Voltarol Emulgel 1% w/w Gel

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Diclofenac sodium

थमां उपलब्ध:

Haleon Ireland Limited

ए.टी.सी कोड:

D11AX; M02AA15

INN (इंटरनेशनल नाम):

Diclofenac sodium

डोज़:

1 percent weight/weight

फार्मास्यूटिकल फॉर्म:

Gel

प्रिस्क्रिप्शन प्रकार:

Product not subject to medical prescription

चिकित्सीय क्षेत्र:

Other dermatologicals; diclofenac

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2003-10-17

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
VOLTAROL EMULGEL 1% W/W GEL
diclofenac diethylammonium 1.16% w/w corresponding to diclofenac
sodium 1% w/w
For joint, back and muscular pain relief
Relieves pain, reduces inflammation, cooling effect
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Voltarol Emulgel 1%
w/w Gel carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again. Note that this
leaflet is revised on a regular
basis with the latest information on your medicine. Please refer to
the date at the end of this
leaflet.
•
Ask your pharmacist if you need more information or advice.
•
You must contact a doctor if your symptoms worsen or do not improve
within 7 days.
•
If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet,
please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1. What Voltarol Emulgel 1% w/w Gel is and what it is used for
2. What you need to know before you use Voltarol Emulgel 1% w/w Gel
3. How to use Voltarol Emulgel 1% w/w Gel
4. Possible side effects
5. How to store Voltarol Emulgel 1% w/w Gel
6. Contents of the pack and other information
1.WHAT VOLTAROL EMULGEL 1% W/W GEL IS AND WHAT IT IS USED FOR
Voltarol Emulgel 1% w/w Gel contains the active ingredient diclofenac
which is from the group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Voltarol Emulgel 1% w/w Gel is
used in adults, the elderly and adolescents aged 14 years and over to
relieve pain and reduce swelling
in a number of painful conditions affecting the joints and muscles,
e.g. sprains, strains and bruises. It
is also used to relieve the pain of muscular rheumatism.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VOLTAROL EMULGEL 1% W/W GEL
DO NOT USE VOLTAROL EMULGEL 1% W/W GEL IF YOU:
• are allergic (hypersensitive) to diclofenac, propylene glycol,
benzyl benzoate, isopropyl alcohol or
any of the oth

उत्पाद विशेषताएं

Health Products Regulatory Authority
05 July 2023
CRN00DPJ2
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voltarol Emulgel 1% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Voltarol Emulgel contains diclofenac diethylammonium 1.16% w/w
corresponding to diclofenac sodium 1% w/w.
Excipients with known effect: Contains propylene glycol (5% w/w) and
benzyl benzoate (0.003% w/w)
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Gel.
Voltarol Emulgel is a white, pleasantly perfumed, homogeneous,
non-greasy emulsion in an aqueous gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults, the elderly and adolescents aged 14 years and over for the
local symptomatic relief of pain and inflammation in:
-trauma of the tendons, ligaments, muscles and joints,
e.g. due to sprains, strains and bruises.
-localised forms of soft tissue rheumatism.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only.
_Adults _
_and children aged 14 years and over: _
Voltarol Emulgel should be rubbed gently into the skin. Depending on
the size of
the affected site to be treated 2-4g (a circular shaped mass
approximately 2.0-2.5cm in diameter) should be applied 3-4 times
daily. After application, the hands should be washed unless they are
the site being treated.
If the condition does not improve or worsens within 7 days of starting
treatment, patient should consult their doctor to exclude
an alternative underlying cause of pain.
_Use in the elderly: _The usual adult dose may be used.
_Children and adolescents below 14 years _: There are insufficient
data on efficacy and safety available for children and
adolescents below 14 years of age (see also contraindications section
4.3).
4.3 CONTRAINDICATIONS
Patients with or without chronic asthma in whom asthma, angioedema,
urticaria or acute rhinitis are precipitated by aspirin or
other non-steroidal anti-inflammatory agents.
During the last trimester of pregnancy.
Hypersensitivity to diclofenac, aspirin or other non-steroidal
ant