1 g oral powder 
Betaine anhydrous

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Cystadane is and what it is used for 
2. What you need to know before taking Cystadane 
3. How to take Cystadane 
4. Possible side effects 
5. How to store Cystadane 6. Contents of the pack 
and other ingredients information

1. What Cystadane is and what it is used for

Cystadane contains betaine anhydrous which is intended to be an adjunctive treatment of homocystinuria, a hereditary (genetic) disease in which the amino acid methionine cannot be completely broken down by the body.

Methionine is found in common food protein (eg meat, fish, milk, cheese, eggs). It is converted to homocysteine which is then normally converted to cysteine during digestion. Homocystinuria is a disease caused by the accumulation of homocysteine that is not converted to cysteine and is characterized by clot formation in the veins, osteoporosis, abnormal changes in the skeleton, and crystal deposits in the lens of the eye. The use of Cystadane together with other treatments such as vitamin B6, vitamin B12, folate, and special diets aims to reduce the elevated levels of homocysteine in your body.

What you need to know before taking Cystadane

Do not take Cystadane

If you are allergic to betaine anhydrous.

Warnings and cautions

Talk to your doctor or pharmacist before taking Cystadane.

If you experience side effects such as headaches, vomiting, or vision changes, and you are of the homocystinuria subtype known as CBS (cystathionine-beta-synthase deficiency), contact your doctor immediately, it may be a sign of swelling in the brain (cerebral edema ). In such cases, your doctor will monitor the methionine level in your body and possibly review your diet. You may need to stop your treatment with Cystadane.

If you are being treated with Cystadane and with other mixtures of amino acids and if you need to take other medicines at the same time, leave 30 minutes between intakes (see section “Other medicines and Cystadane”).

Other medicines and Cystadane

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

If you are taking an amino-acid mixture or medicines such as vigabatrin or Gaba – Analog s (medicines used to treat epilepsy ), please tell your doctor as this may affect your treatment with Cystadane.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor will decide if you can use this medicine during pregnancy and breast-feeding.

Driving and using machines

Cystadane has no or negligible effect on the ability to drive and use machines.

3. How to take Cystadane

This medicine will be used under the supervision of a doctor who has experience in treating patients with homocystinuria.

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose for children and adults is 100 mg/kg/day divided into 2 doses per day.

For some patients, doses above 200 mg/kg/day were required to achieve the intended effect. Your doctor may adjust the dose based on your laboratory values.

You will therefore need regular blood tests to determine the correct daily dose.

You should take Cystadane orally (by mouth).

To measure the dose:

  • shake the jar lightly before opening it
  • use the correct dosing spoon:
    • the small green spoon measures 100 mg of betaine anhydrous powder;
    • the medium-sized blue spoon measures 150 mg of betaine anhydrous powder;
    • the large pink spoon measures up to 1 g of betaine anhydrous powder.
  • take a heaped spoonful of powder from the jar
  • pull with the back of a knife over the spoon
  • the powder left in the spoon is a full spoon
  • take the right number of spoons of powder from the jar

Mix the measured powder dose with water, juice, milk, milk replacer, or food until everything is completely dissolved and ingest immediately after mixing.

If you take more Cystadane then you should

If you accidentally take too much Cystadane, contact your doctor or pharmacist immediately.

If you forget to take Cystadane

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you can and continue with the next dose as planned.

If you stop taking Cystadane

Do not stop treatment without consulting a doctor. Contact a doctor or pharmacist before stopping treatment.

If you have any further questions on the use of this product, 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 with Cystadane, which occurs in more than 1 user in 10 (the frequency is very common), is elevated levels of methionine in the blood.

Methionine levels may be related to swelling of the brain (cerebral edema ), which occurs in less than 1 in 100 users (frequency is less common). If you have morning headaches with vomiting and/or changes in vision, you should contact your doctor immediately (they may be signs of swelling in the brain).

Gastrointestinal disorders such as diarrhea, nausea, vomiting, stomach upset, and inflammation of the tongue are less common (affects less than 1 user in 100).

Other less common side effects (affects less than 1 in 100 people) may include decreased appetite ( anorexia ), agitation, irritability, hair loss, hives, abnormal body odor, lack of urinary incontinence (urinary incontinence).

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 can and carton after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Close the jar tightly. Moisture sensitive.

After opening the jar, the medicine should be used within 3 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is betaine anhydrous. 1 g of oral powder contains 1 g of betaine anhydrous.
  • There are no other ingredients.

What the medicine looks like and the contents of the pack

Cysteine is a white crystalline-free finely divided powder. It is available in bottles with child-resistant closures. Each jar contains 180 g of powder. Each carton contains one jar and three dosing spoons.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Record Rare Diseases

Immeuble, Le Wilson ”

70, avenue du Général de Gaulle

F – 92800 Puteaux

France

Manufacturer

Record Rare Diseases

Real Estate “Le Wilson”

70, avenue du Général de Gaulle

F-92800 Puteaux

France

or

Record Rare Diseases

Eco River Parc

30, rue des Peupliers

F-92000 Nanterre

France

Further information on this medicine can be obtained from the representative of the marketing authorization holder:

BulgariaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France Luxembourg / LuxemburgRecordatiTel: +32 2 46101 36Belgium / Belgium
Czech RepublicRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France HungaryRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58Franciaország
GermanyRecordati Rare Diseases Germany GmbHTel: +49 731 140 554 0 The NetherlandsRecordatiTel: +32 2 46101 36Belgium
GreeceRecord Rare Diseases:Ηλ: +33 (0) 1 47 73 64 58.Αλλία AustriaRecordati Rare Diseases Germany GmbHTel: +49 731 140 554 0Germany
SpainRecordati Rare Diseases Spain SLUTel: + 34 91 659 28 90 PolandRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France
FranceRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58 PortugalJaba Recordati SATel: +351 21 432 95 00
CroatiaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58French RomaniaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France
IrelandRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France SloveniaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France

Muhammad Nadeem

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