50 mg, 150 mg hard capsules 
cysteamine bitartrate (mercaptamine bitartrate)

Read all of this leaflet carefully before you start using this medicine.

  • Save this information, you may need to read about it.
  • 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 may harm them, even if they show symptoms similar to yours
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet you will find information about: 
1. What CYSTAGON is and what it is used for 
2. Before you use CYSTAGON 
3. How to use CYSTAGON 
4. Possible side effects 
5. How to store CYSTAGON 
6. Other information

1. What CYSTAGON is and what it is used for

Cystinosis is a metabolic disease called “nephropathic cystinosis” which is characterized by an abnormal accumulation of the amino acid cystine in various organs of the body such as the kidney, eye, muscles, pancreas, and brain. Cystine accumulation causes kidney damage and excessive secretion of glucose, proteins, and electrolytes. Different organs are affected at different ages.

CYSTAGON is prescribed to treat this unusual hereditary disease. CYSTAGON is a drug that reacts with cysteine and lowers the cystine content in the cells.

Before using CYSTAGON

Do not use CYSTAGON

  • if you -or your child- are allergic (hypersensitive) to cysteamine bitartrate or penicillamine or any of the other ingredients of CYSTAGON.
  • If you are pregnant, this is especially relevant during the first trimester.
  • if you are breast-feeding.

Take special care with CYSTAGON:

  • Once your or your child’s disease has been confirmed by leukocyte cystine measurements, CYSTAGON treatment should be started as soon as possible.
  • A few cases of skin changes on the elbows such as small hard lumps have been reported in children who have been treated with high doses of various cysteamine preparations. These skin changes occurred along with stretch marks and bone injuries such as fractures and bone deformities, as well as overexertion in joints. Your doctor may request regular medical and X-ray examinations of the skin and skeleton to check the effects of the medicine. Examine your or your child’s skin for yourself. If any abnormalities occur in the skin or bones, contact your doctor immediately.
  • Your doctor may ask you to check your blood cell count regularly.
  • CYSTAGON has not been shown to prevent the accumulation of cystine crystals in the eye. If cysteamine drops have been used in the eyes, this treatment should be continued.
  • Unlike phosphocysteamine, another active substance similar to cysteamine bitartrate, CYSTAGON does not contain phosphate. If you are already being treated with phosphate supplements, this dose may need to be changed when switching from phosphocysteamine to CYSTAGON.
  • To avoid the risk of the capsule ending up in the trachea, the capsules should not be given to children under about 6 years of age.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking CYSTAGON with food and drink:

For children under 6 years of age, the hard capsules can be opened and the contents sprinkled on the food (eg milk, potatoes, or starch-based foods) or mixed in infant formula. Do not mix with acidic beverages such as orange juice. Ask your treating physician for complete instructions.

Pregnancy

You should not use CYSTAGON if you are pregnant. Contact your doctor if you are planning to become pregnant.

Breast-feeding

CYSTAGON should not be used during breast-feeding.

Driving and using machines

CYSTAGON may cause some drowsiness. When starting treatment, you or your child should not engage in risky activities until the effects of the medicine are known.

3. How to use CYSTAGON

Always use CYSTAGON exactly as your doctor or your doctor advised. If you are not sure, talk to your doctor.

The dose of CYSTAGON prescribed to you or your baby depends on your or your baby’s age and body weight.

For children up to 12 years, dose one is based on body size (surface area), the usual dose one is 1.30 g / m 2 body surface area per day.

For patients over 12 years of age and weighing more than 50 kg, the usual dose is 2 g / day.

The usual dose should in no case exceed 1.95 g / m 2 / day.

CYSTAGON should only be taken orally and exactly as instructed by your or your child’s doctor. For CYSTAGON to have the right effect, be sure to do the following:

  • Follow your doctor’s instructions carefully. Do not increase or decrease the dose of any of the medicines without your doctor’s consent.
  • Hard capsules should not be given to children younger than about 6 years, as they may have difficulty swallowing and may suffocate. For children under about 6 years of age, the hard capsules can be opened and the contents sprinkled on the food (eg milk, potatoes, or starch-based food) or mixed in infant formula. Do not mix with acidic beverages such as orange juice. Ask your treating physician for complete instructions.
  • Your or your child’s treatment may consist of, in addition to CYSTAGON, among other things supplements to replace important salts lost in the urine. These supplements must be taken exactly according to the instructions. If several doses of the supplements are missed or if weakness or lethargy occurs, the attending physician should be contacted.
  • Regular blood tests to measure the level of cystine in white blood cells are necessary to determine the correct dose of CYSTAGON. The attending physician arranges these samples as well as samples to determine the level of the body’s important salts in blood and urine. This allows your or your child’s doctor to correctly calculate the dose of one of these supplements.

CYSTAGON should be taken 4 times a day, every 6 hours, preferably immediately after or with food. It is important to take a dose as close to every 6 hours as possible.

CYSTAGON treatment is lifelong, according to the instructions of the treating physician.

If you take more CYSTAGON then you should

Contact your or your child’s physician or the hospital emergency department immediately if more medication than prescribed has been taken or in case of lethargy.

If you forget to take CYSTAGON

If a dose of the drug is missed, the drug should be taken as soon as possible. If less than two hours remain until the next dose, skip the missed dose one and return to regular medication times. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, CYSTAGON can cause side effects, although not everybody gets them.

CYSTAGON may cause drowsiness or make the individual less alert than usual. Make sure you know how you or your child will react to the medicine before performing an activity that requires full attention.

The following adverse reactions were reported: very common (occurred in at least one in 10 patients), common (occurred in at least one in 100 patients), uncommon (occurred in at least one in 1000 patients), uncommon (occurred in at least one in 10,000 patients ), very rare (occurred in at least one in 100,000 patients).

  • Very common: Vomiting, nausea, diarrhea, loss of appetite, fever, and drowsiness.
  • Common: Abdominal pain or discomfort, bad breath, and body odor, skin rash, gastritis, fatigue, headache, encephalopathy (brain disease), and abnormal results of liver function tests.
  • Uncommon: Stretch marks, skin changes (small hard lumps on the elbows), strain in the joints, bone pain, bone fracture, scoliosis (curvature of the spine), bone deformities and fragility, discoloration of hair, severe allergic reaction, drowsiness, seizures, nervousness, hallucinations, hallucinations of the number of white blood cells, ulcers in the gastrointestinal tract that manifest as bleeding in the gastrointestinal tract and kidney effects that manifest as swelling of the extremities and weight gain.

As some of the side effects mentioned above are serious, you should ask your doctor or your child to explain any warning signs.

5. How to store CYSTAGON

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Close the package tightly. Sensitive to light. Moisture sensitive.

6. Other information

Content declaration

  • The active substance is cysteamine bitartrate (mercaptamine bitartrate). A hard capsule CYSTAGON 50 mg contains cysteamine (as mercaptamine bitartrate). A hard capsule CYSTAGON 150 mg contains cysteamine (as mercaptamine bitartrate).
  • The other ingredients are microcrystalline cellulose, pregelatinized starch, magnesium stearate/sodium lauryl sulfate, colloidal silica, croscarmellose sodium, capsule shell: gelatin, titanium dioxide, black ink on hard capsules (E172).

What the medicine looks like and the contents of the pack

Hard capsules

  • Cystagon 50 mg: white, opaque hard capsules marked CYSTA 50 on the lower part and MYLAN on the upper part. Jars with 100 or 500 hard capsules. Not all pack sizes may be marketed.
  • Cystagon 150 mg: white, opaque hard capsules marked CYSTAGON 150 on the lower part and MYLAN on the upper part. Jars with 100 or 500 hard capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Record Rare Diseases

Real Estate “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 DiseasesPhone: + 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 GmbH Tel: +49 731 140 554 0
The NetherlandsRecordatiTel: +32 246101 36Belgium
GreeceRecord Rare Diseases:Ηλ: +33 1 47 73 64 58.Αλλία AustriaRecordati Rare Diseases Germany GmbH  
Tel: +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 SA Tel: +351 21 432 95 00
CroatiaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58French RomaniaRecord Rare Diseases Tel: +33 (0) 1 47 73 64 58France
IrelandRecord Rare Diseases Tel: +33 (0) 1 47 73 64 58France SloveniaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France

Muhammad Nadeem

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