Phorpain Gel Maximum Strength 10% 30g is a topical anti-inflammatory pain relief gel containing ibuprofen 10% w/w (100mg per gram). It is used to relieve pain and inflammation associated with backache, rheumatic and muscular pain, sprains, strains, neuralgia and sports injuries.

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that works by reducing pain and inflammation in the affected tissues.

Phorpain Maximum Strength Ibuprofen Gel 10% is also used for the relief of pain associated with non-serious arthritic conditions.

Suitable for adults and children over 12 years of age, the gel is applied directly to the affected skin. Apply 2 to 5cm of gel to the affected area and massage gently until absorbed, leaving at least four hours between applications.

The 30g aluminium tube contains a clear or almost colourless gel for external use. The topical formulation allows the medicine to be applied directly to painful muscles and joints.

Do not exceed four applications in 24 hours. Consult a doctor or pharmacist if symptoms worsen or do not improve after 14 days.

As a pharmacy medicine, a pharmacist can provide advice on its appropriate use where necessary.

Patient Information Leaflet

Main ingredients: Ibuprofen 10% w/w (100mg per gram of gel). Excipients: Hydroxyethylcellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, purified water.

Phorpain Gel Maximum Strength 10% is used for the relief of pain and inflammation associated with backache, rheumatic and muscular pain, sprains, strains, neuralgia, sports injuries and non-serious arthritic conditions.

Adults and the elderly:

• Apply 2 to 5cm of gel to the affected area.
• Gently massage into the skin until absorbed.
• Leave at least 4 hours between applications.
• Do not apply more than 4 times in any 24-hour period.
• Each application provides approximately 50mg to 125mg of ibuprofen.
• Do not exceed the recommended amount.

Children and adolescents:

• The SmPC includes dosing for children over 12 years of age.
• Not recommended for children under 12 years, except on medical advice.

How to apply:

1. Check that the tube seal is intact before first use. Invert the cap to break the seal.
2. Squeeze 2 to 5cm of gel onto the affected area.
3. Massage gently until the gel is absorbed.
4. Wash your hands after application unless your hands are the area being treated.
5. Replace the cap securely after use.

Important administration advice:

• For external use on the skin only.
• Do not apply to broken, damaged, infected or diseased skin.
• Avoid applying near cuts, grazes or the genital area.
• Avoid contact with the eyes and mucous membranes.
• Do not cover the treated area with airtight dressings or plasters.
• Protect treated skin from direct sunlight to reduce the risk of sensitivity reactions.
• If the gel gets into your eyes, rinse with cold water and consult your doctor.
• Stop using the gel if a rash develops.

Treatment duration: If symptoms do not improve after 14 days, or become worse at any time, consult your doctor or pharmacist.

Missed application: If you forget to apply the gel, continue with your next application as normal. Do not apply a double amount to make up for a missed application.

Accidental swallowing: If the gel is accidentally swallowed, rinse your mouth thoroughly and contact your doctor or nearest hospital as soon as possible.

Storage:

• Store below 25°C in a cool, dry place.
• Keep the tube tightly closed.
• Keep out of the sight and reach of children.
• Do not use after the expiry date printed on the tube.

Always follow the instructions provided in the Patient Information Leaflet.

Do not use Phorpain Gel Maximum Strength 10% if you:

• Are allergic to ibuprofen or any of the other ingredients.
• Are allergic to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Have asthma, rhinitis (allergic runny nose) or urticaria (hives).
• Intend to apply the gel to broken, damaged, infected or diseased skin.
• Are in the last 3 months of pregnancy.

Children: Phorpain Gel Maximum Strength is not recommended for children under 12 years of age.

Consult your doctor or pharmacist before use if you:

• Have previously had stomach ulcers or other stomach or intestinal problems.
• Have kidney problems or a history of kidney disease.
• Have bronchial asthma or another allergic condition.
• Are taking aspirin, other NSAIDs or other pain-relieving medicines.
• Are taking medicines for high blood pressure or to prevent blood clots.
• Are pregnant, planning to become pregnant or breastfeeding.

Pregnancy: Do not use Phorpain Gel Maximum Strength during the last 3 months of pregnancy.

During the first 6 months of pregnancy, the gel should not be used unless clearly necessary and advised by your doctor.

If use is necessary during this period, the lowest dose should be used for the shortest possible time.

Oral forms of ibuprofen may cause adverse effects in the unborn baby. It is not known whether the same risks apply when ibuprofen is applied to the skin.

Breastfeeding: Do not use Phorpain Gel Maximum Strength if you are breastfeeding.

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

Particular caution is required with:

• Medicines for high blood pressure, such as atenolol.
• Anticoagulants, such as warfarin.
• Aspirin and other NSAIDs, including other forms of ibuprofen.

This is not a complete list of possible interactions.

Important information about ingredients:

• Contains 1.25mg benzyl alcohol per 125mg of gel.
• Benzyl alcohol may cause allergic reactions and mild local irritation.
• Contains less than 1mmol (23mg) sodium per 125mg of gel and is considered essentially sodium-free.
• Contains isopropyl alcohol.

Fire safety: Do not smoke or go near naked flames while using this medicine.

Clothing, bedding and dressings that have been in contact with the gel may burn more easily and present a serious fire hazard.

Washing clothing and bedding may reduce product build-up but may not remove it completely.

Skin precautions:

• Apply only to healthy, unbroken skin.
• Avoid contact with the eyes and mucous membranes.
• Do not apply to the genital area.
• Do not use under airtight dressings.
• Protect treated areas from excessive sunlight.
• Stop using the gel if a rash develops.

Serious allergic reactions: Stop using the medicine and seek immediate medical attention if you experience:

• Sudden wheezing or difficulty breathing.
• Swelling of the eyelids, face or lips.
• Widespread skin redness, rash or itching.
• Other symptoms of a severe allergic reaction.

Serious skin reactions: Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome and acute generalised exanthematous pustulosis (AGEP), have been reported with ibuprofen.

Stop using the gel and seek immediate medical attention if you develop:

• Widespread skin redness or blistering.
• Peeling skin or sores affecting the mouth, throat, nose, eyes or genital area.
• A widespread rash accompanied by fever or swollen lymph nodes.
• A red, scaly rash with bumps or blisters.

Kidney problems: Although less ibuprofen is absorbed into the bloodstream from topical preparations than from oral medicines, kidney problems may occur in susceptible individuals.

If you notice signs of kidney problems, particularly if you have a history of kidney disease, contact your doctor immediately.

Driving and using machinery: Phorpain Gel Maximum Strength is not expected to affect the ability to drive or operate machinery.

Overdose and accidental swallowing: Overdose from topical application is unlikely. However, swallowing the gel may cause stomach upset.

Severe ibuprofen overdose following ingestion may cause headache, vomiting, drowsiness and low blood pressure.

If the gel is accidentally swallowed, rinse your mouth thoroughly and contact your doctor or nearest hospital as soon as possible.

When to seek medical advice:

• If symptoms persist after 14 days.
• If pain or inflammation worsens at any time.
• If you develop a skin rash or suspected allergic reaction.
• If you experience signs of kidney problems.

Storage and safety:

• Store below 25°C in a cool, dry place.
• Keep the tube tightly closed.
• Keep out of the sight and reach of children.
• Do not use after the expiry date.

For external use only. Do not exceed the recommended dose.

Like all medicines, Phorpain Gel Maximum Strength 10% can cause side effects, although not everybody will experience them.

Additional safety information:

Although Phorpain Gel Maximum Strength is applied to the skin, some ibuprofen may be absorbed into the bloodstream. Systemic side effects are less likely than with oral ibuprofen but may still occur.

Reporting side effects:

If you experience any side effects, including those not listed in the Patient Information Leaflet, speak to your doctor, pharmacist or nurse.

Suspected side effects can also be reported through the MHRA Yellow Card Scheme.

Stop using the medicine and seek immediate medical attention if you experience a severe allergic reaction, serious skin reaction or breathing difficulties.