SOLIFEN TABLET 5 MG 10S

Description

SOLIFEN TABLET 5 MG is a prescription medication specifically formulated to manage the troublesome symptoms of an overactive bladder (OAB). Its active component, Solifenacin Succinate, works by relaxing the bladder muscle, which helps to reduce sudden urges, control frequent urination, and decrease incontinence episodes. This treatment is designed to restore a sense of normalcy and comfort for individuals struggling with bladder control, significantly enhancing their daily quality of life.

Here is a brief summary of what makes SOLIFEN TABLET a leading choice for urinary health:

✔️ Contains Solifenacin Succinate, a proven antimuscarinic agent for OAB.
✔️ Effectively reduces frequent urination and sudden urgency.
✔️ Helps minimize episodes of urinary incontinence or leakage.
✔️ Promotes better sleep by reducing the need for nighttime bathroom visits.
✔️ Manufactured under strict Good Manufacturing Practice (GMP) guidelines for assured quality and potency.

What is Solifen Tablet and How Does it Help with Bladder Control?

SOLIFEN TABLET 5 MG is an antimuscarinic medication belonging to a class of drugs known as urinary antispasmodics. The primary medical use for this pharmaceutical product is the management of overactive bladder syndrome, a condition characterized by a group of urinary symptoms. The core mechanism of action involves blocking specific muscarinic receptors in the detrusor muscle of the bladder. This blockade inhibits involuntary bladder contractions, thereby increasing the bladder’s functional capacity and reducing the frequency and intensity of unwanted signals to urinate. It is a cornerstone therapy for restoring urinary comfort and confidence.

What are the Primary Uses and Key Features of Solifen 5 mg?

Uses and Key Features

SOLIFEN TABLET is prescribed for a targeted range of urological conditions. Its key features are derived from its potent and selective action on the bladder.

Primary Therapeutic Uses of Solifen Succinate

• Treatment of Overactive Bladder (OAB): This is the principal indication. OAB is diagnosed by the presence of urgency, with or without urge incontinence, usually accompanied by frequency and nocturia (waking up at night to urinate).

• Reduction of Urinary Urgency: It specifically targets the sudden, compelling desire to pass urine that is difficult to defer.

• Management of Urinary Frequency: It helps in decreasing the number of times a person needs to urinate during the day, allowing for longer intervals between bathroom breaks.

• Control of Urge Incontinence: It is effective in reducing or preventing the involuntary leakage of urine preceded by a sudden, strong urge.

Distinguishing Key Features and Patient Benefits

• Selective Receptor Action: Solifenacin Succinate demonstrates a high affinity for the M3 muscarinic receptors located in the bladder, which are primarily responsible for muscle contraction. This selectivity may contribute to a potentially favorable side effect profile.

• Once-Daily Dosing Convenience: The 5 mg strength is designed for 24-hour symptom control with a single oral dose, enhancing patient compliance and adherence to the treatment regimen.

• Proven Efficacy in Clinical Studies: Extensive clinical trials and post-market surveillance have consistently shown significant improvements in all major OAB symptoms, leading to clinically meaningful enhancements in health-related quality of life scores.

• Quality of Life Improvement: By effectively controlling symptoms, it allows individuals to engage in social, professional, and physical activities without the constant anxiety and interruption caused by an overactive bladder.

What is the Active Ingredient in SOLIFEN TABLET?

Ingredients

Core Active Pharmaceutical Ingredient

• Solfienacin Succinate 5 mg: This is the sole active moiety in each film-coated tablet. Solifenacin Succinate is a competitive muscarinic receptor antagonist. Its therapeutic benefit comes from its ability to antagonize the M3 receptors in the bladder detrusor muscle, preventing the binding of acetylcholine (the neurotransmitter that stimulates contraction). This results in reduced muscle spasms and increased bladder capacity, providing relief from OAB symptoms.

Inactive Ingredients (Excipients)

The tablet formulation also contains various inactive ingredients that ensure stability, bioavailability, and manufacturability. These typically include:

• Lactose Monohydrate

• Cellulose Microcrystalline

• Starch, Pregelatinized

• Magnesium Stearate

• Hypromellose

• Titanium Dioxide

• Polyethylene Glycol (PEG)

• Talc

(Note: The exact composition of inactive ingredients may vary by manufacturer. Patients with known allergies to any of these components should consult their physician.)

How Should I Take Solifen 5 mg Correctly?

Directions for Use

Proper administration is crucial for the drug’s efficacy and safety.

• Oral Administration: The tablet is to be swallowed whole with a full glass of water. It should not be chewed, crushed, or broken.

• Timing of Dose: It can be taken with or without food. Consistency is key—taking it at the same time each day helps maintain a steady level of the medication in your bloodstream.

• Food Interaction: While food does not significantly affect the absorption of Solifenacin, taking it with a meal may help if you experience an upset stomach.

What is the Recommended Dosage for Solifen Succinate?

Dosage Information

Dosage is always individualized by a healthcare professional based on patient response and tolerance.

• Standard Adult Starting Dose: The recommended initial dose for most adults is 5 mg, taken once daily.

• Dose Titration: If the 5 mg dose is well-tolerated but a greater therapeutic effect is desired, the physician may increase the dosage to 10 mg once daily.

• Special Populations: For patients with severe renal impairment (creatinine clearance ≤ 30 mL/min) or moderate hepatic impairment (Child-Pugh class B), the recommended dose is 5 mg. It is not recommended for use in patients with severe hepatic impairment.

• Elderly Patients: No dosage adjustment is required based on age alone, but it should be based on renal function.

Important Dosage Guidelines to Follow

• Do not exceed the dose prescribed by your doctor.

• If you miss a dose, 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 schedule. Do not take a double dose to make up for a forgotten one.

• Always complete the full course of treatment as directed, even if you start feeling better.

What Precautions Should I Be Aware of Before Taking Solifen?

Precautions

Certain medical conditions and concomitant medications require careful evaluation before starting treatment with SOLIFEN TABLET.

Contraindications and Conditions Requiring Caution

• Hypersensitivity: Do not use if you have a known allergy to Solifenacin Succinate or any of the inactive ingredients.

• Urinary Retention: It is contraindicated in patients who are unable to empty their bladder (urinary retention).

• Severe Gastrointestinal Conditions: This includes conditions like toxic megacolon or myasthenia gravis.

• Narrow-Angle Glaucoma: This medication is not to be used by patients with uncontrolled narrow-angle glaucoma.

• Pregnancy and Lactation: Consult your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. The use of Solifenacin during these periods should be considered only if the potential benefit justifies the potential risk to the fetus or baby.

• Renal and Hepatic Impairment: Dose adjustment is necessary for patients with severe renal or moderate hepatic impairment, as previously mentioned.

Potential Drug Interactions

Inform your doctor about all the medicines you are taking, including:

• Other Anticholinergics: Concurrent use can lead to an enhanced anticholinergic burden, increasing the risk of side effects like severe constipation, dry mouth, and blurred vision.

• Cholinergic Agonists: Solifenacin may antagonize the effects of drugs used to treat myasthenia gravis.

• Potent CYP3A4 Inhibitors: Medicines like Ketoconazole, Itraconazole, or Ritonavir can increase the plasma concentration of Solifenacin. Co-administration requires caution and a maximum dose of 5 mg.

What are the Possible Side Effects of Solifenacin Succinate?

Side Effects

Like all medicines, SOLIFEN TABLET can cause side effects, although not everybody gets them. The side effects are primarily related to its anticholinergic activity.

Common Side Effects (May affect up to 1 in 10 people)

• Dry Mouth

• Constipation

• Blurred Vision

• Nausea

• Indigestion (Dyspepsia)

• Abdominal Pain

Uncommon Side Effects (May affect up to 1 in 100 people)

• Urinary Tract Infection (UTI)

• Difficulty in Passing Urine (Urinary Retention)

• Drowsiness

• Fatigue

• Gastroesophageal Reflux Disease (GERD)

• Dry Skin

• Dry Eyes

Rare but Serious Side Effects (Seek immediate medical attention)

• Angioedema: Swelling of the face, lips, tongue, or throat, which may cause difficulty in breathing.

• Severe Skin Reactions: Such as Stevens-Johnson syndrome.

• QT Prolongation: A serious heart rhythm condition.

• Hallucinations or Confusion: Especially in elderly patients.

If you experience any side effect that is severe or persistent, contact your doctor promptly.

How Should I Store SOLIFEN TABLET 5 MG?

Storage Instructions

Proper storage is essential for maintaining the drug’s stability and shelf life.

• Temperature: Store below 30°C (86°F). Do not freeze.

• Moisture: Keep the tablets in their original blister pack to protect them from moisture and light.

• Place: Store in a cool, dry place, away from direct sunlight.

• Safety: Keep out of the reach and sight of children and pets.

• Expiry: Do not use the medicine after the expiry date stated on the blister and carton.

Who Manufactures SOLIFEN TABLET?

Manufacturer Information

SOLIFEN TABLET is manufactured by a reputable pharmaceutical company committed to high-quality standards. While the specific brand may be marketed by different entities, the production is carried out in facilities that are certified for Good Manufacturing Practices (GMP) by relevant regulatory authorities. This ensures that every batch of the medicine is produced and controlled to the highest quality standards, guaranteeing its identity, strength, purity, and quality. For the specific manufacturer details, please refer to the product packaging and leaflet provided within the box.

What are the Health Benefits of Using Solifen for Overactive Bladder?

Benefits

The advantages of consistent and correct use of SOLIFEN TABLET 5 MG extend beyond simple symptom reduction, offering profound improvements in daily living.

• Regained Bladder Control: Experience a significant reduction in the unpredictable and urgent need to urinate, providing a greater sense of control over your body.

• Reduced Bathroom Trips: Decrease the frequency of urination, allowing you to engage in longer meetings, travel, and social outings without constant interruption.

• Decreased Incontinence Episodes: Minimize or eliminate the embarrassment and discomfort associated with accidental urine leakage.

• Improved Sleep Quality: Experience fewer awakenings at night to urinate (nocturia), leading to more restful and uninterrupted sleep.

• Enhanced Social Confidence: Freedom from the anxiety of locating restrooms or having accidents in public enables greater participation in social and recreational activities.

• Better Hydration Habits: Patients often feel more confident in drinking adequate fluids throughout the day, knowing their bladder symptoms are managed, which contributes to overall health.

• Positive Impact on Mental Well-being: The reduction in stress, anxiety, and embarrassment associated with OAB symptoms can lead to improved overall mood and quality of life.

How Does Solifenacin Compare to Other Overactive Bladder Medications?

Comparison Table: Solifenacin vs. Key Alternatives

This table provides a comparative overview to help inform discussions with a healthcare provider. The best choice is always individualized.

Frequently Asked Questions About SOLIFEN TABLET 5 MG

FAQs

How long does it take for Solifen to start working?
You may notice some improvement in your overactive bladder symptoms within the first week of treatment. However, the full therapeutic benefits of Solifenacin Succinate typically become apparent after 4 to 8 weeks of consistent use as the medication stabilizes in your system and the bladder muscle adapts.

Can I drink alcohol while taking Solifenacin?
It is generally advisable to limit or avoid alcohol while taking SOLIFEN TABLET. Alcohol can impair your nervous system and may potentially worsen some side effects of Solifenacin, such as drowsiness, dizziness, or blurred vision. Always consult your doctor for personalized advice.

What should I do if I experience severe dry mouth or constipation?
These are common anticholinergic side effects. For dry mouth, try sipping water regularly, sucking on sugar-free candies, or using a saliva substitute. For constipation, increase your dietary fiber intake, drink plenty of fluids, and engage in light physical activity. If these side effects become severe or bothersome, contact your doctor. Do not stop taking the medication without medical consultation.

Is Solifenacin suitable for long-term use?
Yes, Solifenacin Succinate is approved for the long-term management of overactive bladder symptoms. Your doctor will periodically reassess your condition to ensure the treatment remains effective and appropriate for you. Do not discontinue long-term therapy abruptly without discussing it with your healthcare provider.

Can this medication cause weight gain?
Weight gain is not a commonly reported side effect of Solifenacin in clinical trials or post-marketing surveillance. The list of common and uncommon side effects does not typically include changes in weight. If you notice any unexpected changes, discuss them with your doctor.

Will Solifenacin cure my overactive bladder?
SOLIFEN TABLET is a treatment that controls and manages the symptoms of overactive bladder; it is not a cure. It works effectively to reduce the frequency of urination, urgency, and incontinence, allowing you to lead a more normal life. Symptoms may return if the medication is discontinued.