Details for: SANDOMIGRAN DS
Company: PALADIN LABS INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00511552 | SANDOMIGRAN DS | PIZOTIFEN (PIZOTIFEN MALATE) | 1 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
Sandomigran is prescribed for the prevention of migraine.
What it does
When Sandomigran is taken regularly it can help to reduce the frequency or severity of migraine. Sandomigran is not intended for the treatment of acute migraines or to stop migraine attacks once they have started.
When it should not be used
Do not use Sandomigran if you:
- are allergic to this medicine, or to any of the components of its formulation (for a list of components, see the section “What the nonmedicinal ingredients are”);
- take a monoamine oxidase inhibitor for treatment of depression (e.g.: Nardil®, Parnate®, Zynoxam®);
- have a problem with food passing out of the stomach either from a complete or partial obstruction (pyloroduonenal obstruction);
- have an ulcer;
- have intolerance to the sugar of milk products (or lactose).
- are less than 12 years old
What the medicinal ingredient is
Pizotifen hydrogen malate
What the non-medicinal ingredients are
Each 0.5 mg tablet contains: lactose monohydrate, corn starch, povidone, magnesium stearate, propyl paraben, acacia, colloidal silicone dioxide, cetyl palmitate, sugar and talc.
Each 1 mg tablet contains: lactose anhydrous, magnesium stearate, and microcrystalline cellulose.
What dosage form it comes in
Tablets; 0.5 mg (Sandomigran), 1 mg (Sandomigran DS)
Warnings and precautions
Keep Sandomigran out of the reach of children. You should not give Sandomigran to anyone as inappropriate use may have severe medical consequences.
BEFORE you use Sandomigran talk to your doctor or pharmacist if you:
- You have raised pressure in your eyes (glaucoma);
- You have difficulty urinating;
- You have a kidney or liver disease;
- You have diabetes or heart disease
- You have a history of seizure/epilepsy (convulsions)
- You are pregnant, planning to become pregnant or you become pregnant while taking this medication.
- You are breastfeeding or plan to breastfeed
- You have intolerance of sugar or lactose
Driving and operating machinery
Sandomigran may impair the mental and/or physical abilities required for performance of potentially hazardous task such as driving a car or operating machinery. If you experience drowsiness or dizziness, such tasks should be avoided.
Avoid alcoholic beverages or taking medications that can cause drowsiness (including sleeping pills, cold syrup, antidepressants etc.) while taking Sandomigran as they can increase the effect of drowsiness and dizziness.
Take this medication as directed by your doctor. Do not stop Sandomigran or Sandomigran DS without advice by your physician. Sudden stoppage of this drug may cause acute withdrawal reactions. Symptoms may include depression, tremor, nausea, anxiety, and/or sleep disorder etc.
Interactions with this medication
Tell your doctor or pharmacist if you are taking or have recently taken any other prescription or over-the-counter medicines, vitamins or natural health products during your treatment with Sandomigran.
Drugs that may interact with Sandomigran & Sandomigran DS include:
- Alcohol;
- Sleeping pills, sedatives and antihistamines drugs (e.g. cold and hay fever medicines)
- Low blood pressure drugs
- Monoamine oxidase inhibitor (MAOI)
Proper use of this medication
Adult and elderly:
The starting dose of Sandomigran is 0.5 mg once daily at bedtime.
The daily dose can be increased gradually to a total dose of 1.5 mg
administered at bedtime or in three divided doses if recommended
by your physician.
Up to 3 mg may be given as a single dose.
Children (12 years and older):
The starting dose of Sandomigran is 0.5 mg once daily at bedtime. A maximum single dose of 1 mg can be given at bedtime. The overall daily dose can be increased gradually up to 1.5 mg divided into three 0.5 mg doses if recommended by your physician.
Overdose
The symptoms of overdose may include sedation, drowsiness rapid heart rate, nausea, vomiting and lack of coordination of muscle movement
Missed Dose
If you normally take Sandomigran tablets 2 or more times a day you should take the last dose you missed as soon as you remember. Do not take it if there is less than 4 hours before your next dose, but go back to your regular dosing schedule. Do not double doses or take more than your maximum daily dose.
Side effects and what to do about them
The most common side effects of Sandomigran are: increased appetite, weight gain, drowsiness, nausea, dry mouth, fatigue and dizziness.
Other side effects such as the following have also been observed: constipation, skin irritation, insomnia, anxiety, muscle and join pain, muscle cramps, delayed menstrual period, breast changes (pain, enlargement, secretion).
| 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 emergency medical help |
|---|---|---|---|
| Rare or very rare | |||
| Yellowing of the skin or eyes (jaundice) | ✔ | ||
| Persistent sad mood | ✔ | ||
| Aggressive behaviour or agitation in children | ✔ | ||
| Convulsions (seizures) or hallucination | ✔ | ||
| Sensation of tingling and/or pricking | ✔ | ||
| Partial or complete loss of vision | ✔ | ||
| Unknown | |||
| Allergic reaction (symptoms include swelling in the mouth, tongue, face, and throat, itching, rash, blistering of the skin, and/or mucous membranes of the lips, eyes, mouth nasal passages or genitals) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Sandomigran or Sandomigran DS, contact your physician or pharmacist.
How to store
- store your Sandomigran tablets at room temperature (between 15-30°C)
- protect from exposure to light and moisture
- keep out of reach and sight of children
- discard any expired medicine or medicine no longer needed
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found at:
http://www.website.document
or by contacting the sponsor, Paladin Labs Inc., at:
1-800-550-6060
This leaflet was prepared by Paladin Labs Inc.
Last revised: October 30, 2012