Detrunorm 15mg Tablet

The treatment of urinary incontinence, as well as urgency and frequency, in unstable bladder conditions, in patients who have either idiopathic bladder instability, or neurogenic bladder (detrusor hyperreflexia) from spinal cord injuries.

For oral use. The recommended daily doses are as follows:

Adults: As a standard dose one coated tablet (= 15 mg propiverine hydrochloride) two times a day is recommended, this may be increased to three times a day. Some patients may respond to a dosage of 15 mg a day. For reflex incontinence a dose of one coated tablet three times daily is recommended. This may be increased to four times a day if necessary and tolerated.

Elderly: Generally there is no special dosage regimen for the elderly. DETRUNORM u00ae contains 0.61 mg of glucose. When taken according to the dosage recommendations a daily dose of 2 tablets supplies 1.22 mg of glucose.

DETRUNORM u00ae Tablets are contra-indicated in patients being hypersensitive to the active substance or to any of the excipients and in patients suffering from one of the following disorders:

• obstruction of the bowel
• significant degree of bladder outflow obstruction where urinary retention may be anticipated
• myasthaenia gravis
• intestinal atony
• severe ulcerative colitis
• toxic megacolon
• glaucoma
• hepatic disorders
• renal impairment
• tachyarrhythmias
• cardiac failure / dysrhythmias
• diabetes mellitus with autonomic dysfunction

Due to lack of data DETRUNORMu00ae should not be used in children.

During long-term therapy hepatic enzymes should be monitored, because reversible changes of liver enzymes may occur. Monitoring of intraocular pressure is recommended in patients at risk of developing glaucoma.

Particular attention should be paid to the residual urine volume in cases of urinary tract infections. DETRUNORMu00ae should be used with caution in patients suffering from autonomic neuropathy. Conditions that may be aggravated following administration of the drug are:

• Hyperthyroidism
• Coronary artery disease
• Congestive heart failure (NYHA IV)
• Cardiac arrhythmias
• Tachycardias
• Prostatic hypertrophy
• Hiatus hernia with reflux oesophagitis
• Cerebral sclerosis

Urinary frequency and nocturia due to renal disease or congestive heart failure as well as organic bladder diseases (e.g. urinary tract infections, malignancy) should be ruled out prior to treatment.

Increased effects due to concomitant medication with tricyclic antidepressants (e.g. imipramine), tranquilisers (e.g. benzodiazepines), anticholinergics, amantadine, neuroleptics (e.g. phenothiazines) and u03b2-sympathomimetics. Decreased effects due to concomitant medication with cholinergic medicines. Reduced blood pressure in patients treated with isoniazid. The effect of prokinetics such as metoclopramide and cisapride may be decreased. Sedative medicines may enhance the drowsiness caused by propiverine hydrochloride.

Contra-indicated during pregnancy and lactation.

Propiverine hydrochloride may produce drowsiness and blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this medicine.

Adverse events of potential clinical relevance are listed below by system organ class. Frequencies are defined as: very common (> 1/10); common (u22651/100, < 1/10); uncommon (u22651/1000, < 1/100); rare (u22651/10000, <1/1000; very rare <1/10000).

The following side-effects can be associated with the use of propiverine hydrochloride:

• Gastrointestinal disorders : Very common : dry mouth
• Common: constipation
• Ocular disorders : Common: blurred vision
• Urinary system disorders : Uncommon : increased residual urine
• Nervous system disorders : Rare: restlessness, irritation
• Vascular disorders : Uncommon : decreased blood pressure, drowsiness, heat sensations
• Cardiac disorders : Very rare : tachycardia
• General disorders : Uncommon : fatigue
• Skin and subcutaneous tissue : Rare : rash due to idiosyncrasy (propiverine hydrochloride) or hypersensitivity (excipients e.g. colourant)

All side-effects are transient and recede after a dose reduction or termination of the therapy after maximum 1 u2013 4 days.

A maximal dosage of 1 mg / kg body weight / day should not be exceeded. Ingestion of toxic quantities (greater than 120 mg single dose) may give rise to: Restlessness, dizziness, muscular weakness, disorders in speech and vision, dryness of mucosa, vertigo, cardiovascular disorders.

Therapy : Initiation of vomiting or gastric lavage using an oiled tube (attention: dryness of mucosa!) followed by symptomatic treatment as in atropine overdose (e.g. physostigmine) with a dosage of 1.0 to 2.0 mg in adults by slow intravenous injection; (may be repeated as necessary to a total of 5 mg); fever should be treated symptomatically with tepid sponging or ice-packs; in cases of pronounced restlessness or excitation, diazepam may be given by intravenous injection up to 10 mg; tachycardia can be treated with propranolol; urinary retention can be treated by catheterisation; in the event of curare-like muscle paralysis, mechanical ventilation may be required.