BIO DOMPERIDONE 10 TABLET

국가: 남아프리카

언어: 영어

출처: South African Health Products Regulatory Authority (SAHPRA)

제공처:

Biotech Laboratories (Pty) Ltd

복용량:

See ingredients

약제 형태:

TABLET

구성:

EACH TABLET CONTAINS DOMPERIDONE 10,0 mg

승인 상태:

Registered

승인 날짜:

2012-02-11

환자 정보 전단

BIOTECH LABORATORIES (PTY) LTD
1.3.2 - Patient Information Leaflet
BIO-DOMPERIDONE 10, film-coated tablets
Each tablet contains 10 mg domperidone
_ _
Page
1
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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
BIO DOMPERIDONE 10, FILM-COATED TABLET
.
DOMPERIDONE
CONTAINS SUGAR (LACTOSE MONOHYDRATE, 58 MG PER TABLET).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING BIO
DOMPERIDONE 10
•
Keep the leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare provider.
•
BIO DOMPERIDONE10 has been prescribed for you personally and you
should not share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1. What BIO DOMPERIDONE10 is and what it is used for
2. What you need to know before you take BIO DOMPERIDONE10
3. How to take BIO DOMPERIDONE10
4. Possible side effects
5. How to store BIO DOMPERIDONE10
6. Contents of the pack and other information
1. WHAT BIO DOMPERIDONE 10 IS AND WHAT IT IS USED FOR
Domperidone, the active ingredient in BIO DOMPERIDONE10
increases the movements or contractions of
the stomach and bowel.
BIO DOMPERIDONE10 is used in adults and adolescents over 12 years of
age and weighing over 35 kg for:
•
Short term relief not exceeding 7 days for stomach discomfort due to
food moving slowly through the
stomach and intestines, where you may feel symptoms such as:
S4
BIOTECH LABORATORIES (PTY) LTD
1.3.2 - Patient Information Leaflet
BIO-DOMPERIDONE 10, film-coated tablets
Each tablet contains 10 mg domperidone
_ _
Page
2
of
11
o
fullness during or shortly after a meal,
o
a “heavy stomach”,
o
bloated feeling,
o
excessive belching,
o
passing wind (flatulence),
o
nausea and vomiting,
o
a burning feeling and/or pain in the stomach area,
•
Short term use not exceeding 7 days for discomfort due to backflow of
stomach acid, where you may
experience belching and/or heartburn,
•
Short term use not exceeding 7 days except when used for nausea and

제품 특성 요약

BIOTECH LABORATORIES (PTY) LTD
1.3.1.1 - Professional Information
BIO-DOMPERIDONE 10, film-coated tablets
Each tablet contains 10 mg domperidone
Page
1
of
14
SCHEDULING STATUS
S4
1 NAME OF THE MEDICINE
BIO DOMPERIDONE 10 Film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg domperidone.
Contains sugar (lactose monohydrate 58 mg per tablet.).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
White, round, film-coated, biconvex tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BIO DOMPERIDONE 10 is indicated in adults and adolescents over 12
years of age and weighing over 35 kg
for:
-
Short-term management (not exceeding 7 days) of delayed gastric
emptying of functional origin with
gastro-oesophageal reflux and/or dyspepsia.
-
Short term management (not exceeding 7 days) for control of nausea and
vomiting of central or local origin.
-
As an anti-emetic in patients receiving cytostatic and radiation
therapy for up to 4 weeks.
-
Facilitation of radiological examination of the upper gastrointestinal
tract administered at the time before
the examination as directed by the radiologist.
BIOTECH LABORATORIES (PTY) LTD
1.3.1.1 - Professional Information
BIO-DOMPERIDONE 10, film-coated tablets
Each tablet contains 10 mg domperidone
Page
2
of
14
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND ADOLESCENTS > 12 YEARS OF AGE AND > 35 KG
It is recommended to take oral BIO DOMPERIDONE 10, 15 – 30 minutes
before meals. If taken after meals,
absorption of the medicine is somewhat delayed.
The dose of BIO DOMPERIDONE 10 film-coated tablets should be the
lowest effective dose for the individual
situation (typically 30 mg/day) with a maximum daily oral dose of 30
mg.
If the conditions mentioned under indications are not resolved within
the time frames indicated, patients should
be re-evaluated and the need for continued treatment be assessed.
FORMULATION
(DOMPERIDONE PER UNIT)
DOSAGE
MAXIMUM DOSE PER DAY
Film-coated tablets