Soolantra 10mg/g Cream

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Ivermectin

Mevcut itibaren:

Lexon (UK) Ltd

ATC kodu:

D11AX; D11AX22

INN (International Adı):

Ivermectin

Doz:

10 milligram(s)/gram

Farmasötik formu:

Cream

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Other dermatologicals; Ivermectin

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2017-10-20

Bilgilendirme broşürü

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.
WHAT IS IN THIS LEAFLET
What Soolantra is and what it is used for
What you need to know before you use
Soolantra
How to use Soolantra
Possible side effects
How to store Soolantra
Contents of the pack and other information
WHAT SOOLANTRA IS AND WHAT IT IS USED
FOR
Soolantra contains the active substance ivermectin
that belongs to a group of medicines called
avermectins. The cream is used on the skin to treat
pimples and spots found with rosacea.
Soolantra should be used in adults only (18 years of
age or older).
WHAT YOU NEED TO KNOW BEFORE YOU USE
SOOLANTRA
DO NOT USE SOOLANTRA:
- if you are allergic to ivermectin or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using
Soolantra.
OTHER MEDICINES AND SOOLANTRA
Other medicines may have an effect on Soolantra,
you should therefore tell your doctor if you are using,
have recently used or might use any other
medicines.
PREGNANCY AND BREAST-FEEDING
Soolantra is not recommended during pregnancy. If
you are breast-feeding, you should not use this
medicine, alternatively, you should stop
breast-feeding before starting treatment with
Soolantra.
You should consult your doctor to help you decide
between using Soolantra and breast-feeding, taking
into account the benefit of the treatment and the
benefit of breast-feeding.
DRIVING AND USING MACHINES
Soolantra has no or negligible influence on the
ability to drive and use machines.
SOOLANTRA CONTAINS:
- CETYL

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Soolantra 10mg/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 10 mg of ivermectin.
Excipient(s) with known effect:
One gram of cream contains cetyl alcohol, stearyl alcohol, methyl
parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216) and propylene glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
_Product imported from Germany_
White to pale yellow hydrophilic cream.
4 CLINICAL PARTICULARS
As per PA0590/028/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0590/028/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Glycerol
Isopropyl palmitate
Carbomer
Dimeticone
Disodium edetate
Citric acid monohydrate
Cetyl alcohol
Stearyl alcohol
Macrogol cetostearyl ether
Sorbitan stearate
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Phenoxyethanol
Propylene glycol
Oleyl alcohol
Sodium hydroxide
Purified water
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6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the tube and outer package of the product on the
market in the country of origin.
After first opening: use within 6 months
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage con