Solifenacin Accord
Anticholinergic for Overactive Bladder Symptoms
Quick Facts About Solifenacin Accord
Key Takeaways About Solifenacin Accord
- Effective for overactive bladder: Solifenacin significantly reduces urinary urgency, frequency, and incontinence episodes in clinical trials with results typically seen within 1–4 weeks
- Once-daily dosing: Its long half-life (45–68 hours) allows convenient once-daily administration, with or without food
- Dry mouth is the most common side effect: Anticholinergic side effects such as dry mouth, constipation, and blurred vision are dose-dependent and usually mild
- Not for everyone: Solifenacin is contraindicated in patients with urinary retention, uncontrolled narrow-angle glaucoma, severe gastrointestinal conditions, and myasthenia gravis
- Drug interactions require attention: Strong CYP3A4 inhibitors (e.g., ketoconazole) can significantly increase solifenacin levels; dose adjustment may be needed
What Is Solifenacin Accord and What Is It Used For?
Solifenacin Accord contains the active substance solifenacin, which belongs to a class of medications called anticholinergics (antimuscarinics). It is used to treat the symptoms of overactive bladder (OAB), including a sudden, strong need to urinate (urgency), needing to urinate more often than usual (frequency), and involuntary urine leakage when you cannot reach the toilet in time (urge incontinence).
Overactive bladder is a common condition affecting an estimated 12–17% of the adult population worldwide, according to the International Continence Society (ICS). The condition occurs when the detrusor muscle in the bladder wall contracts involuntarily, causing sudden and often uncontrollable urges to urinate. While OAB is not life-threatening, it can significantly impair quality of life, affecting social activities, work, sleep, and emotional well-being.
Solifenacin works by selectively blocking muscarinic M3 receptors, which are the primary type of muscarinic receptor found on the detrusor muscle of the bladder. By blocking the action of acetylcholine at these receptors, solifenacin reduces the frequency and intensity of involuntary detrusor contractions. This means you can wait longer before needing to use the toilet, your bladder can hold a larger volume of urine, and you experience fewer episodes of urgency and incontinence.
Compared to some older anticholinergic medications used for OAB, solifenacin demonstrates greater selectivity for M3 receptors over M2 receptors, and it has a relatively low affinity for muscarinic receptors in other organs such as the salivary glands and the central nervous system. This selectivity profile contributes to a favourable balance between efficacy and tolerability, although anticholinergic side effects (particularly dry mouth) remain the most common adverse reactions.
Clinical trials have demonstrated that solifenacin 5 mg once daily significantly reduces the number of urgency episodes, micturitions (urination events), and incontinence episodes per 24 hours compared with placebo. If the 5 mg dose does not provide sufficient symptom relief, the dose may be increased to 10 mg once daily, which provides additional clinical benefit but with a higher incidence of anticholinergic side effects.
Solifenacin is available as a generic medication under several brand names, including Solifenacin Accord, Solifenacin STADA, Solifenacin Sandoz, Solifenacin Krka, and Solifenacin Medical Valley. All these products contain the same active substance (solifenacin succinate) and are therapeutically equivalent. The original branded product was first approved by the European Medicines Agency (EMA) in 2004.
What Should You Know Before Taking Solifenacin Accord?
Before starting solifenacin, inform your doctor about all your medical conditions, particularly any bladder obstruction, gastrointestinal disorders, kidney or liver problems, and glaucoma. Solifenacin has several important contraindications and requires caution in specific patient groups.
Contraindications
You must not take Solifenacin Accord if any of the following apply to you:
- Allergy to solifenacin succinate or any of the other ingredients in the tablet – allergic reactions may include skin rash, itching, swelling, or difficulty breathing
- Urinary retention – difficulty urinating or inability to completely empty the bladder, as solifenacin could worsen this condition by further relaxing the bladder muscle
- Severe gastrointestinal conditions – including toxic megacolon (a serious complication of ulcerative colitis) or other severe gastric or intestinal diseases, because anticholinergics reduce gut motility
- Myasthenia gravis – a neuromuscular disease causing extreme muscle weakness, as anticholinergics may worsen symptoms
- Uncontrolled narrow-angle glaucoma – increased intraocular pressure with progressive loss of vision, as anticholinergics can further raise eye pressure
- Haemodialysis – patients undergoing kidney dialysis should not use this medication
- Severe liver impairment – as solifenacin is extensively metabolised in the liver
- Severe renal impairment or moderate hepatic impairment combined with treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole) – this combination can lead to dangerously high drug levels
Tell your doctor if you have any of the conditions listed above before starting treatment with Solifenacin Accord. Using this medication when contraindicated can lead to serious complications, including acute urinary retention, intestinal obstruction, or a dangerous increase in intraocular pressure.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Solifenacin Accord if you have or have had any of the following conditions:
- Bladder outflow obstruction – difficulty emptying the bladder or a weak urinary stream, as solifenacin may increase the risk of urinary retention
- Gastrointestinal obstructive disorders – including chronic constipation, as anticholinergics can slow bowel movements further
- Risk of decreased gastrointestinal motility – your doctor will have informed you if this applies to you
- Severe renal impairment – the maximum recommended dose is 5 mg daily
- Moderate hepatic impairment – the maximum recommended dose is 5 mg daily
- Hiatus hernia or gastro-oesophageal reflux – anticholinergics may worsen reflux symptoms
- Autonomic neuropathy – a condition affecting the involuntary nervous system
Before starting treatment, your doctor should investigate whether there are other reasons for your frequent urination, such as heart failure, kidney disease, or urinary tract infection. If a urinary tract infection is present, your doctor will prescribe an appropriate antibiotic before starting solifenacin.
Use in Children and Adolescents
Solifenacin Accord is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of solifenacin in this age group have not been established, and paediatric patients with bladder symptoms should be managed by a specialist with experience in childhood urological conditions.
Pregnancy and Breastfeeding
You should not use Solifenacin Accord if you are pregnant unless your doctor has determined that it is absolutely necessary. The potential effects of solifenacin on human pregnancy have not been adequately studied, and as a precautionary measure, this medication should be avoided during pregnancy. If you discover that you are pregnant while taking solifenacin, contact your doctor immediately to discuss alternative management strategies.
Solifenacin should not be used during breastfeeding, as the active substance may pass into breast milk and potentially affect the nursing infant. If treatment for overactive bladder is required during breastfeeding, your doctor will discuss whether to discontinue breastfeeding or to use an alternative treatment approach.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and Operating Machinery
Solifenacin can cause blurred vision and, less commonly, drowsiness or fatigue. If you experience any of these effects, you should not drive a vehicle or operate machinery until the symptoms have resolved. These side effects are more likely to occur at the start of treatment or after a dose increase. You are personally responsible for assessing whether you are fit to drive or perform tasks that require alertness.
Important Information About Excipients
Solifenacin Accord tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
How Does Solifenacin Accord Interact with Other Drugs?
Solifenacin can interact with several medications, including other anticholinergics, CYP3A4 inhibitors (such as ketoconazole and ritonavir), CYP3A4 inducers (such as rifampicin and carbamazepine), and prokinetic agents. Always inform your doctor about all medications you are taking.
Solifenacin is primarily metabolised by the liver enzyme cytochrome P450 3A4 (CYP3A4). Medications that affect this enzyme system can significantly alter solifenacin blood levels. Additionally, because solifenacin has anticholinergic properties, combining it with other anticholinergic drugs can lead to additive side effects, while combining it with cholinergic drugs may reduce the effectiveness of either medication.
Major Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Ketoconazole | Antifungal (CYP3A4 inhibitor) | Strongly inhibits CYP3A4, significantly increasing solifenacin blood levels (up to 2–3 fold) | Do not exceed solifenacin 5 mg/day; contraindicated in severe renal/moderate hepatic impairment |
| Itraconazole | Antifungal (CYP3A4 inhibitor) | Strong CYP3A4 inhibitor that increases solifenacin exposure | Do not exceed solifenacin 5 mg/day; monitor for increased anticholinergic effects |
| Ritonavir / Nelfinavir | HIV protease inhibitors (CYP3A4 inhibitors) | Potent CYP3A4 inhibitors that significantly reduce solifenacin metabolism | Do not exceed solifenacin 5 mg/day; close clinical monitoring recommended |
| Verapamil / Diltiazem | Calcium channel blockers (moderate CYP3A4 inhibitors) | Moderate CYP3A4 inhibition increases solifenacin levels; potential additive cardiac effects | Caution advised; consider limiting solifenacin dose to 5 mg/day |
Moderate Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Rifampicin | Antibiotic (CYP3A4 inducer) | Accelerates solifenacin metabolism, reducing its blood levels and potentially decreasing efficacy | Monitor for reduced OAB symptom control; dose increase may be considered under medical supervision |
| Phenytoin / Carbamazepine | Antiepileptics (CYP3A4 inducers) | Induce CYP3A4, increasing the rate of solifenacin breakdown | Monitor efficacy; alternative OAB treatments may be considered |
| Other anticholinergics | Various (e.g., antihistamines, tricyclics, ipratropium) | Additive anticholinergic effects: increased risk of dry mouth, constipation, urinary retention, cognitive impairment | Avoid combining multiple anticholinergics when possible; minimise anticholinergic burden |
| Metoclopramide / Cisapride | Prokinetic agents | Solifenacin may reduce the effectiveness of prokinetics by opposing their gut motility-enhancing action | Evaluate need for both medications; effects may be mutually antagonistic |
| Bisphosphonates | Osteoporosis medications | Anticholinergics may worsen or contribute to oesophagitis when combined with bisphosphonates | Take bisphosphonates strictly as directed; report any swallowing difficulty or chest pain |
Food and Drink Interactions
Solifenacin Accord can be taken with or without food, according to your preference. Food does not significantly affect the absorption or bioavailability of solifenacin. There are no specific food interactions reported with this medication. However, as with all medicines, it is advisable to maintain adequate fluid intake to support normal bladder function, while balancing this against the overactive bladder symptoms you are managing.
What Is the Correct Dosage of Solifenacin Accord?
The recommended starting dose of Solifenacin Accord is 5 mg once daily, taken as a whole tablet with liquid. If needed and tolerated, the dose may be increased to 10 mg once daily by your doctor. The tablet should be swallowed whole and not crushed.
Always take this medicine exactly as your doctor or pharmacist has told you. Do not change your dose without consulting your healthcare provider first. The effectiveness of solifenacin may take up to 4 weeks to be fully apparent, so it is important to continue taking the medication as prescribed even if you do not notice immediate improvement.
Adults
Standard Adult Dosage
Starting dose: 5 mg once daily
Maximum dose: 10 mg once daily (if 5 mg provides insufficient relief)
Administration: Swallow the tablet whole with a glass of water. Can be taken with or without food at any time of day, but preferably at the same time each day for consistent effect.
Special Populations
Patients with Renal Impairment
Mild to moderate: No dose adjustment required
Severe (CrCl < 30 mL/min): Maximum dose 5 mg daily; use with caution
Haemodialysis: Contraindicated – do not use
Patients with Hepatic Impairment
Mild (Child-Pugh A): No dose adjustment required
Moderate (Child-Pugh B): Maximum dose 5 mg daily
Severe (Child-Pugh C): Contraindicated – do not use
Patients Taking CYP3A4 Inhibitors
If you are also taking a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, ritonavir), the maximum solifenacin dose is 5 mg daily. Your doctor will have informed you if this applies.
Children and Adolescents
Solifenacin Accord should not be used in children and adolescents under 18 years of age. There is insufficient evidence regarding its safety and efficacy in this age group.
Elderly Patients
No specific dose adjustment is required solely based on age. However, elderly patients may be more susceptible to anticholinergic side effects, including dry mouth, constipation, and cognitive effects. The European Association of Urology (EAU) recommends that anticholinergic burden be carefully assessed in elderly patients, particularly those with existing cognitive impairment or those taking other anticholinergic medications.
Missed Dose
If you forget to take a dose at your usual time, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose. Never take more than one tablet per day.
Overdose
If you have taken more Solifenacin Accord than you should, or if a child has accidentally swallowed any tablets, contact your doctor, hospital, or poison control centre immediately for risk assessment and advice.
Symptoms of overdose may include:
- Severe dry mouth
- Headache and dizziness
- Drowsiness and blurred vision
- Hallucinations (seeing or hearing things that are not there)
- Agitation and excitability
- Seizures (convulsions)
- Difficulty breathing
- Rapid heart rate (tachycardia)
- Urinary retention (inability to urinate)
- Dilated pupils (mydriasis)
If someone has taken a large overdose of solifenacin and is experiencing severe symptoms such as difficulty breathing, seizures, or loss of consciousness, call emergency services immediately. Do not attempt to induce vomiting unless instructed by a healthcare professional.
Stopping Treatment
If you stop taking Solifenacin Accord, your overactive bladder symptoms may return or worsen. Always consult your doctor before discontinuing treatment. Your doctor can discuss alternative management options if solifenacin is not providing adequate relief or if side effects are problematic.
What Are the Side Effects of Solifenacin Accord?
Like all medicines, solifenacin can cause side effects, although not everybody gets them. The most common side effect is dry mouth. If you experience a severe allergic reaction (such as swelling of the face, lips, or throat with difficulty breathing), or severe skin reactions (blistering or peeling), seek immediate medical attention.
Anticholinergic side effects are the most frequently reported adverse reactions with solifenacin and are generally dose-dependent. Most side effects are mild to moderate in severity and tend to diminish over time as your body adjusts to the medication. The following frequency grid summarises the known side effects based on clinical trial data and post-marketing surveillance.
Angioedema (allergic swelling of tissue beneath the skin) with airway obstruction (difficulty breathing) has been reported in some patients taking solifenacin. If angioedema occurs, treatment must be stopped immediately and appropriate emergency treatment initiated. Also seek immediate help for severe skin reactions such as blistering or widespread peeling of the skin.
Very Common
- Dry mouth
Common
- Blurred vision
- Constipation
- Nausea
- Dyspepsia (indigestion with symptoms such as fullness, abdominal pain, belching, and heartburn)
- Abdominal discomfort
Uncommon
- Urinary tract infection, bladder infection
- Drowsiness (somnolence)
- Altered taste (dysgeusia)
- Dry or irritated eyes
- Dry nasal mucosa
- Gastro-oesophageal reflux disease
- Dry throat
- Dry skin
- Difficulty urinating
- Fatigue
- Lower limb oedema (swelling)
Rare
- Faecal impaction (large accumulation of hard stool in the colon)
- Urinary retention (inability to empty the bladder)
- Dizziness, headache
- Vomiting
- Itching (pruritus), skin rash
Very Rare and Post-Marketing Reports
The following side effects have been reported very rarely (up to 1 in 10,000 people) or during post-marketing surveillance where the frequency cannot be precisely determined:
- Psychiatric: Hallucinations, confusion, delirium
- Metabolic: Decreased appetite, elevated potassium levels (hyperkalaemia) which may lead to abnormal heart rhythm
- Eye: Increased intraocular pressure (glaucoma)
- Cardiac: Changes in heart electrical activity (ECG), QT prolongation, torsade de pointes, palpitations, tachycardia (rapid heart rate)
- Respiratory: Voice disorders (dysphonia)
- Hepatic: Liver disorders
- Musculoskeletal: Muscle weakness
- Renal: Kidney disorders
- Skin: Erythema multiforme, allergic rash
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed above. You can also report side effects directly to your national medicines regulatory authority. By reporting side effects, you can help provide more information on the safety of this medicine.
How Should You Store Solifenacin Accord?
Solifenacin Accord does not require any special storage conditions. Store the tablets out of sight and reach of children. Do not use after the expiry date stated on the packaging.
There are no special temperature or humidity requirements for storing Solifenacin Accord tablets. Keep the medicine in its original blister packaging to protect it from light and moisture until you are ready to take a dose.
Keep this medicine out of the sight and reach of children at all times. Store all medicines securely to prevent accidental ingestion, particularly by young children.
Do not use Solifenacin Accord after the expiry date which is printed on the blister and the carton after "EXP". The expiry date refers to the last day of that month. Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help to protect the environment and reduce the risk of environmental contamination from pharmaceutical products.
What Does Solifenacin Accord Contain?
Each Solifenacin Accord tablet contains solifenacin succinate as the active ingredient. The 5 mg tablet contains 5 mg solifenacin succinate (equivalent to 3.8 mg solifenacin), while the 10 mg tablet contains 10 mg solifenacin succinate (equivalent to 7.5 mg solifenacin).
Active Ingredient
The active substance is solifenacin succinate. Each film-coated tablet contains either 5 mg or 10 mg of solifenacin succinate. The succinate salt form provides optimal bioavailability and stability for the oral dosage form.
Inactive Ingredients (Excipients)
The other ingredients are:
- Tablet core: Lactose monohydrate, maize starch, hypromellose (3 cps) (E464), magnesium stearate (E572)
- Film coating: Hypromellose (5 cps) (E464), talc (E553b), titanium dioxide (E171), macrogol 6000 (E1521), yellow iron oxide (E172) (for 5 mg tablets), red iron oxide (E172) (for 10 mg tablets)
Tablet Appearance
The tablets can be identified as follows:
- 5 mg tablets: Light yellow, round, approximately 7.1 mm in diameter, biconvex, film-coated tablets, embossed with "EG" on one side and "1" on the other side
- 10 mg tablets: Light pink, round, approximately 7.1 mm in diameter, biconvex, film-coated tablets, embossed with "EG" on one side and "2" on the other side
Pack Sizes
Solifenacin Accord is available in PVC/PVdC-aluminium blister packs containing 3, 5, 10, 20, 30, 50, 60, 90, 100, or 200 tablets. Not all pack sizes may be marketed in all countries.
Marketing Authorisation Holder
Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, The Netherlands.
Frequently Asked Questions About Solifenacin Accord
Solifenacin is used to treat overactive bladder (OAB) symptoms, including urinary urgency (a sudden, strong need to urinate), frequency (needing to urinate more often than normal), and urge incontinence (involuntary leakage of urine when you cannot reach the toilet in time). It works by relaxing the bladder muscle, allowing you to wait longer between bathroom visits and reducing episodes of urgency and incontinence.
The most common side effect is dry mouth, affecting more than 1 in 10 users. Other common side effects include blurred vision, constipation, nausea, and indigestion. These anticholinergic side effects are generally dose-dependent and tend to be mild to moderate. Most improve over time as your body adjusts to the medication.
You may notice some improvement in your symptoms within the first week, but it typically takes up to 4 weeks to experience the full therapeutic benefit of solifenacin. The medication has a long half-life of 45–68 hours, which means it takes several days of dosing to reach steady-state levels in your body. Be patient and continue taking it as prescribed. If you see no improvement after 4–6 weeks, speak with your doctor.
There is no specific interaction between solifenacin and alcohol. However, both solifenacin and alcohol can cause drowsiness and dizziness, so combining them may increase these effects. If you choose to drink alcohol, do so in moderation and be aware of how the combination affects you before driving or operating machinery.
Solifenacin can be used in elderly patients, but special caution is warranted. Older adults are generally more sensitive to anticholinergic side effects, including dry mouth, constipation, urinary retention, drowsiness, and potential cognitive effects. International guidelines recommend assessing the total anticholinergic burden in elderly patients and starting with the lowest effective dose (5 mg). Your doctor will carefully weigh the benefits of OAB symptom relief against the potential risks.
Constipation is a common anticholinergic side effect. Mild constipation can often be managed with increased dietary fibre, adequate fluid intake, and regular physical activity. If constipation becomes severe, persistent, or is accompanied by abdominal pain or bloating, contact your doctor promptly. In rare cases, solifenacin can cause faecal impaction, which may require medical intervention. Your doctor may recommend a dose reduction or alternative treatment.
References
- European Medicines Agency (EMA). Solifenacin – Summary of Product Characteristics. Available at: www.ema.europa.eu.
- Chapple CR, et al. Randomized, double-blind, placebo-controlled trial of solifenacin succinate for overactive bladder. BJU International. 2004;93(3):303–310. doi:10.1111/j.1464-410X.2004.04612.x
- Cardozo L, et al. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled trial. International Urogynecology Journal. 2006;17(1):44–53.
- European Association of Urology (EAU). Guidelines on the Management of Non-Neurogenic Female Lower Urinary Tract Symptoms (LUTS). 2023 Edition.
- American Urological Association (AUA) / Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU). Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment. 2019.
- Abrams P, et al. The standardisation of terminology of lower urinary tract function. Neurourology and Urodynamics. 2002;21(2):167–178.
- Chapple CR, et al. A pooled analysis of three phase III studies to investigate the efficacy, tolerability and safety of darifenacin, an M3 selective receptor antagonist, in the treatment of overactive bladder. BJU International. 2005;95(7):993–1001.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. 2023.
- National Institute for Health and Care Excellence (NICE). Urinary incontinence and pelvic organ prolapse in women: management. NICE guideline [NG123]. 2019.
- Wagg A, et al. Oral antimuscarinics for overactive bladder in elderly patients: understanding the impact of confounders on efficacy and safety. Drugs & Aging. 2019;36(4):305–315.
Editorial Team
This article has been written and reviewed by our medical editorial team, consisting of licensed physicians with specialist expertise in urology, clinical pharmacology, and internal medicine.
iMedic Medical Editorial Team – specialists in urology, clinical pharmacology, and pharmaceutical science with documented clinical and research experience.
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All medical content on iMedic is based on evidence level 1A (systematic reviews and meta-analyses of randomised controlled trials) following the GRADE evidence framework. We have no commercial funding and accept no pharmaceutical sponsorship. Content is reviewed at least annually or when new significant evidence becomes available. Read more about our editorial standards.