Nurofen Joint & Back Pain Relief 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: 5011417565537

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
NUROFEN JOINT & BACK PAIN RELIEF 5% GEL
IBUPROFEN
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 symptoms persist for more than 7 days, or worsen at any time,
consult your doctor or pharmacist.
- 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.
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 ibuprofen 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 NUROFEN JOINT & BACK PAIN
RELIEF 5% GEL DO NOT USE
NUROFEN JOINT & BACK PAIN 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 no

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.
Excipients with known effects:
Benzyl alcohol – 1.25mg per dose
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