Sumatriptan Sun

Patient Information Leaflet

Sumatriptan SUN 6 mg/0.5 ml Solution for Injection

Sumatriptan
Equivalent medicine
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. 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 yours, as it could be harmful. If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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. How to store Sumatriptan SUN
6. Contents of the pack and other information

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

The active substance in Sumatriptan SUN is sumatriptan. It belongs to a group of medicines known as 5HT receptor agonists.
Sumatriptan is used for the treatment of migraine and a rare condition called cluster headache. The symptoms of migraine may be due to a temporary swelling of the blood vessels in the head. Sumatriptan is thought to work by reducing the size of these blood vessels.

2. What you need to know before using Sumatriptan SUN

• Do not use Sumatriptan SUN if you are allergic to sumatriptan or to any of the other ingredients of this medicine (listed in section 6).
• If you have heart problems or have previously had a heart attack.
• If you suffer from circulation problems in the arms and legs.
• If you have had a stroke or a mini-stroke (also known as transient ischemic attack or TIA).
• If you have severe liver disease.
• If you suffer from severe or uncontrolled high blood pressure.
• together with other migraine medications containing ergotamine or similar medicines such as methysergide, or other triptans or 5-HT agonists.
• together with MAOIs (monoamine oxidase inhibitors), or if you have taken an MAOI within the past two weeks.

Warnings and precautions
Talk to your doctor before using Sumatriptan SUN

• if you suffer from any of the following medical conditions: heart disease, such as heart failure, angina, or coronary thrombosis (heart attack), high blood pressure, liver or kidney disease, epilepsy or brain disorders (particularly women in postmenopause and men over 40 years of age should undergo cardiac and vascular assessment before using this medicine),
• if you have risk factors for heart disease, such as a family history of heart disease; diabetes mellitus; high cholesterol levels in the blood; if you are a regular smoker or if you are severely overweight;
• if you are allergic to certain antibiotics (sulfonamides); patients allergic to sulfonamides may develop an allergic reaction to sumatriptan;
• if you are being treated with certain medications for depression (so-called SSRIs or SNRIs), or lithium (a medicine used to treat manic/depressive disorders (bipolar). A serotonin syndrome may occur (including mental confusion, increased heart rate, chills, sweating, and muscle spasms). Consult your doctor if you experience these symptoms.

After reporting the above conditions, your doctor may still recommend the use of
Sumatriptan SUN and instruct you on how to administer the injection.
As with other migraine treatments, excessive use may worsen and increase the frequency of
your migraine attacks.
Use Sumatriptan SUN only when your doctor is certain that you suffer from migraine or cluster headache.
Other medicines and Sumatriptan SUN
Before using Sumatriptan SUN, inform your doctor

• if you are taking other migraine medications containing ergotamine or its derivatives, such as ergotamine tartrate and methysergide maleate (in this case, discontinue their use at least 24 hours before using Sumatriptan SUN),
• if you are taking other medications prescribed by your doctor for depression, such as MAOIs or SSRIs (including citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline), or if you have taken an MAOI within the past 2 weeks,
• if you are taking lithium (a medicine used to treat manic/depressive (bipolar) disorders),
• if you are taking other prescription medicines prescribed by your doctor to help you lose weight or for the treatment of epilepsy,
• if you are taking a herbal preparation containing St. John's wort (Hypericum perforatum). Concomitant use with Sumatriptan SUN may increase the likelihood of side effects. Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before using this medicine,

• if you are pregnant, suspect you may be pregnant, or are planning a pregnancy,
• if you are breastfeeding. Your doctor may still advise you to take sumatriptan, but breastfeeding should be avoided for 12 hours after taking the medicine; milk produced during this time should be discarded.

Driving and using machines
Sumatriptan may cause drowsiness. If affected, do not drive or operate machinery.
Sumatriptan SUN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose (i.e. 0.5 ml), therefore it is
essentially 'sodium-free'.

3. How to use Sumatriptan SUN

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Sumatriptan 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 Sumatriptan SUN just under the skin, quickly and painlessly. DO NOT administer the injection in any other way than described.
DO NOT inject Sumatriptan SUN into a vein.
DO NOT use Sumatriptan SUN to try to prevent or prevent a migraine attack.

For migraine:
Use one pre-filled pen at the first signs of a migraine attack (although the medicine is equally effective at any time during an attack). If, after the first dose, the migraine disappears but then returns, use another pre-filled pen provided at least one hour has passed since the first injection.
Do not administer more than TWO injections within 24 hours.
If the injection does not relieve the migraine, you may take your usual painkiller, provided it does not contain ergotamine or its derivatives. Wait at least six hours after administration of Sumatriptan SUN before taking medicines containing ergotamine or its derivatives.
If the migraine still does not go away, do not take a second painkiller for the same attack. For the next attack, however, you may use Sumatriptan SUN.

For cluster headache:
Use ONE pre-filled pen for each cluster headache attack. It should be used at the first signs of cluster headache (although the medicine is equally effective at any time during an attack). Do not administer more than TWO injections in 24 hours, and ensure that at least one hour has passed between the two 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 the elderly (over 65 years of age)
Experience with injectable sumatriptan is limited in patients over 65 years of age; therefore, the medicine is not usually prescribed for patients in this age group.

If you use more Sumatriptan SUN than you should
Taking more of the product than prescribed is harmful. If you have taken more than the recommended dose, DO NOT DELAY, contact your doctor or go to the nearest emergency department immediately.
If you have any further doubts about using this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Very common: may affect more than 1 in 10 people

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

Common: may affect from 1 to 10 in 100 people

• flushing (reddening of the face lasting several minutes), dizziness, feeling of weakness, fatigue and drowsiness
• short-term increase in blood pressure immediately after administration of the medicine
• feeling unwell (nausea) or malaise (vomiting) – if these symptoms are not already part of the migraine attack
• pain, unusual sensations such as tingling, numbness, sensation of heat or cold, heaviness, pressure. These symptoms usually resolve quickly but may be intense and may affect any part of the body, including the chest and throat. If they persist or are particularly severe, especially chest or heart pain radiating to the arms, contact your doctor immediately, as it has been rarely reported that these problems were caused by a heart attack.
• shortness of breath
• muscle pain (myalgia).

Very rare: may occur in less than 1 in 10,000 people

• changes in liver function: if you have taken sumatriptan and need to undergo blood tests to assess liver function, inform your doctor, as this medicine may affect the results of such tests.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• hypersensitivity reactions, which may range from skin reactions such as rash and urticaria to anaphylactic reactions, for example collapse
• seizures, tremors, muscle contractions, involuntary eye movements
• visual disturbances, including tremor, double vision and blurred vision. Cases of permanent vision defects have been reported.
• low blood pressure, which may cause a feeling of faintness, especially when moving to an upright position
• slowed or rapid heartbeat, palpitations (awareness of rapid heartbeat), changes in heart rhythm
• Raynaud's phenomenon, which may manifest as paleness or bluish discoloration of the skin and/or pain in the fingers of the hands and feet, ears, nose or jaws in response to cold or stress
• heart attack
• chest pain (angina)
• ischemic colitis with the following symptoms: abdominal pain, rectal bleeding and fever
• diarrhoea
• neck stiffness
• joint pain
• anxiety, sweating.

If any of the following side effects occur, contact your doctor immediately and do not use sumatriptan until your doctor allows you to do so.

• sudden onset of breathlessness, chest tightness or constriction, swelling of the eyelids, face or lips, skin rash – red spots or wheals (bumps on the skin), which may be signs of an allergic reaction
• seizures (usually in patients with a history of epilepsy)
• inflammation of the colon (a part of the intestine), which may present as lower left-sided abdominal pain and/or bloody diarrhoea
• Raynaud's phenomenon, which may appear as paleness or bluish discoloration of the skin and/or pain in the fingers of the hands and feet, ears, nose or jaws as a reaction to cold or stress
• chest pain (angina)
• heart attack.

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

5. How to store 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 that month.
This medicine does not require any special storage conditions.
Do not use Sumatriptan SUN if you notice the presence of particles in the solution.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required, including pre-filled pens, or follow local instructions for
disposing of used pens. This will help protect the environment.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sumatriptan SUN contains

• 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.

Description of the appearance of Sumatriptan SUN and contents of the pack
Pre-filled pen containing a clear, colourless to slightly yellow, transparent injectable solution.
Each carton contains 1, 2 or 6 pre-filled pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder (AIC):
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Local representative in Italy:
SUN Pharmaceuticals Italia Srl – Via Luigi Rizzo, 8 - 20151 Milan, Italy

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

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Denmark: Sumatriptan SUN 6 mg/0.5 ml solution for injection
Germany: Sumatriptan-Hormosan Inject 6 mg/0.5 ml solution for injection
Spain: Sumatriptan SUN 6 mg/0.5 ml solution for injection
France: Sumatriptan SUN 6 mg/0.5 ml solution for injection
Italy: Sumatriptan SUN 6 mg/0.5 ml solution for injection
Netherlands: Sumatriptan SUN 6 mg/0.5 ml solution for injection
Norway: Sumatriptan SUN 12 mg/ml solution for injection
Sweden: Sumatriptan SUN 12 mg/ml solution for injection
United Kingdom: Sumatriptan 6 mg/0.5 ml solution for injection

HOW TO USE THE PRE-FILLED PEN
Figure 1
(Front view of the pre-filled pen)
Sumatriptan SUN 6 mg/0.5 ml, Solution for injection

This leaflet explains how to use the Sumatriptan SUN pre-filled pen.
Please read it carefully twice before use. If you have any doubts, consult your doctor or pharmacist.
Use only for patients who have been prescribed a 6 mg dose.

WARNING:

• Check the appearance of Sumatriptan SUN through the inspection window. The solution should be transparent, colourless to pale yellow. Do not inject if the solution appears discoloured or cloudy, or if it contains small particles, flakes or masses.
• Do not remove the white needle cap from the pre-filled pen until you are ready to administer the injection.
• Do not reattach the white needle cap to the pre-filled pen.
• Do not place your thumb, fingers or hand on the white needle cap or press it.

How to use the pre-filled pen
No figure (X)
a) Wash your hands thoroughly.
b) Find a comfortable, well-lit place and have everything you need within reach (pre-filled pen, alcohol swab or sterile wipe).
c) Identify the injection site with an adequate layer of Figure 2
subcutaneous fat, such as the upper arm or thigh. Do not administer the injection into an area where the skin is painful, bruised, red or hardened.
d) Clean the injection site with alcohol or a sterile wipe and allow it to dry. Do not touch this area before administering the injection.
e) Remove the pre-filled pen from its case.
f) Hold the pre-filled pen in one hand and gently pull off the white needle cap with the other hand. Do not unscrew the cap and do not reattach it to the needle, as this may damage the needle inside the pre-filled pen.
g) Without pressing the blue activation button, place the open end of the pre-filled pen against the injection site at a 90° angle and firmly press the needle safety shield against the skin to activate it. The pre-filled pen will work only when the needle safety shield is fully retracted.
Continue to hold the pre-filled pen firmly against the skin. Figure 4

How to start the injection: Figure 5
(1) Press the blue activation button (you will hear a first 'click'). The blue activation button cannot be pressed unless the needle safety shield is fully retracted.
(2) Immediately release your thumb.
This starts the injection.
(3) Do not lift the pre-filled pen from the skin.
(4) Wait until you hear a second 'click'. The inspection window turns blue, confirming that the injection is complete.
(5) Now remove the pen from the injection site. The injection is finished.
(6) If you do not release your thumb from the blue activation button, you will not hear the second 'click'.
In this case, count slowly to 15 before removing the pre-filled pen from the injection site.
(7) Check that the inspection window has turned blue to ensure the injection has been completed before removing the pen.
If the inspection window has not turned blue, do not attempt to reuse the pre-filled pen.
(8) The needle safety shield will automatically extend to cover and enclose the needle. The needle will no longer be visible.
There is no need to replace the white needle cap.
NEVER ATTEMPT TO REUSE A PRE-FILLED PEN.
If you suspect that you did not receive the full dose, do not repeat the injection using a new pre-filled pen.
(9) If you notice a blood spot at the injection site, clean it gently with a cotton ball or swab. Do not rub the injection site. Cover the site with a bandage if necessary.

White needle cap  Blue activation button  Transparent inspection window
Needle safety shield  Reservoir

Figure 1

Pull

White needle cap
Needle safety shield
Figure 3
Figure 4

Needle safety shield flush with the tip of the reservoir
Figure 5

2 Release
1 Press

Figure 6

Before use Before use After use (with needle
(with white needle cap) (without white needle cap) safety shield extended)