SUMATRIPTAN 6 mg /0.5 Ml Injectable Solution

Зміст інструкції

1. Sumatriptan SUN 6 mg/0.5 ml Injectable Solution
   1. What is Sumatriptan SUN 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. Content of the pack and other information

Sumatriptan SUN 6 mg/0.5 ml Injectable Solution

Sumatriptan

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful. If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Sumatriptan SUN and what it is used for

The active substance contained in Sumatriptan SUN is sumatriptan. It belongs to the group of medicines
called 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. It is believed that Sumatriptan works 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 any of the other ingredients of this medicine (listed in section 6).
• If you have heart problems or if you have had a heart attack.
• If you suffer from circulatory problems in the arms and legs.
• If you have had a stroke or a mini-stroke (also called a transient ischemic attack or TIA).
• If you suffer from severe liver disease.
• If you suffer from severe or uncontrolled high blood pressure.
• together with other medicines for the treatment of migraine containing ergotamine or similar medicines, such as metisergide, or other triptans or 5-HT agonists.
• together with MAOIs (monoamine oxidase inhibitors) or if you have taken an MAOI in the last two weeks.

Warnings and precautions
Consult your doctor before using Sumatriptan 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 disease (especially women in postmenopause and men over 40 years of age should undergo a cardiac and vascular check-up before using this medicine),
• in the presence of 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 cigarette smoker or if you are seriously overweight;
• if you are allergic to certain antibiotics (sulfonamides); people allergic to sulfonamides may develop an allergic reaction to sumatriptan;
• if you are being treated with certain medicines for the treatment of depression (so-called SSRIs or SNRIs), or lithium (a medicine used to treat manic/depressive disorders (bipolar). Serotonin syndrome may occur (including mental confusion, increased heart rate, chills, sweating and muscle spasms). Ask your doctor for advice if these symptoms occur.

After informing you of the conditions above, your doctor may still advise you to use
Sumatriptan SUN and instruct you on how to administer the injection.
As with other treatments for migraine, overuse can worsen and make your migraine more frequent.
Use Sumatriptan SUN only when your doctor is sure you are suffering from migraine or cluster headache.

Other medicines and Sumatriptan SUN
Before using Sumatriptan SUN, inform your doctor

• if you are taking other medicines for migraine that contain ergotamine or its derivatives, such as ergotamine tartrate and metisergide maleate (in this case, stop taking them at least 24 hours before using Sumatriptan SUN),
• if you are taking other medicines prescribed by your doctor for the treatment of depression, such as MAOIs or SSRIs (including citalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) or if you have taken an MAOI in the last 2 weeks,
• if you are taking lithium (a medicine used to treat manic/depressive disorders (bipolar))
• if you are taking other medicines prescribed by your doctor to help you lose weight or for the treatment of epilepsy,
• if you are taking a preparation based on the herbal remedy St. John's Wort (Hypericum perforatum). Taking it at the same time as Sumatriptan SUN may increase the possibility of side effects. Tell your doctor or pharmacist if you are using, have recently used or may use any other medicine.

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 with breast milk. Your doctor will still advise you to take sumatriptan, but breastfeeding should be avoided for 12 hours after taking the medicine; the milk produced during these hours should be discarded.

Driving and using machines
Sumatriptan may cause drowsiness. If necessary, do not drive vehicles or use machinery.

Sumatriptan SUN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose (i.e. 0.5 ml), is therefore
essentially ‘sodium-free’.

3. How to use Sumatriptan SUN

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor
or pharmacist.
Sumatriptan SUN is usually injected into the thigh.
pre-filled pen will inject a dose of Sumatriptan SUN immediately under the skin, quickly and in
a painless manner. DO NOTadminister the injection in a manner different from that illustrated.

DO NOTinject Sumatriptan SUN into a vein.

DO NOTuse Sumatriptan SUN to try to prevent or prevent an attack.
For migraine:
Use a pre-filled pen at the first signs of a migraine attack (even if 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 that at least one hour has passed since the first injection.
Do NOTadminister more than TWO injections during the 24 hours.
If the injection does not relieve the migraine, you may take your usual pain reliever, provided that it does not
contain ergotamine or its derivatives. Wait at least six hours after administering Sumatriptan SUN
before taking medicines based on ergotamine or its derivatives.
If the migraine still does not disappear, do not take a second pain reliever for the same attack. For the
next attack, you may instead use Sumatriptan SUN.
For cluster headache:
Use ONE pre-filled pen for each cluster headache attack. It must be used at the first signs of
cluster headache (even if the medicine is equally effective at any time during an
attack). Do NOTpractice more than TWO injections within 24 hours and make sure that at least one hour has passed between
the two administrations.

Use in children and adolescents (under 18 years of age)
Injectable Sumatriptan should 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; the medicine is therefore not
usually prescribed in patients of this age group.

If you use more Sumatriptan SUN than you should
Taking a larger amount of product than prescribed is harmful. If you have
taken a higher dose of the drug, DO NOT HESITATE, ask your doctor what to do or contact the
nearest emergency room.
If you have further doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• hot flushes (redness of the face that lasts a few minutes), dizziness, feeling of weakness, fatigue and drowsiness
• brief increase in blood pressure immediately after administration of the medicine
• feeling unwell (nausea) or feeling sick (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, tightness. These symptoms usually resolve quickly but can be intense and affect any part of the body, including the chest and throat. If they persist or are particularly severe, especially chest or heart pain that spreads to the arms, seek immediatemedical attention, as these problems have been rarely reported to be 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, tell your doctor, as the medicine may affect the results of these tests.

Side effects with unknown frequency(frequency cannot be estimated on the basis of the available
data):

• hypersensitivity reactions that can range from skin reactions, such as rash and urticaria, to anaphylactic reactions, such as collapse
• convulsions, tremors, muscle contractions, involuntary eye movements
• visual disturbances, including flickering, double vision and decreased vision. Cases of permanent visual defects have been reported.
• low blood pressure, which can cause a feeling of fainting, especially when getting up
• slowed or accelerated heartbeat, palpitations (feeling of a fast heartbeat), changes in heart rhythm
• Raynaud's phenomenon, which can manifest 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
• heart attack
• chest pain (angina)
• ischemic colitis with the following symptoms: abdominal pain, rectal bleeding and fever
• diarrhea
• stiff neck
• joint pain
• anxiety, sweating.

If the following side effects occur, contact your doctor immediatelyand do notuse sumatriptan
until your doctor allows it.

• sudden onset of shortness of breath, tightness or oppression of the chest, swelling of the eyelids, face or lips, skin rash - red spots or bumps (raised areas on the skin), which may be a sign of an allergic reaction
• convulsions (usually in patients with a history of epilepsy)
• inflammation of the colon (a part of the intestine) which can present as lower left abdominal pain and/or bloody diarrhea
• Raynaud's phenomenon, which can 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 any side effect occurs, including those not listed in this leaflet, please tell 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 particular storage conditions.
Do not use Sumatriptan SUN if you notice the presence of particles in the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use and how to dispose of pre-filled pens, or follow local
instructions for the disposal of used pens. This will help protect the environment.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Sumatriptan SUN contains

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

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Representative for Italy:
SUN Pharmaceuticals Italia Srl – via Luigi Rizzo, 8 - 20151 Milan

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

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations
Denmark Sumatriptan SUN 6 mg/0.5 ml injektionsvæske, opløsning
Germany Sumatriptan-Hormosan Inject 6 mg/0.5 ml injektionslösung
Spain Sumatriptan SUN 6 mg/0.5 ml solución inyectable
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

Figure 1
(frontalviewof the
pre-filled pen)
HOW TO USE 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.
Read it TWICE before you start. If you have any questions, ask your doctor or
pharmacist.
For use only by patients who have been prescribed a 6 mg dose.

WARNING:

• Checkthe appearance of Sumatriptan SUN through the inspection window. The solution should be clear, from colourless to pale yellow. Do not inject the solution if it appears discoloured or cloudy or if it contains small lumps, flakes or particles.
• Do notremove the white needle protection from the pre-filled pen until you are ready to give the injection.
• DO NOTput the white needle protection back on the pre-filled pen
• DO NOTplace your thumb, fingers or hand on the white needle cover, or press it.

How to use the pre-filled penNo figure (X)
a) Wash your hands thoroughly.
b) Find a comfortable, well-lit place and have everything you need within
easy reach (pre-filled pen, alcohol or sterile wipes).
c) Identify the application area, with an adequate layer of Figure 2
fatty tissue, for example on the upper arm or thigh. Do not inject into an area where the skin is sore,
bruised, red or hardened.
d) Clean the injection site with alcohol or a sterile wipe and allow to
dry. Do not touch this area before giving the injection.
e) Remove the pre-filled pen from its packaging.
f) Hold the pre-filled pen in one hand and gently remove the white needle
protection cap by pulling it with the other hand. Do not unscrew the protection and do not put it back
on the needle; these actions may damage the needle inside the
pre-filled pen.
g) Withoutpressing the blue activation button, place the open end of the
pre-filled pen on the injection site, forming a right angle (90°) and
firmly press the needle safety cover against the skin to
open it. The pre-filled pen only works if the needle safety
cover is fully retracted.

Continue to holdthe pre-filled pen pressed 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 when the needle safety cover is not 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 completion of the injection.
• (5) Now lift the pen from the injection site. The injection is finished.
• (6) If you do not remove your thumb from the blue button, you will not hear the second ‘click’. In this case, count slowly to 15 before lifting the pre-filled pen from the injection site.
• (7) Check that the inspection window is blue to ensure that the injection has been completed before lifting the pre-filled pen.

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

• (8) The needle safety cover will automatically extend to cover Figure 6the needle and lock it inside. The needle will no longer be visible.

You do not need to replace the white needle protection.

NEVER TRY TO REUSE A PRE-FILLED PEN.
If you suspect you have not administered the entire dose, do not repeat the injection
using a new pre-filled pen.

• (9) If you notice a blood spot at the injection site, wipe it with a cotton ball or wipe. Do not rub the injection site. If necessary, cover the injection site with a bandage.

White needle protection
Blue activation button
Transparent inspection window
Reservoir

Figure 2
Fig. 7-8, see RLD
Figure 3
Pull

Figure 1

Protection
white Needle
of the
button
blue
activation
Transparent Inspection
window Reservoir

Figure 2

Pull

Figure 3
Figure 4

The needle safety cover flush
with the tip of the reservoir

Figure 5

2 Release
1 Press

Figure 6

Before use
(with the white
needle protection)
Before use
(without the white
needle protection)
After use (needle
safety cover
lowered)