Prednisolone 5mg gastro-resistant tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Prednisolone

Fáanlegur frá:

Accord-UK Ltd

ATC númer:

H02AB06

INN (Alþjóðlegt nafn):

Prednisolone

Skammtar:

5mg

Lyfjaform:

Gastro-resistant tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 06030200; GTIN: 5012617008763 5012617019998 5012617019790

Upplýsingar fylgiseðill

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Prednisolone, G/R Tablets, 2.5 &
5mg, 28s, 30s, 100s - UK
296x210 (Reel Fed)
50999596
Leaflet for Blisters
4134
RH
24-03-21
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ORIGINATION DATE:
REVISION DATE:
REVISED BY:
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GTIN 13
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PREDNISOLONE 2.5MG & 5MG GASTRO RESISTANT TABLETS PIL - UK
Black
Profile
BBBB1128
C.Grant
12/04/2021
17/06/2021
S.Anson
296x210
8.5pts
Accord Barnstaple
n/a
n/a
03
Version 5
06.12.2019
page 4
page 1
BBBB1128 50999596
PREDNISOLONE 2.5MG AND 5MG
GASTRO-RESISTANT TABLETS
_Continued over page_
_Continued top of next column_
•
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
CHICKEN-POX OR

Vara einkenni

OBJECT 1
Prednisolone 5mg Gastro-resistant
Tablets
Summary of Product Characteristics Updated 09-Jul-2021 | 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 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 Gastro-resistant Tablets
2. Qualitative and quantitative composition
Each tablet contains 5mg Prednisolone.
Excipient with known effect
Each tablet contains 39.13mg Lactose PhEur.
Each tablet also contains ponceau 4R Aluminium Lake (E124) and Sunset
Yellow FCF Aluminum Lake
PhEur (E110)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet.
Red, circular, biconvex, gastro-resistant tablets.
4. Clinical particulars
4.1 Therapeutic indications
1) Allergy and anaphylaxis: Drug hypersensitivity reactions, serum
sickness, angioneurotic oedema,
anaphylaxis, bronchial asthma and occupational asthma.
2) Arteritis/collagenosis: Giant cell arteritis/polymyalgia
rheumatica, mixed connective tissue disease,
polyarteritis nodosa, polymyositis.
3) Blood disorders: Haemo