Bisacodyl Laxative (PSM Healthcare)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Bisacodyl 5mg

Available from:

PSM Healthcare Ltd trading as API Consumer Brands

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 L 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

NEW ZEALAND CONSUMER MEDICINE INFORMATION
New Zealand CMI
Page 1 of 6
BISACODYL LAXATIVE (PHARMACY HEALTH)
EACH ENTERIC COATED TABLET CONTAINS 5 MG BISACODYL BP/PH. EUR
GASTRO RESISTANT TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Bisacodyl Laxative.
It does not contain all available information, nor does it take the
place of talking to your
doctor or pharmacist. Keep this information with your Bisacodyl
Laxative. You may
need to read it again.
To find out more about Bisacodyl Laxative
You should ask your doctor or pharmacist if you have any questions
about Bisacodyl
Laxative or if you have any trouble before, during or after using it.
WHAT BISACODYL LAXATIVE IS USED FOR
Bisacodyl Laxative is mainly used for the treatment of constipation.
Under medical supervision, Bisacodyl Laxative can be used for the
evacuation of the
bowel before a radiological examination or as an enema alternative.
Bisacodyl Laxative works by acting on the lining of the lower bowel to
stimulate
movement and promotes accumulation of water into the bowel to produce
soft
formed stools.
Bisacodyl Laxative is ineffective in altering the digestion or
absorption of calories or
essential nutrients in the small intestine.
BEFORE YOU USE BISACODYL LAXATIVE
_WHEN YOU MUST NOT USE _
_BISACODYL LAXATIVE_
_ _
Do not use Bisacodyl Laxative if you are allergic to Bisacodyl or any
of the other
ingredients in Bisacodyl Laxative. All the ingredients in Bisacodyl
Laxative are under
Product Description.
Some of the symptoms of an allergic reaction may include:
• shortness of breath, wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin
Do not use Bisacodyl Laxative if you have, or have had, any of the
following conditions:
• an acute abdominal condition including appendicitis
• acute inflammatory bowel disease
• severe abdominal pain associated with nausea and vomiting
• blockage of the bowel (ileus)
• a blockage of the intestine
�

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 6
1
PRODUCT NAME
Bisacodyl Laxative
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Bisacodyl Laxative contains bisacodyl 5 mg.
For a full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Enteric coated tablet.
Presentation
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 Laxative 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 Laxative 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 Laxative
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.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 6
Bisacodyl Laxative
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 Special warnings and precautions for
use) the use of the
product is contraindicated.