Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For miglustat, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to miglustat. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Miglustat is not recommended during pregnancy. It has been shown to cause serious birth defects or other problems in animals. Before taking this medicine be sure your doctor knows if you are pregnant or are planning to become pregnant. Be sure you have discussed this with your doctor. Males who are taking this medicine should use effective birth control and should contine using birth control for at least three months after stopping the medicine.

Breast-feeding—It is not known whether miglustat passes into breast milk. It is not recommended for use during breast feeding because it may cause unwanted effects in nursing babies. You should decide to breast feed or take miglustat, but not both. Be sure you have discussed this with your doctor.

Children—This medicine is not used in children under 18 years of age.

Older adults—Many medicines have not been specifically studied in older people. Therefore, it may not be known whether they work the same way the do in younger adults. This medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medical problems—The presence of other medical problems may affect the use of miglustat. Make sure you tell your doctor if you have any other medical problems, especially:

• Gaucher disease, Type 1, severe—this medicine is not currently being used in patients with severe Type 1 Gaucher disease

• Kidney disease—this condition may cause you to have more miglustat in your body; your doctor may want to change the amount of miglustat that you take