Indometacin 100mg suppositories

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Indometacin

Inapatikana kutoka:

A A H Pharmaceuticals Ltd

ATC kanuni:

M01AB01

INN (Jina la Kimataifa):

Indometacin

Kipimo:

100mg

Dawa fomu:

Suppository

Njia ya uendeshaji:

Rectal

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 10010100

Taarifa za kipeperushi

INDOMETACIN 100MG SUPPOSITORIES
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

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.

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.
IN THIS LEAFLET:
1.
WHAT INDOMETACIN SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
2.
BEFORE YOU USE INDOMETACIN SUPPOSITORIES
3.
HOW TO USE INDOMETACIN SUPPOSITORIES
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE INDOMETACIN SUPPOSITORIES
6.
FURTHER INFORMATION
1.
WHAT INDOMETACIN SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Indometacin suppositories belong to a group of medicines called
non-steroidal anti-inflammatory
drugs (NSAIDs). These medicines are pain killers which reduce
swelling.
Indometacin suppositories are for:

inflammatory diseases of the joints such as rheumatoid arthritis,
osteoarthritis and degenerative hip
disease

pain and stiffness in the backbone (ankylosing spondylitis)

sprains and strains (acute muscle and bone disorders)

lower back pain

pain and swelling following muscle or bone surgery

period pain

gout.
2.
BEFORE YOU USE INDOMETACIN SUPPOSITORIES
DO NOT USE INDOMETACIN SUPPOSITORIES IF YOU:

are in the LAST THREE MONTHS OF PREGNANCY

are ALLERGIC (HYPERSENSITIVE) TO INDOMETACIN or any of the ingredients
of Indometacin
suppositories (see section 6)

are ALLERGIC (HYPERSENSITIVE) TO ASPIRIN, IBUPROFEN OR OTHER NSAIDS or
you have developed signs
of asthma (wheezing), runny nose, swelling of the face, lips, tongue
or throat or a skin rash with
pale or red irregular raised patches with severe itching, when taking
these medicines

are taking other NSAIDS (e.g. Naproxen) or COX II INHIBITORS (e.g.
Celecoxib)

suffer with ANGIONEUROTIC OEDEMA (swelling of t

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indometacin Suppositories BP 100mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 100mg Indometacin
3
PHARMACEUTICAL FORM
Yellow suppositories
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indometacin has non-steroidal analgesic and anti-inflammatory
properties.
It is indicated for the following conditions:
•
active stages of rheumatoid arthritis, osteoarthritis, ankylosing
spondylitis,
degenerative joint disease of the hip, acute musculoskeletal
disorders, gout
and lumbago
•
inflammation, pain and oedema following orthopaedic procedures
•
treatment of pain and associated symptoms of primary dysmenorrhoea
Since indometacin is not a simple analgesic, its use should be limited
to the
above conditions.
Indometacin
suppositories
may
be
used
where
night
pain
and
morning
stiffness are prominent. One suppository at bedtime frequently gives
relief
from pain and stiffness for 13-16 hours after administration.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults only_: To be inserted rectally. One suppository (100mg) to be
inserted at
night and repeated in the morning, if necessary.
_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.
_Children_:_ _Safety for use in children has not been established.
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
_Method of Administration _
For rectal administration
4.3
CONTRAINDICATIONS
•
Hypersensitivity to indometacin or to any of the excipients.
•
NSAIDs
are
contraindicated
in
patients
who
have
previously
shown
hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or
urticaria) in
response to ibuprofen, aspirin or other non-steroidal
anti-inf