Soolantra

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Soolantra
10 mg/g, cream
Ivermectin
Please read this leaflet carefully before using this medicine, because it contains
important information for you.

• 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 share it with others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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 to treat inflammatory lesions (papules and pustules) of rosacea.
Soolantra may only be used in adults (aged 18 years or 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 currently used or recently used, as well as any medicines planned for future 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 prior to starting treatment with Soolantra. Please consult your doctor, who will help you decide whether to use the medicine or breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding.
Driving and operating machinery
Soolantra has no effect or has a negligible effect on the ability to drive or 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 reactions),
• propylene glycol, which may cause skin irritation.

3. How to use Soolantra

This medicine should always be used exactly as directed by your doctor. If in doubt, 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, particularly moist surfaces such as the eyes, mouth, or any mucous membranes. Do not swallow.
The recommended dose is one application to the face per day. Apply a pea-sized amount of cream to each of the five areas of the face: the forehead, chin, nose, and each cheek. Then spread the cream evenly 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, eyelids, lips, mouth, or onto any mucous membrane, rinse the area immediately with plenty of water.
Do not use cosmetics (such as facial creams or other makeup products) before applying Soolantra each day. These products may be used after the 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 use 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 no improvement is seen after 3 months, discontinue use of Soolantra and consult your doctor.
Liver function disorders
If you have 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 a child-resistant cap
To avoid spilling the medicine, do not squeeze the tube when opening or closing it.
Press down on the cap and turn it counterclockwise (to the left). Then remove the cap.

How to close the tube with a 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 more than the recommended daily dose is used, 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Soolantra may cause the following adverse reactions:

Common adverse reactions (may occur in up to 1 in 10 people):

• skin burning sensation.

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

• skin irritation
• skin itching
• skin dryness
• worsening of rosacea symptoms (consult a doctor).

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated month.
Duration of use after first opening of the tube: 6 months.
No special storage conditions required.
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 packaging 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, cetostearyl macrogol 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:
Tubes containing 30 g of cream, with a child-resistant closure, in a cardboard box.
For further information, contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Lithuania, country of export:
Galderma International
Tour Europlaza, 20 avenue André Prothin, La Defense 4
92927 Paris La Defense Cedex, France
Manufacturer:
Laboratoires Galderma
Zl Montdésir
74540 Alby-sur-Chéran, France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Lithuania, country of export: LT/1/15/3726/003
Parallel import authorisation number: 112/26
This medicinal product has been authorised for marketing 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