Solifenacin Glenmark
Anticholinergic medication for overactive bladder (OAB)
Solifenacin Glenmark contains the active ingredient solifenacin succinate, an anticholinergic (antimuscarinic) medication prescribed for the treatment of overactive bladder. It works by relaxing the bladder muscle, helping to reduce urgency, frequency of urination, and urinary incontinence. This guide provides comprehensive, evidence-based information about its uses, dosage, side effects, drug interactions, and important precautions.
Quick Facts
Key Takeaways
- Solifenacin Glenmark is a prescription anticholinergic medication that treats overactive bladder symptoms including urgency, frequency, and urge incontinence.
- The recommended starting dose is 5 mg once daily, which may be increased to 10 mg if needed and tolerated.
- Dry mouth is the most common side effect, affecting more than 1 in 10 users; constipation and blurred vision are also common.
- It must not be used by patients with urinary retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, or severe gastrointestinal conditions.
- Significant drug interactions occur with CYP3A4 inhibitors (ketoconazole, ritonavir, verapamil) and inducers (rifampicin, phenytoin), which can alter solifenacin levels in the body.
What Is Solifenacin Glenmark and What Is It Used For?
Quick Answer: Solifenacin Glenmark is an anticholinergic medication containing solifenacin succinate. It is prescribed to treat overactive bladder (OAB), a condition characterized by frequent urination, sudden urges to urinate, and involuntary urine leakage.
Solifenacin Glenmark belongs to the class of drugs known as antimuscarinics or anticholinergics. These medications work by blocking the action of acetylcholine at muscarinic receptors in the detrusor muscle of the bladder. By selectively targeting the M3 muscarinic receptor subtype, solifenacin reduces involuntary bladder contractions, allowing the bladder to hold more urine and decreasing the urgency and frequency associated with overactive bladder.
Overactive bladder is a common urological condition that affects millions of people worldwide, with prevalence estimates ranging from 12% to 17% of the adult population according to large-scale epidemiological studies. The condition is more common in women and its prevalence increases with age, though it can affect individuals of any age group. OAB significantly impacts quality of life, often leading to social isolation, sleep disturbances, depression, and reduced productivity.
Solifenacin Glenmark is indicated for the symptomatic treatment of urge incontinence, urgency, and increased urinary frequency in patients with overactive bladder syndrome. Clinical trials have demonstrated that solifenacin significantly reduces the number of urgency episodes, incontinence episodes, and voiding frequency compared to placebo. In randomized controlled trials, solifenacin 5 mg reduced urgency episodes by approximately 50% and incontinence episodes by up to 60% over 12 weeks of treatment.
The therapeutic effect of solifenacin typically becomes apparent within the first week of treatment, although the full benefit may not be observed until 4 to 8 weeks of consistent use. Your healthcare provider will evaluate the effectiveness and tolerability of the treatment at regular intervals and may adjust the dose accordingly. It is important to continue taking the medication as prescribed, even if symptoms improve, as discontinuation may lead to a return of overactive bladder symptoms.
What Should You Know Before Taking Solifenacin Glenmark?
Quick Answer: Before taking Solifenacin Glenmark, inform your doctor about all medical conditions, particularly urinary retention, gastrointestinal disorders, glaucoma, or liver and kidney problems. It is contraindicated in several conditions and interacts with many medications.
Before starting treatment with Solifenacin Glenmark, your doctor will conduct a thorough medical evaluation to determine whether this medication is appropriate for you. This evaluation will include assessing the underlying cause of your urinary symptoms, since conditions such as heart failure, kidney disease, or urinary tract infections can produce similar symptoms and require different treatment approaches. If a urinary tract infection is identified, your doctor will prescribe antibiotic therapy first.
Contraindications
You should not take Solifenacin Glenmark if you have any of the following conditions:
- Urinary retention — difficulty urinating or inability to completely empty the bladder
- Severe gastrointestinal conditions — including toxic megacolon, a complication that can occur with ulcerative colitis
- Myasthenia gravis — a neuromuscular disease causing weakness in certain muscles
- Uncontrolled narrow-angle glaucoma — elevated eye pressure with pain
- Dialysis — patients currently undergoing hemodialysis
- Severe liver disease
- Severe kidney disease or moderate liver impairment combined with concurrent use of a strong CYP3A4 inhibitor (e.g., ketoconazole)
- Known allergy to solifenacin succinate or any of the tablet's excipients
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before taking Solifenacin Glenmark if any of the following apply to you:
- Difficulty emptying the bladder or weak urinary stream — the risk of urinary retention (urine accumulating in the bladder) is significantly increased in these patients
- Gastrointestinal obstructive disorders — particularly constipation or conditions that slow bowel motility. Anticholinergic medications can worsen constipation
- Risk of decreased gastrointestinal motility — your doctor will have informed you if you belong to this risk group
- Severely impaired kidney function — dose adjustment may be necessary
- Moderately impaired liver function — dose adjustment may be necessary
- Hiatal hernia or gastroesophageal reflux disease (GERD) — anticholinergics can worsen these conditions
- Autonomic neuropathy — a nerve condition that affects involuntary body functions
Elderly patients should be treated with particular caution, as they may be more susceptible to anticholinergic side effects including cognitive impairment, confusion, and falls. The American Geriatrics Society Beers Criteria recommends careful assessment of risks and benefits before prescribing anticholinergic medications to older adults, as these drugs have been associated with an increased risk of cognitive decline and dementia in long-term epidemiological studies.
Pregnancy and Breastfeeding
Solifenacin Glenmark should not be used during pregnancy unless your doctor determines it is absolutely necessary. There are limited data on the use of solifenacin in pregnant women, and the potential risk to the developing fetus is not fully established. Animal studies have shown some evidence of effects on the fetus at high doses, but these findings may not directly translate to humans.
Solifenacin should not be used during breastfeeding, as the active substance may pass into breast milk. If treatment is considered essential, a decision must be made whether to discontinue breastfeeding or to discontinue solifenacin therapy, taking into account the importance of the medication to the mother.
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.
Children and Adolescents
Solifenacin Glenmark is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of solifenacin in the pediatric population have not been established for this formulation.
Driving and Operating Machinery
Solifenacin can affect your vision and may occasionally cause drowsiness and fatigue. If you experience blurred vision, dizziness, or drowsiness while taking this medication, you should not drive or operate machinery. These effects are more likely to occur at the start of treatment or when the dose is increased. You are personally responsible for assessing whether you are fit to drive or perform tasks requiring alertness.
Solifenacin Glenmark tablets contain lactose monohydrate as an inactive ingredient. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
How Does Solifenacin Glenmark Interact with Other Drugs?
Quick Answer: Solifenacin is metabolized primarily by the CYP3A4 enzyme. Drugs that inhibit this enzyme (ketoconazole, ritonavir, verapamil) increase solifenacin levels, while enzyme inducers (rifampicin, phenytoin) decrease its effectiveness. Combining solifenacin with other anticholinergics amplifies side effects.
Drug interactions are an important consideration when taking Solifenacin Glenmark. Solifenacin is primarily metabolized in the liver by the cytochrome P450 enzyme CYP3A4. Medications that affect the activity of this enzyme can significantly alter the blood levels and effects of solifenacin. Always tell your doctor or pharmacist about all medications you are currently taking, have recently taken, or might take.
Major Interactions
The following drug interactions are considered clinically significant and may require dose adjustment, additional monitoring, or avoidance of the combination:
| Interacting Drug | Category | Effect on Solifenacin | Clinical Advice |
|---|---|---|---|
| Ketoconazole | Strong CYP3A4 inhibitor | Increases solifenacin levels significantly | Do not exceed 5 mg solifenacin daily |
| Itraconazole | Strong CYP3A4 inhibitor | Increases solifenacin levels significantly | Do not exceed 5 mg solifenacin daily |
| Ritonavir / Nelfinavir | Strong CYP3A4 inhibitor (HIV protease inhibitor) | Increases solifenacin levels significantly | Do not exceed 5 mg solifenacin daily |
| Verapamil / Diltiazem | Moderate CYP3A4 inhibitor | Moderately increases solifenacin levels | Monitor for increased side effects; dose reduction may be needed |
| Rifampicin | Strong CYP3A4 inducer | Decreases solifenacin levels; may reduce effectiveness | Consider alternative treatment or higher dose under medical supervision |
| Phenytoin / Carbamazepine | CYP3A4 inducer (antiepileptic) | Decreases solifenacin levels; may reduce effectiveness | Monitor treatment response; dose adjustment may be required |
Other Interactions
In addition to the major CYP3A4-related interactions, the following drug classes and specific medications may interact with Solifenacin Glenmark:
- Other anticholinergic drugs — combining solifenacin with other anticholinergics (such as oxybutynin, tolterodine, or antihistamines with anticholinergic properties) can amplify both the therapeutic effects and the side effects, particularly dry mouth, constipation, drowsiness, and urinary retention
- Cholinergic drugs — medications that increase cholinergic activity (such as donepezil, rivastigmine, or bethanechol) may have their effects reduced by solifenacin, and vice versa
- Prokinetic agents (metoclopramide, cisapride) — solifenacin may reduce the effectiveness of these medications that are designed to increase gastrointestinal motility
- Bisphosphonates — these drugs may cause or worsen inflammation of the esophagus (esophagitis), and the anticholinergic effects of solifenacin on gastrointestinal motility could potentially aggravate this risk
Solifenacin Glenmark can be taken with or without food. Food does not significantly affect the absorption or efficacy of the medication. However, grapefruit juice, which is a CYP3A4 inhibitor, should be consumed with caution as it may modestly increase solifenacin levels.
What Is the Correct Dosage of Solifenacin Glenmark?
Quick Answer: The recommended starting dose is 5 mg once daily, swallowed whole with water. The dose may be increased to 10 mg once daily by your doctor. Do not crush or chew the tablets. They can be taken with or without food at any time of day.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Solifenacin Glenmark should be swallowed whole with a little liquid, such as a glass of water. The tablets must not be crushed, split, or chewed as this may affect the release profile and absorption of the active substance.
Adults
Standard Adult Dosage
Starting dose: 5 mg once daily
Maximum dose: 10 mg once daily (if clinically indicated and tolerated)
Administration: Oral, with or without food, at approximately the same time each day
Your doctor will typically start treatment at the lowest effective dose of 5 mg per day. If this dose provides adequate symptom relief and is well tolerated, it will be maintained. If further symptom improvement is needed and the 5 mg dose is well tolerated, your doctor may increase the dose to 10 mg per day. It is important not to exceed the maximum recommended dose of 10 mg daily.
Special Populations
| Patient Group | Recommended Dose | Maximum Dose | Notes |
|---|---|---|---|
| Adults (standard) | 5 mg once daily | 10 mg once daily | Increase only if needed and tolerated |
| Elderly (≥65 years) | 5 mg once daily | 10 mg once daily | No routine dose adjustment; monitor for anticholinergic effects |
| Mild to moderate kidney impairment | 5 mg once daily | 10 mg once daily | Use with caution |
| Severe kidney impairment | 5 mg once daily | 5 mg once daily | Do not exceed 5 mg |
| Mild liver impairment | 5 mg once daily | 10 mg once daily | No dose adjustment needed |
| Moderate liver impairment | 5 mg once daily | 5 mg once daily | Do not exceed 5 mg; contraindicated with strong CYP3A4 inhibitors |
| Children (<18 years) | Not recommended | N/A | Safety and efficacy not established |
Missed Dose
If you forget to take a dose at the usual time, take it as soon as you remember, unless it is nearly time for your next dose. In that case, skip the missed dose and take your next dose at the regular time. Never take a double dose to make up for a forgotten dose. If you are unsure what to do, ask your doctor or pharmacist for advice.
Overdose
If you or someone else takes too much Solifenacin Glenmark, contact a poison control center or emergency services immediately. Symptoms of overdose may include:
- Severe headache and dry mouth
- Dizziness and drowsiness
- Visual disturbances and dilated pupils (mydriasis)
- Hallucinations and confusion
- Agitation and overexcitability
- Seizures (convulsions)
- Breathing difficulties
- Rapid heartbeat (tachycardia)
- Urinary retention
If You Stop Taking Solifenacin Glenmark
If you stop taking this medication, your overactive bladder symptoms are likely to return or worsen. Always consult your doctor before deciding to discontinue treatment. Your doctor can advise you on the best approach, which may include a gradual reduction in dose or a transition to an alternative therapy. Do not stop taking your medication simply because you feel better, as the underlying condition persists and symptoms typically recur upon discontinuation.
What Are the Side Effects of Solifenacin Glenmark?
Quick Answer: 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. Serious but rare side effects include allergic reactions, angioedema, and urinary retention.
Like all medicines, Solifenacin Glenmark can cause side effects, although not everybody gets them. Most side effects are related to the anticholinergic mechanism of action and tend to be dose-dependent. They are generally mild to moderate in severity and may diminish as your body adjusts to the medication over the first few weeks of treatment.
- Severe allergic reactions — skin rash with blistering and peeling
- Angioedema — swelling of the face, lips, tongue, or throat with breathing difficulty (airway obstruction)
Very Common
May affect more than 1 in 10 users
- Dry mouth
Common
May affect up to 1 in 10 users
- Blurred vision
- Constipation
- Nausea
- Dyspepsia (indigestion with fullness, abdominal pain, belching, and heartburn)
- Abdominal discomfort
Uncommon
May affect up to 1 in 100 users
- Urinary tract infection, cystitis
- Drowsiness
- Altered taste (dysgeusia)
- Dry or irritated eyes
- Nasal dryness
- Gastroesophageal reflux disease (GERD)
- Dry throat
- Dry skin
- Difficulty urinating
- Fatigue
- Edema (swelling in arms and legs)
Rare
May affect up to 1 in 1,000 users
- Fecal impaction (severe constipation)
- Urinary retention (inability to completely empty the bladder)
- Dizziness, headache
- Vomiting
- Pruritus (itching), skin rash
Very Rare
May affect up to 1 in 10,000 users
- Hallucinations, confusion
- Allergic skin rash (erythema multiforme)
Frequency Not Known
Cannot be estimated from available data
- Decreased appetite
- Hyperkalemia (high potassium levels causing abnormal heart rhythm)
- Increased intraocular pressure (glaucoma)
- ECG changes, irregular heartbeat, palpitations, tachycardia
- Voice disorders (dysphonia)
- Liver disorder
- Muscle weakness
- Kidney disorder
If you experience any side effects, including any not listed in this guide, talk to your doctor, pharmacist, or nurse. You can also report suspected side effects to your national pharmacovigilance authority. Reporting helps to continuously monitor the benefit-risk balance of the medicine.
It is worth noting that anticholinergic medications as a class have been associated with potential cognitive effects in older adults. A large observational study published in JAMA Internal Medicine (2015) suggested a dose-response relationship between cumulative anticholinergic exposure and the risk of dementia. While this does not establish causation, it is a factor that should be considered, particularly for elderly patients requiring long-term treatment. Discuss the risks and benefits with your healthcare provider.
How Should You Store Solifenacin Glenmark?
Quick Answer: No special storage conditions are required. Keep the tablets out of the sight and reach of children. Do not use after the expiry date printed on the packaging.
Solifenacin Glenmark does not require any special storage conditions. Store the medication at room temperature and keep the blister packs in the outer carton to protect them from light and moisture. As with all medications, keep Solifenacin Glenmark out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after "EXP." The expiry date refers to the last day of that month. Do not use the medication if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via household waste or down the drain. Ask your pharmacist how to dispose of medicines you no longer use. These measures help to protect the environment. Many pharmacies and communities offer take-back programs for safe medication disposal, which is particularly important for preventing accidental ingestion by children or pets and for reducing environmental contamination from pharmaceutical residues in water systems.
What Does Solifenacin Glenmark Contain?
Quick Answer: Each tablet contains solifenacin succinate (5 mg or 10 mg) as the active ingredient. Inactive ingredients include maize starch, lactose monohydrate, hypromellose, magnesium stearate, and various film-coating agents.
Understanding the full composition of your medication is important, particularly if you have known allergies or intolerances to specific excipients. Below is the complete list of ingredients in Solifenacin Glenmark tablets.
Active Substance
- Solifenacin Glenmark 5 mg: Each film-coated tablet contains 5 mg solifenacin succinate
- Solifenacin Glenmark 10 mg: Each film-coated tablet contains 10 mg solifenacin succinate
Inactive Ingredients (Excipients)
Tablet core: Maize starch, lactose monohydrate, hypromellose (E464), magnesium stearate (E572)
Film coating: Hypromellose (E464), macrogol, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)
Appearance and Pack Sizes
The 5 mg tablets are round, light yellow, film-coated and marked with "390" on one side. The 10 mg tablets are round, light pink, film-coated and marked with "391" on one side.
Solifenacin Glenmark is available in blister packs containing 10, 30, 50, 90, or 100 tablets. Not all pack sizes may be marketed in all countries.
Glenmark Arzneimittel GmbH, Industriestr. 31, 82194 Gröbenzell, Germany
Manufacturer: Zentiva s.a., B.d. Theodor Pallady nr 50, 032266 Bucharest, Romania
Frequently Asked Questions About Solifenacin Glenmark
Solifenacin Glenmark is used to treat overactive bladder (OAB), a condition characterized by symptoms such as frequent urination, sudden and strong urges to urinate (urgency), and involuntary leakage of urine (urge incontinence). The active ingredient, solifenacin succinate, works by blocking muscarinic receptors in the bladder muscle, which reduces involuntary bladder contractions and allows the bladder to hold more urine. This helps you go to the bathroom less frequently and reduces episodes of urgency and incontinence.
The most common side effect is dry mouth, which affects more than 1 in 10 users. Other common side effects include blurred vision, constipation, nausea, indigestion, and abdominal discomfort. These side effects are related to the medication's anticholinergic mechanism and are typically mild to moderate. They often improve as your body adjusts to the medication. Drinking water regularly, using sugar-free gum, and maintaining adequate dietary fiber can help manage dry mouth and constipation. If side effects are bothersome or persistent, speak with your doctor.
Solifenacin can interact with several other medications. The most important interactions are with drugs that affect the CYP3A4 liver enzyme. Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, nelfinavir) significantly increase solifenacin levels, requiring a dose limit of 5 mg daily. Moderate CYP3A4 inhibitors (verapamil, diltiazem) can also raise levels. Enzyme inducers (rifampicin, phenytoin, carbamazepine) may reduce solifenacin's effectiveness. Combining it with other anticholinergic medications amplifies side effects. Always inform your doctor about all medications, supplements, and herbal products you use.
Some patients notice improvement in overactive bladder symptoms within the first week of treatment. However, the full therapeutic effect of solifenacin typically develops over 4 to 8 weeks of consistent daily use. It is important to continue taking the medication as prescribed, even if you do not notice immediate improvement. Your doctor will usually evaluate the effectiveness of treatment after approximately 4 weeks and may adjust the dose if necessary. If you see no improvement after 8 weeks at the maximum tolerated dose, your doctor may consider alternative treatments.
Solifenacin Glenmark should not be used during pregnancy unless your doctor considers it absolutely necessary, as there is limited data on its safety in pregnant women. The medication should not be used during breastfeeding because solifenacin may pass into breast milk and could potentially affect the nursing infant. If you are pregnant, breastfeeding, planning to become pregnant, or think you may be pregnant, consult your doctor before taking this medication. Your doctor will weigh the benefits of treatment against the potential risks to help you make an informed decision.
If you forget to take your daily dose of Solifenacin Glenmark, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Never take two doses at the same time or take a double dose to compensate for the forgotten one. Taking more than one dose in a day increases the risk of side effects, particularly dry mouth, constipation, and urinary retention. If you frequently forget doses, consider setting a daily alarm or linking your medication to a daily routine.
References
- European Medicines Agency (EMA). Solifenacin Summary of Product Characteristics. EMA/CHMP. Available at: www.ema.europa.eu
- Chapple CR, et al. Randomized, double-blind, placebo-controlled trial of solifenacin succinate in the treatment of overactive bladder. BJU International. 2004;93(3):303-310. doi:10.1111/j.1464-410X.2003.04656.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, rising-dose trial. BJU International. 2008;102(9):1120-1127.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023. Available at: www.who.int
- British National Formulary (BNF). Solifenacin succinate monograph. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk
- Gray SL, et al. Cumulative Use of Strong Anticholinergics and Incident Dementia: A Prospective Cohort Study. JAMA Internal Medicine. 2015;175(3):401-407. doi:10.1001/jamainternmed.2014.7663
- American Geriatrics Society 2023 Updated AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Journal of the American Geriatrics Society. 2023;71(7):2052-2081.
- Abrams P, et al. The standardisation of terminology of lower urinary tract function: Report from the standardisation sub-committee of the International Continence Society. Neurourology and Urodynamics. 2002;21(2):167-178.
- U.S. Food and Drug Administration (FDA). Solifenacin Succinate Prescribing Information. Available at: www.accessdata.fda.gov
- Irwin DE, et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries. European Urology. 2006;50(6):1306-1315.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising board-certified physicians specializing in urology, internal medicine, and clinical pharmacology. Our content follows the GRADE evidence framework and adheres to international medical guidelines from the WHO, EMA, FDA, and NICE.
iMedic Medical Editorial Team — specialists in urology and pharmacology with extensive clinical and academic experience.
iMedic Medical Review Board — independent panel ensuring accuracy, completeness, and adherence to current evidence-based guidelines.
All information is based on peer-reviewed research, regulatory documents, and established clinical guidelines. This content is provided for educational purposes only and does not constitute medical advice. No commercial funding or pharmaceutical sponsorship is involved in the creation of this content.