MIGLUSTAT 100 mg Kapsułka Twarda
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Treść ulotki
Miglustat Dipharma 100 mg hard capsules
miglustat
Read 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Miglustat Dipharma is and what it is used for.
- 2. What you need to know before you take Miglustat Dipharma.
- 3. How to take Miglustat Dipharma.
- 4. Possible side effects.
- 5. How to store Miglustat Dipharma.
- 6. Contents of the pack and other information.
1. What is Miglustat Dipharma and what is it used for
Miglustat Dipharma contains the active substance miglustat which belongs to a group of medicines that
influence metabolism. It is used to treat two diseases:
- Miglustat Dipharma is used to treat mild to moderate type 1 Gaucher's disease in adults.Type 1 Gaucher's disease is characterized by the accumulation in some cells of the immune system of a substance called glucosylceramide which is not eliminated from the body. This accumulation can lead to enlargement of the liver and spleen, alterations of blood cells and bone diseases. The usual treatment for type 1 Gaucher's disease consists of enzyme replacement therapy. Miglustat Dipharma is used only if a patient is deemed unsuitable for treatment with enzyme replacement therapy.
- Miglustat Dipharma is also used to treat progressive neurological symptoms inNiemann-Pick type C disease in adults and children
If you suffer from Niemann-Pick type C disease, fats (such as glycosfingolipids)
increase inside brain cells. This can cause disturbances of neurological functions such as: slowing of eye movements, balance, swallowing, memory and
convulsions.
Miglustat Dipharma works by inhibiting an enzyme called glucosylceramide-synthetase which is
responsible for the first stage of the synthesis of most glycosfingolipids.
2. What you need to know before taking Miglustat Dipharma
Do not take Miglustat Dipharma:
- 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 Miglustat Dipharma:
- if you have kidney problems;
- if you have liver problems
Before and during treatment with Miglustat Dipharma your doctor will perform the following checks:
- an examination to check the condition of the nerves in your arms and legs;
- measurement of vitamin B levels.
- monitoring of growth if you are a paediatric or adolescent patient with Niemann-Pick disease type C
- checking the number of platelets in your blood
The reason these tests are performed is that, during the intake of Miglustat Dipharma,
some patients have experienced tingling or numbness in their hands and feet, or a decrease in body weight. The
tests will help your doctor determine if these effects are due to your illness or other existing conditions
or adverse effects of Miglustat Dipharma (for further information see section 4).
If you have diarrhoea, your doctor may: decide to modify your diet to reduce lactose and carbohydrate intake such as sucrose (cane sugar); decide not to have you take Miglustat Dipharma
with food; decide to temporarily reduce the dose of Miglustat Dipharma. In some cases
your doctor may prescribe anti-diarrhoeal medicines such as loperamide. If diarrhoea does not
respond to the above measures or if you have any other abdominal discomfort, consult your doctor. In
this case, your doctor may decide to carry out further investigations.
Male patients should use reliable contraceptive methods during treatment
with Miglustat Dipharma and for 3 months after its completion.
Children and adolescents
Do not give this medicine to children and adolescents (under 18 years of age) with Gaucher's disease type 1 as it is not known whether the medicine works in this disease.
Other medicines and Miglustat Dipharma
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 other medicines containing imiglucerase, which are sometimes used
at the same time as Miglustat Dipharma. They may reduce your body's exposure to
Miglustat Dipharma.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, you should not take
Miglustat Dipharma. Your doctor will be able to provide you with further information. During the intake of
Miglustat Dipharma you should use an effective method of contraception. Do not breastfeed while
taking Miglustat Dipharma.
Male patients must continue to use reliable contraceptive methods during the intake
of Miglustat Dipharma, and for 3 months after the end of treatment.
If you are pregnant, suspect you are pregnant or are planning a pregnancy or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Miglust Dipharma can cause dizziness. If you feel dizzy, do not drive vehicles or use tools
or machinery.
3. How to take Miglustat Dipharma
Take this medicine following exactly the instructions of your doctor. If you have any doubts consult your
doctor or pharmacist.
- For type 1 Gaucher disease: For adults, the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening), equivalent to a maximum of three capsules per day (300 mg).
- For type C Niemann-Pick disease: For adults and adolescents (over 12 years of age) the usual dose is 2 capsules (200 mg) 3 times a day (morning, afternoon and evening). This means a maximum daily dose of six capsules (600 mg). For children under 12 years of age,the doctor will appropriately adjust the dose of medication to be used for type C Niemann-Pick disease. If you have kidney problems you may receive a lower dose at the beginning of treatment. The doctor may decide to reduce the dose; for example: one capsule (100 mg) one or two times a day if you suffer from diarrhoea while taking Miglustat Dipharma (see section 4). The doctor will decide and communicate how long the treatment should last.
Miglustat Dipharma can be taken on an empty stomach or with food. The capsule must be swallowed
whole with a glass of water.
If you take more Miglustat Dipharma than you should
If you take more capsules than you should, consult your doctor immediately. Miglustat has been used
in clinical studies at doses up to 3,000 mg: this caused decreases in the amount of white blood cells
and other undesirable effects similar to those described in section 4.
If you forget to take Miglustat Dipharma
Take the next capsule at the usual time. Do not take a double dose to make up for the
forgotten dose.
If you stop taking Miglustat Dipharma
Do not stop taking Miglustat Dipharma without talking to your doctor.
If you have any doubts about 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.
Serious side effects
Some patients have experienced tingling or numbness in the hands and feet (commonly observed).These could be signs of peripheral neuropathy, due to side effects of Miglustat Dipharma or they could be due to existing conditions. To evaluate them, the
doctor will perform some tests before and during treatment with Miglustat Dipharma (see paragraph
2).
If you experience any of these effects, please seek medical advice from your doctor as
soon as possible.
If you experience a slight tremor, usually tremor in the hands, seek medical advice from your
doctoras soon as possible. The tremor often disappears without having to stop treatment.
Sometimes the doctor will need to reduce the dose or stop treatment with Miglustat Dipharma to make
the tremor disappear.
Very common side effects- may affect more than 1 in 10 people
Among the most common side effects are: diarrhea, flatulence (excess intestinal gas), abdominal
pain (stomach), weight loss and decreased appetite.
If you lose weightwhen you start treatment with Miglustat Dipharma, do not worry. Weight loss usually stops as treatment progresses.
Common side effects– may affect up to 1 in 10 people
Common side effects of treatment include headache, dizziness, paresthesia (tingling or
numbness), abnormal coordination, hypoesthesia (decreased sensitivity to touch),
dyspepsia (heartburn), nausea (feeling unwell), constipation and vomiting, bloating or discomfort
abdominal (gastric), thrombocytopenia (reduced levels of platelets in the blood).
Neurological symptoms and thrombocytopenia may be due to the underlying disease.
Other possible side effects are: muscle weakness or spasms, fatigue, chills and
malaise, depression, difficulty sleeping, memory loss and decreased libido.
Most patients complain of one or more of these side effects usually at the beginning of
treatment or at intervals during treatment. These cases are mostly mild and disappear very
quickly. If any of these side effects cause any discomfort, consult your doctor. They
may reduce the dose of Miglustat Dipharma or recommend other medicines to counteract the
side effects.
Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system as detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Miglustat Dipharma
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 blister and the box after the
writing “EXP”. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Miglustat Dipharma contains
- The active ingredient is miglustat 100 mg.
- The other ingredients are magnesium stearate, gelatin, titanium dioxide (E171), printing ink (composed of black iron oxide (E172), propylene glycol (E1520), potassium hydroxide, lacquer)
Description of the appearance of Miglustat Dipharma and contents of the pack
Miglustat Dipharma is a 100 mg opaque white hard capsule with "DPH02" printed in black on the
cap and "100" printed in black on the body.
The capsules are presented in PCTFE/PVC/aluminium blisters, in packs of 84 hard capsules in
non-perforated blisters in a cardboard box or in a wallet pack and 84x1 hard capsules in
divisible blisters for unit doses in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dipharma Arzneimittel GmbH
Offheimer Weg 33
65549 Limburg a. d. Lahn
Germany
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno 48
20089 Quinto dè Stampi – Rozzano (MI)
Italy
Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .
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- Kraj rejestracji
- Postać farmaceutycznaHard capsule, 100 MG
- Kod ATCA16AX06
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki MILUSTAT DIPARMAPostać farmaceutyczna: Hard capsule, 100 MGSubstancja czynna: miglustatProducent: ACCORD HEALTHCARE, S.L.U.Wymaga receptyPostać farmaceutyczna: Hard capsule, 65 mgSubstancja czynna: miglustatProducent: AMICUS THERAPEUTICS EUROPE LIMITEDWymaga recepty
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Substancją czynną w MILUSTAT DIPARMA jest miglustat. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
MILUSTAT DIPARMA jest produkowany przez Dipharma Arzneimittel GmbH. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie MILUSTAT DIPARMA jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić MILUSTAT DIPARMA w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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Inne leki zawierające tę samą substancję czynną (miglustat) to m.in. MILUSTAT AKKORD, MILUSTAT JEN.ORP, OPFOLDA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
