COLCHICINE TIOFARMA HIGH STRENGTH

5 mg, possibly preceded by an initial dose of 1 mg. Treatment should end until the acute attack resolves, or earlier in the event of gastrointestinal symptoms and no improvement after 2 to 3 days. No more than 6 mg should be taken as a course of treatment.

After completion of a course, another course should not be started for at least 3 days (72 hours). If diarrhoea or vomiting occurs, Colchicine Tiofarma High Strength 1000 microgram Tablets should be discontinued immediately as these may be the first signs of an intoxication.

5 – 1 mg per day (to be taken in the evening). Paediatric population Colchicine Tiofarma High Strength 1000 microgram Tablets should not be used in children and adolescents. Specific groups Concomitant treatment of colchicine with several drugs, mostly inhibitors of cytochrome P450 3A4 (CYP3A4)/P-glycoprotein have been shown to increase the risk for colchicine toxicity.

If a patient has received concomitant therapy with a moderate or potent CYP3A4 inhibitor or with a P-glycoprotein inhibitor, the maximum recommended dosage of oral colchicine should be reduced and should be carefully monitored for adverse effects of colchicine.

5 mg per day and should be carefully monitored for adverse effects of colchicine. 3 contraindications. 5 mg per day and should be carefully monitored for adverse effects of colchicine. 3 contraindications. Familial Mediterranean Fever The dose may be given as a single dose or doses higher than 1 mg/day may be divided and given twice daily.

Colchicine dosage should be increased in a stepwise fashion up to a maximum of 3 mg/day to control disease in patients who do not clinically respond to the standard dosage. Any increase of the daily dose should be monitored closely for adverse effects.

Careful monitoring is needed in the presence of impaired renal or liver function. g. ≤ 1mg/day). Adults 1 to 3 mg per day. Paediatric population For paediatric use, colchicine should only be prescribed under the supervision of a medical specialist with the necessary knowledge and experience.

5 mg/day in children over 10 years of age In children with amyloid nephropathy, higher daily doses up to 2 mg/day might be needed. g. 5 mg and 1 mg tablet are not appropriate. Specific groups Concomitant treatment of colchicine with several drugs, mostly inhibitors of cytochrome P450 3A4 (CYP3A4)/P-glycoprotein have been shown to increase the risk for colchicine toxicity.

If a patient has received concomitant therapy with a moderate or potent CYP3A4 inhibitor or with a P-glycoprotein inhibitor, the maximum recommended dosage of oral colchicine should be reduced and should be carefully monitored for adverse effects of colchicine.

g. ≤ 1mg/day) and should be carefully monitored for adverse effects of colchicine. 3 contraindications. g. ≤ 1mg/day) and should be carefully monitored for adverse effects of colchicine. 3 contraindications. Method of Administration Oral route.

Tablet should be swallowed with a glass of water. For children younger than 1 year a colchicine oral solution can be considered.

The following adverse reactions have been observed. The frequencies are unknown, unless listed under one of the following classifications: Very common (≥ 1/10) Common (≥ 1/100, < 1/10) Uncommon (≥ 1/1,000, < 1/100) Rare (≥ 1/10,000, < 1/1,000) Very rare (< 1/10,000) Blood and lymphatic system disorders Bone marrow depression with agranulocytosis and aplastic anemia.

Nervous system disorders Peripheral neuritis, neuropathy Gastrointestinal disorders Common: abdominal pain, nausea, vomiting and diarrhea Hepatobiliary disorders Hepatotoxicity Skin and subcutaneous tissue disorders Alopecia, rash Musculoskeletal and connective tissue disorders Myopathy and rhabdomyolysis Reproductive system and breast disorders Amenorrhoea, dysmenorrhoea, oligospermia, azoospermia Respiratory, thoracic en mediastinal disorders Pharyngolaryngeal pain Metabolism and nutrition disorders Vitamin B12 deficiency Paediatric population No long-term safety data are available in paediatric patients.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard).

Colchicine is potentially toxic so it is important not to exceed the dose prescribed by a medical specialist with the necessary knowledge and experience. Colchicine has a narrow therapeutic window. The administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain, diarrhea occur.

If patients develop signs or symptoms that could indicate a blood cell dyscrasia, such as fever, stomatitis, sore throat, or prolonged bleeding, treatment with colchicine should be immediately discontinued and a full haematological investigation should be conducted.

Caution is advised in case of: • Liver or renal impairment • Cardiovascular disease • Gastrointestinal disorders • Elderly and debilitated patients • Patients with abnormalities in blood counts Colchicine may cause severe bone marrow depression (agranulocytosis, aplastic anaemia, thrombocytopenia).

The change in blood counts may be gradual or very sudden. Aplastic anaemia in particular has a high mortality rate. Periodic checks of the blood count are essential. If skin abnormalities (petechiae) occur, blood counts should be checked immediately.

5). Co-administration with P-gp inhibitors and/or strong CYP3A4 inhibitors will increase the exposure to colchicine, which may lead to colchicine-induced toxicity including fatalities. 5) and patients should be carefully monitored for adverse effects of colchicine.

For patients with an impaired renal or hepatic function, the combined use of colchicine and P-gp inhibitors and/or strong CYP3A4 inhibitors should be avoided whenever possible, as it may be difficult to forecast and control systemic exposure to colchicine.

In those exceptional cases where continuation of colchicine when starting P-gp inhibitors and/or strong CYP3A4 inhibitors is considered a benefit, despite the potential risk of overdose, significant dose reductions of colchicine dose and careful clinical monitoring should be applied.

Long-term use of colchicine may be associated with vitamin B12 deficiency. In case colchicine is used for treatment of acute gout or for prophylaxis of a gout attack during initiation of urate-lowering therapy Patients should be carefully informed about the potential risk of a possible pregnancy and about effective contraception measures to be followed.

6). 6). Paediatric population No long-term safety data are available in paediatric patients. The use of colchicine in children is primarily indicated for the indication FMF. Colchicine Tiofarma High Strength 1000 microgram Tablets contains lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Colchicine Tiofarma High Strength 1000 microgram Tablets contains sodium This medicine contains less than 1 mmol (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. • Patients with blood dyscrasias • Patients with severe renal impairment • Patients with severe hepatic impairment