Medrone 100mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Methylprednisolone

متاح من:

Pfizer Ltd

ATC رمز:

H02AB04

INN (الاسم الدولي):

Methylprednisolone

جرعة:

100mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 06030200; GTIN: 5013457026481

نشرة المعلومات

5. HOW TO STORE MEDRONE
Medrone tablets should not be used after the
expiry date ‘EXP’ shown on the carton and blister
strip. If your medicine is out of date take it to your
pharmacist who will dispose of it safely.
Do not store above 25°C.
Store in the original package.
Keep out of the sight and reach of children.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT MEDRONE CONTAINS
•
The active substance is 100 mg
methylprednisolone.
•
The other ingredients are methylcellulose,
magnesium stearate, microcrystalline cellulose,
Aluminium lakes indigo (E132) and sodium
starch glycolate
.
WHAT MEDRONE LOOKS LIKE AND CONTENTS OF THE
PACK
•
Medrone is a blue, round tablet with UPJOHN
3379 on one side and ‘X’ score mark on the
other side.
•
The tablets are packed in blisters containing 10
tablets and comes in boxes of 20’s & 30’s.
MANUFACTURER AND LICENCE HOLDER
This medicine is manufactured by Pfizer Italia
S.R.L., 63100 Ascoli Piceno (AP), Italy and is
procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.
PL 15184/1939 - Medrone 100mg Tablets
Medrone is a registered trademark of Pfizer
Enterprises Sarl.
Leaflet revision date: 06/05/2022
Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: [phone] to
obtain the leaflet in a
format suitable for you
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMP

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Medrone Tablets 100 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Medrone Tablet contains 100 mg methylprednisolone.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Medrone is a potent corticosteroid with an anti-inflammatory activity
at least
five times that of hydrocortisone. An enhanced separation of
glucocorticoid
and mineralocorticoid effect results in a reduced incidence of sodium
and
water retention.
Medrone is indicated for conditions requiring glucocorticoid activity
such as:-
1.
Collagen diseases/arteritis
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Rheumatic fever with severe carditis
Giant cell arteritis/polymyalgia rheumatica
2.
Dermatological diseases
Pemphigus vulgaris
3.
Allergic states
Bronchial asthma
4.
Respiratory diseases
Pulmonary sarcoid
5.
Haematological disorders
Idiopathic thrombocytopenic purpura
Haemolytic anaemia (autoimmune)
6.
Neoplastic diseases
Leukaemia (acute and lymphatic)
Malignant lymphoma
7.
Gastro-intestinal diseases
Crohn's disease
8.
Miscellaneous
Tuberculous meningitis (with appropriate antituberculous chemotherapy)
Transplantation
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage recommendations shown in the table below are suggested
initial
daily doses and are intended as guides. The average total daily dose
recommended may be given either as a single dose or in divided doses
(excepting in alternate day therapy when the minimum effective daily
dose is
doubled and given every other day at 8.00 am).
Undesirable effects may be minimised by using the lowest effective
dose for
the minimum period (see section 4.4).
The initial suppressive dose level may vary depending on the condition
being
treated. This is continued until a satisfactory clinical response is
obtained, a
period usually of three to seven days in the case of rheumatic
diseases (except
for acute rheumatic carditis), allergic condition