Bisacodyl Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Bisacodyl 5mg

Available from:

Viatris Limited

INN (International Name):

Bisacodyl 5 mg

Dosage:

5 mg

Pharmaceutical form:

Enteric coated tablet

Composition:

Active: Bisacodyl 5mg Excipient: Carnauba wax Hyprolose Hypromellose Methacrylic acid copolymer, Eudragit S 100 Iron oxide yellow Isopropyl alcohol Lactose monohydrate Magnesium stearate   Methacrylic acid copolymer Microcrystalline cellulose Purified talc Purified water   Starch Sucrose Titanium dioxide Triethyl citrate

Prescription type:

Pharmacy only

Manufactured by:

Dishman Carbogen Amcis Limited

Therapeutic indications:

Short term relief of constipation

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al or PVC/PVDC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al or PVC/PVDC/Al - 50 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al or PVC/PVDC/Al - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al or PVC/PVDC/Al - 150 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al or PVC/PVDC/Al - 200 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2017-07-28

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
BISACODYL VIATRIS
_BISACODYL ENTERIC COATED TABLET 5 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Bisacodyl
Viatris.
This leaflet answers some common
questions about Bisacodyl Viatris.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Bisacodyl
Viatris against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT BISACODYL
VIATRIS IS USED FOR
Bisacodyl Viatris is used to treat
constipation.
Under medical supervision,
Bisacodyl Viatris can be used for
the evacuation of the bowel before
a radiological examination or as an
enema alternative.
Bisacodyl Viatris contains the active
ingredient bisacodyl. It belongs to a
group of medicines called stimulant
laxatives.
It works by acting on the lining of
the lower bowel to stimulate
movement and promotes
accumulation of water into the
bowel to product soft formed stools.
Bisacodyl Viatris is ineffective in
altering the digestion or absorption
of calories or essential nutrients in
the small intestine.
Stimulant laxatives including
Bisacodyl Viatris do not help with
weight loss.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine can be purchased
from a pharmacist without a doctor’s
prescription.
BEFORE YOU TAKE
BISACODYL VIATRIS
_WHEN YOU MUST NOT [TAKE _
_IT_
DO NOT TAKE BISACODYL VIATRIS IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
bisacodyl
•
any of the ingredients listed
at the end of this leaflet.
•
Some of the symptoms of
an allergic reaction may
include: shortness of
breath; wheezing or
difficulty breathing; swelling
of the face, lips,

Summary of Product characteristics

Page 1 of 6
NEW ZEALAND DATA SHEET
BISACODYL VIATRIS
1. PRODUCT NAME
Bisacodyl Viatris, 5 mg, enteric coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric coated tablet contains 5 mg of bisacodyl.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Yellow round biconvex coated tablets.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
For short term relief of constipation.
In preparation for diagnostic procedures, in pre- and postoperative
treatment and in conditions
which require defecation, the use of Bisacodyl Viatris must be under
medical supervision.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
Unless otherwise prescribed by a physician, the following dosages are
recommended:
Adults and children over 10 years: 1 to 2 coated tablets at night (5
to 10 mg).
Children 4 to 10 years: One coated tablet at night (5 mg).
Notes: Bisacodyl Viatris tablets are coated. The tablets should be
taken at night to produce
evacuation the following morning. They should be swallowed whole with
adequate fluid.
The coated tablets should not be taken together with products reducing
the acidity of the upper
gastrointestinal tract, such as milk, antacids or certain proton pump
inhibitors, in order not to
prematurely dissolve the enteric coating.
_4.3_
_CONTRAINDICATIONS_
Bisacodyl Viatris should not be used by patients with ileus,
intestinal obstruction, acute surgical
abdominal conditions including appendicitis, acute inflammatory bowel
diseases, and severe
abdominal pain associated with nausea and vomiting which may be
indicative of more severe
conditions.
Page 2 of 6
Bisacodyl
Viatris
is
also
contraindicated
in
severe
dehydration
and
in
patients
with
known
hypersensitivity to bisacodyl or any other component of the product.
In case of rare hereditary conditions that may be incompatible with an
excipient of the product
(refer to section 4.4) the use of the product is contraindicated.
_4.4_
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE_
As with all laxative