Ibuleve Pain Relief 5% Spray

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Ibuprofen

Disponible des:

Diomed Developments Ltd

Codi ATC:

M02AA13

Designació comuna internacional (DCI):

Ibuprofen

Dosis:

50mg/1ml

formulario farmacéutico:

Spray

Vía de administración:

Cutaneous

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 10030200; GTIN: 5016379291920

Informació per a l'usuari

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.
IN THIS LEAFLET:
1. What Ibuleve Pain Relief 5% Spray is and what
it is used for
2. What you need to know before you use
Ibuleve Pain Relief 5% Spray
3. How to use Ibuleve Pain Relief 5% Spray
4. Possible side effects
5. How to store Ibuleve Pain Relief 5% Spray
6. Contents of the pack and other information
1. WHAT IBULEVE PAIN RELIEF 5% 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. WHAT YOU NEED TO KNOW BEFORE YOU
USE IBULEVE PAIN RELIEF 5% SPRAY
DO NOT USE IBULEVE PAIN RELIEF 5% 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

Fitxa tècnica

1
NAME OF THE MEDICINAL PRODUCT
Ibuleve Pain Relief 5% Spray
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 5.0% w/w
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cutaneous spray solution
Clear, colourless, fragrance-free, aqueous-alcoholic topical spray
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For fast local relief of backache, rheumatic pain, muscular aches,
pains or
swellings, such as strains, sprains and sports injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, including the elderly, and children over 12 years
Holding the bottle upright or upside down, spray approximately 4
inches to 6
inches away from the skin. After every two to three sprays, gently
massage the
preparation into the skin, spreading the product over a wide area
around the
affected site. Apply 5 to 10 sprays (1 to 2ml) depending on the extent
and
severity of the condition. This amount may be repeated three to four
times
daily, with individual doses administered at least 4 hours apart.
Patients should
not apply more than 40 sprays (8ml) in any 24 hour period. Not to be
used
with occlusive dressings.
Hands should be washed after use, unless treating them.
Unless recommended by a doctor, advice should be sought about
continued
treatment if symptoms persist for more than 2 weeks.
Do not use on children under 12 years of age except on the advice of a
doctor.
4.3
CONTRAINDICATIONS
Not
to
be
used
if
allergic
to
any
of
the
ingredients,
or
in
cases
of
hypersensitivity to aspirin, ibuprofen or related painkillers
(including when
taken by mouth), especially where associated with a history of asthma,
rhinitis
or urticaria. Not to be used on broken or damaged skin.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product is flammable. Do not spray near flames, electric heaters
or similar
objects.
Instruct patients not to 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.