MEDROL 4 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

METHYLPREDNISOLONE

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

H02AB04

Pharmaceutical form:

TABLETS

Composition:

METHYLPREDNISOLONE 4 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PFIZER INC, USA

Therapeutic group:

METHYLPREDNISOLONE

Therapeutic area:

METHYLPREDNISOLONE

Therapeutic indications:

Anti-allergic, anti-inflammatory for treatment of allergic conditions such as asthma and diverse skin disease, inflammatory states and arthritis.

Authorization date:

2022-05-31

Patient Information leaflet

Medrol, PIL, CC 150623
1
2022-0082236
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
MEDROL
® 4 MG
TABLETS
Each tablet contains: methylprednisolone 4 mg
Inactive ingredients and allergens: See section 2 under ‘Important
information about some of
this medicine’s ingredients’ and section 6 “Further
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or
pharmacist
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if it seems to you that their medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR
?
Medrol is a glucocorticosteroid medicine with anti-allergic and
anti-inflammatory action to treat
allergic conditions, such as asthma, diverse skin diseases,
inflammatory states and arthritis.
THERAPEUTIC GROUP: glucocorticoids.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are SENSITIVE (ALLERGIC) or suffered from any other type of
reaction after having taken
the active ingredient or any of the other ingredients of this medicine
(listed in section 6). An
allergic reaction may cause a skin rash or reddening, swollen face or
lips or shortness of
breath.
•
You suffer from any serious FUNGAL INFECTION, such as a serious fungal
infection in your
lungs or oesophagus (the tube that connects your mouth with your
stomach) or any other
infection which is not being treated with antibiotic or antiviral
medicines.
•
You recently had or are about to have any VACCINATION.
If you suffer from a rash or other symptoms of an infection, TELL YOUR
DOCTOR IMMEDIATELY.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH MEDROL, TELL YOUR DOCTOR IF you have one of the
following conditions.
Your doctor may have to monitor your treatment more closely, alter
your dose or give you
another me

Summary of Product characteristics

Medrol 4 mg, LPD, CC 150623
1
2022-0082236
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Medrol 4 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg methylprednisolone.
Excipients with known effect:
lactose, sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anti-allergic, anti-inflammatory for treatment of allergic conditions
such as asthma and diverse skin disease,
inflammatory states and arthritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The initial dosage of methylprednisolone tablets may vary depending on
the specific disease entity being
treated. In situations of less severity, lower doses will generally
suffice while in selected patients higher
initial doses may be required. Clinical situations in which high-dose
therapy may be indicated include
multiple sclerosis (200 mg/day), cerebral edema (200-1,000 mg/day),
and organ transplantation (up to 7
mg/kg/day). If after a reasonable period of time there is a lack of
satisfactory clinical response,
methylprednisolone tablets should be discontinued and the patient
transferred to other appropriate therapy. If
after long-term therapy the drug is to be stopped, it is recommended
that it be withdrawn gradually rather
than abruptly.
After a favorable response is noted, the proper maintenance dosage
should be determined by decreasing the
initial drug dosage in small decrements at appropriate time intervals
until the lowest dosage which will
maintain an adequate clinical response is reached. It should be kept
in mind that constant monitoring is
needed in regard to drug dosage. Included in the situations which may
make dosage adjustments necessary
are changes in clinical status secondary to remissions or
exacerbations in the disease process, the patient's
individual drug responsiveness, and the effect of patient exposure to
stressful situations not directly related to
the disease entity under treatment; in this latter situation it may b