Nurofen 200mg caplets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

M01AE01

INN (International Name):

Ibuprofen

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5000167056464 5000167056488 5000167056471

Patient Information leaflet

CUSTOMER INFO:
Minimum Point Size =
9.00pt
TR2233156
C
unless the doctor advises otherwise.
Speak to your doctor or pharmacist before taking this medicine if you
are breastfeeding.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS
• This medicine contains 13.71 mg sod
ium (main component of
cooking/table salt) in each tablet or ca
plet. This is equivalent to
0.69 % of the recommended maximum daily dietary intake of
sodium for an adult.
•
This medicine contains Sucrose. If you have been told by your
doctor th
at you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. HOW TO TAKE THIS MEDICINE
This product is for short term use only. The lowest effective dose
should be used for the shortest duration necessary to relieve
symptoms. If you have an infection, consult a doctor without delay if
symptoms (such as fever and pain) persist or worsen (see section 2).
ADULTS, THE ELDERLY AND CHILDREN & ADOLESCENTS BETWEEN 12 AND 18
YEARS:
Take 1 or 2 tablets with water, up to three times a day as required.
Leave at least four hours between doses. Do not take more than 6
tablets in 24 hours.
DO NOT GIVE TO CHILDREN UNDER 12 YEARS.
IN 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.
IN ADULTS:
DO NOT TAKE FOR LONGER THAN 10 DAYS unless your doctor tells you to.
If symptoms persist or the pain or fever worsen, or if any new
symptoms occur, consult your doctor or pharmacist.
IF YOU HAVE TAKEN MORE OF THIS MEDICINE THAN YOU SHOULD, OR IF
CHILDREN HAVE TAKEN THIS MEDICINE BY ACCIDENT ALWAYS CONTACT A
DOCTOR OR NEAREST HOSPITAL TO GET AN OPINION OF THE RISK AND ADVICE
ON ACTION TO BE TAKEN.
The symptoms can include nausea, stomach pain, vomiting (may be
blood streaked), headache, ringing in the ears, confusion and shaky
eye movement. At high doses, drowsiness, chest pain, palpitations,
loss of consciousness, convulsions (mainly in children), wea

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nurofen 200 mg Caplets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200 mg
Excipient(s) with known effect:
Sucrose: 116.1mg/caplet (232.2 mg/ 2 caplets)
Sodium:13.71mg/caplet (27.42 mg/2 caplets)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Coated Tablet
A white to off-white, biconvex, round, sugar coated tablet printed
‘Nurofen’ in
black on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of migraine-headaches, backache, dental pain, neuralgia
and
period pains as well as rheumatic and muscular pains, and pain of
non-serious
arthritic conditions
Nurofen relieves pain and reduces inflammation and temperature as well
as
relieving headaches and other types of pain. It also relieves cold and
flu
symptoms.
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).
During short-term use, if symptoms persist or worsen the patient
should be advised to
consult a doctor.
Adults and children and adolescents between 12 and 18 years:
If in children and adolescents between 12 and 18 years this medicinal
product is
required for more than 3 days, or if symptoms worsen a doctor should
be consulted.
If in adults the product is required for more than 10 days, or if the
symptoms worsen
the patient should consult a doctor.
CHILDREN AND ADOLESCENTS BETWEEN 12 AND 18 YEARS: Take 1 or 2 caplets
with
water, up to three times a day as required.
ADULTS: Take 1 or 2 caplets with water, up to three times a day as
required.
Leave at least four hours between doses.
Do not take more than 6 caplets in any 24 hour period.
Not for use by children under 12 years of age.
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, angioedema, or urticaria) in