Dicetel 50mg Film-Coated Tablet

Country: Malaysia

Language: English

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

Active ingredient:

PINAVERIUM BROMIDE; PINAVERIUM BROMIDE

Available from:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (International Name):

PINAVERIUM BROMIDE; PINAVERIUM BROMIDE

Units in package:

20tablet Tablets

Manufactured by:

Mylan Laboratories SAS

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
DICETEL
® FILM COATED TABLET
_ _
Pinaverium bromide (50mg)
1
WHAT IS IN THIS LEAFLET
1. What Dicetel® is used for
2. How Dicetel® works
3. Before you use Dicetel®
4. How to use Dicetel®
5. While you are using it
6. Side effects
7. Storage and disposal of Dicetel®
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT DICETEL®
IS USED FOR
Dicetel® treats and relieves the
symptoms associated with irritable
bowel syndrome (IBS) such as
abdominal pain, bowel disturbances
(constipation and/or diarrhea) and
intestinal discomfort (bloating).
Dicetel is also used to help relieve
symptoms caused by certain disorders
of the gallbladder associated with
secretion of bile.
HOW DICETEL® WORKS
Dicetel® works by relaxing the
muscles in the walls of the gut (also
called intestine).
BEFORE YOU USE DICETEL®
_- When you must not use it _
•
If you are allergic to
pinaverium bromide or any
of the ingredients listed at
the end of this leaflet
_ _
_- Before you start to use it _
Discuss with your doctor or
pharmacist before taking your
medicine if:
•
You have lesion on your
esophagus and/or hiatus
hernia (a condition where
part of your stomach moves
up into your chest)
•
You have gastrointestinal
movement disorder due to
structural changes on organ
or tissue
_- Taking other medicines _
It is particularly important to tell your
doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines. This also
concerns medicines obtained without
a prescription including herbal
medicines.
HOW TO USE DICETEL®
_- How much to use _
Always take Dicetel® exactly as your
doctor has told you. You should
check with your doctor or pharmacist
if you are not sure.
The recommended dosage is 1 tablet
three times a day. If necessary, your
doctor may increase this dosage to 6
tablets per day.
Swallow the tablets without chewing
or sucking them.
_ _
_- When to use it _
Take the tablets with a glass of water
in the middle

Summary of Product characteristics

Clear copy 090211
_Dicetel_
®
50 mg
Film-coated tablets
_Dicetel_
®
100 mg
Film-coated tablets
50 or 100 mg pinaverium bromide
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
Keep this leaflet. You may need to read it again. If you
have questions not answered by this pamphlet, please
ask your doctor or pharmacist. This medicine has been
prescribed to you personally and you should not pass it
on to others. It may harm them, even if their symptoms
are the same as yours.
Dicetel film-coated tablets are orange coloured film-
coated tablets for oral administration, engraved with
“50” or “100” on one side (depending on the tablet
strength)
and
“S”
on
the
other
side.
Each
tablet
contains 50 mg or 100 mg of pinaverium bromide which
is
equivalent
to
43.25mg
or
86.5mg
Pinaverium
respectively.
Excipients (non-medicinal ingredients):
_Core: _ microcrystalline cellulose, pre-gelatinised starch,
lactose monohydrate, anhydrous colloidal silica, talc,
magnesium stearate.
_Coating: _
basic
butylated
metacrylate
copolymer,
sodium laurylsulfate, stearic acid, talc, microcrystalline
cellulose,
aluminium
lake
“sunset
yellow”
(E110),
titanium dioxide (E171), hydroxypropyl methylcellulose.
INDICATIONS
•
Treatment and relief of symptoms associated with
irritable bowel syndrome (IBS): abdominal pain,
bowel disturbances and intestinal discomfort.
•
Treatment
of
symptoms
related
to
functional
disorders of biliary tract.
DOSAGE AND ADMINISTRATION
Always
take
Dicetel
exactly
as
your
doctor
has
prescribed. If you have any questions, contact your
doctor or pharmacist.
If you forget to take your tablet(s), do not take a double
dose
to
compensate
for
it.
If
you
require
further
information, please ask your doctor or pharmacist for
advice.
Adults:
• _Dicetel 50 mg, fi lm-coated tablets: _
The usual adult dosage is one tablet three times a day
(total
daily
dose
of
150mg).
The
dosage
may
be
increased up to a maximum of 2 tablets taken three
times a day. (maximum total daily dose of 300 mg)
• _Dicet