doctor immediately, and do not use this medication again unless your doctor tells you to:

• sudden wheezing, palpitations, or chest tightness, swelling of the face, lips, or eyelids, skin rash, redness, 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), which can cause lower left abdominal pain and/or bloody diarrhea, with fever (ischemic colitis)
• Raynaud's syndrome, which can manifest as paleness or bluish discoloration of the skin and/or pain in the fingers of the hands and feet, or ear, nose, or jaw in response to cold or stress
• chest pain (angina)

• heart attack

Other side effects

Very common(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)

• flushing (redness of the face for a few minutes), dizziness, feeling of weakness, fatigue, drowsiness
• short-term increases in blood pressure shortly after treatment
• nausea (feeling sick) and vomiting (being sick), not due to the migraine attack
• pain, unusual sensations such as tingling, numbness, sensation of heat or cold, sensation 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 rare reports of such problems being caused by a heart attack.
• feeling of suffocation
• 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)

• 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.
• drops in blood pressure that can lead to feelings of weakness, especially when standing up
• slowing or acceleration of heart rate, palpitations (feeling of rapid heartbeats), changes in heart rhythm
• diarrhea
• stiffness of the neck
• joint pain
• anxiety and sweating.
• If you have had a recent injury or have inflammation (such as rheumatism or colitis), you may experience pain or worsening of pain at the site of the injury or inflammation.
• difficulty swallowing.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sumatriptan SUN

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

Do not use this medication after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special temperature conditions for storage. Store in the original packaging to protect it from light.

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. Container Contents and Additional Information

Composition of Sumatriptan SUN

• The active ingredient is sumatriptan. Each pre-filled pen contains sumatriptan succinate equivalent to 3 mg of sumatriptan.
• The other components are sodium chloride and water for injectable preparations.

Appearance of the Product and Container Contents

The pre-filled pen contains a clear, colorless to pale yellow injectable solution without visible particles.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Județul Cluj

Romania

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

Sun Pharma Laboratories, S.L.

Rambla de Catalunya 53-55

08007-Barcelona

Spain

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

Germany MIGRAPEN

Spain Sumatriptan SUN 3 mg/0.5 ml solution for injection in pre-filled pen

France Sumatriptan SUN

Italy Sumatriptan SUN Pharma

Netherlands Sumatriptan SUN

Norway Sumatriptan SUN

Poland Sumatriptan SUN

Romania Sumatriptan SUN

Sweden Sumatriptan SUN

United Kingdom Sumatriptan

Date of the last revision of this leaflet: September 2020

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

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How to Use Sumatriptan SUN 3mg/0.5ml Solution for Injection in Pre-filled Pen

This leaflet explains how to use the Sumatriptan SUN pre-filled pen.

Read it TWICE before starting with step 1. If you have any doubts, consult your doctor or pharmacist.

Only for use in patients who have been prescribed a dose of 3 mg.

Front View of the Pre-filled Pen

Drawing 1

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

PRECAUTIONS:

• Checkthe appearance of Sumatriptan SUN through the control window. The solution should be clear, colorless to pale yellow. Do not administer the product if it appears discolored or cloudy or contains lumps, scales, or particles.

• Do notremove the white cap that covers the needle of the pre-filled pen until you are ready to inject.

• NEVERput the white needle cap back on the pre-filled pen.

• NEVERplace or press your thumb, fingers, or hand on the white needle cap.

How to Use the Pre-filled Pen

(a) Wash your hands thoroughly.

(b) Find a comfortable and well-lit place, and put everything you need within reach (pre-filled pen, alcohol, or a sterile swab).

(c) Identify an area with sufficient fat, such as the upper arm or thigh for administration (Drawing 2).

Do not inject into areas where the skin is sensitive, bruised, red, or hard.

Drawing 2

(d) Clean the injection site with alcohol or a sterile swab and let the skin dry. Do not touch this area again before administering the injection.

(e) Remove the pre-filled pen from the carton.

(f) Hold the pre-filled pen with one hand and gently remove the white needle cap with the other hand (Drawing 3). Do not twist it, and do not put it back, as this could damage the needle of the pre-filled pen.

Drawing 3

1. Remove (without twisting)
2. White needle cap
3. Safety needle protector

Keep the Pre-filled Pen Pressing Firmly Against the Skin

Drawing 4

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

1. Safety needle protector outward
2. Safety needle protector fully retracted

1. Press and immediately release the blue activation button (you will hear a first click). This starts the injection (Drawing 5a).

Drawing 5aDrawing 5b

1. Press
2. Release
3. Click
4. Blue inspection window
5. Safety protector lowers to protect the needle
6. Click

1. Do not lift the pre-filled pen from the skin.
2. Wait until you hear a second click. The control window will turn blue, confirming that the injection is complete (Drawing 5b).
3. Remove the pre-filled pen from the injection site. The injection is now complete.

If the control window is not blue, do not attempt to reuse the pre-filled pen.

1. The safety needle protector will automatically lower to cover the needle and will remain locked in this position. The needle will no longer be visible. It is not necessary to put the white needle cap back on (Drawing 6).

Drawing 6

1. Before use (with white needle cap)
2. Before use (without white needle cap)
3. After use (safety needle protector lowered)

NEVER ATTEMPT TO REUSE A PRE-FILLED PEN.

If you think you have not received the full dose, do not administer another dose with a new pre-filled pen.

(7) If you see a blood stain at the injection site, clean it with a cotton swab or a handkerchief. Do not rub the injection site. If necessary, you can cover the injection site with a plaster.