Prednisolone 5mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

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资料单张 资料单张 (PIL)
30-11--0001
产品特点 产品特点 (SPC)
11-06-2018
公众评估报告 公众评估报告 (PAR)
18-07-2006

有效成分:

Prednisolone

可用日期:

Genesis Pharmaceuticals Ltd

ATC代码:

H02AB06

INN(国际名称):

Prednisolone

剂量:

5mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 06030200; GTIN: 5060014442758

资料单张

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNISOLONE 5 MG SOLUBLE TABLETS
(Prednisolone sodium phosphate)
•
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 THIS MEDICINE FOR MORE THAN THREE 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.
Read all of this leaflet carefully before you start using 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 Prednisolo
                                
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产品特点

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prednisolone Tablets BP 5 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg prednisolone.
Excipients with known effect: each tablet contains lactose (72 mg).
For the full list of excipients see Section 6.1.
3
PHARMACEUTICAL FORM
Uncoated tablets for oral administration.
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), lymphoma, multiple myeloma, idiopathic thrombocytopenic
purpura.
CARDIOVASCULAR DISORDERS: post-myocardial infarction syndrome,
rheumatic fever
with severe carditis.
ENDOCRINE DISORDERS: primary and secondary adrenal insufficiency,
congenital
adrenal hyperplasia.
GASTRO-INTESTINAL DISORDERS: Crohn's disease, ulcerative colitis,
persistent coeliac
syndrome (coeliac disease unresponsive to gluten withdrawal),
auto-immune chronic
active hepatitis, multisystem disease affecting liver, biliary
peritonitis.
HYPERCALCAEMIA: sarcoidosis, vitamin D excess.
INFECTIONS (WITH APPROPRIATE CHEMOTHERAPY): helminthic infestations,
Herxheimer
reaction, infectious mononucleosis, miliary tuberculosis, mumps
orchitis (adult),
tuberculous meningitis, rickettsial disease.
MUSCULAR DISORDERS: polymyositis, dermatomyositis.
NEUROLOGICAL DISORDERS: infantile spasms, Shy-Drager syndrome,
sub-acute
demyelinating polyneuropathy.
OCULAR DISEASE: scleritis, posterior uveitis, retinal vasculitis,
pseudo-tumours of the
orbit, giant cell arteritis, malignant ophthalmic Graves disease.
RENAL DISORDERS: lupus nephritis, acute interstitial nephritis,
minimal change
glomerulonephritis.
RESPIRATORY DISEASE: allergic pneumonitis, asthma, occupational
asthma, pulmonary
aspergillosis, pulmonary fib
                                
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