Patient Leaflet Updated 13-May-2021 | Diomed Developments Limited
Package leaflet: Information for the user
Ibuprofen 5% w/w
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 have 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.
In this leaflet:
1. What Ibuleve Gel is and what it is used for
2. What you need to know before you use Ibuleve Gel
3. How to use Ibuleve Gel
4. Possible side effects
5. How to store Ibuleve Gel
6. Contents of the pack and other information
1. WHAT IBULEVE GEL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE IBULEVE GEL
Do not use Ibuleve Gel:
Before applying this product for the first time, make sure it is suitable for you to use: Because Ibuleve is delivered through the skin, directly over the painful area, there is less risk of the complications that sometimes occur when ibuprofen (or a similar anti-inflammatory painkiller) is taken by mouth. However, in rare cases you may be at risk:
If any of the above apply to you, only use this product on advice from your doctor or pharmacist.
Warnings and precautions
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.
Take special care when using this product:
Using other medicines
Pregnancy and breast-feeding
You should not use Ibuleve Gel if you are pregnant or breast-feeding.
Driving and using machinery
Using this product is not known to affect your ability to drive or use machinery.
Ibuleve Gel contains propylene glycol (E1520)
Propylene glycol may cause skin irritation. This medicine contains 20 mg propylene glycol in each gram. If your doctor has told you that you have an intolerance to propylene glycol, please talk to your doctor before using this product.
3. HOW TO USE IBULEVE GEL
Before using this tube of gel for the first time, open it as follows:
The 50g and 100g packs also contain a tube key.
The tube squeezer key:
To make Ibuleve easier and more economical to use, a tube squeezer key has been provided. Once fitted to the tube, simply turning the key will dispense the gel more easily for patients who experience difficulty in squeezing tubes. For economy, the key will also help expel the last few grams of Ibuleve when the tube is nearly empty.
To fit the tube squeezer key:
To use the gel (for adults, the elderly and children over 12 years old):
If the gel comes into contact with broken skin or gets into the eyes, nose or mouth
If the gel is accidentally swallowed
If you forget to use this product
Do not worry if you occasionally forget to use this product, just carry on using it when you remember.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibuleve Gel can cause side effects, although not everybody gets them. All side effects listed are of unknown frequency (frequency cannot be estimated from the available data).
Ibuleve gel may cause the following side effects:
If this is unacceptable, or persists, stop using the product and tell your doctor or pharmacist.
If you experience any of the following side effects, stop using Ibuleve Gel immediately and tell your doctor:
If any of the side effects get 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 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.
5. HOW TO STORE IBULEVE GEL
6. CONTENTS OF THE PACK AND OTHERINFORMATION
What Ibuleve Gel contains:
The active ingredient is ibuprofen (5% w/w). The other ingredients are industrial methylated spirit, carbomers, propylene glycol (E1520), diethylamine and purified water.
What Ibuleve Gel looks like and contents of the pack
The Marketing Authorisation Holder is
The manufacturer is
This leaflet was last revised in March 2021
To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge:
0800 198 5000 (UK only).
Please be ready to give the following information:
Ibuleve PL 00173/00413.
This is a service provided by the Royal National Institute of Blind People (RNIB).
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
+44 (0)1462 458 866