Sofenacin 5 mg 30 tablets

Sofenacin 5 mg 30 tablets

Composition:
Active ingredient:
Solifenacin succinate 5 mg (equivalent to 3.8 mg solifenacin).
Excipients:
Lactose monohydrate, HPMC E5, Butylated hydroxylanisole (BHA), Maize starch, Magnesium stearate, Opadry AMB yellow.
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 required, may be increased to 10 mg once daily.
Renal impairment:
- Mild to moderate: no adjustment required.
- Severe impairment (ClCr ≤ 30 ml/min): max 5 mg once daily, use with caution.
Hepatic impairment:
- Mild: no adjustment required.
- Moderate impairment (Child-Pugh 7-9): max 5 mg once daily, use with caution.
Administration:
Swallow whole with liquid.
May be taken with or without food.
Contraindications:
- Urinary retention
- Severe gastrointestinal disorders (incl. toxic megacolon)
- Myasthenia gravis
- Narrow-angle glaucoma or risk thereof
- Hypersensitivity to solifenacin or excipients
- Haemodialysis
- Severe hepatic impairment
- Severe renal impairment or moderate hepatic impairment combined with potent CYP3A4 inhibitors.
Precautions:
Use with caution in:
- Bladder outlet obstruction;
- Obstructive gastrointestinal diseases;
- Decreased gastrointestinal motility;
- Severe renal impairment (≤ 30 ml/min);
- Moderate hepatic impairment;
- Concurrent potent CYP3A4 inhibitors;
- Hiatus hernia/GERD;
- Autonomic neuropathy.
Additional precautions (as provided):
- QT prolongation and torsade de pointes reported in at-risk patients.
- Not for use in hereditary lactose/galactose intolerance.
- Angioedema and anaphylactic reactions reported - discontinue if occur.
- Maximum therapeutic effect after 4 weeks.
Side Effects:
Very common:
Dry mouth.
Common:
Blurred vision, Constipation, Nausea, Dyspepsia, Abdominal pain.
Uncommon:
UTI, Cystitis, Somnolence, Dysgeusia, Dry eyes/nose/throat, Dry skin, Dysuria, GERD, Fatigue, Peripheral oedema.
Rare:
Dizziness, Headache, Colonic obstruction, Faecal impaction, Vomiting, Pruritus, Rash, Urinary retention.
Very rare:
Hallucinations, Confusional state, Erythema multiforme, Urticaria, Angioedema.
Not known:
Anaphylaxis, Decreased appetite, Hyperkalaemia, Delirium, Glaucoma, QT prolongation, Torsade de Pointes, Atrial fibrillation, Palpitations, Tachycardia, Dysphonia, Ileus, Liver disorders, Abnormal LFTs, Exfoliative dermatitis, Muscle weakness, Renal impairment.
Pregnancy and Breastfeeding:
Pregnancy:
No adequate human data.
Animal studies show no direct harm.
Use with caution.
Breastfeeding:
Excretion in human milk unknown.
In mice, excretion occurred with negative 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 containing 3 blisters of 10 film-coated tablets + leaflet.