Prednisolone 5mg soluble tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Prednisolone sodium phosphate

Disponible desde:

Phoenix Labs Ltd

Código ATC:

H02AB06

Designación común internacional (DCI):

Prednisolone sodium phosphate

Dosis:

5mg

formulario farmacéutico:

Soluble tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 06030200; GTIN: 5391513950575

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNISOLONE 5MG
SOLUBLE TABLETS
Active Ingredient: Prednisolone Sodium Phosphate
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, pharmacist or
nurse.
• 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
PREDNISOLONE TABLETS 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 TABLETS CAN CAUSE SIDE EFFECTS IN SOME PEOPLE
(read section 4 “Possible side effects” 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 “Possible side effects” 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.
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.

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prednisolone 5mg Soluble Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of prednisolone as Prednisolone Sodium
Phosphate.
Excipients: - Contains Sodium Benzoate (E211) 7.5mg, Sodium Acid
Citrate
99.17mg, Sodium Bicarbonate 31.7mg and Saccharin Sodium 0.5mg.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
Pink, circular, flat, bevel-edged tablets engraved 'PRED 5’ on one
face and a
breakline on the other.
The scoreline allows the tablet to be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A wide variety of diseases may sometimes require corticosteroid
therapy.
Prednisolone is used principally for its anti-inflammatory and
immunosuppressant
action or anti-neoplastic properties. Prednisolone may also be used as
a replacement
therapy but cortisone is usually preferred.
The major indications are listed below. This list of indications is
not exhaustive but
represents the major established disease states with evidence of an
established and
current role in their management. Prednisolone may be used in a wide
variety of other
inflammatory and immune disorders according to local guidelines and
according to
the assessment of the benefit risk in individual patients.
Inflammatory and immunological disorders
•
Pemphigus
•
Asthma
•
Sarcoid disease
•
Rheumatoid arthritis, polymyalgia rheumatica and giant cell (temporal)
arteritis and polyarteritis nodosa
•
Systemic lupus erythematosus,
•
Polymyositis
•
Inflammatory bowel disease: ulcerative colitis and Crohn's disease
•
Renal disease: minimal change nephrotic syndrome, acute interstitial
nephritis; renal lupus
•
Autoimmune hepatitis,
•
Thrombocytopenic purpura and acquired haemolytic anaemia
•
Immunosuppression – in organ transplantation
Neoplasms Treated with Corticosteroids
Prednisolone is an established component of chemotherapeutic regimes
used in the
treatment of the following neoplasms:
•
A