Clopasa 0.5 mg. 20 tablets

1. What Klopasa is and what it is used for
Klopasa belongs to the group of medicines with antigout action.
Klopasa is used to treat acute attacks of gout, in chronic gout, to prevent acute attacks when starting treatment with other medicines that lower uric acid in the blood and urine or in the treatment of periodic diseases (Familial Mediterranean Fever).
Treatment of acute pericarditis and recurrent pericarditis in adults in combination with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).

2. What you need to know before you take Klopasa:
Do not take Klopasa:
If you are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6);
If you have severe kidney damage;
If you are undergoing haemodialysis;
If you have severe liver failure;
If you have severe gastrointestinal disorders;If you have a stomach ulcer;
If you have heart disease; If you have haematological disorders;
If you are pregnant;
If you have recently taken or are taking other medicines (see "Using Klopasa with other medicines").
Warnings and precautions
Talk to your doctor or pharmacist before taking Klopasa

If you have symptoms such as diarrhoea, nausea, vomiting or abdominal pain during treatment, inform your doctor immediately, as your treatment may need to be stopped or the dose reduced;
If it is to be used by the elderly, children, patients with low body weight or patients who abuse alcohol;
The dose may need to be adjusted in patients with liver or kidney impairment;
Severe muscle and kidney disorders may occur with chronic treatment.

If you are taking Klopasa, potential side effects of this medicine that may affect the blood count should be monitored (e.g. reduction in white blood cells, platelets and red blood cells). Your doctor will probably prescribe regular blood tests to monitor these side effects.

Children and adolescents
There are no data on the safety and efficacy of colchicine in the paediatric population for the treatment of pericarditis.

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

Tell your doctor or pharmacist before taking colchicine if you have recently taken or are taking any medicines containing any of the following active substances. These active substances may affect the elimination of colchicine from the body:

Medicines used to treat infections, such as clarithromycin, erythromycin, telithromycin, azithromycin and other macrolide antibiotics;

Medicines used to treat fungal infections, such as itraconazole and ketoconazole;

Medicines used for hypertension, such as verapamil and diltiazem;

Medicines used to treat HIV, such as indinavir, nelfinavir, ritonavir and saquinavir.
If you take Klopasa with medicines used to lower cholesterol and triglyceride levels such as: atorvastatin, simvastatin, pravastatin, fluvastatin, gemfibrozil, fenofibrate, fenofibric acid or bezafibrate, with medicines used to treat heart disease such as digoxin or with immunosuppressants such as cyclosporine, the occurrence of muscle problems may be promoted. Tell your doctor before using colchicine.

Vitamin B12 absorption may be reduced by chronic use or high doses of colchicine. Vitamin B12 doses may need to be increased.

Klopasa with food, drinks and alcohol
Klopasa should not be combined with grapefruit intake, as the elimination of colchicine from the body may be reduced and thus have a harmful effect on the patient.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine if you are pregnant.

The use of colchicine is not recommended during breast-feeding, as colchicine may pass into breast milk.

Driving and using machines
Clopasa is unlikely to affect your ability to drive or use machines.

3. How to take Clopasa
Always take this medicine exactly as your doctor has told you. If you are not sure how to take this medicine, ask your doctor or pharmacist.

The doses given below should not be exceeded.

Adult patients
Acute attack of gout
The recommended dose is 2 tablets (1 mg colchicine) at the first sign of an acute attack. If pain relief is not achieved, a further 1-2 tablets (0.5 mg to 1 mg colchicine) may be administered 1 or 2 hours after the first dose. Doses higher than 4 tablets (2 mg colchicine) in 24 hours should not be administered. Doses higher than 4 tablets (2 mg colchicine) per day do not show better efficacy but increase the incidence of
and side effects.

Do not take more than 12 tablets for 4 consecutive days of treatment (6 mg colchicine).

If necessary, due to persistent pain from a gout attack, the above regimen can be repeated after a 3-day break.

Recommended dose for the prevention of a gout attack, with initial therapy with allopurinol or uricosuric agents

The recommended dose as a prophylactic treatment of gout attacks is 1 or 2 tablets (0.5 mg to 1 mg colchicine) per day. Your doctor will tell you how long your treatment with Klopasa will last.

Familial Mediterranean Fever
The recommended dose is 2 to 4 tablets (1 mg to 2 mg colchicine) per day. The dose can be divided into two daily doses or taken as a single dose. Your doctor will tell you how long your treatment with Klopasa will last.

Treatment of chronic gout
The recommended dose for the treatment of chronic gout is 1 or 2 tablets (0.5 mg to 1 mg colchicine) per day. Your doctor will tell you how long your treatment with Klopasa will last.

Treatment of pericarditis:
In adults for the treatment of acute pericarditis as an adjunct to aspirin/NSAID treatment (3 months) and for recurrent pericarditis (6 months).

Body weight 70 kg or more: 1 tablet (0.5 mg colchicine), twice daily (1 mg colchicine per day).

Body weight less than 70 kg: 1 tablet (0.5 mg colchicine), once daily (0.5 mg colchicine per day)
Children and adolescents under 18 years of age
Acute gout attack, prevention of gout attacks and chronic gout

There are insufficient data to establish recommendations in this age group.

Familial Mediterranean Fever
The recommended dose for children over 12 years of age is 2 to 4 tablets daily. The dose can be divided into two daily doses or taken as a single dose.

The score line is only to facilitate breaking if you have difficulty swallowing the tablet whole.

Treatment of pericarditis
This medicinal product is not recommended for the treatment of pericarditis in children and adolescents under 18 years of age. Please see “Children and adolescents” in section 2.
If you take more Klopasa than you should
If you accidentally take more Klopasa than you should, contact your doctor immediately or go to the nearest hospital, stating the medicine and the amount taken.

If you take doses above those recommended by your doctor, you may experience intoxication. Intoxications due to colchicine overdose are very serious.

There is no specific antidote for colchicine.

Treatment of intoxication due to taking a large number of tablets should include the use of oral activated charcoal, gastric lavage and intravenous administration of electrolytes.

Signs of overdose usually appear within 24 hours of taking the medicine, but can sometimes be delayed for up to a week. Therefore, if you suspect an overdose, even without visible signs, you should immediately seek emergency medical attention.

The more common symptoms of toxicity are burning and discomfort in the mouth and throat; difficulty swallowing and breathing; digestive disorders such as diffuse abdominal pain, nausea, vomiting, severe diarrhoea, sometimes bloody; confusion; alopecia (hair loss) and hypotension (low blood pressure).

If you forget to take Klopasa
Do not take a double dose to make up for a forgotten dose.

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.

The more common side effects are:

Nausea, vomiting, abdominal pain and diarrhoea.

High doses can cause skin rash, severe diarrhoea, gastrointestinal bleeding and kidney or liver disorders.

Other side effects that may be observed (frequency not known) are:

With prolonged treatment, haematological disorders such as a decrease in white blood cells (leucopenia), a decrease in neutrophils (neutropenia), a decrease in platelets (thrombocytopenia);
Azoospermia (low number or absence of sperm in the semen);
Alopecia (hair loss);
Nerve disorders that are reversible after stopping treatment;
Muscle disorders such as rhabdomyolysis (breakdown of muscle fibres);
Liver damage.
If any of the side effects gets serious, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Klopasa
Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. Store in the original package in order to protect from light.

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 Klopasa contains
The active substance is colchicine. Each Klopasa tablet contains 0.5 mg of colchicine.
Excipients: magnesium stearate, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, silicon dioxide, colloidal anhydrous.
What Klopasa looks like and contents of the pack
Klopasa 0.5 mg tablets are white, round, biconvex tablets with a score line. The score line is The score line is only to facilitate breaking for easier swallowing and not to divide into equal doses.

PVC/Al blister. Pack sizes of 20, 25, 30, 40, 50, 60 and 100 tablets

Not all pack sizes may be marketed.

 

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