Soolantra 10 mg/g Cream

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Ivermectin

Mevcut itibaren:

PCO Manufacturing Ltd.

ATC kodu:

D11AX; D11AX22

INN (International Adı):

Ivermectin

Farmasötik formu:

Cream

Terapötik alanı:

Other dermatologicals; Ivermectin

Yetkilendirme tarihi:

2023-02-03

Bilgilendirme broşürü

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOOLANTRA
® 10 MG/G
CREAM
ivermectin
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:
1.
What Soolantra is and what it is used for
2.
What you need to know before you use Soolantra
3.
How to use Soolantra
4.
Possible side effects
5.
How to store Soolantra
6.
Contents of the pack and other information
7.
s and what it is used for
1.
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).
2.
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.
At the start of the treatment, some patients may experience
worsening of the symptoms of rosacea, however this is
uncommon and usually resolves within 1 week of the treatment.
Talk to your doctor if this happens.
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-

Ürün özellikleri

Health Products Regulatory Authority
03 February 2023
CRN00D9J8
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Soolantra 10 mg/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 light yellow cream.
4 CLINICAL PARTICULARS
As per PA22743/015/001
5 PHARMACOLOGICAL PROPERTIES
As per PA22743/015/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Glycerol
Isopropyl palmitate
Carbomer Type B
Dimeticone
Sodium 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
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
Health Products Regulatory Authority
03 February 2023
CRN00D9J8
Page 2 of 2
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 condition.
6.5 NATURE AND CONTENTS OF CONTAINER
Plastic white tube with child resistant closure.
Pack size: 1 tube of 45 g.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Mitigation measures should be taken in order to prevent or reduce
contamination, in particular the aquatic media.
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.,
Unit 10,
Ashbourne Business Park,
Rath,
Ashbourne,
Co. Meath,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/498/001
9 DATE O