Package leaflet: Information for the patient

Warning! Keep the leaflet! 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 rapid identification of new safety information. You can also help by reporting any side effects you experience after taking the medicine. For information on how to report side effects – 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 give it to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. 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 in patients aged 12 years and older, when numerous open and closed comedones, 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 Aklief, discuss this with your doctor or pharmacist.

During treatment with 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, speak to your doctor. Use of a moisturizer is recommended from the beginning of treatment to help prevent the above-mentioned reactions. If these symptoms occur, your doctor may recommend starting to use a moisturizer (if not already used), applying the cream less frequently, or temporarily discontinuing treatment. If symptoms persist despite these measures, your doctor may recommend completely stopping the use of the cream.
Do not apply Aklief cream to cuts, abrasions, scrapes, or irritated skin.
Avoid contact of Aklief with eyes, eyelids, lips, and mucous membranes. If the medicine 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 cream concurrently with other topical skin medications and cosmetics (see section “Aklief with other medicines”).
Avoid wax depilation on skin areas being treated with Aklief cream.
If a reaction suggesting hypersensitivity to any of the ingredients 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 sun exposure cannot be avoided, it is recommended to use sunscreen products with a sun protection factor (SPF) of at least 30 and protective clothing (such as a hat and shirt) on treated skin 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 with 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 cream 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
Aklief MUST NOT be used during pregnancy or if the patient is planning to become pregnant. For further information, consult your doctor.
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 should 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 (E 1520), 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 doctor. If in doubt, consult a doctor or pharmacist.
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. Once prepared in this way, the pump is ready for use. Apply a thin layer of Aklief cream to affected areas of the face (forehead, nose, chin, right and left cheek) and/or affected areas of the trunk once daily in the evening , on 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, shoulders, and chest). One (1) additional dose may be used if acne also affects the middle and lower back.
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 mouth). If the medicine accidentally comes into contact with any of these areas, immediately rinse thoroughly with large amounts of lukewarm water.
Hands should be washed immediately after applying the medicine.

Depending on individual patient needs, use of a moisturizer is recommended starting from the beginning of treatment. The moisturizer may be applied before or after Aklief cream, provided sufficient time is allowed for the skin to dry between application 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
Do not use Aklief cream in children under 12 years of age.

Use of more than the recommended dose of Aklief
Using more than the recommended dose of Aklief will not speed up or improve treatment outcomes and may cause significant skin irritation, peeling, and redness. If more than the recommended dose has been used, consult a doctor.
Seek immediate medical advice from a doctor or hospital poison control unit:

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 next steps.

Missed dose of Aklief
If the patient forgets to apply Aklief cream in the evening, the next dose should be applied 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 the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
During the use of Aklief cream, local 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".

Medicine Aklief may cause the following adverse reactions:

Common adverse reactions (may occur in up to 1 in 10 people):

Application site irritation, itching (pruritus), sunburn.

Uncommon adverse reactions (may occur in 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 adverse reactions (may occur in up to 1 in 1000 people):

Urticaria
Vesicles
Asteatotic eczema (dry skin with scaling and cracks)
Seborrheic dermatitis (red, flaky, and itchy skin)
Burning sensation of the skin
Skin fissures
Hyperpigmentation (excessive skin pigmentation)
Eyelid desquamation (peeling of eyelid skin) or edema (swelling of eyelid skin)
Chapped lips
Facial erythema (redness of the facial skin).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to 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 packaging. The expiry date refers to the last day of the stated month.
No special storage instructions are required.
Shelf-life after first opening the container: 6 months.
Medicines must 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.

6. Contents of the package 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 (acrylamide/sodium acryloyldimethyltaurate copolymer, 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 multi-dose hermetically sealed container with a pump, containing 75 g of cream, packed 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
4540 Alby-sur-Chéran
France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Portugal, the country of export: 5789052
Parallel import authorisation number: 453/22
This medicinal product is authorised for sale in the European Economic Area member states 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.