BLADURIL TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

200,0 mg

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS FLAVOXATE HYDROCHLORIDE 200,0 mg

Authorization status:

Registered

Patient Information leaflet

Date of approval: 10 May 2022
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S2
BLADURIL, 200 MG FILM-COATED TABLETS
FLAVOXATE HYDROCHLORIDE
CONTAINS SUGAR (LACTOSE MONOHYDRATE): 64 MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING BLADURIL
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
BLADURIL has been prescribed for you personally and you should not
share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1. What BLADURIL is and what it is used for
2. What you need to know before you take BLADURIL
3. How to take BLADURIL
4. Possible side effects
5. How to store BLADURIL
6. Contents of the pack and other information
1. WHAT BLADURIL IS AND WHAT IT IS USED FOR
BLADURIL contains flavoxate hydrochloride. It is a non-specific,
direct-acting, smooth muscle
relaxant. BLADURIL is therefore an anti-spasmodic which works by
inhibiting contractions in
the urinary tract, thereby reducing urinary symptoms and associated
pain.
BLADURIL is used for its antispasmodic (preventing or relieving
spasms) action in urological
disorders (disorders of or relating to urinary tract.)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BLADURIL
DO NOT TAKE BLADURIL:
•
if you are hypersensitive (allergic) to flavoxate hydrochloride or any
of the other ingredients
of BLADURIL listed in section 6.
•
if you have a history of, suffer from or think you may have a blockage
of the stomach, bowel,
or urinary tract; or if you suffer from bleeding from the stomach or
bowel.
•
if you have an inability to swallow (achalasia).
Date of approval: 10 May 2022
PATIENT INFORMATION LEAFLET
•
if you are or think that you might be pregnant or if you are
breastfeeding.
•
if you suffer from urinary retention (the inability to empty the
bladder completely).
•
if you have glaucoma (increased pressure of the fluid inside the eye).
•
if you have a muscle disorder c

Summary of Product characteristics

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PROFESSIONAL INFORMATION
SCHEDULING STATUS
S2
1. NAME OF THE MEDICINE
BLADURIL 200 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg flavoxate hydrochloride.
Excipient with known effect:_ _
•
Contains sugar (lactose monohydrate): 64 mg
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
White, homogeneous film-coated tablets with “F200” embossed.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BLADURIL is indicated for its antispasmodic action in urological
disorders.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults -_ _Take one tablet three times a day (600 mg flavoxate
hydrochloride) for as long as
required.
_PAEDIATRIC POPULATION _
The safety and efficacy of BLADURIL in children aged < 12 years have
not been established
(see section 4.3).
METHOD OF ADMINISTRATION
BLADURIL is for oral use.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to flavoxate hydrochloride or to any of the
excipients of BLADURIL (see
section 6.1).
ADCOCK INGRAM LIMITED
BLADURIL, film-coated tablets
_Contains 200 mg flavoxate hydrochloride _
1.3.1.1 PROPOSED CLEAN PROFESSIONAL
INFORMATION
Version: 0003
_ _
Date of approval: 10 May 2022
•
Pyloric
or
duodenal
obstruction,
obstructive
intestinal
lesions
or
ileus,
achalasia,
gastrointestinal haemorrhage and obstructive uropathies of the lower
urinary tract.
•
Safety in pregnancy and lactation has not been established (see
section 4.6).
•
BLADURIL is not recommended for use in children under 12 years of age.
•
Urinary retention.
•
Glaucoma.
•
Myasthenia gravis.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
•
Since the renal clearance of the active metabolite accounts more than
50 % of the dose,
renal impairment may significantly affect the product kinetics.
Caution is therefore
required in patients with renal impairment.
•
BLADURIL should be used with caution in patients with suspected
glaucoma, especially
narrow angle glaucoma and in patients with seri