Ibuprofen 200 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

200 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Not marketed

Authorization date:

2016-10-07

Patient Information leaflet

IE/H/0755/001-003/IB/018, ver 03, Sep 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN 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 Ibuprofen tablets is and what it is used for
2.
What you need to know before you take Ibuprofen tablets
3.
How to take Ibuprofen tablets
4.
Possible side effects
5.
How to store
Ibuprofen tablets
6.
Contents of the pack and other information
1.
WHAT IBUPROFEN TABLETS IS AND WHAT IT IS USED FOR
Ibuprofen tablets belong to a group of medicines called NSAIDs
(non-steroidal anti-inflammatory
drugs).
In adults and children over 6 years (>20 kg): Short term treatment of
fever and pain of mild to
moderate intensity, including dysmenorrhea.
Long term symptomatic treatment of pain and inflammation in chronic
inflammatory rheumatic
diseases.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN TABLETS
DO NOT TAKE IBUPROFEN TABLETS:
•
if you are allergic (hypersensitive) to ibuprofen or any of the other
ingredients of this medicine
(listed in section 6).
•
if you are in the last three months of pregnancy.
•
if you have an increased tendency to bleed.
•
if you previously have had bleeding or perforation in your stomach or
intestine when treated
with Ibuprofen tablets or a similar product (other NSAIDs).
•
if you have severe liver and kidney disease.
•
if you have severe heart failure or coronary heart disease.
•
if you have a stomach ulcer, duodenal ulcer, or if you have had a
stomach ulcer or duodenal
ulcer pr

Summary of Product characteristics

Health Products Regulatory Authority
27 October 2023
CRN00DSJD
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg ibuprofen
Excipient with known effect: each tablet contains 23 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Ibuprofen 200 mg film-coated tablets: pink coloured, round,
approximately 10 mm in diameter, biconvex film coated tablets
debossed with ‘DJ’ on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults and children over 6 years (>20 kg): Short term treatment of
fever and pain of mild to moderate intensity, including
dysmenorrhea.
Long term symptomatic treatment of pain and inflammation in chronic
inflammatory rheumatic diseases.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment should start with the lowest dose anticipated to be
effective, which can subsequently be adjusted, depending on
the therapeutic response and any undesirable effects. In long-term
treatment a low maintenance dose should be the aim.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4).
_Rheumatic diseases_
- initial treatment of 4x200 mg tablets, three times daily, i.e. 2400
mg per day
- maintenance treatment : 2x200 mg tablets, three to four times daily,
i.e. 1200 to 1600 mg per day.
An interval of at least 4-6 hours should be allowed between doses. The
total daily dose must not exceed 2400mg in divided
doses. Some patients can be maintained on 600 – 1200mg daily. If a
high daily dose is required a different strength of
ibuprofen tablet may be more appropriate.
_Juvenile Rheumatoid Arthritis_
For Juvenile Rheumatoid Arthritis, the recommended dose is
20mg-30mg/kg body weight daily in 3 to 4 divided doses up to a
maximum of 40mg/kg body weight daily in severe cases. In children
weighing less than 30 kg,