- Approval Id
- c7553fe24ea99e97
- Drug Name
- DALISOON F.C. TABLETS 5MG
- Product Name
- DALISOON F.C. TABLETS 5MG
- Approval Number
- SIN16679P
- Approval Date
- 2023-01-18
- Registrant
- NOVEM HEALTHCARE PTE LTD
- Licence Holder
- NOVEM HEALTHCARE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **DOSAGE AND ADMINISTRATION**
_Adults, including the elderly_
The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to a maximum of 10 mg solifenacin succinate once daily.
_Children and adolescents_
Solifenacin succinate is not indicated for treatment of OAB in the pediatric population.
**Special populations**
_Patients with renal impairment_
No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance >30 ml/min). Patients with severe renal impairment (creatinine clearance ≤30 ml/min) should be treated with caution and receive no more than 5 mg once daily.
_Patients with hepatic impairment_
No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh B) should be treated with caution and receive no more than 5 mg once daily. Dalisoon is not recommended for patients with severe hepatic impairment (Child-Pugh C).
_Co-medication_
The maximum dose of Dalisoon should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4- inhibitors e.g. ritonavir, nelfinavir, itraconazole, cyclosporin, macrolide antibiotics (see also INTERACTIONS WITH OTHER DRUGS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**Method of administration**
Dalisoon should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.
- Route Of Administration
- ORAL
- Indication Info
- **INDICATIONS**
Dalisoon is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.
- Contraindications
- **CONTRAINDICATIONS**
Solifenacin is contraindicated in
- patients with urinary retention
- patients with uncontrolled narrow-angle glaucoma
- patients who have demonstrated hypersensitivity to the drug substance or other components of the product
- severe gastro-intestinal condition (including toxic megacolon and gastric retention)
- myasthenia gravis
- patients undergoing haemodialysis
- patients with severe hepatic impairment
- patients with severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole
- Atc Code
- G04BD08
- Atc Item Name
- solifenacin
- Pharma Manufacturer Name
- NOVEM HEALTHCARE PTE LTD
- Company Detail Path
- /organization/3defe21a39b9ebea/novem-healthcare-pte-ltd
