Document: leaflet MAH BRAND_PL 10972-0082 change

• leaflet AAH_PL 10972-0082
• leaflet BOOTS_PL 10972-0082
• leaflet LLOYDS_PL 10972-0082
• leaflet MAH BRAND 2_PL 10972-0082
• leaflet MAH BRAND_PL 10972-0082
• leaflet MAH GENERIC_PL 10972-0082
• leaflet MORRISON_PL 10972-0082
• leaflet NUMARK_PL 10972-0082
• leaflet TESCO_PL 10972-0082
• leaflet THORNTON & ROSS_PL 10972-0082

---

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

Keep this leaflet.You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been recommended for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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 is Fenbid Forte 10% Gel and what it is used for

2.    Before you use Fenbid Forte 10% Gel

3.    How to use Fenbid Forte 10% Gel

4.    Possible side effects

5.    How to store Fenbid Forte 10% Gel

6.    Further information

1. WHAT IS FENBID FORTE 10% GEL AND WHAT IT IS USED FOR

Fenbid Forte 10% Gel contains ibuprofen and belongs to a group of medicines called nonsteroid anti-Inflammatory drugs (NSAID's). These medicines reduce pain and inflammation, and bring down a high temperature.

Fenbid Forte 10% Gel is used to treat a number of painful conditions affecting the joints and muscles such as back pain, sprains, strains and other sport injuries. It is also used for the relief of pain caused by non serious arthritic conditions and nerve pain (neuralgia).

2. BEFORE YOU USE FENBID FORTE 10% GEL

DO NOT use Fenbid Forte 10% Gel:

•    If you are allergic to ibuprofen, aspirin or similar medicines (e.g NSAIDs) or any of the other ingredients in this gel (listed at the end of this leaflet)

•    If you are asthmatic, or suffer from rhinitis (allergic runny nose) or urticaria (hives)

•    On broken, damaged, infected or diseased skin.

Take special care with Fenbid Forte 10% Gel

•    Protect treated areas from direct sunlight to

avoid any sensitivity reaction, e.g. a rash

•    You have had an ulcer or some other problem effecting your stomach, or intestines in the past

•    You have asthma or wheezing attacks (or if you have had asthma in the past)

•    You have any kidney problems

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

•    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. Fenbid Forte 10% Gel IS FOR EXTERNAL USE ONLY Taking/Using other medicines

Can you take Fenbid Forte with other medicines?

Please inform your doctor or pharmacist if you are taking, or have recently taken any other medicine, even those not prescribed by a doctor. 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 (including other forms of Ibuprofen), used for pain and inflammation.

Please tell your doctor or pharmacist if you are taking any of the above, or have recently taken any other medicine - even those not prescribed.

Pregnancy and breast feeding

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

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

Driving and using machines

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

3. HOW TO USE FENBID FORTE 10% GEL

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

Always use Fenbid Forte 10% Gel exactly 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).

Adults: Squeeze 2 to 5cm (i.e. 0.8 to 2 inches) of gel from the tube on affected area.

Massage until absorbed. This dose should not be repeated more frequently than every four hours and no more than four times a day in any 24 hour period. The amount of gel squeezed would be equivalent to 50 to 125mg of ibuprofen.

Fenbid Forte 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. Also, do not use it on the genital area.

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 Fenbid Forte 10% Gel, unless they are the site of treatment.

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

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

If the gel is accidentally swallowed

If you accidentally swallow any Fenbid Forte 10% Gel, rinse out your mouth thoroughly and contact your doctor, or nearest hospital, as soon as possible. If swallowed, the gel may cause an upset stomach.

If you forget to use your Fenbid Forte 10% Gel:

If you miss a dose, just carry on with the next dose as normal. Do not apply a double dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines Fenbid Forte 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 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. 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 FENBID FORTE 10% GEL

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

Do not use Fenbid Forte 10% Gel after the expiry date which is stated on the tube.

The expiry date refers to the last day of that month.

It should be stored in a cool, dry place, below 25°C. Keep the tube tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Remember:

This medicine is for you. Never give this medicine to someone else, it could harm them, even if their symptoms seem the same as yours.

6. FURTHER INFORMATION

What Fenbid Forte 10% Gel contains

The active substance is ibuprofen. Other ingredients are hydroxyethylcellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, purified water.

What Fenbid Forte 10% Gel looks like and contents of the pack

Fenbid Forte 10% Gel is supplied in aluminium tubes containing 30g or 50g gel.

Marketing Authorisation Holder:

Mercury Pharma Group Ltd.,

No. 1 Croydon, 12-16 Addiscombe Road, Croydon cR0 0XT, UK

Manufacturer:

Mercury Pharmaceuticals Ltd.,

No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK

Alternate Manufacturer:

Farmasierra Manufacturing S.L. Carretera De Irun KM 26,200 28700, SAN Sebastian De Los Reyes, Madrid, Spain.

This leaflet was last revised in November 2015. Fenbid is the registered trade mark of Mercury Pharma Group Ltd.

© Mercury Pharma Group Ltd. 2000

100079/LF/049/04

14465/4

Check the seal is intact before first use (invert cap to break seal).

Adults: Squeeze 2 to 5cm (i.e. 0.8 to 2 inches) of gel from the tube on affected area.

Massage until absorbed. This dose should not be repeated more frequently than every four hours and no more than four times a day in any 24 hour period. The amount of gel squeezed would be equivalent to 50 to 125mg of ibuprofen.

Fenbid Forte 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. Also, do not use it on the genital area.

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 Fenbid Forte 10% Gel, unless they are the site of treatment.

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

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

If the gel is accidentally swallowed:

If you accidentally swallow any Fenbid Forte 10% Gel, rinse out your mouth thoroughly and contact your doctor, or nearest hospital, as soon as possible. If swallowed, the gel may cause an upset stomach.

If you forget to use your Fenbid Forte 10% Gel:

If you miss a dose, just carry on with the next dose as normal. Do not apply a double dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines Fenbid Forte 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 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.

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 FENBID FORTE 10% GEL

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

Do not use Fenbid Forte 10% Gel after the expiry date which is stated on the tube.

The expiry date refers to the last day of that month.

It should be stored in a cool, dry place, below 25°C. Keep the tube tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Remember:

This medicine is for you. Never give this medicine to someone else, it could harm them, even if their symptoms seem the same as yours.

6. FURTHER INFORMATION

What Fenbid Forte 10% Gel contains:

The active substance is ibuprofen. Other ingredients are hydroxyethylcellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, purified water.

What Fenbid Forte 10% Gel looks like and contents of the pack:

Fenbid Forte 10% Gel is supplied in aluminium tubes containing 100g gel.

Marketing Authorisation Holder:

Mercury Pharma Group Ltd,

No. 1 Croydon, 12-16 Addiscombe Road, Croydon cR0 0XT, UK

Manufacturer:

Mercury Pharmaceuticals Ltd.,

No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK

Alternate Manufacturer:

Farmasierra Manufacturing S.L. Carretera De Irun KM 26,200 28700, SAN Sebastian De Los Reyes,Madrid, Spain.

This leaflet was last revised in November 2015.

Fenbid is the registered trade mark of Mercury Pharma Group Ltd.

© Mercury Pharma Group Ltd. 2000

100020/LF/049/05

14294/7