Uricon 20mg Granules

Uricon u00ae is indicated for the treatment of adults with detrusor instability / over activity and associated symptoms of urinary frequency, urgency or urge incontinence.

The tablets should be swallowed whole with a glass of water before meals. One tablet twice daily (equivalent to 40 mg of trospium chloride per day).

In patients with moderate renal impairment the recommended dosage is: One tablet per day (equivalent to 20 mg of trospium chloride per day)

Urinary retention, including urinary retention due to prostatic disease (e.g. benign prostatic hyperplasia) and bladder neck and / or urethral stenosis, narrow-angle glaucoma, tachyarrhythmia, myasthenia gravis, severe ulcerative colitis, toxic megacolon, dialysed renal insufficiency, (creatinine clearance < 10 ml/min/1,73 m2). Mechanical stenosis or obstructive lesions of the gastro-intestinal tract. Severe impairment of hepatic function.

Trospium chloride should be used with caution by patients who suffer from:

• Autonomic neuropathy
• Hiatus hernia associated with reflux oesophagitis

Not recommended for use in patients under 18 years of age as insufficient data is available.

Possible potentiation of effects of drugs with anticholinergic action such as amantadine, tricyclic antidepressants, quinidine, antihistamines and disopyramide. Enhancement of tachycardiac action of u03b2-sympathomimetics. Decrease in efficacy of pro-kinetic agents, e.g. metoclopramide and cisapride.

Safety of use in pregnancy and lactation has not been established.

Disorders of accommodation can lower the ability to operate machinery and drive motor vehicles.

Very common (10 %); common (1 % - < 10 %); uncommon (0,1 % - < 1 %); rare (0,01 % - < 0,1 %); very rare (< 0,01 %) including isolated cases.

Anticholinergic effects may occur during the treatment with trospium chloride.

Cardiovascular disorders

• Uncommon: Tachycardia
• Rare: Tachyarrhythmia

Gastro-intestinal disorders

• Common: Dryness of the mouth, dyspepsia, abdominal pain, nausea, constipation
• Uncommon: Diarrhoea, flatulence, vomiting

Hepatobiliary disorders

• Rare: Mild to moderate increase in serum transaminase levels

Nervous system disorders:

• Uncommon: Vision disorders, such as disorders of accommodation

Renal and urinary system disorders

• Uncommon: Micturition disorders, e.g. residual urine
• Rare: Urinary retention

Reproductive disorders

• Common: Decrease bronchial mucous production
• Uncommon: Dyspnoea

Skin and subcutaneous tissue disorders

• Common: Decreased sweating
• Uncommon: Rash
• Rare: Angio-oedema

Whole body disorders

• Uncommon: Asthenia, chest pain, tiredness, headache, somnolence or sleep disorder

After administration of a maximum single dose of 360 mg trospium chloride to healthy volunteers, dryness of the mouth, tachycardia and disorders of micturition were observed to an increased extent. No manifestations of severe overdosage or toxicity in humans have been reported to date. Increased anticholinergic symptoms are to be expected as signs of toxicity. In the case of toxicity, the following measures should be taken:

• gastric lavage and reduction of absorption, e.g activated charcoal
• local administration of pilocarpine to glaucoma patients
• catheterisation in patients with urinary retention
• treatment with a parasympathomimetic agent, e.g. neostigmine, in the case of severe symptoms
• administration of beta-blockers in the case of insufficient response, pronounced tachycardia and/or circulatory instability, e.g. initially 1 mg propranolol intravenous along with monitoring of ECG and blood pressure.