IBULEVE SPEED RELIEF 5% SPRAY

Active substance: IBUPROFEN

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PACKAGE LEAFLET
Information for the user

ibuprofen
Read all of this leaflet carefully before using this product.
This medicine is available without prescription. However you still need to use it carefully
to get the best results from it. Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.You must contact a doctor
if your symptoms worsen or do not improve after a few weeks. If any of the side effects get serious
or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
1. What Ibuleve Speed Relief Spray is and what
it is used for
2. Before you use Ibuleve Speed Relief Spray
3. How to use Ibuleve Speed Relief Spray
4. Possible side effects
5. How to store Ibuleve Speed Relief Spray
6. Further information

1. WHAT Ibuleve Speed Relief Spray
IS AND WHAT IT IS USED FOR
























This product 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:
• muscular backache
• muscular pain
• rheumatic pain
• aches
• pains
• swellings
• sprains
• strains
• sports injuries.
This product is recommended for use by
adults, the elderly and children over the
age of 12 years.
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. BEFORE YOU USE Ibuleve Speed
Relief Spray
Do not use Ibuleve Speed Relief Spray:
• if you are allergic (hypersensitive) to ibuprofen
or any of the other ingredients in this product
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;
• if you have severe joint pain of recent onset that
is not related to an injury or period of overuse;
• if you feel ill, have a temperature or any other
symptoms that accompany the pain.
Before applying this product for the first time,
make sure it is suitable for you to use:
Because this product 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.
Take special care when using this product:
• This product is flammable. Do not spray it
near flames or ignition sources.
• Use it only on the skin.
• Do not use on children under 12 years of
age except on the advice of a doctor.
• Do not apply it to broken or irritated skin.
• Do not use under protective waterproof dressings.
• Do not use more than the recommended dose
(see Section 3).
• Keep the spray away from the face so that it
cannot get into the eyes, nose and mouth.
Using other medicines
• Interaction between this product 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 this product 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 Ibuleve Speed
Relief Spray
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,
leaving at least four hours between applications.
continued...

KD19/11/2 2xxxxx

In this leaflet:

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibuleve Speed Relief Spray
can cause side effects, although not everybody
gets them.
Occasionally, mild skin rashes, itching or irritation
can sometimes occur at the site of application.
If this is unacceptable, or persists, stop using the
product and tell your doctor or pharmacist.
Very rarely, the following side effects can happen
with ibuprofen, although these are extremely
uncommon with products such as Ibuleve Speed
Relief Spray that are applied to the skin.
If you experience any of the following, stop
using this product immediately and tell
your doctor:
• 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.

5. HOW TO STORE Ibuleve Speed
Relief Spray















Keep it out of the reach and sight 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. FURTHER INFORMATION ABOUT
Ibuleve Speed Relief Spray
What this product 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 this product looks like and contents
of the pack
• The product is a clear, colourless spray that
contains no fragrance.
• It is available in a pump spray bottle
containing 35 ml.
The Marketing Authorisation holder is
Diomed Developments Limited, Tatmore Place,
Gosmore, Hitchin, Herts, SG4 7QR, UK.
The Manufacturer is DDD Limited,
94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.
The Distributor is DDD Limited,
94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.
This leaflet was last revised in October 2011.
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:
Ibuleve Speed Relief Spray, 00173/0160.
This is a service provided by the Royal National
Institute of Blind People (RNIB).

KD19/11/2 2xxxxx

• Holding the bottle upright or upside-down,
approximately 4 to 6 inches away from the skin,
spray over the affected area.
• Every 2 to 3 sprays, gently massage the spray
into the skin over and around the painful area.
• At each application apply 5 to 10 sprays
(1 to 2 ml), depending on the extent and severity
of your condition. Do not apply more than 40
sprays (8 ml) in any 24 hour period.
• Wash hands after use, unless treating them.
• Carry on using the spray in this way for up to
two weeks (or longer if recommended by your
doctor), until your condition gets better.
• If your symptoms worsen or continue for
more than two weeks, discuss this with
your pharmacist or 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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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