Soolantra
Poland
Table of Contents
Patient Information Leaflet
Soolantra 10 mg/g cream
Ivermectin
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, please ask 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 as yours.
- If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet Contents
- What Soolantra is and what it is used for
- What you need to know before using Soolantra
- How to use Soolantra
- Possible side effects
- How to store Soolantra
- 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 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, symptoms of rosacea may worsen in some patients; however, this is not common and usually resolves within the first week of treatment. If worsening of rosacea symptoms occurs, inform your doctor.
Soolantra with other medicines
Other medicines may interact with Soolantra; therefore, you must tell your doctor about all medicines currently or recently used, as well as any medicines you plan to use.
Pregnancy and breastfeeding
The use of 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, 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 a negligible effect on the ability to drive motor vehicles and operate machinery.
Soolantra contains:
- cetyl alcohol and stearyl alcohol, which may cause skin reactions (e.g. contact dermatitis),
- methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), 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 the 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 facial skin once daily. Apply an amount of cream equivalent to a pea-sized portion 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, for example inside the nose, mouth, or eyes. If the cream accidentally gets into the eyes or around the eyes, eyelids, lips, mouth, or mucous membranes, immediately rinse the affected areas thoroughly with plenty of water.
Do not apply cosmetics (such as facial creams or other makeup products) before the daily application of Soolantra. These products may be used after the applied cream has dried.
Wash your hands immediately after applying the cream.
Use Soolantra every day throughout the treatment period; the treatment cycle 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 the 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 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 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 begin to 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 side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Soolantra may cause the following side effects:
Common side effects (may occur in up to 1 in 10 people):
- sensation of skin burning
Uncommon side effects (may occur in up to 1 in 100 people):
- skin irritation
- skin itching
- skin dryness
- worsening of rosacea symptoms (consult a doctor)
Side effect with unknown frequency (cannot be estimated from the available data):
- skin redness
- skin inflammation
- facial swelling
- increased liver enzyme activity (AlAT/AspAT)
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to provide more information on the safety of the medicine.
5. How to store Soolantra medicine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after EXP. The expiry date refers to the last day of the stated month.
Storage period after first opening of the tube: 6 months.
This medicine does not require any special storage conditions.
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 pack 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, 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 cream of white to pale yellow colour.
Pack sizes:
Tubes 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 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
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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