DETRUNORM XL

Capsules for oral use. Do not crush or chew the capsules.

The recommended daily doses are as follows:

Adults: As a standard dose one capsule (= 30 mg propiverine hydrochloride) once a day is recommended. 2).

Paediatric population:

Due to a lack of data, this product should not be used in children. 2). Use in renal impairment In patients with mild or moderate impairment of renal function no dose adjustment is required. 2). Use in hepatic impairment In patients with mildly impaired hepatic function there is no need for a 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. 2). Patients receiving concomitant treatment with drugs that are potent inhibitors of CYP 3A4 combined with methimazole In patients receiving drugs that are potent flavin-containing monooxygenase (FMO) inhibitors such as methimazole in combination with potent CYP 3A4/5 inhibitors treatment should start with a dose of 15 mg per day.

The dose may thereafter be titrated to a higher dose. 2). 2). Accordingly, there is no particular recommendation for the intake of propiverine in relation to food.

Within each system organ class, the undesirable effects are ranked under heading of frequency using the following convention: 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).

All undesirable effects are transient and recede after a dose reduction or termination of the therapy after maximum 1-4 days. System organ class (Disorders according to MedDRA) Adverse reactions Immune system disorders Rare: - hypersensitivity Psychiatric disorders Very rare - restlessness, confusion Not known - hallucination Nervous system disorders Common - headache Uncommon - tremor, dizziness, dysgeusia Not known - speech disorder Eye disorders Common - accommodation disorder, visual impairment Cardiac disorders Rare - tachycardia Very rare - palpitation Vascular disorders Uncommon - decreased blood pressure with drowsiness, flushing Gastrointestinal disorders Very common - dry mouth Common - constipation, abdominal pain, dyspepsia Uncommon - nausea/vomiting Skin and subcutaneous tissue disorders Uncommon - pruritus Rare - rash Renal and urinary disorders Uncommon - urinary retention, bladder and urethral symptoms General disorders and administration site conditions Common - fatigue .

During long-term therapy hepatic enzymes should be monitored, because reversible changes of liver enzymes might occur in rare cases. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

2). Symptoms of the following diseases may be aggravated following administration of the drug: - severe congestive heart failure (NYHA IV) - prostatic enlargement - hiatus hernia with reflux oesophagitis - cardiac arrhythmia - tachycardia.

Propiverine, like other anticholinergics, induces mydriasis. Therefore, the risk to induce acute angle-closure glaucoma in individuals predisposed with narrow angles of the anterior chamber may be increased. Drugs of this class, including propiverine, have been reported to induce or precipitate acute angle-closure glaucoma.

g. urinary tract infections, malignancy) should be ruled out prior to treatment. This product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medication.

The drug is contraindicated in patients who have demonstrated hypersensitivity 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 - myasthenia gravis - intestinal atony - severe ulcerative colitis - toxic megacolon - uncontrolled angle closure glaucoma - moderate or severe hepatic impairment - tachyarrhythmias