Fenbid Spansule Capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

Mercury Pharma Group Limited No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, United Kingdom

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 300 mg

Pharmaceutical form:

MODIFIED-RELEASE CAPSULE

Composition:

IBUPROFEN 300 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2006-03-20

Patient Information leaflet

Page 1 of 6
PATIENT INFORMATION LEAFLET
FENBID
®
SPANSULE
®
CAPSULES
(IBUPROFEN)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What are Fenbid® Spansule® Capsules and what they are used for
2. Before you take Fenbid® Spansule® Capsules
3. How to take Fenbid® Spansule® Capsules
4. Possible side effects
5. How to store Fenbid® Spansule® Capsules
6. Further information
1. WHAT ARE FENBID® SPANSULE® CAPSULES AND WHAT THEY ARE USED FOR
Fenbid® Spansule® Capsules contain ibuprofen and belong to a group
of medicines called non-
steroid anti-inflammatory drugs (NSAID’s). These medicines reduce
pain and inflammation, and
bring down a high temperature. Fenbid® Spansule® Capsules are used
for treatment of various
conditions affecting the joints (such as rheumatoid arthritis,
including rheumatoid arthritis in
children over 12 years of age, osteoarthritis and ankylosing
spondylitis), muscles (e.g. low back
pain, soft tissue injuries, such as sprains and strains) and areas of
inflammation within tendons. It
is also used for treatment of dental pain and after operations.
2. BEFORE YOU TAKE FENBID® SPANSULE® CAPSULES
DO NOT TAKE FENBID® SPANSULE® CAPSULES IF:
• You know that you are allergic to ibuprofen, aspirin or similar
medicines, or any of the other
ingredients in these capsules (listed at the end of this leaflet in
Section 6)
• You have or previously have had a peptic ulcer (ulcer in your
stomach, or intestines) or
bleeding in your stomach, or have had two or more episodes of peptic
ulcer, stomach bleeding
or perforation
• You suffer from severe heart, liver or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fenbid Spansule Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 300mg
3
PHARMACEUTICAL FORM
Spansule Capsule.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of rheumatoid arthritis, oesteoarthritis, ankylosing
spondylitis and other
seronegative (non-rheumatoid) atropathies. It is also indicated in
acute periarticular
disorders such as bursitis, capsulitis of the shoulder, tendinitis and
tenosynovitis and
for
the
relief
in
mild
to
moderate
pain
in
sprains,
strains,
low
back
pain,
dysmenorrhoea, dental and post-operative pain.
The evening dose of Fenbid Capsules will maintain a prolonged
therapeutic effect
throughout the night and help to prevent morning stiffness.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
To be taken preferably with or after food.
Dosage:
Adults, Elderly and Children over 12 years.
Usual starting dose is two capsules (600 mg) twice daily, taken
morning and night.
This may be increased to three capsules (900 mg) twice daily until the
acute phase is
controlled.
Maintenance dose: One to two capsules twice daily.
Patients should be instructed not to chew or suck the capsules as this
destroys the
sustained release properties. Providing this is ensured, the contents
of a capsule may
be sprinkled onto a spoonful of soft food, yoghurt, or similar
substance, for patients
who experience difficulty in swallowing the capsule.
Elderly: The elderly are at increased risk of the serious consequences
of adverse
reactions. If an NSAID is considered necessary, the lowest effective
dose should be
used and for the shortest possible duration. The patient should be
monitored regularly
for GI bleeding during NSAID therapy.
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration necessary to control symptoms (see section 4.4).
4.3
CONTRAINDICATIONS
Ibuprofen is contraindicated in patients with hypersensitivity to the
active substance
or to any of the excipients.