Indometacin 25mg capsules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Indometacin

Inapatikana kutoka:

Alliance Healthcare (Distribution) Ltd

ATC kanuni:

M01AB01

INN (Jina la Kimataifa):

Indometacin

Kipimo:

25mg

Dawa fomu:

Oral capsule

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 10010100

Taarifa za kipeperushi

SAME SIZE ARTWORK
430 x 140 mm
Front
•
Lower back pain
•
Pain, inflammation and swelling following muscle or bone surgery
•
Period pain
•
Disease of the hip joint
In addition, Indometacin capsules may be prescribed for acute gouty
arthritis.
2. What you need to know before you take
Indometacin Capsules
Do not take Indometacin capsules if you:
•
are allergic to indometacin or any of the other ingredients of this
medicine (listed in section 6), for example, if you have experienced
breathing difficulties, skin rashes which look like nettle rash, or a
runny
nose or if you are hypersensitive to aspirin or another non steroidal
anti-inflammatory medicine.
•
If you have a peptic ulcer (ulcer in your stomach or duodenum) or
bleeding in your stomach, or have had two episodes of peptic ulcers,
stomach bleeding or perforation.
•
If you have polyps in your nose, associated with itching, nettle rash,
wheezing, or swelling of the face, lips, tongue and/or throat or
difficulties
in swallowing or breathing.
•
If you are in the third trimester of pregnancy or while you are
breastfeeding (see pregnancy, breast feeding and fertility)
Warnings and Precautions
Talk to your doctor or pharmacist before taking Indometacin Capsules
if
y o u :
•
are epileptic
•
have Parkinson’s disease
•
have a psychiatric problem
•
have heart disease, high blood pressure or have a tendency for fluid
retention
•
are being treated for infection or you have a fever
•
know you suffer from asthma, digestive tract, liver or kidney disease,
diabetes or heart failure
•
have a problem with your blood clotting.
140 mm
430 mm
Package leaflet: Information for the user
INDOMETACIN 25 MG CAPSULES
Indometacin
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 ma

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indometacin 25 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25mg Indometacin .
Excipients with known effect: Also contains 145.10 mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule
A hard white capsule printed with ‘BL 25’ containing a white
powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indometacin
is
a
non-steroidal
anti-inflammatory
agent
indicated
for
the
following conditions:
•
Active stages of rheumatoid arthritis, osteoarthritis, ankylosing
spondylitis, acute musculoskeletal disorders, degenerative joint
disease
of the hip, low back pain and acute gouty arthritis.
•
It is also indicated for pain, inflammation and oedema following
orthopaedic procedures; and the treatment of pain and associated
symptoms of primary dysmenorrhoea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ POSOLOGY _
The dosage of Indometacin should be carefully adjusted to suit the
needs of
the individual patient.
In order to reduce the possibility of gastro-intestinal disturbances,
_Indometacin _
_Capsules should always be taken with food or an antacid. _
_Chronic condition:_ In chronic conditions, starting therapy with a
low dosage,
increasing this gradually as necessary, and continuing a trial of
therapy for an
adequate period (in some cases, up to one month) will give the best
results
with a minimum of unwanted reactions. The recommended oral dosage
range
is 50 mg to 200 mg daily in divided doses. Paediatric dosage not
established.
_Dosage in dysmenorrhoea_: Up to 75 mg a day, starting with onset of
cramps
or bleeding, and continuing for as long as the symptoms usually last.
_Dosage in acute gouty arthritis_: 150 mg to 200 mg daily in divided
doses until
all symptoms and signs subside.
_Use in the elderly_: Indometacin should be used with particular care
in older
patients who are more prone to adverse reactions.
_Paediatric population: _The safety and efficacy of indometacin i