Prednisolone 5mg soluble tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prednisolone sodium phosphate

Available from:

Advanz Pharma

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; GTIN: 5021730003456

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNISOLONE 5MG SOLUBLE TABLETS
prednisolone
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.
WHAT IS IN THIS LEAFLET
1.
What Prednisolone Soluble Tablets are and what they are used for
2.
What you need to know before you take Prednisolone Soluble Tablets
3.
How to take Prednisolone Soluble Tablets
4.
Possible side effects
5.
How to store Prednisolone Soluble Tablets
6.
Contents of the pack and other information
1.
WHAT PREDNISOLONE SOLUBLE TABLETS ARE AND WHAT THEY ARE USED FOR
Your doctor has decided that you or your child, need this medicine to
help treat your or their,
condition.
Prednisolone 5mg Soluble Tablets (called Prednisolone Soluble Tablets
throughout the rest of this
leaflet) contain the active ingredient prednisolone. Prednisolone
belongs to a group of medicines
called steroids (the full name is corticosteroids).
Corticosteroids occur naturally in the body and help to maintain
health and wellbeing. Boosting your
body with extra corticosteroid (such as prednisolone) is an effective
way to treat various illnesses
involving inflammation in the body.
Prednisolone Soluble Tablets reduce this inflammation, which could
otherwise go on making your
condition worse. You must take this medicine regularly to get the
maximum benefit from it.
PREDNISOLONE SOLUBLE TABLETS CAN BE USED:
•
to treat breathing difficulties associated with asthma;
•
to treat severe allergic reactions;
•
to treat illnesses which cause inflammation of the skin, small and
medium siz

Summary of Product characteristics

OBJECT 1
PREDNISOLONE 5MG SOLUBLE TABLETS
Summary of Product Characteristics Updated 07-Nov-2017 | ADVANZ Pharma
•
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 5mg prednisolone as the sodium phosphate ester.
Excipient with known effect
Each tablet contains 1.2mmol (28.2mg) sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Soluble Tablet
Pink flat, round soluble tablets engraved with λ5 and break marked on
the same side.
The tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Prednisolone 5mg Soluble Tablets are indicated in adults and children.
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 co