PROPIVERINE

Posology 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 dosage 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. 2).

Paediatric population:

Due to a lack of data Propiverine should not be used in children. 2): Use in renal impairment In patients with mild to 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 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. Its use is therefore not recommended in these patients. 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). A high fat meal increases the bioavailability of propiverine. 2). Method of administration For oral use.

Within each system organ class, the undesirable effects are ranked under headings 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.

MedDRA System Organ Class Frequency Adverse reaction Immune system disorders Rare Hypersensitivity Very rare Restlessness, confusionPsychiatric disorders Not known Hallucination Common Headache Uncommon Tremor, dizziness, dysgeusia Nervous system disorders Not known Speech disorder Eye disorders Common Accommodation disorder, visual impairment Rare TachycardiaCardiac disorders Very rare Palpitation Vascular disorders Uncommon Decreased blood pressure with drowsiness, flushing Very common Dry mouth Common Constipation, abdominal pain, dyspepsia Gastrointestinal disorders Uncommon Nausea/vomiting Uncommon PruritusSkin and subcutaneous tissue disorders 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.

1 and in patients suffering from any 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.