Buplex Rx 200 mg film-coated tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Ibuprofen

Fáanlegur frá:

Actavis Group hf

ATC númer:

M01AE; M01AE01

INN (Alþjóðlegt nafn):

Ibuprofen

Skammtar:

200 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Propionic acid derivatives; ibuprofen

Leyfisstaða:

Marketed

Leyfisdagur:

2009-07-03

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUPLEX RX 200 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 to provide relief from mild to moderate pain such as
headache, including migraine
headache, dental pain, period pain and fever.
If you are over 12 years of age your doctor may also prescribe this or
higher doses 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

Vara einkenni

Health Products Regulatory Authority
29 November 2022
CRN00D6C2
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buplex Rx 200 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film‑coated tablet contains 200 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
Mild to moderate pain, such as headache including migraine headache,
dental pain.
Primary dysmenorrhoea.
Fever.
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).
If a child or adolescent requires this medicinal product for more than
3 days, or if symptoms worsen, a doctor should be
consulted.
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.
_MILD TO MODERATE PAIN AND FEVER_
_Adults and adolescents older than 12 years (≥40 kg):_
200‑400 mg given as a single dose or 3‑4 times a day with an
interval of 4 to 6 hours. The dosage in migraine headache
should be: 400 mg given as a single dose, if necessary 400 mg with
intervals of 4 to 6 hours.
The maximum daily dose should not exceed 1200 mg.
_Children 6‑12 years (>20 kg):_
Children 6‑9 years (20‑29 kg): 200 mg 1‑3 times a day with
intervals of 4 to 6 hours as required.
The maximum daily dose should not exceed 600 mg.
Children 10‑12 years (30‑40 kg): 200 mg 1‑4 times a day with
intervals of 4 to 6 hours as required.
The maximum daily dose should not exceed 800 mg.