Patient Medication Information: uses, side effects, how to take - Sumatriptan Injection
ABOUT THIS MEDICATION
The name of your medicine is SUMATRIPTAN INJECTION (sumatriptan succinate). It can be obtained only by prescription from your doctor, The decision to use SUMATRIPTAN INJECTION is one that you and your doctor should make jointly, taking into account your individual preferences and medical circumstances. If you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over 40), you should tell your doctor, who should evaluate you for heart disease in order to determine if SUMATRIPTAN INJECTION is appropriate for you.
What the medication is used for:
SUMATRIPTAN INJECTION is intended to relieve your migraine headache and other associated symptoms of a migraine attack. SUMATRIPTAN INJECTION should not be used continuously to prevent or reduce the number of attacks you experience. Use SUMATRIPTAN INJECTION only to treat an actual migraine headache attack.
What it does:
Migraine headache is believed to be caused by a widening of the blood vessels in the head. SUMATRIPTAN INJECTION narrows these vessels and relieves the symptoms of migraine headache.
When it should not be used:
Do not use SUMATRIPTAN INJECTION if :
- you are allergic to sumatriptan or any of the non-medicinal ingredients in SUMATRIPTAN INJECTION. (See “What the nonmedicinal ingredients are:”.)
- you have a history, or any symptoms or signs of a heart condition
- you have high blood pressure
- you are taking or have recently taken (within 2 weeks) a monoamine oxidase inhibitor (MAOI)
you are taking or have recently taken (within 24 hours) an ergotamine-containing medication or its
derivatives, or another triptan used to treat migraine
- you have severe liver disease
SUMATRIPTAN INJECTION should not be used for the treatment of other types of headaches that are different from migraine attacks.
SUMATRIPTAN INJECTION should not be given intravenously, but only into the tissues just below the skin (on the outside of the thigh or in the upper arm).
What the medicinal ingredient is:
Sumatriptan succinate
What the nonmedicinal ingredients are:
Sodium chloride solution.
There is no ethanol, gluten, lactose, sulfite or tartazine in SUMATRIPTAN INJECTION.
What dosage forms it comes in:
SUMATRIPTAN INJECTION (6mg; total volume = 0.5 mL) is available in a Pre-filled Single-Dose Syringe within an Autoinjector device. This is a disposable one time use Autoinjector.
WARNINGS AND PRECAUTIONS
BEFORE you use SUMATRIPTAN INJECTION talk to your doctor or pharmacist if:
you are pregnant, think you might be pregnant, are trying to become pregnant, are using inadequate contraception or are breast-feeding.
- you have any chest pain, heart disease, shortness of breath, or irregular heartbeats, you have had a heart attack, or you have angina.
- you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or are you postmenopausal or a male over 40).
- you have ever had to stop taking this or any other medication because of an allergy or other problems, or you are allergic to sulpha-containing drugs.
- you are taking any medications, including migraine medications such as other triptans. 5-HT1 agonists or those containing ergotamine, dihydroergotamine, or methysergide.
- you have ever experienced difficulty moving one side of your body when you have a headache.
you have ever had a stroke, transient ischemic attacks
(TIAs), or Raynaud Syndrome.
- you are under 18 years of age
- you are over 65 years of age.
you are taking any medication for depression (lithium,
monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRIs), or serotonin noradrenaline reuptake inhibitors (SNRIs)?
- you had, or you have any disease of the liver or kidney.
- you had, or have epilepsy or seizures.
this headache is different from your usual migraine
attacks.
SUMATRIPTAN INJECTION should not be used continuously to prevent or reduce the number of attacks you experience. Use SUMATRIPTAN INJECTION only to treat an actual migraine headache attack.
If you use SUMATRIPTAN INJECTION too often, it may make your headaches worse. If this happens, your doctor may tell you to stop taking SUMATRIPTAN INJECTION.
The Use of SUMATRIPTAN INJECTION During Pregnancy:
Do not use SUMATRIPTAN INJECTION if you are pregnant, think you might be pregnant, are trying to become pregnant, or are not using adequate contraception, unless you have discussed this with your doctor.
INTERACTIONS WITH THIS MEDICATION
Do not use SUMATRIPTAN INJECTION if you are taking or have recently taken a monoamine oxidase inhibitors (MAOI) in the last 2 weeks, or any migraine medications containing ergotamine, ergot derivatives (such as dihydroergotamine, or methysergide), or other triptans used to treat migraine within 24 hours.
You should tell your doctor if you are taking or have recently taken any other medications (prescription, non prescription or natural/herbal), before you start taking SUMATRIPTAN INJECTION, especially any anti depressants such as selective serotonin reuptake inhibitors (SSRIs) and certain tricyclics.
PROPER USE OF THIS MEDICATION
The label on the container of your medicine or the leaflet inside should tell you how often to take a dose and the amount you should take in each dose. If it does not or you are not sure, ask your doctor or pharmacist. DO NOT take more medicine or take your medicine more often than you are told.
Usual dose:
SUMATRIPTAN INJECTION is available in a Pre-filled Single-Dose Syringe within an Autoinjector device. Before using the autoinjector, see INSTRUCTIONS FOR USE OF YOUR AUTOINJECTOR.
Adults : Inject 6 mg (single injection), into the tissues just below the skin ( on the outside of the thigh or the upper arm). SUMATRIPTAN INJECTION can be taken at any time during your migraine headache.
If the first injection does not relieve your headache, do not take further doses of sumatriptan for the same attack. However, you may take pain medication other than ergotamine-containing preparations for further pain relief. Sumatriptan may be taken for subsequent attacks.
A second injection (6 mg) can be taken if your symptoms come back provided 1 hour has passed since your last dose. Do not take more than two injections ( 2 x 6 mg) in any 24 hour period.
Overdose:
If you have taken more medication than you have been told, contact either your doctor, hospital emergency department, or nearest poison control center immediately.
| INSTRUCTIONS FOR USE OF YOUR AUTOINJECTOR |
This leaflet explains how to use the SUMATRIPTAN INJECTION Autoinjector device. Read it several times to make sure you understand it, before you begin the first step. If you have any questions, ask your doctor or pharmacist.
Do not activate the SUMATRIPTAN INJECTION autoinjector device until you are ready to give an injection. Keep SUMATRIPTAN INJECTION autoinjector device out of the reach of children.
How to select the injection site:
Patients should be sitting or lying down. Sumatriptan may be injected in the upper outer side of the thigh or the upper outer side of the arm. The injection site should be varied daily.
Clean the area to be injected.
How to use the Autoinjector:
Slide thumb up and remove
flip-off TAB stamped with
# 1
Twist and remove twist-off cap stamped with #2
Firmly push white end of device against the injection site until the safety shield is completely pushed in. Hold for 5 seconds.
After use, remove the device from injection site. The safety shield will be locked, and the window will no longer be clear.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medications, SUMATRIPTAN INJECTION can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Consult your doctor if you experience these or other side effects.
The most commonly reported side effects of SUMATRIPTAN INJECTION are:
pain, pressure or tightness in any part of the body,
including chest and throat
- sensations of heaviness
unusual sensations including numbness, tingling,
heat/burning or cold
- flushing (redness of the face lasting for a short time)
- feeling sick or vomiting
- dizziness
- drowsiness
- tiredness
- weakness
redness at the site of injection, but this usually lasts less
than an hour.
As drowsiness may occur as a result of using SUMATRIPTAN INJECTION, do not drive or operate machinery until you are sure that you are not drowsy.
Other side effects include:
- unusually slow or fast heartbeats, a feeling of irregular and/or forceful heartbeats
- visual disturbances, usually temporary (scotoma, nystagmus, flickering, diplopia).
- dystonia, (shaking, tremors or uncontrolled movements)
- loss of normal colouration in the fingers and toes.
Tell your doctor of these symptoms at your next visit.
Very rarely, some people have reported the following more serious side effects, For information on what to do if you experience these side effects, see the table at the end of this section.
- pain or tightness in the chest or throat
- loss of vision
- shortness of breath; wheeziness; chest tightening; swelling of eyelids, face, or lips; or a skin rash, skin lumps
- a seizure or fit
- sudden and/or severe abdominal pain
- persistent purple discolouration of hands or feet
If you feel unwell in any other way or have any symptoms that you do not understand or find distressing, you should contact your doctor immediately.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptoms/effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
Very Common | Unusual sensations including numbness, tingling. Feeling hot or cold; pain, heaviness or pressure in any part of the body including chest and throat. | √ | ||
| Common | Pain or sensation of tingling, heat, or pressure in any part of the body | √ | ||
| Very rare | Symptoms of a heart attack [ chest pain, sweating, shortness of breath] | √ | ||
| Very rare | Unusually slow or fast heartbeats, or a feeling of irregular and/or forceful heartbeats | √ | ||
| Very rare | Allergic reactions [shortness of breath, sudden wheeziness, chest tightness, swelling of the eyelids, face or lips, lumpy skin rash or hives] | √ | ||
| Very rare | Seizures [ loss of consciousness with uncontrollable | √ | ||
| shaking(“fit”)] | ||||
| Very rare | Lower abdominal pain and/or severe rectal bleeding. | √ | ||
| Very rare | Raynaud’s phenomenon [persistent purple discolouration of hands or feet] | √ | ||
| Very rare | Loss of vision | √ | √ |
This is not a complete list of side effects. For any unexpected effects while taking SUMATRIPTAN INJECTION, contact your doctor or pharmacist.
HOW TO STORE IT
Keep your medicine in a safe place where children cannot reach it. It may be harmful to children.
Keep your syringes away from heat and light which may spoil them. Always keep your injection in carton and store at 2°C to 30°C.
If your medication has expired, throw it away.
If your doctor decides to stop your treatment, do not keep any leftover medicine unless your doctor tells you to. Throw away your medicine as instructed.
Reminder:
REMEMBER: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms appear to be similar to yours.
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
----------------------------------------------------------------------------
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited
at: 1-800-268-4127 ext. 5005 (English)
or 1-877-777-9117 (French)
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9