HYDROCORTISONE CREAM GLENMARK

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Glenmark Pharmaceuticals South Africa (Pty) Ltd

Dosage:

2,0 mg

Pharmaceutical form:

CREAM

Composition:

EACH 1,0 g CREAM CONTAINS HYDROCORTISONE VALERATE 2,0 mg

Authorization status:

Registered

Patient Information leaflet

1.3.2 PATIENT INFORMATION LEAFLET
HYDROCORTISONE CREAM GLENMARK, 0.2 % (HYDROCORTISONE VALERATE,
CREAM)
DATE: 19 SEPTEMBER 2023
APPLICATION NUMBER: 550072
__________________________________________________________________________________
PATIENT INFORMATION LEAFLET
PAGE 1 OF 7
SCHEDULING STATUS: [S4]
HYDROCORTISONE CREAM GLENMARK
(
Cream)
Hydrocortisone valerate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU USE HYDROCORTISONE CREAM
GLENMARK
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare
provider.
•
HYDROCORTISONE CREAM GLENMARK has been prescribed for you personally
and you
should not share your medicine with other people. It may harm them,
even if their symptoms are
the same as yours.
WHAT IS IN THIS LEAFLET
1. What HYDROCORTISONE CREAM GLENMARK is and what it is used for
2. What you need to know before you use HYDROCORTISONE CREAM GLENMARK
3. How to use HYDROCORTISONE CREAM GLENMARK
4. Possible side effects
5. How to store HYDROCORTISONE CREAM GLENMARK
6. Contents of the pack and other information
1. WHAT HYDROCORTISONE CREAM GLENMARK IS AND WHAT IT IS USED FOR
HYDROCORTISONE CREAM GLENMARK contains a medicine called
hydrocortisone valerate. It
belongs to a group of medicines called corticosteroids. HYDROCORTISONE
CREAM GLENMARK
is indicated for the relief of the non-infected inflammatory and
pruritic manifestations of corticosteroid
responsive dermatoses in adult patients.
1.3.2 PATIENT INFORMATION LEAFLET
HYDROCORTISONE CREAM GLENMARK, 0.2 % (HYDROCORTISONE VALERATE,
CREAM)
DATE: 19 SEPTEMBER 2023
APPLICATION NUMBER: 550072
__________________________________________________________________________________
PATIENT INFORMATION LEAFLET
PAGE 2 OF 7
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE CREAM GLENMARK
DO NOT USE HYDROCORTISONE CREAM GLENMARK:
•
If you are hypersensitive (allergic) or have had a previous allergic
reaction to hydrocortisone
valerate or to any of the other ingredients of HYDROC

Summary of Product characteristics

1.3.1.1 PROFESSIONAL INFORMATION
HYDROCORTISONE CREAM GLENMARK, 0.2 % (HYDROCORTISONE VALERATE,
CREAM)
DATE: 19 SEPTEMBER 2023
APPLICATION NUMBER: 550072
__________________________________________________________________________________
PROFESSIONAL INFORMATION
PAGE 1 OF 10
SCHEDULING STATUS
1.
NAME OF THE MEDICINE
HYDROCORTISONE CREAM GLENMARK (Cream)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
HYDROCORTISONE
CREAM
GLENMARK
20
MG:
Each
gram
of
cream
contains
2.0
mg
Hydrocortisone Valerate.
Contains antimicrobial preservative: Methyl paraben 2.0 mg per 1 gram
of cream.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream.
White to off-white homogenous cream.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYDROCORTISONE CREAM GLENMARK is a medium potency corticosteroid
indicated for the
relief of the non-infected inflammatory and pruritic manifestations of
corticosteroid responsive
dermatoses in adult patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
HYDROCORTISONE CREAM GLENMARK should be applied topically to the
affected area as a thin
film two or three times daily depending on the severity of the
condition. Therapy should be
discontinued when control is achieved. If no improvement is seen
within 2 weeks, reassessment of
the diagnosis may be necessary.
S4
1.3.1.1 PROFESSIONAL INFORMATION
HYDROCORTISONE CREAM GLENMARK, 0.2 % (HYDROCORTISONE VALERATE,
CREAM)
DATE: 19 SEPTEMBER 2023
APPLICATION NUMBER: 550072
__________________________________________________________________________________
PROFESSIONAL INFORMATION
PAGE 2 OF 10
HYDROCORTISONE CREAM GLENMARK should not be used with occlusive
dressings unless
directed by a medical practitioner. HYDROCORTISONE CREAM GLENMARK
should not be applied
in the diaper area if the patient requires diapers or plastic pants as
these garments may constitute
occlusive dressing.
4.3 CONTRAINDICATIONS
•
HYDROCORTISONE CREAM GLENMARK is contraindicated in patients who have
a history of
severe hypersensitivity reactions to hydrocortisone valerate or to a