CYSTADANE 1 G Proszek doustny
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Jak stosować KYSTADANE
Treść ulotki
Cystadane 1 g oral powder
Betaine anhydrous
Read this leaflet carefully before 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 Cystadane is and what it is used for
- 2. What you need to know before you take Cystadane
- 3. How to take Cystadane
- 4. Possible side effects 5 How to store Cystadane
- 6. Contents of the pack and other information
1. What is Cystadane and what is it used for
Cystadane contains anhydrous betaine intended for the additional treatment of homocystinuria, a hereditary (genetic) disease in which the amino acid methionine is not completely transformed by the human body.
Methionine is present in normal dietary proteins (e.g. meat, fish, milk, cheese, eggs).
It is transformed into homocysteine, which is then normally transformed in turn into cysteine during digestion. Homocystinuria is a disease caused by the accumulation of homocysteine, which is not transformed into cysteine, and is characterized by the formation of blood clots in the veins, bone weakness and abnormalities of the skeleton and lens. The use of Cystadane, together with other treatments, such as vitamin B6, vitamin B12, folate and a specific diet, is intended to reduce high levels of homocysteine in the body.
2. What you need to know before taking Cystadane
Do not take Cystadane
If you are allergic to anhydrous betaine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cystadane. If you notice undesirable effects such as
headache, vomiting or changes in vision and you do not have the type of homocystinuria called CBS (cystathionine beta-synthetase deficiency), contact your doctor immediately as they could be signs of
swelling in the brain (cerebral edema). In such cases, the doctor will monitor the levels of
methionine in the body and may review your diet. It may be necessary to stop the
treatment with Cystadane.
If you are undergoing treatment with Cystadane and with a mixture of amino acids and need to take
other medicines at the same time, allow 30 minutes between administrations (see “Other
medicines and Cystadane”).
Other medicines and Cystadane
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking amino acid mixtures or medicines such as vigabatrin or GABA analogues
(medicines used to treat epilepsy), as they may interact with treatment with
Cystadane.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor for advice before taking this medicine. The doctor will decide whether the
medicine can be used during pregnancy and breastfeeding.
Driving and using machines
Cystadane has no or negligible influence on the ability to drive and use machines.
3. How to take Cystadane
The use of this medicine will be monitored by a doctor experienced in the treatment of patients with
homocystinuria.
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose in children and adults is 100 mg/kg/day divided into 2 daily doses. In
some patients, doses higher than 200 mg/kg/day have been necessary to achieve therapeutic
targets. The doctor may adjust the dose based on your laboratory values.
You may therefore need to undergo periodic blood tests to establish the correct daily dose.
You must take Cystadane orally (by mouth).
To measure the dose:
- shake the bottle gently before opening it
- take the correct measuring spoon:
- the small green spoon measures 100 mg of anhydrous betaine powder;
- the medium blue spoon measures 150 mg of anhydrous betaine powder;
- the large pink spoon measures 1 g of anhydrous betaine powder.
- take a full spoonful of powder from the bottle
- pass the back of a knife over the spoon
- the remaining powder corresponds to a spoonful
- take the exact number of spoonfuls of powder from the bottle
Mix the measured dose of powder with water, juice, milk, infant formula or food, until
completely dissolved and ingest immediately after mixing.
If you take more Cystadane than you should
If you accidentally take too much Cystadane, inform your doctor or pharmacist immediately.
If you forget to take Cystadane
Do not take a double dose to make up for a missed dose. If you forget to take a
dose, take it as soon as you remember and continue with the next dose as planned.
If you stop taking Cystadane
Do not stop treatment with Cystadane without consulting your doctor. Before stopping it
consult your doctor or pharmacist.
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 everybody gets them.
The most common side effect when taking Cystadane, which can affect more than 1 in 10 people
(very common frequency), is an increase in methionine levels in the blood.
Methionine levels may be linked to swelling in the brain (cerebral edema) which may
affect up to 1 in 100 people (uncommon frequency). If you experience morning headache with vomiting
and/or visual disturbances, contact your doctor immediately (these may be signs of cerebral
edema).
With uncommon frequency (may affect up to 1 in 100 people) gastrointestinal disorders such as diarrhea,
nausea, vomiting, stomach discomfort and inflammation of the tongue may occur.
Other uncommon side effects (may affect up to 1 in 100 people) may include a
decrease in appetite (anorexia), agitation, irritability, hair loss, hives, abnormal skin odor, loss of bladder
control (urinary incontinence).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system indicated in Appendix V.
By reporting side effects you can help to provide more information on the safety of
this medicine.
5. How to store Cystadane
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 label of the bottle and on the
carton after Exp. The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Keep the bottle tightly closed to protect it from moisture.
After the first opening of the bottle, the medicine must be used within 3 months.
Do not dispose of any medicine in wastewater 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 Cystadane contains
- The active ingredient is anhydrous betaine. 1 g of oral powder contains 1 g of anhydrous betaine.
- There are no excipients.
Description of the appearance of Cystadane and contents of the pack
Cystadane is a flowing, crystalline white powder. It is presented in bottles with a
child-resistant closure. Each bottle contains 180 g of powder. Each pack contains one bottle and three
measuring scoops.
Marketing Authorisation Holder
Recordati Rare Diseases
Immeuble “Le Wilson”
70, Avenue du General de Gaulle
F-92 800 Puteaux
France
Manufacturer
Recordati Rare Diseases
Immeuble “Le Wilson”
70, Avenue du General de Gaulle
F-92 800 Puteaux
France
or
Recordati Rare Diseases
Eco River Parc
30, rue des Peupliers
F-92000 Nanterre
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.
Belgique/België/Belgien
Recordati
Tél/Tel: +32 2 46101 36
Lietuva
Recordati AB.
Tel: + 46 8 545 80 230
Sweden
България
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Luxembourg/Luxemburg
Recordati
Tél/Tel: +32 2 46101 36
Belgique/Belgien
Česká republika
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Magyarország
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Danmark
Recordati AB.
Tlf : +46 8 545 80 230
Sweden
Malta
Recordati Rare Diseases
Tel: +33 1 47 73 64 58
France
Deutschland
Recordati Rare Diseases Germany GmbH
Tel: +49 731 140 554 0
Nederland
Recordati
Tel: +32 2 46101 36
België
Eesti
Recordati AB.
Tel: + 46 8 545 80 230
Sweden
Norge
Recordati AB.
Tlf : +46 8 545 80 230
Sweden
Ελλάδα
Recordati Rare Diseases
Τηλ: +33 (0)1 47 73 64 58
France
Österreich
Recordati Rare Diseases Germany GmbH
Tel: +49 731 140 554 0
Germany
España
Recordati Rare Diseases Spain S.L.U.
Tel: + 34 91 659 28 90
Polska
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
France
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
Portugal
Jaba Recordati S.A.
Tel: +351 21 432 95 00
Hrvatska
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France
România
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Ireland
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Slovenija
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Ísland
Recordati AB.
Simi:+46 8 545 80 230
Sweden
Slovenská republika
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Italia
Recordati Rare Diseases Italy Srl
Tel: +39 02 487 87 173
Suomi/Finland
Recordati AB.
Puh/Tel : +46 8 545 80 230
Sweden
Κύπρος
Recordati Rare Diseases
Τηλ : +33 1 47 73 64 58
France
Sverige
Recordati AB.
Tel : +46 8 545 80 230
Latvija
Recordati AB.
Tel: + 46 8 545 80 230
United Kingdom
Recordati Rare Diseases UK Ltd.
Tel: +44 (0)1491 414333
Sweden
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/. Furthermore, links to other websites on rare diseases and related therapeutic treatments are provided.
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- Kraj rejestracji
- Postać farmaceutycznaOral powder, 1 G
- Kod ATCA16AA06
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki KYSTADANEPostać farmaceutyczna: Dispersible tablet, 200 MGSubstancja czynna: carglumic acidProducent: WAYMADE B.V.Wymaga receptyPostać farmaceutyczna: Dispersible tablet, 200 MGSubstancja czynna: carglumic acidProducent: RECORDATI RARE DISEASES SARLWymaga recepty
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KYSTADANE wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w KYSTADANE jest betaine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
KYSTADANE jest produkowany przez RECORDATI RARE DISEASES SARL. 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 KYSTADANE 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 KYSTADANE 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 (betaine) to m.in. AMVERSIO, AKIDO KARLUMIKO WAYMADE, KARBALU. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
