Buplex Rx 600 mg film-coated tablets

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Ibuprofen

Доступно од:

Actavis Group hf

АТЦ код:

M01AE; M01AE01

INN (Међународно име):

Ibuprofen

Дозирање:

600 milligram(s)

Фармацеутски облик:

Film-coated tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Propionic acid derivatives; ibuprofen

Статус ауторизације:

Marketed

Датум одобрења:

2009-07-03

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUPLEX RX 600 MG FILM-COATED TABLETS
ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET
:
1.
What Buplex Rx is and what it is used for
2.
What you need to know before you take Buplex Rx
3.
How to take Buplex Rx
4.
Possible side effects
5.
How to store Buplex Rx
6.
Contents of the pack and other information
1.
WHAT BUPLEX RX IS AND WHAT IT IS USED FOR
Buplex Rx belongs to a group of medicines called NSAID (non-steroidal
anti-inflammatory drugs)
which work by reducing pain, inflammation and fever.
Buplex Rx is used for the treatment of rheumatoid arthritis,
osteoarthritis or other inflammatory or
painful joint conditions, as well as for inflammatory and painful
conditions of soft tissues such as
muscles.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUPLEX RX
DO NOT TAKE BUPLEX RX:
-
if you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed in section
6).
-
if you have had allergic reactions such as asthma, runny nose, itchy
skin rash or swelling of the
lips, face, tongue, or throat after you have taken medicines
containing acetylsalicylic acid or
other drugs for pain and inflammation (NSAIDs).
-
if you have suffered from an ulcer or bleeding in the stomach or small
intestine (duodenum)
related to previous use of drugs for pain and inflammation (NSAIDs)
-
if you are suffering from an ulcer or bleeding in the stomach or small
intestine (duodenum) or if
you have had two or more of these episodes in the past
-
if you suffer from s

Карактеристике производа

Health Products Regulatory Authority
29 November 2022
CRN00D6C2
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buplex Rx 600 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film‑coated tablet contains 600 mg ibuprofen.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film‑coated tablet.
White, oval, biconvex film‑coated tablets with a score on one face.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rheumatic conditions such as arthritic diseases (e.g. rheumatoid
arthritis including juvenile rheumatoid arthritis), degenerative
arthritic conditions (e.g. osteoarthritis), non-articular rheumatic
conditions, other muscular and joint disorders, and soft tissue
injuries.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4).
The ibuprofen dose depends on the patient's age and body weight. The
maximum single dose for adults should not exceed
800 mg of ibuprofen.
_RHEUMATIC DISEASES_
_Adults:_
The usual dose is 400‑600 mg 3 times a day. Maintenance doses of 600
mg‑1200 mg daily may be effective in some patients.
In acute and severe conditions the dose may be increased to a maximum
of 2400 mg in 3 or 4 divided doses.
_Adolescents over 12 years of age (>40 kg):_
The recommended dose is 20 mg/kg to a maximum of 40 mg/kg body weight
daily in 3 to 4 divided doses.
There are other dosage forms which may be more suitable to attain the
required posology in this age and body weight group.
_ _
_PAEDIATRIC POPULATION_
This medicine should not be given to children younger than 12 years.
_Elderly_
NSAIDs should be used with particular caution in elderly patients who
are more prone to adverse events and are at increased
risk of potentially fatal gastrointestinal haemorrhage, ulceration or
perforation (see section 4.4). If treatment is considered
necessary, the lowest dose for the shortest duration