DICETEL 100MG FILM-COATED TABLET

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

PINAVERIUM BROMIDE

Disponible depuis:

ABBOTT LABORATORIES (M) SDN. BHD.

DCI (Dénomination commune internationale):

PINAVERIUM BROMIDE

Unités en paquet:

20Tablet Tablets

Fabriqué par:

Mylan Laboratories SAS

Notice patient

DICETEL FILM-COATED TABLET
PINAVERIUM BROMIDE 100MG
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
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
Each film-coated tablet contains 100mg
of pinaverium. 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 _
Do not take Dicetel tablet if you have
any allergies or have had a reaction to
any of the ingredient in Dicetel (see
Ingredients).
-
_Before you start to use it _
If you are lactose intolerant, talk to your
doctor, as this product contain lactose.
-
_Taking other medicines _
Tell your doctor or prescriber about all
prescription, over-the-counter
(nonprescription), and herbal
medications that you are taking. Also tell
them about any supplements you take.
Since caffeine, alcohol, the nicotine from
cigarettes, or street drugs can affect the
action of many medications, you should
let your prescriber know if you use them.
HOW TO USE DICETEL
The tablet should be swallowed whole
with a glass of water during meals; do
not crush, chew or suck the tablet. The
tablet should not be swallowed when in
the lying position or just before bedtime.
-
_How much to use _
The usual adult dosage is 1 tablet two
times daily. The dosage may be
increased up to a maximum of 1 tablet
three times daily.
-
_When to use it _
Take only as directed by your doctor.
-
_How long to use it _
Continue using Di

Résumé des caractéristiques du produit

DICETEL
PINAVERIUM BROMIDE
PRODUCT NAME
Dicetel 100mg Film-Coated Tablet
BRAND NAME
Dicetel
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: pinaverium bromide.
Each film-coated tablet contains 100mg of pinaverium bromide
For full list of excipients, see section list of excipients.
PHARMACEUTICAL FORM
Round biconvex, yellowish-orange coloured film-coated tablet for oral
administration, engraved with “100”
on one side and 11mm in diameter.
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
_Adults _
▪
The recommended dosage is 1 tablet twice a day
▪
If necessary, this dosage may be increased to 1 tablet three times a
day
_Paediatric population _
The safety and efficacy of Dicetel have not sufficiently been
established in children and experience is
limited (see section warning and precautions).
METHOD OF ADMINISTRATION
The tablets must be swallowed without being chewed or sucked, with a
glass of water in the middle of a
meal in order to avoid contact of pinaverium with the oesophageal
mucosa (risk of oesophageal lesion, see
section side effects).
The tablet should not be swallowed when in the lying position or just
before bedtime.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
WARNING AND PRECAUTIONS
▪
Because of a risk of oesophageal lesion, instructions on the methods
of administration should be
carefully adhered to. Patients with pre-existing oesophageal lesion
and/or hiatus hernia should pay
special attention to correct application of Dicetel.
▪
The safety and efficacy of Dicetel have not sufficiently been
established in children and experience
is limited. Therefore, Dicetel is not recommended for use in children.
▪
This medicinal product contains Lactose. Patients with rare hereditary
problems of galactose
intolerance, the Lapp lactase def