Timodine cream

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Hydrocortisone; Benzalkonium chloride; Dimeticone 350; Nystatin

Dostupno od:

Alliance Pharmaceuticals Ltd

ATC koda:

D01A

INN (International ime):

Hydrocortisone; Benzalkonium chloride; Dimeticone 350; Nystatin

Doziranje:

5mg/1gram ; 1mg/1gram ; 100mg/1gram ; 100000unit/1gram

Farmaceutski oblik:

Cutaneous cream

Administracija rute:

Cutaneous

Razred:

No Controlled Drug Status

Tip recepta:

Never Valid To Prescribe As A VMP

Proizvod sažetak:

BNF: 13040000; GTIN: 5000158061439

Uputa o lijeku

Artwork Information
Magenta text, keylines and shading are NOT to be printed
Product Title:
Timodine® Cream
Date:
30-09-21
Product Size:
160 x 265mm
Label Number:
21-0293
Colours Used:
Black
Fonts Used:
Helvetica Condensed
Font size:
7pt
Version:
3
21-0293
A L L I A N C E
PATIENT INFORMATION LEAFLET
TIMODINE
®
CREAM
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. 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 of the side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Timodine Cream is and what it is used for
2. What you need to know before you use Timodine Cream
3. How to use Timodine Cream
4. Possible side effects
5. How to store Timodine Cream
6. Contents of the pack and other information
1. WHAT TIMODINE CREAM IS AND WHAT IT IS USED FOR
Timodine Cream is used to
treat inflamed skin conditions, particularly where the fungal
infection Candida albicans can occur.
T
imodine Cream contains four different medicines called nystatin,
hydrocortisone, dimeticone and benzalkonium chloride.
•
Nystatin is an antifungal agent which kills Candida albicans
•
Hydrocortisone is a mild corticosteroid (or steroid) which fights the
inflammation that causes redness, swelling and i
tchiness
•
Dimeticone is a water-repellent which stops wetting and chafing
•
Benzalkonium chloride is an antiseptic which kills bacteria.
Where two folds of skin rub together, chafing can occur, leading to a
sore inflamed area of skin. This particularly happens in places such
as the groin or under the breasts where frequent sweating occurs. This
combination of irritated skin and wetness is called inter
trigo. The
same cond

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Timodine Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
%W/W
Nystatin*
3.00
Dimeticone 350
10.00
Hydrocortisone**
0.50
Benzalkonium chloride solution
0.20
(equivalent to benzalkonium chloride 0.10g)
*An overage of 15% is added at manufacture. The 3% w/w is
approximate only to achieve an activity of nystatin in the final
formulation of 100,000 IU/g.
**An overage of 8% is added at manufacture.
EXCIPIENTS
%W/W
Cetostearyl alcohol
1.51
Butylated hydroxyanisole compound (containing
0.40
butylated hydroxyanisole (E320) 20%, propyl gallate 10%,
citric acid 10% and 60% propylene glycol (E1520))
Methyl hydroxybenzoate (E218)
0.10
Propyl hydroxybenzoate (E216)
0.10
Sorbic acid
0.10
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Cream
A pale yellow cream
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the treatment of dermatoses, including intertrigo, eczema,
seborrhoeic
dermatitis, hand dermatitis, and pruritis ani et vulvae, in which
infection with
_Candida albicans_ is a factor. For the treatment of severe nappy rash
in which
infection with _C. albicans_ is a factor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For topical application to the skin.
Adults (including the elderly) and children
Dermatoses: Sufficient Timodine Cream should be applied to cover the
lesion
in a thin layer. It should then be massaged into the skin until the
cream
disappears.
The treatment should be repeated three times a day until the lesion
has healed.
There is no indication that dosage need be modified for the elderly.
Nappy rash: After removal of the soiled nappy, the affected area
should be
cleaned and dried, and a thin layer of Timodine Cream applied. The
treatment
should be repeated after every nappy change. In infants long-term
continuous
topical steroid therapy should be avoided since this can lead to
adrenal
suppression
even
without
occlusion.
A
course
of
treatment
should
not
normally exceed seven days.
4.3
CONTRAINDICATIO