Nurofen Express 400mg liquid capsules

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Ibuprofen

Fáanlegur frá:

Reckitt Benckiser Healthcare (UK) Ltd

ATC númer:

M01AE01

INN (Alþjóðlegt nafn):

Ibuprofen

Skammtar:

400mg

Lyfjaform:

Oral capsule

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 10010100; GTIN: 5000158100770 5000158101081

Upplýsingar fylgiseðill

INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important
information for you. This medicine is available without prescription.
However, you still need to use Nurofen Express 400mg Liquid
Capsules carefully to get the best results from them. Nurofen Express
400mg Liquid Capsules will be referred to as this medicine
throughout this leaflet.
Keep this leaflet. You may want to read it again.
If you have any further questions after you have read it, ask your
doctor or pharmacist.
YOU MUST CONTACT A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT
IMPROVE AFTER 3 DAYS FOR CHILDREN AND ADOLESCENTS BETWEEN 12
AND 18 YEARS AND AFTER 10 DAYS FOR ADULTS.
If any side effects get serious, or if you notice any side effect not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
The active ingredient (which makes the medicine work) is Ibuprofen.
It belongs to a group of medicines known as non-steroidal
anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by
changing the body’s response to pain, swelling, and high
temperature.
This medicine is used for the relief of:
•
HEADACHES AND MIGRAINE PAIN
•
DENTAL PAIN AND NEURALGIA
•
PERIOD PAIN
•
RHEUMATIC, MUSCULAR AND BACK PAIN
•
FEVERISHNESS AND SYMPTOMS OF COLD AND FLU
•
THE PAIN OF NON-SERIOUS ARTHRITIS.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
DO NOT TAKE THIS MEDICINE IF YOU:
•
are allergic to ibuprofen or any of the other ingredients (see
section 6) or to aspirin or other painkillers
•
have (or have had two or more episodes of) a stomach ulcer,
perforation or bleeding
•
have had a worsening of asthma, skin rash, itchy runny nose or
facial swelling when previously taking ibuprofen, aspirin or
similar medicines
•

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nurofen Extra Strength 400 mg Liquid Capsules
Nurofen Express 400 mg Liquid Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, soft contains Ibuprofen 400 mg
Excipients with known effect:
Sorbitol
Ponceau 4R
Potassium hydroxide 50% solution (E525)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, soft.
A clear red oval soft gelatin capsule printed with an identifying logo
in white .
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
_Adults, elderly and Children over 12 years: _
Nurofen Extra Strength 400 mg Liquid Capsules are indicated for
symptomatic relief of non-serious arthritic conditions, rheumatic or
muscular
pain, backache, neuralgia , migraine, headaches, dental pain,
dysmenorrhoea,
feverishness, colds and influenza.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
The lowest effective dose should be used for the shortest duration
necessary to relieve
symptoms (see section 4.4).
Adults, the elderly and children and adolescents between 12 and 18
years:
If in children and adolescents this medicinal product is required for
more than
3 days, or if symptoms worsen a doctor should be consulted.
Adults should consult a doctor if symptoms persist or worsen, or if
the product is
required for more than 10 days.
CHILDREN AND ADOLESCENTS BETWEEN 12 AND 18 YEARS: Take 1 capsule with
water, up
to three times a day as required.
ADULTS: Take 1 capsule with water, up to three times a day as
required.
Leave at least 4 hours between doses.
Do not take more than 3 capsules in any 24 hour period.
4.3
CONTRAINDICATIONS
Hypersensitivity to ibuprofen or any of the excipients in the product.
Patients who have previously shown hypersensitivity reactions (e.g.
asthma, rhinitis,
angioderma or urticaria) in response to aspirin or other non steroidal
anti-
inflammatory drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more
distinct
episodes of proven ulce