NUROFEN ADVANCE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IBUPROFEN LYSINATE

Available from:

Crookes Healthcare Ltd

ATC code:

M01AE01

INN (International Name):

IBUPROFEN LYSINATE

Dosage:

200 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

ibuprofen

Authorization status:

Not Marketed

Authorization date:

2001-07-13

Patient Information leaflet

PAGE 1 OF 6
LEAFLET COPY
Nurofen Advance 200mg Tablets
(Ibuprofen Lysine)
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Nurofen
Advance 200mg Tablets carefully to get the best results from them.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
You must contact a doctor if your symptoms worsen or do not improve
after 3 days
-
If any of the side-effects gets serious, or if you notice any
side-effect not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Nurofen Advance 200mg Tablets are and what they are used for:
2.
Before you take Nurofen Advance 200mg Tablets
3.
How to take Nurofen Advance 200mg Tablets
4.
Possible side-effects
5.
How to store Nurofen Advance 200mg Tablets
6.
Further Information
1.
WHAT NUROFEN ADVANCE 200MG TABLETS ARE AND WHAT THEY
ARE USED FOR?
Nurofen Advance contains ibuprofen 200mg as ibuprofen lysinate.
Ibuprofen belongs to a
group of medicines called Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs). These
medicines provide relief by changing the body’s response to pain,
swelling and high
temperature. Nurofen Advance 200mg tablets provide fast and effective
relief from
headaches, migraine, dental pain, period pain, backache, muscular
pain, for the symptomatic
treatment of cold and flu symptoms and fever.
2.
BEFORE YOU TAKE NUROFEN ADVANCE 200MG TABLETS
DO NOT TAKE NUROFEN ADVANCE 200MG TABLETS IF YOU:

Are allergic to ibuprofen or any of the ingredients of Nurofen Advance
200mg Tablets
listed in section 6.

Have experienced shortness of breath, worsening of asthma, allergic
rash or an itchy
runny nose or swelling of the lips, face, tongue or throat when taking
ibuprofen,
aspirin or other similar medicines

have ever had stomach bleeding or perforation after taking ibuprofen,
aspirin or other
similar medicines

have (or have had two or more episodes of) a s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen Advance 200mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 200mg (as lysine salt).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, film-coated capsule shaped tablet, printed with an identifying
logo in black on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anti-inflammatory, analgesic and anti-pyretic for the relief of
mild to moderate pain, such as headache, migraine,
dental pain, feverishness, period pain, muscular strain and backache.
For the symptomatic relief of fever, colds and
influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4). If this medicinal product is required for
more than 3 days, or if symptoms worsen a doctor
should be consulted.
Adults and children over 12 years: Initial dose is one or two tablets
and subsequently if necessary, one or two tablets
every four hours with a maximum of 6 tablets in a 24 hour period i.e.
a maximum dose of 1200mg in a 24 hour period.
For short-term use only (see above).
Children under 12 years of age: Not recommended.
Elderly: See section 4.4 Special Warnings and Precautions for Use.
NSAIDs should be used with particular caution in elderly patients who
are more prone to adverse events. The lowest
dose compatible with adequate safe clinical control should be employed
please refer to section 4.4. Treatment should
be reviewed at regular intervals and discontinued if no benefit is
seen or intolerance occurs.
METHOD OF ADMINISTRATION
For oral administration. To be taken with water.
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