Nurofen 5% gel

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Ibuprofen

Dostępny od:

Reckitt Benckiser Healthcare (UK) Ltd

Kod ATC:

M02AA13

INN (International Nazwa):

Ibuprofen

Dawkowanie:

50mg/1gram

Forma farmaceutyczna:

Cutaneous gel

Droga podania:

Cutaneous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 10030200; GTIN: 5000158069510

Ulotka dla pacjenta

RB00000
RB00000
N/A
RB00000
N/A
1st Fold
4th Fold
3rd Fold
2nd Fold
Top Front
Top Back
Pharmacode Height = 8mm
Pharmacode Width = 8mm minimum
6mm clear area left and right
6mm clear area above and below
Reverse of Pharmacode is print free
Pharmacode Height = 8mm
Pharmacode Width = 8mm minimum
6mm clear area left and right
6mm clear area above and below
Reverse of Pharmacode is print free
Joint & Back Pain Relief
5% Gel
Ibuprofen
WHAT IS IN THIS LEAFLET:
1. What Nurofen Joint & Back Pain Relief 5% Gel is
and what it is used for
2. What you need to know before you use Nurofen
Joint & Back Pain Relief 5% Gel
3. How to use Nurofen Joint & Back Pain Relief
5% Gel
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT NUROFEN JOINT & BACK PAIN RELIEF
5%
GEL
IS AND WHAT IT IS USED FOR
Nurofen Joint & Back Pain Relief 5% Gel contains
ib
upr
ofen and belongs to a group of medicines
called non-steroid anti-Inflammatory drugs
(NSAID’s). These medicines reduce pain and
inflammation, and bring down a high temperature.
Nurofen Joint & Back Pain Relief 5% Gel is used to
treat a number of painful conditions affecting the
joints and muscles, such as backache, rheumatic
and muscular pain, sprains, strains and sports
injuries.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
N
UROFEN
JOINT & BACK PAIN RELIEF 5% GEL
DO NOT USE NUROFEN JOINT & BACK
P
AIN
RELIEF 5% GEL:
-
if you are allergic to ibuprofen,
aspirin or any of the other
ingredients of this medicine
(see section 6)
-
if you have had previous allergic
reactions (e.g. asthma, runny
nose, swelling, rash) when
taking ibuprofen, aspirin
or similar medicines
-
in the last three months
of pregnancy
-
do not use on broken or
damaged skin
-
in children under 12 years old.
WARNINGS AND PRECAUTIONS
Do not let the product come into contact with the
eyes, mouth or lips.
Take care when using this product to protect the
treated area from sunlight exposure.
Do not smoke or go near naked flames - risk of
severe burns. Fabric (clothing, bedding, dressings
et

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nurofen Joint & Back Pain Relief 5% Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 gram of gel contains 50 mg of ibuprofen.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Gel
Colourless or almost colourless, clear or slightly opalescent gel.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical analgesic and anti-inflammatory for backache, rheumatic and
muscular pain,
sprains, strains and sports injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use.
Adults, the elderly and children over 12 years: Squeeze 50 to 125 mg
(4 to 10 cm) of
the gel from the tube and lightly rub into the affected area until
absorbed.
The dose should not be repeated more frequently than every four hours
and no more
than 4 times in any 24 hour period.
Wash hands after every application. Do not exceed the stated dose.
Review treatment
after 7 days, especially if the symptoms worsen or persist.
Children under 12 years: Do not use on children under 12 years of age
except on the
advice of a doctor.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1. In patients who have previously shown hypersensitivity reactions
(e.g. asthma,
rhinitis or urticarial) in response to ibuprofen, Acetylsalicylic acid
(aspirin), or other
non-steroidal anti-inflammatory drugs.
Do not use in third trimester of pregnancy.
Not to be used on broken or damaged skin.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Discontinue immediately if rash develops.
Apply with gentle massage only. Avoid contact with eyes, mucous
membranes and
inflamed or broken skin.
Hands should be washed immediately after use.
Not for use with occlusive dressings.
The label will state:
Do not exceed the stated dose.
Keep out of the reach and sight of children.
For external use only.
If symptoms persist, consult your doctor or pharmacist.
Do not use if you are allergic to ibuprofen or any of the ingredients,
aspirin or an