AKLIEF

Package leaflet: Information for the user

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. Patients 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 the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Aklief is and what it is used for
2. Important information before using 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 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 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 to become pregnant or who are pregnant (see section "Pregnancy and breastfeeding").

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

• During use of Aklief cream, redness, peeling, dryness, and stinging and/or burning of the skin may occur (see section 4 "Possible side effects"). If such symptoms occur, talk to your doctor. Use of a moisturising product is recommended from the beginning of treatment to help prevent the occurrence of the above-mentioned reactions. If such symptoms occur, your doctor may recommend starting to use a moisturising product (if not already done), less frequent application of the cream, or

temporary discontinuation of use. If, despite these measures, symptoms
persist, your doctor may recommend completely stopping the use of the cream.

• Do not apply Aklief cream to cuts, scrapes, abrasions, or irritated skin.
• Avoid contact of Aklief with eyes, eyelids, mouth, and mucous membranes. If the medicine accidentally gets into the eye, immediately rinse thoroughly with plenty of lukewarm water. Exercise caution when applying Aklief to sensitive skin areas such as the neck or armpits.
• Exercise caution when using Aklief cream simultaneously with other topical skin medications and cosmetics (see section "Aklief and other medicines").
• Depilation using waxing methods should be avoided on skin being treated with Aklief cream.
• 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, and avoid phototherapy. If exposure to sunlight cannot be avoided, it is recommended to apply sunscreen products with a sun protection factor (SPF - Sun Protection Factor) of at least 30 and to wear protective clothing (such as a hat and shirt) on treated skin areas. If the skin on the face, chest, arms, or back becomes 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 cosmetics or anti-acne medications with exfoliating, irritating, or drying effects simultaneously with Aklief, as additive irritating effects may occur. If skin irritation occurs, contact your doctor.
Pregnancy and breastfeeding
Pregnancy
DO NOT use Aklief during pregnancy or if the patient plans to become pregnant. For more information, consult your treating physician.
If pregnancy occurs during treatment with Aklief, discontinue 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 has a negligible effect on the ability to drive vehicles and operate machinery.
Aklief contains propylene glycol (E1520), 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 as directed by the physician. If in doubt, consult a doctor or pharmacist.
Important information: Aklief is intended for topical use only on the facial skin and (or) trunk in patients aged 12 years and older. This medicine should not be used on other areas of the body. Do not swallow.
Aklief should be stored out of sight and reach of children.

Recommended dose

• Before first use, prime the pump by pressing it several times (up to 10 times) until a small amount of cream appears. Once primed, the pump is ready for use. Apply a thin layer of Aklief cream to the affected areas of the face (forehead, nose, chin, right and left cheeks) and/or affected areas of the trunk once daily in the evening , on clean, 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, mouth, and mucous membranes (e.g., inside the nose or oral cavity). If accidental contact occurs, immediately rinse the affected area 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 cream, ensuring adequate time for the skin to dry between applications of Aklief and the moisturizer.
Your doctor will advise you on how long to use Aklief. After three months of treatment, your doctor will assess improvement in acne.

Use in children
Aklief cream 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 dose will not speed up or improve treatment outcomes and may cause significant skin irritation, peeling, and redness. If an excessive dose of Aklief has been applied, consult a doctor.
Seek immediate medical advice from a doctor or a hospital poison control center:

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

Missed dose of Aklief
If the patient forgets to apply Aklief cream in the evening, apply the next dose the following evening. Do not apply a double dose to make up for the missed dose.

Stopping Aklief
Skin lesions (comedones, papules, and inflammatory pustules) will improve only after several applications of this medicine. It is important to continue using Aklief as long as directed by the physician.
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.
When using Aklief cream, local reactions at the application site may occur frequently, 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".
Aklief may cause the following side effects:

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

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

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

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

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

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

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can 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.: +48 22 49-21-301, fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the Marketing Authorisation Holder.
Reporting side effects helps provide more information on the safety of the 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 carton and the multi-dose pump container after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicinal product.
Period of use after first opening of 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. 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 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 sizes:
Aklief is available in a hermetically sealed multi-dose container with a pump, containing 30 g or 75 g of cream, packed in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Galderma Polska Sp. z o.o.
ul. Puławska 145
02-715 Warszawa
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 authorised 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, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, United Kingdom and Sweden: Aklief
Cyprus, Germany, Greece and Italy: Selgamis