Imigran - Sumatriptan uses, dose and side effects

The migraine symptoms and the symptoms of Horton’s headache are probably caused by a temporary dilation of the blood vessels in the head. Imigran is considered to reduce the dilation of these blood vessels. This contributes to the disappearance of the headache as well as other migraine symptoms such as nausea, vomiting, and sensitivity to light and sound.

Imigran injection containing sumatriptan belonging to a group of drugs called triptans (also known as 5-HT ₁ – receptor agonists).

Imigran solution for injection is used for acute treatment of migraine or Horton’s headache.

2. What you need to know before using Imigran

Do not use Imigran

If you are allergic to sumatriptan, or any of the other ingredients of this medicine (listed in section 6).
If you have heart problems, such as narrowed blood vessels (ischemic heart disease) , chest pain (angina) or have previously had a heart attack.
If you have problems with blood circulation in the legs that cause cramp-like pain when you walk (so-called peripheral vascular disease) .
If you have had a stroke (stroke) or TIA (transient circulatory disorder in the brain).
If you have high blood pressure . You can use Imigran if you have been treated for mild hypertension.
If you have any serious liver disease.
If you are taking other medicines to treat migraine which contain ergotamine or compounds similar to ergotamine such as methysergide or any triptan / 5-HT ₁ – receptor agonist (medicines which are also used to treat migraine ).
If you are being treated with antidepressant medicines such as monoamine oxidase inhibitors ( MAOIs ) or if you have been treated with any such medicine within the last two weeks.

If any of the above applies to you:

→ Contact a doctor and do not use Imigran.

Warnings and cautions

Talk to your doctor or pharmacist before using Imigran.

If you have any additional risk factors

if you are a heavy smoker or use nicotine replacement therapy and especially
if you are a man over 40 years or
if you are a woman and have passed the menstrual age.

In very rare cases, severe heart conditions have occurred after taking Imigran despite the fact that no signs of heart disease have been detected. If any of the above risk factors apply to you, it may mean that you have a greater risk of developing heart disease:

→ Tell your doctor so that your heart function can be checked before treatment with Imigran.

If you have previously had seizures or if there are other factors that may increase the risk of seizures, such as brain damage or alcoholism:

→ Tell your doctor so that you can be checked more often.

If you have any liver or kidney disease:

→ Tell your doctor so that you can be checked more often.

If you are allergic to antibiotics of type sulfonamides

In that case, you may also be allergic to Imigran. If you know you are allergic to antibiotics, but if you are not sure if they are sulphonamides:

→ Talk to your doctor or pharmacist before using Imigran.

If you are taking antidepressants called SSRIs (selective serotonin reuptake inhibitors) or SNRIs ( serotonin noradrenaline reuptake inhibitors):

→ Tell your doctor or pharmacist before using Imigran. See also the section “Other medicines and Imigran”.

If you use Imigran frequently

Using Imigran too often can make your headache worse.

→ Tell your doctor if this applies to you. Your doctor may recommend that you stop using Imigran.

If you feel any pain or tightness in your chest after using Imigran

These symptoms can be intense but they usually go away quickly. If they do not disappear quickly or if they get worse:

→ Seek medical attention immediately. See section 4 of this leaflet for more information on these possible side effects.

Imigran dose ampoules may contain latex

The needle cover of the dose ampoule inside the plastic sleeve may contain latex.

→ Tell your doctor if you are allergic to latex.

Imigran contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free.

Other drugs and Imigran

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also includes herbal remedies or over-the-counter remedies.

Some medicines should not be taken with Imigran and others may cause side effects when used concomitantly. You must tell your doctor if you use:

ergotamine , which is used to treat migraines , or similar medicines such as methysergide (see section 2 “Do not use Imigran”). Do not use Imigran at the same time as these medicines. You must stop taking them at least 24 hours before using Imigran. Do not take any medicines that contain ergotamine or compounds similar to ergotamine again for at least 6 hours after taking Imigran.
triptan / 5-HT ₁ – receptor agonist (such as naratriptan, rizatriptan, zolmitriptan) also used for the treatment of migraine (see Section 2 “do not use Imigran”). Do not use Imigran at the same time as these medicines. You must stop taking them at least 24 hours before using Imigran. Do not take any other medicine containing triptan / 5-HT ₁ – receptor agonist again for at least 24 hours after taking Imigran.
SSRIs (selective serotonin reuptake inhibitors) or SNRIs ( serotonin noradrenaline reuptake inhibitors) used in the treatment of depression. Using Imigran with these medicines can cause serotonergic syndrome (a collection of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle twitching, tremors, palpitations and tremors). If you get these symptoms, tell your doctor straight away.
MAOIs ( monoamine oxidase inhibitors ) used in the treatment of depression. Do not use Imigran if you have been taking such medicines in the last two weeks.
St. John’s wort (Hypericum perforatum) . With concomitant use of Imigran and herbal remedies containing St. John’s wort , side effects mayoccur to an increased extent.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is only limited information regarding the safety of Imigran when used in pregnant women, although there is no evidence of an increased risk of birth defects to date. Your doctor will discuss with you whether to use Imigran during pregnancy.
You should not breast-feed your baby for the next 12 hours after using Imigran. Breast milk pumped out during these 12 hours should not be given to your baby but discarded.

Driving and using machines

Both the migraine symptoms and your medication can make you drowsy. 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 attention. 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Imigran

Imigran should only be used when the migraine attack/onset of Horton’s headache has begun.

Do not use Imigran to try to prevent an attack.

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

A step-by-step instruction can be found at the end of the package leaflet (Section 6).

How much to use

Adults (18 to 65 years)

Migraine / Horton’s headache

The usual dose for adults (18 to 65 years) is an Imigran injection of 12 mg / ml of 0.5 ml.

Imigran is not recommended for people younger than 18 years or older than 65 years.

When to use Imigran

It is best to take Imigran as soon as you feel that the migraine attack / onset of Horton’s headache has begun, but you can also take Imigran later in the attack.

If the symptoms start to come back

You can take a second dose after one hour if the symptoms return. Do not take more than two injections in 24 hours.

If the first injection has no effect

Do not use a second dose or any other Imigran product during the same migraine attack / attack of Horton’s headache . If you do not get any effect of Imigran:
Contact a doctor or pharmacist for advice.

If you use more Imigran than you should

Do not use more than two Imigran injections for 24 hours.
Using too much Imigran can make you sick. If you have used more than two injections for 24 hours:
Contact a doctor for advice.

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, always contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you have any further questions on 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. Some symptoms can be caused by the migraine disease itself.

The most commonly reported side effect of Imigran solution for injection is transient local irritation at the injection site. Up to 50% of users may experience this side effect.

Allergic reactions: seek medical attention immediately

The following side effects have occurred in a very small number of people but the exact frequency is not known.

Signs of allergy include skin rash, hives (itchy rash), wheezing, swollen eyelids, face or lips, unconsciousness. If you get any of these symptoms immediately after taking Imigran:
Do not take more of this medicine. Contact a doctor immediately.

Very common

(may affect more than 1 user in 10 ):

Transient local irritation at the injection site (up to 50% of users may experience this side effect ).

Usual

(may affect up to 1 in 10 users):

Pain, heaviness, feeling of pressure or tightness or pain in the chest, pharynx or other parts of the body. Unusual sensations such as numbness, tingling, feeling of heat or cold. These symptoms can be intense but are usually transient. If these symptoms persist or worsen (especially chest pain):
Seek medical attention immediately . In a small number of patients, these symptoms can be caused by a heart attack.

Nausea or vomiting. These symptoms may be part of the migraine attack itself
Fatigue or drowsiness
Dizziness, feeling of weakness, feeling hot and redness ( flush )
Transient increase in blood pressure
Respiratory distress
Muscle aches

Very rare

(may affect up to 1 in 10,000 users):

Changes in liver function. If you are going to have a blood test to check your liver function, tell your doctor or nurse that you are taking Imigran.

Some patients may experience any of the following side effects, but it is not known how often they occur:

Seizures, tremors, muscle cramps, neck stiffness
Visual disturbances such as visual flicker, visual impairment, double vision, loss of vision which in some cases may become permanent. These visual disturbances can also be caused by the migraine attack itself.
Heart problems, slow or rapid heartbeat (palpitations), changes in heart rhythm, chest pain (angina) or heart attack.
Pale, blue skin and / or pain in fingers, toes, ears, nose or jaw in cold or stress (Raynaud’s phenomenon)
Fainting sensation (depending on a drop in blood pressure)
Pain in the lower left part of the abdomen and bloody diarrhea (ischemic colitis )
Diarrhea
If you have recently been injured or if you have an inflammation (such as rheumatism or inflammation of the colon) you may experience pain or worsening pain at the site of the injury or inflammation .
Joint pain
Feeling anxious
Difficulty swallowing
Abundant sweating

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Imigran

Keep this medicine out of the sight and reach of children.

Do not store above 30 ° C. Store in the original package.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is sumatriptan succinate equivalent to 6 mg sumatriptan per injection.

The other ingredients are sodium chloride and water for injections.

What the medicine looks like and contents of the pack

Imigran solution for injection is supplied in packs with an Imigran pen and 2 0.5 ml dose ampoules. Also available in refill packs of 2×0.5 ml or 3x2x0.5 ml.

Not all pack sizes may be provided.

Marketing Authorization Holder and Manufacturer

Step-by-step instructions on how to use Imigran solution for injection

Injection for subcutaneous injection Imigran pen



	Open the case, break the seal and open the lid of one of the dose ampoules. Grasp the grooved surface of the pen. Be careful not to touch the blue push-button on the top of the pen. Take out the pen.
	Insert the pen into the opened cartridge and turn clockwise until it receives (approximately half a turn).
	Pull the pen straight up. A certain resistance is felt. The Imigran pen is now ready for use.Do not touch the blue push button.
	Press the Imigran pen against the skin, usually on the outside of the thigh. The pen can only be pressed off when you press it against the skin and the gray part is pressed down against the blue one. Press and hold the blue push-button on the top of the pen for five seconds (or count to 10).You have now injected the medicine.Carefully remove the pen, as the needle tip is now out.
	Put the Imigran pen back in the empty canister and then turn counterclockwise, about half a turn until the pen comes loose.
	Remove the pen and put the cap on the used ampoule . The “white part” of the suspension mechanism now protrudes from the pen. Each time this is visible, put the pen back in the gray case and press down until a click is heard, before using the pen again.
	Close the lid of the case.
	When both doses have been used, they are exchanged for a new plastic sleeve with dose ampoules. Open the lid of the gray case. Press the two blue buttons on the sides and remove the empty ampoule sleeve, which can now be thrown away. The case with the Imigran pen can be used again, when loaded with a new plastic sleeve with dose ampoules.

Authorized Representative (EC REP) and Manufacturer of Imigran Pen and Case

	Glaxo Operations UK LtdHarmire RoadBarnard CastleDurham CountyDL12 8DTUK
CE 2797

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Imigran – Sumatriptan uses, dose and side effects

1. What Imigran is and what it is used for