DETRUNORM Film-coated tablet Ref.[9724] Active ingredients: Propiverine

Film-coated tablets for oral use.

The recommended daily doses are as follows:

Adults:

As a standard dose one film-coated tablet (=15 mg propiverine hydrochloride) twice daily is recommended, this may be increased to three times daily. Some patients may already respond to a dose of 15 mg daily.

For neurogenic detrusor overactivity a dose of one film-coated tablet three times daily is recommended. The maximum recommended daily dose is 45 mg.

Paediatric population:

Due to a lack of data Detrunorm 15 mg film-coated tablets should not be used in children.

Elderly:

Generally there is no special dose regimen for the elderly (see section 5.2).

Caution should be exercised and physicians should monitor patients carefully for side effects in the following dispositions (see sections 4.4, 4.5):

Use in renal impairment:

In patients with mild or moderate impairment of renal function, no dose adjustment is required; however, they should be treated with caution. In patients with severely impaired renal function (creatinine clearance <30 ml/min), the maximum daily dose is 30 mg.

Use in hepatic impairment:

In patients with mildly impaired hepatic function there is no need for dose adjustment, however, treatment should proceed with caution. No studies have been performed to investigate the use of propiverine in patients with moderately or severely impaired hepatic function. Its use is therefore contraindicated in these patients.

A high fat meal increases the bioavailability of propiverine. Therefore, propiverine should be taken before meals; especially in patients with renal or hepatic impairment (see section 5.2).

Symptoms

Overdose with the muscarinic receptor antagonist propiverine can potentially result in severe anticholinergic effects. Peripheral and central nervous system disturbances may occur, such as:

• severe dry mouth
• bradycardia, possibly leading to tachycardia in the further course
• mydriasis and accommodation disorder
• urinary retention,
• inhibition of intestinal motility
• restlessness, confusion, hallucination, confabulation
• dizziness, nausea, speech disorder, muscular weakness.

Treatment

• In the event of overdose with propiverine the patient should be treated with activated charcoal suspension with plenty amount of water.
• Gastric lavage should only be taken into consideration with protective intubation, use of an oiled tube (dryness of mucosa) and if performed within 1 hour after ingestion of propiverine. Vomiting must not be induced.
• Forced diuresis or hemodialysis is not effective to enhance the renal elimination.
• In case of severe central anticholinergic effects such as hallucinations or pronounced excitation antidote treatment with physostigmine can be attempted.
• Convulsion or pronounced excitation: treatment with benzodiazepines
• Respiratory insufficiency: treatment with artificial respiration
• Urinary retention: treatment with catheterization
• Mydriasis: treatment with pilocarpine eye drops and/or darkening of the patient’s room.

4 years.

This medicinal product does not require any special storage conditions.

They are available in PVC/PVDC/aluminium blister packs of 14, 20, 28, 30, 49, 50, 56, 60, 84, 98, 100, 112, 168, 252, 300 or 500 tablets and multipacks containing 280 (10 packs of 28) film-coated tablets.

Not all pack sizes may be marketed.

No special requirements.