Prednisolone 1mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Prednisolone

Prieinama:

DE Pharmaceuticals

ATC kodas:

H02AB06

INN (Tarptautinis Pavadinimas):

Prednisolone

Dozė:

1mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 06030200

Pakuotės lapelis

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Prednisolone Tablets
1mg x 28’s (UK)
296x210 (Reel Fed)
50963551
Leaflet for Blisters
4132
R.Wrey
13/12/18
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approved for print/date
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DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
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6.
1.
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FMD info
NA (not a carton)

No

Yes
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Details
PREDNISOLONE 1MG 28 TABLETS PIL - UK
Black
Profile
BBBA3619
S.Anson
18.12.18
296 x 210
8pt
Actavis UK
n/a
n/a
1
Version 2
01.11.2017
page 4
page 1
50963551 BBBA3619
PREDNISOLONE 1MG
TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
•
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 SHINGLES, if you have never
had them. They could affect you severely. If
you do co

Prekės savybės

OBJECT 1
PREDNISOLONE 1MG TABLETS
Summary of Product Characteristics Updated 12-Dec-2018 | 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 1mg TABLETS
2. Qualitative and quantitative composition
Each tablet contains 1mg of Prednisolone.
Excipient with known effect
Each 1mg tablet contains 50.00mg of Lactose Monohydrate PhEur.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets.
4. Clinical particulars
4.1 Therapeutic indications
Prednisolone is indicated in the management of all conditions deemed
likely to benefit from short or long
term glucocorticoid therapy. These include:
_ALLERGIC STATES _
Severe, incapacitating allergies unresponsive to conventional
treatment; asthma serum sickness; drug
hypersensitivity reactions.
_COLLAGEN DISORDERS _
Eg systemic lupus erythematosus, polymyositis, polymyalgia rheumatica
and temporal (giant cell)
arteritis, mixed connective tissue disease syndrome, acute rheumatic
carditis.
_