Soolantra 10 mg/g Cream

Soolantra 10 mg/g cream

ivermectin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this 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 signs of illness 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.

What is in this leaflet

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).

Do not use Soolantra:

• if you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Soolantra.

Other medicines and 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.

Pregnancy and breast-feeding

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.

Driving and using machines

Soolantra has no or negligible influence on the ability to drive and use machines.

Soolantra contains:

• Cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis),
• Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzote (E216) which may cause allergic reactions (possibly delayed),
• Propylene glycol which may cause skin irritation.

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.

Hepatic impairment

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

Use in children and adolescents

Soolantra should not be used by children and adolescents.

How to open the tube with child resistant cap

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.

How to close the tube with a child resistant cap

Push down and turn clockwise (turn to the right).

If you use more Soolantra than you should

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

If you forget to use Soolantra

Do not use a double dose to make up for a forgotten dose .

If you stop using Soolantra

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):

• Burning feeling of the skin

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

• Irritation of the skin
• Itching of the skin
• Dry skin

Not known side effect (frequency cannot be estimated from the available data)

• Redness of the skin
• Inflammation of the skin

Reporting of 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. 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.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: medsafety@hpra.ie

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.

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, dimeticone, 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 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.

Marketing Authorisation Holder in UK

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK

PL 10590/0063

 

Marketing Autorisation Holder in Ireland

Galderma International S.A.S.

Tour Europlaza

La Defense 4
20 Avenue Andre Prothin France
PA 22743/015/1

Manufacturer

LABORATOIRES GALDERMA

ZI - MONTDESIR

74540 ALBY-SUR-CHERAN

FRANCE