Ibuspray – patient leaflet, side effects, dosage

1. WHAT IBUSPRAY IS AND WHAT IT IS USED FOR

• Ibuspray is an anti-inflammatory painkiller

  applied to, and absorbed through, the skin.

• It is for the treatment of the following conditions

  involving the musculoskeletal system: • backache

  • rheumatic or muscular pain
  • sprains
  • strains
  • neuralgia.

• It is also for pain relief in common arthritic

  conditions.

• Ibuspray is recommended for use by adults,

  the elderly and children over the age of 12 years. Children under the age of 12 may also use it if recommended by their doctor.

• The active ingredient in this product is

  ibuprofen. This is one of a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

• Ibuprofen works by:

  • relieving pain
  • reducing swelling and inflammation.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE IBUSPRAY

Do not use Ibuspray:

• if you are allergic (hypersensitive) to

  ibuprofen or any of the other ingredients of Ibuspray listed in Section 6;

• 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; • if you are pregnant or breast-feeding;

• on broken, damaged, infected or diseased skin. Before applying this product for the first time,

make sure it is suitable for you to use:

Because Ibuspray 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 you have a stomach ulcer (also called

  a peptic or gastric ulcer);

• if you have ever had kidney problems; • if you have ever had asthma;

• if you have ever had a bad reaction to

  aspirin or ibuprofen taken by mouth.

  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 Ibuspray:

  • This product is flammable. Do not spray it near flames or ignition sources.
  • Use it only on the skin.
  • 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 Ibuspray and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
  • Do not use it on children under 12 years old unless advised by a doctor.
  • Keep the spray away from the eyes, nose and mouth.

Using other medicines

• Interaction between Ibuspray and blood pressure lowering drugs and anticoagulants (medicines that stop blood clotting) is possible, in theory, although very unlikely. If you would like more advice about this, speak to your doctor or pharmacist.
• If you are also taking aspirin or other NSAIDs by mouth, discuss this beforehand with your doctor or pharmacist because these may increase the risk of undesirable effects.
• Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including other medicines obtained without prescription.

Pregnancy and breast-feeding

You should not use Ibuspray 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.

3. HOW TO USE IBUSPRAY

Do not spray near flames, burning cigarettes, electric heaters or similar ignition sources. For adults, the elderly and children over 12 years old:

• Use the spray up to three to four times a day, or as often as advised by your doctor.
• Holding the bottle upright or upside-down, approximately 4 to 6 inches away from the skin, spray over the affected area.

PACKAGE LEAFLET Information for the user

IBUSPRAY 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.

ibuprofen 5% w/w

• Every 2 to 3 sprays, gently massage the spray

  into the skin over and around the painful area.

• The exact amount that you need to apply will

  vary, depending on the extent and severity of your condition, but normally 5 to 10 sprays (1 to 2 ml) should be enough.

• Wash hands after use, unless treating them.

• Carry on using the spray in this way until your

  condition gets better (you may find you need to use it for a few weeks, and your doctor may want you to continue using it for longer than this).

• If your symptoms worsen or continue for more

  than a few weeks, discuss this with your doctor before continuing treatment.

If the spray comes into contact with broken skin or gets into the eyes, nose or mouth

• The product may cause irritation if it comes

  into contact with broken skin or gets into the eyes, nose or mouth. If this happens, rinse the affected areas with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, tell your doctor or pharmacist.

If the spray is accidentally swallowed

• Symptoms may include headache, vomiting,

  drowsiness and low blood pressure.

• If you experience any of these symptoms

  contact a doctor or hospital straight away. 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, Ibuspray 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).

Ibuspray may cause the following side effects:

• Occasionally, mild skin rashes, itching or

  irritation can sometimes occur at the site of application.

• Skin becomes sensitive to light.

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 Ibuspray immediately and tell your doctor:

• Serious skin reactions such as:

  • 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).

• Allergic reactions (particularly in people who

  have a history of asthma or allergic problems), such as:

  • unexplained runny nose and watery eyes, or,

    in more serious cases asthma or aggravated asthma involving breathing difficulties, wheezing or chest tightness;

  • generalised allergic skin reactions involving

    itch, swelling, inflammation, redness and perhaps blistering and light sensitivity;

    • other more serious generalised allergic reactions possibly involving unexplained nausea and vomiting, swollen eyes, face or tongue, difficulty swallowing, dizziness or light-headedness. Unconsciousness could perhaps occur in the most serious cases.

    • Kidney problems (particularly in people who have a history of kidney disease), such as: • decreased urine volume;

      • loss of appetite / weight loss;
      • swelling to abdomen.

    • Problems with the digestive system

      (particularly in people who have a history of stomach ulcers etc), such as:

      • stomach pain;
      • heartburn / indigestion.

If any of the side effects gets 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 IBUSPRAY

• Keep it out of the sight and reach of children. • Always replace the cap after use.
• Store the bottle upright in a safe place away from flames.
• Do not store the product above 25°C.
• Do not use after the expiry date shown on the bottle label and on the carton. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ibuspray contains:

The active ingredient is ibuprofen (5% w/w). The other ingredients are industrial methylated spirit, macrogol 300, macrogol cetostearyl ether (cetomacrogol 1000) and purified water. What Ibuspray looks like and contents of the pack

• The product is a clear, colourless spray that contains no fragrance.
• The product is available in a pump spray bottle containing 100 ml.

The Marketing Authorisation holder is Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK.

The Manufacturer is Aeropak, Viking Road, Great Yarmouth,Norfolk, NR31 0NU, UK.

This leaflet was last revised in November 2023.

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: Ibuspray, 00173/0150.

This is a service provided by the Royal National Institute of Blind People (RNIB).