Sumatriptan Sun 6 mg/0.5 ml solution for injection EFG

Patient Information Leaflet

Introduction

Package leaflet: information for the patient

Sumatriptan SUN 6 mg/0.5 ml injectable solution EFG

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

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

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

Sumatriptan is used to treat migraine attacks and to treat a rare condition called cluster headache. The symptoms of migraine may be caused by the temporary dilation of blood vessels in the head. This medicine reduces that dilation.

2. What you need to know before using Sumatriptán SUN

Do not use Sumatriptán SUN:

• if you are allergic to sumatriptan or to any of the other ingredients of this medicine (listed in section 6)
• if you have ever had heart attacks 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 known as TIA)
• if you have severe liver problems
• if you have significantly high or uncontrolled blood pressure
• together with other medicines containing ergotamine or similar medicines such as methysergide, or with triptans or 5-HT receptor agonists
• with MAOIs (monoamine oxidase inhibitors), or if you have taken MAOIs within the last two weeks

Warnings and precautions

Talk to your doctor or pharmacist before using Sumatriptán SUN

• if you suffer from 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 disorders (especially women after menopause and men over 40 years of age should have their heart and blood vessels checked before taking this medicine)
• if you are at high risk of developing heart disease due to family history, diabetes, high cholesterol, if you are a regular smoker, or if you are overweight
• if you are allergic to certain antibiotics (sulfonamides); people allergic to sulfonamides may have allergic reactions to sumatriptan
• if you are taking certain medicines for depression called selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), or lithium (a medicine used to treat manic/depressive disorders (bipolar)). You may develop serotonin syndrome (including mental confusion, increased heart rate, tremors, sweating, and muscle twitching). Consult your doctor if you experience any of these symptoms.

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

As with other migraine treatments, overuse may cause headaches to worsen and may lead to more frequent migraine attacks.

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

Using Sumatriptán SUN with other medicines

Before taking Sumatriptán SUN, inform your doctor:

• if you are taking migraine medicines containing ergotamine or ergotamine derivatives, such as ergotamine tartrate or methysergide maleate (in such cases, you must stop taking them at least 24 hours before using Sumatriptán SUN)
• if you are taking any prescribed medicines for depression, such as monoamine oxidase inhibitors (MAOIs) or serotonin reuptake inhibitors (SSRIs) (e.g., citalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline), or if you have taken an MAOI within the last two weeks
• if you are taking lithium (a medicine used to treat manic/depressive (bipolar) disorders)
• if you have been prescribed medicines for weight loss or to treat epilepsy
• if you are taking herbal remedies such as St. John’s wort (Hypericum perforatum). Taking these products together with Sumatriptán SUN may increase the likelihood of adverse effects

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using this medicine:

• if you are pregnant, think you might be pregnant, or plan to become pregnant
• if you are breastfeeding. It is possible that your doctor may still recommend using Sumatriptán SUN while breastfeeding. Breastfeeding must be suspended for 12 hours after taking the medicine, and breast milk produced during this period should be discarded.

Some women have reported breast and/or nipple pain after using sumatriptan. This pain is usually temporary and resolves within 3 to 12 hours.

Driving and using machines

This medicine, like migraine itself, may cause drowsiness. If you experience these effects, avoid driving or operating machinery, as it could be dangerous.

Sumatriptán SUN contains sodium

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

3. How to use Sumatriptán SUN

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Sumatriptán SUN is usually injected into the thigh.

Read carefully the section “How to use the pre-filled pen” at the end of this leaflet. The pre-filled pen will deliver a dose of Sumatriptán SUN under the skin quickly and painlessly. The injection MUST NOT be administered in any way other than that described in the leaflet.

DO NOT inject Sumatriptán SUN into a vein.

DO NOT use Sumatriptán SUN to prevent an attack.

For migraine:

Use one pre-filled pen at the first sign of a migraine attack (although it will still be effective if used at any time during an attack). If after the first dose the migraine improves but then returns, you may use a second pre-filled pen, provided at least 1 hour has passed since the first injection. Do NOT use more than TWO injections within 24 hours.

If the injection does not relieve your migraine, you may take painkillers, provided they do not contain ergotamine or its derivatives. Wait at least 6 hours after administration of Sumatriptán SUN before taking any medicine containing ergotamine or its derivatives.

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

For cluster headache:

Use ONE pre-filled pen per attack. It should be used at the first sign of cluster headache (although it will still be effective if used at any time during an attack). Do NOT use more than TWO injections in 24 hours, and ensure at least one hour elapses between doses.

Use in children and adolescents (under 18 years of age)

Injectable sumatriptan must not be used in children and adolescents under 18 years of age.

Use in elderly patients (over 65 years of age)

There is limited experience with the use of injectable sumatriptan in patients over 65 years of age, and therefore it is generally 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 unwell.

In case of overdose or accidental administration, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount administered.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• transient pain at the injection site
• itching/burning, redness, swelling, bruising, and bleeding at the injection site.

Common (may affect up to 1 in 10 people)

• flushing (facial redness lasting a few minutes), dizziness, feeling of weakness, fatigue, drowsiness
• temporary increases in blood pressure shortly after treatment
• feeling of dizziness (nausea) and feeling unwell (vomiting), not due to the migraine attack
• pain, unusual sensations such as tingling, numbness, sensation of heat or cold, feeling of heaviness, pressure or tightness. These symptoms usually pass quickly but may be intense and can occur anywhere in the body, including the chest and throat. If these effects persist or are particularly severe, especially chest or heart pain radiating to the arms, inform your doctor immediately, as there have been reports of such problems being caused by a heart attack.
• sensation of suffocation
• muscle pains (myalgia).

Rare (may affect up to 1 in 1,000 people)

- breast pain.

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 test results.

Frequency not known (cannot be estimated from available data)

• Allergic reactions, ranging from skin reactions such as rash and hives to anaphylactic reactions such as collapse
• Seizures, tremors, muscle contractions, involuntary eye movements
• Vision disorders including flickering, double vision, and reduced vision. Cases of permanent vision defects have been reported.
• Decreases in blood pressure that may lead to feelings of weakness, especially when standing up
• Slowing down or speeding up of heart rate, palpitations (sensation of rapid heartbeat), changes in heart rhythm
• Raynaud's syndrome, which may manifest as paleness, bluish discoloration of the skin, and/or pain in the fingers and toes, ear, nose, or jaw, in response to exposure to cold or stress
• Heart attack
• Chest pain (angina)
• Ischemic colitis with the following symptoms: abdominal pain, rectal bleeding, and fever
• Diarrhea
• Neck stiffness
• Joint pain
• Anxiety and sweating
• If you have recently sustained an injury or have inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening of pain at the site of injury or inflammation
• Difficulty swallowing

If you experience any of the following adverse effects, consult your doctor immediately and do not use Sumatriptan again unless instructed by your doctor:

• Sudden wheezing (whistling sound when breathing), palpitations, chest tightness, swelling of the face, mouth, lips, or eyelids, skin rash, red spots, or hives (lumps on the skin), which may be signs of an allergic reaction
• Seizures (usually in patients with a history of epilepsy)
• Inflammation of the colon (part of the intestine), which may cause lower abdominal pain and/or bloody diarrhea
• Raynaud's syndrome, which may manifest as paleness, bluish discoloration of the skin, and/or pain in the fingers and toes, ear, nose, and/or jaw, in response to exposure to cold or stress
• Chest pain (angina)
• Heart attack

Reporting of adverse reactions

If you experience any adverse reaction, talk to your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Sumatriptan SUN

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice particles in the solution.

Medicines and their containers must not be disposed of via the sewage system or with household waste. Unused medicines and containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Sumatriptan SUN

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

Appearance of the product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007-Barcelona
Spain
Tel: +34 93 342 78 90

This medicinal product is authorised in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: September 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.-----------------------------------------------------------------------------------------------------------------------

Figure 1

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

Figure 2

Figure 3

1. Remove (without twisting)
2. White needle cap
3. Needle safety shield

Figure 4

1. Needle safety shield aligned with tip of the cartridge

1. Needle safety shield extended
2. Needle safety shield fully retracted

Figure 5

1. Press
2. Release
3. Click
4. Blue inspection window
5. Safety shield moves down to protect the needle
6. Click

Figure 6

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

After use (needle safety shield deployed)