Fenbid 5% w/w Gel

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. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

1. What is Fenbid Gel and what it is used for
2. What you need to know before you use Fenbid Gel
3. How to use Fenbid Gel
4. Possible side effects
5. How to store Fenbid Gel
6. Contents of the pack and other information

• If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to aspirin or similar medicines (e.g NSAIDs).
• If you are asthmatic, or suffer from rhinitis (allergic runny nose) or urticaria (hives).
• On broken, damaged, infected or diseased skin.
• If you are in the last 3 months of pregnancy.

Take special care with Fenbid Gel:

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Fenbid Gel and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Talk to your doctor or pharmacist before using Fenbid Gel, if you have any of the below:

• Protect treated areas from direct sunlight to avoid any sensitivity reaction, e.g. a rash
• If you suffer from bronchial asthma or any allergic disease
• 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 develop a rash after using the gel stop using it any further
• Do not smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

FENBID GEL IS FOR EXTERNAL USE ONLY.

Not recommended for children under 12 years

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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.

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 this medicine.

Do not use Fenbid Gel if you are in the last 3 months of pregnancy. You should not use Fenbid Gel during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If you need treatment during this period, the lowest dose for the shortest time possible should be used.

Oral forms (e.g. tablets) of Fenbid Gel can cause adverse effects in your unborn baby. It is not known if the same risk applies to Fenbid Gel when it is used on the skin.

You should not use Fenbid Gel if you are breast-feeding.

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

This medicine contains 1.25 mg benzyl alcohol in each 125mg, which is equivalent to 0.01mg/mg. Benzyl alcohol may cause allergic reactions and mild local irritation.

This medicine contains less than 1 mmol sodium (23 mg) per 125mg, that is to say essentially ‘sodium-free’.

If you accidentally swallow any Fenbid 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 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.

• Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching or reddening (especially affecting your whole body), sore or weeping spots and burning feeling should be reported to a doctor immediately.
• If you notice any signs of kidney problems (particularly in people who have a history of kidney disease) should contact your doctor straightaway.
• Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis).

Other side effects with the following frequency include:

Uncommon (may affect up to 1 in 100 people)

• Abdominal Pain (pains in your stomach).
• Indigestion.

Not known (frequency cannot be estimated from the available data)

• Skin becomes sensitive to light.

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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

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

Fenbid Gel is clear or slightly opalescent, colorless or almost colorless gel supplied in aluminium tubes containing 100g of gel.