Hydrocortisone Bite and Sting Relief 1% cream

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Hydrocortisone

זמין מ:

Galpharm International Ltd

קוד ATC:

D07AA02

INN (שם בינלאומי):

Hydrocortisone

כמות:

10mg/1gram

טופס פרצבטיות:

Cutaneous cream

מסלול נתינה (של תרופות):

Cutaneous

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 13040000; GTIN: 5017353106643

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
SKINCALM BITE AND STING RELIEF 1% CREAM
HYDROCORTISONE
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leafl et or as
your doctor or pharmacist
has told you.
• Keep this leafl et. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leafl et. See section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFL ET:
1. What Skincalm Bite and Sting Relief 1% Cream is and what it is used
for
2. What you need to know before you use Skincalm Bite and Sting Relief
1% Cream
3. How to use Skincalm Bite and Sting Relief 1% Cream
4. Possible side effects
5. How to store Skincalm Bite and Sting Relief 1% Cream
6. Contents of the pack and other information
1. WHAT SKINCALM BITE AND STING RELIEF 1% CREAM IS AND WHAT IT IS USED
FOR
This medicine contains hydrocortisone which belongs to a group of
medicines called
corticosteroids, which act to relieve pain and swelling. It can be
used to relieve the swelling,
itching and irritation caused by insect bite and sting reactions.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SKINCALM BITE AND STING RELIEF
1% CREAM
DO NOT USE SKINCALM BITE AND STING RELIEF 1% CREAM:
• If you are allergic to hydrocortisone or any of the other
ingredients of this medicine
(listed in section 6)
• On the face, eyes, anus or genital areas
• If you have any other skin infection such as athlete’s foot
(tinea pedis), cold sores
(Herpes simplex), impetigo, ringworm or thrush, infected lesions,
ulcerative conditions,
red appearance on face, peri-oral dermatitis or acne
• If you are a child under 10 years old
• For other bites and stings or for other skin conditions.
WARNINGS AND PRECAUTIONS
Talk to you

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Skincalm Bite and Sting Relief 1% Cream
Hydrocortisone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cream containing 1% micronised hydrocortisone
Excipient(s) with known effect
Chlorocresol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
White Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Insect bite and sting reactions only
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To be applied evenly and sparingly once or twice daily for a maximum
period
of 2-3 days.
_ _
_Adults and the elderly:_ The same dose is used for adults and the
elderly, as
clinical evidence would indicate that no special dosage regimen is
necessary in
the elderly.
If the condition does not improve consult your doctor.
_Children aged 10 years and above:_ Long term therapy should be
avoided
where possible.
Do not use for children under 10 years old.
Method of administration
For cutaneous use.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1.
•
Use on the eyes, face or ano-genital region.
•
Use on untreated bacterial (e.g. impetigo), fungal (e.g. candida or
dermatophyte) or viral (e.g. herpes simplex) infections of the skin,
infected
lesions, ulcerative conditions, rosacea, peri-oral dermatitis or acne.
•
Children under 10 years of age.
•
Not to be used for other bites and stings or other skin conditions.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Visual disturbance:
Visual disturbance may be reported with systemic and topical
corticosteroid
use. If a patient presents with symptoms such as blurred vision or
other visual
disturbances,
the
patient
should
be
considered
for
referral
to
an
ophthalmologist for evaluation of possible causes which may include
cataract,
glaucoma or rare diseases such as central serous chorioretinopathy
(CSCR)
which have been reported after use of systemic and topical
corticosteroids.
Remarks on indications
1. There is no good evidence t