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Nurofen Joint & Back Pain Relief Max Strength 10 % Gel

Document: leaflet RECKITT BENCKISER HEALTHCARE_PL 10972-0089 change

FRONT


NUROF€N /*^v

Joint & Back Pain Relief 1 m Max Strength 10% Gel

Ibuprofen

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

-    You must talk to a doctor if you do not feel better or if you feel worse after 14 days What is in this leaflet:

1 .What Nurofen 10% Gel is and what it is used for

2.    What you need to know before you use Nurofen 10% Gel

3.    How to use Nurofen 10% Gel

4.    Possible side effects

5.    How to store Nurofen 10% Gel

6.    Contents of the pack and other information


1. What Nurofen 10% Gel is and what it is used for.

This product is called Nurofen Joint & Back Pain Relief Max Strength 10% Gel and contains Ibuprofen. It will be referred to as Nurofen 10% Gel in the rest of the patient information leaflet.

Nurofen 10% Gel contains ibuprofen and belongs to a group of medicines called non-steroid anti-inflammatory drugs (NSAIDs).

Nurofen 10% Gel is used to treat a number of painful conditions affecting the joints and muscles such as back pain, rheumatic and muscular pain, sprains, strains and sports injuries


2. What you need to know before you use Nurofen 10% Gel.

DO NOT use Nurofen 10% Gel:

•    If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), aspirin or similar medicines (e.g. NSAIDs)

•    If you are asthmatic, or suffer from rhinitis (allergic runny nose) or urticaria (hives) and have ever had a bad reaction to aspirin, ibuprofen or other NSAIDs in the past.

■ On broken, damaged, infected or diseased skin.

Take special care with Nurofen 10% Gel:

•    If you have had an ulcer or some other problem affecting your stomach, or intestines in the past

•    If you have any kidney problems

•    If you suffer from bronchial asthma or any allergic disease

If any of the above apply to you, only use this product on advice from your doctor or pharmacist.

•    When applying the gel to the skin, be careful to avoid the eyes, lips and mouth, and any damaged skin

•    Protect treated areas from direct sunlight to avoid any sensitivity reaction, e.g. a rash

•    Do not use on the genital area.

•    Do not apply a dressing to the same area after using the gel

•    If you develop a rash after using the gel stop using it any further.

Nurofen 10% Gel is FOR APPLICATION TO THE SKIN ONLY.

Other medicines and Nurofen 10% Gel:

Speak to your doctor or pharmacist before using Nurofen 10% Gel if you are using or have recently taken or might use any other medicines, including medicines obtained without a prescription.

The effect of this medicine may affect or be affected by taking the following medicines at the same time:

•    Medicines to lower your blood pressure (e.g. atenolol)

•    Medicines used to thin the blood (e.g. warfarin)

•    Aspirin or other NSAIDS, used for pain and inflammation.

Pregnancy and breast feeding

You should not use Nurofen 10% Gel if you are pregnant or breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

Nurofen 10% Gel should not affect the ability to drive or use machines.



Pharmacode Reads This Way


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3. How to use Nurofen 10% Gel

Nurofen 10% Gel is designed for topical (on the skin) application only. Never take the gel by mouth.

Always use Nurofen 10% Gel exactly as this leaflet tells you. You should check with your doctor or pharmacist if you are not sure.

Check the seal is intact before first use (invert cap to break seal). If the seal is not intact, do not use the gel.

Adults, the elderly and children over 12 years: Squeeze 2 to 5cm (i.e. 0.8 to 2 inches) of gel (equivalent to 50mg to 125mg ibuprofen) from the tube on affected area. Massage until absorbed. Do not use more frequently than every four hours and no more than 4 times in any 24 hour period.

Nurofen 10% Gel should only be used on healthy, unbroken skin. Do not use it on or near cuts or grazes or under dressings such as plasters. Do not let any gel come in contact with your eyes. If it does, rinse your eyes with cold water and consult your doctor. Hands should be washed after applying Nurofen 10% Gel, unless they are the site of treatment. Do not use on the genital area.

If the condition does not improve after two weeks use, or becomes worse at any time, speak to your doctor or pharmacist.

Children under 12 years: Nurofen 10% Gel is not recommended for use in children under 12 years.

If you accidentally swallow any Nurofen 10% Gel, rinse your mouth thoroughly. In the case of an upset stomach, speak to your doctor or pharmacist for advice.

If you forget to use Nurofen 10% Gel:

If you miss a dose, just carry on with the next dose as normal. Do not apply a double dose to make up for a forgotten dose.


4. Possible side effects

Like all medicines Nurofen 10% Gel can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

Other side effects include:

•    Itching or reddening of the skin

•    A burning feeling

•    Sore or weeping spots

•    Abdominal Pain (pains in your stomach) or other abnormal stomach symptoms

•    Kidney problems (particularly in people who have a history of kidney disease).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.'


5. How to store Nurofen 10% Gel

jKeep this medicine out of the sight and reach of children.

iDo not use this medicine after the expiry date which is stated on the carton and tube after !"EXP". The expiry date refers to the last day of that month.

Do not store above 25°C. Keep the tube in the outer carton in order to protect from light.

;Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away 'medicines you no longer use. These measures will help to protect the environment.


6. Contents of the pack and other information.

What Nurofen 10% Gel contains

The active substance is ibuprofen. The other ingredients are hydroxyethylcellulose (E1525),] sodium hydroxide (E524), benzyl alcohol (E1519), isopropyl alcohol, purified water.

What Nurofen 10% Gel looks like and contents of the pack

Nurofen 10% Gel is a transparent gel supplied in aluminium tube containing 30g and 40g    !

gel. Not all pack sizes may be marketed.    !

Marketing Authorisation Holder & Manufacturer:

Mercury Pharma Group Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK.| Manufacturer : Farmasierra Manufacturing S.L. Carretera De Irun KM 26,200 28700, SAN ! Sebastian De Los Reyes, Madrid, Spain.    ;

Distributor: Reckitt Benckiser Healthcare (UK) Ltd, HU8 7DS.    |

This leaflet was last revised in October 2015.    !

______________________________________________________8235DZZ17247/4!


CUSTOMER INFO: Minimum Point Size = 9.00pt 3mm baseline to baseline

RB Artwork arid Print Specification


Trident Reference No: RB187359

ZEN Ref:

TR965122

Action:

E

Brand:

Nurofen

Category:

Adult

Segment Group:

Indication Specific Pain

Segment:

Ibuprofen 10 percent Gel

Pack Size:

40g

Market/Country:

UK

Date:

27/10/16

RBH Contact:

Lianne Johnson

Artwork Type

: IDM Commercial

Component Code (2D if applicable): 8235077 17247/4 Parent Technical Packaging

Specification:

D8061516

Finished Goods Code: 3022649

Supply Point:

3P Farmasierra

Pharmacode No/NE:

00100010(289)

Edgemark Position:

NA

CAD Cam Ref:

N-Lft-D8061516-150x290mm

Printer:

S. GONZALEZ, S.L (Madrid, Spain)

Substrate:

Paper White

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* Reckitt Benckiser


Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, HU8 7DS, UX

TRIDENT

Connaught House, Connaught Road, Kingswood Business PaTk, Hull, HU7 3AP, England.

T: +44(0) 1482 828100


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


STUDIO USE ONLY Alan Smith    v2.0

Sm*Art check results: 6=1;0=2; R=0; - AS-27/10/1512:19:20


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Date:_______________________


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