Colhican

Package Leaflet: Information for the User

COLCHICAN, 0.5 mg, coated tablets

Colchicinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Colchican and what is it used for
• 2. Important information before taking Colchican
• 3. How to take Colchican
• 4. Possible side effects
• 5. How to store Colchican
• 6. Contents of the pack and other information

1. What is Colchican and what is it used for

Colchican is used to treat acute attacks of gout (gouty arthritis). Gout is a disease characterized by inflammation of the joints caused by the deposition of monosodium urate crystals in tissues (joints and periarticular structures). The medicine reduces inflammation in acute gout attacks. The medicine is also used to prevent acute gout attacks during treatment with drugs that lower uric acid levels, such as allopurinol, febuxostat, probenecid, and sulfinpyrazone. The medicine does not affect uric acid levels in the blood and tissues.

2. Important information before taking Colchican

When not to take Colchican:

Warnings and precautions

Special caution should be exercised when taking Colchican:

Before taking Colchican, you should inform your doctor if you are taking cyclosporine or macrolide antibiotics.

Colchican and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take. The medicine may worsen the absorption of vitamin B. Tell your doctor about the medicines you are taking, such as cyclosporine, statins (cholesterol-lowering medicines, e.g., simvastatin, lovastatin), or macrolide antibiotics (e.g., erythromycin, clarithromycin), especially if you have kidney function disorders, as taking them together with Colchican may cause bone marrow disorders. Cimetidine (a medicine used to treat stomach ulcers) may cause a life-threatening increase in the level of the medicine in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. You should not take Colchican if you are pregnant or breastfeeding.

Driving and using machines

No studies have been conducted on the effects of Colchican on driving and using machines. Due to the possibility of dizziness after taking the medicine, you should not drive or operate machines.

Colchican contains lactose

The medicine contains lactose (one tablet contains 118 mg of lactose). If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Colchican

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Take the tablet with a sufficient amount of water. Repeat treatment of an acute gout attack may only be done after an interval of at least three days from the previous treatment.

Adult dosage

Dosage for the treatment of acute gout attacks:
The recommended dose is initially 2 tablets, followed by 1 tablet after 1 hour. Do not take more than 1 tablet in the next 12 hours. If necessary, after this time, you can continue treatment, taking a maximum dose of 1 tablet three times a day, until symptoms disappear. The treatment cycle should be stopped after symptoms disappear or after taking 12 tablets of Colchican. Do not take more than 12 tablets during one treatment cycle. After completing the treatment cycle with Colchican, the next cycle can be started no earlier than after an interval of at least three days.
Dosage for the prevention of acute gout attacks during treatment with other medicines:
The recommended dose is 1 to 2 tablets per day. Therapy usually lasts up to 6 months from the start of treatment with allopurinol, febuxostat, or uricosuric agents (increasing uric acid excretion in the urine). If gastrointestinal side effects occur, you should stop taking the medicine immediately.
Children and adolescents
Colchican is not recommended for use in children under 18 years of age.
Elderly patients
Colchican should be used with caution in elderly patients.
Patient with liver disorders
Colchican should be used with caution in patients with liver function disorders. The medicine is contraindicated in patients with severe liver function disorders.
Patient with kidney disorders
The following dosing is recommended:

• with creatinine clearance > 50 ml/min, 0.5 mg of colchicine orally twice a day;
• with creatinine clearance 35-49 ml/min, 0.5 mg of colchicine orally once a day;
• with creatinine clearance 10-34 ml/min, 0.5 mg of colchicine orally every 2-3 days;
• with creatinine clearance <10 ml min, the use of colchicine is contraindicated. not recommended for patients undergoing hemodialysis.< li>

Overdose of Colchican

In case of overdose, contact your doctor immediately. The first symptoms of overdose may occur after a latency period of 2 to 12 hours.

Missed dose of Colchican

Do not take a double dose to make up for a missed dose. Consult your doctor to determine the time of the next dose.

Stopping Colchican treatment

Always take Colchican exactly as your doctor has told you. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Colchican can cause side effects, although not everybody gets them. During clinical trials of the medicine, the following side effects were very common (in more than 1 in 10 people): nausea, diarrhea, and abdominal pain. Side effects observed after the medicine was marketed (based on available data, the frequency of occurrence cannot be estimated):

• decrease in the number of white blood cells called granulocytes (agranulocytosis),
• bone marrow failure,
• decrease in the number of normal blood cells (pancytopenia),
• decrease in the number of blood platelets (thrombocytopenia),
• neurogenic muscle disease,
• damage to striated muscle tissue (rhabdomyolysis),
• kidney damage,
• hypersensitivity (allergy),
• myopathy (muscle tissue disease),
• aplastic anemia (a disease in which the bone marrow does not produce any blood cells),
• hemolytic anemia (shortened lifespan of red blood cells),
• liver damage,
• others: dizziness, vomiting, itching, rash, skin burning, hair loss, nail disorders.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: (22) 49 21 301, Fax: (22) 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Colchican

Keep the medicine out of the sight and reach 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. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Colchican contains

• The active substance is colchicine. One coated tablet contains 0.5 mg of colchicine.
• The other ingredients are: lactose, microcrystalline cellulose, pregelatinized starch, povidone K-25, stearic acid, talc, magnesium stearate. Coating: lactose monohydrate, hypromellose 6 cP, titanium dioxide (E 171), macrogol 6000, iron oxide red (E 172).

What Colchican looks like and contents of the pack

Colchican is a pink, round, biconvex, coated tablet with a nominal diameter of 8 mm, without spots and damage. Outer packaging: cardboard box. The pack contains 20 or 30 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A., ul. Józefów 9, 99-300 Kutno, Poland, Tel.: (24) 357 44 44, Fax: (24) 357 45 45, e-mail: [email protected]

Date of last revision of the leaflet: