EFACTI 10 mg /G Крем

Содержание инструкции

1. Efacti 10 mg/g cream
   1. What is Efacti and what is it used for
   2. What you need to know before you use Efacti
   3. How to use Efacti
   4. Possible side effects
   5. How to store Efacti
   6. Contents of the pack and other information

Efacti 10 mg/g cream

ivermectin

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Efacti and what is it 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 boils present in cases of rosacea.
Efacti should only be used in adults (from 18 years of age onwards).

2. What you need to know before you use Efacti

Do not use Efacti:

• 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 Efacti.
At the beginning of treatment, some patients may experience a worsening of rosacea symptoms,
however this is uncommon and usually resolves within 1 week of treatment. See your doctor
if this happens.

Other medicines and Efacti
Other medicines may have an effect on Efacti, so tell your doctor if you are taking, have recently
taken or might take any other medicines.

Pregnancy and breastfeeding
Efacti is not recommended during pregnancy.
If you are breastfeeding, you should not use this medicine or, alternatively, you should 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 and operate machines.

Efacti contains:

• Cetyl alcoholand stearyl alcoholwhich can cause local skin reactions (e.g. contact dermatitis),
• Methyl parahydroxybenzoate (E218)and propyl parahydroxybenzoate (E216)which can cause allergic reactions (including delayed reactions),
• Propylene glycolwhich can cause skin irritation.

3. How to use Efacti

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or
pharmacist.

Important:Efacti is intended for adults and for use on the skin of the face only. Do not use this medicine on
other parts of the body, especially on moist body surfaces, such as the eyes, mouth or on any
mucous membrane. Do not ingest.
The recommended dose is one application per day, to the skin of the face. Apply an amount of cream equal to
the size of a pea to each of the five areas of the face: forehead, chin, nose and each of the cheeks.
Then, spread the cream in a thin layer over the entire face.
Make sure to avoid the eyelids, lips and any mucous membrane 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, wash the area immediately with plenty of water.
Do not apply cosmetics (such as other face creams or makeup) before the daily application of Efacti.
These products can 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 can be repeated. The doctor will tell you for
how long it will be necessary 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 after 3 months there is no
improvement, you should stop 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 by children and adolescents.

How to open the tube with a child-resistant cap
To avoid leakage, do not squeeze the tube while opening or closing.
Push the cap down and turn it counterclockwise (turn to the left). Then remove the cap.

How to close the tube with a child-resistant cap
Push down and turn 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 what action to take.

If you forget to use Efacti
Do not use a double dose to make up for a missed dose.

If you stop using Efacti
Pimples and boils will only be reduced after a few applications of this medicine. It is important that you
continue to use Efacti for the period prescribed by your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Efacti 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
• Skin itching
• Dry skin
• Worsening of rosacea (consult your doctor) Side effects with unknown frequency (frequency cannot be estimated based on available data):
• Skin redness
• Skin inflammation
• Facial swelling

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the 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 does not require any particular storage conditions.
Do not dispose of unused Efacti cream via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Efacti contains

• The active ingredient is ivermectin. One gram of cream contains 10 mg of ivermectin.
• The other ingredients are glycerol, isopropyl palmitate, carbomer, dimethicone, disodium edetate, citric acid monohydrate, cetyl alcohol, stearyl alcohol, cetostearyl macrogol ether, sorbitan stearate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), phenoxyethanol, propylene glycol, oleyl alcohol, sodium hydroxide, purified water

Description 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 it is not present for the 2 g tube.
Pack of 1 tube.
Not all pack sizes may be marketed.

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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: Soolantra10 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 ITALIA S.p.A.
via dell’Annunciata 21, Milano

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