Aklief

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Aklief,50 micrograms/g, cream
Trifarotenum
▼This medicinal product is subject to additional monitoring. This will allow for the quick
identification of new safety information. The medicine user can also help by reporting any adverse reactions that occur after taking the medicine. To find out how to report adverse reactions, see section 4.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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 or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Aklief and what is it 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 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 with multiple comedones (open and closed), papules and pustules (inflammatory).

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 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 the use of Aklief cream, redness, flaking, 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, the doctor may recommend starting to use a moisturizing product (if not already done), less frequent use of the cream, or temporary discontinuation of use. If, despite these measures, the symptoms persist, the doctor may recommend complete discontinuation of the cream.
• Aklief cream should not be used on wounds, scratches, abrasions, or skin eruptions.
• Contact with the eyes, eyelids, mouth, and mucous membranes should be avoided. If the medicine 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.
• Caution should be exercised when using Aklief cream with other topical skin medicines and cosmetics (see section "Aklief and other medicines").
• Waxing hair removal treatments should be avoided on skin treated with Aklief cream.
• If a reaction suggesting hypersensitivity to any of the ingredients occurs, the use of Aklief should be discontinued.
• Aklief should not be used on sunburned skin. During treatment, prolonged exposure to sunlight should be avoided, sunbeds 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, the use of the medicine should be discontinued on the sunburned areas of the skin until the skin heals.

Aklief and other medicines

The doctor or pharmacist should be informed about all medicines currently being used by the patient
or recently used, as well as any medicines the patient plans to use.
Caution should be exercised when using cosmetics or anti-acne medicines with a drying, irritating, or exfoliating effect, as the irritating effect may be cumulative. If skin irritation occurs, the doctor should be consulted.

Pregnancy and breastfeeding

Pregnancy
Aklief should not be used during pregnancy or when planning to become pregnant. More
information can be obtained from the doctor.
If pregnancy occurs during treatment with Aklief, treatment should be discontinued and the doctor informed as soon as possible.
Breastfeeding
During the use of Aklief, there is a risk that the active substance in the cream may pass into breast milk, and the risk to the newborn or infant cannot be excluded. The doctor, together with the patient, must decide whether to use the medicine or breastfeed, 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 breast.

Driving and using machines

Aklief has no influence or negligible influence on the ability to drive and use machines.
Aklief contains propylene glycol (E 1520),which may cause skin irritation.
This medicine also contains 50 mg of alcohol (ethanol)per gram, which is 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 doctor. In case of doubt, the doctor or pharmacist should be consulted.
Important information:Aklief is intended for use only on the skin of the face and (or)
trunk in patients aged 12 and older. This medicine should not be used on 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 dispenser 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 cream should be applied to the affected areas on the face (forehead, nose, chin, right and left cheek) and on the affected areas on the trunk, once daily, in the evening, on 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 per day.
• Contact with the eyes, eyelids, mouth, and mucous membranes (e.g., inside the nose and mouth) should be avoided. If the medicine accidentally gets into the above-mentioned areas of the body, they should be rinsed immediately with a large amount of lukewarm water.
• After using the medicine, 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 product. The moisturizing product can be used before or after applying Aklief cream, allowing sufficient time for the skin to dry between applying Aklief and the moisturizing product.
The doctor will inform the patient how long to use Aklief. After three months of treatment, the 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 than the recommended dose of Aklief

Using more medicine than recommended does not speed up or improve the treatment result and may cause significant irritation, flaking, and redness of the skin. If more than the recommended dose of Aklief is used, the doctor should be consulted.
The doctor or hospital emergency department should be contacted immediately:

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

Missing a dose of Aklief

If the patient forgets to use Aklief in the evening, the next dose should be used the following evening. A double dose should not be used to make up for a missed dose.

Stopping the use of Aklief

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

4. Possible side effects

Like all medicines, Aklief can cause side effects, although not everybody gets them.
During the use of Aklief cream, local reactions such as redness, flaking, dryness, and stinging or burning of the skin may frequently occur. For information on how to proceed in case of 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
• Depigmentation (loss of skin pigmentation)
• Erosion (skin erosion)
• Rash
• Edema
• Skin irritation
• Acne
• Allergic contact dermatitis (skin allergy)
• Flush (redness of the skin).

Rare side effects (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)
• Dry mouth
• Redness of the skin.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Aklief

The medicine should be kept out of sight and reach of children.
Do not use this medicine 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.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack 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 (E 1520), 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, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

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
4540 Alby-sur-Chéran
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Portugal, the country of export:5789052

Parallel import authorization number: 453/22

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, Latvia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Spain, and Sweden: Aklief.
Cyprus, Germany, Greece, and Italy: Selgamis.
Date of approval of the leaflet: 30.12.2022
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