Nurofen 5% w/w Gel

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Ibuprofen

थमां उपलब्ध:

Reckitt Benckiser Ireland Ltd

ए.टी.सी कोड:

M02AA; M02AA13

INN (इंटरनेशनल नाम):

Ibuprofen

डोज़:

5 percent weight/weight

फार्मास्यूटिकल फॉर्म:

Gel

प्रिस्क्रिप्शन प्रकार:

Product not subject to medical prescription

चिकित्सीय क्षेत्र:

Antiinflammatory preparations, non-steroids for topical use; ibuprofen

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2000-03-31

सूचना पत्रक

NUROFEN 5% W/W GEL
Ibuprofen
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
Nurofen 5% w/w Gel carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve
after 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.
In this leaflet:
1.What Nurofen 5% w/w Gel is and what it is used for
2. Before you use Nurofen 5% w/w Gel
3. How to use Nurofen 5% w/w Gel
4. Possible side-effects
5. How to store Nurofen 5% w/w Gel
6. Further Information
1.WHATNUROFEN5%W/WGEL IS AND WHAT IT IS USED FOR?
Nurofen 5% w/w Gel contains the active ingredient ibuprofen which
belongs to a
group of medicines known as non steroidal anti-inflammatory drugs
(NSAIDs).
It is gently rubbed into the skin
• to relieve pain, reduce local heat, swelling and inflammation
• in conditions such as backache, rheumatic and muscular pain,
sprains, strains and
sports injuries.
2. BEFORE YOU USE NUROFEN 5% W/W GEL:
Do not use Nurofen 5% w/w Gel if you:
• are allergic to ibuprofen or any of the ingredients of Nurofen 5%
w/w Gel listed in
Section 6.
• are allergic to aspirin or other pain relievers known as non
steroidal anti-
inflammatory drugs (NSAIDs)
• have ever had an asthma attack, rash or runny nose after taking
aspirin or any
NSAIDs
•have broken or damaged skin
• are UNDER 12 YEARS OF AGE
• are in the third trimester of pregnancy
CONSULT YOUR DOCTOR OR PHARMACIST BEFORE TAKING NUROFEN 5%W/W GEL IF
YOU
• have asthma or have suffered from asthma
• are TAKING ASPIRIN, IBUPROFEN OR OTHER NSAID pain relievers
• Are pregnant
Reckitt Benckiser
0003 PA 979/32/3 Addition of 50g Pack
1.3.1 Package Leaflet Clean
Nurofen Gel 5% National eCTD
Page 1
Warnings and Precauti

उत्पाद विशेषताएं

Health Products Regulatory Authority
03 March 2023
CRN00DF22
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen 5% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains 50mg ibuprofen (5% w/w)
Excipient with known effect:
One gram of gel contains 10mg benzyl alcohol (1% w/w)
For a full list of excipients, see 6.1
3 PHARMACEUTICAL FORM
Gel.
A clear, colourless and smooth gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For local symptomatic relief of pain and inflammation in the trauma of
the tendons, ligaments, muscles and joints and in
localised forms of soft tissue rheumatism.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS : Unscrew and invert
cap to pierce seal. Apply a thin layer (1.0 to 2.5g) of gel
to the affected area and massage gently until absorbed.
Leave four hours between doses and do not apply more than 4 times in
any 24 hour period. Maximum daily dose is 10 g of
gel, which equates to 500 mg ibuprofen.
Wash hands after each application. Do not exceed the stated dose.
The product should be applied according to the pack instructions for
up to a maximum of 7 days. Seek medical advice if
symptoms persist for more than one week.
ELDERLY: No special dose adjustment is necessary.
CHILDREN UNDER 12 YEARS: Do not use on children under 12 years of age.
Method of administration:
For topical application to the skin, short term use only.
4.3 CONTRAINDICATIONS
Hypersensitivity to ibuprofen or to any of the excipients in the
product.
In patients who have previously shown hypersensitivity reactions (e.g.
bronchospasm, asthma, rhinitis, angioedema or urticaria)
in response to ibuprofen, acetylsalicylic acid (Aspirin) or other
non-steroidal anti-inflammatory drugs (NSAIDs).
Do not use in third trimester of pregnancy.
Not to be used on broken or damaged skin.
Health Products Regulatory Authority
03 March 2023
CRN00DF22
Page 2 of 5
Children under 12 years
4.3 CONTRAINDICATIONS
Hypersensitivity to ibuprofe