Patient Medication Information: uses, side effects, how to take - Sandomigran
ABOUT THIS MEDICATION
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 (pyloro-duonenal 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 nonmedicinal 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 forms 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).
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your physician or pharmacist | Stop taking drug and seek emergency medical help | ||
| Only if severe | In all cases | |||
| 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.
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
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
Last revised: October 30, 2012
HOW TO STORE IT
REPORTING SUSPECTED 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 3 ways:
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- 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, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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.