Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Zavesca (Miglustat). If you are concerned about side effects, discuss the risks and benefits of Zavesca (Miglustat) with your doctor.

The following side effects have been reported by at least 1% of people taking Zavesca (Miglustat). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Constipation
• decreased appetite
• Diarrhea
• dizziness
• Dry Mouth
• flu-like symptoms
• gas
• generalized weakness
• headache
• heartburn
• muscle cramps
• nausea
• sensation of spinning
• stomach or abdominal pain
• tremor (shakiness)
• unusual tiredness
• vision problems
• vomiting
• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• numbness, burning, or tingling in the hands and feet
• stomach or abdominal pain (severe)
• unusual bruising or bleeding

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Zavesca (Miglustat).

Each white opaque capsule, with "OGT 918" in black on the cap and "100" in black on the body of the capsule, contains Zavesca (Miglustat) 100 mg. Nonmedicinal ingredients: magnesium stearate, povidone (K30), sodium starch glycollate, gelatin, titanium dioxide (E171), water, black iron oxide (E172), potassium hydroxide, propylene glycol, and shellac.

Zavesca (Miglustat) should not be taken by anyone who:

• is allergic to Zavesca (Miglustat) or to any of the ingredients of the medication
• is pregnant or attempting to become pregnant

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Zavesca (Miglustat).

Bleeding: Zavesca (Miglustat) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible.

Diarrhea: Diarrhea is a very common side effect of Zavesca (Miglustat). If you experience diarrhea, taking Zavesca (Miglustat) between meals may help. If the diarrhea is bothersome, contact your doctor.

Dizziness/reduced alertness: Zavesca (Miglustat) commonly causes dizziness. Avoid driving or operating machinery until you know how Zavesca (Miglustat) affects you.

Kidney Disease: Zavesca (Miglustat) is removed from the body by the kidneys and its elimination may be reduced in people with kidney disease. If you have kidney disease, discuss with your doctor how Zavesca (Miglustat) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zavesca (Miglustat), and whether any special monitoring is needed.

Severe Gaucher disease: The safety and effectiveness of Zavesca (Miglustat) have not been evaluated for people with severe Gaucher disease. Zavesca (Miglustat) is used for mild-to-moderate type 1 Gaucher disease.

Pregnancy: Zavesca (Miglustat) should not be used by women during pregnancy as it may cause harm to the unborn baby. Both men and women should use a reliable method of contraception. Men should not father a child while they are taking Zavesca (Miglustat) and for 3 months after stopping the medication. If you become pregnant while you are taking Zavesca (Miglustat), contact your doctor immediately.

Breast-feeding: It is not known if Zavesca (Miglustat) passes into breast milk. If you are a breast-feeding mother and are taking Zavesca (Miglustat), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Zavesca (Miglustat) for type I Gaucher disease have not been established for children under 18 years of age. The safety and effectiveness of using Zavesca (Miglustat) for Niemann-Pick type C disease have not been established for children under 4 years of age.