12 mg/ml solution
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 called 5HT 1 – receptor agonists.
Sumatriptan is used to treat migraine headaches and a rare condition called cluster headaches. The symptoms of migraine may be due to temporary swelling of the blood vessels in the head. Sumatriptan is thought to work by reducing the size of these blood vessels.
The sumatriptan contained in Sumatriptan SUN may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
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 problems with your heart or if you have previously had a heart attack
- if you have problems with blood circulation 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 have pronounced or uncontrolled high blood pressure
- together with migraine medicines containing ergotamine or similar medicines such as methysergide or any other triptan or 5 – HT agonist
- with MAO inhibitors ( monoamine oxidase inhibitors ) or if you have taken MAO inhibitors in the last two weeks.
Warnings and precautions
Talk to your doctor or pharmacist before using Sumatriptan SUN:
- if you suffer from any of the following medical conditions: heart diseases such as heart failure, angina pectoris or coronary thrombosis (heart attack), high blood pressure, liver or kidney disease, epilepsy or brain disease (especially postmenopausal women and men over 40 should have their heart and blood vessels checked before using this medicine),
- if you have any of the risk factors for heart disease such as family heart disease; diabetes mellitus; high blood cholesterol; if you smoke cigarettes regularly or if you are very overweight,
- if you are allergic to certain antibiotics ( sulfonamides ); people who are allergic to sulfonamides may experience an allergic reaction to sumatriptan.
- if you are using certain medicines to treat depression (so-called SSRIs or SNRIs ) or lithium (a medicine used to treat manic-depressive (bipolar) disorders). You may experience serotonin syndrome (including confusion, increased heart rate, tremors, sweating, and muscle twitching). Ask your doctor for advice if you notice any of these symptoms.
After you have discussed the above, it may happen that the doctor still advises you to use Sumatriptan SUN and shows you how to give yourself an injection.
As with other migraine treatments, using too much of the medication can make your migraines worse and make them happen more often.
You may only use Sumatriptan SUN when the doctor is sure that you suffer from migraine headaches or cluster headaches.
Other medicines and Sumatriptan SUN
Before using Sumatriptan SUN, tell the doctor if:
- you are taking other medications for migraine that contain ergotamine or derivatives of ergotamine such as ergotamine tartrate or methysergide maleate (in which case you should stop taking them at least 24 hours before using Sumatriptan SUN),
- you are taking any prescribed medication for the treatment of depression such as MAO inhibitors or SSRIs (including citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline ) or if you have taken any MAO inhibitor in the last two weeks,
- you are taking lithium (a medicine used to treat manic-depressive (bipolar) disorders),
- you are taking any prescribed medications to help you lose weight or to treat epilepsy,
- you are taking any natural remedy/natural medicine that contains St. John’s wort ( Hypericum perforatum ). Using this together with Sumatriptan SUN may increase the likelihood of side effects.
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Pregnancy and breastfeeding
Consult a doctor or pharmacist before using this medicine
- if you are pregnant, think you may be pregnant or are planning to have a baby
- if you are breastfeeding. The doctor may still advise you to take sumatriptan, but breastfeeding should be avoided for 12 hours after a dose has been taken, and during this time any expressed breast milk should be discarded.
Driving ability and use of machinery
Sumatriptan may cause drowsiness. If you are affected, do not drive or operate machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Sumatriptan SUN contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose (ie 0.5 ml), i.e. it is almost ‘sodium-free’.
How to use Sumatriptan SUN
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Sumatriptan SUN is usually injected into the thigh.
Carefully read the section “How to use the pre-filled pen” at the end of this leaflet. With the pre-filled pen, a dose of Sumatriptan SUN is injected quickly and painlessly just under the skin. Injection one must NOT be given in any way other than as shown.
DO NOT inject Sumatriptan SUN into a blood vessel.
Do NOT use Sumatriptan SUN to try to prevent an attack.
For migraines:
Use a pre-filled pen at the first sign of a migraine attack ( however, dose one is equally effective regardless of when it is used during an attack). If the migraine goes away after the first dose but then comes back, you can use another pre-filled pen provided that at least one hour has passed since the first injection. Do NOT use more than TWO injections within 24 hours.
If the migraine is not relieved by the injection, you can then take your usual painkillers provided they do not contain ergotamine or its derivatives. Wait at least six hours after using Sumatriptan SUN before taking any medicines containing ergotamine or its derivatives.
If a migraine does not stop, do not use the medicine again for the same attack. Sumatriptan SUN can be used in the next attack.
For cluster headaches:
Use ONE pre-filled pen for each cluster attack. It should be used at the first sign of a cluster headache (although it is equally effective if used at any time during an attack). DO NOT use more than TWO injections in 24 hours and be sure to leave at least one hour between the two doses.
Use for children and adolescents (under 18 years)
Sumatriptan injection should not be used in children and adolescents under 18 years of age.
Use for the elderly (over 65)
There is little experience with injecting sumatriptan in people over 65, which is why it is not usually prescribed for this age group.
If you have used too much Sumatriptan SUN
You can get sick if you use more than the prescribed dose. If you take an overdose DO NOT DELAY to ask the doctor what to do or contact the nearest emergency room.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, or hospital for an assessment of the risk and advice.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 users)
- temporary pain at the injection site
- stinging/burning sensation, redness, swelling, bruising, and bleeding at the injection site.
Common (may affect up to 1 in 10 users)
- flushing ( redness of the face for a few minutes), dizziness, feelings of weakness, tiredness, and drowsiness
- short-term increase in blood pressure shortly after the medicine is used
- nausea or vomiting – when they are not part of the migraine attack
- pain, experiences of unusual feelings, e.g. tingling, numbness, heat or cold, heaviness, and pressure or tension. These symptoms are usually temporary but they can 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 that spreads to the arms, tell the doctor immediately as there have been a few reports of such problems being caused by heart attacks.
- shortness of breath
- muscle pain ( myalgia ).
Very rare (may affect up to 1 in 10,000 users)
- changes in liver function: Tell the doctor if you have a blood test to check liver function and have used Sumatriptan SUN, as it may affect the results.
Not known (cannot be calculated from available data)
- hypersensitivity reaction, which can vary from skin reactions such as rash, and hives to anaphylactic reactions such as the 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 et which can lead to a feeling of dizziness, especially when standing up
- decreased or increased heart rate, palpitations (feeling of fast heart rate), changes in heart rhythm
- Raynaud’s phenomenon, which may appear as pale or bluish skin and/or pain in the fingers, toes, ears, nose, or jaw when cold or stressed
- myocardial infarction
- chest pain (angina)
- ischemic colitis with the following symptoms: abdominal pain, rectal bleeding, and fever
- diarrhea
- stiff neck
- pain in the joints
- anxiety, sweating.
If you get the following side effects, contact your doctor immediately and do not use more Sumatriptan SUN unless your doctor tells you to.
- sudden wheezing, fluttering or tight feeling in the chest, swollen eyelids, face or lips, rash or hives (bumpy skin), which may be signs of an allergic reaction
- convulsions (usually in people who have previously had epilepsy )
- inflammation of the colon, which may appear as pain in the lower left part of the abdomen and/or bloody diarrhea
- Raynaud’s phenomenon, which may appear as pale or bluish skin and/or pain in the fingers, toes, ears, nose, or jaw when cold or stressed
- chest pain (angina)
- myocardial infarction.
How to store Sumatriptan SUN
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after the Expiration date. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if you notice any particles in the solution.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is sumatriptan. Each pre-filled pen contains 6 mg of sumatriptan as sumatriptan succinate.
- Other ingredients are sodium chloride and water for injections.
Appearance and package sizes of the medicine
Pre-filled pen containing a clear, colorless to slightly colored solution for injection.
Each box contains 1,2, 6 or 12 pre-filled pens.
Not all pack sizes may be marketed.
Sun Pharmaceutical Industries Europe BV
87 Polaris Avenue
2132 JH Hoofddorp
Netherlands
+31-(0)23-5685501
+31-(0)23-5685505
| This medicine is approved in the European Economic Area under the names: | |
|---|---|
| Germany | TEMPIL 6 mg/0.5 ml Injection solution |
| Denmark | Sumatriptan SUN 12 mg/ml solution for injection |
| Spain | Sumatriptan SUN 6 mg/0.5 ml solución injectable 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 injectionie |
| Norway | Sumatriptan SUN 12 mg/ml solution for injection |
| UK | Sumatriptan 6 mg/0.5 ml solution for injection |
| Sweden | Sumatriptan SUN 12 mg/ml solution for injection |