AKLIEF 50 micrograms/g cream

Introduction

PATIENT INFORMATION LEAFLET

Patient Information Leaflet: Information for the Patient

Aklief 50 micrograms/g cream

trifarotene

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

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.

Contents of the pack

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

1. What is Aklief and what is it used for

Aklief contains the active substance trifarotene, which belongs to a group of medicines known as retinoids.

This medicine is used for the cutaneous treatment of acne vulgaris on the face, chest and/or back in patients over 12 years of age, when they have many comedones (blackheads and whiteheads), numerous papules and pustules (inflamed spots).

2. What you need to know before you use Aklief

Do not use Aklief:

• If you are planning to become pregnant or if you are pregnant (see section Pregnancy and breast-feeding)

Warnings and precautions

• You may experience redness, flaking, dryness and burning/stinging with the use of Aklief cream (see section 4 "Possible side effects"). Consult your doctor if you experience these symptoms. Your doctor may recommend applying a moisturizer from the start of treatment that may help prevent such reactions. If symptoms appear, your doctor may advise you to use a moisturizer (if you have not already done so), to use the cream less frequently or to stop using it for a short period of time. If the symptoms persist despite these measures, your doctor may advise you to stop using it altogether.
• Aklief should not be used on areas where you have cuts, scratches, abrasions or eczema.
• Aklief should not come into contact with the eyes, eyelids, lips or mucous membranes. If the product accidentally gets into the eye, rinse immediately with plenty of warm water. Be careful when applying it to sensitive areas of the skin such as the neck or armpits.

• Caution should be exercised when applying Aklief cream at the same time as other products, including cosmetics (see section Other medicines and Aklief).
• Wax depilation should not be used as a hair removal 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 skin with sunburn. Excessive exposure to the sun, including sunlamps or phototherapy, should be avoided during treatment. The use of a sunscreen with a sun protection factor (SPF) of 30 or higher and protective clothing (such as a hat and shirt) over treated areas is recommended when sun exposure cannot be avoided. If, despite this, your face, chest, shoulders or back become sunburned, stop applying the medicine to the affected area until the skin has healed.

Other medicines and Aklief

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

Avoid using this medicine at the same time as cosmetics or acne medicines that are irritating, drying or exfoliating the skin during use, as they may produce additive irritating effects with this medicine. If you experience skin irritation, consult your doctor.

Pregnancy and breast-feeding

Pregnancy

DO NOT use Aklief if you are pregnant or planning to become pregnant. Your doctor may give you more information.

If you become pregnant during treatment, you should stop using this medicine and consult a doctor immediately.

Breast-feeding

When using Aklief, there is a risk that the active substance in the cream may pass into breast milk and the risk to the breast-fed child cannot be excluded. You and your doctor will have to decide whether to stop breast-feeding or stop Aklief treatment, taking into account the benefit of breast-feeding for the child and the benefit of treatment for the mother.

To avoid the risk of ingestion and/or contact exposure of a baby, breast-feeding women should not apply trifarotene cream to the chest or breast area.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible.

Aklief contains propylene glycol (E1520)

This medicine may cause skin irritation.

This product also contains 50 mg of alcohol (ethanol)per gram, which is equivalent to 5% w/w. This may cause a burning sensation on damaged skin.

3. How to use Aklief

Follow exactly the instructions of administration of this medicine given to you by your doctor. In case of doubt, consult your doctor or pharmacist again.

Important:Aklief is indicated in patients over 12 years of age for use on the skin of the face, chest and/or back. Do not use this medicine on other parts of the body. Do not ingest.

Keep this medicine out of the reach of children.

Method of administration

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

• One (1) press should be enough to cover the entire face (e.g. forehead, cheeks, nose and chin).
• Two (2) presses should be enough to cover the upper trunk (e.g. upper back, shoulders and chest). One (1) additional press may be used for the middle and lower back, if acne is present.
• No more than four (4) presses per day are recommended.

• Avoid contact with the eyes, eyelids, lips and mucous membranes such as the inside of the nose or mouth. If cream accidentally gets into any of these areas, rinse them immediately with plenty of warm water.
• Wash your hands immediately after applying the cream.

It is recommended to use a moisturizer as frequently as necessary from the start of treatment with Aklief. The moisturizer can be used before or after applying Aklief, leaving enough time for the skin to dry between the application of the moisturizer and Aklief.

Your doctor will tell you how long you need to use Aklief. After three months of treatment, your doctor may need a new assessment to evaluate the improvement of your acne with treatment.

Use in children

This medicine should not be used in children under 12 years of age.

If you use more Aklief than you should

If you use more Aklief than you should on the skin, your acne will not be eliminated more quickly, but your skin may become irritated, flake and redden. Contact your doctor if you have used more Aklief than you should.

Contact your doctor or the health center if:

• a child has taken this medicine accidentally.
• you or someone else has taken this medicine accidentally

Your doctor will tell you what measures to take.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Aklief

If you forget to apply Aklief at night, apply it the next night. Do not apply a double dose to make up for forgotten doses.

If you stop treatment with Aklief

Spots (spots, blackheads and whiteheads) will only be reduced after several applications of this medicine. It is important that you continue using Aklief for the time your doctor tells you.

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

4. Possible side effects

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

You may often experience redness, flaking, dryness and burning/stinging with the use of Aklief cream. See section 2 "Warnings and precautions" for more information on what to do if you experience these symptoms.

Aklief may cause the following side effects:

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

• irritation at the application site, pruritus (itching), sunburn

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

• skin pain
• skin dryness
• skin discoloration (change in skin color)
• erosion (skin loss)
• rash
• swelling
• skin irritation
• acne
• allergic dermatitis (skin allergy)
• erythema (redness)

Rare side effects (may affect up to 1 in 1,000 people)

• urticaria (hives)
• vesicles
• asteatotic eczema (dry skin with scales and cracks)
• seborrhoeic dermatitis (red, scaly and itchy skin)
• burning sensation on the skin
• skin cracks
• hyperpigmentation of the skin (darkening of skin pigmentation)
• exfoliation of the eyelids (exfoliation of the eyelid skin) or edema (swelling of the eyelid skin)
• chapped lips
• rubor (red face)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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/multidose container after EXP. The expiry date is the last day of the month shown.

Shelf life after first opening: 6 months.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Aklief

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

Appearance and packaging

Aklief is a homogeneous white cream.

Aklief is available in 5 g tubes or in 15 g, 30 g or 75 g multidose containers. The containers will have a tube or a multidose container.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Laboratoires Galderma

Z.I. Montdésir

74540 Alby sur Chéran

France

This medicine is authorised in the Member States of the European Economic Area under the following names:

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

Cyprus, Germany, Greece and Italy: Selgamis

Date of last revision of this leaflet:

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es