What it is and what it is used for

for This product is called Nurofen Joint & Back Pain Relief Max Strength 10% Gel and contains Ibuprofen. It will be referred to as Nurofen 10% Gel in the rest of the patient information leaflet. Nurofen 10% Gel contains ibuprofen and belongs to a group of medicines called non-steroid anti-Inflammatory drugs (NSAIDs). Nurofen 10% Gel is used to treat a number of painful conditions affecting the joints and muscles such as back pain, rheumatic and muscular pain, sprains, strains and sports injuries.

What you need to know before you take it

e Nurofen 10% Gel Do not use Nurofen 10% Gel:

• 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) and have ever had a bad reaction to aspirin, ibuprofen or other NSAIDs in the past
• On broken, damaged, infected or diseased skin.
• If you are in the last 3 months of pregnancy. Warnings and precautions Take special care with Nurofen 10% 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 Nurofen 10% 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 Nurofen 10% Gel, if you have any of the below:

• 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 suffer from bronchial asthma or any allergic disease
• When applying the gel to the skin, be careful to avoid the eyes, lips and mouth, and any damaged skin
• Protect treated areas from direct sunlight to avoid any sensitivity reaction, e.g. a rash
• Do not use on the genital area
• Do not apply a dressing to the same area after using the gel
• 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. Nurofen 10% Gel is FOR APPLICATION TO THE SKIN ONLY. Children Not recommended for children under 12 years Other medicines and Nurofen 10% Gel: Tell your doctor or pharmacist if you are taking or have recently taken or might use 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, used for pain and inflammation. Pregnancy and breast-feeding 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 Nurofen 10% Gel if you are in the last 3 months of pregnancy. You should not use Nurofen 10% 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 Nurofen 10% Gel can cause adverse effects in your unborn baby. It is not known if the same risk applies to Nurofen 10% Gel when it is used on the skin. You should not use Nurofen 10% Gel if you are breast-feeding. Driving and using machines Nurofen 10% Gel should not affect the ability to drive or use machines. Nurofen 10% Gel contains benzyl alcohol and sodium: 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'.

How to take it

Nurofen 10% Gel Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Nurofen 10% Gel is designed for topical (on the skin) application only. Never take the gel by mouth. Check the seal is intact before first use (invert cap to break seal). If the seal is not intact, do not use the gel. The recommended dose is Adults, the elderly and children over 12 years: Squeeze 2 to 5cm (i.e. 0.8 to 2 inches) of gel (equivalent to 50mg to 125mg ibuprofen) from the tube on affected area. Massage until absorbed. Do not use more frequently than every four hours and no more than 4 times in any 24 hour period. Nurofen 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. 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 Nurofen 10% Gel, unless they are the site of treatment. Do not use on the genital area. If the condition does not improve after two weeks use, or becomes worse at any time, speak to your doctor or pharmacist. Use in children : Nurofen 10% Gel is not recommended for use in children under 12 years. If you accidentally swallow any Nurofen 10% Gel, rinse your mouth thoroughly. In the case of an upset stomach, speak to your doctor or pharmacist for advice. If you forget to use your Nurofen 10% Gel: 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. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using ibuprofen and seek medical attention immediately if you notice any of the following symptoms: •

• •

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness (asthma), worsening of existing asthma, 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 or peeling, blistering 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. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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.'

How to store it

Nurofen 10% Gel Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube after "EXP". The expiry date refers to the last day of that month. Do not store above 25°C. Keep the tube in the outer carton in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Contents of the pack and other information

What Nurofen 10% Gel contains The active substance is ibuprofen. The other ingredients are hydroxyethylcellulose (E1525), sodium hydroxide (E524), benzyl alcohol (E1519), isopropyl alcohol, purified water. What Nurofen 10% Gel looks like and contents of the pack Nurofen 10% Gel is a clear or slightly opalescent, colourless or almost colourless gel supplied in aluminium tube containing 30g and 40g gel. Not all pack sizes may be marketed. Marketing Authorisation Holder : Mercury Pharma Group Ltd, Dashwood House, 69 Old Broad Street, London EC2M 1QS, UK. Manufacturer: Farmasierra Manufacturing S.L. Carretera De Irun KM 26,200, 28706, SAN Sebastian De Los Reyes,Madrid, Spain. Distributor: RB UK Commercial Limited, 103-105 Bath Road, Slough, SL1 3UH, UK. Product licence number: PL 10972/0089 This leaflet was last revised in June 2026.