SOLIFEN Tablet

Indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency or frequent micturition.

Dosage

SOLIFEN should be taken with liquids and swallowed whole. SOLIFEN can be administered with or without food.

Adults

The recommended dose is 5mg once daily. If needed, the dose may be increased to 10mg once daily.

Patients with renal impairment

No dose adjustment is necessary for patients with mild to moderate renal impairment (CLcr>30mL/min). Patients with severe renal impairment (CLcr<30mL/min) should be treated with caution and receive no more than 5mg once daily.

Patients with hepatic impairment

No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Push score of 7-9) should be treated with caution and receive no more than 5mg once daily.

Potent Inhibitors of CYP3A4

Maximum dose of 5mg is recommended in the patients receiving drugs such as ketoconazole or ritonavir that are strong inhibitors of the CYP450 isoenzyme CYP3A4.

In patients with

- Hypersensitivity to the active substance or to any of the excipients.

- Urinary retention.

- Gastric retention.

- Uncontrolled narrow-angle glaucoma.

- Myasthenia gravis.

- Patients undergoing hemodialysis.

- Patients with severe hepatic impairment and renal impairment.

Solifenacin succinate should not be used in children as safety and efficacy in children have not yet been established.

Very common: Dry mouth

Common: Constipation, nausea, dyspepsia, abdominal pain, blurred vision.

Uncommon: Gastroesophageal reflux diseases, dry throat, urinary tract infection, cystitis, somnolence, dysgeusia, dry eyes, fatigue, peripheral edema, nasal dryness, dry skin, difficulty in micturation.

Rare: Colonic obstruction, fecal impaction, urinary retention.

- Drugs having anticholinergic properties

- Drugs that stimulate the motility of gastrointestinal tract (e.g., metoclopramide, cisapride)

- CYP3A4 inhibitors: CYP3A4 substrates with higher affinity (e.g., ketoconazole, verapamil, diltiazem), CYP3A4 inducers (e.g., rifampacin, phenytoin, carbamazepin).

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Solifenacin succinate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether solifenacin succinate is excreted in human milk. Because many drugs are excreted in human milk, solifenacin succinate should not be administered during nursing. A decision should be made whether to discontinue nursing or to discontinue solifenacin succinate in nursing mothers.

Solifenacin succinate should be administered with caution to patients:

- with clinically significant bladder outflow obstruction because of the risk of urinary retention.

- with decreased gastrointestinal motility.

- being treated for narrow-angle glaucoma.

- with reduced renal function.

- with reduced hepatic function.

- of hiatus hernia/Gastroesophageal reflux who are concurrently taking medicinal products (such as bisphosphonates) that cause or exacerbate oesophagitis.

Hereditary problems

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-glucose malabsorption should not take this medicinal product.

Congenital or Acquired QT prolongation

Caution should be taken for the patients with known history of QT prolongation or the patients who are taking the medications known to prolong the QT interval.

Solifenacin is a competitive, muscarinic acetylcholine receptor antagonist. The binding of acetylcholine to these receptors, particularly the M3 receptor subtype, plays a critical role in the contraction of smooth muscles. By preventing the binding of acetylcholine to these receptors, solifenacin reduces smooth muscle tone in the bladder, allowing the bladder to retain larger volumes of urine and reducing the number of micturition, urgency and incontinence episodes.