PACKAGE LEAFLET: INFORMATION FOR THE USER Cromiva 100 mg hard capsules

Miglustat

Read all of this leaflet carefully before you start

taking this medicine because it contains important

information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, 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 is in this leaflet

1.    What Cromiva is and what it is used for

2.    What you need to know before you take Cromiva

3.    How to take Cromiva

4.    Possible side effects

5.    How to store Cromiva

6.    Contents of the pack and other information

1. What Cromiva is and what it is used for

Cromiva contains the active substance miglustat which belongs to a group of medicines that affect metabolism.

Cromiva is used to treat mild to moderate type 1 Gaucher disease in adults.

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. Cromiva is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.

2. What you need to know before you take Cromiva

Do not take Cromiva

-    if you are allergic to miglustat or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Cromiva

-    if you suffer from kidney disease

-    if you suffer from liver disease

If any of these apply to you, tell your doctor before you take Cromiva.

Your doctor will perform the following tests before treatment and during treatment with Cromiva:

-    an examination to check the nerves in your arms and legs

-    measurement of vitamin B₁₂ levels

-    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 Cromiva. 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 Cromiva (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 Cromiva 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 Cromiva, and for 3 months after finishing treatment.

Children and adolescents

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. Other medicines and Cromiva 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 Cromiva. They may lower the amount of miglustat in your body.

Pregnancy, breast-feeding and fertility You should not take Cromiva if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information. You must use effective birth control while taking Cromiva. Do not breast-feed while you are taking Cromiva.

Male patients should use reliable birth control methods during their treatment with Cromiva, 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.

Driving and using machines

Cromiva may make you feel dizzy. Do not drive or use any tools or machines if you feel dizzy.

3. How to take Cromiva

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

For type 1 Gaucher disease: For adults, the usual dose is one hard capsule (100 mg) three times a day (morning, afternoon and evening). This means a daily maximum of three hard capsules (300 mg).

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 hard capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Cromiva (see section 4). Your doctor will tell you how long your treatment will last.

Cromiva can be taken with or without food. You should swallow the whole hard capsule with a glass of water.

If you take more Cromiva than you should

If you take more hard capsules than you were told to, consult your doctor immediately. Cromiva has been used in clinical trials at doses ten times higher than the recommended dose: this caused decreases in white blood cells and other side effects similar to those described in section 4.

If you forget to take Cromiva

Take the next hard capsule at the usual time. Do not

take a double dose to make up for a forgotten dose.

If you stop taking Cromiva

Don’t stop taking Cromiva without talking to your

doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most serious side effects:

Some patients have had tingling or numbness in the hands and feet (seen commonly). They could be signs of peripheral neuropathy, due to side effects of Cromiva or they could be due to existing conditions. Your doctor will perform some tests before and during treatment with Cromiva to assess this (see section 2).

If you do get any of these effects, please seek medical advice from your doctor as soon as possible.

If you get a slight tremor, usually trembling hands, seek medical advice from your doctor

as soon as possible. The tremor often disappears without needing to stop the treatment. Sometimes your doctor will need to reduce the dose or stop Cromiva treatment to stop the tremor.

Very common effects - may affect more than 1 in 10 people

The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite.

If you do lose some weight when you start treatment with Cromiva don’t worry. People usually stop losing weight as treatment goes on.

Common effects - may affect up to 1 in 10 people 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 Cromiva or recommend other medicines to help control side effects.

Reporting of side effects

If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.co.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cromiva

Keep this medicine out of the sight and reach of children.

Do not use 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Cromiva contains

The active substances is miglustat. Each hard capsule contains 100 mg Miglustat.

The other ingredients are:

Capsule contents: sodium starch glycolate type A, povidone, magnesium stearate.

Capsule shell: titanium dioxide (E171), gelatin.

What Cromiva looks like and contents of the pack

Cromiva are white hard gelatin capsules, filled with a homogenous, white to off-white granulate.

Cromiva is available in pack sizes of 21, 84 or 126 hard capsules in perforated Aclar-Alu (PVC/PE/ PCTFE-Alu) blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue,

Kenton, Middlesex, HA3 0BU United Kingdom

Manufacturer G.L. Pharma GmbH

Schlossplatz 1, Austria and

Glenmark Pharmaceuticals s.r.o.

Fibichova 143,

566 17 Vysoke Myto Czech Republic

This leaflet was last revised in 09/2014.