Hydrocortisone 10mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Hydrocortisone

から入手可能:

Advanz Pharma

ATCコード:

H02AB09

INN（国際名）:

Hydrocortisone

投薬量:

10mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 06030200; GTIN: 05021691035329

情報リーフレット

PATIENT INFORMATION LEAFLET
HITODEN
® 10 MG AND 20 MG TABLETS
(HYDROCORTISONE)
THIS LEAFLET CONTAINS IMPORTANT INFORMATION ABOUT HITODEN TABLETS.
READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
This medicine has been prescribed for you personally and you should
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
•
HITODEN TABLETS ARE 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
•
HITODEN TABLETS 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 CHICKEN-POX OR SHINGLES, if you have
never had them. 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 important
information on the safe and effective use of this medicine
that might be especially important for you.
IN THIS LEAFLET
1.
WHAT HITODEN TABLETS ARE AND WHAT ARE THEY USED FOR

製品の特徴

OBJECT 1
HYDROCORTISONE 10 MG TABLETS
Summary of Product Characteristics Updated 14-Aug-2017 | Concordia
International - formerly AMCo
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:
Contains lactose monohydrate (199.94 mg per tablet).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
A white, round, biconvex tablet.
4. Clinical particulars
4.1 Therapeutic indications
Hydrocortisone Tablets are indicated for replacement therapy in
congenital adrenal hyperplasia in
children.
Hydrocortisone Tablets are also used for the emergency treatment of
severe bronchial asthma, drug
hypersensitivity reactions, serum sickness, angioneurotic oedema and
anaphylaxis in adults and children.
4.2 Posology and method of administration
Posology
_Replacement therapy_
_Paediatric population _10-30 mg in divided doses is the normal daily
requirement (see section 4.4).
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.
_Acute emergencies_
60-80 mg every 4-6 hours for 24 hours then gradually reduce the dose
over several days.
_Elderly _
Steroids should be used cautiously in the elderly, since adverse
effects are enhanced in old age (see
section 4.4).
When long term treatment is to be discontinued, the dose should be
gradually reduced over a period of
weeks or months, depending on dosage and duration of therapy (see
section 4.4).
Undesirable effects may be minimised by using the lowest effective
dose for the minimum period, and by
administering the daily requirement as a single morning dose, or
whenever possible, as a single morning
dose on alternative days. Frequent patient review is required to
titrate the dose against disease activity.
Method of administration
For oral adminis