Aklief

Package Leaflet: Information for the Patient

Aklief, 50 micrograms/g, cream

Trifarotene
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. To learn how to report side effects, see section 4.

Read all of 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 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.

Contents of the pack

• 1. What is Aklief and what is it used for
• 2. Before you use Aklief
• 3. How to use Aklief
• 4. Possible side effects
• 5. How to store Aklief
• 6. Contents of the pack and other information

1. What is Aklief and what is it used for

Aklief contains the active substance trifarotene, which belongs to a group of medicines called retinoids.
Aklief is used for the topical treatment of acne vulgaris of the face and/or trunk in patients aged 12 years and older, in the presence of multiple open and closed comedones, papules and pustules (inflammatory).

2. Before you use Aklief

When not to use Aklief:

• if you are allergic to trifarotene or any of the other ingredients of this medicine (listed in section 6).
• in women who are planning to become pregnant or who are pregnant (see subsection “Pregnancy and breast-feeding”).

Warnings and precautions

Before starting treatment with Aklief, discuss it with your doctor or pharmacist.

• During treatment with Aklief cream, redness, scaling, dryness, and stinging or burning of the skin may occur (see section 4 “Possible side effects”). If such symptoms occur, you should talk to your doctor. It is recommended to use a moisturizing product from the start of treatment to prevent the occurrence of the above-mentioned reactions. If such symptoms occur, your doctor may recommend starting to use a moisturizing product (if not already done), using the cream less frequently, or

temporarily stopping treatment. If, despite these measures, the symptoms persist, your doctor may recommend completely stopping treatment with the cream.

• Aklief cream should not be used on cuts, scrapes, eczema, or sunburned skin.
• Contact with the eyes, eyelids, mouth, and mucous membranes should be avoided. If the product accidentally gets into the eye, it should be rinsed immediately with a large amount of lukewarm water. Caution should be exercised when applying the product to sensitive areas of the skin, such as the neck or armpits.
• Caution should be exercised when using Aklief cream concomitantly with other topical skin products or cosmetics (see section “Aklief and other medicines”).
• Wax epilation should be avoided on skin treated with Aklief cream.
• If a reaction suggesting hypersensitivity to any of the ingredients occurs, treatment with Aklief should be discontinued.
• Aklief should not be used on sunburned skin. During treatment, prolonged exposure to sunlight should be avoided, sunlamps should not be used, and phototherapy should not be used. If exposure to sunlight cannot be avoided, a sunscreen product with a Sun Protection Factor (SPF) of at least 30 and protective clothing (such as a hat and shirt) should be used on treated areas of skin. However, if the skin of the face, chest, arms, or back becomes sunburned, treatment with Aklief should be discontinued on the sunburned areas of skin until the skin has healed.

Aklief and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Caution should be exercised when using cosmetics or other anti-acne medicines with a drying, irritating, or exfoliating effect, as the irritating effect may be cumulative. If skin irritation occurs, you should contact your doctor.

Pregnancy and breast-feeding

Pregnancy
Aklief should not be used during pregnancy or when planning to become pregnant. More information can be obtained from your doctor.
If you become pregnant during treatment with Aklief, you should stop treatment and inform your doctor as soon as possible.
Breast-feeding
During treatment with Aklief, there is a risk that the active substance in the cream may pass into breast milk, and therefore, a risk to the newborn or infant cannot be excluded. Your doctor will decide together with you whether to use the medicine or to breast-feed, taking into account the benefit of treatment for the mother and the benefit of breast-feeding for the child.
To prevent ingestion and/or exposure of the infant to the medicine, breast-feeding mothers should not apply the cream to the breast.

Driving and using machines

Aklief has no or negligible influence on the ability to drive and use machines.
Aklief contains propylene glycol (E1520),which may cause skin irritation.
This medicine contains 50 mg of ethanol (alcohol) per gram, which is equivalent to 5% w/w. It may cause burning sensation on damaged skin.

3. How to use Aklief

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Important information:Aklief is for use on the skin only, on the face and/or trunk, in patients aged 12 years and older. Do not use this medicine on other areas of the body. Do not swallow.
Aklief should be kept out of the sight and reach of children.
Recommended dose

• Before first use, press the pump dispenser a few times (up to 10 times) until a small amount of cream appears. The pump is then ready for use. A thin layer of Aklief cream should be applied to the affected areas on the face (forehead, nose, chin, right and left cheek) and to the affected areas on the trunk, once daily, in the evening, to washed and dried skin:
• One (1) dose should be sufficient to cover the face (e.g., forehead, cheeks, nose, and chin).
• Two (2) doses should be sufficient to cover the upper part of the trunk (e.g., upper back, arms, and chest). One (1) additional dose may be used if acne also occurs in the middle and lower back areas.
• No more than four (4) doses should be used in a 24-hour period.
• Contact with the eyes, eyelids, mouth, and mucous membranes should be avoided (e.g., inside the nose and mouth). If the product accidentally gets into these areas, they should be rinsed immediately with a large amount of lukewarm water.
• After using the medicine, wash your hands immediately.

From the start of treatment, depending on individual patient needs, a moisturizing product may be used. The moisturizing product may be used before or after applying Aklief cream, allowing sufficient time for the skin to dry between application of Aklief cream and the moisturizing product.
Your doctor will tell you how long to use Aklief. After three months of treatment, your doctor will assess the improvement of acne.

Use in children

Aklief cream should not be used in children under 12 years of age.

Using more Aklief than you should

Using more medicine than prescribed will not make it work faster, but it may cause significant irritation, scaling, and redness of the skin. If you use more Aklief than you should, contact your doctor.
You should immediately contact your doctor or hospital casualty department:

• if a child has accidentally used the medicine,
• if you or someone else has accidentally swallowed the medicine. Your doctor will advise what to do.

Forgetting to use Aklief

If you forget to use Aklief in the evening, the next dose should be used the following evening. Do not use a double dose to make up for a forgotten dose.

Stopping treatment with Aklief

Pimples (blackheads, whiteheads, and inflammatory red patches) will decrease only after several applications of the medicine. It is important to continue using Aklief as long as your doctor recommends.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Aklief cream, local skin reactions such as redness, scaling, dryness, and stinging or burning of the skin may frequently occur. For information on how to manage such symptoms, see section 2 “Warnings and precautions”.
Aklief may cause the following side effects:

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

• Irritation at the application site, itching of the skin (pruritus), sunburn.

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

• Skin pain
• Dry skin
• Discoloration (loss of skin pigmentation)
• Erosion (skin ulceration)
• Rash
• Swelling
• Skin irritation
• Acne
• Allergic skin reaction (allergic contact dermatitis)
• Redness (erythema)

Rare side effects (may affect up to 1 in 1,000 people):

• Hives
• Blisters
• Asteatotic eczema (dry skin with scales and cracks)
• Seborrhoeic dermatitis (red, scaly, and itchy skin)
• Burning sensation of the skin
• Cracking of the skin
• Discoloration (excessive skin pigmentation)
• Exfoliation of the eyelids (exfoliation of the eyelid skin) or swelling (swelling of the eyelid skin)
• Dry mouth
• Redness of the skin of the face

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. Side effects can be reported to the national reporting system listed below:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aklief

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 blister pack after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicinal product.
Shelf-life after first opening: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Aklief contains

• The active substance is trifarotene. One gram of cream contains 50 micrograms of trifarotene.
• The other ingredients (excipients) are: allantoin, Simulgel 600 PHA (copolymer of acrylamide and sodium acryloyldimethyltaurine, isohexadecane, polysorbate 80, sorbitan oleate), cyclopentadimethylsiloxane, ethanol 96%, phenoxyethanol, propylene glycol, medium-chain triglycerides, purified water.

What Aklief looks like and contents of the pack

Aklief is a white, homogeneous cream.
Pack sizes:
Aklief is available in a 30 g or 75 g pump dispenser, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Galderma Poland Sp. z o.o.
Puławska 145
02-715 Warsaw
Poland
tel.: +48 22 331 21 80

Manufacturer:

Laboratoires Galderma
Z.I. Montdésir
74540 Alby-sur-Chéran
France
or
Galderma Laboratorium GmbH
Toulouser Allee 23a
40211 Düsseldorf
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, United Kingdom, and Sweden: Aklief

Cyprus, Germany, Greece, and Italy: Selgamis
Date of last revision of the leaflet:02/2022