Solifenacin

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Solifenacin on Prescriptsy

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Solifenacin is a selective muscarinic M3 receptor antagonist used to treat the symptoms of overactive bladder (OAB) syndrome in adults.

Overactive bladder is a condition characterised by urinary urgency, with or without urge incontinence, usually accompanied by increased daytime frequency and nocturia (waking at night to urinate).

Solifenacin works by blocking involuntary contractions of the bladder muscle, increasing bladder capacity, and reducing the sensation of urgency.

It is the generic form of Vesicare and is available in 5 mg and 10 mg tablets for once-daily oral administration.

Solifenacin is a prescription-only medicine (POM) in the United Kingdom.

This page provides a detailed clinical guide to solifenacin, covering how it works, dosage instructions, side effects, safety warnings, and how to obtain it in the United Kingdom.

Overactive bladder affects an estimated 12% to 17% of adults in the UK, with prevalence increasing with age.

It is more common in women than men, although male OAB is frequently underdiagnosed.

The condition can have a profound impact on quality of life, affecting sleep, work productivity, social activities, mental health, and intimate relationships.

Many people with OAB restrict their fluid intake, avoid going out, or plan their activities around toilet availability.

Despite its prevalence, OAB is undertreated: studies suggest that fewer than half of affected individuals seek medical help, often due to embarrassment or the mistaken belief that urinary symptoms are a normal part of ageing.

Important safety information about solifenacin

Before reading further, please note these essential safety points.

• Solifenacin can cause dry mouth, constipation, and blurred vision. Do not drive or operate machinery until you know how the medicine affects you.
• Tell your prescriber if you have difficulty passing urine, glaucoma, severe constipation, myasthenia gravis, or significant kidney or liver disease.
• Solifenacin may impair the ability to sweat. Take precautions to avoid overheating in hot weather or during vigorous exercise.
• Antimuscarinic medicines may affect cognition in older adults. The lowest effective dose should be used.
• Do not stop taking solifenacin without discussing it with your prescriber, as symptoms may return.

Understanding overactive bladder

The bladder is a hollow muscular organ that stores urine produced by the kidneys.

During the filling phase, the detrusor muscle (the smooth muscle wall of the bladder) normally relaxes to accommodate increasing urine volume, while the urethral sphincter remains contracted to maintain continence.

When the bladder is comfortably full (typically 300 to 500 mL), stretch receptors send signals via afferent nerves to the pontine micturition centre in the brainstem, generating the sensation of needing to urinate.

Voluntary voiding occurs when the brain sends efferent signals via parasympathetic nerves (S2 to S4) that release acetylcholine, which binds to muscarinic M3 receptors on the detrusor, causing it to contract.

Simultaneously, the urethral sphincter relaxes, allowing urine to flow.

In overactive bladder, this process is disrupted. The detrusor muscle contracts involuntarily during the filling phase, before the bladder is full.

These involuntary contractions generate the characteristic symptoms of urgency (a sudden, compelling desire to urinate that is difficult to defer), frequency (urinating more than 8 times in 24 hours), nocturia (waking from sleep to urinate one or more times per night), and urge incontinence (involuntary leakage of urine accompanied by or preceded by urgency).

The pathophysiology is incompletely understood but likely involves a combination of increased detrusor smooth muscle excitability, altered sensory signalling from the urothelium and suburothelium, and changes in central nervous system processing of bladder afferent signals.

How solifenacin works

Solifenacin succinate is a competitive antagonist at muscarinic acetylcholine receptors, with selectivity for the M3 subtype.

The M3 receptor is the primary mediator of detrusor contraction; blocking it inhibits the involuntary contractions that cause OAB symptoms.

During voluntary voiding, the high concentrations of acetylcholine released by parasympathetic nerve terminals are sufficient to partially overcome the competitive blockade, allowing micturition to occur, though potentially with slightly reduced detrusor contractility.

The selectivity of solifenacin for M3 over M2 receptors is clinically relevant.

M2 receptors are the predominant muscarinic subtype in cardiac tissue, and drugs that block M2 receptors may cause tachycardia. Solifenacin's lower affinity for M2 reduces this risk.

Similarly, solifenacin's relatively lower penetration into the central nervous system compared with older antimuscarinics (such as oxybutynin) may reduce the risk of cognitive side effects, although this risk is not eliminated entirely.

After oral administration, solifenacin is well absorbed with a bioavailability of approximately 90%. It reaches peak plasma concentrations in 3 to 8 hours.

The long elimination half-life (approximately 45 to 68 hours) supports once-daily dosing and provides stable plasma levels throughout the day.

Solifenacin is primarily metabolised by CYP3A4 in the liver.

Clinical evidence for solifenacin

The efficacy of solifenacin has been demonstrated in large, randomised, placebo-controlled trials.

The STAR trial (Solifenacin and Tolterodine as Active Comparator in a Randomised Trial) compared solifenacin 5 mg and 10 mg with tolterodine ER 4 mg and placebo in 1,200 patients with OAB.

Solifenacin was associated with significantly greater reductions in urgency episodes, frequency, and incontinence episodes compared with placebo.

At the 5 mg dose, solifenacin reduced the mean number of urgency episodes by approximately 3 per 24 hours compared with placebo.

At 10 mg, additional benefit was seen in some measures. Solifenacin also demonstrated superiority over tolterodine ER in reducing urgency episodes.

Long-term extension studies have shown that the benefits of solifenacin are maintained over 12 months, with continued improvements in quality-of-life measures. Patient satisfaction and willingness to continue treatment are generally high, reflecting the acceptable tolerability profile of the medicine.

Solifenacin compared with other treatments

Several antimuscarinic medicines are available for OAB in the UK, including oxybutynin, tolterodine, fesoterodine, trospium, and darifenacin.

Solifenacin is one of the newer agents and has a favourable balance of efficacy and tolerability.

Oxybutynin (the oldest antimuscarinic for OAB) is effective but has a higher incidence of dry mouth and cognitive side effects, particularly the immediate-release formulation.

Tolterodine has a better tolerability profile than immediate-release oxybutynin but may be slightly less effective than solifenacin in some measures.

Mirabegron (Betmiga) is a beta-3 adrenoceptor agonist that represents a different pharmacological class. It works by relaxing the detrusor muscle through beta-3 receptor stimulation rather than muscarinic blockade.

Mirabegron does not cause dry mouth and has minimal antimuscarinic side effects, making it a good alternative for patients who cannot tolerate antimuscarinics.

It can also be used in combination with solifenacin for patients who do not respond adequately to either medicine alone.

Non-pharmacological treatments are an important part of OAB management and should be offered before or alongside medication.

Bladder training (gradually increasing the intervals between voids to retrain the bladder), pelvic floor muscle exercises (Kegel exercises), fluid management (avoiding excess caffeine and alcohol), and weight management in overweight patients have all demonstrated benefit.

NICE Clinical Guideline NG123 on urinary incontinence recommends bladder training as first-line treatment for OAB, with antimuscarinic medicines or mirabegron added if symptoms persist.

Dosage and administration

Take one solifenacin tablet (5 mg or 10 mg) once daily, swallowed whole with water. The starting dose is 5 mg.

If this provides insufficient relief and is tolerated well, your prescriber may increase the dose to 10 mg once daily.

Take the tablet at the same time each day. It can be taken with or without food.

The full benefit of solifenacin may take 4 to 8 weeks to become apparent.

Continue taking the medicine regularly and discuss your progress with your prescriber at your follow-up appointment.

Do not stop taking solifenacin without medical advice, as your symptoms may return.

Side effects of solifenacin

Common side effects

Dry mouth is the most frequently reported side effect, occurring in approximately 10% to 15% of patients taking 5 mg and up to 20% at 10 mg.

It is usually mild and can be managed by sipping water frequently, chewing sugar-free gum, using saliva substitutes, or sucking sugar-free sweets.

If dry mouth is severe or persistent, contact your prescriber. Constipation is the second most common side effect, affecting approximately 5% to 10% of users.

Increase your dietary fibre intake, drink plenty of water, and maintain regular physical activity. A mild laxative may be used if needed.

Uncommon side effects

Blurred vision may occur, particularly when reading or doing close-up work. This is caused by antimuscarinic effects on the ciliary muscle. Drowsiness, fatigue, dizziness, and nausea have been reported. Urinary tract infection has been observed in clinical trials.

Rare side effects

Urinary retention (inability to empty the bladder) is a rare but important side effect, particularly in men with benign prostatic hyperplasia.

Seek medical attention if you cannot pass urine. Cognitive effects, including confusion and hallucinations, have been reported very rarely, mainly in elderly patients.

Contact your prescriber if you notice any changes in memory or thinking.

Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk.

Warnings and precautions

Contraindications

Solifenacin must not be used in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment, or known hypersensitivity to solifenacin or any excipient in the formulation. It should not be used in patients undergoing haemodialysis.

Use in elderly patients

Antimuscarinic medicines may increase the risk of falls, confusion, and cognitive decline in older adults.

NICE and the Medicines and Healthcare products Regulatory Agency (MHRA) advise caution when prescribing antimuscarinics to elderly patients, particularly those with pre-existing cognitive impairment or dementia.

The lowest effective dose should be used, and regular review of the ongoing need for treatment is recommended. Non-pharmacological measures should be optimised alongside or instead of medication.

Drug interactions

Potent CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, nelfinavir) increase solifenacin plasma levels; the maximum dose should be limited to 5 mg daily.

CYP3A4 inducers (rifampicin, phenytoin, carbamazepine) may reduce solifenacin efficacy. Avoid concurrent use with other antimuscarinic medicines. Use caution with medicines known to prolong the QT interval.

Pregnancy and breastfeeding

Solifenacin is not recommended during pregnancy or breastfeeding unless clearly necessary. Discuss alternatives with your prescriber.

When to seek further help

If OAB symptoms do not improve after 4 to 8 weeks of solifenacin, or if they worsen, consult your prescriber.

Persistent urinary symptoms, particularly blood in the urine (haematuria), painful urination, or unexplained weight loss, should always be investigated to exclude other conditions such as urinary tract infection, bladder stones, or bladder cancer.

Referral to a urologist or urogynaecologist may be appropriate for symptoms that do not respond to first-line treatment.

How to get solifenacin in the UK

Solifenacin is available on NHS prescription from your GP or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Prepayment certificates are available for those who need multiple prescription items. Solifenacin may also be prescribed privately.

Sources

• Solifenacin succinate, Summary of Product Characteristics (EMC)
• Solifenacin succinate, British National Formulary (BNF)
• Lower urinary tract symptoms in women, NICE CKS
• Urinary incontinence, NHS
• MHRA Yellow Card Scheme