Zavesca
miglustat
miglustat
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects,talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What Zavesca is and what it is used for
What you need to know before you take Zavesca
How to take Zavesca
Possible side effects
How to store Zavesca
Contents of the pack and other information
Zavesca contains the active substance miglustat which belongs to a group of medicines that affect metabolism. It is used to treat two conditions:
In type 1 Gaucher disease, a substance called glucosylceramide is not removed from your body. It starts to build up in certain cells of the body’s immune system. This can result in liver and spleen enlargement, changes in the blood, and bone disease.
The usual treatment for type 1 Gaucher disease is enzyme replacement therapy. Zavesca is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
If you have Niemann-Pick type C disease, fats such as glycosphingolipids build up in the cells of your brain. This can result in disturbances in neurological functions such as slow eye movements, balance, swallowing, and memory, and in seizures.
Zavesca works by inhibiting the enzyme called ‘glucosylceramide synthase’ which is responsible for the first step in the synthesis of most glycosphingolipids.
if you are allergic to miglustat or any of the other ingredients of this medicine (listed in section 6)
Talk to your doctor or pharmacist before taking Zavesca
if you suffer from kidney disease
if you suffer from liver disease
Your doctor will perform the following tests before treatment and during treatment with Zavesca:
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
The reason for these tests is that some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Zavesca. The tests will help the doctor decide whether these effects are due to your disease or other existing conditions, or due to side effects of Zavesca (see section 4 for further details).
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 Zavesca 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 Zavesca, and for 3 months after finishing treatment.
Do not give this medicine to children and adolescents (below 18 years old) with type 1 Gaucher disease because it is not known if it works in this disease.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Zavesca. They may lower the amount of Zavesca in your body.
You should not take Zavesca if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information. You must use effective birth control while taking Zavesca. Do not
breast-feed while you are taking Zavesca.
Male patients should use reliable birth control methods during their treatment with Zavesca, and for 3 months after finishing treatment.
If you are pregnant, breast feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Zavesca may make you feel dizzy. Do not drive or use any tools or machines if you feel dizzy.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
(300 mg).
For children less than 12 years old, your doctor will adjust the dose for Niemann-Pick type C disease. If you have a problem with your kidneys you may receive a lower starting dose. Your doctor may
reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when
taking Zavesca (see section 4). Your doctor will tell you how long your treatment will last.
Separate at perforations
Peel back paper at arrows
Push product through foil
Zavesca can be taken with or without food. You should swallow the whole capsule with a glass of water.
If you take more capsules than you were told to, consult your doctor immediately. Zavesca has been used in clinical trials at doses up to 3000 mg: this caused decreases in white blood cells and other side effects similar to those described in section 4.
Take the next capsule at the usual time. Do not take a double dose to make up for a forgotten dose.
Don’t stop taking Zavesca without talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Mostserioussideeffects:
be signs of peripheral neuropathy, due to side effects of Zavesca or they could be due to existing conditions. Your doctor will perform some tests before and during treatment with Zavesca to assess
this (see section 2).
The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite.
Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets).The neurological symptoms and thrombocytopenia could be due to the underlying disease.
Other possible side effects are muscular spasms or weakness, fatigue chills and malaise, depression, difficulty sleeping, forgetfulness, and less libido.
Most patients get one or more of these side effects, usually at the start of treatment or at intervals during treatment. Most cases are mild and disappear quite quickly. If any of these side effects cause problems, consult your doctor. He or she may reduce the dose of Zavesca or recommend other medicines to help control side effects.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreporting systemlistedinAppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 30C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer take. These measures will help protect the environment.
Gelatin,
Titanium dioxide (E171).
Black iron oxide (E172), Shellac.
Zavesca is a white 100 mg capsule with “OGT 918” printed in black on the cap and “100” printed in black on the body.
Box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules.
B-2340 Beerse Belgium
Janssen Pharmaceutica NV Turnhoutseweg 30
B-2340 Beerse
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88
„Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00
Janssen-Cilag NV Tél/Tel: +32 14 64 94 11
Janssen-Cilag A/S Tlf: +45 4594 8282
AM MANGION LTD Tel: +356 2397 6000
Janssen-Cilag GmbH Tel: +49 2137 955 955
Janssen-Cilag B.V. Tel: +31 76 711 1111
UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410
Janssen-Cilag AS Tlf: +47 24 12 65 00
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Tηλ: +30 210 80 90 000
Janssen-Cilag Pharma GmbH Tel: +43 1 610 300
Janssen-Cilag, S.A. Tel: +34 91 722 81 00
Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 00
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600
Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700
Johnson & Johnson România SRL Tel: +40 21 207 1800
Janssen Sciences Ireland UC Tel: +353 1 800 709 122
Johnson & Johnson d.o.o. Tel: +386 1 401 18 00
Janssen_safety_slo@its.jnj.com
Janssen-Cilag AB c/o Vistor hf.
Sími: +354 535 7000
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
Βαρνάβας Χατζηπαναγής Λτδ Τηλ: +357 22 207 700
Janssen-Cilag AB Tfn: +46 8 626 50 00
UAB "JOHNSON & JOHNSON" filiāle Latvijā Tel: +371 678 93561
Janssen Sciences Ireland UC Tel: +44 1 494 567 444
There are also links to other websites about rare diseases and treatments.