SOOLANTRA 10 mg /G Cream

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Soolantra 10 mg/g Cream
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet
3. What is Soolantra and what is it used for
4. Important information before using Soolantra
   1. When not to use Soolantra:
   2. Warnings and precautions
   3. Soolantra and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. What Soolantra contains
5. How to use Soolantra
   1. Liver function disorders
   2. Use in children and adolescents
   3. How to open the child-resistant tube
   4. How to close the child-resistant tube
   5. Using more Soolantra than recommended
   6. Missing a dose of Soolantra
   7. Stopping Soolantra treatment
6. Possible side effects
   1. Reporting side effects
7. How to store Soolantra
8. Contents of the pack and other information
   1. What Soolantra contains
   2. What Soolantra looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Soolantra 10 mg/g Cream

Ivermectin

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

• Keep this package 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package 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 a group of medicines called avermectins. This medicine is used on the skin to treat bumps and pimples that occur with rosacea.
Soolantra can only be used in adults (18 years and 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 resolves within the first week of treatment. If worsening of rosacea symptoms occurs, tell your doctor.

Soolantra and other medicines

Other medicines may affect Soolantra; therefore, tell your doctor about all medicines you are 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 to 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 (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (also late-type),
• propylene glycol, which may cause skin irritation.

3. How to use Soolantra

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Important information:Soolantra is only for use on the face skin in adults. Do not use this medicine on other parts of the body, especially on moist body surfaces, such as the eyes, mouth, or any mucous membrane. Do not swallow.
The recommended dose is one application to the face skin 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 in a thin layer over the entire face.
Do not apply the cream near the eyes, mouth, 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, mouth, or mucous membranes, rinse these areas immediately with a large amount of water.
Do not use cosmetics (such as face creams or other makeup) before daily use of Soolantra. These products can be used after the applied 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 counterclockwise (to the left). Then remove the cap.

How to close the child-resistant tube

Press the cap and turn it clockwise (to the right).

Using more Soolantra than recommended

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 use a double dose to make up for a missed dose.

Stopping Soolantra treatment

The bumps and pimples 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):

• skin burning sensation

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

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

Frequency not known (cannot be estimated from the available data):

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

Reporting 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. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
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 which is stated on the carton and tube after EXP. The expiry date refers to the last day of that month.
Shelf life after first opening the tube: 6 months.
This medicine does not require any special storage precautions.
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 (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 light yellow cream.
Pack sizes:
Tube containing 15 g or 30 g of cream, with a child-resistant closure, in a cardboard box.
Not all pack sizes may be marketed.
This medicinal product has been authorized in the Member States of the EEA 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:
Denmark:
Soolantra 10 mg/g krém
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

Marketing authorization holder and manufacturer

Marketing authorization holder

Galderma Polska Sp. z o.o.
ul. Puławska 145
02-715 Warsaw
Poland
tel.: +48 22 331 21 80

Manufacturer

Laboratoires Galderma
Z.I. Montdésir
74 540 Alby sur Chéran
France

Date of last revision of the leaflet: