PHARMACOLOGICAL CLASSIFICATION: A.18 (drugs acting on genito-urinary system).
PHARMACOLOGICAL ACTION: Spasmo-Urgenin relaxes smooth muscles and prevents renewed spasm; in this way it abolishes pain.
INDICATIONS: For relief of painful urinary symptoms and tenesmus in acute or chronic prostatitis, adenoma of the prostate (benign prostatic hypertrophy) in the early stages, prostatism, irritable bladder, cystitis (including post-irradiation cystitis), urethritis, bladder neck fibrosis; also for pain after instillation, bouginage and other diagnostic or operative procedures.
CONTRA-INDICATIONS: Acute retention of urine; cases of prostatic enlargement in which surgical treatment is indicated (excessive residual urine); glaucoma.
DOSAGE AND DIRECTIONS FOR USE: Unless otherwise directed the usual dose is 2 dragees three times daily after meals. It is advisable to continue treatment for a reasonable length of time. Spasmo-Urgenin may be safely taken at the same time as other drugs such as antibiotics, sulphonamides and hormones, or during spa treatment or radiotherapy. The diet should be light and free from irritants.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Gastric upsets and diarrhoea are rare and are seen only in patients predisposed to such disorders.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: There have been no reports of overdosage with the use of Spasmo-Urgenin. However, should overdosage occur, the treatment is the same as after intoxication with parasympatholytics. The use of neostigmine I.M. or I.V. as an antagonist is recommended.
CONDITIONS OF REGISTRATION: None.
IDENTIFICATION: White sugar-coated tablets.
PRESENTATION: Packs of 40 and 100 dragees.
STORAGE INSTRUCTIONS: Keep in a cool, dry place (below 25°C). Keep container tightly closed. Keep out of reach of children.
REGISTRATION NUMBER: D/18/239.
NAME AND BUSINESS ADDRESS OF THE APPLICANT: MADAUS PHARMACEUTICALS (PTY) LTD
2nd Road (cnr. 16th Road)
Randjespark Midrand 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 4/10/71
POSTAL ADDRESS: MADAUS PHARMACEUTICALS (PTY) LTD
P O Box 3435,
Halfway House, 1685