Soolantra

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Soolantra

10 mg/g, cream

Ivermectin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Soolantra and what is it used for
• 2. Important information before using 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 is Soolantra and what is it used for

Soolantra contains the active substance ivermectin, which belongs to the avermectin group of medicines.
This medicine is used on the skin to treat papules and pustules in rosacea.
Soolantra can only be used in adults (18 years or older).

2. Important information before using Soolantra

When not to use Soolantra:

• if you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Soolantra, discuss it with your doctor or pharmacist.
At the beginning of treatment, some patients may experience worsening of rosacea symptoms,
however, this is not common and usually subsides within the first week of treatment. If you experience
worsening of rosacea symptoms, tell your doctor.

Soolantra and other medicines

Other medicines may affect Soolantra; therefore, tell your doctor about all medicines you are currently
taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

Soolantra should not be used during pregnancy.
If you are breastfeeding, do not use this medicine; alternatively, you can stop breastfeeding before
starting treatment with Soolantra. Consult your doctor, who will help you decide whether to use the
medicine or breastfeed, considering the benefits of treatment and the benefits of breastfeeding.

Driving and using machines

Soolantra has no or negligible influence on the ability to drive and use machines.

What Soolantra contains:

• cetyl alcohol, stearyl alcohol, which may cause skin reactions (e.g. contact dermatitis),
• methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (also of a delayed type),
• propylene glycol, which may cause skin irritation.

3. How to use Soolantra

Always use this medicine exactly as your doctor has told you.
In case of doubt, consult your doctor or pharmacist.
Important information:Soolantra is for use on the face only in adults. Do not use this medicine on other parts of the body, especially on moist surfaces, such as the eyes, mouth, or any mucous membrane. Do not swallow.
The recommended dose is one application to the face per day. Apply a pea-sized amount to each of the five areas of the face: forehead, chin, nose, and each cheek. Then spread the cream thinly and evenly across the entire face.
Do not apply the cream near the eyes, mouth, or any mucous membrane, for example, inside the nose, mouth, or eyes. If the cream accidentally gets into the eyes or around the eyes, eyelids, mouth, or mucous membrane, rinse the area immediately with a large amount of water.
Do not use cosmetics (such as facial creams or other makeup products) before applying Soolantra daily. These products can be applied after the cream has dried.
Wash your hands immediately after applying the cream.
Use Soolantra every day for the entire treatment period; the treatment cycle can be repeated.
Your doctor will tell you how long to use Soolantra. The treatment duration may vary from person to person and depends on the severity of skin lesions.
Improvement can be seen after 4 weeks of treatment. If there is no improvement after 3 months, stop using Soolantra and consult your doctor.

Liver function disorders

If you have liver problems, consult your doctor before using Soolantra.

Use in children and adolescents

Do not use Soolantra in children and adolescents.

How to open the child-resistant tube

To avoid spilling the medicine, do not squeeze the tube while opening or closing it.
Press the cap and turn it in the opposite direction of the arrow (to the left).
Then remove the cap.

How to close the child-resistant tube

Press the cap and turn it in the direction of the arrow (to the right).

Using more than the recommended dose of Soolantra

If you use more than the recommended dose, contact your doctor, who will advise you on what actions to take.

Missing a dose of Soolantra

Do not take a double dose to make up for a missed dose.

Stopping treatment with Soolantra

Papules and pustules will decrease only after several applications of this medicine. It is important to continue using Soolantra for as long as your doctor recommends.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Soolantra can cause side effects, although not everybody gets them.
Soolantra may cause the following side effects:
Common side effects (may affect up to 1 in 10 people):

• burning sensation of the skin.

Uncommon side effects (may affect up to 1 in 100 people):

• skin irritation
• skin itching
• skin dryness
• worsening of rosacea symptoms (contact your doctor).

Side effects of unknown frequency (cannot be estimated from the available data):

• skin redness
• skin inflammation
• facial swelling
• increased liver enzyme activity (ALT/AST).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 stated on the packaging.
The expiry date refers to the last day of the month stated.
Shelf-life after first opening of the tube: 6 months.
No special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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, dimethicone, disodium edetate, citric acid monohydrate, cetyl alcohol, stearyl alcohol, macrogol cetostearyl ether, sorbitan stearate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), phenoxyethanol, propylene glycol, oleyl alcohol, sodium hydroxide, purified water.

What Soolantra looks like and contents of the pack

Soolantra is a white to light yellow cream.
Pack size:
Tube containing 30 g of cream, with a child-resistant closure, in a cardboard box.
For more detailed information, contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Greece, the country of export:

GALDERMA INTERNATIONAL
Tour Europlaza, 20 avenue André Prothin - La Défense 4
92 927 La Défense Cedex, France

Manufacturer:

Laboratoires GALDERMA
Zone Industrielle-Montdésir
74 540 Alby sur Chéran, France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Marketing authorisation number in Greece, the country of export:92257/17/30-4-2018
55148/16-6-2021

Parallel import authorisation number: 264/24

This medicinal product has been authorised in the Member States of the EEA under the following names:
Austria, Germany, Portugal:
Soolantra 10 mg/g Cream
Belgium, Luxembourg:
Soolantra 10 mg/g crème
Soolantra 10 mg/g Cream
Bulgaria:
Soolantra 10 mg/g Крем
Cyprus, Greece:
Soolantra 10 mg/g Κρέμα
Czech Republic, Hungary, Slovakia:
Soolantra 10 mg/g krém
Denmark:
Soolantra
Estonia:
Soolantra 10 mg/g kreem
Finland:
Soolantra 10 mg/g emulsiovoide
France, Netherlands:
Soolantra 10 mg/g crème
Iceland, Norway, Poland:
Soolantra 10 mg/g krem
Ireland, United Kingdom:
Soolantra 10 mg/g cream
Italy:
Efacti 10 mg/g Crema
Latvia:
Soolantra 10 mg/g krēms
Lithuania:
Soolantra 10 mg/g kremas
Malta:
Soolantra 10 mg/g krema
Romania:
Soolantra 10 mg/g Cremă
Spain:
Soolantra 10 mg/g crema
Sweden:
Soolantra 10 mg/g kräm

Date of revision of the leaflet: 01.07.2024

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