BETAFED SYRUP

Quốc gia: Nam Phi

Ngôn ngữ: Tiếng Anh

Nguồn: South African Health Products Regulatory Authority (SAHPRA)

Sẵn có từ:

Ranbaxy Pharmaceutical (Pty) Ltd û Roodepoort

Liều dùng:

See ingredients

Dạng dược phẩm:

SYRUP

Thành phần:

EACH 5,0 ml SYRUP CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30,0 mgTRIPROLIDINE HYDROCHLORIDE 1,25 mg

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

1998-01-06

Tờ rơi thông tin

Page 1 of 10
1.3.2 CURRENT APPROVED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S2
BETAFED SYRUP
Pseudoephedrine hydrochloride, Triprolidine hydrochloride
Preservatives:
Methyl hydroxybenzoate
0,18 % _m/v _
Propyl hydroxybenzoate
0,02 % _m/v _
Alcohol content 1,92 % _v/v _
Contains sugar:
Liquid glucose: 0,25 g /5 ml
Sorbitol 70 %: 2,5 ml / 5 ml
Glycerol: 0,25 ml / 5 ml
Contains sweetener: Saccharin sodium: 0,5 mg / 5 ml
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
BETAFED SYRUP is available without a doctor’s prescription, for you
to treat a mild illness.
Nevertheless, you still need to use BETAFED SYRUP carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share BETAFED SYRUP with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve.
WHAT IS IN THIS LEAFLET
1.
What BETAFED SYRUP is and what it is used for
Page 2 of 10
2.
What you need to know before you take BETAFED SYRUP
3.
How to take BETAFED SYRUP
4.
Possible side effects
5.
How to store BETAFED SYRUP
6.
Contents of the pack and other information
1.
WHAT BETAFED SYRUP IS AND WHAT IT IS USED FOR
BETAFED SYRUP is a medicine which is used to relieve the
symptoms
of
colds
and
allergies
including
sneezing,
runny
nose,
watery
eyes,
nasal
congestion and blocked sinuses. The liquid contains pseudoephedrine
hydrochloride, which is
a decongestant that relieves nasal and sinus congestion and
triprolidine hydrochloride which
is an antihistamine that helps stop sneezing, runny nose and watery
eyes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAFED SYRUP
DO NOT TAKE BETAFED SYRUP :
•
if you are hypersensitive (allergic) to triprolidine, pseudoephedrine
or any of the other
ingredients of BETAFED SYRUP (listed in section 6)
•
if you are taking, or have taken in the last two weeks, drugs for
DEPRESSION known as
Monoamine Oxidase Inhibitors (MAOIs), as this

Đặc tính sản phẩm

Page 1 of 9
1.3.1.1 CURRENT APPROVED PROFESSIONAL INFORMATION FOR MEDICINES FOR
HUMAN USE
SCHEDULING STATUS
S2
1.
NAME OF THE MEDICINE
BETAFED SYRUP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains:
Triprolidine HCl
1,25 mg
Pseudoephedrine HCl
30,00 mg
Preservatives:
Methyl hydroxybenzoate
0,18 % _m/v _
Propyl hydroxybenzoate
0,02 % _m/v _
_ _
Alcohol content 1,92 % _vv _
_ _
Contains sugar:
Liquid glucose: 0,25 g /5 ml
Sorbitol 70 %: 2,5 ml / 5 ml
Glycerol: 0,25 ml / 5 ml
Contains sweetener: Saccharin sodium: 0,5 mg / 5 ml
For full list of excipients, see section 6.1
Page 2 of 9
3.
PHARMACEUTICAL FORM
Syrup
A clear, bright yellow, slightly viscous, pleasant tasting syrup.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BETAFED SYRUP is indicated for the relief of symptoms associated with
colds and influenza
such as nasal and sinus congestion, allergic rhinitis, vasomotor
rhinitis and the common cold.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 12 years: 2 medicine measures (10 ml)
orally three times daily.
Children 6 to 12 years: 1 medicine measure (5 ml) orally three times
daily.
Children 2 to 5 years: ½ medicine measure (2,5 ml) orally three times
daily.
METHOD OF ADMINISTRATION
For oral use.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to pseudoephedrine hydrochloride, triprolidine
hydrochloride or to any of
the excipients listed in section 6.1.
•
BETAFED SYRUP is contraindicated in patients who are taking or have
taken monoamine
oxidase inhibitors within the preceding two weeks as this may cause a
rise in blood
pressure. The antibacterial agent furazolidone is known to cause a
dose-related inhibition
Page 3 of 9
of monoamine oxidase. For this reason BETAFED SYRUP and furazolidone
should not be
taken together.
•
BETAFED SYRUP is contraindicated during acute attacks of asthma.
•
BETAFED SYRUP is contraindicated in children under the age of 2 years.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use of BETAFED SYRUP may lead to drowsiness which is aggravated by
th