Attributes
- Form
- Dosage mg
- Pack
- Description en
- Aklief 50 mcg/g cream trifarotene This medicinal product is subject to additional monitoring. This allows for rapid identification of new safety information. You can help by reporting any side effects. See the last part of section 4 for side effects. Read the package leaflet carefully in its entirety before you start using this medicine because it contains important information for you. - Keep this package 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 personally. Do not pass it on to others. It may harm them, even if they have the same signs of illness. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4. The package leaflet contains: 1. What Aklief is and what it is used for 2. What you need to know before using 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, which belongs to a group of medicines called retinoids. Aklief is used for the topical treatment of common acne (Acne Vulgaris) on the face and/or trunk in patients aged 12 years and older, when there are many comedones (whiteheads and blackheads), papules and pustules (inflammatory pus-filled spots). 2. What you need to know before using Aklief Do not use Aklief: - if you are a woman who is planning to become pregnant or 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 occur when using Aklief cream (see section 4 "Possible side effects"). Contact your doctor if you experience these symptoms. It is recommended to use a moisturiser at the start of treatment, which will help to avoid similar reactions. If symptoms occur, your doctor may advise you to use a moisturiser (if you are not already), use the cream less frequently or stop treatment for a short period. If symptoms persist, despite these measures, it may be necessary to stop using the cream. · Aklief must not be used on wounds, cuts, grazes or eczematous skin. · Aklief must not come into contact with the eyes, eyelids, lips or mucous membranes. If the product accidentally gets into your eyes, rinse immediately with plenty of lukewarm water. Be careful when applying to sensitive areas of the skin, such as the neck or armpits. · Caution is advised when Aklief cream is used at the same time as other topical medicinal products, including cosmetics (see also section "Other medicines and Aklief"). · Do not use "waxing" as a method of hair removal on skin treated with Aklief. · If a sensitivity reaction to any component of the product occurs, use of Aklief should be discontinued. · Aklief must not be used on sunburned skin. Excessive exposure to sunlight, including sunbeds or phototherapy, should be avoided during treatment. It is recommended to use sunscreen with a sun protection factor (SPF) of at least 30 and protective clothing (such as a hat and shirt) on treated areas when exposure cannot be avoided. If you do get sunburned on your face, chest, shoulders or back, stop using the medicine on the affected areas until the skin has recovered. Other medicines and Aklief Tell your doctor if you are taking, have recently taken or might take any other medicines. Caution is needed if you are using cosmetic products or acne treatments - with peeling, irritating or drying effects, as they may have an additional irritating effect with the medicinal product. If your skin becomes irritated, consult your doctor. Pregnancy and breast-feeding Pregnancy Do not use Aklief if you are pregnant or think you might be pregnant. Your doctor can provide you with more information. If you discover you are pregnant during treatment, stop using this medicine and contact your doctor immediately. Breast-feeding When using Aklief, there is a risk that the active substance in the cream may be excreted in breast milk and a risk to the newborn/infant cannot be excluded. You and your doctor must decide whether to stop breast-feeding or refrain from Aklief therapy, taking into account the benefits of breast-feeding for the baby and the benefits of therapy for the mother. Breast-feeding women should not use Aklief on the chest or breast area to avoid the risk of ingestion and/or contact exposure in infants. Effects on ability to drive and use machines Aklief has no or negligible influence on the ability to drive and use machines. Aklief contains propylene glycol (E1520), which may cause skin irritation. This medicine 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 Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Important: Aklief is intended for patients aged 12 years and older for use on the skin of the face and/or trunk only. Do not use this medicine on other parts of the body. Do not swallow. Keep Aklief out of the reach of children. How to use · Before using the pump for the first time, prime it by pressing it several times (up to 10 times) until a small amount of product is dispensed. The pump is now ready for use. Apply a thin layer of Aklief cream to the affected areas of the face (forehead, nose, chin, right and left cheeks) and affected area of the trunk once daily, in the evening, on clean and dry skin: - One (1) actuation of the pump should be sufficient to cover the face (i.e. forehead, cheeks, nose and chin). - Two (2) actuations of the pump should be sufficient to cover the upper part of the trunk (i.e. the reachable back, shoulders and chest). One (1) additional pump actuation may be used for the mid and lower back if acne is also present there. - More than four (4) pump actuations per day are not recommended. · Avoid contact with eyes, eyelids, lips and mucous membranes, such as inside the nose or mouth. If the cream accidentally gets into any of these areas, rinse it off immediately with plenty of lukewarm water. Wash your hands immediately after applying the cream. You should use a moisturiser as often as needed, starting from the beginning of Aklief treatment. Moisturiser can be applied before or after Aklief, with sufficient interval to allow the skin to dry between moisturiser and Aklief application. Your doctor will tell you how long you need to use Aklief. After three months of treatment, your doctor may need to assess further improvement of your acne. Use in children Aklief must 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 your skin, you will not get rid of acne faster, but your skin may become irritated, peel and turn red. Tell your doctor if you use more Aklief than you should. Seek immediate medical attention or contact a poison control centre if: - a child accidentally uses this medicine; - you or someone else accidentally swallows this medicine. Your doctor will advise you on what actions to take. If you forget to use Aklief If you forget to use Aklief in the evening, use it the following evening. Do not use a double dose to make up for a forgotten dose. If you stop using Aklief Spots (whiteheads, blackheads and inflammatory pus-filled spots) will only decrease after several uses of this medicine. It is important to continue using Aklief as prescribed by your doctor. If you have any further 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. Reactions at the site of application, such as redness, peeling, dryness and stinging/burning are common when using Aklief cream. See section 2 "Warnings and precautions" for information on what to do if you experience such symptoms. Aklief may cause the following side effects: Common side effects (may affect up to 1 in 10 people): irritation at application site, itching, sunburn. Uncommon side effects (may affect up to 1 in 100 people): skin pain; dry skin; hypopigmentation (loss of skin pigment); erosion (loss of skin); rash; swelling; skin irritation; acne; allergic dermatitis (skin allergy); erythema (redness). Rare side effects (may affect up to 1 in 1000 people): urticaria (hives); blisters; eczema "asteatosic" (dry skin with peeling and cracks); seborrhoeic dermatitis (red, flaky skin and itching); skin burning sensation; skin cracks; skin hyperpigmentation (darkening of skin pigment); eyelid peeling (peeling of eyelid skin) or swelling (swelling of eyelid skin); chapped lips; flushing (reddening of the face). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the national reporting system, as shown in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store Aklief Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube/pump. The expiry date is the last day of that month. Discard the tube or pump 6 months after first opening. This medicinal product does not require any special storage conditions. Do not throw away any unused Aklief cream in household waste or down the drain. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Aklief contains - The active substance is trifarotene, each gram of cream contains 50 micrograms of trifarotene. - The other ingredients are allantoin, simulgel 600 PHA (acrylamide and sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate), cyclomethicone, ethanol, phenoxyethanol, propylene glycol (E1520), medium-chain triglycerides and purified water. Appearance of Aklief and contents of the pack Aklief is a white and homogeneous cream. Aklief is available in a tube containing 5 grams of cream or in a pump containing 15, 30 or 75 grams of cream. Pack sizes 1 tube or 1 pump. Not all pack sizes may be marketed. Prescription status Pharmaceutical product group II, dispensed by prescription №3
- Active
- trifarotene
What is it?
Aklief 50 mcg/g cream trifarotene This medicinal product is subject to additional monitoring. This allows for rapid identification of new safety information. You can help by reporting any side effects. See the last part of section 4 for side effects. Read the package leaflet carefully in its entirety before you start using this medicine because it contains important information for you. - Keep this package 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 personally. Do not pass it on to others. It may harm them, even if they have the same signs of illness. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4. The package leaflet contains: 1. What Aklief is and what it is used for 2. What you need to know before using 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, which belongs to a group of medicines called retinoids. Aklief is used for the topical treatment of common acne (Acne Vulgaris) on the face and/or trunk in patients aged 12 years and older, when there are many comedones (whiteheads and blackheads), papules and pustules (inflammatory pus-filled spots). 2. What you need to know before using Aklief Do not use Aklief: - if you are a woman who is planning to become pregnant or 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 occur when using Aklief cream (see section 4 "Possible side effects"). Contact your doctor if you experience these symptoms. It is recommended to use a moisturiser at the start of treatment, which will help to avoid similar reactions. If symptoms occur, your doctor may advise you to use a moisturiser (if you are not already), use the cream less frequently or stop treatment for a short period. If symptoms persist, despite these measures, it may be necessary to stop using the cream. · Aklief must not be used on wounds, cuts, grazes or eczematous skin. · Aklief must not come into contact with the eyes, eyelids, lips or mucous membranes. If the product accidentally gets into your eyes, rinse immediately with plenty of lukewarm water. Be careful when applying to sensitive areas of the skin, such as the neck or armpits. · Caution is advised when Aklief cream is used at the same time as other topical medicinal products, including cosmetics (see also section "Other medicines and Aklief"). · Do not use "waxing" as a method of hair removal on skin treated with Aklief. · If a sensitivity reaction to any component of the product occurs, use of Aklief should be discontinued. · Aklief must not be used on sunburned skin. Excessive exposure to sunlight, including sunbeds or phototherapy, should be avoided during treatment. It is recommended to use sunscreen with a sun protection factor (SPF) of at least 30 and protective clothing (such as a hat and shirt) on treated areas when exposure cannot be avoided. If you do get sunburned on your face, chest, shoulders or back, stop using the medicine on the affected areas until the skin has recovered. Other medicines and Aklief Tell your doctor if you are taking, have recently taken or might take any other medicines. Caution is needed if you are using cosmetic products or acne treatments - with peeling, irritating or drying effects, as they may have an additional irritating effect with the medicinal product. If your skin becomes irritated, consult your doctor. Pregnancy and breast-feeding Pregnancy Do not use Aklief if you are pregnant or think you might be pregnant. Your doctor can provide you with more information. If you discover you are pregnant during treatment, stop using this medicine and contact your doctor immediately. Breast-feeding When using Aklief, there is a risk that the active substance in the cream may be excreted in breast milk and a risk to the newborn/infant cannot be excluded. You and your doctor must decide whether to stop breast-feeding or refrain from Aklief therapy, taking into account the benefits of breast-feeding for the baby and the benefits of therapy for the mother. Breast-feeding women should not use Aklief on the chest or breast area to avoid the risk of ingestion and/or contact exposure in infants. Effects on ability to drive and use machines Aklief has no or negligible influence on the ability to drive and use machines. Aklief contains propylene glycol (E1520), which may cause skin irritation. This medicine 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 Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Important: Aklief is intended for patients aged 12 years and older for use on the skin of the face and/or trunk only. Do not use this medicine on other parts of the body. Do not swallow. Keep Aklief out of the reach of children. How to use · Before using the pump for the first time, prime it by pressing it several times (up to 10 times) until a small amount of product is dispensed. The pump is now ready for use. Apply a thin layer of Aklief cream to the affected areas of the face (forehead, nose, chin, right and left cheeks) and affected area of the trunk once daily, in the evening, on clean and dry skin: - One (1) actuation of the pump should be sufficient to cover the face (i.e. forehead, cheeks, nose and chin). - Two (2) actuations of the pump should be sufficient to cover the upper part of the trunk (i.e. the reachable back, shoulders and chest). One (1) additional pump actuation may be used for the mid and lower back if acne is also present there. - More than four (4) pump actuations per day are not recommended. · Avoid contact with eyes, eyelids, lips and mucous membranes, such as inside the nose or mouth. If the cream accidentally gets into any of these areas, rinse it off immediately with plenty of lukewarm water. Wash your hands immediately after applying the cream. You should use a moisturiser as often as needed, starting from the beginning of Aklief treatment. Moisturiser can be applied before or after Aklief, with sufficient interval to allow the skin to dry between moisturiser and Aklief application. Your doctor will tell you how long you need to use Aklief. After three months of treatment, your doctor may need to assess further improvement of your acne. Use in children Aklief must 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 your skin, you will not get rid of acne faster, but your skin may become irritated, peel and turn red. Tell your doctor if you use more Aklief than you should. Seek immediate medical attention or contact a poison control centre if: - a child accidentally uses this medicine; - you or someone else accidentally swallows this medicine. Your doctor will advise you on what actions to take. If you forget to use Aklief If you forget to use Aklief in the evening, use it the following evening. Do not use a double dose to make up for a forgotten dose. If you stop using Aklief Spots (whiteheads, blackheads and inflammatory pus-filled spots) will only decrease after several uses of this medicine. It is important to continue using Aklief as prescribed by your doctor. If you have any further 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. Reactions at the site of application, such as redness, peeling, dryness and stinging/burning are common when using Aklief cream. See section 2 "Warnings and precautions" for information on what to do if you experience such symptoms. Aklief may cause the following side effects: Common side effects (may affect up to 1 in 10 people): irritation at application site, itching, sunburn. Uncommon side effects (may affect up to 1 in 100 people): skin pain; dry skin; hypopigmentation (loss of skin pigment); erosion (loss of skin); rash; swelling; skin irritation; acne; allergic dermatitis (skin allergy); erythema (redness). Rare side effects (may affect up to 1 in 1000 people): urticaria (hives); blisters; eczema "asteatosic" (dry skin with peeling and cracks); seborrhoeic dermatitis (red, flaky skin and itching); skin burning sensation; skin cracks; skin hyperpigmentation (darkening of skin pigment); eyelid peeling (peeling of eyelid skin) or swelling (swelling of eyelid skin); chapped lips; flushing (reddening of the face). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the national reporting system, as shown in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store Aklief Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube/pump. The expiry date is the last day of that month. Discard the tube or pump 6 months after first opening. This medicinal product does not require any special storage conditions. Do not throw away any unused Aklief cream in household waste or down the drain. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Aklief contains - The active substance is trifarotene, each gram of cream contains 50 micrograms of trifarotene. - The other ingredients are allantoin, simulgel 600 PHA (acrylamide and sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate), cyclomethicone, ethanol, phenoxyethanol, propylene glycol (E1520), medium-chain triglycerides and purified water. Appearance of Aklief and contents of the pack Aklief is a white and homogeneous cream. Aklief is available in a tube containing 5 grams of cream or in a pump containing 15, 30 or 75 grams of cream. Pack sizes 1 tube or 1 pump. Not all pack sizes may be marketed. Prescription status Pharmaceutical product group II, dispensed by prescription №3