Sumatriptan 6 mg/0.5 ml Solution for Injection

• 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.

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

• If you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in Section 6).
• If you have heart problems or you already had a heart attack
• If you have circulation problems in your arms and legs
• If you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA)
• If you have serious liver disease
• If you have severe or uncontrolled high blood pressure.
• With other migraine medicines containing ergotamine, or similar medicines like methylsergide, or any triptan or 5-HT agonist.
• With MAOIs (monoamine oxidase inhibitors) or if you have taken a MAOI in the last two weeks.

Talk to your doctor before using Sumatriptan Injection, if

• you have any of the following medical conditions: heart disease such as heart failure, angina or coronary thrombosis (heart attack), high blood pressure, disease of the liver or kidneys, epilepsy or brain disease (especially postmenopausal women and males over 40 years of age should have their heart and blood vessels checked before using this medicine),
• you have any risk factors for heart disease such as family history of heart disease; sugar diabetes; high blood cholesterol; if you are a regular cigarette smoker or if you are very overweight,
• you are allergic to certain antibiotics (sulphonamides); people allergic to sulphonamides may experience an allergic reaction to sumatriptan.
• you use certain medicines to treat a depression (a so called SSRI or SNRI) or lithium (a medicine used to treat manic/depressive (bipolar) disorders). You may develop the serotonin syndrome (including mental confusion, increased heart rate, shivering, sweating and muscle twitching). Ask your doctor for advice if you notice any of these symptoms.

After discussing the above, your doctor may still advise you to use Sumatriptan Injection and will instruct you about using the injection.

As with other migraine treatments, overuse could make your migraine worse and make them occur more often.

You may only use Sumatriptan Injection when your doctor is certain that you suffer from migraine headache or cluster headache.

Before using Sumatriptan Injection tell your doctor if:

• you are taking any medicines for your migraine which 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 Injection),
• you are taking any medicines on a doctor’s prescription for the treatment of depression such as MAOI's or SSRI's (including citalopram, fluoxetine, fluvoxamine, paroxetine and sertraline), or if you have taken an MAOI in the last 2 weeks,
• you are taking lithium (a medicine used to treat manic/depressive (bipolar) disorders),
• you are taking any medicines on a doctor’s prescription to help you lose weight, or for the treatment of epilepsy,
• you are taking anything containing the herbal remedy St John’s Wort (Hypericum perforatum). Taking this together with Sumatriptan Injection may increase the likelihood of you suffering side effects.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Ask your doctor or pharmacist for advice before taking this medicine

• if you are pregnant, think you may be pregnant or are planning to have a baby
• if you are breastfeeding. Your doctor may still advise you to use sumatriptan, but breastfeeding should be avoided for 12 hours after a dose and during this time any breast milk expressed should be discarded.

Sumatriptan Injection may cause drowsiness. If you are affected do not drive or operate machinery.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose (i.e. 0.5 ml), i.e. essentially ‘sodium-free’.

Use one 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 your first dose, your migraine goes away but then returns, you may use another pre-filled pen, provided it is at least an hour since the first injection. DO NOT use more than TWO injections in 24 hours.

If the injection does not ease your migraine, you may then take your usual ’pain killers’, provided they do not contain ergotamine or its derivatives. Wait at least six hours after using Sumatriptan Injection before taking any medicines containing ergotamine or its derivatives.

If your migraine does not go, do not use a second one for the same attack. Sumatriptan Injection can be used for your next attack.

Use ONE pre-filled pen for each cluster attack. It should be used at the first sign of cluster headaches (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 you leave at least one hour between the two doses.

Sumatriptan Injection should not be used in children and adolescents under 18 years of age.

There is little experience of Sumatriptan Injection in those over 65 years of age so it is not usually prescribed for this age group.

Using more than prescribed may make you ill. If an overdose is used, DO NOT DELAY, ask your doctor what to do or contact your nearest accident and emergency department.

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

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, website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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

Pre-filled pen, containing a clear colourless to pale solution for injection.

Each carton contains 1, 2, 6 or 12 pre-filled pens.

Not all package sizes may be marketed.

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany TEMPIL 6 mg/0,5 ml Injektionslösung

Denmark Sumatriptan SUN 12 mg/ ml injektionsvæske, opløsning

Spain Sumatriptán SUN 6 mg/0,5 ml solución inyectable EFG

France Sumatriptan SUN 6 mg/0,5 ml solution injectable

Italy Sumatriptan SUN 6 mg/0,5 ml soluzione iniettabile

Netherlands Sumatriptan SUN 6 mg/0,5 ml oplossing voor injectie

Norway Sumatriptan SUN 12 mg/ml injeksjonsvæske, oppløsning

Sweden Sumatriptan SUN 12 mg/ml injektionsvätska, lösning

United Kingdom Sumatriptan 6 mg/0.5 ml solution for injection

• Check the appearance of Sumatriptan, through the inspection window. It must be a clear, colorless to pale yellow solution. Do not inject the solution if it looks discolored or cloudy or contains lumps, flakes, or particles.
• Do not remove the white needle shield from the pre-filled pen until you are ready to inject.
• NEVER put the white needle shield back into the pre-filled pen.
• NEVER put or press thumb, fingers, or hand over white needle cover.

a) Wash your hands thoroughly.
b) Find a comfortable, well-lit place and put everything you need where you can reach it (pre-filled pen, alcohol or sterile swabs).
c) Identify the application area with an adequate fatty tissue layer, for example on the upper arm or thigh.
Do not inject into areas where the skin is tender, bruised, red, or hard.
d) Wipe the injection site with alcohol or a new sterile swab and allow your skin to dry. Do not touch this area again before giving the injection.
e) Take out the pre-filled pen from carton box.
f) Pick up the pre-filled pen in one hand and smoothly remove the white needle shield by pulling it straight off with your other hand. Do not twist it off, and do not recap the white needle shield, as either of these may damage the needle inside the pre-filled pen.

(1) Without pressing the blue activation button, place the open end of the pre-filled pen on the injection site, straight up at a right angle (90º) and push the safety needle cover firmly against the skin to unlock. The pre-filled pen works only when the safety needle cover is fully retracted.

Continue to hold the pre-filled pen firmly against the skin.

(2) Press and release the blue activation button (a first click will sound). This starts the injection.
(3) Do not lift the pre-filled pen off the skin.
(4) Wait until you hear a second click. The inspection window will turn blue, confirming that the injection is complete.
(5) Lift the pre-filled pen straight up from the injection site. The injection is finished.

If the inspection window is not blue, do not try to use the pre-filled pen again.

(6) The safety needle cover on the pre-filled pen will automatically extend to cover the needle and lock into place. The needle will not be visible now.

There is no need to replace the white needle shield.

NEVER ATTEMPT TO REUSE A PRE-FILLED PEN.

If you suspect you have not received the full dose, do not repeat the injection using a new pre-filled pen.

(7) If you notice a spot of blood at the injection site, dab away with a cotton ball or tissues. Do not rub the injection site. If needed, you may cover the injection site with a bandage.