SOLFISAN 5/MG FC TAB 30/FC TAB

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

Overactive bladder (adults): 5 mg orally once daily initially; may increase to 10 mg once daily if needed and tolerated; maximum 10 mg/day (do not exceed 5 mg/day with strong CYP3A4 inhibitors or in severe renal impairment/moderate hepatic impairment).

Initial Dose

5 mg once daily

Maintenance Dose

5 mg to 10 mg once daily

Maximum Dose

10 mg once daily

Children's Dosage

Not approved for children in tablet form. Oral suspension is used for neurogenic detrusor overactivity in children aged 2 years and older, with dosing based on body weight.

Dose Adjustment Notes

For patients with severe renal impairment (CrCl < 30 mL/min), moderate hepatic impairment (Child-Pugh B), or those taking strong CYP3A4 inhibitors (e.g., ketoconazole), the maximum dose should not exceed 5mg once daily. Not recommended for patients with severe hepatic impairment (Child-Pugh C).

How to Take

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

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (>10%): Dry mouth. Common (1-10%): Constipation, blurred vision. (Other common effects reported in labeling include nausea/dyspepsia; urinary retention and QT prolongation are uncommon/rare but clinically important warnings rather than typical frequent events.)

Safety & Warnings

Contraindications

Urinary retention; gastric retention; uncontrolled narrow‑angle glaucoma; hypersensitivity to solifenacin/excipients; severe hepatic impairment; severe renal impairment (CrCl <30 mL/min) when used with strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole/ritonavir).

Warnings & Precautions

Use caution in bladder outlet obstruction; decreased GI motility/obstructive GI disorders; controlled narrow‑angle glaucoma; renal impairment and moderate hepatic impairment; risk factors for QT prolongation; CNS effects (somnolence/confusion) especially in elderly; heat prostration risk due to reduced sweating; reflux/hiatus hernia is a recognized caution in some labeling.

Age Restriction

Not recommended/approved for patients <18 years (safety and efficacy not established).

Driving Warning

May cause dizziness or drowsiness; avoid driving or operating machinery until you know how it affects you.

Drug Interactions

Drug Interactions

Strong CYP3A4 inhibitors increase solifenacin exposure (dose limit/avoid in severe renal or moderate hepatic impairment); CYP3A4 inducers may reduce effect; additive anticholinergic effects with other anticholinergics; caution with QT‑prolonging drugs in at‑risk patients.

Interaction Severity

MAJOR: Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir/cobicistat) - increased exposure; do not exceed 5 mg/day. MODERATE: QT-prolonging drugs (additive QT risk, especially in predisposed patients); other anticholinergics (additive anticholinergic effects); CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St John’s wort) may reduce efficacy.

Food Interaction

No clinically significant food effect; may be taken with or without food; avoid/limit grapefruit or grapefruit juice (CYP3A4 inhibition may increase exposure).

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children in tablet form. Oral suspension is used for neurogenic detrusor overactivity in children aged 2 years and older, with dosing based on body weight.

Elderly

Standard adult dosing (5 mg once daily); use with caution due to increased risk of anticholinergic side effects including cognitive impairment and urinary retention; no routine dose reduction required based on age alone

Kidney Impairment

CrCl ≥30 mL/min: no adjustment; CrCl <30 mL/min: do not exceed 5 mg once daily.

Liver Impairment

Mild (Child-Pugh A): No adjustment needed. Moderate (Child-Pugh B): Do not exceed 5 mg once daily. Severe (Child-Pugh C): Contraindicated

Storage & Patient Advice

Stopping the Medicine

Can be stopped without taper; symptoms of overactive bladder may return-stop based on clinician advice if possible.

Overdose

Expect anticholinergic toxicity (e.g., mydriasis/blurred vision, dry mouth/skin, tachycardia, agitation/confusion, urinary retention, decreased GI motility, hyperthermia); management is supportive, consider activated charcoal if early, and physostigmine may be used in severe central anticholinergic syndrome under expert supervision; seek urgent care/poison center.

Patient Counseling

Take 1 tablet once daily at the same time, with or without food; swallow whole. Common effects include dry mouth and constipation-maintain hydration and fiber; seek care for inability to urinate, severe constipation/abdominal pain, or palpitations. May cause blurred vision/dizziness/drowsiness-avoid driving until effects are known. Reduced sweating/heat intolerance can occur-avoid overheating. Tell your clinician about all medicines, especially strong CYP3A4 inhibitors and QT-prolonging drugs.

Monitoring Requirements

Monitor clinical response and anticholinergic adverse effects (dry mouth, constipation, blurred vision, cognitive/CNS effects), and assess for urinary retention; consider ECG/QT risk assessment in patients with risk factors or on QT-prolonging drugs; monitor renal/hepatic function when impairment is present to guide dosing.

Pharmacology

Mechanism of Action

Competitive muscarinic receptor antagonist with relative M3 selectivity in the bladder, reducing acetylcholine-mediated detrusor contractions to decrease urgency, frequency, and urge incontinence.

Duration of Effect

Approximately 24 hours, allowing for once-daily dosing.

Bioavailability

Approximately 90%.

Metabolism

Extensively hepatically metabolized primarily by CYP3A4 to multiple metabolites (including 4R-hydroxy solifenacin).

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 direct OTC alternative to solifenacin for overactive bladder.

Urological Condition

Overactive Bladder

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