Ibuprofen 600mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen

Available from:

Zentiva Pharma UK Ltd

ATC code:

M01AE01

INN (International Name):

Ibuprofen

Dosage:

600mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

_Title:_
_Ref:_
_Date:_
_Size (mm):_
_Modified:_
Ibuprofen 600mg PIL
D-IBU
13/02/18
297(H) x 210(W)
03/12/19
_Colours_
_(Printed)_
PROCESS
BLACK
_Colours_
_(Non printed)_
SPECIAL
CUTTER
D A L K E I T H
L A B O R A T O R I E S
In this leaflet:
1. What Ibuprofen Tablets are and what they are used for
2. Before you take Ibuprofen Tablets
3. How to take Ibuprofen Tablets
4. Possible side effects
5. How to store Ibuprofen Tablets
6. Further information
Read all of this leaflet carefully before you start taking
this medicine.
•
Keep this leaflet. You may need to read it again.
•
This medicine is only for you. Do not give it to anyone else to
take. It may harm them, even if their symptoms are the same
as yours.
•
If you have any further questions, please ask 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.
Patient Information Leaflet
Ibuprofen 600 mg Tablets BP
This medicine will be called Ibuprofen Tablets in this leaflet.
D0001/2
1. What Ibuprofen Tablets are and what they are
used for
These tablets contain the active ingredient, ibuprofen. Ibuprofen
is a non-steroidal anti-inflammatory drug (NSAID) which relieves
pain and reduces inflammation.
Ibuprofen Tablets are used to relieve mild or moderate pain for
instance when you have:
•
Rheumatoid arthritis or osteoarthritis
•
Ankylosing spondylitis (where you get stiff and painful back
and hip joints)
•
Pain and swelling in and around other joints
•
An injury to the soft tissues such as sprains and strains.
2. Before you take Ibuprofen Tablets
Some people
must not take these tablets. Do not take
these tablets if:
•
You know you are allergic to ibuprofen or to any of the other
ingredients (these are listed in section 6)
•
You have had allergic reactions (e.g. asthma, blocked or runny
nose, swelling of the face or throat or itching) when you have
taken aspirin or other NSAID painkillers e.g. naproxen
•
You have a peptic ulcer

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ibuprofen Tablets 600mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen
BP
600.0mg
Excipient(s) with known effect
Ponceau 4R lake (E124)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mild to moderate pain such as in dysmenorrhoea, dental and
post-operative
pain and for the symptomatic relief of headache including migraine
headache.
Rheumatoid arthritis (including juvenile rheumatoid arthritis or
Still's disease)
Ankylosing spondylitis
Osteoarthritis
Sero-negative arthropathies
Pain relief of peri-articular disorders such as frozen shoulder
(capsulitis),
bursitis, tendonitis, tenosynovitis, low back pain and soft tissue
injuries such
as sprains and strains.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The lowest effective dose should be used for the shortest duration
necessary to
relieve symptoms (see section 4.4).
_Adults: _1200 to 1800 mg daily in divided doses. Some patients can be
maintained on 600-1200 mg daily. Total daily dosage must not exceed
2400mg even in divided doses.
_Paediatric population: _This presentation is not recommended for
children.
Method of administration
For oral use. The tablets should be swallowed with or after food.
4.3
CONTRAINDICATIONS
Ibuprofen is contraindicated in patients with hypersensitivity to the
active
substance or to any of the excipients listed in section 6.1.
Ibuprofen should not be used in patients who have previously shown
hypersensitivity reactions (e.g. asthma, urticaria, angioedema or
rhinitis)
after taking ibuprofen, aspirin or other NSAIDs.
Ibuprofen is also contraindicated in patients with a history of
gastrointestinal
bleeding or perforation, related to previous NSAID therapy. Ibuprofen
should not be used in patients with active, or history of, recurrent
peptic
ulcer or gastrointestinal haemorrhage (two or more distinct episodes
of
proven ulceration or bleeding).
Ibuprofen should not be given to patients