AISOSKIN 10 mg Софт Капсула

Содержание инструкции

1. Aisoskin 10 mg soft capsules, 20 mg soft capsules
   1. What is Aisoskin and what is it used for
2. Aisoskin must be prescribed only by or under the supervision of physicians who have
   1. What you need to know before using Aisoskin
   2. How to take Aisoskin
   3. Possible side effects
   4. How to store Aisoskin
   5. Contents of the pack and other information

Aisoskin 10 mg soft capsules, 20 mg soft capsules

Isotretinoin
Generic medicine

WARNING
MAY CAUSE SERIOUS HARM TO THE FETUS
Women must use effective contraceptive methods
Do not use if you are or think you might be pregnant

Medicinal product subject to additional monitoring. This will allow the rapid identification
of new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section
4 for information on how to report adverse effects.

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Aisoskin and what is it used for

Aisoskin contains the active substance isotretinoin and belongs to a class of medicines
called retinoids.
Aisoskin is used for the treatment of severe forms of acne (such as conglobate acne, nodular acne or
with a risk of permanent scarring), which have proven resistant to adequate courses
of standard antibiotic therapy and to topical treatment.

Aisoskin must be prescribed only by or under the supervision of physicians who have

experience in the use of medicines for the treatment of severe acne and who fully understand
the risks of treatment and the need for close patient monitoring.

2. What you need to know before using Aisoskin

Do not use Aisoskin

• if you are pregnant or breastfeeding
• if there is any possibility of becoming pregnant, you must adopt the precautions reported in the “Pregnancy Prevention Program” in the “Warnings and precautions” section
• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to peanuts or soy. Aisoskin contains soybean oil, partially hydrogenated soybean oil;
• if you suffer from liver problems (hepatic insufficiency);
• if you have high levels of cholesterol or triglycerides in the blood (hypercholesterolemia, hypertriglyceridemia);
• if you have high levels of vitamin A in the body (hypervitaminosis A);
• if you are taking medicines called tetracyclines (see section “Other medicines and Aisoskin”);

Warnings and precautions
Pregnancy Prevention Program
Pregnant women must not use AISOSKIN
This medicine can seriously damage the fetus (it is said to be “teratogenic”) – it
can cause abnormalities in the unborn child to the brain, face, ear, eye, heart and
some glands (thymus and parathyroid glands). It can also likely induce
miscarriage. This can happen even if AISOSKIN is used for only a short time during
pregnancy.

• Do not use AISOSKIN if you are pregnant or think you may be.
• Do not use AISOSKIN if you are breastfeeding. The medicine can pass into the milk and harm the newborn.
• Do not use AISOSKIN if you could become pregnant during treatment.
• Do not become pregnant for one month after finishing this treatment as some medicines may remain in your body.

For women who may become pregnant, AISOSKIN is prescribed with very
restrictive rules. This is due to the risk of harm that may be caused to the fetus.
These are the rules:

• The doctor must explain the risk of harm to the fetus - you must understand that you must not become pregnant and what you need to do to prevent pregnancy.
• The doctor must have spoken to you about contraception (birth control). The doctor will give you information on how not to become pregnant. The doctor may refer you to a specialist for contraceptive counseling.
• Before starting treatment, the doctor will tell you to take a pregnancy test. The test must show that you are not pregnant when you start treatment with AISOSKIN.

Women must use effective contraceptive treatment before, during and after
using AISOSKIN

• You must agree to use at least a very reliable contraceptive method (for example an intrauterine device or a contraceptive implant) or, two effective methods that work in different ways (for example hormonal contraceptive pill and a condom). Talk to your doctor about which method may be suitable for you.
• You must use contraception for one month before using AISOSKIN, during treatment and for one month after the end of treatment.
• You must use contraception even if you do not have your period or if you are not sexually active (unless your doctor tells you it is not necessary). Women must agree to undergo pregnancy tests before, during and afterusing AISOSKIN
• You must agree to undergo regular check-up visits, preferably every month
• You must agree to undergo regular pregnancy tests, preferably every month during treatment and, as some medicines may remain in your body, 1 month after stopping AISOSKIN (unless your doctor decides this is not necessary in your case).
• You must agree to perform additional pregnancy tests if your doctor asks you to.
• You must not become pregnant during treatment or in the following month as some medicines may remain in your body.
• The doctor will discuss all these points with you, using a checklist and will ask you (or a relative/guardian) to sign it. This document will serve to confirm that you have been informed of the risks and that you will follow the above rules.

If you become pregnant while taking AISOSKIN, stop taking
this medicine immediately, and consult your doctor. The doctor may refer you to a specialist for
consultation.
Also, if you become pregnant within one month of stopping AISOSKIN, you should contact
your doctor. The doctor may refer you to a specialist for consultation.

Advice for men
Levels of oral retinoids in the seminal fluid of men using AISOSKINare too low to
harm the fetus of their partner. However, you should never share your medicines with
anyone.

Further precautions
You should never give this medicine to anyone else. At the end of treatment return the
unused capsules to the pharmacist.
You should not donate blood during treatment with this medicine and for 1 month after
stopping AISOSKIN as if a pregnant patient were to receive your
blood it could damage her fetus.
Talk to your doctor before taking AISOSKIN:

• if you have not had mental health problems. This includes depression, aggressive tendencies or mood swings. This also includes thinking about harming yourself or ending your life. This is because your mood may change while taking AISOSKIN.
• if your acne suddenly worsens in the early period of therapy; this usually happens within 7-10 days and resolves spontaneously without the need for dose adjustment. See the paragraph “Observe the following precautions during thetreatment with Aisoskin” for further precautions to be taken;
• if you experience a sudden reduction in night vision (see section “Driving and operating machinery” and “Possible side effects”); in this case it may be appropriate to undergo an eye examination and your doctor may consider it necessary to stop treatment with Aisoskin;
• if you do intense exercise you may experience muscle pain, joint pain and increased levels in the blood of enzymes indicative of heart and muscle damage (creatine phosphokinase). In this case it is necessary to reduce the intensity of physical activity during treatment with Aisoskin;
• if you experience symptoms and signs of increased pressure in the head (intracranial hypertension) such as headache, nausea and vomiting, visual disturbances, contact your doctor who will advise you to stop treatment immediately (see section “Possible side effects”);
• if you suffer from liver disease. Aisoskin can increase levels of liver enzymes, for this reason your doctor will tell you to have periodic blood tests and if these levels do not return to normal values, they will indicate a dose reduction or suspension of treatment;
• if you suffer from kidney disease, you may need to start treatment with a reduced dose (see section “How to take Aisoskin”);
• if you suffer from high levels of fats in the blood, such as triglycerides or cholesterol. The doctor may consider it appropriate to change the dose or stop treatment with Aisoskin, even if usually it may be sufficient to change your diet. If these levels are too high or signs of inflammation of the pancreas (acute pancreatitis, which can sometimes be fatal) occur, treatment should be stopped;
• if you suffer from inflammatory bowel disease and if severe episodes of bloody diarrhea occur, contact your doctor who will indicate the immediate suspension of treatment;
• if you are allergic to peanuts or soy as you may experience allergic reactions even severe, which do not only concern the skin. If you develop a severe allergic reaction, contact your doctor who will stop therapy and subject you to adequate control;
• if you have diabetes, your doctor will subject you to more frequent checks of blood glucose levels throughout the duration of treatment;
• if you are overweight, your doctor will subject you to more frequent checks of blood lipid levels throughout the duration of treatment;
• if you drink alcohol regularly.

Mental health problems
You may not notice some changes in your mood and behavior and therefore it is very important
that you tell your friends and family that you are taking this medicine. They can
notice these changes and help you identify problems that need to be
discussed with your doctor.
Before, during and after treatment you will regularly have blood tests to
check that there are no changes in the values relating to kidneys and liver, cholesterol and
blood sugar. If changes occur, the doctor may decide to adjust the dose or
suspend treatment.

Observe the following precautions during the treatment with Aisoskin:

• avoid prolonged exposure to sunlight or ultraviolet (UV) radiation. If necessary, use a high protection sunscreen (at least 15);
• avoid cosmetic procedures for smoothing the skin surface (dermabrasion) or for reducing skin blemishes (laser therapy) for at least a period of 5-6 months after the end of treatment with Aisoskin. These procedures can cause scarring of the skin, alteration of the color (increased or decreased pigmentation) or skin irritation. Avoid using waxing hair removal for at least 6 months after the end of treatment, due to the risk of skin tears;
• avoid taking Aisoskin together with anti-acne products to be applied to the skin that dissolve the superficial tissues of the skin (keratolytic or exfoliating) as this may cause an increase in local irritation (see section “Other medicines and Aisoskin”);
• if you experience dry skin or lips, apply a greasy skin ointment and a lip balm from the beginning of treatment;
• if you experience dry eyes, blurred vision and corneal inflammation, you can apply an ointment or artificial tears. During treatment you may become intolerant to contact lenses and may be forced to wear glasses.

Children and adolescents
Aisoskin is not indicated for the treatment of acne in prepubertal age and use is not recommended
in children under the age of 12 years.

Other medicines and Aisoskin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take Aisoskin together with the following medicines:

• medicines containing vitamin A, as there is a risk of developing symptoms caused by high levels of vitamin A (hypervitaminosis A) such as severe headache, nausea or vomiting, drowsiness, irritability and itching;
• medicines used to treat bacterial infections such as tetracyclines. Cases of increased intracranial pressure (benign intracranial hypertension, pseudotumor cerebri) have been reported during the use of Aisoskin together with tetracyclines (see section “Warnings and precautions”);
• medicines or other topical anti-acne products used for dissolving the superficial tissues of the skin (keratolytic or exfoliating) as this may cause an increase in local irritation (see section “Warnings and precautions - Observe the following precautions during the treatment with Aisoskin”).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.

Aisoskin must not be used in any case in pregnancy(see section “What you need to
know before using Aisoskin – Do not use Aisoskin”). If despite these precautions a
pregnancy occurs during treatment with Aisoskin or in the following month, there is a
high risk of very serious and severe malformations in your baby.
If pregnancy should occur during treatment with Aisoskin, stop the
treatment and immediately contact a doctor specializing in congenital malformations
(teratologist) for evaluation and consultation.
This medicine is very likely to pass into breast milk with resulting harm to
the baby. For this reason, the use of Aisoskin is contraindicated in breastfeeding women.
For further information on pregnancy and contraception, see section 2 of the “Pregnancy
Prevention Program”.

Driving and operating machinery
Be careful when driving vehicles and operating machinery as Aisoskin can cause
reduced night vision, even suddenly, which rarely persists once treatment is finished (see section “Warnings and Precautions” and “Possible side effects”).
Treatment with Aisoskin can cause drowsiness, dizziness and visual disturbances. For this reason you must
refrain from driving vehicles or undertaking any activity in which altered attention
could expose you or others to serious risks.

AISOSKIN 10 mg contains 3.717 mg of sorbitol per soft capsule.
AISOSKIN 20 mg contains 11.89 mg of sorbitol per soft capsule.
AISOSKIN contains less than 1 mmol (23 mg) of sodium per soft capsule, which is essentially
‘sodium-free’.
AISOSKIN contains soybean oil and partially hydrogenated soybean oil. If you
are allergic to peanuts or soybeans, do not use this medicine.

AISOSKIN contains E124 (Ponceau 4R). It may cause allergic reactions.

3. How to take Aisoskin

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The dosage will be calculated on an individual basis according to body weight and may be adjusted by the
doctor during treatment.
The recommended initial dose is 0.5 mg/kg per day, however your doctor will establish your individual
needs. For most patients the dose is between 0.5 and 1.0 mg/kg per day.
The duration of treatment will depend on the individual daily dose.
The capsules should be taken once or twice a day during meals.
Generally, complete healing from acne is achieved with a treatment cycle of 16-24
weeks.
In case of certain recurrence, your doctor will prescribe a new treatment cycle with Aisoskin at the
same daily dose and with the same cumulative dose.
Your skin may continue to improve up to 8 weeks after the end of treatment, so
wait at least until the end of this 8-week period before starting a new course of treatment, if
necessary.
If you are unable to tolerate the recommended dose, your doctor will reduce your dose and the treatment
will last longer.
If you suffer from severe kidney problems, your doctor will prescribe a lower dosage (for example 10
mg/day). The dosage should then be increased to 1 mg/kg/day or to the maximum
tolerated dose, according to the doctor's opinion.

Use in children
Aisoskin is not recommended in children under the age of 12 years.

If you take more Aisoskin than you should
In case of accidental intake of an excessive dose of the medicine, contact your
doctor immediately or go to the nearest hospital.
If you take more capsules than prescribed by your doctor, you may experience symptoms caused by high
levels of Vitamin A, which include severe headache, nausea or vomiting, drowsiness,
irritability, and itching. Symptoms are expected to be reversible and not require treatment.

If you forget to take Aisoskin
Do not take a double dose to make up for a missed dose.
If you have any doubts about 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 everyone will experience them.
These effects often subside during treatment, or after stopping it, or after modifying the dosage. In some cases they may persist after discontinuation of the treatment.

Serious side effects
Contact your doctor immediately if the following serious side effects occur, urgent medical treatment may be necessary.

• blurred vision, night blindness, reduced night vision, papilledema (swelling of the optic disc), visual disturbances;
• severe allergic reactions (anaphylaxis) causing difficulty breathing, dizziness, collapse, shock, severe itching and/or swelling;
• increased intracranial pressure (benign intracranial hypertension), convulsions, drowsiness, dizziness;
• severe skeletal muscle damage (rhabdomyolysis).

The following side effects are serious and the frequency cannot be estimated based on available data:

• severe forms of skin allergies (cutaneous rash, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis) which are potentially life-threatening to the patient and require immediate medical intervention. These initially appear as circular patches often with central blisters generally on the arms and hands or on the legs and feet, more severe rashes may include the formation of blisters on the chest and back. Severe forms can progress to widespread skin peeling which can be life-threatening. These severe forms of skin allergies are often preceded by headache, fever, body aches (flu-like symptoms). If these skin symptoms occur, stop taking Aisoskin and contact your doctor immediately.

Other side effects are listed by frequency:

Very common(occurs in at least 1 in 10 patients treated):

• decreased red blood cells (anemia) and platelets (thrombocytopenia), increased number of platelets (thrombocytosis), increased erythrocyte sedimentation rate;
• inflammation of the eyelids (blepharitis) and the inner mucous membrane of the eyeball (conjunctivitis), dry eyes, eye irritation;
• increased levels of certain liver enzymes (transaminases) (see section “Warnings and precautions”);
• dry lips (cheilitis), skin inflammations (dermatitis), dry skin, localized exfoliation, itching, erythematous rash, skin fragility (risk of friction trauma);
• joint pain (arthralgia) and muscle pain (myalgia), back pain (particularly in children and adolescents);
• increased triglycerides and decreased high-density lipoproteins.

Common(occurs in at least 1 in 100 and less than 1 in 10 patients treated):

• decreased neutrophils (neutropenia);
• headache;
• nosebleeds (epistaxis), dry nose, inflammation of the nose and pharynx (nasopharyngitis);
• increased cholesterol and sugar in the blood (cholesterolemia and glycemia), presence of blood and protein in the urine (hematuria and proteinuria).

Rare(occurs in at least 1 in 10,000 and less than 1 in 1,000 patients treated)

• allergic skin reaction, hypersensitivity;
• hair loss (alopecia).

Very rare(occurs in less than 1 in 10,000 patients treated):

• bacterial infections (mucocutaneous) from Gram-positive bacteria;
• abnormal growth of lymph nodes (lymphadenopathy);
• diabetes mellitus, high uric acid levels in the blood (hyperuricemia);
• alteration in color vision, cloudy surface of the eye (cataract), intolerance to contact lenses, corneal opacity, inflammation of the cornea (keratitis), excessive sensitivity to light (photophobia);
• hearing loss;
• inflammation of blood vessels (for example, Wegener's granulomatosis, allergic vasculitis);
• difficulty breathing, especially in patients with asthma (bronchospasm), alteration of voice tone (hoarseness);
• inflammation of the intestines (colitis and ileitis), dry throat, gastrointestinal bleeding, diarrhea and bleeding, nausea, inflammation of the pancreas (pancreatitis);
• hepatitis;
• fulminant acne (also known as febrile ulcerative acne, a severe form of acne that appears suddenly especially in males), worsening of acne (acne exacerbation), erythema (facial), rashes (exanthema), changes in hair structure, abnormal hair growth (hirsutism), changes in nail growth (nail dystrophy), infections of the fingertips (paronychia), allergies from sun exposure (photosensitivity reactions), reddish skin lesions (pyogenic granuloma), dark skin spots (skin hyperpigmentation), increased sweating;
• chronic inflammation of the joints (arthritis), calcification of ligaments and tendons (calcinosis), premature epiphyseal welding, bone diseases (exostosis and hyperostosis), reduced bone density, tendinitis;
• inflammatory kidney diseases (glomerulonephritis);
• excessive formation of wound regeneration tissue, malaise;
• increased levels in the blood of enzymes indicative of heart and muscle damage (creatine phosphokinase).

Not known(frequency cannot be defined based on available data):

• problems achieving or maintaining an erection
• decreased libido
• enlargement of the breasts with or without tenderness in men

Mental health problems
Rare effects (may affect up to 1 in 1,000 people)

• Depression or related disorders. Symptoms of this include sadness or altered mood, anxiety, feelings of emotional distress
• Worsening of existing depression
• Becoming violent or aggressive

Very rare effects (may affect up to 1 in 10,000 people):

• Some people have had thoughts or intentions to harm themselves or end their lives (suicidal ideas), have attempted to end their lives (suicide attempt), or have ended their lives (suicide). These people may not appear depressed.
• Unusual behavior.
• Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that are not there.

Contact your doctor immediately if you experience symptoms of any of these mental health problems.The
doctor may tell you to stop taking AISOSKIN. This may not be enough to end the effects: you may need further help, and the doctor can arrange this.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can contribute to providing more
information on the safety of this medicine.

5. How to store Aisoskin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Expiry. The
expiry date refers to the last day of that month.
The expiry date indicated on the packaging refers to the product in intact packaging,
correctly stored.
Store at a temperature not exceeding 25 °C. Store in the original packaging and keep the
blister in the outer packaging to protect it from humidity and light.
Dispose of unused capsules at the end of treatment, using the appropriate containers
for the separate collection of medicines.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aisoskin contains
The active ingredient of Aisoskin is: isotretinoin
Each Aisoskin 10 mg soft capsule contains: 10 mg of isotretinoin.
The other ingredients are: soybean oil, DL-alpha-tocopherol, disodium edetate,
butylhydroxyanisole, Lipodan HP-100 (hydrogenated triglycerides Grindsted PS 101), yellow wax, soybean oil
partially hydrogenated. Components of the gelatin capsule shell: gelatin, glycerol,
sorbitol 70% (non-crystallizing), purified water, Ponceau 4R (E 124), black iron oxide (E
172), titanium dioxide (E 171).
Each Aisoskin 20 mg soft capsule contains: 20 mg of isotretinoin
The other ingredients are: soybean oil, DL-alpha-tocopherol, disodium edetate,
butylhydroxyanisole, Lipodan HP-100 (hydrogenated triglycerides Grindsted PS 101), yellow wax, soybean oil
partially hydrogenated. Components of the gelatin capsule shell: gelatin, glycerol,
sorbitol 70% (non-crystallizing), purified water, Ponceau 4R (E 124), indigotine (E 132), titanium
dioxide (E 171).

Description of the appearance of Aisoskin and contents of the pack
Aisoskin is presented in the form of soft capsules. The capsules are packaged in heat-sealed blisters
of PVC/PVDC and aluminum.
Each blister of Aisoskin 10 mg contains 30 soft capsules.
Each blister of Aisoskin 20 mg contains 30 soft capsules.

Marketing authorisation holder and manufacturer
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)