Hydrocortisone 10mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Hydrocortisone

Fáanlegur frá:

Flynn Pharma Ltd

ATC númer:

H02AB09

INN (Alþjóðlegt nafn):

Hydrocortisone

Skammtar:

10mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 06030200; GTIN: 5060106551566

Upplýsingar fylgiseðill

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 may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Hydrocortisone Tablets are and
what they are used for
2. What you need to know before you take
Hydrocortisone Tablets
3. How to take Hydrocortisone Tablets
4. Possible side effects
5. How to store Hydrocortisone Tablets
6. Contents of the pack and other information
- HYDROCORTISONE IS A STEROID MEDICINE,
prescribed for many different conditions, including
serious illnesses.
- YOU NEED TO TAKE IT REGULARLY
to get the maximum
benefit.
- DON’T STOP TAKING THIS MEDICINE
without talking to
your
doctor
-
you
may
need
to
reduce
the
dose
gradually.
- HYDROCORTISONE CAN CAUSE SIDE EFFECTS IN SOME
PEOPLE
(read section 4 below). Some problems such as
mood
changes
(feeling
depressed,
or
‘high’),
or
stomach problems can happen straight away. If you
feel unwell in any way, keep taking your tablets, but
SEE YOUR DOCTOR STRAIGHT AWAY.
-
Some
side
effects
only
happen
after
weeks
or
months. These include weakness of arms and legs, or
developing a rounder face (read section 4 for more
information).
- IF YOU TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET A
BLUE ‘STEROID TREATMENT CARD’:
always keep it with
you and show it to any doctor or nurse treating you.
- KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN POX OR
SHINGLES,
even if you had them previously (see section
2 for further information). They could affect you
severely. If you do come into contact with chicken pox
or shingles, see your doctor straight away.
NOW READ THE REST OF THIS LEAFLET.
It includes other
imp

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg hydrocortisone
Excipients with known effect:
Each tablet contains 146.75 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
White to off white, elliptical shape, flat, bevelled edge tablet with
“BL 10” on one
side and crossed break lines on other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Corticosteroid
•
For use as replacement therapy in congenital adrenal hyperplasia in
children.
•
Treatment of adrenal insufficiency in children and adolescents < 18
years of
age.
•
Emergency treatment of severe bronchial asthma, drug hypersensitivity
reactions, serum sickness, angioneurotic oedema and anaphylaxis in
adults
and children.
•
Pre-operatively, and during serious trauma or illness in children with
known adrenal insufficiency or doubtful adrenocortical reserve.
Hydrocortisone tablets are indicated in adults and children aged from
1 month
to 18 years where the dose of 10 mg, 20mg and tablet formulation is
considered appropriate
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage must be individualised according to the response of the
individual
patient. The lowest possible dosage should be used.
In patients requiring replacement therapy, the daily dose should be
given when
practicable, in two doses. The first dose in the morning should be
larger than
the second dose in the evening, thus simulating the normal diurnal
rhythm of
cortisol secretion.
Patients should be observed closely for signs that might require
dosage
adjustment, including changes in clinical status resulting from
remissions or
exacerbations of the disease, individual drug responsiveness, and the
effect of
stress (e.g. surgery, infection, trauma). During stress it may be
necessary to
increase the dosage temporarily
To avoid hypoadrenalism and/or a relapse of the under