Cystadane 1 g oral powder
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the Patient
Cystadane 1 g oral powder
Anhydrous betaine
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet as 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 other people, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Leaflet Contents
- 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 and is indicated as a complementary treatment for homocystinuria, a hereditary (genetic) disorder in which the body is unable to fully break down the amino acid methionine.
Methionine is present in the proteins of normal foods (e.g.: meat, fish, milk, cheese, eggs). It is converted into homocysteine, which is normally subsequently converted into cysteine during digestion. Homocystinuria is a disease caused by the accumulation of homocysteine that fails to be converted into cysteine, and is characterized by the formation of blood clots in the veins, bone weakness, and skeletal and lens abnormalities. The use of Cystadane, together with other treatments such as vitamin B6, vitamin B12, folic acid, and a specific diet, aims to reduce the elevated levels of homocysteine in your body.
2. What you need to know before starting 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
Consult your doctor or pharmacist before starting to take Cystadane.
If you experience adverse effects such as headaches, vomiting, or changes in vision and you have the CBS subtype of homocystinuria (cystathionine beta-synthase deficiency), contact your doctor immediately, as these could be signs of brain swelling (cerebral edema). In such a case, your doctor will monitor the methionine levels in your body and may adjust your diet. It may be necessary to discontinue treatment with Cystadane.
If you are receiving treatment with Cystadane and an amino acid mixture, and if you need to take additional medications at the same time, wait 30 minutes between administrations (see section "Other medicines and Cystadane").
Other medicines and Cystadane
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
If you are taking an amino acid mixture or medicines such as vigabatrin or Gaba analogues (medicines used to treat epilepsy), please inform your doctor, as these may interact with your Cystadane treatment.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will decide whether you can use this medicine during pregnancy and breastfeeding.
Driving and using machines
The influence of Cystadane on the ability to drive and use machines is none or negligible.
3. How to take Cystadane
The use of this medicine will be supervised by a physician experienced in the treatment of patients with homocystinuria.
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose in children and adults is 100 mg/kg/day in two divided doses per day. In some patients, doses higher than 200 mg/kg/day may be required to achieve therapeutic goals. Your doctor may adjust the dose based on laboratory values.
Therefore, you will need to have periodic blood tests to determine the correct daily dose.
You must take Cystadane orally (by mouth).
To measure the dose:
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Gently shake the bottle before opening it.
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Take the appropriate graduated spoon:
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the small spoon provides 100 mg of anhydrous betaine powder;
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the medium spoon provides 150 mg of anhydrous betaine powder;
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the large spoon provides 1 g of anhydrous betaine powder.
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take one heaping spoonful of powder from the bottle
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level the spoon with the flat side of a knife
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the powder remaining in the spoon is one measure
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remove the correct number of measures of powder from the bottle
Mix the measured dose of powder with water, juice, milk, infant formula, or food until completely dissolved, and take it immediately after mixing.
If you take more Cystadane than you should
If you accidentally take an excessive amount of Cystadane, inform a doctor or pharmacist immediately.
If you forget to take Cystadane:
Do not take a double dose to make up for missed doses. If you forget to take a dose, take it as soon as you remember, and then continue with your next dose as scheduled.
If you stop taking Cystadane
Do not stop treatment without consulting your doctor. Consult your doctor or pharmacist before stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most common adverse effect when taking Cystadane, which may affect more than 1 in 10 people (very common), is elevated levels of methionine in the blood.
Elevated methionine levels may be associated with brain swelling (cerebral edema), which may affect up to 1 in 100 people (uncommon). If you experience morning headaches with vomiting and/or visual disturbances, consult your doctor immediately (these may be signs of brain swelling).
Gastrointestinal disorders such as diarrhea, nausea, vomiting, gastric discomfort, and inflammation of the tongue may occur uncommonly (may affect up to 1 in 100 people).
Other uncommon adverse effects (may affect up to 1 in 100 people) may include decreased appetite (anorexia), agitation, irritability, hair loss, urticaria, abnormal skin odor, and lack of bladder control (urinary incontinence).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cystadane
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and carton after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
Keep the bottle tightly closed to protect it from moisture.
After opening the bottle, the medicine should be used within 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cystadane
- The active substance is anhydrous betaine. 1 g of oral powder contains 1 g of anhydrous betaine.
- There are no other components.
Appearance of Cystadane and contents of the pack
Cystadane is a white, crystalline, free-flowing powder. It is supplied in bottles with child-resistant closures. Each bottle contains 180 g of powder. Each carton contains one bottle and three graduated 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
Further information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder.
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Date of the most recent review of this package leaflet
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.emea.europa.eu/. Links to other websites on rare diseases and orphan medicinal products are also provided.