Calcort 6mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Deflazacort

MAH:

Waymade Healthcare Plc

ATC_code:

H02AB13

INN:

Deflazacort

dosage:

6mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 06030200

PIL

89034570 - 753360 4/4
89034570 - 753360 1/4
OTHER SERIOUS SIDE EFFECTS INCLUDE:
NOT KNOWN (frequency cannot be estimated from
the available data)
• A very sore throat. You may also have difficulty
in swallowing and the inside of your mouth
may have white areas on the surface.
• Headache, which is usually worse in the
morning, on coughing or straining, and feeling
sick (nausea). Also, fits, fainting, eyesight
problems, painful eyes or confusion can occur.
• In infants with a low birth weight a heart
muscle disease (hypertrophic cardiomyopathy)
may occur.
If you notice any of these problems TALK TO A
DOCTOR STRAIGHT AWAY.
OTHER SIDE EFFECTS:
Please tell y
our doctor or pharmacist if any of the
following side effects gets serious or lasts longer
than a few days.
UNCOMMON (affects 1 to 10 users in 1,000)
• 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.
• Mood changes, difficulty in sleeping.
• 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 (affects 1 to 10 users in 10,000)
• 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 p

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Calcort 6mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Deflazacort 6mg
Excipient(s) with known effect:
Lactose monohydrate 153mg
For a 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 6mg of
deflazacort has
approximately
the
same
anti-inflammatory
potency
as
5mg
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 Warnings and Precautions).
ADULTS
For acute dis