1. WHAT IS A COLCHICUM-DISPERT AND WHAT IS IT USED FOR
The active substance in Colchicum-Dispert® is colchicine, which is extracted from the seeds of the Colchicum plant (autumn crocus). Colchicum-Dispert® is a drug with anti-inflammatory and anti-gout action, which is used to treat:
Acute gout attacks and prevention of gout attacks in adults
Familial Mediterranean Fever (an inherited disease that causes pain and swelling in the joints and organs of the body)
Pericarditis (swelling and inflammation of the pericardium, the thin, sac-like membrane that surrounds your heart) and prevention of coronary heart disease
Relief of symptoms in Behçet's disease (systemic disorder of recurrent acute inflammation).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLCHICUM-DISPERT®
Do not take Colchicum-Dispert®:
if you are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6)
if you are pregnant, you may become pregnant or breast-feeding
if you suffer from severe kidney damage
if you have severe cardiovascular disease
if you have severe liver disease
Warnings and precautions
Talk to your doctor or pharmacist before taking Colchicum-Dispert®.
Take special care with Colchicum-Dispert® if:
you have problems with your heart, kidneys, liver or digestive system
you have blood disorders
Other medicines and Colchicum-Dispert®
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking another medicine with Colchicum-Dispert® may affect the way the other medicine works. You may be at greater risk of side effects if you take Colchicum-Dispert® medicines such as cyclosporine, statins (medicines that lower cholesterol, such as simvastin, lovastine) or marcolide antibiotics (erythromycin, clarithromycin), especially if you have kidney damage. Cimetidine (a medicine used to treat ulcers), as well as excessive intake of grapefruit juice (1000 milliliters / day), can increase blood colchicine levels, which can be life-threatening.
Colchicum-Dispert® may impair the absorption of vitamin B12. You may need to take extra vitamin B12 if you need to take Colchicum-Dispert® in large doses or for a long time.
Pregnancy, breast-feeding and fertility
Colchicum-Dispert® is not recommended if you are pregnant or trying to become pregnant. Colchicine passes into breast milk. Do not take Colchicum-Dispert® if you are breast-feeding.
Driving and using machines
No studies on the effects of colchicine on the ability to drive and use machines have been performed.
Given that dizziness may occur after taking the medicine, your ability to drive and use machines may be impaired and you should not drive or use machines.
Colchicum-Dispert® contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Colchicum-Dispert® contains Opalux AS 250,000 dyes as excipients. These substances can cause allergic reactions.
3. HOW TO TAKE COLCHICUM-DISPERT®
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.
The recommended dose is:
TREATMENT OF ACUTE ATTACKS OF Gout:
In acute attacks of gout, the dose is 2 coated tablets at the moment and 1-2 tablets after 1 hour.
You should not take more than 3-4 coated tablets every 24 hours. Then treatment with a low dose of 1-2 coated tablets a day can be continued until the pain is relieved.
PREVENTION OF Gout attacks:
To prevent a seizure, take 1 coated tablet once or twice a day.
You should not take more than 2 coated tablets a day.
With the prophylactic dose, the risk of a gout attack can be reduced in the next three months.
TREATMENT OF FAMILY MEDITERRANEAN FEVER (FTS):
The usual dose for adults at the beginning of FST treatment is 2-3 coated tablets per day, which can be increased to 2-4 coated tablets per day.
If serious side effects occur, treatment should not be stopped if possible, but the dose may need to be reduced until the side effects disappear or become tolerable.
The daily dose can be given as a single dose, which is usually recommended if no side effects occur or the dose can be divided into twice a day (morning and evening).
Children and adolescents (4 to 18 years):
The usual dose is the same as for adults. The recommended starting dose for children is:
1 coated tablet per day for children over 5 years of age
2 coated tablets per day for children from 5 to 10 years of age
3 coated tablets per day for children over 10 years of age.
The dose should then be increased in steps (1 tablet / foot) to a maximum dose of 4 coated tablets per day.
Colchicine should not be used in children under 4 years of age!
TREATMENT OF PERICARDITIS: The
recommended starting dose of Colchicum-Dispert® in acute pericarditis is 2-4 coated tablets per day.
After one or two days, the dose should be increased to 1-2 coated tablets per day for 6 months.
For the prevention of recurrent pericardium, the usual dose is 1-2 coated tablets daily.
PREVENTION OF CORONARY HEART DISEASE: The
recommended dose of Colchicum-Dispert® for the prevention of coronary heart disease is 1-2 coated tablets per day.
BEHCHET'S DISEASE: The
recommended dose of Colchicum-Dispert® for Behcet's disease is 2-4 tablets per day.
If gastrointestinal side effects occur, stop taking immediately.
If you are elderly or have kidney or liver problems, a lower dose may need to be adjusted by your doctor.
Swallow the coated tablets with enough liquid.
Do not split or break the tablet.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. If you are not sure, talk to your doctor or pharmacist.
If you take more Colchicum-Dispert® than you should
Do not take a double dose to make up for a forgotten tablet. Your doctor will decide when you should take the next dose of Colchicum-Dispert®. You should discuss this with your doctor.
If you stop taking Colchicum-Dispert®
If you have any further questions on the use of 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.
In total, the following drug reactions have been reported with colchicine. They were usually reversible upon temporary discontinuation of treatment or reduction of colchicine dose:
Common (may affect between 1 in 10 and 1 in 100 people):
nausea, vomiting, diarrhea, stomach cramps, stomach pain.
Uncommon (may affect between 1 in 10 and 1 in 1,000 people):
blood cell disorders;
bone marrow can be suppressed: aplastic anemia (a condition in which the bone marrow cannot produce enough blood cells), haemolytic anemia (a condition in which there are not enough red blood cells in your blood);
changes in liver enzymes (observed in tests);
hair loss and nail disease;
increase in the level of blood creatine phosphokinase (observed in tests);
muscle weakness and muscle pain, muscle fiber breakdown (rhabdomyolysis);
Rare (may affect between 1 in 1,000 and 1 in 10,000 people):
a significant reduction in the number of white blood cells called granulocytes (agranulocytosis);
urticaria, purpura (purple discoloration of the skin), itchy skin rash, redness of the skin, swelling;
lack of sperm in the semen or decreased concentration of sperm in the semen.
Very rare (may affect less than 1 in 10,000 people):
neuropathy (a disease affecting the nerves), dizziness, hypersensitivity.
Reporting side effects
If you get any side effects, talk to your nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly by: