COLCHICINE INDOCO 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Colchicine Indoco 0.5 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Colchicine Indoco and what is it used for

Colchicine Indoco contains the active substance colchicine. It belongs to the group of anti-gout medicines and is used to prevent or treat gout attacks.

In patients with gout, the concentration of uric acid in the blood increases. This can cause uric acid crystals to precipitate in the synovial fluid of the joints. Colchicine inhibits the resulting inflammatory response.

Colchicine Indoco is indicated in adults:

• For the treatment of acute gout
• For the prevention of gout attacks during urate-lowering therapy

2. What you need to know before you take Colchicine Indoco

Do not take Colchicine Indoco

• If you are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6).
• If you have a severe blood disorder.
• If you have severe kidney impairment.
• If you have severe liver impairment.
• If you are a woman of childbearing age, unless you are using effective contraceptive methods to prevent pregnancy.

Warnings and precautions

At the first signs of toxicity such as nausea, vomiting, stomach pain, and diarrhea, stop taking Colchicine Indoco and contact your doctor immediately. There is a narrow difference between the therapeutic dose and the dose that can cause symptoms of toxicity.

Consult your doctor or pharmacist before starting to take this medicine if any of the following apply to you or have applied in the past:

o If you have kidney or liver disease.

o If you have any cardiovascular disease.

o If you have any gastrointestinal disease.

o If you are an elderly person and feel weak.

o If you have a blood disorder.

Colchicine may cause a significant reduction in bone marrow function (disappearance of certain white blood cells from the blood [agranulocytosis]), decreased platelet count (thrombocytopenia), decreased red blood cells, and pigment due to lack of production of red blood cells (aplastic anemia). Blood tests should be performed regularly to monitor any changes.

If you experience symptoms indicative of abnormal blood counts such as fever, mouth inflammation, sore throat, or persistent bleeding, bruising, or skin changes, stop taking this medicine and consult your doctor immediately. These can be signs of a serious blood disorder. Blood tests should be performed immediately.

Other medicines and Colchicine Indoco

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. Special caution is needed when using medicines that affect the blood count or have a negative effect on kidney or liver function.

When Colchicine Indoco is given at the same time as any of the following medicines, serious and potentially life-threatening side effects may occur due to colchicine toxicity:

• 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 (used to prevent organ rejection, for psoriasis, and rheumatoid arthritis)
• Antifungal medicines such as ketoconazole, itraconazole, and voriconazole
• Certain medicines for heart conditions such as verapamil and diltiazem

If you are taking any of these medicines, your doctor may decide to adjust the dose of colchicine or temporarily stop treatment with this medicine. If you have kidney or liver disease and are taking any of these medicines, you should not take colchicine.

It is important to inform your doctor or pharmacist if you are taking any of the following medicines:

• Cimetidine (used to reduce stomach acid), as it may increase the concentration of colchicine in the blood
• Tolbutamide (used to control blood sugar), as it may increase the concentration of colchicine in the blood
• Vitamin B12 (cyanocobalamin), as colchicine may reduce the absorption of vitamin B12 in the digestive tract
• Macrolide antibiotics such as azithromycin (used to treat infections caused by microorganisms; for example, bacteria), as it may increase the concentration of colchicine in the blood
• Statins such as simvastatin, fluvastatin, or pravastatin (medicines to reduce cholesterol), fibrates (medicines used to reduce cholesterol and some lipids in the blood), cyclosporin (immune inflammatory response), and digoxin (medicine used to treat certain heart conditions), as the simultaneous use of these medicines with colchicine may cause muscle disorders (myopathy) and muscle tissue damage, accompanied by muscle cramps, fever, and change in urine color (from reddish to brown) (rhabdomyolysis).

Using Colchicine Indoco with food and drinks

Do not drink grapefruit juice during treatment with colchicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In animal studies, it has been shown that colchicine is harmful to the fetus. Do not take this medicine if you are of childbearing age, unless you are using effective contraceptive methods. Since colchicine is excreted in breast milk, this medicine should not be taken during breastfeeding.

Driving and using machines

No data are available on the influence of colchicine on the ability to drive and use machines. However, it should be taken into account that it may cause drowsiness and dizziness.

Colchicine Indoco contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Colchicine Indoco

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Colchicine is potentially toxic, so it is important not to exceed the dose prescribed by your doctor.

Adults:

Dosage for an acute gout attack:

The recommended dose is 0.5 mg two to three times a day. Your doctor may decide to prescribe an additional dose of 1 mg for the first day of treatment. Treatment should be stopped if gastrointestinal side effects occur, if no effect is observed after 2-3 days, or if symptoms disappear.

Dosage for prevention of a gout attack:

The recommended dose is 0.5 mg to 1 mg per day. It should be taken at night.

Dosage in patients with kidney or liver impairment:

In patients with mild to moderate liver or kidney impairment, the recommended dose is 1 tablet (0.5 mg of colchicine) per day. If you have severe liver or kidney impairment, you should not take this medicine. See section “Do not take Colchicine Indoco”.

Method of administration:

Oral use

Take the tablets with a glass of water.

Duration of treatment:

Your doctor will tell you how many tablets to take and for how long.

Consult your doctor or pharmacist if you feel that the effect of the colchicine tablets is too strong or not strong enough.

If you take more Colchicine Indoco than you should

If you take more Colchicine Indoco than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Signs of poisoning:

• After taking a dose higher than the dose of colchicine prescribed by your doctor, the first symptoms of overdose appear after a few hours. These symptoms include a burning sensation in the throat, stomach, and skin, nausea, vomiting, abdominal cramps, bloody diarrhea, which can cause excessive decrease in blood pH, dehydration, decreased blood pressure, and cardiocirculatory shock.
• Between 24 and 72 hours after taking a dose higher than the recommended dose, the following potentially fatal complications may occur: altered consciousness with possible episodes of hallucinations (delirium), coma, paralysis, respiratory failure, cardiac arrest, fluid retention in the lungs, kidney damage, and blood deficiency.
• After 7 days of taking a dose higher than the recommended dose, a temporary increase in white blood cell count (leukocytosis) and hair loss may occur.

If you forget to take Colchicine Indoco

Do not take a double dose to make up for forgotten doses.

If you forget to take a dose, take it as soon as possible. If it is almost time for the next dose, do not take the missed dose, just continue with the prescribed dosage regimen. If in doubt, consult your doctor or pharmacist.

If you stop taking Colchicine Indoco

If you stop treatment with this medicine suddenly, it is possible that the symptoms you had before starting treatment with this medicine may return. Consult your doctor if you are thinking of stopping treatment with colchicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the following side effects have been reported for colchicine, and most of them resolve within a short period after stopping treatment or reducing the dose of colchicine.

Frequent (may affect up to 1 in 10 people):

• Gastrointestinal disorders:nausea, vomiting, abdominal cramps, and diarrhea.

Frequency not known (cannot be estimated from the available data):

• Nervous system disorders:neuropathy (nervous system disease), neuritis with pain, sensory disturbance, and frequently reduced neuronal function (peripheral neuritis).

• Vascular disorders:colchicine may cause serious bone marrow disorders (bone marrow depression), which can cause changes in the blood count, for example, decreased white blood cell count (agranulocytosis) accompanied by high fever, severe sore throat, and mouth ulcers, and anemia (aplastic anemia).

• Skin and subcutaneous tissue disorders:hair loss, rashes.

• Renal and urinary disorders:change in urine color (from reddish to brown) (rhabdomyolysis).

• Musculoskeletal and connective tissue disorders:muscle disease (myopathy), muscle pain, fatigue.

• Reproductive system and breast disorders:absence of menstrual cycle for a period of 6 months or more (amenorrhea), pain and/or cramps during the menstrual cycle (dysmenorrhea), decreased sperm count in the semen (oligospermia), and absence of sperm in the semen (azoospermia).

• Hepatobiliary disorders:liver damage.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Colchicine Indoco

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special storage temperature. Keep in the outer packaging to protect from light.
• Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date is the last day of the month stated.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Colchicine Indoco

• The active substance is colchicine. Each tablet contains 500 micrograms of colchicine.
• The other ingredients are:

Lactose monohydrate

Microcrystalline cellulose

Sodium carboxymethyl starch type A (potato)

Magnesium stearate

Appearance of Colchicine Indoco and contents of the pack

Colchicine Indoco are round, white to pale yellow tablets marked with ‘C 75’ on one side.

Colchicine Indoco is available in blister packs of 10, 12, 20, 30, 50, 100, 150, or 200 tablets in each blister.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Indoco Remedies Czech s.r.o.

Trtinová 260/1, Cakovice,

196 00 Praha 9, Czech Republic

Manufacturer

Formula Pharmazeutische und chemische Entwicklungs GmbH

Goerzallee 305 b 14167, Berlin, Germany.

MISOM Labs Limited

Malta Life Sciences Park, LS2.01.06

Industrial Estate, San Gwann, SGN 3000, Malta.

Local representative:

MABO-FARMA, S.A.

Calle Via de los Poblados, 3, Edificio 6

28033, Madrid, Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Colchicine Indoco 0.5 mg, tabletten

Czech Republic: Colchicine Indoco

Finland: Colchicine Indoco 500 mikrogrammaa, tabletit

Germany: Colchicin Indoco 0.5 mg Tabletten

Ireland: Colchicine Indoco 500 microgram Tablets

Slovakia: Colchicine Indoco 0.5 mg tablety

Spain: Colchicina Indoco 0.5 mg comprimidos EFG

Croatia: Kolhicin Indoco 0.5 mg tablete

Date of last revision of this leaflet:August 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/