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Details for: PMS-SUMATRIPTAN

Company: PHARMASCIENCE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02256428PMS-SUMATRIPTANSUMATRIPTAN (SUMATRIPTAN SUCCINATE)25 MGTABLETORAL
02256436PMS-SUMATRIPTANSUMATRIPTAN (SUMATRIPTAN SUCCINATE)50 MGTABLETORAL
02256444PMS-SUMATRIPTANSUMATRIPTAN (SUMATRIPTAN SUCCINATE)100 MGTABLETORAL
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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

pms-SUMATRIPTAN are intended to relieve your migraine headache and other associated symptoms of a migraine attack. pms-SUMATRIPTAN should not be used continuously to prevent or reduce the number of attacks you experience. Use pms-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. pms-SUMATRIPTAN narrows these vessels and relieves the symptoms of migraine headache.

When it should not be used

Do not use pms-SUMATRIPTAN if:

  • you are allergic to sumatriptan or to any of the ingredients in pms-SUMATRIPTAN (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 medicines or its derivatives, or another triptan used to treat migraine.
  • you have any degree of liver disease.

pms-SUMATRIPTAN 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

25mg and 50mg: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene glycol, Polyvinyl Alcohol, Sodium Starch Glycolate, Talc and Titanium Dioxide.

100 mg: Colloidal Silicon Dioxide, Fractionated coconut oil, Hypromellose, Iron oxide red, Lactose Monohydrate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polydextrose, Sodium Starch Glycolate, Talc and Titanium Dioxide.

What dosage form it comes in

Tablets: 25 mg, 50 mg and 100 mg

Warnings and precautions

BEFORE you use pms-SUMATRIPTAN, 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 you are 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, 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.

pms-SUMATRIPTAN should not be used continuously to prevent or reduce the number of attacks you experience. Use pms-SUMATRIPTAN only to treat an actual migraine headache attack.

If you use pms-SUMATRIPTAN too often, it may make your headaches worse. If this happens, your doctor may tell you to stop taking pms-SUMATRIPTAN.

The Use of pms-SUMATRIPTAN During Pregnancy:

Do not use pms-SUMATRIPTAN 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 pms-SUMATRIPTAN 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 pms-SUMATRIPTAN, 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 the ergotamine-containing preparations for further pain relief. pms-SUMATRIPTAN may be taken for subsequent attacks. pms-SUMATRIPTAN 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.

pms-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

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.
Side effects and what to do about them

Like all medications, pms-SUMATRIPTAN 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 succinate 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

As drowsiness may occur as a result of pms- SUMATRIPTAN, 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, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and seek immediate emergency medical attention
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 pms-SUMATRIPTAN tablets, 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 pms-SUMATRIPTAN (sumatriptan succinate). They can be obtained only by prescription from your doctor. The decision to use pms-SUMATRIPTAN 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 pms-SUMATRIPTAN tablets are appropriate for you.

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Pharmascience Inc. at 1-888-550-6060.

This leaflet was prepared by
Pharmascience Inc.
Montreal, Canada
H4P 2T4

www.pharmascience.com

Last revised: December 5, 2014

Date modified: