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Active substance(s): IVERMECTIN

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Galderma - SOOLANTRA (Ivermectin 10 mg/g Cream)
GDC.01.DEU.0414.V10 - February 2017 - eCTD sequence 0024
Decentralised Procedure SE/H/1428/001/IA/010



10 mg/g cream

Package leaflet: Information for the patient
Soolantra 10 mg/g 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 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.
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 alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis),
- Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzote (E216) which may cause allergic reactions (possibly delayed),
- Propylene glycol which may cause skin irritation.

3. How to use Soolantra
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Important: Soolantra is intended for adults and only for use on the skin of the face. Do not use this medicine on other parts of your
body, especially not moist body surfaces, e.g. your eyes, your mouth or any mucosa. Do not swallow.
The recommended dose is one application on facial skin per day. Apply a pea size amount of the cream to each of the five areas of the
face: forehead, chin, nose and each cheek. Then spread the cream as a thin layer across the entire face.
Make sure to avoid the eyelids, lips and any mucosa such as inside the nose, the mouth and the eyes. If you accidentally get cream in
the eyes or near the eyes, eyelids, lips, mouth or mucosa wash the area immediately with plenty of water.
Do not apply cosmetics (such as other facial creams or make-up) before the daily application of Soolantra. These products can be used
after the applied cream has dried.
Wash your hands immediately after applying the cream.
You should use Soolantra daily over the treatment course and the treatment course may be repeated. Your doctor will tell you how
long you will need to use Soolantra. The duration of treatment can vary from person to person and depends on the severity of the
skin disorder. You may notice an improvement after 4 weeks of treatment. In case of no improvement after 3 months, you should
discontinue Soolantra and consult your doctor.
Hepatic impairment
If you have liver problems, please consult your doctor before using Soolantra.
Use in children and adolescents
Soolantra should not be used by children and adolescents.
How to open the tube with child resistant cap
To avoid spilling, do not squeeze the tube while opening or closing.
Push down on the cap and turn counter clockwise (turn to the left). Then pull the cap off.

Section 1.3.2 - Mock-up - Package Leaflet (proposed clean) - IE / UK

Galderma - SOOLANTRA (Ivermectin 10 mg/g Cream)
GDC.01.DEU.0414.V10 - February 2017 - eCTD sequence 0024
Decentralised Procedure SE/H/1428/001/IA/010

How to close the tube with a child resistant cap
Push down and turn clockwise (turn to the right).

If you use more Soolantra than you should
If you use more than the daily recommended dose, please contact your doctor, who will advise you on what action to take.
If you forget to use Soolantra
Do not use a double dose to make up for a forgotten dose .
If you stop using Soolantra
Pimples and spots will be reduced only after several applications of this medicine. It is important that you continue using Soolantra as
long as prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Soolantra may cause the following side effects:
Common side effect (may affect up to 1 in 10 people):
- Burning feeling of the skin
Uncommon side effects (may affect up to 1 in 100 people):
- Irritation of the skin
- Itching of the skin
- Dry skin
Not known side effect (frequency cannot be estimated from the available data)
- Redness of the skin
- Inflammation of the skin
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can
also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of
this medicine.
United Kingdom
Yellow Card Scheme
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website:; E-mail:

5. How to store Soolantra
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. The expiry date refers to the last day
of that month.
After first opening of the tube, use the product within 6 months.
This medicine does not require any special storage conditions.
Do not throw away unused Soolantra cream via wastewater or household waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information


What Soolantra contains
- The active substance is ivermectin. One gram of cream contains 10 mg of ivermectin.
- The other ingredients are 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.
What Soolantra looks like and contents of the pack
Soolantra is a white to pale yellow cream. It is supplied in tubes containing 2, 15, 30, 45 or 60 grams of cream. The larger tubes have a
child resistant closure whilst the 2g tube does not.
Pack size of 1 tube.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Galderma (UK) Limited
Meridien House
69-71 Clarendon Road
WD17 1DS
PL 10590/0063
PA 590/28/1
This leaflet was last revised in 02/2017.
This medicinal product is authorised in the Member States of the EEA under the following name:
Austria, Germany, Portugal: Soolantra 10 mg/g Creme
Ireland, United Kingdom: Soolantra 10 mg/g cream
Belgium, Luxemburg: Soolantra 10 mg/g crème
Italy: Efacti 10 mg/g crema
Soolantra 10 mg/g Creme
Latvia: Soolantra 10 mg/g krēms
Bulgaria: Soolantra 10 mg/g Крем
Lithuania: Soolantra 10 mg/g kremas
Cyprus, Greece: Soolantra 10 mg/g Κρέμα
Malta: Soolantra 10 mg/g krema
Czech Republic, Hungary, Slovakia: Soolantra 10 mg/g krém
Romania: Soolantra 10 mg/g Cremă
Denmark: Soolantra
Spain: Soolantra 10 mg/g crema
Estonia: Soolantra 10 mg/g kreem
Sweden: Soolantra 10 mg/g kräm
Finland: Soolantra 10 mg/g emulsiovoide
France, Netherlands: Soolantra10 mg/g crème
Iceland, Norway, Poland: Soolantra 10 mg/g krem

Section 1.3.2 - Mock-up - Package Leaflet (proposed clean) - IE / UK

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