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

The drug should be used with caution in patients suffering from:

• autonomic neuropathy
• renal impairment (see section 4.2)
• hepatic impairment (see section 4.2)

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.

Pollakiuria 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.

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 medicine.

Due to its high strength Detrunorm 15 mg film-coated tablets should not be used in children younger than 12 years and adults with a body weight below 35 kg.

• Increased effects due to concomitant medication with tricyclic antidepressants (e. g. imipramine), tranquillisers (e.g. benzodiazepines), anticholinergics (if applied systemically), amantadine, neuroleptics (e.g. phenothiazines) and beta-adrenoceptor agonists (beta-sympathomimetics).
• Decreased effects due to concomitant medication with cholinergic drugs.
• Reduced blood pressure in patients treated with isoniazid.
• The effect of prokinetics such as metoclopramide may be decreased.
• Pharmacokinetic interactions are possible with other drugs metabolised by cytochrome P450 3A4 (CYP 3A4). However, a very pronounced increase of concentrations for such drugs is not expected as the effects of propiverine are small compared to classical enzyme inhibitors (e.g. ketoconazole or grapefruit juice). Propiverine may be considered as weak inhibitor of CYP 3A4. Pharmacokinetic studies with patients concomitantly receiving potent CYP 3A4 inhibitors such as azole antifungals (e.g. ketoconazole, itraconazole) or macrolide antibiotics (e.g. erythromycin, clarithromycin) have not been performed.
• 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. However, caution should be exercised and physicians should monitor these patients carefully for side effects (see section 5.2).

Pregnancy

There are no data from the use of propiverine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).

Detrunorm 15 mg film-coated tablets are not recommended during pregnancy.

Breast-feeding

It is unknown whether propiverine or metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of propiverine or metabolites in milk (for details see section 5.3).

A risk to the newborn or infant cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Detrunorm 15 mg film-coated tablets therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There are no human data on the effect of propiverine on fertility.

Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

No studies on the effects on the ability to drive and use machines have been performed.

Propiverine may produce drowsiness and blurred vision. This may impair the patient’s ability to exert activities that require mental alertness such as operating a motor vehicle or other machinery, or to exert hazardous work while taking this drug.

Sedative drugs may enhance the drowsiness caused by propiverine.

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.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.

Not applicable.