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Ibuprofen 5% W/W Gel

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187.8 mm

164.8 mm



Information for the user


Ibuprofen Gel

Read all of this leaflet carefully because it contains important information for you.


This medicine is available without prescription to treat minor conditions. However, you still need to use it 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 pharmacist

or doctor if your symptoms worsen or do not improve after 14 days

What this medicine is for

This medicine contains Ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which act to relieve pain and reduce inflammation (swelling).

It can be used to relieve mild to moderate pain and inflammation (swelling) caused by backache, rheumatic and muscular pain, sprains, strains and sports injuries.


Before you use this medicine

This medicine can be used by adults and children of 14 years and over. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

XDo not use:

•    If you are allergic to ibuprofen or any other ingredients of the product

•    If you have asthma, allergic runny nose (rhinitis) or itchy, red, raised skin rash (urticaria) and have ever had a bad reaction to aspirin, ibuprofen or other NSAIDS in the past

•    On broken, damaged, diseased or infected skin

•    If you are under 14 years of age,

unless your doctor tells you to

•    If you are pregnant or breastfeeding,

unless your doctor tells you to


! Talk to your pharmacist or doctor:    j

•    If you have a stomach ulcer or an i

ulcer in the intestine, or have had one] in the past    i

•    If you have kidney problems    1

•    If you have asthma, or a history of asthma]

•    If you develop a rash when using the i gel - and do not apply any more gel ]

Other important information

This gel may make your skin more i sensitive to sunlight. Keep treated ] areas out of direct sunlight, but do , not cover with plasters or dressings. 1

If you use other medicines >

Before you use this gel, make sure ] that you tell your pharmacist about i ANY other medicines you might be ] using at the same time, particularly , the following:    1

•    Aspirin, or other non-steroidal i anti-inflammatory pain killers (if you ] use these medicines with Ibuprofen i gel you may notice more side effects)1

•    Medicines to treat high blood

pressure, or medicines to thin the ' blood (Ibuprofen gel may rarely affect ] these medicines)    i

If you are unsure about interactions ! with any other medicines, talk to yourpharmacist. This includes medicines ] prescribed by your doctor and i medicine you have bought for ] yourself, including herbal and i homeopathic remedies.    1

/How to use this medicine ]

Check the tube seal is not broken before , first use. If it is, do not use the gel. 1


i Pierce tube seal with the point in the ] end of cap.

Age

How much to use

How often to use

Adults

and

children of 14 years and over

4-10cm of gel

(50-125 mg of ibuprofen) on the

affected area

Every 4 hours, if you need to. Don’t use more than

4 times in 24 hours.

Gently massage the gel into the affected area until it is absorbed.


These other effects are less serious. If they bother you talk to a pharmacist:

•    Stomach pain, heartburn

•    Kidney problems (particularly in people with a history of kidney problems)

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.


Wash your hands as soon as you have used the gel.

Apply only to the skin.

Avoid contact with eyes, mouth, lips or nose, or inflamed or broken skin.

Do not apply plasters or dressings over the gel.

Do not use on children under 14 years, unless your doctor tells you to.

Do not use more than the amount recommended above.

Stop using the gel if a rash develops.

If symptoms worsen, or do not go away after 14 days talk to your doctor.

If you use too much: It is unlikely to cause any harm.

f If anyone accidentally swallows some: If you accidentally swallow any gel, rinse out the mouth thoroughly and contact your doctor, or nearest hospital, as soon as possible. If swallowed, the gel may cause an upset stomach.

Possible side effects

Most people will not have problems, but some may get some, f If you get any of these serious side effects, stop using the gel.

See a doctor at once:

•    Unexplained wheezing (asthma), worsening of existing asthma, difficulty in breathing, swelling of the face, tongue, neck or throat (severe allergic reactions)

•    Allergic skin reactions such as itchy, red, raised rash (which can sometimes be severe and include peeling, blistering, weeping and lesions of the skin)


How to store this medicine

Store below 25°C.

Store in the original package.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

The gel contains Ibuprofen 5% w/w, which is the active ingredient.

As well as the active ingredient, the gel also contains ethylhydroxycellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, purified water.

The pack contains 35 g or 50 g of gel.


Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by Farmasierra Manufacturing S.L Carretera De Irun KM 26,200 28700 SAN Sebastian De Los Reyes Madrid Spain and Mercury Pharma Group Ltd Capital House 85 King William Street London EC4N 7BL UK. Marketing Authorisation held by Mercury Pharms Group Ltd Capital House 85 King William Street London EC4N 7BL UK. Leaflet prepared April 2014 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA


ARTWORK ONLY


ARTWORK TEXT SIZE


Main Headings:    lOpt

Sub Headings:    9pt

Body Copy:    8pt


Trident Reference No: BTC147144

Zen Ref:

TR786267

Category:

Healthcare

Sub-Category:

Analgesics

Brand:

Core

Pack Type:

Leaflet

Variant:

Ibuprofen Gel 5% 35 g/50 g

Action:

A

Date:

22/04/14

Country:

UK

Component Code:

N/A

Item Code:

N/A

CAD Ref No:

As BTC103565 Action C

Printer:

N/A

Substrate:

White Paper

Barcode Type:

N/A

Barcode Number:

N/A

Magnification:

N/A

Barcode Truncated By: (smallest bar)

N/A

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical ft Non Printing Items Cutter | Guides


PACK 1VIOCK LIP

Product Name: Ibuprofen Gel Product Licence No.: 10972/0045

Wording Ref: MHRAApproved v 1 dated 27/06/2012 (BTC103565v C) Status: Internally Approved Pack Details: Aluminium tube with internal epoxy phenolic cotaing.

Pack Size: 35 g or 50 g tube

Version No.

Date Issued

Reason For Change

1

08/04/2014

Change to MA Address


Colours

PAMONE280 C

1


E3

TRIDENT

Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100


TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


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.


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.


STUDIO USE ONLY Danielle Drury    v1.0

Sm»Art check results: G=1; 0=0; R=0; - DD- 22/04/14 12:28:22