Colchianova

Package leaflet: Information for the user

Colchianova, 500 micrograms, tablets
Colchicinum
Important warning!
Do not exceed the recommended dose. Overdose, including due to ignoring interactions, may
lead to severe, irreversible poisoning resulting in death. See sections 2, 3
and 4 of this package leaflet.
This medicinal product must be stored before and after use in a place inaccessible
to other persons.
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of the leaflet

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

1. What Colchianova is and what it is used for

Colchianova contains the active substance called colchicine. This substance belongs to a group of medicines used against gout and is used in the treatment or prevention of gout attacks.
Gout attacks in adults
Colchicine is used in adults for short-term treatment of acute gout attacks and for preventing recurrence of gout.
Colchicine is used to prevent acute gout attacks at the beginning of treatment with allopurinol and uricosuric medicinal products.
In gout, the concentration of uric acid in the blood is elevated. This may lead to deposition of uric acid crystals in the fluid within joints.
Colchicine inhibits the inflammatory response to these crystals.
If there is no improvement or if the patient feels worse, contact a 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 serious kidney diseases,
• if the patient has serious liver diseases.

Warnings and precautions
There is a very narrow margin between the effective dose of Colchianova and the dose causing symptoms of poisoning. This means that even a slightly excessive dose may cause symptoms of acute poisoning. If the patient experiences symptoms such as nausea, vomiting, abdominal pain, or diarrhoea, administration of Colchianova should be discontinued immediately and the patient should contact a doctor (see section 4 "Possible side effects").
Before starting treatment with Colchianova, discuss with a doctor or pharmacist if any of the following conditions apply or have applied to the patient:

• the patient has liver or kidney disease,
• the patient has heart or vascular disease,
• the patient has gastrointestinal problems,
• the patient is elderly or debilitated,
• the patient has been diagnosed with a blood disorder.

Colchicine may seriously impair blood cell production in the bone marrow [causing suppression of production of a certain subgroup of white blood cells (a condition known as agranulocytosis), low platelet count (a condition known as thrombocytopenia), or reduced number of red blood cells and haemoglobin in peripheral blood due to lack of their production in the bone marrow (a condition known as aplastic anaemia)].
The patient should have regular blood tests to monitor for possible abnormalities.
If the patient experiences symptoms such as fever, inflammation of the mucous membranes of the mouth, sore throat, prolonged bleeding, increased tendency to bruising, or skin problems, the use of this medicine should be discontinued immediately and the patient should contact a doctor without delay. These may be symptoms of a serious blood disorder, and the doctor may wish to perform blood tests immediately (see section 4 "Possible side effects").
Long-term use of colchicine may lead to vitamin B12 deficiency.

Colchianova and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use by the patient.
Caution is advised when using this medicine together with drugs that may reduce blood cell counts or negatively affect liver or kidney function. In such cases, contact the doctor.
When Colchianova is used concomitantly with any of the following medicines, the risk of adverse effects due to colchicine toxicity increases, and such effects may be very serious. Inform the doctor or pharmacist if the patient is taking:

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

Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• Concomitant use of the following medicines during colchicine treatment may cause severe muscle disease (myopathy) and breakdown of muscle tissue, accompanied by painful muscle cramps, fever, and red discoloration of 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 blood lipids), * digoxin (a medicine used to treat heart failure and arrhythmias).
• cimetidine (a medicine used to relieve duodenal and gastric ulcers) and tolbutamide (a medicine used to lower blood sugar levels). These medicines may enhance the effects of colchicine.
• vitamin B12 (cyanocobalamin). Colchicine may reduce absorption of vitamin B12 from the gastrointestinal tract.

Colchianova with food and drink
Grapefruit juice should not be consumed during colchicine treatment.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Women of childbearing potential:
Treatment of gout:
Women of childbearing potential must use effective contraception during treatment with Colchianova for gout and for at least 3 months after completion of treatment. If pregnancy occurs during this period, genetic counselling should be sought.

Pregnancy:
Treatment of gout:
If the patient is or may be pregnant, she should not use Colchianova. If pregnancy occurs during treatment with Colchianova or within 3 months after completion of treatment, genetic counselling should be sought.

Breastfeeding:
The active substance of this medicine—colchicine—passes into breast milk. Colchianova should not be used in women who are breastfeeding and have gout.

Fertility:
Treatment of gout:
Male patients should not cause pregnancy during treatment with colchicine and for at least six months after discontinuation of treatment. If pregnancy occurs during this period, genetic counselling should be sought.

Driving and operating machinery
There are no available data on the effect of colchicine on the ability to drive vehicles or operate machinery. However, the possibility of drowsiness and dizziness should be considered.

Colchianova contains lactose
Colchianova contains lactose monohydrate.
If the doctor has diagnosed the patient with an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to use Colchianova

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt,
consult your doctor or pharmacist.
An excessive dose of colchicine may be highly toxic; therefore, it is essential that the patient
does not exceed the dose prescribed by the doctor.
If the patient feels that the effect of 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 daily. Your doctor may decide
to prescribe an additional 1 mg (1000 micrograms) on the first day of treatment.
Treatment with this medicine should be discontinued if gastrointestinal symptoms occur or if no
therapeutic effect is observed after 2 to 3 days of treatment.
In a single treatment cycle, the total dose of Colchianova should not exceed 6 mg.
A new treatment cycle with Colchianova (or any other medicine containing colchicine) should not be
started until at least three days have passed since the end of the previous cycle.

Prophylaxis 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.
Your doctor will inform you how long you should continue taking 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 such patients should be closely monitored. Patients with severe
liver dysfunction or severe kidney dysfunction should not take this medicine — see section
“When not to use Colchianova”.

Children and adolescents
Colchianova should not be used in the treatment of gout in children and adolescents.

Method of administration
Tablets should be swallowed whole with a glass of water.

Overdose of Colchianova
If an overdose of Colchianova is taken or if the medicine is accidentally swallowed by a child,
there is a risk of poisoning. In such cases, contact your doctor, pharmacist, or the emergency
department of the nearest hospital immediately.

Symptoms of poisoning

• Early symptoms of overdose may appear within a few hours after ingestion of excessive colchicine tablets. These include burning sensation in the throat, stomach, and on the skin, nausea, vomiting, colicky abdominal pain, and bloody diarrhea, which may lead to decreased blood pH, dehydration, low blood pressure, and shock.
• Subsequently, 24–72 hours after ingestion of an excessive dose, life-threatening complications may develop: disturbances of consciousness with possible delusions (delirium), coma, paralysis symptoms, respiratory depression, pulmonary edema, kidney damage, hemorrhage, and cardiac arrest.
• Approximately 7 days after ingestion of an excessive dose, transient leukocytosis (increased white blood cell count) and hair loss may occur.

Missed dose of Colchianova
Do not take a double dose to make up for a missed dose.
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the
next dose, the missed dose should be skipped and the next dose taken at the usual time.
In case of doubt, consult your doctor or pharmacist.

Stopping treatment with Colchianova
If the patient suddenly stops taking this medicine, symptoms that were present before starting
treatment may recur. If the patient is considering stopping colchicine, they should discuss this
with their doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur in the patient, discontinue use of Colchianova and consult a doctor or the emergency department of the nearest hospital immediately:

• Nausea, vomiting, cramping abdominal pain, diarrhoea. These adverse reactions occur uncommonly (i.e. occurring in no more than 1 in 10 people).
• Muscle weakness (myopathy), red to brown discoloration of urine (rhabdomyolysis), muscle pain, feeling of fatigue. These adverse reactions occur uncommonly (i.e. occurring in no more than 1 in 100 people).
• Infections presenting, for example, with fever, severe sore throat and oral ulcers, as well as a serious form of anaemia, i.e. aplastic anaemia (also known as aplastic anaemia). These adverse reactions occur rarely (i.e. occurring in no more than 1 in 1000 people).

The following adverse reactions have also been reported.
Frequency unknown (frequency cannot be estimated from available data):

• Hair loss, rash
• Reduced sperm count in semen or complete absence of sperm in semen
• Sore throat
• Neuropathy (nerve disease), nerve inflammation that may cause pain, tingling sensations, and sometimes impaired nerve function
• Absence of menstruation for at least 6 months and occurrence of pain and (or) cramping pain during menstruation
• Vitamin B12 deficiency

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Colchianova

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
No special temperature storage requirements for this medicine.
Do not use the medicine Colchianova after the expiry date stated on the blister and the
cardboard box after: EXP. The expiry date refers to the last day of the stated month.
The shelf-life after first opening the tablet container, which is an HDPE bottle, is 100 days.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.
This leaflet does not contain all information regarding this medicine. If you have any
questions, please consult your doctor or pharmacist.

6. Contents of the pack and other information

What Colchianova contains

• The active substance is colchicine. Each Colchianova tablet contains 500 micrograms of colchicine.
• The other ingredients (excipients) are: monohydrate lactose, pregelatinized starch (corn), sodium carboxymethyl starch (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, uncoated tablets with an embossed mark
“L” on one side and smooth on the other side (diameter approximately 5 mm, thickness approximately 2.6 mm).
Colchianova tablets are packed in blisters made of PVC/PVDC/Aluminium foil, inside a cardboard box.
Each pack contains 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98 or 100 tablets.
Colchianova tablets are also packed in HDPE bottles with PP closure and child-resistant safety cap, inside a cardboard box. Each bottle contains 30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Pharmaselect International Beteiligungs GmbH
Ernst-Melchior-Gasse 20
1020 Vienna
Austria
Tel. No.: +43 (0) 1 786 03 86-00
To obtain this leaflet in another format or to report an adverse reaction, please contact the Marketing Authorisation Holder listed above.