Aklief

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Aklief, 50 micrograms/g, cream

Trifarotene
▼ This medicinal product is subject to additional monitoring. This will allow for the quick
identification of new safety information. The user of the medicinal product can also help by
reporting any adverse reactions that occur after taking the medicinal product. To find out how to
report adverse reactions, see section 4.

You should carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicinal product has been prescribed specifically for you. Do not pass it on to others. The medicinal product may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Aklief and what is it used for
• 2. Important information before taking Aklief
• 3. How to take Aklief
• 4. Possible adverse reactions
• 5. How to store Aklief
• 6. Contents of the packaging and other information

1. What is Aklief and what is it used for

Aklief contains the active substance trifarotene, which belongs to the group of retinoids.
Aklief is used for the local treatment of common acne ( Acne vulgaris) of the face and (or)
trunk in patients aged 12 and older, in cases where there are numerous comedones (open and closed), papules and pustules (inflammatory).

2. Important information before taking Aklief

When not to take Aklief:

• if the patient is allergic to trifarotene or any of the other ingredients of this medicinal product (listed in section 6).
• in patients planning to become pregnant or who are pregnant (see subsection "Pregnancy and breastfeeding").

Warnings and precautions

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

• During treatment with Aklief, redness, flaking, dryness, and stinging or burning of the skin may occur (see section 4 "Possible adverse reactions"). If such symptoms occur, you should talk to your doctor. It is recommended to use a moisturizing preparation 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 preparation (if this has not been done before), less frequent application of the cream, or temporary discontinuation of treatment. If, despite these measures, the symptoms persist, your doctor may recommend complete discontinuation of the cream.
• Aklief should not be applied to cuts, abrasions, eczema, or sunburned skin. Page 1 5
• Aklief should be kept away from the eyes, eyelids, mouth, and mucous membranes. If the medicinal product accidentally gets into the eye, it should be rinsed immediately with a large amount of lukewarm water. Caution should be exercised when applying Aklief to sensitive areas of the skin, such as the neck or armpits.
• Care should be taken when using Aklief with other topical skin products and cosmetics (see section "Aklief and other medicinal products").
• Waxing (hair removal) should be avoided on skin treated with Aklief.
• If a reaction suggesting hypersensitivity to any of the ingredients occurs, treatment with Aklief should be discontinued.
• Aklief should not be applied to 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, it is recommended to use sun protection products with a sun protection factor (SPF) of at least 30 and protective clothing (such as a hat and shirt) on the treated areas of the skin. However, if the skin on the face, chest, arms, or back becomes sunburned, treatment with Aklief should be discontinued on the sunburned areas of the skin until the skin heals.

Aklief and other medicinal products

You should tell your doctor or pharmacist about all medicinal products you are currently taking or have recently taken, as well as any medicinal products you plan to take.
Care should be taken when using cosmetics or anti-acne medicinal products 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 breastfeeding

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 while taking Aklief, you should stop treatment and inform your doctor as soon as possible.
Breastfeeding
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, together with you, will decide whether to use the medicinal product or to breastfeed, taking into account the benefits of treatment for the mother and the benefits of breastfeeding for the child.
To avoid ingestion and exposure of the infant to the medicinal product, breastfeeding mothers should not apply the cream to the breast.

Driving and using machines

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

3. How to take Aklief

This medicinal product should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
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Important information:Aklief is intended for use only on the skin of the face and (or) trunk in patients aged 12 and older. This medicinal product should not be applied to other areas of the body. Do not swallow.
Aklief should be kept out of sight and reach of children.
Recommended dose

• Before the first use, the pump should be pressed several times (up to 10 times) until a small amount of cream appears. The prepared pump is then ready for use. A thin layer of Aklief 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 a day, in the evening, to clean and dry 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 per day.
• Care should be taken to avoid contact with the eyes, eyelids, mouth, and mucous membranes (e.g., inside the nose and mouth). If the medicinal product accidentally gets into these areas, they should be rinsed immediately with a large amount of lukewarm water.
• After applying the medicinal product, hands should be washed immediately.

From the start of treatment, depending on the individual needs of the patient, it is recommended to use a moisturizing preparation. The moisturizing preparation can be used before or after applying Aklief, allowing sufficient time for the skin to dry between applying Aklief and the moisturizing preparation.
Your doctor will inform you how long to take Aklief. After three months of treatment, your doctor will assess the improvement of acne.

Use in children

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

Use of a higher than recommended dose of Aklief

Using more of the medicinal product than recommended does not accelerate or improve the treatment result and may cause significant irritation, flaking, and redness of the skin. If a higher dose of Aklief than recommended is used, you should consult your doctor.
You should contact your doctor or the hospital emergency department immediately:

• if a child has accidentally used the medicinal product,
• if the patient or another person has accidentally swallowed the medicinal product. Your doctor will advise what to do next.

Missing a dose of Aklief

If you forget to apply Aklief in the evening, the next dose should be applied the following evening. A double dose should not be used to make up for a missed dose.

Discontinuing Aklief

Lesions (comedones, papules, and pustules) will decrease only after several applications of this medicinal product. It is important to continue using Aklief for as long as your doctor recommends.
If you have any further doubts about using this medicinal product, you should consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, this medicinal product can cause adverse reactions, although not everybody gets them.
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During treatment with Aklief, local reactions such as redness, flaking, dryness, and stinging or burning of the skin may frequently occur. For information on what to do if such symptoms occur, see section 2 "Warnings and precautions".
Aklief may cause the following adverse reactions:
Common adverse reactions (may affect up to 1 in 10 people):

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

Uncommon adverse reactions (may affect up to 1 in 100 people):

• Skin pain
• Dryness of the skin
• Depigmentation (loss of skin pigmentation)
• Erosion (skin erosion)
• Rash
• Edema
• Skin irritation
• Acne
• Allergic contact dermatitis (skin allergy)
• Redness (erythema).

Rare adverse reactions (may affect up to 1 in 1000 people):

• Urticaria
• Blisters
• Asteatotic eczema (dry skin with scales and cracks)
• Seborrhoeic dermatitis (red, flaky, and itchy skin)
• Burning sensation of the skin
• Cracking of the skin
• Hyperpigmentation (excessive skin pigmentation)
• Exfoliation of the eyelids (exfoliation of the eyelid skin) or edema (swelling of the eyelid skin)
• Chapped lips
• Redness of the skin of the face.

Reporting adverse reactions

If you experience any adverse reactions, including any adverse reactions not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, you can help provide more information on the safety of this medicinal product.

5. How to store Aklief

The medicinal product should be kept out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Shelf life after first opening the packaging: 6 months.
Medicinal products should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.
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6. Contents of the packaging and other information

What Aklief contains

• The active substance of Aklief 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), cyclomethicone, ethanol 96%, phenoxyethanol, propylene glycol, triglycerides of medium-chain fatty acids, purified water.

What Aklief looks like and contents of the packaging

Aklief is a white, homogeneous cream.
Pack size:
Aklief is available in a hermetically sealed multidose container with a pump, containing 75 g of cream, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Laboratorios Galderma SA – Sucursal em Portugal, Rua Afonso Praça nº30 – 7ºandar, 1495-061 Algés,
Portugal

Manufacturer:

Laboratoires Galderma, Z.I. Montdésir, 74540 Alby-sur-Chéran, France

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Portuguese marketing authorization number, country of export: 5789052

Parallel import authorization number: 174/23

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,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Spain, and Sweden: Aklief
Cyprus, Germany, Greece, and Italy: Selgamis

Date of revision of the leaflet: 28.08.2023

[Information about the trademark]
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