Fludrocortisone Acetate 0.1mg Tablets

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

FLUDROCORTISONE ACETATE, LACTOSE MONOHYDRATE

Tilgjengelig fra:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC-kode:

H02AA02

INN (International Name):

FLUDROCORTISONE ACETATE 0.1 mg LACTOSE MONOHYDRATE 93.4 mg

Legemiddelform:

TABLET

Sammensetning:

FLUDROCORTISONE ACETATE 0.1 mg LACTOSE MONOHYDRATE 93.4 mg

Resept typen:

POM

Terapeutisk område:

CORTICOSTEROIDS FOR SYSTEMIC USE

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2017-01-09

Informasjon til brukeren

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUDROCORTISONE ACETATE 0.1 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.
•
FLUDROCORTISONE ACETATE 0.1 MG TABLET 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.
•
FLUDROCORTISONE ACETATE 0.1 MG TABLET 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
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.
WHAT IS IN THIS LEAFLET
1. What Fludrocortisone Acetate is and what it is used for

Preparatomtale

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1.
NAME OF THE MEDICINAL PRODUCT
Fludrocortisone Acetate 0.1 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.1 mg fludrocortisone acetate.
Excipient(s) with known effect:
Each tablet also contains 93.4 mg of lactose monohydrate
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white round tablet, marked with ‘FL 0.1’ on one side
and a break-line on the other
side.
The break-line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For partial replacement therapy for primary and secondary
adrenocortical insufficiency in
Addison's disease and for the treatment of salt-losing adrenogenital
syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
A daily dosage range of 0.05-0.3 mg Fludrocortisone Acetate tablets
orally. Supplementary
parenteral administration of sodium-retaining hormones is not
necessary. When an enhanced
glucocorticoid effect is desirable, cortisone or hydrocortisone by
mouth should be given
concomitantly with Fludrocortisone Acetate tablets.
Elderly:
No specific dosage recommendations (See 4.4 Precautions).
Children:
May be used adjusted to the age and weight of the child according to
the severity of the
condition. Caution should be used in the event of exposure to
chickenpox, measles or other
communicable diseases. (See 4.3 Contraindications).
4.3
CONTRAINDICATIONS
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Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
Systemic infections unless specific anti-infective therapy is
employed.
Because of its marked effect on sodium retention, the use of
Fludrocortisone Acetate in the
treatment of conditions other than those indicated, is not advised.
Since Fludrocortisone Acetate is a potent mineralocorticoid both the
dosage and salt intake
should be carefully monitored to avoid the development of
hypertension, oedema or weight
gain. Periodic checking of serum electrolyte l