Prednisolone 2.5mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prednisolone

Available from:

Phoenix Labs Ltd

ATC code:

H02AB06

INN (International Name):

Prednisolone

Dosage:

2.5mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200; GTIN: 5036631002132 5036631002125

Patient Information leaflet

Prednisolone gastro-resistant tablets PIL UK 013
PATIENT INFORMATION LEAFLET
PREDNISOLONE
GASTRO-RESISTANT TABLETS
PREDNISOLONE LEAFLET – HEADLINES
•
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
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, 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 CHICKEN-POX OR SHINGLES, if you have
never had them. They could affect you severely. If you do come into
contact
with chicken-pox 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.
THIS LEAFLET WAS LAST REVISED IN JUNE 2020.
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 or pharmacist.
•
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 or pharmacist. This
includes any
possible side effects not listed in this leaflet. See

Summary of Product characteristics

OBJECT 1
PREDNISOLONE 2.5 MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 18-Nov-2020 | Phoenix Labs
•
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
Deltacortril
®
2.5mg Gastro-resistant Tablets
Prednisolone 2.5mg Gastro-resistant Tablets
2. Qualitative and quantitative composition
Each tablet contains 2.5mg of Prednisolone.
Excipients: also includes lactose (33.0mg).
For a full list of excipients, see Section 6.1.
3. Pharmaceutical form
Gastro-resistant Tablets:
Uniformly brown in colour, circular gastro-resistant tablets of 6.8mm
in diameter.
4. Clinical particulars
4.1 Therapeutic indications
_ALLERGY AND ANAPHYLAXIS_: bronchial asthma, drug hypersensitivity
reactions, serum sickness,
angioneurotic oedema, anaphylaxis.
_ARTERITIS/COLLAGENOSIS_: giant cell arteritis/polymyalgia rheumatica,
mixed connective tissue disease,
polyarteritis nodosa, polymyositis.
_BLOOD DISORDERS_: haemolytic anaemia (auto-immune), leukaemia (acute
and chronic lymphoc