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Ibuprofen 5% W/W Gel

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Document: leaflet DAY LEWIS_PL 00189-0024 change

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Patient Information Leaflet

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; Auxifen

Gel Ibuprofen 5%w/w

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Read all of this leaflet carefully before you start using this medicine.

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Keep this leaflet. You may need to read it again. If you have any further questions ask your doctor or pharmacist.

This medicine may have been prescribed for you by your doctor. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.

This medicine is also available without prescription from your pharmacy. However, you still need to use Auxifen Gel carefully to get the best results from it.

You must see a doctor if your symptoms do not improve after 2 weeks.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

In this leaflet:

1.    What Auxifen Gel is and what it is used for

2.    Before you use Auxifen Gel

3.    How to use Auxifen Gel

4.    Possible side effects

5.    How to store Auxifen Gel

6.    Further information

1.    What Auxifen Gel is and what it is used for

Auxifen Gel is a pain relieving gel to be applied to the skin. It is used for the relief of

Rheumatic pain (pain caused by problems with muscles, tendons, joints or bones)

Muscular aches and pains Pain from strains and sprains Backache

Lumbago (lower back pain)

Fibrositis (muscle tenderness or stiffness).

Auxifen Gel contains one active ingredient

Ibuprofen is one of a group of medicines called NSAIDs which provide effective pain relief and reduce both inflammation and swelling.

2.    Before you use Auxifen Gel Do not use Auxifen Gel if you:

have an allergy to ibuprofen or any of the

ingredients in Auxifen Gel

(see end of Section 2 and Section 6)

have an allergy to aspirin or other pain-relieving

medicines known as non-steroidal

anti-inflammatory drugs (NSAIDs) including

those you take orally by mouth

have asthma and know that aspirin or NSAIDs

may bring on an asthma attack, a runny nose

(rhinitis), itching or rashes

are more than 6 months pregnant

are breast feeding

have broken skin or your skin is infected or inflamed.

Do not use Auxifen Gel on:

•    children under 14 years old

•    your lips, nostrils, eyes, genital or anal areas, or other sensitive areas. If this occurs accidentally, wash away with plenty of clean water.

•    the same area with other medicines that you put on the skin.

Auxifen Gel is only for use on the skin.

Do not take by mouth.

Take special care with Auxifen Gel

See your doctor before using Auxifen Gel if you:

•    have ever had allergic symptoms such as skin rashes or itching caused by medicines or cosmetics

•    have a kidney problem (now or in the past)

•    have a stomach ulcer (now or in the past)

•    are up to 6 months pregnant or think you might be pregnant

•    are having problems conceiving or having fertility treatment.

Avoid getting Auxifen Gel on or near the eyes and other sensitive areas.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you have bought without a prescription.

See your doctor before using Auxifen Gel if you are taking:

•    aspirin

•    any other pain relieving medicine

•    or any other medicines regularly.

Pregnancy and breast feeding

See your doctor if you are pregnant or think you might be pregnant. Do not use Auxifen Gel if you are more than 6 months pregnant.

Do not use Auxifen Gel if you are breast feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of Auxifen Gel

Auxifen Gel contains:

•    propylene glycol which may cause skin irritation.

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3.    How to use Auxifen Gel

Auxifen Gel is for adults and children over 14 years old.

•    Always try on a small area first.

•    Use 1-4cm each time you use Auxifen Gel.

•    Apply the gel as a thin layer over the affected area.

•    Gently rub in the gel until it is absorbed.

•    Do not use more gel than recommended.

•    Repeat these steps up to 3 times a day but no more. Do not use more often than every 4 hours. If the pain or swelling continues after using the gel for 2 weeks see your doctor.

•    Unless you are treating your hands always wash your hands immediately after use.

•    Replace the cap tightly.

•    Stop using Auxifen Gel if you get excessive skin irritation or other unwanted effects.

Do not cover the skin with bandages, plasters or any other dressing. However, it is safe to cover the skin with your clothes.

If you use more Auxifen Gel than you should

If you accidently squeeze out too much gel use a tissue to wipe off any excess.

If you or a child accidentally swallow the gel contact your doctor or hospital immediately.

If you forget to use Auxifen Gel

Apply Auxifen Gel again when you remember making sure you do not use the gel more than 3 times in one day or more often than every 4 hours.

4.    Possible side effects

Like all medicines, Auxifen Gel can cause side effects, although not everybody gets them.

Stop using Auxifen Gel straight away and tell your doctor if you experience any of the following effects:

•    unexplained wheezing

•    shortness of breath

•    blisters or a rash on the skin

•    itching, redness or bruising of the skin

•    swelling of the face

A slight redness, drying, tingling or burning feeling may occur where you have applied the gel. This is not a cause for concern. However, if this gets worse stop using Auxifen Gel and tell your doctor. Unwanted effects may be reduced if you use the smallest dose for as short a time as possible.

More rarely you may suffer from:

•    Stomach pains or indigestion.

•    Kidney problems if you have kidney disease.

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 medicines.


5.    How to store Auxifen Gel

Keep out of the sight and reach of children.

Close the cap tightly and store in a cool place (below 25°C).

Do not use Auxifen Gel after the expiry date which is printed on the carton and tube. The ’expiry’ date refers to the last day of that month.

Take any Auxifen Gel that is out of date to a pharmacist for disposal.

6.    Further information What Auxifen Gel contains

The active substance is:

• ibuprofen (5%w/w)

The other ingredients are propylene glycol, carbomer, di-isopropanolamine, ethanol and water (see the end of Section 2).

What Auxifen Gel looks like and contents of the pack

Auxifen Gel is a clear gel.

Each tube contains 15, 35, 50g or 100g.

Not all pack sizes may be marketed.


Marketing authorisation holder and manufacturer

The Mentholatum Company Limited,

East Kilbride, G74 5PE, Scotland, UK.

Tel: 01355 848484

Distributor:

Cradlecrest Ltd.

2 Peterwood Way Croydon CRO4UQ

Telephone: +44 208 256 6200 PL 00189/0024

For any information about this product please contact the manufacturer at the above address.

This leaflet was last revised March 2016.


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