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CROMIVA 100 MG HARD CAPSULES

Active substance(s): MIGLUSTAT

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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 Vysoké Mýto
Czech Republic
This leaflet was last revised in 09/2014.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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