COLCHICINE Tablet

Indications:

This medicine is recommended for

• Treatment and prevention of gout attacks,

• Familial Mediterranean fever,

• Behcet's disease,

• Other acute attacks of microcrystalline arthritis.

Dosage:

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Acute gout attack

The whole or half-tablet doses of COLCHICINE OPOCALCIUM should be spread throughout the day, making sure not to take more than 1 mg colchicine (1 tablet) at any one time.

In the case of early treatment, low doses of between 1 mg and 2 mg colchicine should be used on the 1st day of treatment. On the following days, 1 mg colchicine should be taken (if there are no risk factors for overdose).

In some cases, higher doses may be prescribed on an exceptional basis. Never exceed:

• 3 mg colchicine on the first day of treatment, divided throughout the day,

• 2 mg colchicine on the second and third days of treatment, divided throughout the day,

• 1 mg colchicine on the fourth and subsequent days of treatment

If you experience diarrhoea, contact your doctor immediately. A dose reduction or suspension of the treatment may be necessary.

- Prophylaxis of acute gout attack/other acute attacks of microcrystalline arthritis/Behcet's disease:

1 mg colchicine per day.

Reduce the dose to 0.5 mg colchicine (1/2 tablet) in the event of diarrhoea.

- Familial Mediterranean fever

• Adults: 1 mg to 2 mg colchicine daily.

your doctor may increase the dose in increments of 0.5 mg (1/2 tablet) to a maximum of 2 mg colchicine per day, based on the clinical and laboratory response.

• Children: 0.5 mg to 2 mg colchicine per day (1/2 to 2 tablets) in one or two doses. The dose will be adjusted based on age and clinical response. The colchicine dose will be increased by your doctor in a progressive manner.

- Frequency of administration :

This medication should preferably be taken at meal times.

Do not take COLCHICINE OPOCALCIUM 1 mg, scored tablet:

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6. 1)

• If you have severe kidney disease (kidney dysfunction),

• If you have severe liver disease (liver dysfunction),

• If you are receiving treatment with antibiotics such as pristinamycin or antibiotics from the class of macrolides (with the exception of spiramycin).

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

• Gastrointestinal problems (diarrhoea, nausea, vomiting), hives, rash.

• In very rare cases: blood disorders (decrease in the number of white blood cells in the blood [leukopenia], decrease in the number of certain white blood cells [neutrophils] in the blood [neutropenia], decrease in the number of platelets [thrombocytopenia]) (see section 'Warnings and precautions for use').

• Azoospermia (absence of sperm in semen> and neuromuscular disorders, reversible upon discontinuation of treatment.

IF YOU NOTICE THE ONSET OF SIGNIFICANT DIARRHOEA (WATERY BOWEL MOVEMENTS MORE THAN 3 TIMES PER DAY) DURING TREATMENT, CONTACT YOUR DOCTOR QUICKLY. A DOSE REDUCTION OR SUSPENSION OF THE TREATMENT MAY BE NECESSARY.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This medicine must not be taken at the same time as some antibiotics (such as pristinamycin or antibiotics from the class of macrolides (with the exception of spiramycin).

If you are taking one of these medicines, you must not take colchicine at the same time. Talk to your doctor or pharmacist about this.

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

Special warnings:

If you notice the onset of diarrhoea (watery bowel movements more than 3 times per day) during treatment, contact your doctor quickly. A dose reduction or suspension of the treatment may be necessary

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this medicine.

The use of colchicine together with some antibiotics (see section "Other medicines and COLCHICINE OPOCALCIUM 1 mg, scored tablet") is contraindicated.

Precautions for use:

In the event of long-term treatment, monitor blood count regularly.

In the event of liver and kidney disease, CONSULT YOUR DOCTOR

IF you HAVE ANY FURTHER QUESTIONS ON THE USE OF THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.