Sofenacin 10 mg 20 tablets

Sofenacin 10 mg 20 tablets

Composition:
Active substance:
Solifenacin succinate 10 mg (equivalent to 7.5 mg solifenacin).
Excipients:
Lactose monohydrate, HPMC E5, Butylated hydroxylanisole (BHA), Maize starch, Magnesium stearate, Opadry AMB pink.
Description:
Sofenacin is used to treat symptoms of overactive bladder.
It helps reduce frequent and sudden urges to urinate and episodes of urge incontinence.
The medicine decreases excessive detrusor activity and improves bladder control.
Indications:
Symptomatic treatment of:
- Urge urinary incontinence,
- Increased urinary frequency,
- Urgency episodes associated with overactive bladder syndrome.
Dosage and Method of Administration:
- Adults, including elderly:
Recommended dose: 5 mg once daily.
If needed, may be increased to 10 mg once daily.
- Renal impairment:
Mild and moderate: no dose change required.
Severe (ClCr ≤ 30 ml/min): do not exceed 5 mg daily, use with caution.
- Hepatic impairment:
Mild: no dose adjustment.
Moderate (Child-Pugh 7-9): do not exceed 5 mg daily, use with caution.
Administration:
Swallow whole with liquid; may be taken with or without food.
Contraindications
- Urinary retention
- Severe gastrointestinal conditions incl. toxic megacolon
- Myasthenia gravis
- Narrow-angle glaucoma or risk thereof
- Hypersensitivity to the active substance or excipients
- Haemodialysis
- Severe hepatic impairment
- Severe renal impairment or moderate hepatic impairment with potent CYP3A4 inhibitors.
Precautions:
Use with caution in:
- Bladder outflow obstruction
- Obstructive gastrointestinal disease
- Decreased GI motility
- Severe renal impairment
- Moderate hepatic impairment
- Concomitant CYP3A4 inhibitors
- Hiatus hernia/GERD
- Autonomic neuropathy
Additional precautions provided:
- QT prolongation and torsade de pointes may occur in predisposed patients.
- Not suitable for patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Angioedema and anaphylactic reactions reported; discontinue if occur.
- Maximum effect reached after 4 weeks.
Side Effects:
- Very common:
Dry mouth
- Common:
Blurred vision, Constipation, Nausea, Dyspepsia, Abdominal pain.
- Uncommon:
Urinary tract infection, Cystitis, Somnolence, Dysgeusia, Dry eyes, Dry nasal mucosa, Dry throat, Dry skin, Difficulty in micturition, Fatigue, Peripheral oedema, GERD.
- Rare:
Dizziness, Headache, Colonic obstruction, Faecal impaction, Vomiting, Pruritus, Rash, Urinary retention.
- Very rare:
Hallucinations, Confusional state, Erythema multiforme, Urticaria, Angioedema.
- Not known:
Anaphylaxis, Hyperkalaemia, Decreased appetite, Delirium, Glaucoma, QT prolongation, Torsade de Pointes, Atrial fibrillation, Palpitations, Tachycardia, Dysphonia, Ileus, Abdominal discomfort, Liver disorders and abnormal LFTs, Exfoliative dermatitis, Muscle weakness, Renal impairment.
Pregnancy and Breastfeeding:
Pregnancy:
Insufficient clinical data.
Animal studies show no direct harmful effects.
Use with caution.
Breastfeeding:
Human milk excretion unknown.
In mice, excreted in milk with adverse effects on offspring.
Use not recommended.
Storage Conditions:
Store below 30°C, in a dry place.
Keep out of reach of children.
Packaging:
Carton box with 2 strips of 10 film-coated tablets + leaflet.