Details for: SANDOZ MIGLUSTAT
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02456257 | SANDOZ MIGLUSTAT | MIGLUSTAT | 100 MG | CAPSULE | 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
Sandoz Miglustat is used for:
- the treatment of mild to moderate Type 1 Gaucher disease in adult patients over 18 years of age who cannot use imiglucerase, or enzyme replacement therapy.
- to slow the progression of some of the neurologic symptoms in patients with Niemann-Pick Type C disease (affecting the brain and nervous system).
What it does
Sandoz Miglustat (miglustat) prevents an enzyme called glucosylceramide synthase from working, thereby reducing the production of fatty substances called glycosphingolipid glucosylceramide in cells.
Type I Gaucher disease is a condition in which there is a build-up of glucosylceramide in certain cells of the body's immune system called macrophages. This results in liver and spleen enlargement, changes in the blood, and bone disease.
In Niemann-Pick Type C disease, glycosphingolipids (fats) buildup in cells in the brain. This can result in problems with eye movement, eye sight (vision), balance, swallowing, speech, and memory, and in seizures (fits).
When it should not be used
Do not use Sandoz Miglustat if you:
- are allergic to miglustat or any of the other ingredients in Sandoz Miglustat
- are pregnant or planning to get pregnant. Sandoz Miglustat may cause harm to the unborn baby.
What the medicinal ingredient is
Miglustat
What the non-medicinal ingredients are
Capsule contents: magnesium stearate, povidone, sodium starch glycolate.
Capsule shell: gelatin, titanium dioxide.
What dosage form it comes in
Capsule 100 mg
Warnings and precautions
Sandoz Miglustat should be prescribed by a doctor experienced in the management of patients with Gaucher disease or NiemannPick Type C disease.
BEFORE you use Sandoz Miglustat talk to your doctor or pharmacist if you:
- have or have had kidney problems
- have liver problems
- have gastrointestinal disease, including inflammatory bowel syndrome
- are pregnant or planning to become pregnant. Pregnancy should be ruled out before taking Sandoz Miglustat
- are breastfeeding
Female patients should use a reliable method of contraception while taking Sandoz Miglustat.
Male patients should not father a child while taking Sandoz Miglustat and for three months after taking the last dose of this drug.
Do not drive a car or operate machinery until you know how Sandoz Miglustat affects you. Sandoz Miglustat may cause dizziness.
Interactions with this medication
You should always tell your doctor about all drugs you are taking or plan to take including prescription, nonprescription, vitamins and dietary supplements before starting Sandoz Miglustat.
Proper use of this medication
Always take Sandoz Miglustat exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Sandoz Miglustat capsules should be swallowed whole with water. The risk of diarrhea may be reduced if Sandoz Miglustat is taken between meals.
Usual Dose
Type 1 Gaucher disease: Adult over 18 years of age: 100 mg three times daily taken at regular intervals.
Niemann-Pick Type C disease: Adults and juveniles: 200 mg three times daily.
Children under 12 years old: the dose is based on body surface area (BSA mg/m2).
If you have a problem with your kidneys you may receive a lower starting dose. If your kidney problem is severe, it is unlikely that your doctor will prescribe Sandoz Miglustat. Your doctor will tell you how long your treatment will last.
Overdose
If you take more Sandoz Miglustat than you should, contact your doctor, or poison control centre, or emergency room of the nearest hospital immediately.
In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you forget to take a dose of Sandoz Miglustat, do not take another dose to make up for the missed dose. Take the next capsule at the usual time.
Side effects and what to do about them
Sandoz Miglustat can have side effects. Very common side effects: weight loss, diarrhea, dizziness, flatulence, tremor, abdominal (stomach) pain, nausea and headache.
Common side effects: loss of appetite, eating disorder (anorexia), constipation, paresthesia (tingling, pricking, or numbness), generalized weakness, flu like symptoms, discomfort in the stomach (dyspepsia), increased bleeding or bruising (thrombocytopenia), dizziness, vertigo, change in vision, cramps, dry mouth, muscular spasm and tiredness (fatigue).
Serious side effects: neurological problems (neuritis and neuropathy), tremor, numbness or tingling.
Call your doctor if pain, loss of reflexes, tremors, numbness or tingling occur while taking Sandoz Miglustat, or if the hand tremors you already have get worse.
The known serious side effects are described in the box below, which also tells you what to do about them.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Very Common | |||
| Diarrhea | ✔ | ||
| Weight loss | ✔ | ||
| Nausea | ✔ | ||
| Abdominal pain | ✔ | ||
| Headache | ✔ | ||
| Dizziness | ✔ | ||
| Flatulence | ✔ | ||
| Tremors | ✔ | ||
| Common | |||
| Tingling or numbness or pain | ✔ | ||
| Muscle cramps | ✔ | ||
| Anorexia | ✔ | ||
| Decreased appetite | ✔ | ||
| Dyspepsia | ✔ | ||
| Constipation | ✔ | ||
| Vomiting | ✔ | ||
| Cramps | ✔ | ||
| Increase bleeding or bruising (thrombocytopenia) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Sandoz Miglustat, contact your doctor or pharmacist.
How to store
- Keep out of the sight and reach of children
- Store at room temperature between 15-30°C
- Store in the original container
- Do not use after the expiry date stated on the container
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 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.
More information
- 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/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website (www.sandoz.ca) or by calling 1-800-3613062.
or by written request at:
110 Rue de Lauzon
Boucherville Québec
J4B 1E6
or by e-mail at:
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Date of Revision: January 2, 2020