INDORAMIN

Posology Hyperplasia Adults: 20 mg twice daily Dosage may be increased in 20 mg increments at two-weekly intervals up to max. 100 mg per day if required. Elderly: 20 mg at night may be adequate. Paediatric population Not recommended. There is no relevant use of indoramin in the paediatric population Route of administration Oral

In general, indoramin is well tolerated. The following undesirable effects have been observed and reported during treatment with indoramin with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

MedDRA System Organ Class Frequency Undesirable effects Immune system disorders Rare Hypersensitivity Psychiatric disorders Unknown Depression Nervous system disorders Rare Unknown Parkinson’s disease Dizziness Headache Sedation or Drowsiness Somnolence Vascular disorders Unknown Hypotension, with or without syncope Orthostatic hypotension (postural hypotension) Respiratory, thoracic and mediastinal disorders Unknown Nasal congestion Gastrointestinal disorders Unknown Dry mouth Skin and subcutaneous tissue disorders Rare Rash Pruritus Reproductive system and breast disorders Unknown Ejaculation failure General disorders and administration site conditions Unknown Fatigue Investigation Unknown Weight increased 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.

Special warnings Incipient cardiac failure should be controlled before treatment with indoramin. Caution should be observed in prescribing indoramin for patients with hepatic or renal insufficiency. A few cases of extrapyramidal disorders have been reported in patients treated with indoramin.

Caution should be observed in prescribing indoramin in patients with Parkinson's disease. In animals and in the one reported case of overdose in humans, convulsions have occurred. Due consideration should be given and great caution exercised in the use of indoramin in patients with epilepsy.

The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded.

As IFIS may lead to increased procedural complications during the cataract operation current or part use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery. Caution should be observed in prescribing indoramin for patients with a history of depression.

Clearance of indoramin may be affected in the elderly. A reduced dose, and/or reduced frequency of dosing may be sufficient in some elderly patients. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1 Patients with established heart failure. Patients already under treatment with a monoamine oxidase inhibitor.