Prednisolone 5mg soluble tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Prednisolone sodium phosphate

Disponível em:

Accord-UK Ltd

Código ATC:

H02AB06

DCI (Denominação Comum Internacional):

Prednisolone sodium phosphate

Dosagem:

5mg

Forma farmacêutica:

Soluble tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 06030200; GTIN: 5012617026996

Folheto informativo - Bula

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PREDNISOLONE 5MG SOLUBLE TABLETS PIL - UK
Black
Profile
BBBB1122
NM
13/04/2021
13/04/2021
NM
210x297mm
9pts
Wasdell Packaging Ltd
N/A
02
Version 7
12.02.2020
Cartons and label leaflets only
(labels only when specified)
02970210X01480035L00-M050UWASS
FRONT
HEAD
LAST BAR
LAST BAR
>> READ DIRECTION
>> READ DIRECTION
1ST BAR
1ST BAR
•
PREDNISOLONE 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.
• PREDNISOLONE 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 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.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prednisolone 5mg Soluble Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg prednisolone as prednisolone sodium
phosphate
Excipient with known effect
Each tablet contains:
1.18 mmol (27.22 mg) sodium
Sodium benzoate (E211) 7 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Soluble Tablet
White, 7mm, round, with a score line on one side, imprinted with
“A” and “615”
respectively on each side of the score.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A wide variety of diseases may sometimes require corticosteroid
therapy. Some of the
principal indications are:
bronchial asthma, severe hypersensitivity reactions, anaphylaxis;
rheumatoid arthritis,
systemic lupus erythematosus, dermatomyositis, mixed connective tissue
disease
(excluding systemic sclerosis), polyarteritis nodosa;
inflammatory skin disorders, including pemphigus vulgaris, bullous
pemphigoid and
pyoderma gangrenosum;
minimal change nephrotic syndrome, acute interstitial nephritis;
ulcerative colitis, Crohn's disease; sarcoidosis;
rheumatic carditis;
haemolytic anaemia (autoimmune), acute lymphoblastic and chronic
lymphocytic
leukaemia, malignant lymphoma, multiple myeloma, idiopathic
thrombocytopenic
purpura;
immunosuppression in transplantation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The lowest dosage that will produce an acceptable result should be
used (See
precautions section); when it is possible to reduce the dosage, this
must be
accomplished by stages. During prolonged therapy any intercurrent
illness, trauma or
surgical procedure will require a temporary increase in dosage; if
corticosteroids have
been stopped following prolonged therapy they may need to be
temporarily re-
introduced.
_Adult _
The dose used will depend upon the disease, its severity, and the
clinical response
obtained. The following regimens are for guidance only. Divided dosage
is usually
emp