Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Trifarotene
Galderma International
D10AD06
Trifarotene
50 microgram per gram
Cream
Trifarotene
Not marketed
2020-02-21
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AKLIEF 50 MICROGRAM/G CREAM trifarotene This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for 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. WHAT IS IN THIS LEAFLET 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 1. WHAT AKLIEF IS AND WHAT IT IS USED 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. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE AKLIEF DO NOT USE AKLIEF: - 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) WARNINGS AND PRECAUTIONS • 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 t Preberite celoten dokument
Health Products Regulatory Authority 03 November 2022 CRN00D5C9 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT Aklief 50 microgram/g Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cream contains 50 micrograms of Trifarotene. Excipient(s) with known effect One gram of cream contains 300 milligrams of propylene glycol (E1520) and 50 milligrams of ethanol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream White and homogenous cream 4 CLINICAL PARTICULARS 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. Health Products Regulatory Authority 03 November 2022 CRN00D5C9 Page 2 of 10 Apply a thin layer of Aklief cream to the affec Preberite celoten dokument