Efacti

Package leaflet: Information for the patient

Efacti 10 mg/g cream

ivermectin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Efacti is and what it is used for
2. What you need to know before using Efacti
3. How to use Efacti
4. Possible side effects
5. How to store Efacti
6. Contents of the pack and other information

1. What Efacti is and what it is used for

Efacti contains the active substance ivermectin, which belongs to a group of medicines called avermectins.
The cream is used on the skin to treat pimples and pustules associated with rosacea.
Efacti should only be used in adults (aged 18 years and older).

2. What you need to know before using Efacti

Do not use Efacti:

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

Warnings and precautions
Talk to your doctor or pharmacist before using Efacti.
At the beginning of treatment, some patients may experience a worsening of rosacea symptoms; however, this is not common and usually resolves within 1 week of treatment. Consult your doctor if this occurs.

Other medicines and Efacti
Other medicines may interact with Efacti. Inform your doctor if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding
Efacti is not recommended during pregnancy.
If you are breastfeeding, you must not use this medicine or, alternatively, you must stop breastfeeding before starting treatment with Efacti.
Consult your doctor, who will help you decide between using Efacti and breastfeeding, taking into account the benefits of treatment and the benefits of breastfeeding.

Driving and using machines
Efacti has no or negligible influence on the ability to drive vehicles and use machinery.

Efacti 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 (including delayed reactions),
• Propylene glycol, which may cause skin irritation.

3. How to use Efacti

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
Important: Efacti is intended for adults and for topical use on the facial skin only. Do not use this medicine on
other parts of the body, especially on moist body surfaces such as the eyes, mouth, or any mucous membranes. Do not ingest.
The recommended dose is one application per day to the facial skin. Apply a pea-sized amount of cream to each of the five areas of the face: forehead, chin, nose, and each cheek.
Then, spread the cream as a thin layer over the entire face.
Make sure to avoid the eyelids, lips, and any mucous membranes such as the inside of the nose, mouth, and eyes. If the cream accidentally gets into the eyes, near the eyes, on the eyelids, lips, mouth, or mucous membranes, immediately rinse the area thoroughly with plenty of water.
Do not apply cosmetics (such as other facial creams or makeup) before the daily application of Efacti.
These products may be used after the applied cream has dried.
Wash your hands immediately after applying the cream.
You must use Efacti every day during treatment, and the treatment may be repeated. Your doctor will tell you how long you need to use Efacti. The duration of treatment may vary from person to person and depends on the severity of the skin condition.
You may notice an improvement after 4 weeks of treatment. If there is no improvement after 3 months, you must stop using Efacti and consult your doctor.
Hepatic impairment
If you have liver problems, consult your doctor before using Efacti.
Use in children and adolescents
Efacti must not be used in children and adolescents.
How to open the tube with child-resistant cap
To prevent leakage, do not squeeze the tube when opening or closing.
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 the cap clockwise (turn to the right).

If you use more Efacti than you should
If you use more than the recommended daily dose, contact your doctor, who will advise you on the necessary actions.
If you forget to use Efacti
Do not use a double dose to make up for the missed dose.
If you stop using Efacti
Pimples and pustules will only be reduced after several applications of this medicine. It is important that you continue using Efacti for the period prescribed by your doctor.
If you have any 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 gets them.
Efact may cause the following side effects:

Common side effects (may affect up to 1 in 10 people):

• Skin burning sensation

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

• Skin irritation
• Itching of the skin
• Dry skin
• Worsening of rosacea (consult your doctor)

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Skin redness
• Skin inflammation
• Facial swelling

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efacti

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 the tube, use the product within 6 months.
This medicine requires no special storage conditions.
Do not dispose of unused Efacti cream by flushing it down the drain or into household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Efacti contains

• 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 cetostearyl ether, sorbitan stearate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), phenoxyethanol, propylene glycol, oleyl alcohol, sodium hydroxide, purified water.

Description of the appearance of Efacti and contents of the pack
Efacti is a cream ranging in colour from white to pale yellow. It is supplied in tubes containing 2, 15, 30, 45 or 60 grams of cream. Larger packs have a child-resistant cap, while the 2 g tube does not.
Pack: 1 tube.
Not all pack sizes may be marketed.

This medicinal product is authorised in the European Economic Area 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 cream
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 ITALIA S.p.A.
Via dell’Annunciata 21, Milan, Italy

Manufacturer
Laboratoires Galderma
Z.I. Montdésir, 74450 Alby-sur-Chéran, France