Soolantra 10mg/g Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Galderma International

ATC code:

D11AX; D11AX22

INN (International Name):

Ivermectin

Dosage:

10 milligram(s)/gram

Pharmaceutical form:

Cream

Therapeutic area:

Other dermatologicals; Ivermectin

Authorization status:

Marketed

Authorization date:

2015-04-24

Patient Information leaflet

1
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
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 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-feeding before
starting treatment with Soolantra.

Summary of Product characteristics

Health Products Regulatory Authority
03 November 2022
CRN00D5C9
Page 1 of 8
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 35 mg of cetyl alcohol, 25 mg of stearyl
alcohol, 2 mg of methyl parahydroxybenzoate (E218),
1 mg of propyl parahydroxybenzoate (E216) and 20 mg of propylene
glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
White to pale yellow hydrophilic cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Soolantra is indicated for the topical treatment of inflammatory
lesions of rosacea (papulopustular) in adult patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One application a day for up to 4 months. Soolantra should be applied
daily over the treatment course. The treatment course
may be repeated. It can be applied as monotherapy or as part of
combination treatment (see section 5.1).
In case of no improvement after 3 months, the treatment should be
discontinued.
_Special population_
_Renal impairment_
No dosage adjustment is necessary.
_Hepatic impairment_
Caution should be exercised in patients with severe hepatic
impairment.
_Elderly patients_
No dosage adjustment is necessary in the geriatric population (see
also section 4.8).
_Paediatric population_
The safety and efficacy of Soolantra in children and adolescents aged
less than 18 years have not been established. No data are
available.
Method of administration
Cutaneous use only.
Cutaneous application of a pea-size amount of medicinal product to
each of the five areas of the face: forehead, chin, nose,
and each cheek. The medicinal product should be spread as a thin layer
across the entire face, avoiding the eyes, lips and
mucosa.
Soolantra should be applied only to the face.
Hands should be washed after applying the medicinal product.
Cosmetics may be applied after the medicinal product has dried.
4.3 CONT