Soolantra 10 mg/g cream
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the Patient
Soolantra 10 mg/g Cream
Ivermectin
Read the entire leaflet carefully before you start 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 questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. 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. The cream is applied to the skin of the face to treat pimples and inflammatory lesions associated with rosacea.
Soolantra should only be used in adults (aged 18 years and older).
2. What you need to know before using Soolantra
Do not use Soolantra:
- if you are allergic to ivermectin or to any of the other ingredients of this medicine (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 uncommon and usually resolves within the first week of treatment. Speak with your doctor if this occurs.
Use of Soolantra with other medicines
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, as these could affect your treatment with Soolantra.
Pregnancy and breastfeeding
The use of Soolantra is not recommended during pregnancy.
If you are breastfeeding, you must not use this medicine. Breastfeeding must be discontinued before starting treatment with Soolantra.
You should consult your doctor to decide between using Soolantra or continuing breastfeeding, taking into account the benefit of treatment with Soolantra versus the benefit of breastfeeding.
Driving and using machines
The influence of Soolantra on the ability to drive and use machines is none or negligible.
Soolantra contains:
- Cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).
- Methyl parahydroxybenzoate (E218) and Propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).
- Propylene glycol, which may cause skin irritation.
3. How to use Soolantra
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, please consult your doctor or pharmacist again.
Important: Soolantra is indicated for use in adults only and is intended solely for application on the facial skin. Do not use this medicine on any other part of the body, especially on moist body surfaces such as the eyes, mouth, or any mucous membranes. Do not swallow.
It is recommended to apply Soolantra once daily to the face. Apply a small amount of cream, approximately the size of a pea, to each of the five facial areas—forehead, chin, nose, and both cheeks—and then gently and evenly spread a thin layer over each area.
Avoid the eyelids, lips, and any mucous membranes, such as inside the nasal passages, mouth, or eyes. If the cream is accidentally applied to the eyes or near the eyes, eyelids, lips, mouth, or mucous membranes, immediately rinse the area thoroughly with plenty of water.
Do not apply any other cosmetics (such as other facial creams or makeup) before the daily application of Soolantra.
These products should only be used after applying the cream, once it has dried completely.
Wash your hands immediately after applying the cream.
You should use Soolantra daily throughout the course of treatment, which may be repeated. Your doctor will determine how long you need to continue using Soolantra. The duration of treatment may vary from person to person and depends on the severity of the skin condition.
You should notice improvement after 4 weeks of treatment. If there is no improvement after 3 months, you should discontinue treatment with Soolantra and consult your doctor.
Hepatic impairment
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 tube with child-resistant cap
Do not squeeze the tube when opening or closing to avoid leakage.
Press down on the cap and turn it counterclockwise (turn to the left), then remove the cap.
How to close the tube with child-resistant cap
Press down and turn clockwise (turn to the right).
If you use more Soolantra than you should
If you apply more than the recommended daily dose, contact your doctor, who will advise you on the necessary steps.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested.
If you forget to use Soolantra
Do not apply a double dose to make up for a missed dose.
If you stop using Soolantra
Pimples and inflammatory lesions will improve after several applications of this medicine. It is important that you continue using Soolantra for the length of time prescribed by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Soolantra may cause the following adverse effects:
Common adverse effects (may affect between 1 and 10 out of 100 people):
- Sensation of burning on the skin
Uncommon adverse effects (may affect between 1 and 10 out of 1,000 people):
- Skin irritation - Itching of the skin - Dry skin
- Worsening of rosacea (please consult your doctor)
Adverse effects with unknown frequency (cannot be estimated from available data):
- Redness of the skin
- Skin inflammation
- Facial swelling
- Increased liver enzymes (ALAT/ASAT)
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Soolantra
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube. The expiry date is the last day of the month indicated.
Period of validity after first opening of the tube: 6 months.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Soolantra
- The active substance is ivermectin. One gram of cream contains 10 mg of ivermectin.
- The other components are glycerol, isopropyl palmitate, carbomer, dimethicone, disodium edetate, citric acid monohydrate, cetyl alcohol, stearyl alcohol, macrogol cetearyl ether, sorbitan stearate, methylparaben (E218), propylparaben (E216), phenoxyethanol, propylene glycol, oleic alcohol, sodium hydroxide, purified water.
Appearance of Soolantra and contents of the pack
Soolantra is a cream, white to pale yellow in colour. It is available in tubes containing 2, 15, 30, 45 or 60 grams of cream. The larger tubes have a child-resistant cap, whereas the 2 g tube does not.
Pack containing 1 tube.
Only certain pack sizes may be marketed.
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria, Germany, Portugal: | Soolantra 10 mg/g Cream |
Belgium, Luxembourg: | Soolantra 10 mg/g cream Soolantra 10 mg/g Cream |
Bulgaria: | Soolantra 10 mg/g ???? |
Cyprus, Greece: | Soolantra 10 mg/g Κρ?μα |
Czech Republic, Hungary, | Soolantra 10 mg/g krém Soolantra |
Estonia: | Soolantra 10 mg/g cream |
Finland: | Soolantra 10 mg/g emulsion ointment |
France, Netherlands: | Soolantra 10 mg/g cream |
Iceland, Norway, Poland: | Soolantra 10 mg/g cream |
Ireland, United Kingdom: | Soolantra 10 mg/g cream |
Italy: | Efacti 10 mg/g Cream |
Latvia: | Soolantra 10 mg/g cream |
Lithuania: | Soolantra 10 mg/g cream |
Malta: | Soolantra 10 mg/g cream |
Romania: | Soolantra 10 mg/g Cream |
Spain: | Soolantra 10 mg/g cream |
Sweden: | Soolantra 10 mg/g cream |
Marketing Authorization Holder and Manufacturing Responsible Party
Marketing Authorization Holder:
Laboratorios Galderma, S.A.
Serrano Galvache, 56
28033 Madrid
Spain
Manufacturing Responsible Party:
Laboratoires Galderma
Z.I. – Montdésir
74 540 Alby-sur-Chéran
France
Date of latest review of this leaflet: February 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.es