Package leaflet: Information for the patient

Dolcur, 500 micrograms, tablets
Colchicinum
Please read 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 ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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.

Leaflet contents:

What Dolcur is and what it is used for
Important information before taking Dolcur
How to take Dolcur
Possible side effects
How to store Dolcur
Contents of the pack and other information

1. What Dolcur is and what it is used for

The active substance in Dolcur is colchicine.
Colchicine is a medicine used to treat gout.
Dolcur is used to treat acute attacks of gout. It may also be used to prevent acute gout attacks during the initiation of treatment with other medicines such as allopurinol, probenecid, and sulfinpyrazone.

2. Important information before taking Dolcur

When not to take Dolcur:

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 disorders;
during pregnancy;
while breastfeeding;
in women of childbearing age who are not using effective methods of contraception;
if the patient has severe impairment of kidney or liver function;
in dialysed patients;
if the patient has impaired kidney or liver function and is taking certain medicines (see "Dolcur and other medicines").

If in doubt whether any of the above conditions apply to the patient, consult a doctor or pharmacist.
Warnings and precautions
Before starting to take Dolcur, discuss with a doctor or pharmacist:

if the patient has disorders of heart, kidney, liver or gastrointestinal function;
if the patient is elderly and frail;
if the patient has blood disorders.

Dolcur may be toxic, so it is important not to exceed the dose prescribed by the doctor.
The difference between an effective dose and an overdose of Dolcur is small. Therefore, if symptoms such as nausea, vomiting, abdominal pain and diarrhoea occur, stop taking Dolcur immediately and contact the doctor without delay (see also section 4 "Possible side effects").
Dolcur may cause severe bone marrow suppression leading to reduced numbers of certain white blood cells (agranulocytosis), reduced numbers of certain red blood cells and haemoglobin (aplastic anaemia) and/or low platelet count (thrombocytopenia). Regular blood tests should be performed to monitor for any changes.
If symptoms such as fever, mouth ulcers, sore throat, prolonged bleeding, bruising or skin disorders occur, stop taking the medicine immediately and contact the doctor without delay. These may be symptoms of a serious blood disorder. The doctor may decide to perform an immediate blood test (see section 4 "Possible side effects").
Dolcur and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use. Taking other medicines during treatment with Dolcur may affect the action of this medicine and of other medicines.
If Dolcur is taken together with any of the following medicines, there is an increased risk of adverse effects due to the toxic action 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),
cyclosporine (a medicine used to prevent organ rejection after transplantation, and in the treatment of psoriasis and rheumatoid arthritis),
antifungal medicines such as itraconazole or ketoconazole,
certain medicines used for heart conditions such as verapamil and diltiazem,
disulfiram (a medicine used as an aid in the treatment of alcoholism).

If the patient is taking any of the above medicines, the doctor may decide to adjust the dose of Dolcur or temporarily discontinue treatment with this medicine. Do not take Dolcur if the patient has impaired kidney or liver function and is taking any of the above medicines.
It is also important to inform the doctor or pharmacist if the patient is taking any of the following medicines:

cimetidine (a medicine used to reduce gastric acid production), as this medicine may increase the blood concentration of colchicine,
tolbutamide (a medicine used to regulate blood sugar levels), as this medicine may increase the blood concentration of colchicine,
digoxin (a medicine used in the treatment of certain heart conditions) and fibrates (medicines that reduce blood cholesterol levels), as these medicines may increase the risk of developing a muscle disease called rhabdomyolysis. Taking Dolcur together with cyclosporine or statins also increases the risk of developing this condition.

Talk to a doctor before starting Dolcur if the patient is taking any medicines that may damage the liver or kidneys or cause blood disorders.
In case of doubt, consult a doctor.
Dolcur may reduce the intestinal absorption of vitamin B.

Dolcur with food and drink
Grapefruit juice may increase the concentration of colchicine. Therefore, grapefruit juice should not be consumed during treatment with Dolcur.
Pregnancy and breastfeeding
Do not take this medicine if the patient is pregnant, suspects she may be pregnant, or is planning to have a child.
Women of childbearing age who are not using effective contraception must not take this medicine.
Colchicine passes into breast milk. Do not take this medicine if the patient is breastfeeding.
Driving and operating machinery
Be aware of the possibility of drowsiness and dizziness. If these symptoms occur, do not drive or operate machinery.
Dolcur contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Dolcur contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Dolcur

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The doctor will inform the patient how many Dolcur tablets to take and for how long the
treatment should last.
Tablets should be swallowed whole with a glass of water.
Use in adults
Dose used in the treatment of acute gout attacks:
The recommended dose is initially 2 tablets, followed by 1 tablet after 1 hour. No further tablets
should be taken for the next 12 hours. If necessary, after this time, treatment may be continued
with a maximum dose of 1 tablet three times daily until symptoms resolve.
The treatment cycle should be completed after symptoms have resolved or after taking all 12
Dolcur tablets. Do not take more than 12 tablets in a single treatment cycle. After completing a
Dolcur treatment cycle, the next cycle may not be started earlier than after at least three days.
Dose used to prevent acute gout attacks when starting treatment with other medicines:
The recommended dose is 1 tablet twice daily.
The doctor will inform the patient how long the treatment should last.
Use in patients with impaired kidney or liver function
The doctor may recommend a lower dose of Dolcur and close monitoring for adverse reactions.
Dolcur must not be used if the patient has severe impairment of kidney or liver function.
Taking more than the recommended dose of Dolcur
If more than the recommended dose of the medicine has been taken, seek immediate medical
attention from a doctor or go to the nearest hospital emergency department. Bring this leaflet
and any remaining tablets with you.
Taking too high a dose of Dolcur may cause severe poisoning, which may even be fatal. Early
symptoms of overdose (usually occurring about 3 hours or later) may include nausea, vomiting,
abdominal pain, bloody diarrhoea, and low blood pressure.
Missed dose of Dolcur
If a dose is missed, 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 at all.
Do not take a double dose to make up for a missed tablet.
Do not take Dolcur at intervals shorter than those prescribed by the doctor.
If you have any further doubts 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 experiences them.
If any of the following adverse reactions occur, stop taking the medicine Dolcur and contact your doctor or the emergency department of the nearest hospital immediately:
nausea, vomiting, abdominal pain and diarrhoea (see also section 2 "Warnings and precautions"). These adverse reactions are common (may occur in 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 occurrence of these adverse reactions is unknown (frequency cannot be estimated from the available data).
Other observed adverse reactions (frequency unknown):

inflammation of nerves causing pain, weakness, tingling or numbness,
nerve damage,
gastrointestinal bleeding,
liver damage,
hair loss,
rash,
muscle pain or weakness,
abnormal muscle breakdown which may lead to kidney dysfunction (rhabdomyolysis),
kidney damage,
absence of menstruation,
painful menstruation,
reduced sperm production (low or no sperm count).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Dolcur

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation LOT indicates the batch number.
Medicines must 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: monohydrate lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate.

What Dolcur looks like and contents of the pack
Dolcur is a white to almost white, round, flat tablet with bevelled edges and engraved number "0.5" on one side, 6 mm in diameter.
Pack sizes:
20, 30, 50 or 100 tablets in blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation 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