Details for: SUMATRIPTAN DF
Company: SIVEM PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02385570 | SUMATRIPTAN DF | SUMATRIPTAN (SUMATRIPTAN SUCCINATE) | 50 MG | TABLET | ORAL |
| 02385589 | SUMATRIPTAN DF | SUMATRIPTAN (SUMATRIPTAN SUCCINATE) | 100 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
SUMATRIPTAN DF Tablets are intended to relieve your migraine headache and other associated symptoms of a migraine attack. SUMATRIPTAN DF Tablets should not be used continuously to prevent or reduce the number of attacks you experience. Use SUMATRIPTAN DF Tablets 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 DF narrows these vessels and relieves the symptoms of migraine headache.
When it should not be used
Do not use SUMATRIPTAN DF if :
- you are allergic to sumatriptan succinate or to any of the ingredients in SUMATRIPTAN DF (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 any degree of liver disease
SUMATRIPTAN DF Tablets should not be used for the treatment of other types of headaches that are different from migraine attacks.
What the medicinal ingredient is
Sumatriptan succinate
What the non-medicinal ingredients are
SUMATRIPTAN DF (25 mg, 50 mg and 100 mg Tablets):
colloidal silicon dioxide, lactose, magnesium stearate,
microcrystalline cellulose and crospovidone
The film-coating for the 25 mg and 50 mg tablets for
SUMATRIPTAN DF consists of titanium dioxide, polydextrose,
hydroxypropyl methylcellulose, triacetin, polyethylene glycol.
The film-coating for the 100 mg tablet for SUMATRIPTAN DF
consists of titanium dioxide, polydextrose, hydroxypropyl
methylcellulose, triacetin, polyethylene glycol, synthetic red iron
oxide.
What dosage form it comes in
SUMATRIPTAN DF is available as pink 100 mg, white 50 mg, or white 25 mg film-coated tablets in bottles of 50 and blister packs of 6, 24 & 100 Tablets.
Warnings and precautions
BEFORE you use SUMATRIPTAN DF talk to your doctor or pharmacist if:
- you are pregnant, think you might be pregnant, you are trying to become pregnant, you are using inadequate contraception or you 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’s 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 or 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 you have epilepsy or seizures.
- this headache is different from your usual migraine attacks.
SUMATRIPTAN DF Tablets should not be used continuously to
prevent or reduce the number of attacks you experience. Use
SUMATRIPTAN DF Tablets only to treat an actual migraine
headache attack.
If you use SUMATRIPTAN DF Tablets too often, it may make
your headaches worse. If this happens, your doctor may tell you
to stop taking SUMATRIPTAN DF Tablets.
The Use of SUMATRIPTAN DF During Pregnancy
Do not use SUMATRIPTAN DF Tablets 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 DF Tablets 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, nonprescription or
natural/herbal), before you start taking SUMATRIPTAN DF
Tablets, especially any antidepressants 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
Adults: Take as directed by your doctor. If the first tablet does
not relieve your headache, do not take further doses of
sumatriptan for the same attack. You may take pain medication
other than ergotamine-containing preparations for further pain
relief. SUMATRIPTAN DF Tablets may be taken for subsequent
attacks.
SUMATRIPTAN DF Tablets can be taken at any time during
your migraine headache.
If your symptoms come back, and it has been two hours since
your first tablet, you may take a second tablet.
Do not take more than 200 mg in any 24 hour period.
SUMATRIPTAN DF Tablets may be taken with or without food.
The tablet should be swallowed whole with water. It should not
be crushed, chewed or split.
Overdose
Side effects and what to do about them
Like all medications, SUMATRIPTAN DF Tablets 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
DF Tablets 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
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.
- 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
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Seek immediate medical emergency assistance |
|---|---|---|---|
| Common | |||
| Unusual sensations including numbness, tingling, feeling hot or cold; pain, heaviness or pressure in any part of the body including chest and throat. | ✔ | ||
| Very Rare | |||
| Symptoms of a heart attack [chest pain, sweating, shortness of breath]. | ✔ | ||
| Unusually slow or fast heartbeats, or a feeling of irregular and/or forceful heartbeats. | ✔ | ||
| Allergic reactions [shortness of breath, sudden wheeziness, chest tightness, swelling of the eyelids, face or lips, lumpy skin rash or hives]. | ✔ | ||
| Seizures [loss of consciousness with uncontrollable shaking (“fit”)]. | ✔ | ||
| Lower abdominal pain and/or severe rectal bleeding. | ✔ | ||
| Raynaud’s phenomenon [persistent purple discolouration of hands or feet]. | ✔ | ||
| Loss of vision. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking SUMATRIPTAN DF, contact your doctor or pharmacist.
How to store
Keep your medicine in a safe place where children cannot reach
it. It may be harmful to children.
Keep your tablets in a cool, dry place (15°C to 30°C).
If your medication has expired (the expiration date is printed on
the treatment pack), throw it away as instructed.
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.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three 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 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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
The name of your medicine is SUMATRIPTAN DF (sumatriptan succinate) Tablets. They can be obtained only by prescription from your doctor. The decision to use SUMATRIPTAN DF Tablets 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 DF Tablets are appropriate for you.
This document plus the full product monograph, prepared for
health professionals can be found by contacting:
Sivem Pharmaceuticals ULC at:
1-855-788-3153
This leaflet was prepared by:
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent, Québec H4R 2P7
Last revised: July 8, 2015