URISPAS 200 TABLET

Country: Մալայզիա

language: անգլերեն

source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

active_ingredient:

FLAVOXATE HYDROCHLORIDE

MAH:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN:

FLAVOXATE HYDROCHLORIDE

units_in_package:

90Tablet Tablets

manufactured_by:

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.

PIL

URISPAS 200 TABLET
Flavoxate hydrochloride (200mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What URISPAS is used for
2.
How URISPAS works
3.
Before you use URISPAS
4.
How to use URISPAS
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of URISPAS
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT URISPAS IS USED FOR
URISPAS is used to treat urinary tract
symptoms which may be a result of
inflammation. URISPAS can also be
used to relieve symptoms which may
occur as a result of surgery and
procedures such as cystoscopy or
catheterization.
HOW URISPAS WORKS
URISPAS contains flavoxate
hydrochloride which works by relaxing
the muscles in the bladder and helps to
relieve symptoms such as painful
urination, excessive urination at night,
inability to control urine flow and
associated pain.
BEFORE YOU USE URISPAS
-
_When you must not use it _
˗
if you are allergic to flavoxate
hydrochloride or any of the other
ingredients of this medicine (listed
in section inactive ingredients)
˗
if you have a gastrointestinal
obstruction/ bleeding
˗
if you have inability to swallow
˗
If you are not able to completely
empty your bladder (urinary
retention)
˗
if you have increased pressure in
your eye (glaucoma)
˗
if you have muscle weakness
_ _
_Pregnancy and lactation _
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine.
The safety of this medicine use during
pregnancy and lactation has not been
established. If you are pregnant or breast-
feeding, this medicine is not
recommended.
_ _
-
_Before you start to use it _
Talk to your doctor or pharmacist before
taking URISPAS:
-
If you have impaired kidney function.
Children
-
URISPAS should not be used in children
younger than 12 years of age.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescriptio

SPC

URISPAS 200
Flavoxate hydrochloride
PRESENTATION:
Each tablet contains 200 mg flavoxate hydrochloride.
MANUFACTURED BY:
Recordati Industria Chimica e Farmaceutica S.p.A., Via Matteo Civitali
1, 20148, Milan,
Italy
The white, film-coated tablets are embossed with “F200”.
USES:
Urispas is indicated for the symptomatic relief of dysuria, urgency,
nocturia, vesical
supra-pubic pain, frequency and incontinence as may occur in cystitis,
prostatitis,
urethritis, urethrocystitits and urethrotrigonitis.
In addition, the preparation is indicated for the relief of
vesico-urethral spams due to
the
catheterization,
cystoscopy
or
indwelling
catheters;
prior
to
cystoscopy
or
catheterization; sequelae of surgical intervention of the lower
urinary tract.
DOSAGE AND ADMINISTRATION:
Oral administration.
_Adults (including the elderly): _The recommended adult dosage is 200
mg three times
a day for as long as required.
_Children: _Not recommended for children under 12 years of age.
CONTRA-INDICATIONS:
- Hypersensitivity to the active substance or to any of the excipients
- Gastrointestinal obstructive conditions or ileus
- Gastro-intestinal haemorrhage
- Achalasia
- Urinary retention
- Glaucoma
- Myasthenia gravis.
SPECIAL PRECAUTIONS:
The use in children below the age of <12 years is not recommended.
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.
As the tablets contain lactose, its use is not recommended in patients
with rare
hereditary problems of galactose intolerance, the total lactase
deficiency or
glucose-galactose malabsorption.
SIDE EFFECTS:
The source of the below ADRs frequencies is represented by data
collected through
clinical trials, observational studies and spontaneous reporting.
In the table below, adverse reactions are reported and listed by
MedDRA system
organ class and frequency: very common (≥1/10); common (≥1/100 to
<1/10);
uncommon (≥1/