Patient Medication Information: uses, side effects, how to take - Nu-Sumatriptan
ABOUT THIS MEDICATION
The name of your medicine is NU-SUMATRIPTAN (sumatriptan succinate) Tablets. It can be obtained only by prescription from your doctor. The decision to use NU-SUMATRIPTAN 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 NU-SUMATRIPTAN Tablets is appropriate for you.
What is the medication used for:
NU-SUMATRIPTAN Tablets are intended to relieve your migraine headache and other associated symptoms of a migraine attack. NU-
SUMATRIPTAN Tablets should not be used continuously to prevent or reduce the number of attacks you experience. Use NU-SUMATRIPTAN 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. NU-SUMATRIPTAN Tablets narrows these vessels and relieves the symptoms of migraine headache.
When it should not be used:
Do not use NU-SUMATRIPTAN Tablets if:
- you are allergic to sumatriptan or to any of the ingredients in NU-SUMATRIPTAN Tablets (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.
NU-SUMATRIPTAN 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 important non-medicinal ingredients are:
NU-SUMATRIPTAN Tablets contain 25 mg, 50 mg or 100 mg of sumatriptan base, as the succinate salt. The tablets also contain colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate and microcrystalline cellulose (film coating: carnauba wax, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide and red ferric oxide (100 mg tablet only).
What dosage forms it comes in:
Tablets, 25 mg, 50 mg and 100 mg
WARNINGS AND PRECAUTIONS
BEFORE you use NU-SUMATRIPTAN Tablets talk to your doctor of 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 high blood pressure
- you have ever had to stop taking this or any other medication because of an allergy or other problems, you are allergic to sulpha-containing drugs
you are taking any medications, including
migraine medications such as other 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 or selective serotonin reuptake inhibitors [SSRIs])
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
NU-SUMATRIPTAN Tablets should not be used continuously to prevent or reduce the number of attacks you experience. Use NU-SUMATRIPTAN Tablets only to treat an actual migraine headache attack.
The Use of NU-SUMATRIPTAN Tablets During Pregnancy:
Do not use NU-SUMATRIPTAN 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 NU-SUMATRIPTAN 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, non-prescription or natural/herbal), before you start taking NU-SUMATRIPTAN 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 tablets 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. NU-SUMATRIPTAN Tablets may be taken for subsequent attacks.
NU-SUMATRIPTAN 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.
NU-SUMATRIPTAN 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:
If you have taken more medication than you have been told, contact either your doctor, hospital emergency department, or nearest poison control center immediately.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medications, NU-SUMATRIPTAN 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 NU-SUMATRIPTAN Tablets are:
- tingling
- pain, pressure of tightness in any part of the body, including chest and throat
- sensations of heaviness
- sensations of heat/burning
- flushing (redness of the face lasting for a short time)
- feeling sick or vomiting
- dizziness
- drowsiness
- tiredness
- weakness
As drowsiness may occur as a result of using NU-SUMATRIPTAN Tablets, 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 | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Pain or sensations of tingling, heat, or pressure in any part of the body. | U | ||
| Very rare | Symptoms of a heart attack [chest pain, sweating, shortness of breath]. | U | ||
| Very rare | Unusually slow or fast heartbeats, or a feeling of irregular and/or forceful heartbeats. | U | ||
| Very rare | Allergic reactions [shortness of breath, sudden wheeziness, chest tightness, swelling of the eyelids face or lips, lumpy skin rash or hives] | U | ||
| Very rare | Seizures [loss of consciousness with uncontrollable shaking (“fit”)] | U | ||
| Very rare | Lower abdominal pain and/or sever rectal bleeding. | U | ||
| Very rare | Raynaud’s phenomenon [persistent purple discolouration of hands or feet]. | U | ||
| Very rare | Loss of vision. | U | U | |
This is not a complete list of side effects. If you have any unexpected effects after receiving NU-SUMATRIPTAN Tablets, 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 tablets in a dry place stored at room temperature 15-30ºC (59-86ºF). Protect from light by keeping blister packs inside the cardboard box.
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 SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health product to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free to 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 Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you should require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Nu-Pharm Inc. at:
1-800-267-1438