SWISS RELIEF SPRAY GEL

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DICLOFENAC SODIUM

متاح من:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC رمز:

S01BC03

الشكل الصيدلاني:

SOLUTION

تركيب:

DICLOFENAC SODIUM 4 %W/W

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

MIKA PHARMA, GERMANY

المجموعة العلاجية:

DICLOFENAC

المجال العلاجي:

DICLOFENAC

الخصائص العلاجية:

For the local symptomatic relief of mild to moderate pain and inflammation following acute blunt trauma of small and medium-sized joints and periarticular structures.

تاريخ الترخيص:

2023-07-31

نشرة المعلومات

Patient leaflet in accordance with
the Pharmacists’ Regulations
)Preparations( 1986
This medicine can be sold without a
doctor’s prescription
Swiss Relief
®
Spray
Gel
Solution
Active ingredient: 1 gram contains:
Diclofenac Sodium 40 mg (4% w/w).
Inactive ingredients and allergens
in‏
the‏
medicine‏
-‏
see‏
section‏
2‏
"
Important
information
about
some
of
the
ingredients
of
this
medicine
"
‏ and‏ section‏ 6‏
"
Additional
information
"
in the leaflet.
Read this entire leaflet carefully
before using this medicine. This
leaflet contains concise information
about the medicine. If you have any
further questions, ask the doctor or
pharmacist.
You
should
use
the
medicine
according
to
the
instructions
in
section 3 of‏this‏leaflet.‏Consult‏the‏
pharmacist if you need additional
information.‏Contact‏the‏doctor‏if‏the‏
symptoms of illness get worse or if
they do not improve after 3 days.
1. What is the medicine
intended for?
For local relief of mild to moderate
pain
and
inflammation,
following
trauma
of
small‏
to‏
medium-sized‏
joints and periarticular structures.
Therapeutic group: Non-steroidal‏
anti-inflammatory‏drugs‏)NSAIDs(.
2. Before using the medicine
Do not use the medicine:
• If you are hypersensitive (allergic)
to the active ingredient diclofenac
sodium, to soy, to peanuts or to
any of the other ingredients this
medicine
contains
(see
list
in
section‏6(.‏
• If you have ever had an allergic
reaction to aspirin (acetylsalicylic
acid)
or
to
any
other
drug
belonging‏to‏the‏non-steroidal‏anti-
inflammatory class (NSAIDs) such
as ibuprofen, which is manifested
by difficulty in breathing, skin rash
and runny nose.
• If you are in the last three months
of pregnancy – please read section
2‏
"
Pregnancy, breastfeeding and
fertility
"
.
• On open injuries, inflammations or
infections of the skin as well as on
eczema‏or‏mucous‏membranes.
• This medicine is not intended for
children and adolescents under
15 years of age. Under this ag

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Swiss relief spray gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1g of solution contains 40 mg of diclofenac sodium (4%w/w).
Excipients with known effects: 150 mg propylene glycol / gram solution
99.98 mg Soybean lecithin 76% / gram solution
33.32 mg Ethanol anhydrous / gram solution
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cutaneous spray, Solution.
A golden-yellow, transparent solution, which turns to a gel-like
consistency after administration.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
For the local symptomatic relief of mild to moderate pain and
inflammation following acute blunt
trauma of small and medium-sized joints and periarticular structures.
4.2
Posology and method of administration
Posology
_Adults _
Sufficient solution of Swiss relief Spray Gel should be sprayed onto
the skin of the affected site.
Depending on the size of area to be treated 4-5 pump strokes (0.8-1.0
g of spray containing 32-40
mg of diclofenac sodium) should be applied 3 times daily in regular
intervals. A maximum single
dose of 1.0 g of the product should not be exceeded. The maximum daily
dose is 15 pump strokes
(3.0 g of spray containing 120 mg of diclofenac sodium).
Swiss relief Spray Gel should be massaged gently into the skin. After
this the hands should be
washed unless they are the site to be treated. After application some
minutes for drying should be
allowed before dressing or binding the treated area.
The treatment may be discontinued when the symptoms (pain and
swelling) have subsided.
Treatment should not be continued beyond 7-8 days without review. The
patient is requested to
consult the doctor if no improvement is seen after 3 days.
_Older people _
The posology is the same as for adults.
_Paediatric population _
There are insufficient data on efficacy and safety available for the
children and adolescents below
15 years of age.
In children aged 15 years and over, if this product is required for
more than 7 days