Soolantra 10 mg/g cream
1. What Soolantra is and what it is used for
2. What you need to know before you use Soolantra
3. How to use Soolantra
4. Possible side effects
5. How to store Soolantra
6. Contents of the pack and other information
Soolantra contains the active substance ivermectin that belongs to a group of medicines called avermectins. The cream is used on the skin to treat pimples and spots found with rosacea.
Soolantra should be used in adults only (18 years of age or older).
Talk to your doctor or pharmacist before using Soolantra.
Other medicines may have an effect on Soolantra, you should therefore tell your doctor if you are using, have recently used or might use any other medicines.
Soolantra is not recommended during pregnancy. If you are breast-feeding, you should not use this medicine, alternatively, you should stop breast-feeding before starting treatment with Soolantra.
You should consult your doctor to help you decide between using Soolantra and breast-feeding, taking into account the benefit of the treatment and the benefit of breast-feeding.
Soolantra has no or negligible influence on the ability to drive and use machines.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Important: Soolantra is intended for adults and only for use on the skin of the face. Do not use this medicine on other parts of your body, especially not moist body surfaces, e.g. your eyes, your mouth or any mucosa. Do not swallow.
The recommended dose is one application on facial skin per day. Apply a pea size amount of the cream to each of the five areas of the face: forehead, chin, nose and each cheek. Then spread the cream as a thin layer across the entire face.
Make sure to avoid the eyelids, lips and any mucosa such as inside the nose, the mouth and the eyes. If you accidentally get cream in the eyes or near the eyes, eyelids, lips, mouth or mucosa wash the area immediately with plenty of water.
Do not apply cosmetics (such as other facial creams or make-up) before the daily application of Soolantra. These products can be used after the applied cream has dried.
Wash your hands immediately after applying the cream.
You should use Soolantra daily over the treatment course and the treatment course may be repeated. Your doctor will tell you how long you will need to use Soolantra. The duration of treatment can vary from person to person and depends on the severity of the skin disorder. You may notice an improvement after 4 weeks of treatment. In case of no improvement after 3 months, you should discontinue Soolantra and consult your doctor.
If you have liver problems, please consult your doctor before using Soolantra.
Soolantra should not be used by children and adolescents.
To avoid spilling, do not squeeze the tube while opening or closing.
Push down on the cap and turn counter clockwise (turn to the left). Then pull the cap off.
Push down and turn clockwise (turn to the right).
If you use more than the daily recommended dose, please contact your doctor, who will advise you on what action to take.
Do not use a double dose to make up for a forgotten dose .
Pimples and spots will be reduced only after several applications of this medicine. It is important that you continue using Soolantra as long as prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Soolantra may cause the following side effects:
Common side effect (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Not known side effect (frequency cannot be estimated from the available data)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
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.
After first opening of the tube, use the product within 6 months.
This medicine does not require any special storage conditions.
Do not throw away unused Soolantra cream via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Soolantra is a white to pale yellow cream. It is supplied in tubes containing 2, 15, 30, 45 or 60 grams of cream. The larger tubes have a child resistant closure whilst the 2g tube does not.
Pack size of 1 tube.
Not all pack sizes may be marketed.
Galderma (UK) Limited
69-71 Clarendon Road
Marketing Autorisation Holder in Ireland
Galderma International S.A.S.
La Defense 4
20 Avenue Andre Prothin France
ZI - MONTDESIR