Ibuprofen 600mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Ibuprofen

Prieinama:

DE Pharmaceuticals

ATC kodas:

M01AE01

INN (Tarptautinis Pavadinimas):

Ibuprofen

Dozė:

600mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 10010100

Pakuotės lapelis

_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

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ibuprofen Tablets B.P. 600 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 600 mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pink capsule shaped, biconvex 22 x 10 mm, film coated tablets marked
with “ FIL/
I600” on one side and decorative scoreline on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ibuprofen is indicated for its analgesic and anti-inflammatory effect
in rheumatoid
arthritis (including juvenile rheumatoid arthritis or Still’s
disease) ankylosing
spondylitis, osteoarthritis and other non-rheumatoid arthropathies.
In non-articular rheumatoid conditions, ibuprofen is indicated in
periarticular
conditions e.g. frozen shoulder, bursitis, tendinitis, tenosynovitis
and low back pain.
Ibuprofen can be used in soft-tissue injuries, e.g. sprains and
strains.
It is also indicated for the relief of mild to moderate pain, e.g.
dental and post-
operative pain and dysmenorrhoea.
It is also indicated for the relief of migraine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration. To be taken preferably with or after food.
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
Adults:
Initial dosage is 1800 mg daily in divided doses. Some patients can be
maintained on
600 -1800 mg daily. In severe or acute conditions it may be
advantageous to
increase the dosage provided that the total daily dosage does not
exceed
2400 mg in divided doses.
Elderly:
The elderly are at increased risk of the serious consequences of
adverse
reactions. If an NSAID is considered necessary, the lowest effective
dose
should be used and for the shortest possible duration. The patient
should be
monitored regularly for GI bleeding during NSAID therapy.
Children:
Ibuprofen BP 600 mg tablets are not suitable for children.
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration n