NOVOLAX TABLET 5MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Bisacodyl

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

Bisacodyl

Unit dalam pakej:

105Tablet Tablets

Dikeluarkan oleh:

KRKA

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NOVOLAX TABLET
Bisacodyl (5mg)
1
WHAT IS IN THIS LEAFLET
1.
What Novolax is used for
2.
How Novolax works
3.
Before you use Novolax
4.
How to use Novolax
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Novolax
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT NOVOLAX IS USED FOR
Novolax is used:

for relief of acute and chronic
constipation.

for evacuation of the colon in
preparation for the radiologic
examination or surgical operation of
abdomen.
Novolax is intended for use in adults
and children over 4 years of age.
HOW NOVOLAX WORKS
Novolax coated tablets contain the
active substance bisacodyl,
a laxative, which acts in stimulation of
defecation, reduction of transit time,
and softening of the stool. This
specifically stimulates the natural
evacuation process in the lower region
of the gastrointestinal tract. The tablets
are effective in 6 to 12 hours.
BEFORE YOU USE NOVOLAX
-
_When you must not use it_

if you are allergic (hypersensitive)
to bisacodyl or any of the other
ingredients of Novolax;

if you have an abdominal condition
sudden in onset, such as
appendicitis;

if you have a blocked bowel
(intestinal obstruction);

if you have noticed intestinal
bleeding.
-
_Before you start use it_
Prolonged excessive use may lead to
fluid and electrolyte imbalance and
hypokalemia. Intestinal loss of fluids
can promote dehydration which may be
harmful and Novolax Tablets should be
discontinued and only be restarted
under medical supervision.
Stimulant laxatives including
bisacodyl do not help with weight
loss.
-
_Taking other medicines_
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines, including
medicines obtained without a
prescription.
Use of adrenocorticosteroids or
diuretics with Novolax may increases
the risk of abnormal concentration of
electrolytes in the body which may
affect the heart. Concomitant use of
other laxatives may

Ciri produk

1.3.1
Bisacodyl
SPC, Labeling and Package Leaflet
SmPCPIL163126_3
– Updated: 29.06.2021
Page 1 of 5
NOVOLAX
_Bisacodyl _
NAME OF THE MEDICINAL PRODUCT
Novolax 5 mg coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 5 mg bisacodyl.
The coated tablets are round, biconvex, yellow, coated tablets with
smooth and shiny surface.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS

_In acute constipation: _atonic, spastic, constipation due to
haemorrhoids, changes of nutrition.

_In Chronic constipation:_ habitual, constipation in bed-ridden
patients.

For evacuation of the colon in preparation for the radiological
examination or surgical
operation of abdomen.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Children aged 10 years or younger with chronic constipation should
only be treated under the guidance
of a physician. Bisacodyl should not be used in children younger than
4 years old.
Short-term treatment for constipation:
_ _
_Adults and children over 10 years: _
1 - 2 coated tablets (5 - 10 mg) daily before bedtime.
_ _
_Children 4 - 10 years: _
1 coated tablet (5 mg) daily before bedtime.
For preparation of diagnostic procedures and preoperatively
Should only be used under medical supervision.
_ _
_Adults and children over 10 years: _
2 coated tablets (10 mg) in the morning and 2 coated tablets (10 mg)
in the evening and 1 suppository
(10 mg) on the following morning is recommended.
_Children 4-10 years of age: _
1.3.1
Bisacodyl
SPC, Labeling and Package Leaflet
SmPCPIL163126_3
– Updated: 29.06.2021
Page 2 of 5
1 coated tablet (5 mg) in the evening and 1 suppository (5 mg) on the
following morning is
recommended.
Method of administration
The tablets should be swallowed whole with some liquid (not milk).
They should not be chewed or
crushed as they might irritate the gastric mucous membrane.
During treatment with Novolax, sufficient amounts of liquid should be
consumed.
The tablets are best taken in the evening at bedtime, but they can
also be taken in the morning. They
produc