Indometacin 25mg capsules

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Indometacin

Disponible depuis:

Bristol Laboratories Ltd

Code ATC:

M01AB01

DCI (Dénomination commune internationale):

Indometacin

Dosage:

25mg

forme pharmaceutique:

Oral capsule

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 10010100; GTIN: 5060013942631

Notice patient

SAME SIZE ARTWORK
480 x 180 mm
Front
•
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) including COX II inhibitors
(e.g.
celecoxib)
•
suffer with angioneurotic oedema (swelling of the face, lips, tongue
or throat)
•
have or have had a history of two or more episodes of peptic ulcers
(ulcer in your
stomach or duodenum) or bleeding in your stomach or intestines in the
past.
Symptoms may include vomiting particles that look like coffee-grounds,
black
tarry stools and blood in your faeces (stools/motions)
•
have nasal obstruction (nasal polyps)
WARNINGS AND PRECAUTIONS
If you are elderly or you have previously had stomach ulcers, you have
a higher risk
of getting side effects, especially from the stomach. Your doctor
should therefore
prescribe the lowest dose that gives you sufficient relief. If you
experience any
usual symptoms from the stomach, you must tell your doctor about it.
Medicines such as Indometacin may be linked to a small increased risk
of heart
attack or stroke. Any risk is more likely with high doses or prolonged
treatment. Do
not exceed the recommended dose or duration of treatment.
TAKING PAIN KILLERS FOR HEADACHES TOO OFTEN OR FOR TOO LONG CAN MAKE
THEM
WORSE.
Tell your doctor before you take this medicine if you:
•
have heart problems, previous stroke or think you might be at risk of
these
conditions (e.g. if you have high blood pressure, diabetes or high
cholesterol or
are a smoker)
•
are elderly, have ulcerative colitis or Crohn’s disease, as there is
a higher risk of
stomach problems (e.g. ulcers or bleeding)
•
have or have had any problems with your liver, heart or kidneys that
may cause
fluid retention
•
have asthma, mental health problems, epilepsy or Parkinson’s disease
(tremor,
stiffness and shuffl

Résumé des caractéristiques du produit

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 according to
the needs
of the individual patient.
To reduce the possibility of gastro-intestinal disturbances,
Indometacin
Capsules should always be taken with food, milk 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 in