Colhianova

Package Leaflet: Information for the User

Colchianova, 500 micrograms, tablets

Colchicinum
Important warning!
Do not exceed the recommended dose. Overdose, even due to ignoring interactions, can
lead to very painful and irreversible poisoning ending in death. See sections 2, 3
and 4 of this package leaflet.
This medicinal product should be stored out of reach of other persons before and after use.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

You should keep this leaflet, so you can read it again if you need to.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Colchianova and what is it used for

Colchianova contains the active substance colchicine. This substance belongs to the group of
medicines for gout and is used to treat or prevent gout attacks.
Gout attacks in adults
Colchicine is used in adults for the short-term treatment of acute gout attacks and to prevent their recurrence.
Colchicine is used to prevent acute gout attacks at the start of treatment with allopurinol and uricosuric medicines.
In gout, the level of uric acid in the blood is elevated. This can lead to the deposition of uric acid crystals in the fluid filling the joints.
Colchicine inhibits the inflammatory response to these crystals.
If there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before using Colchianova

When not to use Colchianova:

• if the patient is allergic to colchicine or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe blood disease,
• if the patient has severe kidney disease,
• if the patient has severe liver disease.

Warnings and precautions

The difference between the effective dose of Colchianova and the dose that causes symptoms of poisoning is very small. This means that taking even a slightly higher dose can cause symptoms of acute poisoning. If the patient experiences such symptoms as nausea, vomiting, abdominal pain, and diarrhea, they should stop taking Colchianova and immediately contact their doctor (see section 4 "Possible side effects").
Before starting to take Colchianova, the patient should discuss with their doctor or pharmacist if any of the following statements are or have been true for them:

• the patient has liver or kidney disease,
• the patient has heart or blood vessel disease,
• the patient has gastrointestinal problems,
• the patient is elderly or weakened,
• the patient has blood disease.

Colchicine can seriously disrupt the production of blood cells by the bone marrow [causing
inhibition of the production of a certain subgroup of white blood cells (a condition known as agranulocytosis), a decrease in platelet count (a condition known as thrombocytopenia), a decrease in the number of red blood cells and their pigment in the peripheral blood due to their lack of production in the bone marrow (a condition known as aplastic anemia)].
The patient should have regular blood tests to monitor any deviations.
If the patient experiences symptoms such as fever, inflammation of the mucous membrane of the mouth, sore throat, prolonged bleeding, increased tendency to bruise, or skin problems, they should stop taking this medicine and immediately contact their doctor. These may be symptoms of a serious blood disorder, and the doctor may want to perform blood tests on the patient immediately (see section 4 "Possible side effects").
Long-term use of colchicine can lead to the development of vitamin B12 deficiency.

Colchianova and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Cautions are advised when using this medicine with medicines that can lower the number of blood cells in the peripheral blood or negatively affect liver or kidney function.
In such cases, the patient should contact their doctor.
If the patient is taking Colchianova with any of the following medicines, the risk of side effects caused by colchicine toxicity increases, and these effects can be very serious. The patient should inform their doctor or pharmacist if they are taking:

• erythromycin, telithromycin, and clarithromycin (antibiotics used to treat bacterial infections). Taking these antibiotics during colchicine treatment can cause poisoning. If possible, the patient should not take these antibiotics during colchicine treatment. If there is no alternative treatment, the doctor may reduce the dose of colchicine and keep the patient under observation.
• ketoconazole, itraconazole, and voriconazole (antifungal medicines). The patient should not take these antibiotics during colchicine treatment.
• ritonavir, atazanavir, amprenavir, saquinavir, nelfinavir, fosamprenavir, and indinavir (protease inhibitors used to treat HIV infection). The patient should not take these medicines during colchicine treatment.
• verapamil, quinidine, and diltiazem (medicines used to treat heart disease);
• cyclosporine (a medicine used to weaken the patient's immune system).

The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• Taking the following medicines during colchicine treatment can cause severe muscle disease (myopathy) and muscle tissue breakdown, accompanied by painful muscle cramps, fever, and red discoloration of the urine (a condition known as rhabdomyolysis): simvastatin, fluvastatin, or pravastatin (statins used to lower cholesterol levels), fibrates (medicines used to lower cholesterol and certain other fatty substances in the blood), digoxin (a medicine used to treat heart failure and arrhythmia).
• cimetidine (a medicine used to relieve stomach ulcers and stomach pain) and tolbutamide (a medicine used to lower blood sugar levels). These medicines can enhance the effect of colchicine.
• vitamin B12 (cyanocobalamin). Colchicine can reduce the absorption of vitamin B12 from the gastrointestinal tract.

Colchianova with food and drink

The patient should not drink grapefruit juice during colchicine treatment.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Women of childbearing potential:
Gout treatment
Women of childbearing potential must use effective contraception during gout treatment with Colchianova and for at least 3 months after the end of treatment. If the patient becomes pregnant during this period, they should receive genetic counseling.
Pregnancy:
Gout treatment:
If the patient is or may be pregnant, they should not use Colchianova. If the patient becomes pregnant during colchicine treatment or within 3 months of the end of treatment, they should receive genetic counseling.
Breastfeeding:
The active substance of this medicine, colchicine, passes into breast milk. Colchianova should not be used in breastfeeding women with gout.
Fertility:
Gout treatment:
Male patients should not cause pregnancy during colchicine treatment and for at least 6 months after the end of treatment. If a woman becomes pregnant during this period, she should receive genetic counseling.

Driving and using machines

There is no available data on the effect of colchicine on the ability to drive and use machines. However, the patient should consider the possibility of drowsiness and dizziness.

Colchianova contains lactose

Colchianova contains lactose monohydrate.
If the doctor has told the patient that they have an intolerance to some sugars, the patient should contact their doctor before taking this medicine.

3. How to use Colchianova

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
Taking too much colchicine can be very toxic, so it is essential that the patient does not exceed the dose prescribed by their doctor.
If the patient feels that the effect of the colchicine tablets is too strong or too weak, they should contact their doctor or pharmacist.

Use in adults

Use in gout
Treatment of acute gout attack:
The recommended dose is 0.5 mg (500 micrograms) two to three times a day. The doctor may decide to prescribe an additional 1 mg (1000 micrograms) on the first day of treatment.
The patient should stop taking this medicine if they experience gastrointestinal symptoms or if there are no expected treatment results after 2 to 3 days of treatment.
In one treatment cycle, the patient should not take more than 6 mg of Colchianova in total.
The patient should not start another treatment cycle with Colchianova (or another medicine containing colchicine) if it has not been at least 3 days since the end of the previous cycle.
Prevention of gout attacks:
The recommended dose is 0.5-1 mg per day (500-1000 micrograms per day). This dose should be taken in the evening.
The doctor will inform the patient about how long they will need to take Colchianova.
If the patient has kidney or liver disease
In patients with impaired liver or kidney function, the recommended dose of colchicine is 0.5 mg (500 micrograms) per day, and these patients should be closely monitored. Patients with severe liver or kidney impairment should not take this medicine — see "When not to use Colchianova".
Children and adolescents
Colchianova should not be used to treat gout in children and adolescents.

Method of administration

The tablets should be swallowed whole, with a glass of water.

Use of a higher than recommended dose of Colchianova

In case of taking a higher dose of Colchianova than recommended or accidental ingestion by a child, there is a risk of poisoning. The patient should immediately contact their doctor, pharmacist, or the emergency department of the nearest hospital.
Symptoms of poisoning

• After taking too much colchicine, early symptoms of overdose appear within a few hours. These symptoms include a burning sensation in the throat, stomach, and skin, nausea, vomiting, crampy abdominal pain, and bloody diarrhea, which can lead to a decrease in blood pH, dehydration, a drop in blood pressure, and shock.
• Then, 24-72 hours after taking too much colchicine, the following life-threatening complications may develop: impaired consciousness with possible hallucinations (delirium), coma, paralysis symptoms, respiratory depression, pulmonary edema, kidney damage, blood loss, and cardiac arrest.
• About 7 days after taking too much colchicine, a transient increase in white blood cell count (leukocytosis) and hair loss may occur.

Missing a dose of Colchianova

The patient should not take a double dose to make up for a missed dose.
If the patient misses a dose, they should take it as soon as possible. If it is almost time for the next dose, the patient should not take the missed dose, but instead take the next dose at the usual time. In case of doubts, the patient should consult their doctor or pharmacist.

Stopping Colchianova treatment

If the patient suddenly stops taking this medicine, the symptoms that occurred before treatment may return. If the patient is considering stopping colchicine treatment, they should discuss it with their doctor.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should stop taking Colchianova and immediately consult their doctor or the emergency department of the nearest hospital:

• Nausea, vomiting, crampy abdominal pain, diarrhea. These side effects occur uncommonly (i.e., with a frequency not exceeding 1 in 10 people).
• Muscle weakness (myopathy), red to brown discoloration of the urine (rhabdomyolysis), muscle pain, feeling of tiredness. These side effects occur uncommonly (i.e., with a frequency not exceeding 1 in 100 people).
• Infections with symptoms such as fever, severe sore throat, and mouth ulcers, as well as a serious form of anemia, namely aplastic anemia. These side effects occur rarely (i.e., with a frequency not exceeding 1 in 1000 people).

The following side effects have also been reported.
Frequency not known (frequency cannot be estimated from the available data):

• Hair loss, rash
• Decreased sperm count in the semen or complete absence of sperm in the semen
• Sore throat
• Neuropathy (nerve disease), nerve inflammation that can cause pain, numbness, and sometimes impaired nerve function
• Absence of menstruation for at least 6 months and painful or crampy menstrual pain
• Vitamin B12 deficiency

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Colchianova

The medicine should be stored out of sight and reach of children.
Store in the original package to protect from light.
There are no special instructions for the storage temperature of the medicine.
Do not use Colchianova after the expiration date stated on the blister pack and carton after: EXP. The expiration date refers to the last day of the specified month.
The shelf life after opening the container of tablets, which is an HDPE bottle, is 100 days.
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.
This leaflet does not contain all the information about this medicine. In case of any questions, the patient should consult their doctor or pharmacist.

6. Contents of the pack and other information

What Colchianova contains

• The active substance of Colchianova is colchicine. Each tablet of Colchianova contains 500 micrograms of colchicine.
• The other ingredients (excipients) are: lactose monohydrate, cornstarch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, stearic acid.

What Colchianova looks like and contents of the pack

Colchianova, 500 micrograms, tablets
White to almost white, biconvex, round tablets without coating with the inscription "L" on one side and smooth on the other side (diameter approximately 5 mm, thickness approximately 2.6 mm).
Colchianova tablets are packaged in a blister pack of PCV/PVDC/Aluminum foil, in a carton box. Each pack contains 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, and 100 tablets.
Colchianova tablets are packaged in an HDPE bottle with a PP closure with a child-resistant lock in a carton box. Each bottle contains 30 and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Pharmaselect International Beteiligungs GmbH
Ernst-Melchior-Gasse 20
1020 Vienna
Austria
Phone: +43 (0) 1 786 03 86-00
To obtain this leaflet in a different format or to report a side effect, the patient should contact the above-mentioned marketing authorization holder.

Date of last revision of the leaflet: