Calcort 6mg tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Deflazacort

थमां उपलब्ध:

Neon Healthcare Ltd

ए.टी.सी कोड:

H02AB13

INN (इंटरनेशनल नाम):

Deflazacort

डोज़:

6mg

फार्मास्यूटिकल फॉर्म:

Oral tablet

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 06030200; GTIN: 5000283653356

सूचना पत्रक

875418 4/4
875418 1/4
PLEASE TELL YOUR DOCTOR OR PHARMACIST IF ANY OF
THE FOLLOWING SIDE EFFECTS GETS SERIOUS OR LASTS
LONGER THAN A FEW DAYS.
UNCOMMON (MAY AFFECT UP TO 1 IN 100 PEOPLE)
• Stomach or bowel problems such as feeling full or
bloated, indigestion, heartburn or stomach pain.
• Increase in appetite and weight gain including
around your face, or you may lose weight or feel
weak.
• Hair, including body or facial hair, grows more
than normal.
• Increased thirst and needing to pass water more
often than usual. These could be signs of
diabetes. If you are already diabetic, your doctor
may prescribe more of your diabetes medicine to
balance the effects of deflazacort. You should
discuss this with your doctor.
• Raised blood pressure and increased water
retention.
• Tiredness, confusion, muscle weakness or muscle
cramps. This may be due to low levels of
potassium in your body.
• If you have had tuberculosis (TB) in the past it
may return.
• Skin problems such as acne, appearance of
stretch marks.
• You may get infections more easily than usual.
RARE (MAY AFFECT UP TO 1 IN 1,000 PEOPLE)
• Bleeding under the skin, redness.
• General muscle weakness or tiredness.
NOT KNOWN (FREQUENCY CANNOT BE ESTIMATED FROM
THE AVAILABLE DATA)
• Bones and tendons may break or tear more easily
than usual. Also, tendons may get inflamed and
become painful.
• Irregular periods in women or they may stop
altogether.
• Becoming dependent on deflazacort (also called
psychological dependence).
• If you have schizophrenia your symptoms may get
worse.
• Fungal infection such as thrush.
• Eye disease that causes detachment of the retina
and bulging eyes.
• Eye problems such as glaucoma and cataracts can
happen if you take this medicine for a long time.
• Eye infections (viral) may spread or return if you
have had them in the past.
• Blurred vision.
• Increase in the risk of clots forming in your blood.
• Blood problems such as leucocytosis.
• Wounds and cuts do not heal as quickly as usual.
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उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Calcort 6mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Deflazacort 6 mg
Excipient(s) with known effect:
Lactose monohydrate 153 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Round, white, uncoated tablets, flat with bevelled edge, 8.5mm in
diameter; marked
with a cross on one face and a 6 on the other face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A wide range of conditions may sometimes need treatment with
glucocorticoids. The indications include:
Anaphylaxis, asthma, severe hypersensitivity reactions
Rheumatoid arthritis, juvenile chronic arthritis, polymyalgia
rheumatica
Systemic lupus erythematosus, dermatomyositis, mixed connective tissue
disease (other than systemic sclerosis), polyarteritis nodosa,
sarcoidosis
Pemphigus, bullous pemphigoid, pyoderma gangrenosum
Minimal change nephrotic syndrome, acute interstitial nephritis
Rheumatic carditis
Ulcerative colitis, Crohn's disease
Uveitis, optic neuritis
Autoimmune haemolytic anaemia, idiopathic thrombocytopenic purpura
Acute and lymphatic leukaemia, malignant lymphoma, multiple myeloma
Immune suppression in transplantation
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Deflazacort is a glucocorticoid derived from prednisolone and 6 mg of
deflazacort has
approximately the same anti-inflammatory potency as 5 mg prednisolone
or prednisone.
Doses vary widely in different diseases and different patients. In
more serious and life-
threatening conditions, high doses of deflazacort may need to be
given. When deflazacort is
used long term in relatively benign chronic diseases, the maintenance
dose should be kept as
low as possible. Dosage may need to be increased during periods of
stress or in exacerbation
of illness.
The dosage should be individually titrated according to diagnosis,
severity of disease and
patient response and tolerance. The lowest dose that will produce an
acceptable response
should be used (see section 4.4).
Adults