Jamp Zolmitriptan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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 post-menopausal 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.

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 IMPORTANT NONMEDICINAL 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 FORMS 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)?

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

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)

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those that can be bought without a prescription.

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:

• feeling sick
• vomiting
• dizziness
• tiredness
• weakness

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:

• muscle aches and pains
• difficulty swallowing
• dry mouth
• headache
• stomach pain

Uncommon side effects include:

• increase in the production of urine or in the frequency of urination

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:

• spasm of the blood vessels of the heart
• spasm of the blood vessels of the Gastro-Intestinal tract and spleen with possible infarctions

See the following table for what to do about serious side effects.

For any unexpected effects while taking Zolmitriptan Tablets, contact your doctor or pharmacist.

HOW TO STORE IT

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

MORE INFORMATION

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.

Date of Preparation: June 6, 2018