Colhicine Genoptim

Package Leaflet: Information for the Patient

Dolcur, 500 micrograms, 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Dolcur and what is it used for

The active substance of the medicine is colchicine.
Colchicine is a medicine for gout.
Dolcur is used to treat acute gout attacks. The medicine can also be used to prevent acute gout attacks when starting treatment with other medicines, such as allopurinol, probenecid, and sulfinpyrazone.

2. Important information before taking Dolcur

When not to take Dolcur:

• if you are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6);
• if you have severe blood disorders;
• during pregnancy;
• while breastfeeding;
• in women of childbearing age who do not use effective methods of contraception;
• if you have severe kidney or liver disorders;
• in patients undergoing dialysis;
• if you have kidney or liver disorders and are taking certain medicines (see "Dolcur and other medicines").

If you are unsure whether any of the above applies to you, talk to your doctor or pharmacist.

Warnings and precautions

Before taking Dolcur, discuss with your doctor or pharmacist:

• if you have heart, kidney, liver, or gastrointestinal disorders;
• if you are elderly and frail;
• if you have blood disorders.

Dolcur may be toxic, so it is essential not to exceed the dose prescribed by your doctor.
The difference between an effective dose and an overdose of Dolcur is small. Therefore, if symptoms such as nausea (vomiting), vomiting, abdominal pain, and diarrhea occur, stop taking Dolcur and contact your doctor immediately (see also section 4 "Possible side effects").
Dolcur may cause severe bone marrow suppression leading to a decrease in the number of certain white blood cells (agranulocytosis), a decrease in the number of certain red blood cells and blood pigment (aplastic anemia), and (or) a low platelet count (thrombocytopenia). Regular blood tests should be performed to monitor any changes.
If symptoms such as fever, mouth inflammation, sore throat, prolonged bleeding, bruising, or skin disorders occur, stop taking the medicine immediately and contact your doctor. These may be symptoms of a severe blood disorder. Your doctor may decide to perform a blood test immediately (see section 4 "Possible side effects").

Dolcur and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Taking other medicines during treatment with Dolcur may affect the action of this medicine and other medicines used.
If Dolcur is used with any of the following medicines, there is a higher risk of side effects due to the toxic effects of colchicine:

• certain antibiotics, such as clarithromycin, erythromycin, and telithromycin (used to treat infections),
• antiviral medicines, such as ritonavir, atazanavir, and indinavir (used to treat HIV infection),
• cyclosporin (a medicine used to prevent organ rejection after transplantation, to treat psoriasis, and rheumatoid arthritis),
• antifungal medicines, such as itraconazole or ketoconazole,
• certain medicines used to treat heart conditions, such as verapamil and diltiazem,
• disulfiram (a medicine used to support the treatment of alcoholism).

If you are taking any of these medicines, your doctor may decide to adjust the dose of Dolcur or temporarily stop treatment with this medicine.
Do not take Dolcur if you have kidney or liver disorders and are taking any of these medicines.
It is also important to tell your doctor or pharmacist about taking any of the following medicines:

• cimetidine (a medicine used to reduce stomach acid production), as it may increase the concentration of colchicine in the blood,
• tolbutamide (a medicine used to regulate blood sugar levels), as it may increase the concentration of colchicine in the blood,
• digoxin (a medicine used to treat certain heart conditions) and fibrates (medicines used to lower cholesterol levels in the blood), as they may increase the risk of a muscle disease called rhabdomyolysis. Taking Dolcur with cyclosporin or statins also increases the risk of this disease.

Before taking Dolcur, talk to your doctor if you are taking any medicines that may harm the liver, kidneys, or cause blood disorders.
In case of doubt, consult your doctor.
Dolcur may reduce the absorption of vitamin B from the gut.

Dolcur with food and drink

Grapefruit juice may increase the concentration of colchicine. Therefore, do not consume grapefruit juice while taking Dolcur.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant, think you may be pregnant, or plan to have a baby.
Women of childbearing age who do not use effective contraception must not take this medicine.
Colchicine passes into breast milk. Do not take this medicine if you are breastfeeding.

Driving and using machines

Be aware of the possibility of drowsiness and dizziness. If these symptoms occur, do not drive or operate machinery.

Dolcur contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

Dolcur contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Dolcur

Always take this medicine exactly as your doctor or pharmacist has told you.
In case of doubt, consult your doctor or pharmacist.
Your doctor will tell you how many Dolcur tablets to take and how long the treatment should last.
Swallow the tablets whole with a glass of water.

Use in adults

Dose used to treat acute gout attacks:
The recommended dose is initially 2 tablets, followed by 1 tablet after 1 hour. Do not take more tablets for the next 12 hours. If necessary, after this time, treatment can be continued with a maximum dose of 1 tablet three times a day until symptoms resolve.
Treatment should be stopped after symptoms resolve or after all 12 Dolcur tablets have been taken. Do not take more than 12 tablets during one treatment cycle. After completing a treatment cycle with Dolcur, the next cycle can be started no sooner than 3 days later.
Dose used to prevent acute gout attacks when starting treatment with other medicines:
The recommended dose is 1 tablet twice a day.
Your doctor will tell you how long the treatment should last.

Use in patients with kidney or liver disorders

Your doctor may recommend a lower dose of Dolcur and close monitoring for side effects.
Do not take Dolcur if you have severe kidney or liver disorders.

Taking a higher dose of Dolcur than recommended

If you take more Dolcur than you should, contact your doctor or go to the emergency department of your nearest hospital immediately. Bring this leaflet and any remaining tablets with you.
Taking too much Dolcur can cause severe poisoning, which can be life-threatening. Early symptoms of overdose (usually occurring 3 hours or later) may include nausea, vomiting, abdominal pain, bloody diarrhea, and low blood pressure.

Missing a dose of Dolcur

If you miss a dose, take the next dose as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose.
Do not take a double dose to make up for a missed tablet.
Do not take Dolcur at intervals shorter than recommended by your doctor.
In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dolcur can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Dolcur and contact your doctor or the emergency department of your nearest hospital immediately:
nausea (vomiting), vomiting, abdominal pain, and diarrhea (see also section 2 "Warnings and precautions"). These side effects are common (may affect up to 1 in 10 people).
Symptoms such as fever, mouth inflammation, sore throat, prolonged bleeding, bruising, or skin disorders. These may be symptoms of a severe blood disorder due to bone marrow suppression (see also section 2 "Warnings and precautions"). The frequency of these side effects is unknown (cannot be estimated from the available data).
Other observed side effects (of unknown frequency):

• nerve inflammation, causing pain, weakness, tingling, or numbness,
• nerve damage,
• gastrointestinal bleeding,
• liver damage,
• hair loss,
• rash,
• muscle pain or weakness,
• abnormal muscle breakdown, which can cause kidney disorders (rhabdomyolysis),
• kidney damage,
• absence of menstruation,
• painful menstruation,
• reduced sperm production (low or absent sperm count).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 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 Dolcur

Keep the medicine out of the sight and reach of children.
Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dolcur contains

• The active substance is colchicine. Each tablet contains 500 micrograms (µg) of colchicine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate.

What Dolcur looks like and contents of the pack

Dolcur is available as white to almost white, round, flat tablets with beveled edges and a engraved "0.5" on one side, with a diameter of 6 mm.
Pack sizes:
Blisters containing 20 and 100 tablets.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer/Importer

Teva Czech Industries s.r.o.
Ostravská 305/29, Komárov
747 70 Opava
Czech Republic
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
Date of last revision of the leaflet:July 2025