Colchium Dispert 0.5 mg. 25 tablets

1. WHAT COLCHICUM-DYSPERT IS AND WHAT IT IS USED FOR
The active substance of Colchicum-Dyspert is colchicine, which is extracted from the seeds of the Colchicum plant (autumn crocus). Colchicum-Dyspert is a medicinal product with anti-inflammatory and antigout effects, which is used to treat:

Acute attacks of gout and prevention of gout attacks in adults
Familial Mediterranean Fever (an inherited disease that causes pain and swelling of 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 (a systemic disorder of recurrent acute inflammation).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLCHICUM-DYSPERT
Do not take Colchicum-Dyspert:
if you are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6)
if you are pregnant, might become pregnant or are breast-feeding
if you suffer from severe kidney impairment
if you have severe cardiovascular disease
if you have severe liver disease
Warnings and precautions
Talk to your doctor or pharmacist before taking Colchicum-Dyspert®.

Take special care with Colchicum-Dyspert® if:
you have problems with your heart, kidneys, liver or digestive system
you have blood disorders
Other medicines and Colchicum-Dyspert
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 effect of the other medicine. You may be at greater risk of side effects if you take medicines such as cyclosporine, statins (cholesterol-lowering medicines such as simvastatin, lovastatin) or marcolide antibiotics (erythromycin, clarithromycin) at the same time as Colchicum-Dispert, especially if you have kidney damage. Cimetidine (a medicine used to treat ulcers) and excessive intake of grapefruit juice (1000 millilitres/day) may increase the levels of colchicine in the blood, which can be life-threatening.

Colchicum-Dispert may impair the absorption of vitamin B12. You may need to take additional vitamin B12 if you need to take Colchicum-Dispert® in large doses or for a long time.

Pregnancy, breast-feeding and fertility
The use of Colchicum-Dyspert is not recommended if you are pregnant or trying to become pregnant. Colchicine passes into breast milk. Do not take Colchicum-Dyspert® if you are breast-feeding.

Driving and using machines
No studies have been conducted on the effects of colchicine on the ability to drive and use machines.

Considering that dizziness may occur after taking the medicine, the ability to drive and use machines may be impaired and you should not drive or use machines.

Colchicum-Dyspert® contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this product.

Colchicum-Dyspert contains the colouring agent Opalux AS 250,000 as an excipient. These substances may cause allergic reactions.

3. HOW TO TAKE COLCHICUM-DYSPERT
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is:
TREATMENT OF ACUTE GOUT ATTACKS:
For acute gout attacks, the dose is 2 coated tablets at the time and 1-2 tablets after 1 hour. 
You should not take more than 3-4 coated tablets in 24 hours. After that, treatment with a low dose of 1-2 coated tablets per day can be continued until the pain is relieved.
PROPHYLAXIS OF GOUT ATTACKS:
To prevent an attack, take 1 coated tablet once or twice a day. 
You should not take more than 2 coated tablets per day. 
With the prophylactic dose, the risk of a gout attack can be reduced in the following three months.
TREATMENT OF FAMILIAL MEDITERRANEAN FEVER (FMF):
The usual dose for adults at the beginning of FMF treatment is 2-3 coated tablets per day, which may be increased to 2-4 coated tablets per day. 
If serious side effects occur, treatment should not be interrupted if possible, but the dose may need to be reduced until the side effects disappear or become tolerable. 
The daily dose can be administered as a single dose, which is usually recommended if no side effects occur, or the dose can be divided into two doses per 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 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/step) to the maximum
a minimum dose of 4 coated tablets per day.

Colchicine should not be administered to children under 4 years of age!

TREATMENT OF PERICARDITIS:
The recommended initial 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 pericarditis, the usual dose is 1-2 coated tablets per day. 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® in Behchet's disease is 2-4 tablets per day.
If gastrointestinal side effects occur, discontinue use immediately.
If you are elderly or have kidney or liver problems, a lower dose may be required, which should 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 has told you. If you are not sure, ask 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 your 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 general, the following drug reactions have been reported with colchicine. They were usually reversible when treatment is temporarily stopped or the dose of colchicine is reduced:

Common (may affect between 1 in 10 and 1 in 100 people):
nausea, vomiting, diarrhoea, stomach cramps, stomach pain.
Uncommon (may affect between 1 in 10 and 1 in 1,000 people):
blood cell disorders;
the bone marrow may be suppressed: aplastic anaemia (a condition in which the bone marrow cannot produce enough blood cells), haemolytic anaemia (a condition in which there are too few red blood cells in your blood);
changes in liver enzymes (seen in tests);
hair loss and nail disorders;
increased blood creatine phosphokinase levels (seen in tests);
muscle weakness and muscle pain, breakdown of muscle fibres (rhabdomyolysis);
kidney disorders.
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); 
hives, purpura (purple discoloration of the skin), skin rashes that may itch, redness of the skin, swelling; 
absence of sperm in the semen or reduced sperm concentration in the semen. 
Very rare (may affect less than 1 in 10,000 people):
neuropathy (disease affecting the nerves), dizziness, hypersensitivity. 

5. HOW TO STORE COLCHICUM-DISPERT
Keep out of the reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Colchicum-Dispert contains
The active substance is:
One coated tablet contains: Crocus, dry standardized seed extract 3.5% (containing 35 mg total alkaloids/g, as colchicine).

The amount of active ingredient in a dosage unit is 0.5 mg.

The other ingredients are:
Lactose monohydrate, microcrystalline cellulose, corn starch, talc, copovidone, stearic/palmitic acid, magnesium stearate, polyvidone K 25, titanium dioxide (E 171), gum arabic, macrogol 6000, light magnesium oxide, carmellose sodium, sucrose, shellac, dyes - Opalux AS 250 000 (containing E 104 and E 124), carnauba wax.

What does Kolhikum-Dispert look like and what is in the package
Packs of 20, 25, 50 and 60 tablets

 

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