Aklief 50 microgram/g cream – patient leaflet, side effects, dosage

1. What Akliefis and what it is used for

Aklief contains the active substance trifarotene that belongs to a group of medicines called retinoids.

Aklief is used for the cutaneous treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones (whiteheads and blackheads), papules and pustules (inflammatory pimples) are present.

1. 2. Whatyou need to know before you use Aklief

Do not use Aklief:

• If you are a woman planning pregnancy or ifyou are pregnant (see section "Pregnancy and breast-feeding")
• If you are allergic to trifarotene or any of the other ingredients ofthis medicine (listed in section 6)

Warnings and precautions

Redness, peeling, dryness, and stinging/burning may be experienced with the use of Aklief cream (see section 4 "Possible side effects"). Talk to a doctor if you experience these symptoms. You are recommended to apply a moisturizer from the initiation of treatment, which may help prevent such reactions. If symptoms do occur the doctor may instruct you to start using a moisturizer (if you have not already), to use the cream less often or to stop for a short time. Ifthe symptoms persist, despite these measures, you may be asked to stop the cream altogether.

Aklief should not be used on cuts, scrapes, abraded oreczematous skin.

Akliefshould not come into contact with the eyes, eyelids, lips, or mucous membranes. Ifthe product accidentaly enters the eye, wash immediately and abundantly with luke warm water. Be careful when applying to sensitive areas ofthe skin such as the neck or armpits.

Caution should be exercised when Aklief cream is applied at the same time as other preparations used on the skin including cosmetics (see also section "Other medicines and Aklief").

You should not use "waxing" as a depilatory method on skin treated with Aklief.

If a reaction suggesting sensitivity to any component ofthe formula occurs, the use of Akliefshould be discontinued.

Akliefshould not be used onsunburned skin. Excessive exposuretosunlight, including sunlamps orphototherapyshould beavoided during thetreatment. Use ofsunscreen with Sun Protection Factor (SPF) ofat least 30 and protective clothing (such as a hat and ashirt) overtreated areas is recommendedwhen exposure cannot be avoided. If neverthelessyour face, chest, shouldersor back become sunburned, stop medication on the affected area until your skin is healed. Other medicines and Aklief

Tell your doctor ifyou are using, have recently used or might use any other medicines.

Caution should be exercised if cosmetics or acne medications with peeling, irritant or drying effects are used, as they may produce additive irritant effects with the medicinal product. Ifyour skin becomes irritated, contactyour doctor.

Pregnancy and breast-feeding

Pregnancy

DO NOT use Aklief ifyou are pregnant or thinking of becoming pregnant. Yourdoctor can give you more information.

If you discover you are pregnant during treatment, stop application of this medicine and consult a doctor immediately.

Breast-feeding

When using Akliefthere is a risk that the active substance in cream passes into your breast milk and a risk to the newborn/infant cannot be excluded. You and your doctor must make a decision whether to discontinue breast-feeding orto abstain from Aklieftherapy, taking into account the benefit of breast-feeding for the child and the benefit oftherapy for the mother.

To avoid the risk ofingestion by, and/or contact exposure of, an infant, nursing women should not apply Akliefto the chestor breast area. Driving and using machines

Aklief has no or negligible influence on the ability to drive and use machines.

Aklief contains propylene glycol (E1520), alcohol (ethanol) and polysorbate 80 (E433).

Propylene glycol (E1520) may cause skin irritation.

Polysorbates can cause allergic reactions.

This medicine contains 50 mg alcohol (ethanol) in each gram which is equivalent to 5% w/w. It may cause burning sensation on damaged skin.

1. 3. How to use Aklief

Always use this medicine exactly as your doctor has told you. Checkwith your doctor or pharmacist ifyou are not sure.

Important Aklief is intended for patients from 12 years of age and older only for use on the skin ofthe face and/or the trunk. Do not use this medicine on any other

now use ANICI

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist ifyou are not sure.

Important Aklief is intended for patients from 12 years of age and older only for use on the skin of the face and/or the trunk. Do not use this medicine on any other parts ofyour body. Do not swallow.

Keep Aklief away from children.

Method of administration

Before using the pump for the firsttime, prime it by pressing down several times until a small amount of medicine isdispensed (up to 10 times maximum). The pump is now ready to use. Apply a thin layer of Akliefcream to the affected areas ofthe face (forehead, nose, chin and right and left cheeks) and all affected areas ofthe trunk once a day, in the evening, on a clean and dry skin:

• One (1) pump actuation should be enough to cover the face (i.e. forehead, cheeks, nose and chin).
• Two (2) pump actuations should be enough to coverthe upper trunk (i.e. reachable upper back, shoulders and chest). One (1) additional pump actuation may be used for middle and lower back if acne is present.
• More than four (4) pump actuations in one day is not recommended.

Avoid contact with the eyes, eyelids, lips and mucous membranes such as inside the nose or the mouth. If you accidentally get cream in any of these areas wash them immediately with plenty of luke warm water.

Wash your hands immediately after applying the cream.

Dieline Number/Format: MT.09.DRA.0352.R03.2 Dimensions: 180X315 MM

PrintProcess: N/A

PrintSpec: N/A

AWDescription: AKLIEF CRE 75

Regulatoryminimumtextfontheight: 9 pt/2.292 mm

Service Order: 404502952 Date: 13-06-2026

Operator: AL

Barcode: N/A

Mag: N/A

BWR: N/A

Braille: N/A

Translation: N/A

Version No:

GALDERMA NOTICE RECTO 180x315

PLAN n° MT.09.DRA.0352.R03.2

AKLIEF®

Aklief 50 microgram/g cream

trifarotene

Ill Ill

Package leaflet: Information for the patient

Aklief 50 microgram/g cream

trifarotene

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. -If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet

1. 1. What Aklief is and what it is used for
2. 2. What you need to know before you use Aklief
3. 3. How to use Aklief
4. 4. Possible side effects
5. 5. How to store Aklief
6. 6. Contents of the pack and other information
7. 1. What Aklief is and what it is used for

Aklief contains the active substance trifarotene that belongs to a group of medicines called retinoids.

Aklief is used for the cutaneous treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones (whiteheads and blackheads), papules and pustules (inflammatory pimples) are present.

2. What you need to know before you use Aklief

Do not use Aklief:

-If you are a woman planning pregnancy or if you are pregnant (see section "Pregnancy and breast-feeding")

-If you are allergic to trifarotene or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

• Redness, peeling, dryness, and stinging/burning may be experienced with the use of Aklief cream (see section 4 "Possible side effects"). Talk to a doctor if you experience these symptoms. You are recommended to apply a moisturizer from the initiation of treatment, which may help prevent such reactions. If symptoms do occur the doctor may instruct you to start using a moisturizer (if you have not already), to use the cream less often or to stop for a short time. If the symptoms persist, despite these measures, you may be asked to stop the cream altogether.
• Aklief should not be used on cuts, scrapes, abraded or eczematous skin.
• Aklief should not come into contact with the eyes, eyelids, lips, or mucous membranes. If the product accidentaly enters the eye, wash immediately and abundantly with lukewarm water. Be careful when applying to sensitive areas of the skin such as the neck or armpits.
• Caution should be exercised when Aklief cream is applied at the same time as other preparations used on the skin including cosmetics (see also section "Other medicines and Aklief").
• You should not use "waxing" as a depilatory method on skin treated with Aklief.
• If a reaction suggesting sensitivity to any component of the formula occurs, the use of Aklief should be discontinued.
• Aklief should not be used on sunburned skin. Excessive exposure to sunlight, including sunlamps or phototherapy should be avoided during the treatment. Use of sunscreen with Sun Protection Factor (SPF) of at least 30 and protective clothing (such as a hat and a shirt) over treated areas is recommended when exposure cannot be avoided. If nevertheless your face, chest, shoulders or back become sunburned, stop medication on the affected area until your skin is healed. Other medicines and Aklief

Tell your doctor if you are using, have recently used or might use any other medicines.

Caution should be exercised if cosmetics or acne medications with peeling, irritant or drying effects are used, as they may produce additive irritant effects with the medicinal product. If your skin becomes irritated, contact your doctor.

Pregnancy and breast-feeding

Pregnancy

DO NOT use Aklief if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information.

If you discover you are pregnant during treatment, stop application of this medicine and consult a doctor immediately.

Breast-feeding

When using Aklief there is a risk that the active substance in cream passes into your breast milk and a risk to the newborn/infant cannot be excluded. You and your doctor must make a decision whether to discontinue breast-feeding or to abstain from Aklief therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.

To avoid the risk of ingestion by, and/or contact exposure of, an infant, nursing women should not apply Aklief to the chest or breast area. Driving and using machines

Aklief has no or negligible influence on the ability to drive and use machines.

Aklief contains propylene glycol (E1520), alcohol (ethanol) and polysorbate 80 (E433).

Propylene glycol (E1520) may cause skin irritation.

Polysorbates can cause allergic reactions.

This medicine contains 50 mg alcohol (ethanol) in each gram which is equivalent to 5% w/w. It may cause burning sensation on damaged skin.

3. How to use Aklief

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Important: Aklief is intended for patients from 12 years of age and older only for use on the skin of the face and/or the trunk. Do not use this medicine on any other parts of your body. Do not swallow.

Keep Aklief away from children.

Method of administration

• Before using the pump for the first time, prime it by pressing down several times until a small amount of medicine is dispensed (up to 10 times maximum). The pump is now ready to use. Apply a thin layer of Aklief cream to the affected areas of the face (forehead, nose, chin and right and left cheeks) and all affected areas of the trunk once a day, in the evening, on a clean and dry skin:

  -One (1) pump actuation should be enough to cover the face (i.e. forehead, cheeks, nose and chin).

  -Two (2) pump actuations should be enough to cover the upper trunk (i.e. reachable upper back, shoulders and chest). One (1) additional pump actuation may be used for middle and lower back if acne is present.

  -More than four (4) pump actuations in one day is not recommended.

• Avoid contact with the eyes, eyelids, lips and mucous membranes such as inside the nose or the mouth. If you accidentally get cream in any of these areas wash them immediately with plenty of lukewarm water.

• Wash your hands immediately after applying the cream.

  AW Description: AKLIEF CRE 75

  Regulatoryminimumtextfontheight: 9 pt I 2.292 mm

  Dieline Number/Format: MT.09.DRA.0352.R03.2 Dimensions: 180X315 MM

  Print Process: N/A

  Print Spec: N/A

  Service Order: 404502952 Date: 13-06-2026

  Operator: AL

  Barcode: N/A

  Mag: N/A

  BWR:N/A

  Braille: N/A

  Translation: NIA

  Version No:

  GALDERMA I Sg<' NOTICE VERSO 180x315

PLAN n°

You are recommended to use a moisturizer asfrequently as needed fromthe initiation oftheAklieftreatment.The moisturizercan either be applied beforeor after Aklief, allowing sufficient time to letthe skin to dry between the moisturizer and Akliefapplication.

Your doctorwill tell you howlongyouwill needto useAklief.Afterthree monthsoftreatmentyourdoctormay needtoassessthe continued improvementofyouracne. Use in children

Akliefshould not be used by children below 12 years ofage.

Ifyou use more Akliefthan you should

Ifyou use more Akliefthanyou should onyourskin, youwill notgetrid ofyour acne anyquicker, butyourskin may becomeirritated, scaly and red. Talkto the doctor ifyou have used more Akliefthan you should.

Contact a doctor orthe national poison centre immediately if:

• a child has accidentally used this medicine
• you orsomeone else accidentally swallow this medicine.

Your doctor will adviseyou on what action needs to be taken.

Ifyou forget to use Aklief

Ifyou forget to use Aklief in the evening, use itthe next evening. Do not apply a double dose to make upfor a forgotten dose. Ifyou stop using Aklief

The spots (whiteheads,blackheads and inflammatory pimples) will be reduced only afterseveral applications ofthis medicine. It is important thatyou continue using Aklief as long as prescribed by your doctor.

Ifyou have any further questions on the use ofthis medicine, askyour doctor or pharmacist.

4. Possible side effects

I all medicines this medicine can cause side effects ^although not ^{everybody gets} them

1. 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Application site reactions such as redness, peeling, dryness, and stinging/burning of the skin may often be experienced with the use of Aklief cream. See section 2 "Warnings and precautions" for information on what to do ifyou experience such symptoms.

Aklief may cause the following side effects:

Common side effect (mayaffectup to 1 in 10people):

Application site irritation, pruritus (itch), sunburn.

Uncommon side effect(mayaffect up to 1 in 100people):

Pain ofthe skin

Dry skin

Discolouration (loss ofskin pigmentation)

Erosion (skin loss)

Rash

Swelling

Skin irritation

Acne

Dermatitis allergic (skin allergy)

Erythema (redness)

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

Urticaria (hives)

Vesicles

Eczema "asteatotic" (dry skin with scales and fissures)

Seborrheic dermatitis (red, scaly and itchy skin)

Skin burning sensation

Skin fissures

Skin hyperpigmentation (darkening ofskin pigmentation)

Skin hyperpigmentation (darkening ofskin pigmentation)

Eyelid exfoliation (peeling ofthe eyelid skin) oroedema (swelling ofthe eyelid skin)

Eyena extollation (peeling the eyena SKIN) or oedema (swelling the eyena SKIN)

Chapped lips

Flushing (red face)

Reporting ofside effects

Ifyou get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety ofthis medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcar orsearch for MHRAYellow Card in the Google Play or Apple App Store.

5. How to store Aklief

Keep this medicine out ofthe sight and reach ofchildren.

Do not usethis medicine afterthe expiry date which isstated on the carton and tube/pump after EXP. The expiry date refersto the last dayofthat month. Discard the tube or pump 6 months after first opening.

This medicinal product does not require any special storage condition.

Do not throw away unused Aklief cream via wastewater or household waste. Askyour pharmacist howto throw away medicinesyou no longer use. These measures will help protect the environment.

1. 6. Contents ofthe packand other information

What Aklief contains

• The active substance is trifarotene, one gram ofcream contains 50 micrograms oftrifarotene.
• The other excipients are allantoin, Simulgel 600 PHA (copolymer of acrylamide and sodium acryloyldimethyltaurate, isohexadecane, polysorbate 80 (E433), sorbitan oleate), cyclomethicone, ethanol, phenoxyethanol, propylene glycol (E1520), triglycerides medium-chain and purified water. WhatAklieflooks like and contents ofthe pack

Aklief is a white and homogenous cream.

Aklief is available in tubes containing 5 grams of cream or pump of 15, 30 or 75 grams ofcream.

Pack sizes of 1 tube or 1 pump.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Galderma (UK) Ltd

Evergreen House North

Grafton Place

London

NW1 2DX

United Kingdom

PL 10590/0071

Manufacturer

Manufacturer

Laboratoires Galderma

Z.I. Montdésir

74540 Alby-sur-Chéran

France

This medicinal product is authorised in the MemberStates ofthe EEA underthefollowing names:

Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, Finland, France, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, United Kingdom (Northern Ireland)and Sweden: Aklief

Cyprus, Germany, Greece and Italy: Selgamis

This leafletwas lastrevised in ^June 2026

Detailed information on this medicine is available on the web site of: MHRA GALDERMA

DielineNumber/Format: MT.09.DRA.0352.R03.2 Dimensions: 180X315 MM

PrintProcess: N/A

PrintSpec: N/A

AW Description: AKLIEF CRE 75

Regulatoryminimumtextfontheight: 9 pt/2.292 mm

Service Order: 404502952 Date: 13-06-2026

Operator: AL

Barcode: N/A

Mag:N/A

BWR:N/A

Braille:N/A

Translation: N/A

Version No:

GALDERMA NOTICE VERSO 180x315

PLAN n° MT.09.DRA.0352.R03.2

You are recommended to use a moisturizer as frequently as needed from the initiation of the Aklief treatment. The moisturizer can either be applied before or after Aklief, allowing sufficient time to let the skin to dry between the moisturizer and Aklief application.

Your doctor will tell you how long you will need to use Aklief. After three months of treatment your doctor may need to assess the continued improvement of your acne. Use in children

Aklief should not be used by children below 12 years of age.

If you use more Aklief than you should

If you use more Aklief than you should on your skin, you will not get rid of your acne any quicker, but your skin may become irritated, scaly and red. Talk to the doctor if you have used more Aklief than you should.

Contact a doctor or the national poison centre immediately if:

-a child has accidentally used this medicine

-you or someone else accidentally swallow this medicine.

Your doctor will advise you on what action needs to be taken.

If you forget to use Aklief

If you forget to use Aklief in the evening, use it the next evening. Do not apply a double dose to make up for a forgotten dose. If you stop using Aklief

The spots (whiteheads.blackheads and inflammatory pimples) will be reduced only after several applications of this medicine. It is important that you continue using Aklief as long as prescribed by your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

1. 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Application site reactions such as redness, peeling, dryness, and stinging/burning of the skin may often be experienced with the use of Aklief cream. See section 2 "Warnings and precautions" for information on what to do if you experience such symptoms.

Aklief may cause the following side effects:

Common side effect (may affect up to 1 in 10 people):

• Application site irritation, pruritus (itch), sunburn.

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

• Pain of the skin
• Dry skin
• Discolouration (loss of skin pigmentation)
• Erosion (skin loss)
• Rash
• Swelling
• Skin irritation
• Acne
• Dermatitis allergic (skin allergy)
• Erythema (redness)

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

• Urticaria (hives)
• Vesicles
• Eczema "asteatotic" (dry skin with scales and fissures)
• Seborrheic dermatitis (red, scaly and itchy skin)
• Skin burning sensation
• Skin fissures
• Skin hyperpigmentation (darkening of skin pigmentation)
• Eyelid exfoliation (peeling of the eyelid skin) or oedema (swelling of the eyelid skin)
• Chapped lips
• Flushing (red face)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

1. 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 which is stated on the carton and tube/pump after EXP. The expiry date refers to the last day of that month. Discard the tube or pump 6 months after first opening.

This medicinal product does not require any special storage condition.

Do not throw away unused Aklief cream via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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 excipients are allantoin, Simulgel 600 PHA (copolymer of acrylamide and sodium acryloyldimethyltaurate, isohexadecane, polysorbate 80 (E433), sorbitan oleate), cyclomethicone, ethanol, phenoxyethanol, propylene glycol (E1520), triglycerides medium-chain and purified water. What Aklief looks like and contents of the pack

Aklief is a white and homogenous cream.

Aklief is available in tubes containing 5 grams of cream or pump of 15, 30 or 75 grams of cream.

Pack sizes of 1 tube or 1 pump.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Galderma (UK) Ltd

Evergreen House North

Grafton Place

London

NW1 2DX

United Kingdom

PL 10590/0071

Manufacturer

Laboratoires Galderma

Z.I. Montdesir

74540 Alby-sur-Cheran

France

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, Finland, France, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, United Kingdom (Northern Ireland) and Sweden: Aklief

Cyprus, Germany, Greece and Italy: Selgamis

This leaflet was last revised in June 2026

Detailed information on this medicine is available on the web site of: MHRA

AW Description: AKLIEF CRE 75

Regulatoryminimumtextfontheight: 9 pt I 2.292 mm

Dieline Number/Format: MT.09.DRA.0352.R03.2 Dimensions: 180X315 MM

Print Process: N/A

Print Spec: N/A

Service Order: 404502952 Date: 13-06-2026

Operator: AL

Barcode: N/A

Mag: N/A

BWR:N/A

Braille: N/A

Translation: NIA

GALO ERMA

Version No:

GALDERMA I Sg<'