Sandomigran DS: Uses, Side Effects and Dosage

What is SANDOMIGRAN DS used for?

SANDOMIGRAN DS is used in adolescents (12 to 17 years of age) and adults to prevent migraines.

How does SANDOMIGRAN DS work?

Migraine headaches are believed to be caused by a widening of the blood vessels in the head. SANDOMIGRAN DS is thought to affect certain chemicals in the brain, which in turn prevent blood vessels from widening and may also change our sensitivity to pain. This helps to prevent and reduce the number of migraines. SANDOMIGRAN DS does not treat migraines or stop them once they have started.

What are the ingredients in SANDOMIGRAN DS?

Medicinal ingredient: Pizotifen malate

Non-medicinal ingredients: Lactose anhydrous, magnesium stearate and microcrystalline cellulose

SANDOMIGRAN DS comes in the following dosage forms:

Tablets: 1 mg

Do not use SANDOMIGRAN DS if:

• you are allergic to pizotifen or to any of the other ingredients in SANDOMIGRAN DS.
• you are currently taking or have taken in the last 14 days a monoamine oxidase inhibitor (MAOI) medication (such as linezolid, methylene blue, moclobemide, phenelzine, procarbazine, and tranylcypromine).

• you have a problem with food passing from the stomach into the small intestine either from a complete or partial blockage (pyloro-duonenal obstruction). This includes ulcers that narrow the opening from the stomach into the small intestines (stenosing pyloric ulcer).

• you are less than 12 years old.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SANDOMIGRAN DS. Talk about any health conditions or problems you may have, including if you:

• have glaucoma (an eye condition usually caused by high pressure in the eye).
• have difficulty urinating.
• have kidney or liver problems.
• have diabetes or heart problems.
• have epilepsy or seizures (sudden and uncontrolled burst of electrical activity in the brain)
• are at risk of excessive weight changes.
• are pregnant, think you might be pregnant, or planning to become pregnant.
• are breastfeeding or plan to breastfeed.

• have one of the following rare genetic conditions:

  • Galactose intolerance
  • Lactase deficiency
  • Glucose-galactose malabsorption

SANDOMIGRAN DS contains lactose.

Other warnings you should know about:

Stopping your treatment: Do not suddenly stop taking SANDOMIGRAN DS without first talking to your healthcare professional. If you do this, it may cause withdrawal symptoms such as depression, shaking (tremor), nausea, anxiety, a general feeling of discomfort, dizziness, sleep problems, fainting, loss of appetite and rapid weight loss. Stopping your treatment should be a gradual process that you discuss with your healthcare professional.

Tolerance: You may develop a tolerance to SANDOMIGRAN DS if you have taken it for a long time. Tell your healthcare professional if you feel like SANDOMIGRAN DS no longer works as well as it once did. They may increase your dose.

Weight: You may experience weight gain while taking SANDOMIGRAN DS. Monitor your weight on a regular basis during your treatment. You may experience weight loss after stopping your treatment.

Driving and using machinery: SANDOMIGRAN DS may cause dizziness, sleepiness, or a lack of energy. Do not drive, use machinery, or do activities that require you to be alert until you know how SANDOMIGRAN DS affects you.

Pregnancy: It is not known if SANDOMIGRAN DS can harm your unborn baby. Only take SANDOMIGRAN DS during pregnancy if you and your healthcare professional have discussed the risks and have decided that you should. If you discover that you are pregnant while taking SANDOMIGRAN DS, tell your healthcare professional right away.

Breastfeeding: SANDOMIGRAN DS can pass into breast milk and may harm a breastfed baby. Therefore, SANDOMIGRAN DS is not recommended during breastfeeding. Talk to your healthcare professional about the best way to feed your baby during this time.

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 SANDOMIGRAN DS if you:

• are taking or have recently taken (in the last 14 days) any MAOIs such as linezolid, methylene blue, moclobemide, phenelzine, procarbazine, and tranylcypromine.

Ask your healthcare professional if you are unsure.

The following may also interact with SANDOMIGRAN DS:

• central nervous system (CNS) depressant used to slow down the nervous system. These can include:

  • medicines used to help reduce anxiety.
  • medicines used to treat depression, psychotic symptoms, or other mental health disorders.
  • sleeping pills.
  • medicines used to treat allergies.
  • cough and cold medicines.
• medicines used to lower blood pressure.
• alcohol. SANDOMIGRAN DS may lower your alcohol tolerance. This means you may feel the effects of alcohol when taking less alcohol than usual. Drinking alcohol while taking SANDOMIGRAN DS may increase your risk of dizziness and sleepiness. It is best not to drink alcohol at all while taking SANDOMIGRAN DS to avoid side effects.

How to take SANDOMIGRAN DS:

• Take SANDOMIGRAN DS exactly as prescribed by your healthcare professional.

• The effects of your medicine may not be noticeable in the first few weeks of treatment. If you are concerned that your medicine is not working:

  • continue taking your medicine as prescribed as it may take some time for SANDOMIGRAN DS to work; and
  • discuss this with your healthcare professional.
• Do not stop taking SANDOMIGRAN DS without talking to your healthcare professional first. Stopping SANDOMIGRAN DS suddenly may cause unwanted side effects.

Usual dose:

Adults:

• The starting dose is 0.5 mg once daily at bedtime.
• Your daily dose may be gradually increased to the usual maintenance dose of 1.5 mg at bedtime or in three divided doses.
• The dosage range is 1 mg to 6 mg daily. Up to 3 mg may be given in a single dose.

Adolescents (12 to 17 years of age):

• The starting dose is 0.5 mg once daily at bedtime.
• A maximum single dose of 1 mg can be given at bedtime.
• The total daily dose may be gradually increased up to 1.5 mg given in divided doses.

Overdose:

Symptoms of an overdose with SANDOMIGRAN DS may include:

• dry mouth
• dilated pupils
• drowsiness
• dizziness
• low blood pressure
• nausea or vomiting

• fast heartbeat

  • difficulty breathing
  • lack of coordination
  • confusion
  • feeling agitated or restless
  • seizures
  • coma

[Minor update to align with the 2024 Product Monograph Master Template.]

Missed Dose:

If you normally take SANDOMIGRAN DS tablets 2 or more times a day, you should take the last dose you missed as soon as you remember. However, if there is less than 4 hours left before your next dose, skip the missed dose and take your next dose at the usual time. Do not double doses or take more than your maximum daily dose.

What are possible side effects from using SANDOMIGRAN DS?

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

Side effects may include:

• increased appetite, which may lead to weight gain
• drowsiness
• lack of energy
• dizziness
• nausea or vomiting
• dry mouth
• constipation
• muscle or joint pain
• sleep problems
• feeling anxious
• absence of menstrual periods in females
• breast pain or growth, production of breast milk

If you think you, or a person you are caring for, have taken too much SANDOMIGRAN DS, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no signs or symptoms.

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 (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:

•

• Store your SANDOMIGRAN DS tablets at room temperature (between 15°C - 30°C).

•

• Protect from light and moisture.

•

• Keep out of reach and sight of children.

If you want more information about SANDOMIGRAN DS:

•

• 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 (https://knighttx.com), by emailing medinfo@knighttx.com, or by calling 1-844-483-5636.

Last Revised: NOV 28, 2025