Soolantra 10mg/g Cream

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Ivermectin

Beszerezhető a:

Lexon Pharmaceuticals (Ireland) Limited

ATC-kód:

D11AX; D11AX22

INN (nemzetközi neve):

Ivermectin

Adagolás:

10 milligram(s)/gram

Gyógyszerészeti forma:

Cream

Terápiás terület:

Other dermatologicals; Ivermectin

Engedély dátuma:

2017-10-20

Betegtájékoztató

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.
At the start of treatment, some patients may
experience worsening of the symptoms of rosacea,
however this is uncommon and usually resolves
within 1 week of 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-feeding before starting treatment with
Soolantra.
You should consult your doctor to help you decide
between using Soolantra and breast-feeding, taking
into acco

Termékjellemzők

Health Products Regulatory Authority
04 February 2022
CRN00CS1K
Page 1 of 2
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
6.2 INCOMPATIBILITIES
Not applicable
Health Products Regulatory Authority
04 February 2022
CRN00CS1K
Page 2 of 2
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 condition.
6.5 NATURE AND CONTENTS OF CONTAINER
Plastic white tube with child resistant closure.
Pack size: 1 tube of 30 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
Lexon Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Harcourt Road
Dublin 2
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/014/001
9 DATE