Patient Medication Information: uses, side effects, how to take - Riva-Sumatriptan
ABOUT THIS MEDICATION
What the medication is used for:
The name of your medicine is RIVA SUMATRIPTAN. It can be obtained only by prescription from your doctor.
RIVA SUMATRIPTAN is intended to relieve your migraine headache and other associated symptoms of a migraine attack. RIVA SUMATRIPTAN should not be used continuously to prevent or reduce the number of attacks you experience. Use RIVA SUMATRIPTAN 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. RIVA SUMATRIPTAN narrows these vessels and relieves the symptoms of migraine headache.
When it should not be used:
Do not use RIVA SUMATRIPTAN (Sumatriptan Succinate)
in patients with history, symptoms, or signs of
heart disease.
in patients with uncontrolled or severe
hypertension (high blood pressure), • Concurrently with the administration of MAO
inhibitors or within 2 weeks of
discontinuation of MAO inhibitor therapy. • within 24 hours before or after treatment with
other 5-HT1 receptor agonists, or ergotamine-containing drugs or their derivatives (eg. dihydroergotamine, methysergide). • in patients with severe hepatic impairment. • in patients with hemiplegic, basilar, or
ophthalmoplegic migraine.
in patients with allergic reactions to
Sumatriptan or any of the ingredients of the formulations.
What the medicinal ingredient is:
Sumatriptan Succinate
What the important nonmedicinal ingredients are:
| The following inactive ingredients are common to all tablet | |
| strengths | |
: croscarmellose sodium, lactose, magnesium stearate, and microcrystalline cellulose.
In addition, the 100 mg tablet also contains Red 30 Iron Oxide as an inactive ingredient.
What dosage forms it comes in:
Tablets, 25 mg, 50 mg, and 100 mg
WARNINGS AND PRECAUTIONS
BEFORE you use RIVA SUMATRIPTAN talk to your doctor or pharmacist if:
you are pregnant, if you think you might be pregnant or if you are trying to become pregnant? If you are using inadequate contraception or if you are breast-feeding?
- you have any chest pain, heart disease, shortness of breath, or irregular heartbeats;
- you had a heart attack; you have angina or 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 ever had a stroke, transient ischemic attacks (mini stroke that produces stroke like symptoms but no lasting damage), or Raynaud Syndrome ( a condition in which small arteries, most commonly in the fingers and toes, spasm and cause the skin to turn pale or a patchy red to blue)?
- you ever had to stop taking this or any other prescription or non-prescription medication because of an allergy or other problems or you are allergic to sulpha-containing drugs?
- you ever experienced difficulty moving one side of your body when you have a headache?
- you are over 65 years of age? • 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?
- if you are taking any other drug, prescription or non-prescription.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with RIVA SUMATRIPTAN include:
migraine medications such as other 5-
HT1 agonists or those containing ergotamine, dihydroergotamine, or methysergide. Do not take these drugs within 24 hours of using RIVA SUMATRIPTAN.
medication for depression (lithium,
monoamine oxidase inhibitors, selective serotonin reuptake inhibitors [SSRIs) or tricyclic antidepressants )
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.
RIVA SUMATRIPTAN can be taken at any time during your migraine headache.
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.
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 may be taken for subsequent attacks.
A second tablet may be taken 2 hours after the first dose if your symptoms come back. Do not take more than 200 mg in any 24 hour period.
RIVA SUMATRIPTAN 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 centre immediately.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Although the vast majority of those who have taken Sumatriptan Succinate have not experienced any significant side effects, some individuals have experienced problems.
Some people may have feelings of
tingling, heat, flushing (redness of face lasting a short time), heaviness or pressure after treatment with
Sumatriptan Succinate tablets. A few people may feel drowsy, dizzy, tired, or sick. You may have irritation or burning in the throat. Tell your doctor of these symptoms at your next visit.
Drowsiness may occur as a result of
using Sumatriptan. Do not drive or operate machinery until you are sure that you are not drowsy.
- 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 tightness in the chest or throat tingling, heat, flushing (redness of face lasting a short time), heaviness or pressure | T T | T | |
| Uncommon | sudden and/or severe abdominal pain Shortness of breath; wheeziness; heart throbbing; swelling of eyelids, face or lips; or a skin rash, skin lumps, or hives drowsy, dizzy, tired, or sick | T | T T | T T |
This is not a complete list of side effects. For any unexpected effects while taking RIVA SUMATRIPTAN, 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 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.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Laboratoires RIVA Inc., at: 1-800 363-7988
Laboratoires RIVA, Inc 660 Boul. Industriel
Blainville, Quebec J7C 3V4 Canada
Last revised: August 24, 2005.
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