Sandoz Zolmitriptan: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What are Sandoz Zolmitriptan and Sandoz Zolmitriptan ODT used for?

Sandoz Zolmitriptan / Sandoz Zolmitriptan ODT is used in adults to relieve migraine headache and other associated symptoms of a migraine attack.

Sandoz Zolmitriptan / Sandoz Zolmitriptan ODT should not be used to prevent or reduce the number of attacks you experience. Only use Sandoz Zolmitriptan / Sandoz Zolmitriptan ODT to treat an actual migraine headache attack.

How do Sandoz Zolmitriptan and Sandoz Zolmitriptan ODT work?

Migraine headache is believed to be caused by a widening of the blood vessels in the head. Sandoz Zolmitriptan / Sandoz Zolmitriptan ODT narrows these vessels and relieves the pain and other symptoms of migraine headache.

What are the ingredients in Sandoz Zolmitriptan and Sandoz Zolmitriptan ODT?

Sandoz Zolmitriptan:

Medicinal ingredients: zolmitriptan.

Non-Medicinal ingredients: anhydrous lactose, colloidal anhydrous silica, crospovidone, ferric oxide yellow, hydroxypropylcellulose, hypromellose, macrogol, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide.

Sandoz Zolmitriptan ODT

Medicinal ingredients: zolmitriptan.

Non-medicinal ingredients: aspartame, citric acid anhydrous, silica colloidal anhydrous, crospovidone, magnesium stearate, mannitol, silicified microcrystalline cellulose, sodium hydrogen carbonate, sweet orange flavour

Sandoz Zolmitriptan and Sandoz Zolmitriptan ODT come in the following dosage forms:

Sandoz Zolmitriptan is supplied in tablets of 2.5 mg, in blister packs containing 3 or 6 tablets.

Sandoz Zolmitriptan ODT is supplied in orally disintegrating tablet of 2.5 mg, in blister packs containing 2 or 6 tablets.

Do not use Sandoz Zolmitriptan or Sandoz Zolmitriptan ODT if:

• you are allergic to zolmitriptan or any of the other ingredients in Sandoz Zolmitriptan / Sandoz Zolmitriptan ODT (see “What are the ingredients in Sandoz Zolmitriptan and Sandoz 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

  • -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 Sandoz Zolmitriptan or Sandoz 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
• have a rare hereditary galactose intolerance such as Lapp lactase deficiency or glucose-galactose malabsorption, because Sandoz Zolmitriptan contains lactose
• have phenylketonuria, because Sandoz Zolmitriptan ODT contains 2.5 mg of aspartame.

Other warnings you should know about:

Driving and Using Machines: Sandoz Zolmitriptan / Sandoz Zolmitriptan ODT can cause sedation. Avoid driving or using machines until you know how the medication affects you.

Overuse of Sandoz Zolmitriptan / Sandoz Zolmitriptan ODT: As with other migraine treatments, using too much Sandoz Zolmitriptan / Sandoz 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 Sandoz Zolmitriptan / Sandoz Zolmitriptan ODT to correct the problem.

Risk of Eye Problems: Long-term use of Sandoz Zolmitriptan / Sandoz 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 interact with Sandoz Zolmitriptan and Sandoz 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 Sandoz Zolmitriptan and Sandoz Zolmitriptan ODT

• Take Sandoz Zolmitriptan / Sandoz Zolmitriptan ODT exactly as your healthcare professional has told you to.

Usual dose:Sandoz Zolmitriptan

• 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.

Sandoz Zolmitriptan ODT

• The usual starting dose is 2.5 mg at the first sign of a migraine attack.
• The blister pack should be peeled open as shown on the foil (tablets should not be pushed through the foil).
• 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 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 Sandoz Zolmitriptan or Sandoz Zolmitriptan ODT, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

What are possible side effects from using Sandoz Zolmitriptan and Sandoz Zolmitriptan ODT?

These are not all the possible side effects you may have when taking Sandoz Zolmitriptan and Sandoz Zolmitriptan ODT. 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

Serious side effects and what to do about them

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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/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.

Storage:

Sandoz Zolmitriptan: Store your medication between 15 and 30ºC, away from direct heat.

Sandoz Zolmitriptan ODT: Store your medication between 15 and 30ºC, 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 Sandoz Zolmitriptan or Sandoz Zolmitriptan ODT:

• 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.sandoz.ca or by calling 1-800-361-3062.

Or by written request at:

110, Rue de Lauzon

Boucherville, (QC), Canada

J4B 1E6

or by e-mail at:

medinfo@sandoz.com

Last revised: NOV 22, 2024