INDOMETHACIN BIOTECH 25 CAPSULES

Land: Suður-Afríka

Tungumál: enska

Heimild: South African Health Products Regulatory Authority (SAHPRA)

Fáanlegur frá:

Biotech Laboratories (Pty) Ltd

Skammtar:

See ingredients

Lyfjaform:

CAPSULES

Samsetning:

EACH CAPSULE CONTAINS INDOMETHACIN 25 mg

Leyfisstaða:

Registered

Leyfisdagur:

1988-06-08

Upplýsingar fylgiseðill

BIOTECH LABORATORIES (PTY) LTD
INDOMETHACIN BIOTECH 25
Each capsule contains 25 mg indomethacin
1.3.2
Page 1 of 15
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S3
INDOMETHACIN BIOTECH 25 CAPSULES
INDOMETHACIN
SUGAR FREE.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
INDOMETHACIN BIOTECH 25.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare
provider.
•
INDOMETHACIN BIOTECH 25 has been prescribed for you personally and you
should not
share your medicine with other people. It may harm them, even if their
symptoms are the same
as yours.
WHAT IS IN THIS LEAFLET:
1.
What INDOMETHACIN BIOTECH 25 is and what it is used for
2.
What you need to know before you take INDOMETHACIN BIOTECH 25
3.
How to take INDOMETHACIN BIOTECH 25
4.
Possible side effects
5.
How to store INDOMETHACIN BIOTECH 25
6.
Contents of the pack and other information.
1.
WHAT INDOMETHACIN BIOTECH 25 IS AND WHAT IT IS USED FOR
INDOMETHACIN BIOTECH 25 contains the active ingredient indomethacin,
which belongs to a
group of medicines called nonsteroidal anti-inflammatory drugs
(NSAIDs). NSAIDs are used to
BIOTECH LABORATORIES (PTY) LTD
INDOMETHACIN BIOTECH 25
Each capsule contains 25 mg indomethacin
1.3.2
Page 2 of 15
reduce inflammation, pain and fever.
INDOMETHACIN BIOTECH 25 is used for:
•
rheumatoid arthritis (an autoimmune and inflammatory disease that may
cause joint pain,
inflammation, and damage throughout your body);
•
osteoarthritis (degenerative joint disease, causing pain and stiffness
of your joints);
•
ankylosing spondylitis (pain and stiffness in your back);
•
deterioration of the cartilage that serves as a cushion in the joints
of your hips (degenerative
joint disease of your hip);
•
acute gouty arthritis (a form or arthritis in which crystals build up
in your joints);
•
musculoskeletal disorders (such as, bursitis, tendonitis, synovitis,
tenosynovitis, capsulitis of the
shoulder, sprains and
strains);
•
lower b

Vara einkenni

BIOTECH LABORATORIES (PTY) LTD
INDOMETHACIN BIOTECH 25
Each capsule contains 25 mg indomethacin
1.3.1.1
Page 1 of 32
PROFESSIONAL INFORMATION FOR INDOMETHACIN BIOTECH 25
SCHEDULING STATUS:
S3
1.
NAME OF THE MEDICINE:
INDOMETHACIN BIOTECH 25 Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each capsule contains indomethacin 25 mg.
Sugar free.
For the full list of excipients, see section 6 .1.
3.
PHARMACEUTICAL FORM:
Capsules, hard.
Opaque, yellow, hard gelatine capsule containing a white powder.
4.
CLINICAL PARTICULARS:
4.1
THERAPEUTIC INDICATIONS:
INDOMETHACIN BIOTECH 25 is indicated in active stages of:
•
rheumatoid arthritis;
•
osteoarthritis;
•
ankylosing spondylitis;
•
degenerative joint disease of the hip;
•
acute gouty arthritis.
INDOMETHACIN BIOTECH 25 is also indicated for:
•
acute musculoskeletal disorders, such as, bursitis, tendonitis,
synovitis, tenosynovitis, capsulitis
BIOTECH LABORATORIES (PTY) LTD
INDOMETHACIN BIOTECH 25
Each capsule contains 25 mg indomethacin
1.3.1.1
Page 2 of 32
of the shoulder, sprains and strains;
•
low back pain (commonly referred to as lumbago);
•
fever (as a short-term adjunct to specific therapy);
•
inflammation, pain, trismus and swelling following dental procedures;
•
inflammation, pain and swelling following orthopaedic surgical
procedures and nonsurgical
procedures associated with reduction and immobilisation of fractures
or dislocations;
•
pain and associated symptoms of primary dysmenorrhoea
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
POSOLOGY:
_ADULTS: _
The recommended dose of INDOMETHACIN BIOTECH 25 is 50 mg to 200 mg
daily in divided doses,
individually adjusted to the patient’s response and tolerability to
the medicines. Use the lowest
effective dose for the shortest duration consistent with individual
patient treatment goals, starting
with a low dose.
A loading dose of INDOMETHACIN BIOTECH 25 is not necessary. In chronic
rheumatic disorders,
initiating therapy with low doses, increasing gradually when
necessary, and continuing for a