Details for: JAMP ZOLMITRIPTAN
Company: JAMP PHARMA CORPORATION
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02477106 | JAMP ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5 MG | TABLET | ORAL |
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
Jamp Zolmitriptan belong to a group of anti-migraine
drugs called 5-HT1 agonists. Jamp Zolmitriptan is used to
relieve your migraine headache and other associated
symptoms of a migraine attack.
Jamp Zolmitriptan should not be used continuously to
prevent or reduce the number of attacks you
experience. Use Jamp Zolmitriptan 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. Jamp Zolmitriptan narrows the vessels and relieves the pain and other symptoms of migraine headache.
When it should not be used
Jamp Zolmitriptan should not be used if:
- you are allergic to zolmitriptan or any of the other ingredients in zolmitriptan tablets (see “WHAT THE NONMEDICINAL INGREDIENTS ARE”)
- you have a history, or any symptoms or signs of a heart condition
- you have severe or uncontrolled hypertension
- you are taking or have recently taken (within 24 hours) an ergotamine containing or ergot-like drug, or another triptan used to treat migraines
- you have another type of headache that is different from a migraine attack
- you are taking or have recently taken (within 2 weeks) a monoamine oxidase inhibitor (MAOI)
What the medicinal ingredient is
Zolmitriptan tablets contain 2.5 mg of zolmitriptan as the active ingredient.
What the non-medicinal ingredients are
Zolmitriptan tablets contain: hypromellose, lactose anhydrous magnesium stearate, microcrystalline cellulose, polyethylene glycol 400 and 8000, red iron oxide, sodium starch glycolate, titanium dioxide.
What dosage form it comes in
Zolmitriptan tablets are supplied in 2.5 mg in packs of 2 blister strips, each containing 3 tablets.
Warnings and precautions
BEFORE you use Jamp Zolmitriptan talk to your doctor or pharmacist if the answer to any of the following questions is YES, or if you do not know the answer:
- Are you pregnant, think you might be pregnant, or trying to become pregnant? Are you using inadequate contraception? Are you breastfeeding?
- Do you or have you ever experienced any pain or tightness in the chest, (which may or may not spread to your neck, jaw, or upper arm), shortness of breath, or irregular heart beats? Do you have angina? Have you ever had heart or blood vessel disease? Do you have a history of cerebral bleeding? Have you had a heart attack or stroke?
- Do you have risk factors for heart disease, such as: high blood pressure, high cholesterol, smoking, obesity, diabetes, or strong family history of heart disease?
- Do you have rare hereditary problems of galactose intolerance?
- Are you post-menopausal or a male over 40?
- Do you have high blood pressure?
- Have you ever had to stop taking this or any other medication because of an allergy or other problems?
- Are you taking any other migraine 5-HT1 agonist medications such as sumatriptan succinate, naratriptan hydrochloride, rizatriptan benzoate, almotriptan malate or migraine medications containing ergotamine, dihydroergotamine, or methysergide?
- Are you taking any medications for depression such as selective serotonin reuptake inhibitors (SSRI’s), for example, fluoxetine hydrochloride, sertraline hydrochloride, fluvoxamine maleate, paroxetine hydrochloride, etc., or serotonin norepinephrine reuptake inhibitors (SNRIs), for example, venlafaxine hydrochloride, or monoamine oxidase inhibitors (MAOIs), for example, phenelzine sulfate, tranylcypromine sulfate or moclobemide?
- Have you ever experienced numbness on one side of your body when you have a headache?
- Have you ever had epilepsy or seizures?
- Have you ever had liver disease?
- Are you over 65 years of age?
- Is this headache different from your usual migraine attacks?
- Are you taking cimetidine (for treatment of indigestion or stomach ulcers) or a member of the quinolone family of antibiotics (for example ciprofloxacin)?
Zolmitriptan tablets contain lactose which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest milk or some sugars, talk to your doctor before taking this medicine.
Use of Jamp Zolmitriptan during pregnancy:
Do not use Jamp Zolmitriptan if you are pregnant, think you might be pregnant, are trying to become pregnant or are using inadequate contraception, unless you have discussed this with your doctor.
Interactions with this medication
Tell your doctor or pharmacist about any other drugs you take, including:
- other 5-HT1 agonist migraine drugs (sumatriptan succinate, naratriptan hydrochloride, rizatriptan benzoate, almotriptan malate) or migraine drugs that contain ergotamine, dihydroergotamine, methysergide
- drugs for depression such as selective serotonin reuptake inhibitors (SSRI’s), for example, fluoxetine hydrochloride, sertraline hydrochloride, fluvoxamine maleate, paroxetine hydrochloride, etc., or serotonin norepinephrine reuptake inhibitors (SNRIs), for example, venlafaxine hydrochloride, or monoamine oxidase inhibitors (MAOIs), for example, phenelzine sulfate, tranylcypromine sulfate or moclobemide
- drugs used to treat upset stomach or stomach ulcers (cimetidine)
- antibiotics from the quinolone family (for example ciprofloxacin)
Proper use of this medication
USUAL DOSE:
Adults
The usual dosage is 2.5 mg, or lower if recommended by
your doctor. A lower dose can be obtained by manually
breaking a conventional tablet in half. The dose should be
taken as soon as your migraine appears, but it may be
taken at any time during your migraine headache.
Swallow your dose with water.
A second dose may be taken if your headache returns, but
not sooner than 2 hours following the first tablet. For any
attack where you have no response to the first dose, do
not take a second dose without first consulting your
doctor.
Do not administer more than 10 mg in any 24 hour period.
OVERDOSE:
Side effects and what to do about them
Although the vast majority of Jamp Zolmitriptan users
have not experienced any significant problems, you
should be aware that the following side effects may occur.
Commonly reported side effects of Jamp Zolmitriptan are:
Jamp Zolmitriptan may cause drowsiness. Do not drive or operate machinery until you are sure that you are not drowsy.
Other common side effects include:
Uncommon side effects include:
Tell your doctor of these symptoms at your next visit.
Migraineurs may be at risk of certain cerebrovascular events such as cerebral bleeding and stroke. In very rare cases, as with other drugs of this type, such diseases have been reported in association with the use of Jamp Zolmitriptan.
In very rare cases, as with other drugs of this type (5HT1 agonists), the following side effects have been reported:
See the following table for what to do about serious side effects.
Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and seek immediate emergency medical attention |
---|---|---|---|
Common (frequency greater than or equal to 1% but in less than 10% of patients) | |||
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 (frequency greater than or equal to 0.1% but in less than 1% of patients) | |||
Fast heart rate | ✔ | ||
Temporary increase in blood pressure | ✔ | ||
Rare (frequency greater than or equal to 0.01% but in less than 0.1% of patients) | |||
Shortness of breath, wheeziness, heart throbbing, swelling of the eyelids, face, or lips; or a skin rash, itchy rash, skin lumps or hives, or swelling with fluid in the tissues | ✔ | ||
Very rare (frequency in less than 0.01% of patients) | |||
Symptoms of a heart attack (chest pain, sweating, shortness of breath) | ✔ | ||
Sudden or severe abdominal pain or bloody diarrhea | ✔ |
How to store
Keep your medicine in a safe place where children cannot
reach it. Jamp Zolmitriptan could be harmful to children.
Store your medication at controlled room temperature
(15ºC to 30ºC), away from direct heat.
If your doctor decides to stop your treatment, return your
medicine to the pharmacist for disposal. Do not take your
medication after the expiry date on the package and
blister foil. Return the tablets to your pharmacist for
disposal.
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 (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) 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.
More information
The name of your medicine is Jamp Zolmitriptan which
can only be obtained by prescription from your doctor.
The decision to use Jamp Zolmitriptan 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 a postmenopausal female, or a male over 40), tell your
doctor.
Your doctor should evaluate you for heart disease in order
to determine if Jamp Zolmitriptan is appropriate for you.
NOTE: This CONSUMER INFORMATION leaflet
provides you with the most current information at the
time of printing.
For the most current information, the Consumer
Information Leaflet plus the full Product Monograph,
prepared for health professionals can be obtained by
contacting the sponsor, Jamp Pharma Corporation
1-866-399-9091.
This leaflet was prepared by Jamp Pharma Corporation .
Date of Preparation: June 6, 2018