Cystagon 150 mg hard capsules

CYSTAGON 50 mg Hard Capsules

CYSTAGON 150 mg Hard Capsules

cysteamine bitartrate (mercaptamine bitartrate)

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, muscle, pancreas, and brain. Cystine build up causes kidney damage and excretion of excess amounts of glucose, proteins and electrolytes. Different organs are affected at different ages.

CYSTAGON is prescribed to manage this rare inherited disorder. CYSTAGON is a medicine that reacts with cystine to decrease its level within the cells.

Always use this medicine exactly as your doctor or your child’s doctor has told you. Check with your doctor if you are not sure.

The dose of CYSTAGON prescribed for you or your child will depend on your or your child's age and weight.

For children up to age 12 years, the dose will be based on the body size (surface area), the usual dose being 1.30 g/m² of body surface area per day.

For patients over age 12 and over 50 kg weight, the usual dose is 2g/day.

In any case the usual dose should not exceed 1.95 g/m²/day.

CYSTAGON should be taken or given only by mouth and exactly as your or your child's doctor directs. In order for CYSTAGON to work correctly, you must do the following:

• Follow your doctor's directions exactly. Do not increase or decrease the amount of medicine without your doctor's approval.
• Hard capsules should not be given to children under approximately six years of age because they may not be able to swallow them and they may choke. For children under approximately six years of age, the hard capsule may be opened and the contents sprinkled on food (e.g. milk, potatoes or starch based foods) or mixed in formula. Do not add to acidic drinks e.g. orange juice. Consult the doctor for complete directions.
• Your or your child's medical treatment may include, in addition to CYSTAGON, one or more supplements to replace important electrolytes lost through the kidneys. It is important to take or give these supplements exactly as instructed. If several doses of the supplements are missed or weakness or drowsiness develops, call the doctor for instructions.
• Regular blood tests to measure the amount of cystine inside white blood cells are necessary to help determine the correct dose of CYSTAGON. Your or your child's doctor will arrange for the blood tests to be done. Regular blood and urine tests to measure the levels of the body's important electrolytes are also necessary to help your or your child's doctor correctly adjust the doses of these supplements.

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

Treatment with CYSTAGON should continue indefinitely, as instructed by your doctor.

To easily open and close the Cystagon bottle, please follow the instructions below:

Directions for opening and closing the container

To Open

Place pen or similar object between the raised sections of the lid and turn in the direction shown (anticlockwise)

To Close

Place pen or similar object between the raised sections of the lid and turn in the direction shown (clockwise)

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

CYSTAGON may cause some people to become drowsy or less vigilant than they are normally. Make sure you know how you or your child reacts to this medicine before doing anything that could be dangerous if not alert.

The following side effects were reported as follows: very common (occurring in at least one in 10 patients), common (occurring in at least one in 100 patients), uncommon (occurring in at least one in1,000 patients), rare (occurring in at least one in 10,000 patients), very rare (occurring in at least one in 100,000 patients).

• Very common: vomiting, nausea, diarrhoea, loss of appetite, fever and sensation of sleep
• Common: abdominal pain or discomfort, unpleasant breath and body odour, skin eruption, gastroenteritis, fatigue, headache, encephalopathy (brain disorder) and liver function test abnormalities.
• Uncommon: skin striae, skin lesion (little-hard lumps on elbows), joint laxity, leg pain, bone fracture, scoliosis (deviation of the vertebral column), bone deformity and fragility, hair discoloration, severe allergic reaction, somnolence, fits, nervousness, hallucination, decrease in white blood cells, gastrointestinal ulcer manifested by bleeding in the digestive tract and effect on the kidney manifested by swelling of the extremities and weight gain.

Since some of these side effects are serious, ask your or your child’s doctor to explain their warning signs.

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 after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C and keep the container tightly closed in order to protect from light and moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: