Evigrade

Propiverine

AEMPS

Muscarinic blocker with additional calcium channel blockade

ATC code: G04BD06

Brand names: Mictonorm, Detrunorm

Updated · Methodology

Indications

B

Neurogenic detrusor overactivity

First line

Propiverine is indicated for neurogenic detrusor overactivity in adults and in children over 5 years (multiple sclerosis, spinal cord injury, spina bifida, cerebral palsy). EAU Neuro-Urology Guidelines 2024 note propiverine's advantage over pure antimuscarinics due to its additional calcium-blocking activity. Use requires regular bladder ultrasound and post-void residual monitoring; with residual over 100 mL, add clean intermittent catheterisation.

ICD-10: N31.1 · ICD-11: GC01.4

B

Overactive bladder

Second line

Propiverine is a second-line muscarinic blocker for overactive bladder. AEMPS approves it in adults and children over 5 years. NG123 (2024) and EAU 2024 place behavioural therapy first; propiverine is added if symptoms persist. Starting dose 15 mg twice daily (or 30 mg SR once daily), up to 45 mg/day if needed. The Madersbacher meta-analysis (2014) showed propiverine has efficacy comparable to oxybutynin with less dry mouth.

ICD-10: N32.8 · ICD-11: GC50.0

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Frequent urination without prior evaluation

Not recommended

Propiverine is marketed as a drug for «frequent toilet visits» without proper diagnostic workup. Increased urinary frequency is a symptom that may mean UTI, diabetes mellitus, BPH, neurological disease, or excess caffeine and fluid intake. Before any muscarinic blocker, the patient needs a bladder ultrasound with post-void residual, urinalysis and a 3-day voiding diary. In men over 50 with untreated BPH, the drug raises the risk of acute urinary retention. If propiverine was prescribed without a bladder ultrasound or urinalysis, consider seeking a second opinion.

ICD-10: R35 · ICD-11: MF50.0

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Dual action: 1) competitive blockade of detrusor muscarinic receptors (postsynaptic M3); 2) inhibition of bladder smooth muscle Ca²⁺ channels via the active N-oxide metabolite. This distinguishes it from pure antimuscarinic agents and produces stronger reduction in involuntary detrusor contraction amplitude. Bioavailability around 40%, half-life 14–22 hours, CYP3A4-metabolised. Used in neurogenic detrusor overactivity (multiple sclerosis, spinal cord injury) where pure antimuscarinics are less effective.

Safety

Contraindications

  • Hypersensitivity to propiverine
  • Urinary retention
  • Gastric retention
  • Uncontrolled narrow-angle glaucoma
  • Myasthenia gravis
  • Tachyarrhythmias
  • Toxic megacolon and severe ulcerative colitis

Serious adverse effects

  • Acute urinary retention
  • Tachycardia and palpitations
  • Cognitive impairment in older patients
  • Acute angle-closure glaucoma
  • Hepatotoxicity (rare)

Common adverse effects

  • Dry mouth (15–20%)
  • Constipation (5–10%)
  • Dry eyes and blurred near vision
  • Headache
  • Somnolence
  • Fatigue

Pregnancy: can you take Propiverine?

Limited human pregnancy data. AEMPS does not recommend use in pregnancy unless the expected benefit outweighs the risk. Effective contraception is reasonable in women of reproductive age on therapy.

Breastfeeding: can you take Propiverine?

No human lactation data. AEMPS advises discontinuing either the drug or breastfeeding. Lactation-compatible antimuscarinics: oxybutynin or trospium.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions12 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • antidepresivos tricíclicosclass named in the label
    «Incremento del efecto debido a tratamiento concomitante con antidepresivos tricíclicos (ej. imipramina), tranquilizantes (ej. benzodiacepinas), anticolinérgicos (si se administran vía sistémica)…»

    AEMPS, section 4.5 · Open on CIMA

  • antifúngicos azólicosclass named in the label
    «Pueden observarse interacciones con otros fármacos que se metabolizan a través del citocromo P4503A4 (CYP 3A4). No obstante, no se espera un incremento significativo en las concentraciones de estos…»

    AEMPS, section 4.5 · Open on CIMA

  • antipsicóticosclass named in the label
    «Incremento del efecto debido a tratamiento concomitante con antidepresivos tricíclicos (ej. imipramina), tranquilizantes (ej. benzodiacepinas), anticolinérgicos (si se administran vía sistémica)…»

    AEMPS, section 4.5 · Open on CIMA

  • benzodiazepinasclass named in the label
    «Incremento del efecto debido a tratamiento concomitante con antidepresivos tricíclicos (ej. imipramina), tranquilizantes (ej. benzodiacepinas), anticolinérgicos (si se administran vía sistémica)…»

    AEMPS, section 4.5 · Open on CIMA

  • «Pueden observarse interacciones con otros fármacos que se metabolizan a través del citocromo P4503A4 (CYP 3A4). No obstante, no se espera un incremento significativo en las concentraciones de estos…»

    AEMPS, section 4.5 · Open on CIMA

  • «Pueden observarse interacciones con otros fármacos que se metabolizan a través del citocromo P4503A4 (CYP 3A4). No obstante, no se espera un incremento significativo en las concentraciones de estos…»

    AEMPS, section 4.5 · Open on CIMA

  • inhibidores del CYP3A4class named in the label
    «Pueden observarse interacciones con otros fármacos que se metabolizan a través del citocromo P4503A4 (CYP 3A4). No obstante, no se espera un incremento significativo en las concentraciones de estos…»

    AEMPS, section 4.5 · Open on CIMA

  • «Pueden observarse interacciones con otros fármacos que se metabolizan a través del citocromo P4503A4 (CYP 3A4). No obstante, no se espera un incremento significativo en las concentraciones de estos…»

    AEMPS, section 4.5 · Open on CIMA

  • «Pueden observarse interacciones con otros fármacos que se metabolizan a través del citocromo P4503A4 (CYP 3A4). No obstante, no se espera un incremento significativo en las concentraciones de estos…»

    AEMPS, section 4.5 · Open on CIMA

  • macrólidosclass named in the label
    «Pueden observarse interacciones con otros fármacos que se metabolizan a través del citocromo P4503A4 (CYP 3A4). No obstante, no se espera un incremento significativo en las concentraciones de estos…»

    AEMPS, section 4.5 · Open on CIMA

  • «Puede reducirse el efecto de procinéticos como la metoclopramida.»

    AEMPS, section 4.5 · Open on CIMA

  • simpaticomiméticosclass named in the label
    «Incremento del efecto debido a tratamiento concomitante con antidepresivos tricíclicos (ej. imipramina), tranquilizantes (ej. benzodiacepinas), anticolinérgicos (si se administran vía sistémica)…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Propiverine used for?

Propiverine is evaluated for the following indications with varying evidence strength: Overactive bladder (evidence tier B), Neurogenic detrusor overactivity (evidence tier B), Frequent urination without prior evaluation (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Propiverine?

Common side effects of Propiverine (≥ 1 in 100): Dry mouth (15–20%), Constipation (5–10%), Dry eyes and blurred near vision, Headache, Somnolence, Fatigue. See the Safety section for uncommon and serious reactions.

Is Propiverine safe during pregnancy?

Limited human pregnancy data. AEMPS does not recommend use in pregnancy unless the expected benefit outweighs the risk. Effective contraception is reasonable in women of reproductive age on therapy.

Is Propiverine compatible with breastfeeding?

No human lactation data. AEMPS advises discontinuing either the drug or breastfeeding. Lactation-compatible antimuscarinics: oxybutynin or trospium.

Who should not take Propiverine?

Propiverine is contraindicated in: Hypersensitivity to propiverine; Urinary retention; Gastric retention; Uncontrolled narrow-angle glaucoma; Myasthenia gravis. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

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