Product Information for the Patient

Soolantra 10 mg/g Cream

Ivermectin

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information.See section 4.

1. What is Soolantra and how is it used

2. What you need to know before starting to use Soolantra

3. How to use Soolantra

4. Possible adverse effects

5. Storage of Soolantra

6. Contents of the package and additional information

Soolantra contains the active ingredient ivermectin, which belongs to a group of medicines called avermectins. The cream is applied to the skin of the face to treat acne and inflammatory lesions that appear in rosacea.

Soolantra should only be used in adults (18 years of age or older).

Do not use Soolantra:

-if you are allergic to ivermectin or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Soolantra.

At the beginning of treatment, some patients may experience a worsening of rosacea symptoms, however, this is rare and usually resolves within the first week of treatment. Talk to your doctor if this occurs.

Use of Soolantra with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, as these medications may affect your treatment with Soolantra.

Pregnancy and breastfeeding

Soolantra is not recommended during pregnancy.

If you are breastfeeding, do not use this medication. Before starting treatment with Soolantra, you must stop breastfeeding.

You should consult your doctor to decide between using Soolantra and breastfeeding, taking into account the benefit of treatment with Soolantra or the benefit of breastfeeding.

Driving and operating machines

The influence of Soolantra on the ability to drive and use machines is negligible or insignificant.

Soolantra contains:

• Cetyl alcoholandstearyl alcoholwhich may cause local skin reactions (e.g. contact dermatitis).
• Methyl parahydroxybenzoate (E218)andpropyl parahydroxybenzoate (E216)which may cause allergic reactions (possibly delayed).

Propylene glycol which may cause skin irritation,

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Important:Soolantra is indicated for adults and is only to be used on the skin of the face. Do not use this medication on any other part of your body, especially on moist body surfaces, for example,the eyes, mouth, or any mucous membranes.Do not ingest.

It is recommended to apply Soolantra on the face only once a day. You should apply a small amount of cream the size of a peain each of the five facial areas,forehead, chin, nose, and both cheeks, and then gently and evenly spread a thin layer of cream over each area.

You should avoid the eyelids, lips, and any mucous membranes, such as the inside of the nostrils, mouth, and eyes. If the cream is accidentally applied to the eyes or near the eyes, eyelids, lips, mouth, or mucous membranes, wash the area immediately with plenty of water.

Do not apply any other cosmetics(such as other facial creams or makeup)before the daily application of Soolantra.

You should only use these products after the cream has been applied and has dried.

You should wash your hands immediately after applying the cream.

You should use Soolantra daily during the treatment period, the treatment course may be repeated. Your doctor will tell you how long you will need to use Soolantra. The duration of treatment may vary from person to person, depending on the severity of the skin disease.

You will notice an improvement in 4 weeks of treatment. If there is no improvement after 3 months, you should discontinue treatment with Soolantra and consult your doctor.

Liver insufficiency

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

Use in children and adolescents

Do not use Soolantra in children or adolescents.

How to open the child-resistant tube

Do not squeeze the tube when opening or closing it to avoid spillage.

Press the cap and turn it counterclockwise (turn to the left). Then remove the cap.

How to close the child-resistant tube

Press and turn clockwise (turn to the right).

If you use more Soolantra than you should

If you use a quantity greater than the recommended daily dose,contact your doctor, who will advise you on what action to take.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Soolantra

Do not apply a double dose to compensate for the missed doses.

If you interrupt treatment with Soolantra

The pimples and inflammatory lesions will decrease after several applications of this medication. It is essential to continue using Soolantra for the time your doctor has prescribed.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.Soolantra may cause the following adverse effects:

Common Adverse Effects (may affect between 1 and 10 of every 100 people):

- Burning sensation on the skin

Less Common Adverse Effects (may affect between 1 and 10 of every 1,000 people):

- Skin irritation - Itching of the skin - Dryness of the skin

- Exacerbation of rosacea (please consult your doctor)

Adverse Effects of Unknown Frequency (cannot be estimated from available data):

- Redness of the skin

- Inflammation of the skin

- Swelling of the face

- Increase in liver enzymes (ALAT/ASAT)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the tube. The expiration date is the last day of the month indicated.

Shelf life after the first opening of the tube: 6 months.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Soolantra

• The active ingredient is ivermectin. One gram of cream contains 10 mg of ivermectin.
• The other components areglycerol, isopropyl palmitate, carbomer, dimethicone, disodium edetate, citric acid monohydrate, cetyl alcohol, stearyl alcohol, cetostearyl macrogol ether, sorbitan stearate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), phenoxyethanol, propylene glycol, oleic alcohol, sodium hydroxide, purified water.

Appearance of Soolantra and contents of the package

Soolantra is a white to pale yellow cream. It is presented in tubes of 2, 15, 30, 45 or 60grams of cream. The larger tubes have child-resistant closures, while the 2 g tube does not.

Package with1tube.

Only some package sizes may be marketed

This medicine is authorized in the member states of the European Economic Area with the following names:

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Galderma Laboratories, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer:

Galderma Laboratories

Z.I. – Montdésir

74540Alby-sur-Chéran

France

Last review date of this leaflet: February 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es