SK8541D
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Skinoren Cream %20 30 Gr ingredient Azelaic acid
Acne vulgaris, topical antibiotic.
Two times a day, local.
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INSTRUCTION MANUAL
SKINOREN® Cream 20%, 30g
It is applied externally.
• Active substance: 1 gram of skinoren contains 200 mg (20%) of micronized azelaic acid.
• Adjuncts: Arlaton 983 S, caprine CBS, stearyloctanoate, propylene glycol, 85%
glycerol, benzoic acid, demineralised water.
You should read this USE INSTRUCTION carefully before you start using this medicine, because it contains important information for you.
• Keep these instructions for use. You can need to read again.
• If you have other questions, please talk your doctor or pharmacist.
• This medicine has been prescribed for you personally, do not give it to others.
• When using this medicine, tell your doctor or doctor if you go to the hospital.
• We sleep exactly as written in this instruction. Do not use high or low doses other than the recommended dose for the medication.
In this Instructions for Use:
1. What is SKINORINE and what is it used for?
2. Things to watch out for before using SKINOREN
3. How is skinoren used?
4. What are the possible side effects?
5. Hiding of skinoren
Their headlines are in place.
1. What is SKINORINE and what is it used for?
• 1 gram of SKINOREN contains 200 mg azelaic acid, SKINOREN is a cream used in the treatment of acne (acne) and melasma, presented in 30g packages.
• SKINOREN is effective against bacterial infection (Propionibacterium acnes), which plays an important role in the formation of acne. It prevents the growth of rough and hardened skin cells that block the pores of the skin and thus the formation of black and white spots. SKINOREN is also used in the treatment of melasma.
SKINOREN combats the viability and viability of abnormal melanocyte cells (the cells that produce the pigment) that cause the darkening of the skin pigmentation known as the melasma.
2. Things to consider before using SKINOREN
YOU DO NOT USE SKINOREN in the following situations:
If,
• If you are sensitive to any of the active ingredients in the content of SKINOREN or any of the adjuncts,
USE SENSIBLY SKINOREN in the following situations:
SKINOREN is only applied to the skin.
SKINOREN does not only cling to the diseased area.
• If you apply SKINOREN to face, be careful not to touch your eyes. In case of accident; eyes, mouth and / or other affected areas immediately with plenty of water. If eye irritation persists, consult a doctor.
• Wash your hands after each application.
• In some patients, rarely reported hypersensitivity and aggravation of asthma tablets.
• Since SKINOREN is not effective and safe for children under 12 years of age, its use is not recommended.
Please consult your doctor if these warnings apply to you, even at any time in the past.
Use of SKINOREN with food and drink
It is only used externally. SKINOREN has no interaction with food and beverages.
Pregnancy
Consult your doctor or pharmacist before using this medication.
Tell your doctor that you are pregnant or you may be because your doctor SKINOREN will want to consider this situation before prescribing it. There are no adequate and well-controlled studies performed with azelaic acid topical application in pregnant women.
Caution should be exercised when using it in pregnant women.
Red: For the arrangements made in accordance with the letter of our Ministry dated 28.03.2017 and numbered E 69775
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If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.
Breast-feeding
Consult your doctor or pharmacist before using this medication.
If azelaic acid, the active ingredient of skinoren, is present in very low quantities, the mother can go to bed. However, the amount of active substance passed daily from mother to baby is very small and does not involve any risk, especially when considering the very low toxicity of the active substance.
However, they should be cautious during their use in lactating women.
Babies should not contact the treated skin and / or chest.
Vehicle and machine use
SKINOREN has no effect on driving and machine use.
Important information about some auxiliary substances in the content of SKINOREN
The benzoic acid contained in the preparation may have a slightly irritating effect on the skin, eyes and other mucosal membranes. Propylene glycol can cause irritation of the deep.
Use with other medicines
There is no known interaction.
At the same time as SKINOREN you do not apply another medicine or substance.
Please inform your doctor or pharmacist if you are using or have recently used any medicine with or without a prescription.
3. How is skinoren used?
You should always use SKINOREN as your doctor tells you. If you are not sure, consult your doctor or pharmacist again.
Instructions for proper use and dose / application frequency:
SKINOREN is applied twice a day (morning and evening) (Approx. 2.5 cm cream is sufficient for the entire face area).
It is important that SKINOREN is administered continuously and regularly during the prescribed treatment period.
The duration of use of SKINOREN can vary from person to person and depends on the weight of the skin problem. In general, a significant improvement occurs after approximately 4 weeks of treatment.
Red: For the arrangements made in accordance with the letter of our Ministry dated 28.03.2017 and numbered E 69775
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For best results, SKINOREN should be used for several months. It should not be applied for longer than 12 months.
In melanoma, the shortest duration of treatment should be approximately 3 months; the use of SKINOREN should be continued on a regular basis to get the best results. Treatment of a broad spectrum sunscreen (UVA and UVB) during the entire treatment period is necessary to prevent solar-induced exacerbations and / or re-pigmented areas from re-pigmenting.
In case of severe irritation of the skin, the amount of cream used in each application should be reduced or this should be reduced to once a day until the SKINOREN application frequency. If necessary, the treatment can be temporarily suspended for a few days.
Application route and method: Before applying SKINOREN to your skin, thoroughly clean and dry your skin with water. You can also use a lightweight skin cleanser. Apply SKINOREN by gently rubbing it apart from the diseased areas of your skin. After each application, wash your hands.
Different age groups:
Use in children: No dosage adjustment is required for acne treatment for teenagers (ages 12 to 18).
It is not recommended to use SKINOREN for the treatment of acne in children younger than 12 years since the safety and efficacy of SKINOREN has not been established.
Use in the elderly: No special use.
Special use cases:
Kidney failure, liver failure, etc.: No special use.
If you have an impression that the effect of SKINOREN is too strong or weak, talk to your doctor or pharmacist.
If you use more SKINOREN than you need
There is no expectation of a possible risk of taking a single dose of SKINOREN (increased absorption by widespread use) or accidental ingestion.
Continue to use it as recommended by your doctor.
If you use SKINOREN more than you should, do not worry, talk to a doctor or pharmacist.
If you forget to use SKINOREN
Do not use double doses to compensate for forgotten doses.
Continue to use it as recommended by your doctor.
Effects that may occur when treatment with SKINOREN is terminated
If you stop using SKINOREN, your disease may progress. Before you stop using SKINOREN, consult your doctor.
4. What are the possible side effects?
As with all medicines, there may be side effects in people sensitive to ancillary substances in the context of SKINOREN.
The side effects seen with SKINOREN are listed in the following categories:
Very common: it can be seen in at least 1 of 10 patients.
Common: less than one in 10 patients, but more than one in 100 patients or more.
Uncommon: less than one in 100 patients, but more than one or more in 1,000 patients.
Rare: less than one in 1,000 patients, but more than one or more in 10,000 patients.
Very rare: less than one in 10,000 patients.
Unknown: Not predictable by available data.
Very common:
• burn in the application area,
• itching in the application area (pruritus)
• redness in the application area (erythema)
Common:
• pain in the application area
• peeling in the application area (exfoliation)
• dryness in the application area,
• color variation in the application area
• irritation in the application area
Unusual:
• Scaling
• grease on the skin (sebore)
• color loss (depigmentation)
• acne (acne)
• numbness, tingling (paresthesia)
• dermatitis (contact skin disease) in the treatment area
• discomfort in the practice area
Red: For the arrangements made in accordance with the letter of our Ministry dated 28.03.2017 and numbered E 69775
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• edema
Rare:
• lip inflammation
• cracking in the mouth
• temperature increase in the application area
• the aqueous bubble (vesicle)
• eczema in the application area
• ulcer in the application area
• hypersensitivity (sensitivity or allergy)
• aggravation of asthma symptoms
Unknown (the frequency is not predictable at hand):
• angioedema (sudden swelling under the skin)
• contact dermatitis (contact dermatitis)
• eye swelling
• Percent swelling (may occur with hypersensitivity)
• urticaria (hives)
• rash
If you experience any side effects not mentioned in these instructions for use, inform your doctor or pharmacist.