PROSPECTUS

Prospectus: information for the patient

Aklief 50 micrograms/g cream

trifaroteno

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospectus carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed only for you, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

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

This medicine is used for the topical treatment of mild to moderate acne vulgaris on the face, chest, and/or back in patients aged 12 years and older, who have many blackheads and whiteheads, numerous papules, and pustules.

Do not use Aklief:

• If you plan to become pregnant or are pregnant (see Pregnancy and Breastfeeding section)
• If you are allergic to trifaroteno or any of the other components of this medication (included in section 6)

Warnings and precautions

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

• Care should be taken when applying Aklief cream at the same time as another product, including cosmetics (see section Other Medications and Aklief).
• The "wax" method should not be used as a depilatory on skin treated with Aklief.
• If a reaction occurs that suggests sensitivity to any component of the formula, the use of Aklief should be suspended.

Aklief should not be used on sunburned skin. Excessive sun exposure, including sunlamps or phototherapy, should be avoided during treatment. A sunscreen with a sun protection factor (SPF) of 30 or higher and protective clothing (such as a hat and shirt) should be used over treated areas when sun exposure cannot be avoided. If, despite this, your face, chest, shoulders, or back become sunburned, stop applying the medication to the affected area until the skin has healed.

Other medications and Aklief

Inform your doctor if you are using, have used recently, or may need to use any other medication.

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

Pregnancy and breastfeeding

Pregnancy

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

If you become pregnant during treatment, discontinue use of this medication and consult a doctor immediately.

Breastfeeding

When using Aklief, there is a risk that the active ingredient in the cream may pass into breast milk and the risk to the infant cannot be excluded. You and your doctor should make the decision to stop breastfeeding or discontinue treatment with Aklief, taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

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

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Aklief contains propylene glycol (E1520)

This medication may cause skin irritation.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Keep this medication out of the reach of children.

Administration Form

• Before using the container for the first time, you must prepare it by pressing several times until a small amount of medication is dispensed (up to 10 times maximum). The container 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 cheek) and all affected areas of the trunkonce a day, at night, on clean and dry skin:

• One (1) pump should be sufficient to cover the entire face (for example, forehead, cheeks, nose, and chin).
• Two (2) pumps should be sufficient to cover the upper part of the trunk (for example, the upper back, shoulders, and chest). You can use one (1) additional pump for the middle and lower back, if you have acne.
• Do not recommend more than four (4) pumps per day.

• Avoid contact with the eyes, eyelids, lips, and mucous membranes such as the inside of the nose or mouth. If, accidentally, the cream enters any of these areas, wash 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 needed 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 evaluation to assess the improvement of your acne with the treatment.

Use in children

This medication should not be used by children under 12 years old.

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 faster, but your skin may become irritated, flaky, and red. Contact your doctor if you have used more Aklief than you should.

Contact your doctor or healthcare center if:

• A child has taken this medication accidentally.
• You or another person ingest this medication accidentally

Your doctor will indicate what measures should be taken.

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

If you forgot to use Aklief

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

If you interrupt treatment with Aklief

The pimples (pimples, blackheads, and whiteheads) will only decrease after several applications of this medication. It is essential to continue using Aklief for the time your doctor indicates.

If you have any other doubts about using this medication, consult your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

You may often experience redness, peeling, dryness, and itching/burning 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 produce the following adverse effects:

Frequent Adverse Effects (may affect up to 1 in 10 people)

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

Less Frequent Adverse Effects (may affect up to 1 in 100 people)

• Dermatitis
• Dry skin
• Decoloration of the skin (change in skin color)
• Erosion (skin loss)
• Urticaria (hives)
• Swelling
• Skin irritation
• Acne
• Allergic dermatitis (skin allergy)
• Erythema (redness)

Rare Adverse Effects (may affect up to 1 in 1000 people)

• Urticaria (hives)
• Blisters
• Asteatotic eczema (dry, scaly, and cracked skin)
• Seborrheic dermatitis (red, scaly, and itchy skin)
• Burning sensation in the skin
• Skin cracks
• Hypopigmentation of the skin (darkening of skin pigmentation)
• Exfoliation of eyelids (exfoliation of eyelid skin) or edema (swelling of eyelid skin)
• Cracked lips
• Rubor (red face)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and multi-dose container/pack after CAD/EXP. The expiration date is the last day of the month indicated.

Expiration date after first opening: 6 months.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Aklief

• The active ingredient is trifarotene. One gram of cream contains 50 micrograms of trifarotene.
• The other components are: alantoin, Simulgel 600 PHA(copolymer of acrylamide and acryloildimetiltaurato sodium,isohexadecane, polisorbate 80,oleate of sorbitan), cyclomethicone, ethanol, phenoxethanol, propylene glycol (E1520), triglycerides of medium chain and purified water.

Appearance of the product and contents of the packaging

Aklief is a white homogeneous cream.

Aklief is available in tubes of 5 g or in multi-dose packaging of 15, 30 or 75 g. The packaging will contain a tube or multi-dose packaging.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

Laboratoires Galderma

Z.I. Montdésir

74540 Alby sur Chéran

France

This medicinal product is authorized in the member states of the European Economic Area with 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 the last review of this leaflet:

The detailed and updated information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es