Prednisolone 5mg soluble tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prednisolone sodium phosphate

Available from:

DE Pharmaceuticals

ATC code:

H02AB06

INN (International Name):

Prednisolone sodium phosphate

Dosage:

5mg

Pharmaceutical form:

Soluble tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200

Patient Information leaflet

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Details
PREDNISOLONE 5MG SOLUBLE TABLETS PIL - UK
Black
Profile
BBBA4012
T. Hull
15.02.2019
21.02.2019
T. Hull
210x297
9pt
Wasdell
18.02.2019
19.02.2019
3
Version 2
01.11.2017
•
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 USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•

Summary of Product characteristics

OBJECT 1
PREDNISOLONE 5MG SOLUBLE TABLETS
Summary of Product Characteristics Updated 12-Apr-2019 | Accord-UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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.
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
(exclud