Difflam Forte Anti-Inflammatory Throat Spray 0.3%wv

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BENZYDAMINE HYDROCHLORIDE

Boleh didapati daripada:

iNova Pharmaceuticals (Singapore) Pte Ltd (incorporated In Singapore) Malaysia Branch

INN (Nama Antarabangsa):

BENZYDAMINE HYDROCHLORIDE

Unit dalam pakej:

15 ml

Dikeluarkan oleh:

Aziende Chimiche Riunite Angelini Francesco ACRAF SPA

Risalah maklumat

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DIFFLAM FORTE ANTI-INFLAMMATORY
THROAT SPRAY 0.3%W/V
Benzydamine hydrochloride (0.3%w/v)
WHAT IS IN THIS LEAFLET
1.
What Difflam Forte Anti-
inflammatory Throat Spray
0.3%w/v is used for
2.
How Difflam Forte Anti-
inflammatory Throat Spray
0.3%w/v works
3.
Before you use Difflam Forte
Anti-inflammatory Throat Spray
0.3%w/v
4.
How to use Difflam Forte Anti-
inflammatory Throat Spray
0.3%w/v
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Difflam
Forte Anti-inflammatory Throat
Spray 0.3%w/v
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DIFFLAM FORTE ANTI-
INFLAMMATORY THROAT SPRAY
0.3%W/V IS USED FOR
Benzydamine hydrochloride in Difflam
Forte Anti-inflammatory Throat Spray
0.3%w/v is used to temporary relief of
painful conditions of the mouth and
throat including sore throat, ulcers,
after dental surgery or procedures.
HOW DIFFLAM FORTE ANTI-
INFLAMMATORY THROAT SPRAY
0.3%W/VS WORKS
Difflam Forte Anti-inflammatory
Throat Spray 0.3%w/v works by
reducing the pain, redness and swelling
of painful mouth and throat conditions.
BEFORE YOU USE DIFFLAM FORTE ANTI-
INFLAMMATORY THROAT SPRAY
0.3%W/V
_-When you must not use it _
Do not use this medicine if you have
an allergy to:
•
any medicine containing
Benzydamine hydrochloride
•
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, tongue or
other parts of the body
_ _
•
rash, itching or hives on the skin.
If any of the above happen, tell your
doctor immediately or go to Accident
and Emergency at your nearest
hospital.
Pregnancy and breastfeeding
If you are pregnant, trying to become
pregnant or breastfeeding, ask your
pharmacist or doctor for advice before
using Difflam Forte Anti-inflammatory
Throat Spray 0.3%w/v.
Do not use this medicine after the
expiry date printed on the pack o

Ciri produk

PMS
Black 6C
Guide
ARTWORK
COLOUR
100%
JOB NO. :
JB-02135
UIC
:
A2928
SKU
:
104154
A2928_
DIFFLAM FORTE THROAT SPRAY 15ML
COMPONENT : LEAFLET
COUNTRY : MY
DIELINE REF: PP-1267
EMO: ANGELINI
PRINTER: Xxxxxx Xxxxxxxxxxxx
PLEASE NOTE
V1
G247 FILE NAME:
89083_A2928_DIFFLAM FORTE
THROAT SPRAY 15ML_MY_LT_V1
15.10.19 - V0 - Artwork build - Yuki
23.10.19 - V1 - Amends - Carina
RE-TYPESET ARTWORK. DUE TO THE NATURE OF THE FILES RECEIVED, THIS
ARTWORK HAS BEEN RE-TYPESET.
THIS HI RES PDF IS NOT TO BE USED AS FINAL ARTWORK
SUPPLIER INFORMATION MAY BE PRESENT ON THE
PACKAGING
EMO/PRINTING VENDOR:
PLEASE SHARE THE ARTWORK PDF TO PRINTER FOR
CHECKS ON:
• COLOURS - NO. OF COLOURS, SEQUENCE, CMYK/PMS
• TEXT - LINE THICKNESS, FONT SIZE
• DIELINE - SIZE, EYEMARK, PRINT DIRECTION
• CODING - SIZE, LOCATION, VFA, FORMAT BKG COLOUR
ANY ADDITONAL INFORMATION AND TECHNICAL CHECK
REQUIRED BY EMO ON THE ARTWORK BEFORE
APPROVING.
PRODUCT DESCRIPTION
White, metered dose, aerosol pump with a green lid containing 15mL of
clear solution.
FORTE ANTI-INFLAMMATORY THROAT SPRAY 0.3%W/V
A2928
6.648 mm
2.981 mm
1.536 mm
1.868 mm
1.868 mm
1.2 mm
2 sprays (1 mg) directly onto sore/inflamed area and swallow gently.
Repeat every 1½ to 3 hours as
necessary.
Children under 6 years:
Not recommended.
Uninterrupted treatment should not exceed seven days, unless under
medical supervision.
Cleaning Instructions:
After use, wipe the nozzle with a clean tissue to prevent blockage.
CONTRAINDICATIONS
Patients with known hypersensitivity to benzydamine or to the other
components listed.
WARNINGS AND PRECAUTIONS
If a sore throat is either caused or complicated by a bacterial
infection, appropriate antibacterial therapy
should be considered in addition to the use of Difflam
®
Forte Anti-Inflammatory Throat Spray 0.3%w/v.
PREGNANCY AND LACTATION
Studies in animals are inadequate or may be lacking, but available
data show no evidence of an
increased occurrence of foetal damage. The safety of benzydamine
hydrochloride has not been
established in pregnant patie