Prednisolone 1mg gastro-resistant tablets

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Prednisolone

Доступно од:

Phoenix Labs Ltd

АТЦ код:

H02AB06

INN (Међународно име):

Prednisolone

Дозирање:

1mg

Фармацеутски облик:

Gastro-resistant tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 06030200; GTIN: 5036631002293 5391513951299

Информативни летак

Prednisolone 1mg PIL UK 005
PATIENT INFORMATION LEAFLET
PREDNISOLONE 1MG
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 or 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 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.
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: 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 section 4.
Predniso

Карактеристике производа

OBJECT 1
PREDNISOLONE 1 MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 27-Aug-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 1 mg Gastro-resistant Tablets
Prednisolone 1 mg Gastro-resistant Tablets
2. Qualitative and quantitative composition
Each tablet contains 1mg of Prednisolone.
Excipients: also includes lactose (33.80mg).
For a full list of excipients, see Section 6.1.
3. Pharmaceutical form
Gastro-resistant Tablets
Yellow, round biconvex gastro-resistant tablets of approximately 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 lymphocytic),
l