Soolantra

Patient Information Leaflet

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Soolantra, 10 mg/g, cream
Ivermectinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Soolantra is and what it is used for
2. What you need to know 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 Soolantra is and what it is used for

Soolantra contains the active substance ivermectin, which belongs to a group of medicines called avermectins.
This medicine is applied to the skin for the treatment of inflammatory lesions (papules and pustules) associated with rosacea.
Soolantra should only be used in adults (aged 18 years and older).

2. Important information before using Soolantra

When not to use Soolantra:

• if the patient is 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 this with your doctor or pharmacist.
At the beginning of treatment, some patients may experience a worsening of rosacea symptoms; however, this is not common and usually resolves within the first week of treatment. If worsening of rosacea symptoms occurs, inform your doctor.
Soolantra and other medicines
Other medicines may interact with Soolantra; therefore, you must tell your doctor about all medicines you are currently using or have recently used, as well as any medicines you plan to use.
Pregnancy and breastfeeding
Soolantra is not recommended during pregnancy.
If the patient is breastfeeding, she should not use this medicine; alternatively, breastfeeding may be discontinued before starting treatment with Soolantra. Please consult your doctor,
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who will help decide whether to use the medicine or to breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding.
Driving and operating machinery
Soolantra has no effect or has negligible effect on the ability to drive and operate machinery.
Soolantra contains:

• cetyl alcohol and 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 (including delayed-type),
• propylene glycol, which may cause skin irritation.

3. How to use Soolantra

This medicine should always be used exactly as your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist.
Important information: Soolantra is intended for topical use on the facial skin of adults only. Do not use this medicine on other parts of the body, especially moist areas such as eyes, mouth, or any mucous membranes. Do not swallow.
The recommended dose is one application to the face once daily. Apply an amount of cream equivalent to a pea-sized portion to each of five areas of the face: forehead, chin, nose, and each cheek. Then spread the cream as a thin layer over the entire facial skin.
Do not apply the cream near the eyelids, lips, or any mucous membranes, such as inside the nose, mouth, or eyes. If the cream accidentally gets into the eyes or around the eyes, eyelids, lips, mouth, or onto a mucous membrane, immediately rinse the area thoroughly with plenty of water.
Do not apply cosmetics (such as facial moisturizers or other makeup products) before applying Soolantra each day. These products may be used after the applied cream has dried.
Wash your hands immediately after applying the cream.
Use Soolantra every day for the entire duration of treatment; the treatment course may be repeated. Your doctor will inform you how long you should continue using Soolantra. The duration of treatment may vary between individuals and depends on the severity of skin lesions.
Improvement may be observed after 4 weeks of treatment. If there is no improvement after 3 months, discontinue use of Soolantra and consult your doctor.
Liver function disorders
If you have any liver problems, consult your doctor before using Soolantra.
Use in children and adolescents
Soolantra must not be used in children and adolescents.
How to open the tube with child-resistant cap
To avoid spilling the medicine, do not squeeze the tube while opening or closing it.
Press down on the cap and turn it counterclockwise (to the left).

How to close the tube with child-resistant cap
Press down on the cap and turn it clockwise (to the right).

Use of more than the recommended dose of Soolantra
If you use more than the recommended daily dose, contact your doctor for advice on what actions to take.
Missed dose of Soolantra
Do not use a double dose to make up for a missed dose.
Stopping treatment with Soolantra
Pimples and bumps will only improve 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicinal product may cause adverse effects, although not everyone will experience them.
Soolantra may cause the following adverse effects:
Common adverse effects (may occur in up to 1 in 10 people):

• sensation of skin burning

Uncommon adverse effects (may occur in up to 1 in 100 people):

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

Adverse effect with unknown frequency (cannot be estimated from available data):

• skin redness
• skin inflammation
• facial swelling
• increased liver enzyme activity (AlAT/AspAT)

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps 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 container. The expiry date refers to the last day of the stated month.
Period of use after first opening of the tube: 6 months.
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Soolantra contains

• The active substance is ivermectin. One gram of cream contains 10 mg of ivermectin.
  Other ingredients are: glycerol, isopropyl palmitate, carbomer, dimethicone, disodium edetate, monohydrate citric acid, 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 cream with a white to pale yellow colour.
Pack size:
Laminated tube made of PE/Al/PE containing 30 g of cream, with a white cap made of HDPE and PP providing child-resistant protection, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, 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
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Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Greece, country of export: 55148/16-6-2021
92257/17/30-4-2018
Parallel Import Licence number: 28/26
This medicinal product has been authorised in EEA Member States under the following names:
Austria, Germany, Portugal: Soolantra 10 mg/g Creme
Belgium, Luxembourg: Soolantra 10 mg/g crème
Soolantra 10 mg/g Creme
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
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