Products

Sofenacin

Solifenacin Succinate 5 mg
Solifenacin Succinate 10 mg

Expand All
Collapse All

Active ingredient

Solifenacin succinate 5 mg
Solifenacin succinate 10 mg
 

Indications

Sofenacin is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency
, and urinary frequency.

Dosage and Administration

• The recommended dose of Sofenacin is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased
to 10 mg once daily. 
• Sofenacin should be taken with liquids and swallowed whole.
• Sofenacin can be administered with or without food.
• Dose Adjustment in Renal Impairment.
- For patients with severe renal impairment (CLcr < 30 mL/min).
- A daily dose of Sofenacin greater than 5 mg is not recommended. 
• Dose Adjustment in Hepatic Impairment.
- For patients with moderate hepatic impairment (Child-Pugh B).
- A daily dose of Sofenacin greater than 5 mg is not recommended.
- Use of Sofenacin in patients with severe hepatic impairment (Child-Pugh C) is not recommended.
• Dose Adjustment CYP3A4 Inhibitors.
- When administered with therapeutic doses of ketoconazole or other potent CYP3A4 inhibitors, a daily dose of Sofenacin greater than 5 mg is not recommended.

Contraindication

Sofenacin is contraindicated in patients with:
• Urinary retention.
• Gastric retention.
• Uncontrolled narrow-angle glaucoma.
• Hypersensitivity to the drug substance or other components of the product.

Side effects

The most common side effects with Sofenacin are:
• Blurred vision: Use caution while driving or doing dangerous activities until you know how Sofenacin affects you.
• Dry mouth.
• Constipation.
• Heat prostration (due to decreased sweating), can occur when drugs such as Sofenacin are used in a hot environment.

Drug Interaction

Do not exceed a 5 mg daily dose of Sofenacin when administered with therapeutic doses of ketoconazole or other potent CYP3A4 inhibitors.

Pregnancy and Lactation

Pregnancy
• Pregnancy Category C: Because animal reproduction studies are not always predictive of human response.
• Sofenacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• The effect of Sofenacin on labour and delivery in humans has not been studied. 
Lactation
• It is not known whether solifenacin is excreted in human milk. Because many drugs are excreted in human milk, Sofenacin should not be administered during nursing.
• A decision should be made whether to discontinue nursing or to discontinue Sofenacin in nursing mothers.

Warning and Precaution

  • Bladder Outflow Obstruction
    Sofenacin, like other anticholinergic drugs, should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. 
  • Gastrointestinal Obstructive Disorders and Decreased GI Motility.
    Sofenacin, like other anticholinergics, should be used with caution in patients with decreased gastrointestinal motility.
  • Controlled Narrow-Angle Glaucoma.
    Sofenacin should be used with caution in patients being treated for narrow-angle glaucoma. 
  • Reduced Renal Function.
    Sofenacin should be used with caution in patients with reduced renal function.
    Doses of Sofenacin greater than 5 mg are not recommended in patients with severe renal impairment (CLcr < 30 mL/min).

Package and Storage

• Package: 1 box containing 2 blisters, each of 10
- Tablets 5 mg yellow Tablets.
- Tablets 10 mg pink Tablets.
• Storage:
- Store Sofenacin at room temperature (15° to 30°C). Keep the bottle closed.
- Keep Sofenacin and all other medications out of the reach of children.

Mother Company

Manufactured by Marcyrl