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SUMATRIPTAN 6 MG/0.5 ML SOLUTION FOR INJECTION

Active substance(s): SUMATRIPTAN SUCCINATE

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3. How to use Sumatriptan Injection
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Package Leaflet: Information for the patient

Sumatriptan Injection is usually injected into the thigh.
Carefully read the ‘How to use the pre-filled pen’ section as provided at the end of this leaflet.

Sumatriptan 6 mg/0.5 ml Solution for Injection

The pre-filled pen will inject a dose of Sumatriptan Injection just below the skin quickly and without pain.
The injection must NOT be given in any other way than the way shown.

Sumatriptan

DO NOT inject Sumatriptan Injection into a vein.
DO NOT use Sumatriptan Injection to try and prevent an attack.

Read all of this leaflet carefully before you start using this medicine medicine because it
contains important information for you.
- 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.

For migraine:
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.

What is in this leaflet
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 your migraine does not go, do not use a second one for the same attack. Sumatriptan Injection can be
used for your next attack.
For cluster headaches:
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.

1. What Sumatriptan Injection is and what it is used for
The active substance in Sumatriptan Injection is Sumatriptan. It is one of a group of medicines called 5HT1
receptor agonists.
Sumatriptan Injection is used to treat migraine headache and a rare condition called cluster headache. The
symptoms of migraine may due to temporary swelling of blood vessels in the head. Sumatriptan is
believed to work by reducing the size of these blood vessels.

2. What you need to know before you use Sumatriptan Injection

Very common( may affect more than 1 in 10 people)
- temporary pain at the place the injection was given
- stinging/burning, redness, swelling, bruising and bleeding at the place the injection was given.

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.
Other medicines and Sumatriptan Injection
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.

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

Folding
375--3 --46.87 mm
248--1 --124 mm

375 mm

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

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

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

If you use more Sumatriptan Injection than you should
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.

4. Possible side effects

Warnings and precautions
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.

Pregnancy and breast-feeding
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.

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

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

Do not use Sumatriptan Injection
- 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.

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

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

Common (may affect up to 1 in 10 people)
- flushing (redness of the face lasting a few minutes), dizziness, feelings of weakness, tiredness and
drowsiness
- short lasting increases in blood pressure soon after using the medicine
- feeling sick (nausea) or being sick (vomiting) - when not part of migraine attack
- pain, feelings of unusual sensations including tingling, numbness, heat or cold, heaviness and pressure
or tightness. These symptoms usually pass quickly but may be intense and can affect any part of the
body including the chest and throat. If these effects continue or are particularly severe, especially chest
or heart pain which spreads to the arms, tell your doctor immediately as there have been rare reports of
such problems being caused by a heart attack
- shortness of breath
- aching muscles (myalgia).
Very rare (may affect up to 1 user in 10,000 people)
- liver function changes: if you have a blood test to check how your liver is working and have used
Sumatriptan, tell your doctor as it may affect the results.
Not known (frequency cannot be estimated from the available data)
- hypersensitivity reactions, which may vary from cutaneous reactions like rash, urticaria to anaphylactic
reactions such as collapse
- seizures, tremors, muscle contractions, involuntary eye movements
- visual disturbances including flickering, double vision and reduced vision. There have been cases where
permanent vision defects have occurred.
- lowering of blood pressure that can lead to feeling of faintness especially on standing up
- slowing or quickening in the speed of your heart beat, palpitations (feeling of fast heart beat), changes
in heart rhythm
- Raynaud’s phenomenon, which might appear as paleness or a blue tinge to the skin and/or pain of the
fingers, toes, ears, nose or jaw in response to cold or stress
- heart attack
- chest pain (angina)
- ischaemic colitis with the following symptoms: abdominal pain, rectal bleeding and fever
- diarrhoea
- stiffness in the neck
- joint pain
- anxiety, sweating.
If you get the following side effects, you should contact your doctor immediately and do not use any
more Sumatriptan unless your doctor tells you to do so.
- sudden wheeziness, fluttering or tightness in the chest, swelling of eyelids, face or lips, skin rash - red
spots or hives (skin lumps), which may be signs of an allergic reaction
- fits (usually in people with a history of epilepsy)
- inflammation of the colon (part of the intestine), which may present as lower left-sided tummy pain
and/or bloody diarrhoea
- Raynaud’s phenomenon, which might appear as paleness or a blue tinge to the skin and/or pain of the
fingers, toes, ears, nose or jaw in response to cold or stress
- chest pain (angina)
- heart attack.
Reporting of side effects
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.

248 mm

Size: 248x375 mm

SUN EUROPE
UK

100

95

75

25

5

0

Sumatriptan 6 mg-0-5 ml-EUUK-248x375mm-PIL-REV3-24-06-14
24 June 2014 19:19:29

Do not print grey area

5. How to store Sumatriptan Injection
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the
last day of that month.

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.

This medicinal product does not require any special storage conditions.

g) 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.

Do not use this medicine if you notice any particles in the solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use, and how to dispose of the used pre-filled pens, or follow local
instructions for disposal of the used pens. These measures will help to protect the environment.

Pull Straight off
White Needle
Shield

6. Contents of the pack and other information
What Sumatriptan Injection contains
- 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 injections.

Needle Safety Cover

What Sumatriptan Injection looks like and contents of the pack
Pre-filled pen, containing a clear colourless to pale solution for injection.
Each carton contains 1, 2 or 6 pre-filled pens.

Figure 3
Continue to hold the pre-filled pen firmly against the skin.

Not all package sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
+31-(0)23-5685501
+31-(0)23-5685505

90°

This medicinal product is authorised in the Member States of the EEA under the following names:
Germany
Sumatriptan-Hormosan Inject 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

Needle Safety
Cover Fully pushed in

Figure 4

375 mm

How to start the injection:
(1) Press the blue activation button (first click will sound). The blue activation button cannot be pressed if
the safety needle cover is not fully retracted.
(2) This starts the injection.
(3) Do not lift the pre-filled pen off the skin. Hold down the button and count slowly to ten before you lift the
pre-filled pen from the injection site.
(4) The inspection window will be blue, confirming the injection is complete.
(5) Lift the pre-filled pen straight up from the injection site. The injection is finished.
(6) Verify that the inspection window is blue to ensure that the injection is complete before lifting the prefilled pen.

This leaflet was last revised in 06/2014

HOW TO USE THE PRE-FILLED PEN

Sumatriptan 6 mg/0.5 ml, Solution for Injection

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

This leaflet explains how to use the Sumatriptan pre-filled pen.
Read it TWICE before you begin the first step. If you have any questions,ask your doctor or pharmacist.
Only for use in patients for whom a 6 mg dose has been prescribed.

Count slowly
to 10

Click

Blue Activation Button

White Needle Shield

Needle Safety
Cover out

Needle Safety Cover flush with tip of barrel

Press

10
Clear Inspection Window

Barrel

Blue
Inspection
Window

Figure 1
(frontal view of pre-filled pen)

Needle Safety Cover
extends to cover needle

CAUTIONS:
- 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.

(7) 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.

- Do not remove the white needle shield from the pre-filled pen until you are ready to inject.

There is no need to replace the white needle shield.

- NEVER put the white needle shield back into the pre-filled pen.

NEVER ATTEMPT TO REUSE A PRE-FILLED PEN.

- NEVER put or press thumb, fingers, or hand over white needle cover.

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

Figure 5

How to use the pre-filled pen
(8) 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.

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.

e) Take out the pre-filled pen from carton box.

Before Use
(With White
Needle Shield)

Figure 6
Before Use
(Without White
Needle Shield)

After Use
(Needle Safety
Cover down)

Figure 2

Folding
375--3 --46.87 mm
248--1 --124 mm

248 mm

Suppliers LOGO /ID here

044BP1778D

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.

Size: 248x375 mm

SUN EUROPE
UK

100

95

75

25

5

0

Sumatriptan 6 mg-0-5 ml-EUUK-248x375mm-PIL-REV3-24-06-14
24 June 2014 19:19:29

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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