Patient Medication Information: uses, side effects, how to take - IPG-Zolmitriptan

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 IPG-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 IPG-ZOLMITRIPTAN. This can be fatal.
Chest Pain: IPG-ZOLMITRIPTAN 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 IPG-ZOLMITRIPTAN. These conditions can be fatal.

If you think you are experiencing any of the above, contact your healthcare professional or get immediate medical help.

What are IPG-ZOLMITRIPTAN used for?

IPG-ZOLMITRIPTAN is used in adults to relieve migraine headache and other associated symptoms of a migraine attack.

IPG-ZOLMITRIPTAN should not be used to prevent or reduce the number of attacks you experience. Only use IPG-ZOLMITRIPTAN to treat an actual migraine headache attack.

How do IPG-ZOLMITRIPTAN work?

Migraine headache is believed to be caused by a widening of the blood vessels in the head. IPG-ZOLMITRIPTAN narrows these vessels and relieves the pain and other symptoms of migraine headache.

What are the ingredients in IPG-ZOLMITRIPTAN?

IPG-ZOLMITRIPTAN:

Medicinal ingredients: zolmitriptan.

Non-medicinal ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and the Film Coating ingredients containing the following: Hypromellose, Polyethylene glycol, Titanium dioxide and Yellow iron oxide.

IPG-ZOLMITRIPTAN come in the following dosage forms:

IPG-ZOLMITRIPTAN: tablets, 2.5 mg.

Do not use IPG-ZOLMITRIPTAN if:

you are allergic to zolmitriptan or any of the other ingredients in IPG-ZOLMITRIPTAN
(see “What are the ingredients in IPG-ZOLMITRIPTAN?”)
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 IPG-ZOLMITRIPTAN. 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
have a rare hereditary galactose intolerance such as Lapp lactase deficiency or glucose-galactose malabsorption, because IPG-ZOLMITRIPTAN tablets contain lactose

Other warnings you should know about:

Driving and Using Machines: IPG-ZOLMITRIPTAN can cause sedation. Avoid driving or using machines until you know how the medication affects you.

Overuse of IPG-ZOLMITRIPTAN: As with other migraine treatments, using too much IPG-ZOLMITRIPTAN 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 IPG-ZOLMITRIPTAN to correct the problem.

Risk of Eye Problems: Long-term use of IPG-ZOLMITRIPTAN 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.

Serious Drug Interactions

Do NOT take IPG-ZOLMITRIPTAN 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 IPG-ZOLMITRIPTAN (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.

The following may interact with IPG-ZOLMITRIPTAN:

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 IPG-ZOLMITRIPTAN:

Take IPG-ZOLMITRIPTAN exactly as your healthcare professional has told you to.

Usual dose:

IPG-ZOLMITRIPTAN Tablets:

The usual starting dose is 2.5 mg at the first sign of a migraine attack.
Swallow the tablet with water.
If your healthcare professional has recommended a smaller dose for you, the tablet can be broken in half.

If your headache returns and it has been at least 2 hours since you took your first dose, you may take a 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:

If you think you, or a person you are caring for, have taken too much IPG-ZOLMITRIPTAN, 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.

What are possible side effects from using IPG-ZOLMITRIPTAN?

These are not all the possible side effects you may have when taking IPG-ZOLMITRIPTAN. If you experience any side effects not listed here, tell your healthcare professional.

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
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.

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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

IPG-ZOLMITRIPTAN: Store between 15°C and 30°C.

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 IPG-ZOLMITRIPTAN:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug- product-database.html; the manufacturer’s website www.marcanpharma.com or by calling 1-855-627-2261.

Rx or OTC	Prescription (Rx)?
DIN	02398036
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Zolmitriptan 2.5 MG
Dosage form(s)	Tablet
Route(s) of administration	Oral
Drug class (WHO ATC)	N Nervous system drugs N02 Analgesics N02C Antimigraine preparations N02CC Selective serotonin (5HT1) agonists, antimigraine drugs N02CC03 Zolmitriptan
Company	MARCAN PHARMACEUTICALS INC
Current status	Approved
Current status date	March 15, 2016

IPG-Zolmitriptan: Uses, Side Effects and Dosage