Betnovate Scalp Application 0.1% w/v Cutaneous Solution

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Betamethasone

Доступно од:

GlaxoSmithKline (Ireland) Limited

АТЦ код:

D07AC; D07AC01

INN (Међународно име):

Betamethasone

Дозирање:

0.1 percent weight/volume

Фармацеутски облик:

Cutaneous solution

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Corticosteroids, potent (group III); betamethasone

Статус ауторизације:

Marketed

Датум одобрења:

1984-03-05

Информативни летак

Reason for update: HPRA PAC- ADDITION OF PROTECT FORM LIGHT & MOISTURE
STATEMENT
Market: Ireland
Agency Approval Date:
Text Date: 13/04/2022
Text Issue and Draft No.: Issue 6, Draft 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETNOVATE SCALP APPLICATION 0.1% W/W CUTANEOUS SOLUTION
betamethasone (as valerate)
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 or pharmacist.
•
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 or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
•
In this leaflet, Betnovate Scalp Application 0.1% w/w Cutaneous
Solution will be
called Betnovate.
WHAT IS IN THIS LEAFLET
1.
What Betnovate is and what it is used for
2.
What you need to know before you use Betnovate
3.
How to use Betnovate
4.
Possible side effects
5.
How to store Betnovate
6.
Contents of the pack and other information
1
WHAT BETNOVATE IS AND WHAT IT IS USED FOR
Betnovate contains the active substance betamethasone valerate which
belongs to a
group of medicines called corticosteroids that help to reduce redness,
swelling and
irritation of the skin. These should not be confused with “anabolic
steroids” misused
by some body builders and taken as tablets or injections.
Betnovate is used to help reduce the redness and itchiness of certain
scalp problems,
such as psoriasis (thickened patches of inflamed, red skin, often
covered by silvery
scales), an inflamed scalp due to severe dandruff, and dermatitis in
adults and children
over the age of 1 year.
Betnovate also contains an alcohol which has an antiseptic effect.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE BETNOVATE
DO NOT USE BETNOVATE:
•
if you are allergic (hypersensitive) to betamethasone valera

Карактеристике производа

Health Products Regulatory Authority
20 September 2022
CRN00CYFT
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betnovate Scalp Application 0.1% w/v Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml of cutaneous solution contains 0.01 g betamethasone (0.1%
w/w) as betamethasone valerate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Solution
A colourless, hazy, slightly viscous liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betnovate Scalp Application is a topical corticosteroid used in the
management of steroid-responsive dermatoses of the scalp,
such as psoriasis, seborrhoea capitis and inflammation associated with
severe dandruff.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, Elderly and Children over 1 year_
A small quantity of Betnovate Scalp Application should be applied to
the scalp night and morning until improvement is
noticeable for up to 4 weeks. It may then be possible to sustain
improvement by applying once a day, or even less frequently.
Due to the flammable nature of Betnovate Scalp Application, patients
should avoid smoking or being near an open flame
during application and immediately after use.
Administration in Children
Betamethasone valerate is contraindicated in children under 1 year of
age.
Children are more likely to develop local and systemic side effects of
topical corticosteroids and, in general, require shorter
courses and less potent agents than adults.
Care should be taken when using betamethasone valerate to ensure the
amount applied is the minimum that provides
therapeutic benefit.
Administration in the Elderly
Clinical studies have not identified differences in responses between
the elderly and younger patients. Since renal and hepatic
dysfunctions are more common in the elderly population, elimination
could be reduced in the case of systemic absorption.
Therefore the minimum quantity should be used for the shortest
duration to achieve the desired clinical benefit.
A