Aklief 50 microgram/g cream

• 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.

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

• 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)

• 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 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 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.

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

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.

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

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.

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

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 in the evening, use it the next evening. Do not apply a double dose to make up for a forgotten dose.

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 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

or search for MHRA Yellow Card in the Google Play or Apple App Store.

• 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.

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

PL 10590/0071

Manufacturer