Vesicare

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Vesicare on Prescriptsy

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Vesicare is a prescription-only medicine containing solifenacin succinate, an antimuscarinic (anticholinergic) agent developed by Astellas Pharma for the treatment of overactive bladder syndrome (OAB).

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

Vesicare works by blocking muscarinic receptors in the bladder wall, reducing involuntary detrusor muscle contractions and increasing functional bladder capacity.

It is available as 5 mg and 10 mg film-coated tablets for once-daily oral administration and is classified as a prescription-only medicine (POM) in the United Kingdom.

Overactive bladder affects an estimated 12% to 17% of the adult population in the United Kingdom.

The prevalence increases with age and the condition affects both men and women, though women are more likely to experience urge incontinence.

OAB has a profound impact on quality of life, affecting work productivity, social activities, sleep quality, and mental health.

Many people with OAB symptoms delay seeking help due to embarrassment, meaning the condition is significantly underdiagnosed.

This page provides a comprehensive clinical guide to Vesicare, covering how it works, dosage and administration, side effects, safety warnings, and how to obtain a prescription in the United Kingdom.

Important safety information about Vesicare

Before reading further, note these essential safety points.

• Vesicare must not be used in patients with urinary retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, or severe hepatic impairment.
• If you become unable to pass urine while taking Vesicare, stop the medicine and seek urgent medical attention.
• Antimuscarinic drugs contribute to anticholinergic burden, which is a particular concern in elderly patients and those already taking other anticholinergic medicines.
• Common side effects include dry mouth and constipation; these are usually manageable and often improve over time.

Understanding overactive bladder

Overactive bladder is defined by the International Continence Society (ICS) as a syndrome of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology.

The underlying pathophysiology involves detrusor overactivity, where the detrusor muscle contracts involuntarily during the filling phase of the micturition cycle.

These involuntary contractions can be demonstrated on urodynamic testing, though OAB is primarily a clinical diagnosis based on symptoms.

Several mechanisms contribute to detrusor overactivity. Myogenic changes in the detrusor muscle itself can increase excitability and propagation of contractile signals between smooth muscle cells.

Neurogenic factors include altered afferent signalling from the bladder to the brain, reduced central inhibitory control of the micturition reflex, and changes in local neurotransmitter release.

In men, benign prostatic hyperplasia (BPH) can contribute to OAB by causing bladder outlet obstruction, which leads to secondary detrusor changes including hypertrophy, increased collagen deposition, and altered receptor expression.

The bladder is innervated by parasympathetic nerves from the sacral spinal cord (S2 to S4).

During bladder filling, the sympathetic nervous system promotes storage by relaxing the detrusor (via beta-3 adrenoceptors) and contracting the bladder neck (via alpha-1 adrenoceptors).

When the bladder reaches functional capacity, sensory afferent signals trigger the micturition reflex, and parasympathetic efferent impulses release acetylcholine, which acts on M3 and M2 muscarinic receptors on detrusor smooth muscle to cause contraction and voiding.

In OAB, this process becomes dysregulated, with inappropriate detrusor contractions occurring before the bladder has reached normal capacity.

How Vesicare works

Solifenacin is a competitive, selective muscarinic receptor antagonist. Five subtypes of muscarinic receptor have been identified (M1 to M5).

The human detrusor muscle expresses predominantly M2 and M3 receptor subtypes.

Although M2 receptors are more numerous, it is the M3 receptor that is primarily responsible for mediating detrusor contraction.

Solifenacin has preferential affinity for the M3 receptor subtype, which contributes to its clinical selectivity for the bladder over other muscarinic receptor-rich organs.

By blocking M3 receptors on detrusor smooth muscle cells, solifenacin reduces the contractile response to acetylcholine released from parasympathetic nerve terminals.

This decreases the frequency and amplitude of involuntary detrusor contractions during the filling phase, increasing functional bladder capacity and reducing the sensation of urgency.

The net clinical effect is a reduction in urgency episodes, frequency of micturition, and episodes of urge incontinence.

Solifenacin also has some activity at M1 receptors (found in salivary glands and the central nervous system) and M2 receptors (found in the heart), though its selectivity for M3 means that side effects at these sites are generally less pronounced than with non-selective antimuscarinics such as oxybutynin.

However, no antimuscarinic is completely bladder-selective, which is why side effects such as dry mouth (M1 and M3 effects on salivary glands) still occur.

Clinical evidence for Vesicare

Solifenacin has been evaluated in several large, randomised, double-blind, placebo-controlled trials.

The pivotal trials (the STAR study and the solifenacin phase III programme) demonstrated statistically significant reductions in urgency episodes, micturition frequency, and incontinence episodes compared with placebo over 12 weeks.

The STAR trial (Solifenacin and Tolterodine as an Active comparator in a Randomised trial) compared solifenacin 5 mg and 10 mg with tolterodine extended-release 4 mg.

Solifenacin was shown to be non-inferior to tolterodine for the primary endpoint of micturition frequency, with superior efficacy for reducing urgency and incontinence episodes at the 10 mg dose.

A Cochrane systematic review of antimuscarinic drugs for OAB confirmed that solifenacin is effective in reducing OAB symptoms. The review also highlighted that the choice between antimuscarinic agents often depends on tolerability, as efficacy differences between agents are generally modest.

NICE guideline NG123 (urinary incontinence and pelvic organ prolapse in women) and NICE guideline NG97 (lower urinary tract symptoms in men) recommend antimuscarinic drugs as second-line pharmacological treatment for OAB after conservative measures (bladder training, lifestyle modifications) have been tried.

Mirabegron is recommended as an alternative when antimuscarinics are contraindicated, not tolerated, or ineffective.

Dosage and administration

The recommended starting dose of Vesicare is 5 mg once daily, taken by mouth with water.

If the 5 mg dose provides insufficient symptom control and is well tolerated, the dose may be increased to 10 mg once daily.

The tablet should be swallowed whole and can be taken with or without food. Take Vesicare at approximately the same time each day.

The full clinical benefit may take up to 4 weeks to develop. Continue taking Vesicare as prescribed during this period. If symptoms have not improved after 4 to 8 weeks at the maximum tolerated dose, discuss alternatives with your prescriber.

Dose adjustments are required in certain populations. In severe renal impairment (creatinine clearance below 30 mL/min), the maximum dose is 5 mg daily.

In moderate hepatic impairment (Child-Pugh B), the maximum dose is 5 mg daily. Vesicare is contraindicated in severe hepatic impairment (Child-Pugh C).

In patients taking strong CYP3A4 inhibitors (ketoconazole, ritonavir), the maximum dose is 5 mg daily.

No dose adjustment is required solely on the basis of age or mild renal or hepatic impairment.

Side effects of Vesicare

Common side effects

Dry mouth is the most frequently reported side effect, occurring in approximately 10% of patients at 5 mg and up to 27% at 10 mg.

Dry mouth results from antimuscarinic blockade of salivary gland muscarinic receptors. It is usually mild to moderate and may diminish with time.

Practical measures include sipping water frequently, using sugar-free chewing gum, and maintaining good oral hygiene.

Persistent dry mouth increases the risk of dental caries, oral candidiasis, and difficulty swallowing, so regular dental check-ups are advisable.

Constipation is reported in approximately 5% at 5 mg and 13% at 10 mg. It results from reduced gastrointestinal motility due to antimuscarinic effects on the bowel.

Adequate fluid intake, dietary fibre, and regular physical activity can help manage this. Laxatives may be needed if conservative measures are insufficient.

Blurred vision can occur due to reduced accommodation (antimuscarinic effects on the ciliary muscle). This is usually mild and transient. If it affects your ability to drive or operate machinery, avoid these activities until vision returns to normal.

Less common and rare side effects

Nausea, dyspepsia, abdominal pain, gastro-oesophageal reflux, dry eyes, dry throat, urinary tract infection, peripheral oedema, fatigue, and drowsiness have all been reported.

Urinary retention is uncommon but clinically important, particularly in men with bladder outflow obstruction. If you become unable to pass urine, stop Vesicare and seek urgent medical attention.

Very rare but serious reactions include angioedema, anaphylaxis, erythema multiforme, and hepatotoxicity (abnormal liver function). Cognitive effects including confusion, hallucinations, and memory impairment have been reported with antimuscarinic drugs, particularly in elderly patients.

Report suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk.

Warnings and precautions

Anticholinergic burden in older adults

Antimuscarinic drugs contribute to the cumulative anticholinergic burden. Many commonly prescribed medicines have anticholinergic properties, and the total burden increases with the number of such medicines taken concurrently.

A high anticholinergic burden has been associated with increased risk of cognitive impairment, falls, hospitalisation, and mortality in older adults.

Before starting Vesicare, prescribers should review the patient's complete medication list and consider whether the total anticholinergic burden is acceptable.

Mirabegron, a beta-3 adrenoceptor agonist that does not have antimuscarinic activity, may be a more appropriate choice in elderly patients or those already taking other anticholinergic medicines.

Urinary retention

Antimuscarinic drugs can precipitate or worsen urinary retention, particularly in patients with bladder outflow obstruction (for example from benign prostatic hyperplasia).

Patients should be informed of this risk and advised to seek urgent medical attention if they develop difficulty passing urine or become unable to void.

Glaucoma

Vesicare is contraindicated in uncontrolled narrow-angle (angle-closure) glaucoma.

It should be used with caution in controlled narrow-angle glaucoma only if the potential benefit outweighs the risk, and with ophthalmological monitoring.

Antimuscarinic drugs can precipitate acute angle-closure by causing pupillary dilatation (mydriasis).

Gastrointestinal disorders

Reduced gastrointestinal motility is an expected antimuscarinic effect. Use Vesicare with caution in patients with gastrointestinal obstructive disorders, severe constipation, ulcerative colitis, and conditions predisposing to impaired gastric emptying. It is contraindicated in patients with toxic megacolon and gastric retention.

Pregnancy, breastfeeding, and fertility

Vesicare should not be used during pregnancy unless clearly necessary. It is not known whether solifenacin passes into human breast milk, and breastfeeding should be avoided during treatment. There are no data on the effects of solifenacin on human fertility.

How to get Vesicare in the UK

Vesicare 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 (PPC) are available for patients who need multiple prescription items regularly. A 3-month PPC costs 31.25 pounds and a 12-month PPC costs 111.60 pounds.

Before prescribing Vesicare, your GP will usually want to confirm that you have tried conservative measures including bladder training and lifestyle changes (reducing caffeine and alcohol, managing fluid intake, weight management).

They may also wish to exclude other causes of urinary symptoms such as urinary tract infection, diabetes, or, in men, prostatic disease.

Sources

• Vesicare 5 mg and 10 mg tablets, Summary of Product Characteristics (EMC)
• Solifenacin succinate, British National Formulary (BNF)
• Urinary incontinence and pelvic organ prolapse in women: management, NICE NG123
• Lower urinary tract symptoms in men: management, NICE NG97
• Urinary incontinence, NHS
• MHRA Yellow Card Scheme