Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Aklief, 50 micrograms/g, cream
Trifarotene
▼ This medicinal product will be subject to additional monitoring. This will allow for rapid
identification of new safety information. You can also help by reporting any adverse reactions that occur after using the medicine. For information on how to report adverse reactions – see section 4.
Please read this leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Aklief is and what it is used for
Important information before using Aklief
How to use Aklief
Possible side effects
How to store Aklief
Contents of the pack and other information

1. What Aklief is and what it is 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 facial and/or truncal acne vulgaris ( Acne vulgaris ) in patients aged 12 years and older, particularly when numerous comedones (open and closed), papules, and pustules (inflammatory lesions) are present.

2. Important information before using Aklief

When not to use Aklief:

if the patient is allergic to trifarotene or any of the other ingredients of this medicine (listed in section 6).
in female patients planning pregnancy or who are pregnant (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting treatment with Aklief, discuss this with your doctor or pharmacist.

During treatment with Aklief, redness, peeling, dryness, and stinging and/or burning of the skin may occur (see section 4, "Possible side effects"). If such symptoms occur, speak to your doctor. It is recommended to use a moisturizing product from the beginning of treatment to help prevent these reactions. If such symptoms occur, your doctor may recommend starting to use a moisturizer (if not already done), applying the cream less frequently, or temporarily stopping treatment. If symptoms persist despite these measures, your doctor may advise completely discontinuing use of the cream.
Do not apply Aklief to cuts, scrapes, abrasions, or irritated skin. Page 1 of 5
Avoid contact of Aklief with eyes, eyelids, lips, and mucous membranes. If the product accidentally gets into the eye, rinse immediately with plenty of lukewarm water. Exercise caution when applying Aklief to sensitive areas of skin such as the neck or armpits.
Exercise caution when using Aklief together with other topical skin medications or cosmetics (see section "Aklief and other medicines").
Avoid waxing procedures on skin treated with Aklief.
If a reaction suggesting hypersensitivity to any ingredient occurs, discontinue use of Aklief.
Aklief should not be applied to sunburned skin. During treatment, avoid prolonged exposure to sunlight, do not use sunbeds (tanning booths), and avoid phototherapy. If exposure to sunlight cannot be avoided, it is recommended to apply sunscreen products with a sun protection factor (SPF) of at least 30 and wear protective clothing (such as a hat and shirt) on treated areas. If the face, chest, arms, or back become sunburned, discontinue use of the medicine on the affected areas until the skin has healed.

Aklief and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Exercise caution when using Aklief together with cosmetics or anti-acne products that have exfoliating, irritating, or drying effects, as their irritating effects may be additive. If skin irritation occurs, contact your doctor.

Pregnancy and breastfeeding
Pregnancy
DO NOT use Aklief during pregnancy or if the patient is planning to become pregnant. For further information, consult your doctor.
If pregnancy occurs during treatment with Aklief, stop treatment immediately and inform your doctor as soon as possible.

Breastfeeding
When using Aklief, there is a risk that the active substance in the cream may pass into breast milk; therefore, a risk to the newborn and/or infant cannot be excluded.
The decision whether to use the medicine or to breastfeed must be made by the doctor together with the patient, taking into account the benefits of treatment for the mother and the benefits of breastfeeding for the child.
To prevent ingestion and/or exposure of the infant to the medicine, breastfeeding mothers should not apply the cream to the chest area.

Driving and operating machinery
Aklief has no effect or negligible effect on the ability to drive and operate machinery.

Aklief contains propylene glycol, which may cause skin irritation.
This medicine also contains 50 mg of alcohol (ethanol) per gram, equivalent to 5% w/w.
It may cause a burning sensation on damaged skin.

3. How to use Aklief

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Page 2 of 5
Important information: Aklief is intended for topical use 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 stored out of sight and reach of children.
Recommended dosage

Before first use, press the pump dispenser several times (up to 10 times) until a small amount of cream appears. The pump is then ready for use. A thin layer of Aklief should be applied to affected areas of the face (forehead, nose, chin, right and left cheek) and to affected areas of the trunk, once daily in the evening, onto 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 trunk (e.g. upper back, shoulders and chest). One (1) additional dose may be used if acne is also present in the middle and lower back areas.
- Do not use more than four (4) doses per day.
Avoid contact with eyes, eyelids, lips and mucous membranes (e.g. inside the nose and mouth). If the medicine accidentally gets into any of the above areas, immediately rinse thoroughly with large amounts of lukewarm water.
Hands should be washed immediately after applying the medicine.

Depending on individual patient needs, the use of a moisturizer is recommended starting from the beginning of treatment. The moisturizer may be applied before or after Aklief, ensuring adequate time for the skin to dry between applications of Aklief and the moisturizer.
Your doctor will inform you how long you should continue using Aklief. After three months of treatment, your doctor will assess improvement in acne.
Use in children
Aklief should not be used in children under 12 years of age.
Use of more than the recommended dose of Aklief
Using more than the recommended amount of Aklief does not speed up or improve treatment outcomes and may cause significant skin irritation, peeling and redness. If more than the recommended dose of Aklief has been used, consult your doctor.
Seek immediate medical advice from a doctor or hospital poison control center:

if a child has accidentally used the medicine,
if the patient or another person has accidentally swallowed the medicine. The doctor will advise on the necessary steps.

Missed dose of Aklief
If the patient forgets to apply Aklief in the evening, apply the next dose the following evening. Do not apply a double dose to make up for a missed dose.
Stopping Aklief
Lesions (comedones, papules and inflammatory pustules) will only begin to improve after several applications of this medicine. It is important to continue using Aklief for as long as directed by your doctor.
If you have any further 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.
Page 3 of 5
When using Aklief, reactions at the application site may commonly occur, such as redness, peeling, dryness, and stinging and/or burning of the skin. For information on how to manage such symptoms, see section 2 "Warnings and precautions".
The medicine Aklief may cause the following side effects:
Common side effects (may affect up to 1 in 10 people):

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

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

Skin pain
Dry skin
Depigmentation (loss of skin pigmentation)
Erosion (skin erosion)
Rash
Swelling
Skin irritation
Acne
Allergic dermatitis (skin allergy)
Erythema (redness).

Rare side effects (may affect up to 1 in 1000 people):

Urticaria (hives)
Vesicles (small blisters)
Asteatotic eczema (dry skin with scaling and cracks)
Seborrhoeic dermatitis (red, scaly, and itchy skin)
Sensation of skin burning
Skin cracking
Skin hyperpigmentation (excessive skin pigmentation)
Eyelid desquamation (peeling of eyelid skin) or swelling (eyelid skin swelling)
Chapped lips
Facial skin redness.

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting side effects helps 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 stated on the container. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Shelf life after first opening the container: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Page 4 of 5

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 acryloyldimethyltaurate, isohexadecane, polysorbate 80, sorbitan oleate), cyclomethicone, 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 size:
Aklief is available in a hermetically sealed multidose container with a pump, containing 75 g of cream,
packaged in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Portugal, the country of export: 5789052
Parallel import authorisation number: 174/23
This medicinal product is authorised for sale in the European Economic Area countries under the
following names:
Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Iceland, Ireland,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Spain and Sweden: Aklief
Cyprus, Germany, Greece and Italy: Selgamis
Page 5 of 5