Patient Medication Information: uses, side effects, how to take - Zolmitriptan-ODT
What is ZOLMITRIPTAN-ODT used for?
ZOLMITRIPTAN-ODT is used in adults to relieve migraine headache and other associated symptoms of a migraine attack.
ZOLMITRIPTAN-ODT should not be used to prevent or reduce the number of attacks you experience. Only use ZOLMITRIPTAN-ODT to treat an actual migraine headache attack.
How does ZOLMITRIPTAN-ODT work?
Migraine headache is believed to be caused by a widening of the blood vessels in the head. ZOLMITRIPTAN-ODT narrows these vessels and relieves the pain and other symptoms of migraine headache.
What are the ingredients in ZOLMITRIPTAN-ODT?
Medicinal ingredients: zolmitriptan.
Non-medicinal ingredients: acesulfame potassium, amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, low-substituted hydroxypropyl cellulose, magnesium aluminometasilicate, magnesium stearate, mannitol, peppermint flavor, sodium lauryl sulfate, talc.
Serious Warnings and Precautions
- Risk of Heart Attack: Serious heart events including heart attack have been reported within a few hours of starting treatment with zolmitriptan. Do NOT use this medication if you have any form of coronary artery disease.
- Heart Rhythm Problems: Life-threatening instances of heart rhythm disturbances have been reported within a few hours of starting treatment with zolmitriptan. This can be fatal.
- Chest Pain: ZOLMITRIPTAN-ODT may cause chest pain, even in patients without a history of coronary artery disease.
- Risk of Stroke: Bleeding in the brain and stroke have been reported in patients taking medications like ZOLMITRIPTAN-ODT. These conditions can be fatal.
If you think you are experiencing any of the above, contact your healthcare professional or get immediate medical help.
ZOLMITRIPTAN-ODT comes in the following dosage form:
Orally disintegrating tablets: 2.5 mg.
Do not use ZOLMITRIPTAN-ODT if:
you are allergic to zolmitriptan or any of the other ingredients in ZOLMITRIPTAN-ODT
(see “what are the ingredients in ZOLMITRIPTAN-ODT?”)
- you have a history, or any signs or symptoms of a heart problem or condition
- you have ever had a heart attack or stroke
- you suffer from chest pain, occurring either on exertion or at rest
- you have severe or uncontrolled hypertension
- you are taking or have recently taken (within the last 24 hours) an ergotamine containing or ergot-like drug, or another triptan used to treat migraines
- you are taking or have recently taken (within 2 weeks) a monoamine oxidase inhibitor (MAOI)
you have another type of headache, that is different from a migraine attack (if you are not sure, ask your healthcare professional. These include:
- Hemiplegic migraines: these are migraine headaches where you have weakness on one side of your body.
- Basilar migraines: these are migraine headaches that start in the lower part of the brain.
- Ophthalmoplegic migraines: these are migraine headaches where you have pain around the eyes.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ZOLMITRIPTAN-ODT. Talk about any health conditions or problems you may have, including if you:
- have any liver problems
are at risk of developing heart disease, risk factors include if you:
- have high blood pressure
- have high cholesterol
- are obese
- have diabetes
- have a family history of heart disease
- are a smoker
- are a postmenopausal female
- are a male over 40 years of age
- have a condition called Wolff-Parkinson-White syndrome
- have any other allergies or sensitivities
- have a history of epilepsy or structural brain lesions
- have a history of drug use
are pregnant, think you are pregnant or are planning to become pregnant
- are breastfeeding, or plan to breastfeed
- are over 65 years of age
Other warnings you should know about:
Driving and Using Machines: ZOLMITRIPTAN-ODT can cause sedation. Avoid driving or using machines until you know how the medication affects you.
Overuse of ZOLMITRIPTAN-ODT: As with other migraine treatments, using too much ZOLMITRIPTAN-ODT can cause daily headaches or make your migraine headaches worse. Ask your healthcare professional if you think this is the case for you. You may need to stop using ZOLMITRIPTAN-ODT to correct the problem.
Risk of Eye Problems: Long-term use of ZOLMITRIPTAN-ODT may cause eye problems. If you develop any problems with your eyes, tell your healthcare professional right away.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may also interact with ZOLMITRIPTAN-ODT:
- medicines used to treat upset stomach or stomach ulcers (such as cimetidine)
- antibiotics from the quinolone family (such as ciprofloxacin)
- oral contraceptives
- propranolol, a beta blocker used to treat heart rhythm problems
- smoking or tobacco
alcohol
- excessive amounts of green tea or green tea extract
- herbal remedies containing St John’s Wort
How to take ZOLMITRIPTAN-ODT:
- Take ZOLMITRIPTAN-ODT exactly as your healthcare professional has told you to.
Usual dose:
- The usual starting dose is 2.5 mg at the first sign of a migraine attack.
- Place the tablet on your tongue and let it dissolve, then swallow.
- Do NOT break the orally disintegrating tablet in half.
If your headache returns and it has been at least 2 hours since you took your first dose, you may take a
Serious Drug Interactions
Do NOT take ZOLMITRIPTAN-ODT if you are taking or have taken:
- In the last 24 hours, any medications that contain ergotamine (such as dihydroergotamine, methysergide).
- In the last 24 hours, other medications like ZOLMITRIPTAN-ODT (such as sumatriptan, naratriptan, almotriptan, rizatriptan or eletriptan).
- Within the last 2 weeks, a monoamine oxidase inhibitor (MAOI) (such as phenelzine sulfate, tranylcypromine sulfate, moclobemide).
- Any selective serotonin reuptake inhibitors (SSRI’s) such as fluoxetine, sertraline, fluvoxamine, paroxetine, or any serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine hydrochloride. These medications are often used in the treatment of depression.
second dose. The maximum dose is 10 mg in any 24 hour period. If your first dose did not relieve your migraine headache, do not take a second dose without talking to your healthcare professional first.
Overdose:
What are possible side effects from using ZOLMITRIPTAN-ODT?
These are not all the possible side effects you may have when taking ZOLMITRIPTAN-ODT. If you experience any side effects not listed here, tell your healthcare professional.
Side effects with ZOLMITRIPTAN-ODT may include:
- feeling sick
- vomiting
- dizziness
- tiredness
- weakness
- muscle aches and pains
- difficulty swallowing
- dry mouth
- headache
- stomach pain
- increase in the production of urine or in the frequency of urination
Serious side effects and what to do about them
Symptom / effect
Talk to your healthcare
professional
Stop taking drug and get immediate medical help
Only if severe
In all cases
COMMON
Irregular heart beat
✓
Sensations of pain, pressure or tightness in the chest, neck, throat, jaw, arms, or legs
✓
Sensations of tingling, heat, heaviness or pressure
✓
UNCOMMON
Fast heart rate
✓
Temporary increase in blood pressure
✓
RARE
If you think you, or a person you are caring for, have taken too much ZOLMITRIPTAN-ODT, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Allergic reaction: shortness of breath, sudden wheeziness, chest tightness, swelling of the eyelids, face, lips, mouth, tongue or neck, lumpy skin rash, or hives | ✓ | ||
|---|---|---|---|
| VERY RARE | |||
| Sudden or severe abdominal pain or bloody diarrhea | ✓ | ||
| Symptoms of a heart attack: chest pain, sweating, shortness of breath | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Serotonin toxicity: a reaction which may cause feelings of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (>38 °C), or rigid muscles. | ✓ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Storage:
- Store ZOLMITRIPTAN-ODT at room temperature between 15°C and 30°C, away from direct heat.
- Do not take your medication after the expiry date on the package and blister foil. If you have any leftover medication that you do not need or is expired, return the tablets to your pharmacist for disposal.
- Keep out of reach and sight of children.
If you want more information about ZOLMITRIPTAN-ODT:
- Talk to your healthcare professional
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling the distributor, Mint Pharmaceuticals Inc. at 1-877-398-9696.
1A- Sector 16A, Institutional Area,
Noida, Uttar Pradesh, India, 201301.
Importer/Distributor:
Mint Pharmaceuticals,
6575 Davand Drive
Mississauga, Ontario L5T 2M3,
Canada