MIGLUSTAT 100 mg Kapsułka Twarda
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Treść ulotki
Miglustat Accord 100 mg capsule
Equivalent Medicine
Read this leaflet carefully before you start taking this medicine as 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 they have the same symptoms as you, as it may 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 Accord is and what it is used for
- 2. What you need to know before you take Miglustat Accord
- 3. How to take Miglustat Accord
- 4. Possible side effects
- 5. How to store Miglustat Accord
- 6. Contents of the pack and other information
1. What Miglustat Accord is and what it is used for
Miglustat Accord contains the active ingredient miglustat which belongs to a group of medicines
that affect metabolism. It is used to treat two diseases:
- Miglustat Accordis used to treat mild to moderate type 1 Gaucher disease in adults.
Type 1 Gaucher 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 treatment usually provided for type 1 Gaucher disease consists of enzyme replacement therapy. Miglustat Accord is used only if a patient is considered unsuitable for treatment with enzyme replacement therapy.
Miglustat Accord is also used to treat progressive neurological symptoms in Niemann-Pick type C disease in adults and children.
If you have Niemann-Pick type C disease, fats such as glycosfingolipids
accumulate inside brain cells. This can cause disturbances in neurological functions such as slowing of eye movements, balance, swallowing, memory and
convulsions.
Miglustat Accord 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 you take Miglustat Accord
Do not take Miglustat Accord
- 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 Accord
- if you have kidney problems
- if you have liver problems
Before and during treatment with Miglustat Accord, your doctor will perform the following checks:
- an examination to check the condition of the nerves in your arms and legs;
- measurement of vitamin B12 levels;
- monitoring of growth if you are a child or adolescent with Niemann-Pick disease type C
- checking the number of platelets in your blood.
The reason these tests are performed is that, while taking Miglustat Accord,
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 to
other existing conditions or to undesirable effects of Miglustat Accord (for further information
see section 4).
If you have diarrhoea, your doctor may decide to modify your diet to reduce lactose and the consumption of
carbohydrates such as sucrose (cane sugar) or decide not to take Miglustat
Accord with food or decide to temporarily reduce the dose. 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 must use reliable contraceptive methods during
treatment with Miglustat Accord 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 Accord
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 Accord. They may decrease your body's exposure to
Miglustat Accord.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, do not take
Miglustat Accord. Your doctor will be able to provide you with further information. While taking
Miglustat Accord, you must use an effective method of contraception. Do not breastfeed while
taking Miglustat Accord.
Male patients must continue to use reliable contraceptive methods during
taking Miglustat Accord, and for 3 months after the end of treatment.
If you are pregnant, breastfeeding, suspect you are pregnant or are planning
to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Miglustat Accord can cause dizziness. If you feel dizzy, do not drive or
use tools or machines.
3. How to take Miglustat Accord
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, noon and evening), equivalent to a maximum of three capsules a day (300
mg).
If you have kidney problems you may receive a lower dose at the beginning of treatment. Your 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 Accord (see section 4). The doctor will decide and
communicate how long the treatment should last.
Miglustat Accord can be taken on an empty stomach or with food. The capsule must be swallowed
whole with a glass of water.
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 adjust the dose of medication to be used for
type C Niemann-Pick disease.
If you take more Miglustat Accord than you should
If you take more capsules than you should, consult your doctor immediately. Miglustat has been
used in clinical studies at doses 10 times higher than the recommended dose: this has caused
decreases in the number of white blood cells and other undesirable effects similar to those described
in section 4.
If you forget to take Miglustat Accord
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 Accord
Do not stop taking Miglustat Accord without talking to your doctor.
If you have any questions 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 everyone will experience 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 Accord or they may be due to pre-existing conditions. To evaluate them, the doctor will perform some tests before and during treatment with Miglustat Accord
(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 your doctor may need to reduce the dose or stop treatment with
Miglustat Accord to eliminate the tremor.
Very common effects- may affect more than 1 in 10 people
The most common side effects include: diarrhea, flatulence (excess intestinal gas),
abdominal (gastric) pain, weight loss and decreased appetite.
If you lose weightwhen starting treatment with Miglustat Accord, do not worry. Weight loss usually stops as treatment progresses.
Common effects– may affect up to 1 in 10 people
Common side effects of treatment include headache, dizziness, paresthesia
(tingling or numbness), abnormal coordination, hypoesthesia (reduced sensitivity to touch), dyspepsia (heartburn), nausea (feeling unwell), constipation and vomiting, swelling or
abdominal (gastric) discomfort, thrombocytopenia (reduced platelet levels 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 discomfort
consult your doctor. They may reduce your dose of Miglustat Accord or recommend other medicines
able to counteract the side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Miglustat Accord
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 pack after Exp. The expiry
date refers to the last day of that month.
This medicine does not require any 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 Accord contains
- The active ingredient is miglustat.
- The other ingredients are Sodium starch glycolate (Type A), Povidone K30, Magnesium stearate, Titanium dioxide (E171) and Gelatin.
Description of the appearance of Miglustat Accord and contents of the pack
Miglustat Accord is a white gelatin hard capsule of 100 mg, filled with a
granulate from white to off-white, packaged in PVC/PE/PCTFE-Aluminum blisters.
Cartons of 14 x 1 or 84 x 1 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare s.l.u.
Moll De Barcelona S/N, Worldtrade Center, Edificio EST, 6th floor
08039 Barcelona, Spain
Manufacturer
G.L. Pharma GmbH
Schlossplatz 1
Lannach – 8502
Austria
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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 AKKORDPostać farmaceutyczna: Hard capsule, 100 MGSubstancja czynna: miglustatProducent: Dipharma Arzneimittel GmbHWymaga receptyPostać farmaceutyczna: Hard capsule, 65 mgSubstancja czynna: miglustatProducent: AMICUS THERAPEUTICS EUROPE LIMITEDWymaga recepty
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Substancją czynną w MILUSTAT AKKORD jest miglustat. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
MILUSTAT AKKORD jest produkowany przez ACCORD HEALTHCARE, S.L.U.. 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 AKKORD 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 AKKORD w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (miglustat) to m.in. MILUSTAT DIPARMA, 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.
