Buplex 200mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Actavis Group hf

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

200 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Marketed

Authorization date:

2009-07-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUPLEX 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.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse
- after 3 days in children and adolescents
- after 7 days in adults.
WHAT IS IN THIS LEAFLET
:
1.
What Buplex is and what it is used for
2.
What you need to know before you take Buplex
3.
How to take Buplex
4.
Possible side effects
5.
How to store Buplex
6.
Contents of the pack and other information
1.
WHAT BUPLEX IS AND WHAT IT IS USED FOR
Buplex belongs to a group of medicines called NSAID (non-steroidal
anti-inflammatory drugs) which work
by reducing pain, inflammation and fever.
Buplex 200 mg is used to provide relief from mild to moderate pain
such as headache, including migraine
headache, dental pain, period pain and fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUPLEX
DO NOT TAKE BUPLEX:
-
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 suffe

Summary of Product characteristics

Health Products Regulatory Authority
18 February 2022
CRN00CJPW
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buplex 200mg 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.
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).
This product is for short-term use only, not longer than 7 days in
adults. If symptoms persist or worsen a doctor should be
consulted.
<200 mg:> If a child or adolescent requires this medicinal product for
more than 3 days, or if symptoms worsen, a doctor
should be consulted.
<400 mg:> If an adolescent requires this medicinal product for more
than 3 days, or if symptoms worsen, a doctor should be
consulted.
_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.
<200 mg only:>
_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.
_PRIMARY DYSMENORRHOEA_
_Adults and adolescents over 12 years of age:_
200‑400 mg 1‑3 times a day, with an interval