COLCHICUM 0.5 mg Tablets

Contents of the leaflet

1. Patient Information Leaflet: User Information
2. Colchicum Dispert, 0.5 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents:
3. What is Colchicum Dispert and what is it used for
4. Important information before taking Colchicum Dispert
   1. When not to take Colchicum Dispert
   2. Warnings and precautions
   3. Treatment of elderly patients
   4. Children and adolescents
   5. Colchicum Dispert and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Colchicum Dispert contains lactose and sucrose
5. How to take Colchicum Dispert
   1. Treatment of acute gout attacks
   2. Prevention of acute gout attacks during initiation of diuretic treatment:
   3. Elderly patients or patients with liver or kidney function disorders
   4. Method of administration
   5. Overdose of Colchicum Dispert
   6. Missed dose of Colchicum Dispert
   7. Discontinuation of Colchicum Dispert
6. Possible side effects
   1. Very rare (neuropathy (nerve disease), dizziness, hypersensitivity.Reporting side effects
7. How to store Colchicum Dispert
8. Package contents and other information
   1. What Colchicum Dispert contains
   2. What Colchicum Dispert looks like and package contents
   3. Marketing authorization holder and manufacturer
   4. Date of approval of the leaflet:

Patient Information Leaflet: User Information

Colchicum Dispert, 0.5 mg, coated tablets

Colchici seminis extractum siccum

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents:

• 1. What is Colchicum Dispert and what is it used for
• 2. Important information before taking Colchicum Dispert
• 3. How to take Colchicum Dispert
• 4. Possible side effects
• 5. How to store Colchicum Dispert
• 6. Package contents and other information

1. What is Colchicum Dispert and what is it used for

Colchicum Dispert contains colchicine - an extract from the seeds of autumn crocus ( Colchicum autumnale L.). Colchicum Dispert is an anti-inflammatory medicine used to treat acute gout attacks in adults. The medicine can also be used to prevent acute gout attacks when starting treatment with diuretics.

2. Important information before taking Colchicum Dispert

When not to take Colchicum Dispert

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• in pregnant or breastfeeding women, or women planning to become pregnant,
• in patients undergoing hemodialysis,
• if the patient has severe liver disease,
• if the patient has severe kidney damage,
• if the patient has severe gastrointestinal disorders.

Warnings and precautions

Before starting treatment with Colchicum Dispert, the patient should discuss it with their doctor or pharmacist.
Particular caution is advised:

• if the patient has heart, kidney, liver, or gastrointestinal problems,
• if the patient has blood diseases.

Before taking Colchicum Dispert, the patient should inform their doctor if they are taking cyclosporine or macrolide antibiotics.

Treatment of elderly patients

Caution is advised when determining the dose for elderly patients, taking into account the more frequent occurrence of kidney and liver function disorders. The dose should be adjusted based on the patient's kidney and liver function. If other medicines that may increase the risk of toxic accumulation are taken concurrently, the doctor will adjust the dose of Colchicum Dispert accordingly.

Children and adolescents

The medicine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.

Colchicum Dispert and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Taking other medicines during treatment with Colchicum Dispert may affect their action. Concurrent use of Colchicum Dispert with medicines such as cyclosporine, statins (cholesterol-lowering medicines, e.g., simvastatin, lovastatin), or macrolide antibiotics (e.g., erythromycin, clarithromycin), especially in patients with kidney disorders, may increase the risk of side effects. Concurrent use of colchicine with erythromycin or clarithromycin is contraindicated.
Cimetidine (a medicine used to treat stomach ulcers) or excessive consumption of grapefruit juice (1000 ml/day) may cause life-threatening increases in the concentration of the medicine in the blood.
The medicine may impair the absorption of vitamin B. In cases of high doses or prolonged therapy, supplementation with vitamin B should be considered.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Colchicum Dispert should not be used in breastfeeding women, as colchicine passes into breast milk.

Driving and using machines

No studies have been conducted on the effect of Colchicum Dispert on driving or operating machinery.
Due to the possibility of dizziness after taking the medicine, the patient should not drive or operate machinery.

Colchicum Dispert contains lactose and sucrose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.
The medicine contains a colorant: Opalux AS 250000, which may cause allergic reactions.

3. How to take Colchicum Dispert

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.

Treatment of acute gout attacks

The recommended initial dose for treating acute gout attacks is 2 coated tablets, followed by 1-2 coated tablets after 1 hour. The patient should not take more than 3-4 coated tablets per day. If necessary, treatment can be continued for subsequent days until the pain subsides, taking 1-2 coated tablets per day.

Prevention of acute gout attacks during initiation of diuretic treatment:

1 coated tablet 1-2 times a day.
The doctor will determine the duration of treatment based on the frequency of attacks, disease duration, and the presence and size of tophi.
If severe gastrointestinal side effects occur, the patient should immediately stop taking Colchicum Dispert.

Elderly patients or patients with liver or kidney function disorders

In elderly patients or patients with kidney or liver failure, the dose of Colchicum Dispert may need to be reduced according to the doctor's recommendations.

Method of administration

Oral administration.
The coated tablet should be swallowed whole with a sufficient amount of water. The tablets should not be broken or divided.

Overdose of Colchicum Dispert

In case of overdose, the patient should immediately consult their doctor.
The first symptoms of overdose may occur 2 to 12 hours after ingestion.

Missed dose of Colchicum Dispert

The patient should not take a double dose to make up for a missed dose. They should consult their doctor to determine the next dose.

Discontinuation of Colchicum Dispert

In case of further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Colchicum Dispert can cause side effects, although not everybody gets them.
During treatment with colchicine, the following side effects have been reported, which usually subsided after discontinuation of the medicine or reduction of the dose.
Common (1/100 to <1>

• nausea, vomiting, diarrhea, abdominal cramps, abdominal pain.

Uncommon (1/1,000 to <1>

• blood cell disorders;
• bone marrow function disorders: aplastic anemia (a disease in which the bone marrow does not produce any blood cells), hemolytic anemia (shortened lifespan of red blood cells);
• changes in liver enzyme activity (visible in tests);
• hair loss and nail disorders;
• increased creatine kinase levels in the blood (visible in tests);
• weakness and muscle pain, muscle breakdown (rhabdomyolysis);
• kidney function disorders.

Rare (1/10,000 to <1>

• significant decrease in the number of white blood cells called granulocytes (agranulocytosis);
• hives, purpura (purple skin rash), itchy skin rash, redness, swelling;
• absence or decreased sperm count in semen.

Very rare (<1>

• neuropathy (nerve disease), dizziness, hypersensitivity.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Colchicum Dispert

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry Date (EXP). The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Colchicum Dispert contains

Each coated tablet contains 12.71 mg to 15.86 mg of dry extract from the seeds of autumn crocus ( Colchicum autumnale L.), equivalent to 0.5 mg of alkaloids, calculated as colchicine.
The other ingredients of the medicine are:
Core: lactose monohydrate, corn starch, talc, copovidone K 28, stearic acid, magnesium stearate.
Coating: talc, povidone K 25, titanium dioxide, arabic gum, macrogol 6000, light magnesium oxide, sodium carmellose, sucrose, shellac, Opalux AS 250000 (sucrose, cosin Y (E 124), quinoline yellow (E 104), titanium dioxide (E 171), povidone), carnauba wax.
Auxiliary substances used to adjust the primary extract to a specified content of substances with known therapeutic activity: lactose monohydrate, microcrystalline cellulose.

What Colchicum Dispert looks like and package contents

Colchicum Dispert is available in aluminum/PVC/PVDC blisters in cardboard boxes containing 20 or 50 tablets.

Marketing authorization holder and manufacturer

Pharmaselect International Beteiligungs GmbH
Ernst – Melchior Gasse 20
1020 Vienna, Austria

Date of approval of the leaflet: