Hydrocortisone 20mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Hydrocortisone

Dostopno od:

Resolution Chemicals Ltd

Koda artikla:

H02AB09

INN (mednarodno ime):

Hydrocortisone

Odmerek:

20mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 06030200; GTIN: 5060301920129

Navodilo za uporabo

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, please ask
your doctor or your 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.
• HYDVENTIA
® TABLETS ARE 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.
• HYDVENTIA
® 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 as soon as possible.
• 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 THIS MEDICINE 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 have had them previously
(read Section 2 for additional information). 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.
WHAT IS IN THIS LEAFLET:
1. WHAT HYDVENTIA
® TABLETS ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYDVENTIA
® TABLETS
3. HOW TO

Lastnosti izdelka

1. NAME OF THE MEDICINAL PRODUCT
Hydventia 20 mg Tablets
Hydrocortisone 20 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
20mg - Each tablet contains 20 mg of hydrocortisone.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
20mg – A white oval, half scored tablet marked ‘F2’ on one side
and ’20’ on reverse. The
tablet can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Corticosteroid
Hydrocortisone Tablets are indicated for:
•
use as replacement therapy in primary, secondary, or acute
adrenocortical insufficiency. Pre-
operatively, and during serious trauma or illness in patients with
known adrenal insufficiency
or doubtful adrenocortical reserve.
•
replacement therapy in congenital adrenal hyperplasia in children.
•
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
Method of Administration
For oral administration.
Posology
Dosage must be individualised according to the response of the
individual patient. The lowest
possible dosage should be used.
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.
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 _
In chronic adrenocortical insufficiency, a dosage of 20 to 30mg a day
is usually
recommended, sometimes together with 4-6 g of sodium chloride or
50-300 micrograms of
fludrocortisone daily.
When immediate support is mandatory, one of the soluble adrenocortical
hormone
preparations (e.g. dexamethasone sodium phosphate), which may be
effective within minutes
after par