Ibuprofen Pinewood 200 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Pinewood Laboratories Ltd

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

200 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Not marketed

Authorization date:

1980-12-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN PINEWOOD 200 MG FILM-COATED TABLETS
IBUPROFEN PINEWOOD 400 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.
-
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. This includes any
possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Ibuprofen Pinewood tablets are and what they are used for
2. What you need to know before you take Ibuprofen Pinewood tablets
3. How to take Ibuprofen Pinewood tablets
4. Possible side effects
5. How to store Ibuprofen Pinewood tablets
6. Contents of the pack and other information
1. WHAT IBUPROFEN PINEWOOD TABLETS ARE AND WHAT THEY ARE USED FOR
Ibuprofen Pinewood tablets contain the active ingredient ibuprofen
which is a non-steroidal
anti-inflammatory drug (NSAID). They are used for the treatment of
mild to moderate pain
and inflammation associated with the following conditions:
•
post-operative pain
•
toothache
•
period pain
•
soft tissue injury (muscles and ligaments)
•
stiffness and pain in the back and muscles
•
types of arthritis e.g. rheumatoid, osteoarthritis
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN PINEWOOD TABLETS
DO NOT TAKE IBUPROFEN PINEWOOD TABLETS:
•
if you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed
in section 6)
•
if you previously experienced stomach bleeding or perforation after
taking ibuprofen
or other non-steroidal anti-inflammatory drugs (NSAIDs)
•
if you currently have a peptic ulcer (ulcer in your stomach or
duodenum) or bleeding
in your stomach, or have had two or more episodes of peptic ulcers,
stomach bleeding
or perforation in the past
�

Summary of Product characteristics

Health Products Regulatory Authority
12 January 2023
CRN00D8HW
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen Pinewood 200 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of Ibuprofen.
Excipient(s) with known effect
Each tablet contains 0.546 mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet (Tablet).
Pink, circular, film-coated tablets with the markings ‘IBU 200’ on
one side and plain on reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ibuprofen Pinewood tablets are indicated in the management of various
arthroses such as rheumatoid arthritis including Stills
disease and osteoarthritis, fibrositis, and ankylosing spondylitis and
other muscular syndromes, such as low back pain, soft
tissue trauma and various inflammations of the tendon, joint capsules
and ligaments.
Ibuprofen Pinewood tablets are also indicated for the treatment of
mild to moderate pain (such as dysmenorrhoea, dental and
post-operative pain).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For oral administration.
In general, NSAIDS should only be used when an anti-inflammatory
effect is required. NSAIDs should be used with particular
caution in the elderly who are more prone to adverse events.
Undesirable effects may be minimized by using the lowest
effective dose for the shortest duration necessary to control symptoms
(_see section 4.4, Special warnings and precautions for _
_use). _Treatment should be reviewed at regular intervals and
discontinued if no benefit is seen or intolerance occurs.
Adults:
The usual dose is 1200 to 1600 mg daily in divided doses. Some
patients may be maintained on 600-1200 mg daily. The
maximum daily dose should not exceed 2400 mg.
Elderly:
The recommended adult dose is appropriate. No specific dosage
modifications are required unless renal or hepatic function is
impaired, in which case dosage should be assessed individually.
Care should be taken in elderly