Fludrocortisone Acetate Renata 0.1 mg tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Fludrocortisone acetate

Beschikbaar vanaf:

Renata Pharmaceuticals (Ireland) Limited

ATC-code:

H02AA02

INN (Algemene Internationale Benaming):

Fludrocortisone acetate

farmaceutische vorm:

Tablet

Therapeutisch gebied:

fludrocortisone

Autorisatie-status:

Not marketed

Autorisatie datum:

2023-12-15

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUDROCORTISONE ACETATE
RENATA 0.1 MG TABLETS
Fludrocortisone acetate
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
THE FOLLOWING SIDE EFFECTS ARE PRESENTED IN ORDER OF SEVERITY.
THE MOST SEVERE SIDE EFFECTS ARE LISTED FIRST. SIDE EFFECTS THAT
ARE CONSIDERED TO BE OF THE SAME SEVERITY ARE LISTED ON THE
SAME LINE.
STOP TAKING FLUDROCORTISONE ACETATE TABLETS AND CONTACT
YOUR DOCTOR STRAIGHT AWAY/IMMEDIATELY
if the following happen as these may be signs of an allergic
reaction (hypersensitivity reaction including anaphylaxis):
•
Difficulty breathing
•
Swelling of the face, lips or tongue
•
Severe pains in your stomach or abdomen
•
Skin rash.
SERIOUS EFFECTS: TELL YOUR DOCTOR STRAIGHT AWAY:
Steroids including fludrocortisone acetate can cause serious
mental health problems. These are common in both adults and
children. They can affect about 5 in every 100 people taking
medicines like Fludrocortisone acetate.
•
Feeling depressed, including thinking about suicide.
•
Feeling high (mania) or have moods that go up and down.
•
Feeling anxious, having problems sleeping, difficulty in
thinking or being confused and losing your memory.
•
Feeling, seeing or hearing things which do not exist. Having
strange and frightening thoughts, changing how you act or
having feelings of being alone.
TELL YOUR DOCTOR
if the following occur:
•
An increased susceptibility to infections (lowered resistance
to infections)
•
Infection of the veins in the legs
•
Blood clots (thromboembolism)
•
Thrush (white patches) or fungal infections (or sores in your
mouth)
•
Muscle weakness, pain or wasting, tendon rupture (where
muscles connect to bones)
•
Bone problems, including thinning or wasting or fractures
and delays in bone healing
•
Pancreatitis (inflammation of the pancreas) which causes
severe pain in the abdomen and back
•
Diverticulitis which is an inflammatory condition which
may cause abdominal pain

Productkenmerken

Health Products Regulatory Authority
26 March 2024
CRN00F798
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fludrocortisone Acetate Renata 0.1 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.1 mg of fludrocortisone acetate.
Excipient with known effect:
Also contains lactose, 94.4 mg per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
6.5 mm, round, white to off-white tablets, marked with 'F01' on one
side and a break-line on the other side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For partial replacement therapy for primary adrenocortical
insufficiency in Addison's disease and for the treatment of
salt-losing adrenogenital syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
Addison's Disease
A daily dosage range of 0.05 to 0.3 mg Fludrocortisone acetate tablets
orally. Supplementary parenteral administration of
sodium-retaining hormones is not necessary. When an enhanced
glucocorticoid effect is necessary, this should be achieved by
concurrent administration of cortisone (6.25 to 25 mg) or
hydrocortisone (5 to 20 mg) daily.
Salt-losing Adrenogenital Syndrome
The recommended oral dosage for treating salt-losing adrenogenital
syndrome is one tablet (0.1 mg) to two tablets (0.2 mg) of
Fludrocortisone acetate daily. Restriction of sodium intake and
supplementary potassium administration may be required.
_Paediatric population_
One half tablet (0.05 mg) to one tablet (0.1 mg) daily. Daily dosage
should be adjusted to the age and weight of the child and
the severity of the condition. Caution should be used in the event of
exposure to chickenpox, measles or other communicable
diseases. (See section 4.4).
ELDERLY
No specific dosing recommendations (see section 4.4).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Use in patients with peptic ulcer, active tuberculosis, acute
psychosis, acute bac