Cystadane
Italy
Table of Contents
Package leaflet: Information for the patient
Cystadane 1 g oral powder
Anhydrous betaine
Please read all of this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Cystadane is and what it is used for
- What you need to know before taking Cystadane
- How to take Cystadane
- Possible side effects
- How to store Cystadane
- Contents of the pack and other information
1. What Cystadane is and what it is used for
Cystadane contains anhydrous betaine for the additional treatment of homocystinuria, a hereditary (genetic) disorder in which the amino acid methionine is not completely metabolized by the human body.
Methionine is present in normal dietary proteins (e.g., meat, fish, milk, cheese, eggs). It is converted into homocysteine, which is normally further transformed into cysteine during digestion. Homocystinuria is a disease caused by the accumulation of homocysteine, which fails to be converted into cysteine, and is characterized by the formation of blood clots in veins, bone weakness, and skeletal and lens abnormalities. The use of Cystadane, together with other treatments such as vitamin B6, vitamin B12, folate, and a specific diet, aims to reduce elevated 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 or to any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Cystadane. If you experience side effects such as headache, vomiting, or vision changes and you do not have the type of homocystinuria called CBS (cystathionine beta-synthase deficiency), contact your doctor immediately, as these symptoms could be signs of brain swelling (cerebral edema). In such a case, your doctor will monitor your methionine levels and may revise your diet. It may be necessary to stop treatment with Cystadane.
If you are being treated with Cystadane and an amino acid mixture and need to take other medicines, leave a 30-minute interval between administrations (see "Other medicines and Cystadane").
Other medicines and Cystadane
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking amino acid mixtures or medicines such as vigabatrin or GABA analogues (medicines used to treat epilepsy), as these may interact with treatment with Cystadane.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine. Your doctor will decide whether this medicine can be used during pregnancy and breastfeeding.
Driving and using machines
Cystadane has no or negligible influence on the ability to drive vehicles or operate machinery.
3. How to take Cystadane
Your use of this medicine will be monitored by a doctor experienced in treating patients with homocystinuria.
Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose for children and adults is 100 mg/kg/day, divided into two daily doses. In some patients, doses higher than 200 mg/kg/day have been required to achieve therapeutic goals. Your doctor may adjust the dose based on your laboratory results.
Therefore, you may need to undergo periodic blood tests to determine the correct daily dose.
You must take Cystadane by mouth (orally).
To measure the dose:
- Gently shake the bottle before opening it.
- Select the correct dosing 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.
- Run the back of a knife across the spoon.
- The powder remaining in the spoon corresponds to a level spoonful.
- Take the exact number of spoonfuls of powder from the bottle as prescribed.
Mix the measured dose of powder with water, juice, milk, infant formula, or food, stirring until completely dissolved, and take 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 the missed dose. If you forget to take a dose, take it as soon as you remember, then continue with your next dose as scheduled.
If you stop taking Cystadane
Do not stop treatment with Cystadane without consulting your doctor. Talk to your doctor or pharmacist before stopping.
If you have any doubts about how to use 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 may affect more than 1 in 10 people (very common frequency), is an increase in blood methionine levels.
Elevated methionine levels may be associated with brain swelling (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).
Gastrointestinal disorders such as diarrhoea, nausea, vomiting, stomach discomfort and inflammation of the tongue may occur uncommonly (may affect up to 1 in 100 people).
Other uncommon side effects (may affect up to 1 in 100 people) may include decreased appetite (anorexia), agitation, irritability, hair loss, urticaria, abnormal skin odour, and loss of bladder control (urinary incontinence).
Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V.
By reporting side effects, you can help 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 above 25°C.
Keep the bottle tightly closed to protect it from moisture.
After first opening the bottle, the medicine should be used within 3 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Cystadane contains
- The active substance 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 white, free-flowing crystalline powder. It is supplied in bottles with child-resistant caps. Each bottle contains 180 g of powder. Each carton contains one bottle and three measuring spoons.
Marketing Authorization Holder
Recordati Rare Diseases
Tour Hekla
52 avenue du Général de Gaulle
F-92 800 Puteaux
France
Manufacturer
Recordati Rare Diseases
Tour Hekla
52 avenue du Général 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder.
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More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.emea.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.