Hydrocortisone 10mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Hydrocortisone

Dostopno od:

Teva UK Ltd

Koda artikla:

H02AB09

INN (mednarodno ime):

Hydrocortisone

Odmerek:

10mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 06030200; GTIN: 5017007014508

Navodilo za uporabo

HYDROCORTISONE 10 MG AND
20 MG TABLETS
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.
• HYDROCORTISONE IS A STEROID MEDICINE,
prescribed for many different conditions,
including serious illnesses.
• YOU NEED TO TAKE IT REGULARLY to get the
maximum benefit.
• DO NOT 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 ‘Possible side effects’ section
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 ‘Possible
side effects’ section for more information).
• IF YOU TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET
A BLUE ‘STEROID CARD’: always keep it with you
and show it to any doctor or nurse treating you.
• KEEP AWAY FROM PEOPLE WHO HAVE CHICKENPOX
OR SHINGLES, if you have never had them. They
could affect you severely. If you do come into
contact with chickenpox or shingles, SEE YOUR
DOCTOR STRAIGHT AWAY.
NOW READ THE REST OF THIS LEAFLET. It includes other
important information on the safe and effective
use of this medicine that might be especially
important for you.
1. WHAT HYDROCORTISONE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
HYDROCORTISONE
3. HOW TO TAKE HYDROCORTISONE

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg hydrocortisone
Excipient(s) with known effect
Each tablet contains 142.4 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, oval shaped tablet, engraved “H10” on one side and bisect
breakline on
the other. Dimensions: Approx. 7 mm x 11 mm.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Replacement therapy in congenital adrenal hyperplasia in children.
•
Treatment of adrenal insufficiency in children and adolescents.
•
Emergency treatment of severe bronchial asthma, drug hypersensitivity
reactions, serum sickness, angioneurotic oedema and anaphylaxis in
adults and
children.
Hydrocortisone Tablets are indicated in adults and children aged from
1
month to 18 years where the doses of 10 mg and 20 mg and tablet
formulation are considered appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dose must be individualised according to the response of the
individual patient. The
lowest possible dose should be used.
In patients requiring replacement therapy, the first dose in the
morning should be
higher than the other doses, to simulate the normal diurnal rhythm of
cortisol
secretion.
Patients should be observed closely for signs that might require dose
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, and trauma). During stress it may be necessary to increase
the dose
temporarily.
To avoid hypoadrenalism and/or a relapse of the underlying disease, it
may be
necessary to withdraw the drug gradually (see section 4.4).
Replacement therapy
_Paediatric population _
In congenital adrenal hyperplasia, 9–15 mg/m
2
/day divided in 3 doses, adjusted
according to response.
In adrenocortical insuffici