Nurofen 200mg tablets

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: 5000167056518 5000167056532 5000167056600 5000167056549 5000167056525 5000167056556

Patient Information leaflet

CUSTOMER INFO:
Minimum Point Size =
9.00pt
TR2233621
C
200mg Tablets and
Nurofen 200mg Caplets
Contains Ibuprofen
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 200mg Tablets and Nurofen 200mg Caplets carefully
to get the best results from them. Nurofen 200mg Tablets and Nurofen
200mg Caplets 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 ever had a stomach ulcer, perforation or bleeding
• have had a worsening of asthma, skin r

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nurofen 200 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200 mg
Excipient(s) with known effect:
Sucrose: 116.1mg/tablet (232.2 mg/ 2 tablets)
Sodium: 13.71mg/tablet (27.42 mg/ 2 tablets)
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 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 tablets
with water,
up to three times a day as required.
ADULTS: 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 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 response to aspirin