Aklief

Trifarotene.

One gram of cream contains 50 micrograms of trifarotene.
Excipients/Inactive Ingredients: The other excipients are allantoin, Simulgel 600 PHA (copolymer of acrylamide and sodium acryloyldimethyltaurate, isohexadecane, polysorbate 80, sorbitan oleate), cyclomethicone, ethanol, phenoxyethanol, propylene glycol (E1520), triglycerides medium-chain and purified water.

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.

Always use this medicine exactly as told by the doctor. Check with the doctor or pharmacist if unsure.
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 the 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 the cream accidentally gets in any of these areas, wash them immediately with plenty of lukewarm water.
Wash hands immediately after applying the cream.
It is recommended to use a moisturizer as frequently as needed from the initiation of Aklief treatment. The moisturizer can either be applied before or after Aklief, allowing sufficient time to let the skin dry between the moisturizer and Aklief application.
The doctor will advise how long Aklief will need to be used. After three months of treatment, the doctor may need to assess the continued improvement of the acne.
Contact a doctor or hospital immediately: if this medicine has been accidentally used by a child; if this medicine is accidentally swallowed. The doctor will advise on what action needs to be taken.
Use in children: Aklief should not be used by children below 12 years of age.
Forgot to use Aklief: If Aklief is forgotten to be used in the evening, it should be used the next evening. Do not apply a double dose to make up for a forgotten dose.
Stopping Aklief use: The spots (whiteheads, blackheads and inflammatory pimples) will be reduced only after several applications of this medicine. It is important to continue using Aklief as long as prescribed by the doctor.
If there are any further questions on the use of this medicine, ask the doctor or pharmacist.

Using more Aklief will not get rid of the acne any quicker, but it may cause the skin to become irritated, scaly and red. Talk to the doctor if this happens.

Do not use Aklief: if pregnant or planning pregnancy (see Use in Pregnancy & Lactation); if allergic to trifarotene or any of the other ingredients of this medicine (listed in Description).

Redness, peeling, dryness, and stinging/burning may be experienced with the use of Aklief cream (see Side Effects). Talk to a doctor if these symptoms are experienced. It is recommended to apply a moisturizer from the initiation of treatment, which may help prevent such reactions. If symptoms do occur, the doctor may instruct to start using a moisturizer (if not already doing so), to use the cream less often, or to stop for a short time. If the symptoms persist despite these measures, it may be advised 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 accidentally enters the eye, wash immediately and abundantly with 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 Interactions).
"Waxing" should not be used 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 the face, chest, shoulders or back become sunburned, stop medication on the affected area until the skin is healed.
Aklief contains propylene glycol (E1520) which may cause skin irritation.
Driving and using machines: Aklief has no or negligible influence on the ability to drive and use machines.

Pregnancy: Do not use Aklief if pregnant or thinking of becoming pregnant. The doctor can provide more information.
If pregnancy is discovered 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 the cream passes into the breast milk and a risk to the newborn/infant cannot be excluded. A decision must be made 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.

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 Precautions for information on what to do if such symptoms are experienced.
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 any side effects are experienced, talk to the doctor or pharmacist. This includes any possible side effects not previously listed.

Tell the doctor if 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 the skin becomes irritated, contact the doctor.

Do not throw away unused Aklief cream via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

Store below 30°C. Discard the tube or pump 6 months after first opening.

Acne Treatment Preparations

D10AD06 - trifarotene ; Belongs to the class of topical retinoid preparations. Used in the treatment of acne.

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