LIFANCE 5/MG FC TAB 30/FC TAB

Indications

Approved Uses

Overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency

Off-Label Uses

Neurogenic detrusor overactivity/neurogenic bladder (e.g., spinal cord injury, multiple sclerosis) - off‑label in some settings.

Dosage & Administration

Dosing by Condition

Overactive bladder: 5 mg orally once daily initially; may increase to 10 mg once daily if needed and tolerated; do not exceed 5 mg once daily in severe renal impairment (CrCl <30 mL/min), moderate hepatic impairment (Child‑Pugh B), or with strong CYP3A4 inhibitors.

Initial Dose

5 mg once daily

Maintenance Dose

5mg to 10mg once daily.

Maximum Dose

10 mg once daily

Children's Dosage

Not approved for children under 2 years. For neurogenic detrusor overactivity in children 2 years and older, dosing is weight-based and administered as an oral suspension.

Dose Adjustment Notes

Maximum 5 mg once daily in severe renal impairment (CrCl <30 mL/min) or moderate hepatic impairment (Child‑Pugh B), and when used with strong CYP3A4 inhibitors; avoid/use contraindicated in severe hepatic impairment (Child‑Pugh C).

How to Take

Swallow the film‑coated tablet whole with water; may be taken with or without food; do not crush or chew; take once daily (preferably at the same time each day).

Side Effects

Common Side Effects

Dry mouth, constipation, blurred vision, dry eyes, dyspepsia, nausea, urinary tract infection, fatigue

Side Effect Frequency

Very common (>10%): Dry mouth, constipation. Common (1-10%): Blurred vision, nausea, dyspepsia. Uncommon (0.1-1%): Urinary tract infection, fatigue, upper abdominal pain. Rare/very rare (<0.1%) or frequency not known: Urinary retention, QT prolongation/torsades risk (especially predisposed), angioedema/anaphylaxis, hallucinations/confusion, somnolence, dysgeusia, gastroesophageal reflux, pruritus/rash (incl. erythema multiforme).

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to solifenacin/excipients; urinary retention; gastric retention; uncontrolled narrow‑angle glaucoma; severe hepatic impairment (Child‑Pugh C); severe renal impairment (CrCl <30 mL/min) when used with a strong CYP3A4 inhibitor.

Warnings & Precautions

Precautions: bladder outflow obstruction (risk urinary retention); decreased GI motility/obstructive GI disorders and severe constipation; controlled narrow‑angle glaucoma (monitor); renal impairment and hepatic impairment (dose limits/avoid severe); risk of QT prolongation (congenital/acquired QT prolongation, electrolyte disturbances, or concomitant QT‑prolonging drugs); CNS effects (somnolence, dizziness, confusion/hallucinations); heat prostration risk.

Age Restriction

Not approved/recommended for use in children and adolescents (<18 years).

Driving Warning

Blurred vision may impair ability to drive or operate machinery; use caution until effects known

Drug Interactions

Drug Interactions

Key interactions: strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/clarithromycin) increase solifenacin exposure (dose limit/avoid in severe renal/hepatic impairment); other anticholinergics add anticholinergic adverse effects; QT‑prolonging drugs add QT risk; CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin) may reduce exposure/efficacy.

Interaction Severity

MAJOR: Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/clarithromycin) - increased exposure; limit solifenacin to 5 mg/day; QT‑prolonging drugs (e.g., amiodarone, sotalol, certain antipsychotics) - additive QT risk. MODERATE: Other anticholinergics (additive anticholinergic effects/urinary retention/constipation). MINOR to MODERATE: CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - reduced efficacy.

Food Interaction

No restriction.

Special Populations

Children

Not approved for children under 2 years. For neurogenic detrusor overactivity in children 2 years and older, dosing is weight-based and administered as an oral suspension.

Elderly

Standard adult dosing (5-10 mg once daily); no routine dose adjustment required, but use with caution due to increased sensitivity to anticholinergic effects including cognitive impairment and constipation

Kidney Impairment

CrCl ≥30 mL/min: no adjustment (usual dosing). CrCl <30 mL/min: do not exceed 5 mg once daily; avoid/limit further when combined with strong CYP3A4 inhibitors (do not exceed 5 mg and generally avoid if severe renal impairment plus strong inhibitor).

Liver Impairment

Mild (Child-Pugh A): No adjustment needed. Moderate (Child-Pugh B): Maximum dose 5 mg once daily. Severe (Child-Pugh C): Contraindicated.

Storage & Patient Advice

Missed Dose

If a dose is missed, skip it and take the next dose at the usual time the next day; do not take two doses in the same day.

Stopping the Medicine

Can be stopped without tapering; overactive bladder symptoms may recur after discontinuation.

Overdose

Overdose: prominent anticholinergic toxicity (e.g., mydriasis, tachycardia, agitation/delirium/hallucinations, dry mouth, constipation/ileus, urinary retention) and possible QT prolongation; management is urgent medical evaluation with supportive care, ECG monitoring, and decontamination (activated charcoal if early) with consideration of physostigmine in severe anticholinergic delirium under expert supervision.

Patient Counseling

Take once daily with or without food; swallow the film‑coated tablet whole with water (do not crush/chew). Common effects: dry mouth, constipation, blurred vision/drowsiness-use caution driving until effects known; increase fluids/fiber as appropriate. Seek care for difficulty urinating/urinary retention, severe constipation/abdominal pain, palpitations/syncope (QT concern), or allergic swelling.

Monitoring Requirements

Monitor symptom response and anticholinergic adverse effects (dry mouth, constipation, blurred vision); monitor for urinary retention (especially with bladder outlet obstruction); consider ECG/QT risk assessment in patients with risk factors or on QT‑prolonging drugs; monitor intraocular pressure/avoid in uncontrolled narrow‑angle glaucoma.

Pharmacology

Mechanism of Action

Competitive muscarinic receptor antagonist (primarily M3) in the bladder, reducing detrusor contractions and increasing functional bladder capacity to improve urgency, frequency, and urge incontinence.

Onset of Action

Some symptom improvement may occur within a few days to 1-2 weeks; maximal benefit typically assessed after ~4-8 weeks.

Duration of Effect

Approximately 24 hours (supports once-daily dosing); clinical symptom control is maintained with continued daily use.

Half-Life

45-68 hours.

Bioavailability

Approximately 90%.

Metabolism

Extensively hepatic metabolism primarily via CYP3A4, forming metabolites including 4R‑hydroxy‑solifenacin (among others).

Product Information

Available Dosage Forms

Film‑coated tablet (oral).

Composition per Dose

Each film-coated tablet: 5 mg solifenacin succinate

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Urological Condition

Overactive Bladder

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