What You Should Know About Ibuleve Mousse
ibuprofen
Read these instructions carefully before use
About your treatment
The name of your treatment is Ibuleve Mousse. It contains 5.0% of ibuprofen as the active ingredient. It also contains the inactive ingredients propylene glycol, carbomer, phenoxyethanol, diethylamine and purified water. The ozone-friendly aerosol propellant is butane 40. The container holds 75 g of Ibuleve Mousse. It is a white, fragrance-free mousse which is non-sticky and non-greasy.
Ibuprofen is a proven non-steroidal anti-inflammatory drug (NSAID), which works by relieving pain, reducing swelling and easing inflammation. Ibuleve Mousse is designed to be rapidly absorbed into the skin for effective relief at the point of pain. The mousse also exerts a soothing and cooling effect when applied to the affected area.
IBULEVE MOUSSE IS MADE FOR THE MARKETING AUTHORISATION HOLDER
AT
Your doctor or pharmacist has recommended or supplied Ibuleve Mousse for the relief of pain and inflammation in conditions such as:
- Backache
- Rheumatic and muscular pain
- Sprains
- Strains
- Lumbago
- Fibrositis
- Neuralgia
- Common arthritic conditions
When NOT to apply Ibuleve Mousse
- Do not use if you are allergic to any of its ingredients (as listed earlier).
- Do not use if you have experienced problems in the past with aspirin, ibuprofen or related painkillers (including when taken by mouth), especially where associated with a history of asthma, allergic rhinitis (nasal allergy) or urticaria (allergy of the skin associated with weals).
- Do not use if you are pregnant or breast feeding.
- Keep away from broken skin, the eyes, nose and mouth.
- Do not use on infected or diseased skin.
Before you apply Ibuleve Mousse
Make sure it is appropriate for you to use Ibuleve Mousse.
Because the mousse is applied to the skin, directly over the painful area, there is less risk
of the complications that sometimes arise when ibuprofen (or similar anti-inflammatory painkillers) are taken by mouth. However, there are certain categories of patients who may be at risk in rare cases.
Do not use Ibuleve Mousse in any of the following cases without first seeking medical advice from a doctor or a pharmacist:
- If you have ever suffered from asthma.
- If you have a stomach ulcer (also called a peptic or gastric ulcer).
- If you have ever suffered from kidney problems.
- If you are already taking aspirin or other painkillers.
For your safety
- FLAMMABLE: Do not spray near flames, burning cigarettes, electric heaters or similar objects.
- Ibuleve Mousse is for external use only.
- Ibuleve Mousse is not normally recommended for use on children under the age of 12 years, unless instructed by their doctor.
- Interaction between Ibuleve Mousse and blood pressure lowering drugs and anticoagulants is possible, in theory, although very unlikely.
- Where aspirin or other NSAID tablets are taken concurrently, it is important to
bear in mind that these may increase the incidence of undesirable effects.
If you would like more advice, speak to your doctor or a pharmacist.
Any overdose with ibuprofen applied to the skin is extremely unlikely. In case of severe
overdosage (for example, if the mousse is accidentally swallowed), symptoms include headache, vomiting, drowsiness and low blood pressure, and the patient should be taken to a doctor or hospital straight away.
How to apply Ibuleve Mousse
Ibuleve Mousse is for external use only.
Do not spray near flames, burning cigarettes, electric heaters or similar objects.
Shake container well before use. Hold container upright, then press nozzle to dispense the mousse into the palm of your hand. Gently massage the mousse into and around the affected area until absorbed. The exact amount to be applied will vary, depending on the extent and severity of the condition, but it should normally be sufficient to apply 1 to 2 g (1 to 2 golf-ball sized
quantities of mousse dispensed into the palm of the hand). This amount may be repeated 3 to 4 times daily unless otherwise directed by the doctor. Wash hands after use, unless treating them. If your symptoms persist for more than a few weeks, consult your doctor or a pharmacist before continuing treatment.
During your treatment
The transient cooling effect of the mousse may cause the skin to pale temporarily. Because the preparation is applied to the skin, directly over the affected area, there is less risk of the complications that can sometimes arise when ibuprofen is taken by mouth.
However, undesirable effects can occur very occasionally. Mostly these involve application site skin rashes, itching or irritation. Very rarely, wheezing may occur in people who already have a history of asthma or allergic problems, or kidney problems may occur in people with kidney disease. Abdominal pain or stomach upset have been reported in rare instances, as have non-specific allergic reactions. If you are in any doubt about your treatment, or if you experience any of the following, stop treatment immediately and tell your doctor or pharmacist: unexplained bruising, wheezing, shortness of breath, skin rash, itching, facial swelling, or any other undesirable effect.
How to store Ibuleve Mousse
This product should not be used after the expiry date shown on the base of the container.
Always replace the protective cap after use. Keep Ibuleve Mousse upright in a safe place
where children cannot see or reach it. Do not store above 25°C. Protect from sunlight and do not expose pressurised container to temperatures higher than 50°C. Do not pierce or burn container even when empty.
Date last revised: September 2007
Distributed by:
DDD Limited
94 Rickmansworth Road
Watford
Herts
UK
‘IBULEVE’ is a registered trademark of Diomed Developments Limited.
KD45/07/4
No comments:
Post a Comment