Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Aklief 50 microgram/g cream
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Trifarotene may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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.
What you need to know before you take it
e Aklief Do not use Aklief: and If you are a woman planning pregnancy or if you are pregnant (see section you are allergic to trifarotene or any of the other ingredients of this in section 6) Warnings and Redness, peeling, dryness, and stinging/burning may be experienced with the use of Aklief cream (see section 4 "Possible side 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 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. enters the eye, wash immediately and Aklief should not come into contact with the eyes, eyelids, lips, or mucous membranes. If the product abundantly with luke warm 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 preparation used on the skin including cosmetics (see also section "Other medicines and You should not use as a depilatory method on skin treated with Aklief. 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 should be avoided during the treatment. Use (such as a hat and shirt) over treated areas is recommended when exposure of sunscreen with Sun Protection Factor (SPF) of at least 30 and protective 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 –
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Pregnan
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.
When using 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 doctor must make a decision whether to discontinue breast-feeding or to abstain from Aklief therapy, taking into account the benefit of breast-feeding or 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 no or negligible influence on the ability to drive and use machines. Aklief contains propylene glycol (E1520) which may cause skin irritation. This medicine also contains 50 mg alcohol (ethanol) in each gram which is equivalent to 5% w/w. It may cause burning sensation on damaged skin.
How to take it
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: forehead, cheeks, nose and chin). One (1) pump actuation should be enough to cover the face 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 ot luke warm water. Wash your hands immediately after applying the cream. 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.
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Galderma Laboratories
Printing Colors
Product code: P201159-1 Product description: AKLIEF CRE 75 Market: GBR Article: Leaflet Font size: 9,5 pt Flat size: 180×315 Fold size: 180×26,25 Pharmacode: 1593 LABORATOIRES GALDERMA
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Galderma
GALDERMA
DI E N ES
NOTICE VERSO 180×315 PLAN
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: 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.
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) (peeling of the eyelid or oedema (swelling of the eyelid skin)
skin)
Chapped
Flushing
lips
(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.
How to store it
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.
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 and sodium acryloyldimethyltaurate, isohexadecane, polysorbate 80, 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 tube 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 Montdésir 74540 Alby-sur-Chéran 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 08/2022 Detailed information on this medicine is available on the web site of: MHRA –
GALD E RMA
Galderma Laboratories
Printing Colors
Product code: Product description: AKLIEF CRE 75 Market: GBR Article: Leaflet Font size: 9,5 pt Flat size: Fold size: 180×26,25 Pharmacode: 1593 GRAPHIC DESIGNER: Guillaume ANDRE
INDUSTRIALIZATION DEPARTMENT LABORATOIRES GALDERMA
Galderma 74540 –
GALDERMA
ELI N ES
P201159-1
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Frequently asked questions about Aklief 50 microgram/g cream
How do I take Aklief 50 microgram/g cream?
Aklief 50 microgram/g cream comes as cream containing 50mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Aklief 50 microgram/g cream?
The active substance in Aklief 50 microgram/g cream is trifarotene.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Aklief 50 microgram/g cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Aklief 50 microgram/g cream without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: trifarotene
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Aklief is indicated 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, papules and pustules are present.
4.2. Posology and method of administration
Posology
Apply a thin layer of Aklief cream to the affected areas of the face and/or trunk once a day, in the evening, on clean and dry skin.
It is recommended that the physician assesses the continued improvement of the patient after three months of treatment.
Special populations
Elderly patients
The safety and efficacy of Aklief in geriatric patients aged 65 years and above have not been established.
Renal and hepatic impairment
Aklief has not been studied in patients with renal and hepatic impairment.
Paediatric population
The safety and efficacy of Aklief in children below 12 years old have not been established.
Method of administration
For cutaneous use only.
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 clean and dry skin:
- One pump actuation should be enough to cover the face (i.e. forehead, cheeks, nose, and chin).
- Two pump actuations should be enough to cover the upper trunk (i.e. reachable upper back, shoulders and chest). One additional pump actuation may be used for middle and lower back if acne is present.
Patients should be instructed to avoid contact with the eyes, eyelids, lips and mucous membranes and to wash their hands after applying the medicinal product.
The use of a moisturizer is recommended as needed from the initiation of treatment, while allowing sufficient time before and after the application of Aklief cream to allow the skin to dry.
4.3. Contraindications
• Pregnancy (see section 4.6)
• Women planning a pregnancy
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Erythema, scaling, dryness, and stinging/burning may be experienced with use of Aklief cream (see section 4.8). To mitigate the risk of such reactions, patients should be instructed to use a moisturizer from the initiation of treatment, and, if appropriate, reduce the frequency of application of Aklief cream, or suspend use temporarily. Despite mitigation measures, if severe reactions persist the treatment may be discontinued.
The product should not be applied to cuts, abrasions, eczematous or sunburned skin.
As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with Aklief.
If a reaction suggesting sensitivity to any component of the formula occurs, the use of Aklief should be discontinued. Caution should be exercised if cosmetics or acne medications with desquamative, irritant or drying effects are concomitantly used with the medicinal product, as they may produce additive irritant effects.
Aklief should not come into contact with the eyes, eyelids, lips, or mucous membranes. If the product enter the eye, wash immediately and abundantly with luke warm water.
Excessive exposure to sunlight, including sunlamps or phototherapy should be avoided during the treatment. Use of a broad-spectrum, water-resistant sunscreen with a Sun Protection Factor (SPF) of 30 or higher and protective clothing over treated areas is recommended when exposure cannot be avoided.
This product contains propylene glycol (E1520) that may cause skin irritation.
Aklief also contains 50 mg alcohol (ethanol) in each gram which is equivalent to 5% w/w. It may cause burning sensation on damaged skin.
4.5. Interaction with other medicinal products and other forms of interaction
Effect of Aklief cream on other medicinal products
A clinical drug-drug interaction study has shown that topical application of trifarotene did not affect the circulating concentrations of hormonal contraceptives (ethinyl estradiol and levonorgestrel) administered by oral route.
Effect of other medicinal products on Aklief cream
No clinical drug-drug interaction studies were performed to assess effects of other drugs on trifarotene systemic levels (see section 5.2).
There is no data on the pharmacodynamic interaction potential of trifarotene. Caution should be exercised if cosmetics or acne medications with desquamative, irritant or drying effects are concomitantly used with the medicinal product, as they may produce additive irritant effects (see section 4.4).
4.6. Fertility, pregnancy and lactation
Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Pregnancy
Aklief is contraindicated (see section 4.3) during pregnancy or in women planning a pregnancy.
Studies in animals with trifarotene by the oral route have shown reproductive toxicity at high systemic exposure (see section 5.3).
If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
Breast-feeding
It is unknown whether trifarotene or its metabolites are excreted in human milk.
Available pharmacodynamic/toxicological data in animals have shown excretion of Trifarotene/metabolites in milk (for details see 5.3).
A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Aklief therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
To avoid the risk of ingestion by, and/or contact exposure of, an infant, nursing women should not apply Trifarotene cream to the chest or breast area.
Fertility
No human fertility studies were conducted with Aklief.
No effects of trifarotene on fertility were found in rats in reproductive studies of oral administration. However, after oral administration to dogs, findings of Germ cell degeneration were observed, see section 5.3.
4.7. Effects on ability to drive and use machines
Aklief has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of safety profile
Local cutaneous reactions (such as erythema, scaling, dryness, and stinging/burning) were collected separately from other adverse events as a measure of local tolerance. These cutaneous reactions are very common and of mild, moderate and severe intensity for up to 39%, 29.7% and 6.2% of patients, respectively on the face. On the trunk, up to 32.9%, 18.9%, 5.2% of patients had mild, moderate and severe reactions respectively. The maximum severity typically occurred at Week 1 for the face, and at Week 2 to 4 for the trunk, and decreased with continued use of the medication (see section 4.4).
The most “commonly” reported adverse reactions as described below in Table 1 are application site irritation, application site pruritus and sunburn, occurring in 1.2% to 6.5% of patients treated with Aklief cream in clinical studies.
Tabulated summary of adverse reactions:
Adverse reactions reported in the 12-week vehicle-controlled Phase 3 studies in 1220 patients treated with Aklief cream (and for which the rate for Aklief cream exceeds the rate for vehicle cream) are presented in Table 1.
The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Table 1 Adverse reactions
System Organ Class
Frequency
Adverse reactions
General disorders and administration site conditions
Common
Application site irritation
Application site pruritus
Uncommon
Application site pain
Application site dryness
Application site discolouration
Application site erosion
Application site rash
Application site swelling
Rare
Application site erythema
Application site urticaria
Application site vesicles
Injury, poisoning and procedural complications
Common
Sunburn
Skin and subcutaneous tissue disorders
Uncommon
Skin irritation
Acne
Dermatitis allergic
Erythema
Rare
Eczema asteatotic
Seborrheic dermatitis
Skin burning sensation
Skin fissures
Skin hyperpigmentation
Eye disorders
Rare
Eyelid exfolliation
Eyelid oedema
Gastrointestinal disorders
Rare
Cheilitis
Vascular disorders
Rare
Flushing
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Aklief is for once-daily cutaneous use only.
If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur. In this event, discontinue use and wait until the skin has recovered.
In case of accidental ingestion, appropriate symptomatic measures should be taken. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- AKLIEF 50 micrograme/g prescriptionTRIFAROTEN · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- AkliefTrifarotenum
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Aklief 50 microgram/g cream. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.