Patient Medication Information: uses, side effects, how to take - Ava-Sumatriptan Df
ABOUT THIS MEDICATION
The name of your medicine is AVA-SUMATRIPTAN DF (sumatriptan succinate) Tablets. They can be obtained only by prescription from your doctor, The decision to use AVA-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 AVA-SUMATRIPTAN DF Tablets are appropriate for you.
What the medication is used for:
AVA-SUMATRIPTAN DF Tablets are intended to relieve your migraine headache and other associated symptoms of a migraine attack. AVA-SUMATRIPTAN DF Tablets should not be used continuously to prevent or reduce the number of attacks you experience. Use AVA-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. AVA-SUMATRIPTAN DF narrows these vessels and relieves the symptoms of migraine headache.
When it should not be used:
Do not use AVA-SUMATRIPTAN DF if:
- you are allergic to sumatriptan succinate or any of the non-medicinal ingredients in the product (See What the nonmedicinal ingredients are, below).
- 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
AVA-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 nonmedicinal ingredients are:
AVA-Sumatriptan DF: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose and crospovidone The film-coating for the 25 mg and 50 mg tablets consists of titanium dioxide, polydextrose, hydroxypropyl methylcellulose, triacetin, polyethylene glycol.
The film-coating for the 100 mg tablet consists of titanium dioxide, polydextrose, hydroxypropyl methylcellulose, triacetin, polyethylene glycol, synthetic red iron oxide.
What dosage forms it comes in:
AVA-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 AVA-SUMATRIPTAN DF 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 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 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 have epilepsy or seizures.
this headache is different from your usual migraine
attacks.
AVA-SUMATRIPTAN DF Tablets should not be used continuously to prevent or reduce the number of attacks you experience. Use AVA-SUMATRIPTAN DF Tablets only to treat an actual migraine headache attack.
The Use of AVA-SUMATRIPTAN DF During Pregnancy
Do not use AVA-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 AVA-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, non prescription or natural/herbal), before you start taking AVA-SUMATRIPTAN DF Tablets, 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:
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. Another tablet should not be taken for two hours after the first dose. You may take pain medication other than ergotamine-containing preparations for further pain relief. AVA-SUMATRIPTAN DF Tablets may be taken for subsequent attacks.
AVA-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.
AVA-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:
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, AVA-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 AVA-SUMATRIPTAN DF Tablets are:
- pain, pressure 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 AVA-SUMATRIPTAN DF 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 | ||||
| Symptoms/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 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 | 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 | √ | √ | |
| Very rare | Allergic reactions [shortness of breath, sudden wheeziness, chest tightness, swelling of the eyelids, face or lips, lumpy skin rash or hives] | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking AVA-SUMATRIPTAN DF, 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.
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
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 Avanstra Inc. at: at: 1-855-708-3678
or medinfo@avanstra.com
Avanstra Inc.
10761 – 25th NE
Suite 110, Building “B”
Calgary, Alberta
T2C 3C2, Canada