Miglusca ®_manufactured by Faran Shimi Pharmaceutical company_ contains the active ingredient miglustat, a glucosylceramide synthase inhibitor indicated as monotherapy for treatment of adult patients with mild/moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option.
Miglusca is available in 100mg capsules. 21 capsules are in one bottle and 2 bottles are packaged in one box with a leaflet.
The dosage of each drug is determined by the doctor, but the usual dosage of Migluska capsules is as follows:
Type 1 Gaucher disease in adults: one capsule (100 mg) every 8 hours
Type C Niemann-Pick disease in adults and adolescents over 12 years of age: two capsules (200 mg) every 8 hours.
The dosage of this medicine in children under 12 years of age with type C Niemann-Pick disease is determined by the doctor.
May be administered with or without food; administration between meals may decrease the incidence of diarrhea. Capsules should be taken at the same time each day at regular intervals. If patient is unable to tolerate or swallow capsule whole and powder is administered, mix powder into a liquid immediately prior to use (do not store); sweetening agents are not expected to interact.
There are no known significant interactions.
It is not recommended to use this medicine during pregnancy, breastfeeding or planning for pregnancy.
• Take a missed dose as soon as you think about it.
• If it’s close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
If you think there has been an overdose, call your doctor, pharmacist, or other health care provider right away.
Hypersensitivity to miglustat or any component of the formulation; females who are or may become pregnant.
• Talk to your doctor or pharmacist before taking miglusca
– if you suffer from kidney disease and liver disease
• Your doctor will perform the following tests before treatment and during treatment
-an examination to check the nerves in your arms and legs
– measurement of vitamin B12 levels
– monitoring growth if you are a child or adolescent with Niemann-Pick type C disease
– monitoring of blood platelet counts
• tingling or numbness in the hands and feet, or a decrease in body weight, may occur while taking miglusca.
• If you have diarrhoea, your doctor may ask you to change your diet to reduce your lactose and carbohydrate intake such as sucrose (cane sugar), or not to take miglusca together with food, or to temporarily reduce your dose. In some cases the doctor may prescribe anti-diarrhoeal medicines such as loperamide. If your diarrhoea does not respond to these measures, or if you have any other abdominal complaint, consult your doctor. In such case, your doctor may decide to conduct further investigations.
• Male patients should use reliable birth control methods during their treatment with miglusca, and for 3 months after finishing treatment.
The following adverse drug reactions are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Endocrine & metabolic: Weight loss
Gastrointestinal: Abdominal pain, diarrhea, flatulence, nausea, vomiting
Nervous system: Asthenia, dizziness, headache, tremor
Neuromuscular & skeletal: Lower limb cramp, muscle cramps
Ophthalmic: Visual disturbance
1% to 10%:
Endocrine & metabolic: Menstrual disease
Gastrointestinal: Abdominal distention, anorexia, bloating, constipation, dyspepsia, epigastric pain, xerostomia
Hematologic & oncologic: Thrombocytopenia
Nervous system: Feeling of heaviness (limbs), memory impairment, migraine, paresthesia, peripheral neuropathy, unsteady gait
Neuromuscular & skeletal: Back pain
Post marketing: Nervous system: Psychosis
This medicine can only be obtained with a doctor's prescription
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