Sofenacin Plus 50 mg/5 mg 30 tablets

Sofenacin Plus 50 mg/5 mg 30 tablets

Сomposition:
Each modified release tablet contains:
- Mirabegron 50 mg
- Solifenacin succinate 5 mg (equivalent to 3.77 mg solifenacin).
Excipient:
Lactose monohydrate, Polyethylene Oxide 7,000,000, Microcrystalline Cellulose PH101, Hypromellose (Methocel K100), Quinoline yellow lake, Hydroxypropyl cellulose, Butylated hydroxytoluene, Butylated hydroxyanisole, Magnesium stearate, Copovidone, Croscarmellose sodium, Povidone K30, Opadry AMB Yellow coating (containing lecithin (soya)).
Description:
Sofenacin Plus is a combination product containing the β3-adrenoceptor agonist mirabegron and the antimuscarinic agent solifenacin, used to treat overactive bladder (OAB) symptoms.
It reduces urgency, urinary frequency and episodes of urgency incontinence in adult patients.
Indications for use:
- Symptomatic treatment of urgency, increased micturition frequency and/or urgency urinary incontinence in adults with overactive bladder (OAB) syndrome.
Dosage and method of administration:
Adults (including elderly):
The recommended dose is one tablet once daily.
Renal impairment:
- Mild and moderate: no dose adjustment for solifenacin; mirabegron dose depends on CYP3A inhibitors (see original table).
- Severe renal impairment: solifenacin max 5 mg/day; mirabegron not recommended.
- End-stage renal disease or haemodialysis: mirabegron not recommended.
Hepatic impairment:
- Moderate: solifenacin should not exceed 5 mg/day; mirabegron not recommended with strong CYP3A inhibitors.
- Severe hepatic impairment: mirabegron contraindicated.
Method of administration:
Tablets must be swallowed whole with water.
Do not chew, divide, or crush.
May be taken with or without food.
Contraindications:
- Hypersensitivity to the active substances or any excipients.
- Severe uncontrolled hypertension (SBP ≥180 mm Hg and/or DBP ≥110 mm Hg).
- Urinary retention, severe gastrointestinal disorders (including toxic megacolon), myasthenia gravis, narrow-angle glaucoma.
- Haemodialysis.
- Severe hepatic impairment.
- Severe renal impairment or moderate hepatic impairment in patients receiving strong CYP3A4 inhibitors.
- Pregnancy and breastfeeding.
Precautions:
- Rule out other causes of frequent urination (e.g., heart failure, renal disease).
- Treat urinary tract infection before starting therapy.
- Use with caution in renal or hepatic impairment.
- Monitor blood pressure (mirabegron may increase BP).
- Caution in patients with QT prolongation or taking QT-prolonging drugs.
- Use with caution in bladder outlet obstruction, GI obstruction, decreased GI motility.
- Caution with potent CYP3A4 inhibitors (ketoconazole, ritonavir, etc.).
- Risk of angioedema or anaphylaxis; discontinue immediately if symptoms occur.
- Product contains lactose-contraindicated in patients with lactose metabolism disorders.
Side effects:
Most common:
- Dry mouth
- Tachycardia
- Urinary tract infection
Other possible reactions:
- Headache, dizziness
- Constipation, nausea, abdominal pain
- Hypertension
- Urinary retention
- Visual disturbances (dry eyes, blurred vision)
- Skin reactions (rash, urticaria, itching)
- Angioedema.
Pregnancy and breastfeeding:
Pregnancy:
Not recommended during pregnancy due to insufficient data.
Lactation:
Mirabegron is excreted in animal milk; breastfeeding is not advised during therapy.
Storage conditions:
Store at a temperature not exceeding 30 °C. 
Store in a cool, dry place away from direct sunlight.
Keep out of reach of children.
Packaging:
Carton box containing 3 strips, each strip with 10 tablets, an insert leaflet.