Phorpain Gel 5% 30g is a topical anti-inflammatory pain relief gel containing ibuprofen 5% w/w (50mg per gram). It is used to relieve pain and inflammation associated with backache, rheumatic and muscular pain, sprains, strains and sports injuries.

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It works by reducing pain and inflammation in the affected tissues.

Phorpain Ibuprofen Gel 5% is applied directly to the affected area of the skin, providing a topical formulation for the relief of painful muscular and joint conditions.

Suitable for adults and adolescents aged 12 years and over, the gel can be applied up to four times daily, leaving at least four hours between applications.

Each 30g aluminium tube contains a clear or almost colourless gel for external use. Apply 4 to 10cm of gel to the affected area and massage gently until absorbed.

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

Patient Information Leaflet

Main ingredients: Ibuprofen 5% w/w (50mg per gram of gel). Excipients: Hydroxyethylcellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, purified water.

Phorpain Gel 5% is used for the relief of backache, rheumatic and muscular pain, sprains, strains and sports injuries.

Adults and the elderly:

• Apply 4 to 10cm of gel to the affected area.
• Gently massage the gel into the skin until absorbed.
• Repeat when required, leaving 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 use more gel than recommended.

Children and adolescents:

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

How to apply:

1. Before first use, check that the tube seal is intact. Invert the cap to break the seal.
2. Squeeze 4 to 10cm of gel onto the affected area.
3. Massage gently until the gel has been absorbed.
4. Wash your hands after application unless your hands are the area being treated.
5. Keep the tube tightly closed after use.

Important administration advice:

• For external use on the skin only.
• Do not apply to broken, damaged, infected or inflamed skin.
• Do not apply near cuts, grazes or the genital area.
• Avoid contact with the eyes, nose and mouth.
• Do not cover the treated area with airtight dressings or plasters.
• Protect treated areas from direct sunlight to reduce the risk of skin reactions.
• If the gel comes into contact with your eyes, nose, mouth or broken skin, rinse thoroughly with water.
• If irritation persists, consult your doctor or pharmacist.

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 5% 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 is not recommended for children under 12 years of age.

Consult your doctor or pharmacist before use if you:

• Have bronchial asthma or another allergic condition.
• Have previously had stomach or intestinal ulcers or other gastrointestinal problems.
• Have kidney problems.
• Are taking aspirin, ibuprofen 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 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 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:

• Blood pressure medicines, 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 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 the build-up of the product but may not remove it completely.

Skin precautions:

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

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

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, eyes or genital area.
• A rash accompanied by fever or swollen lymph nodes.
• A widespread red, scaly rash with bumps or blisters.

Kidney problems: Although less ibuprofen is absorbed into the bloodstream from the skin than from oral preparations, 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 is not expected to affect the ability to drive or operate machinery.

Overdose and accidental swallowing: Using excessive amounts of gel may increase the risk of adverse effects.

If the gel is accidentally swallowed, rinse the mouth thoroughly and seek medical advice 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 other 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 5% can cause side effects, although not everybody will experience them.

Additional safety information:

Although Phorpain Gel 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.