YARGESA 100 mg Kapsułka Twarda
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Treść ulotki
Yargesa 100 mg hard capsules
miglustat
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 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 Yargesa is and what it is used for
- 2. What you need to know before you take Yargesa
- 3. How to take Yargesa
- 4. Possible side effects
- 5. How to store Yargesa
- 6. Contents of the pack and other information
1. What is Yargesa and what is it used for
Yargesa contains the active ingredient miglustat which belongs to a group of medicines that
affect metabolism. It is used to treat two diseases:
- Yargesa is used to treat mild to moderate type 1 Gaucher disease inadults.
Type 1 Gaucher disease is characterised 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 the
blood cells and bone diseases.
The treatment usually provided for type 1 Gaucher disease consists of enzyme replacement therapy. Yargesa is used only if a patient is deemed unsuitable for
treatment with enzyme replacement therapy.
- Yargesa is also used to treat progressive neurological symptoms in Niemann-Pick type C disease inadults and children
If you suffer from Niemann-Pick type C disease, fats (such as lycosfingolipids)
increase within brain cells. This can cause disturbances of neurological functions such as: slowing of eye movements, balance, swallowing, memory and
convulsions.
Yargesa works by inhibiting an enzyme called glucosylceramide synthase which is responsible for
the first stage of the synthesis of most glycosphingolipids.
2. What you need to know before taking Yargesa
Do not take Yargesa:
- 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 Yargesa:
- if you have kidney problems;
- if you have liver problems .
Before and during treatment with Yargesa, your doctor will perform the following checks:
- an examination to check the condition of the nerves in your upper and lower limbs;
- 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 Yargesa, some patients
have experienced tingling or numbness in the 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 to
undesirable effects of this medicine (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); not give you Yargesa with food; temporarily reduce
the dose of Yargesa. 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, the doctor may decide to
carry out further investigations.
Male patients should use reliable contraceptive methods during treatment
with Yargesa 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 if the medicine works for this disease.
Other medicines and Yargesa
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
concurrently with Yargesa. They may decrease your body's exposure to Yargesa.
Pregnancy, breastfeeding and fertility
If you are pregnant, or planning a pregnancy, do not take Yargesa. Your doctor will be
able to provide you with further information. During the intake of Yargesa you must use
an effective method of contraception. Do not breastfeed while taking Yargesa.
Male patients must continue to use reliable contraceptive methods during the intake
of this medicine, and for 3 months after the end of treatment.
If you are pregnant, suspect 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
Yargesa can cause dizziness. If you experience dizziness, do not drive vehicles or use tools or
machinery.
Yargesa contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially "sodium-free".
3. How to take Yargesa
Take this medicine always exactly as your doctor has instructed. If you have any doubts, ask your doctor or pharmacist.
Dose
- For Type 1 Gaucher’s 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 a 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 start 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 Yargesa (see section 4). The doctor will tell you how long the
treatment should last.
To remove the capsule:
- 1. Tear along the perforated line
- 2. Remove the paper at the arrows
- 3. Press the product to make it come out of the film
Yargesa 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 Yargesa 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 3000 mg: this 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 Yargesa
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 Yargesa
Do not stop taking this medicine 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.
More serious side effects
Some patients have experienced tingling or numbness in their hands and feet (commonly observed).These could be signs of peripheral neuropathy, due to side effects of
Yargesa, or they could be due to pre-existing conditions. To evaluate them, the doctor will perform
some tests before and during treatment with Yargesa (see section 2).
If you experience any of these effects, consult your doctor as soon as possible.
If you experience a slight tremor, usually tremor in the hands, consult 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 Yargesa to make the tremor disappear.
Very common side effects– may affect more than 1 in 10 people
The most common side effects include: diarrhoea, flatulence (excess gas), abdominal (stomach) pain, weight loss and decreased appetite.
If you lose weightwhen you start treatment with Yargesa, 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, paraesthesia (tingling or
numbness), abnormal coordination, hypoaesthesia (decreased sensitivity to touch),
dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, bloating or discomfort
in the abdomen (gastric) and thrombocytopenia (decreased levels of platelets in the blood).
Neurological symptoms and thrombocytopenia may be due to the underlying disease.
Other possible side effects are: muscle spasms or weakness, 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 the dose of Yargesa or recommend other medicines to counteract the effects
undesirable.
Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.
- 5. How to store Yargesa
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 any special storage conditions.
Do not dispose of any medicine via water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help to protect the environment.
- 6. Contents of the pack and other information
What Yargesa contains
- The active ingredient is miglustat. Each hard capsule contains 100 mg of miglustat.
- The other ingredients are
capsule content: sodium starch glycolate (type A), povidone (K-29/32), magnesium
stearate,
capsule shell: gelatin, titanium dioxide (E171),
printing ink: shellac, iron oxide black (E172), propylene glycol and
concentrated ammonia solution.
What Yargesa looks like and contents of the pack
Yargesa is a white hard capsule consisting of a cap and a white opaque body with the
number "708" printed in black on the body. The capsule size is 4 (14.3 mm x 5.3 mm).
The capsules are presented in a PVC and polychlorotrifluoroethylene (PCTFE) blister divisible
per unit dose sealed with aluminum foil.
Pack of 84 x 1 hard capsules.
Marketing Authorisation Holder
Piramal Critical Care B.V.
Rouboslaan 32 (ground floor)
2252 TR, Voorschoten
Netherlands
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 YARJESAPostać farmaceutyczna: Hard capsule, 100 MGSubstancja czynna: miglustatProducent: ACCORD HEALTHCARE, S.L.U.Wymaga receptyPostać farmaceutyczna: Hard capsule, 100 MGSubstancja czynna: miglustatProducent: Dipharma Arzneimittel GmbHWymaga recepty
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YARJESA wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w YARJESA jest miglustat. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
YARJESA jest produkowany przez PIRAMAL CRITICAL CARE B.V.. 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 YARJESA 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 YARJESA 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 DIPARMA, MILUSTAT JEN.ORP. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
