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Urocalm 5/10

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Solifenacin Succinate Tablets 5/10 mg




Each Film-Coated Tablet Contains:

Solifenacin Succinate BP 5 mg



Each Film-Coated Tablet Contains:

Solifenacin Succinate BP 10 mg


Product Description

UROCALM 5: Yellow coloured, circular, biconvex film coated tablets plain on both sides.

UROCALM 10: Pink coloured, circular, biconvex film coated tablets plain on both sides.


Indications and Usage

UROCALM is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of unintentional loss of urine (urinary incontinence) urgency, and urinary frequency.


Pharmacological properties

Mechanism of Action

Solifenacin is a competitive, specific cholinergic-receptor antagonist.


Muscarinic receptors (M3) play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle and stimulation of salivary secretion. solifenacin reduces smooth muscle tone in the bladder, allowing the bladder to retain larger volumes of urine and reducing the number of incontinence episodes.


Other special populations


No dosage adjustment based on patient age is required.


The pharmacokinetics of solifenacin has not been established in Paediatric children and adolescents.


The pharmacokinetics of solifenacin are not influenced by gender.


The pharmacokinetics of solifenacin are not influenced by race.

Renal impairment

The AUC and Cmax of solifenacin in mild and moderate renally impaired patients, was not significantly different from that found in healthy volunteers. Pharmacokinetics in patients undergoing haemodialysis have not been studied.




Hepatic Impairment

In patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) the Cmax is not affected, AUC increased with 60% and t1/2doubled. Pharmacokinetics of solifenacin in patients with severe hepatic impairment have not been studied.


Recommended 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 10 mg solifenacin succinate once daily.

Do not exceed 5 mg tablet once daily in patients with:

Use of UROCALM is not recommended in patients with severe hepatic impairment (Child-Pugh C).

Method of administration

Solifenacin succinate should be taken orally and should be swallowed whole with liguids. It can be taken with or without food.


Solifenacin is contraindicated in patients with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma in patients who have demonstrated hypersensitivity to the drug.

Warnings and Precautions

Other causes of frequent urination (heart failure or renal disease) should he assessed before treatment with Solifenacin. If urinary tract infection is present, an appropriate antibacterial therapy should be started.

Solifenacin should be used with caution in patients with:

Interactions with Other Medicaments

Drug Interactions

Drugs Metabolized by Cytochrome P450

At therapeutic concentrations, solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 derived from human liver microsomes .

Pharmacological interactions

The therapeutic effect of Solifenacin may be reduced by concomitant administration of cholinergic receptor agonists.

An interval of approximately one week should be allowed after stopping treatment with Solifenacin, before commencing other anticholinergic therapy.

Solifenacin can reduce the effect of medicinal products that stimulate the motility of the gastro-intestinal tract, such as metoclopramide and cisapride.

Effect of other medicinal products on the pharmacokinetics of solifenacin

Solifenacin is metabolised by CYP3A4. Simultaneous administration of ketoconazole (200 mg/day),a potent CYP3A4 inhibitors resulted in two fold increase of the AUC of Solifenacin Therefore, the maximum dose of Solifenacin should be restricted to 5 mg, when used simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors (e.g. ritonavir, nelfinavir, itraconazole).

Simultaneous treatment of solifenacin and a potent CYP3A4 inhibitor is contra-indicated in patients with severe renal impairment or moderate hepatic impairment.

Effect of solifenacin on the pharmacokinetics of other medicinal products

Oral Contraceptives

Intake of Solifenacin showed no pharmacokinetic interaction of sollfenacin on combined oral contraceptives (ethinylestradiol/ levonorgestrel).


Intake of Solifenacin did not alter the pharmacokinetics of R-warfarin or S-warfarin or their effect on prothrombin time.


Intake of Solifenacin showed no effect on the pharmacokinetics of digoxin.

Pregnancy and Lactation

Pregnancy- Category C

The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women.


The use of Solifenacin should be avoided during breast-feeding.

Adverse drug reactions

Blurred vision, Dry mouth, constipation, Nausea, Dyspepsia and Abdominal pain, Urinary tract infection, Cystitis, Somnolence, Dysgeusia, Dizziness, Headache, Dry eyes, Nasal dryness, Gastrosophageal reflux diseases, Dry throat, Colonic obstruction, Faecal impaction, Vomiting, Dry skin, Prurities, Rash, Difficulty in micturition, Urinary retention, Fatigue Peripheral edema. This is not a complete list of ADR and others may occur.

Overdose and Treatment


Overdosage with solifenacin succinate can potentially result in severe anticholinergic effects.


In the event of overdose with solifenacin succinate the patient should consult healthcare.


Store below 30°C. Protect from light and moisture.


Blister Pack of 10 x10 Tablets.


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