ISOTRETINOINA 40 mg Софт Капсулы

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1. Isotretinoina difa 40 mg Soft capsules
   1. What is Isotretinoina difa and what is it used for?
   2. What you need to know before you use Isotretinoina difa
   3. How to use Isotretinoina difa
   4. Possible side effects
   5. How to store Isotretinoina difa
   6. Other information

Package leaflet: information for the user

Isotretinoina difa 40 mg Soft capsules

Isotretinoin

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.

Contents of this leaflet:

• 1. What Isotretinoina difa is and what it is used for
• 2. What you need to know before you use Isotretinoina difa
• 3. How to use Isotretinoina difa
• 4. Possible side effects
• 5. How to store Isotretinoina difa
• 6. Further information

1. What is Isotretinoina difa and what is it used for?

Isotretinoina difa contains the active ingredient isotretinoin, a derivative of
Vitamin A, belonging to the class of retinoids.
Isotretinoina difa is used for the treatment of severe forms of acne (such as
nodular acne or conglobate acne or acne with a risk of permanent scarring)
resistant to appropriate standard therapies with oral antibiotics and topical
therapy.

2. What you need to know before you use Isotretinoina difa

Read this leaflet carefully before taking this medicine

• 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 personally. Never give it to others.In fact, this medicine could be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Isotretinoin must be prescribed and monitored by a dermatologist (a doctor
specialized in the treatment of skin problems), who is aware of the risk
of treatment with isotretinoin and the need for monitoring.
The doctor will inform you about the precautions to follow when taking Isotretinoina
difa. In addition, the doctor will give you an informative guide.
If the doctor has not delivered these guides or has not explained the precautionary measures or they have not been fully understood, before starting treatment
with Isotretinoina difa talk to your doctor.

Do not use Isotretinoina difa

• If you are pregnant or breastfeeding
• If there is any possibility that you may become pregnant, you must take the precautions reported in the “Pregnancy Prevention Program”, in the “Warnings and Precautions” section.
• In the presence of hypersensitivity (allergy) to isotretinoin, soy, peanuts, or any of the excipients
• In the presence of liver diseases
• in the presence of excessively high levels of lipids in the blood (cholesterol, triglycerides)
• In the presence of excessively high levels of vitamin A in the body (hypervitaminosis A)
• If you are taking tetracyclines (antibiotics)

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

• You must not use Isotretinoina difa if you are pregnant or if you think you might be.
• You must not use Isotretinoina difa if you are breastfeeding. The medicine can pass into the milk and harm the newborn.
• You must not use Isotretinoina difa if you could become pregnant during treatment.
• You must not become pregnant one month after finishing this treatment, as some medicines can remain in your body.

For women who may become pregnant, Isotretinoina difa is prescribed with very
restrictive rules. This is due to the risk of serious harm that can 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 talked to you about contraception (birth control). The doctor will give you information on how not to become pregnant. The doctor may send 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 Isotretinoina difa

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

• You must agree to use at least one 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 contraceptives for one month before using Isotretinoina difa, during treatment and for one month after the end of treatment
• You must use contraceptives even if you do not have your period or if you are not sexually active (unless your doctor tells you that it is not necessary).

Women must agree to undergo pregnancy tests before, during and
after using Isotretinoina difa

• 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 can remain in your body, 1 month after stopping Isotretinoina difa (unless your doctor decides that 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 month following it, as some medicines can 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 have to follow the above rules. If you become pregnant while taking Isotretinoina difa, immediately stoptaking this medicine, and consult your doctor. The doctor may send you to a specialist for a consultation. Also, if you become pregnant within one month of stopping Isotretinoina difa, you should contact your doctor. The doctor may send you to a specialist for a consultation.

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

Further precautions
Never give this medicine to anyone else. At the end of the treatment return
the unused capsules to the pharmacist.
Do not donate blood during treatment with this medicine and for 1 month
after stopping using Isotretinoina difa as if a pregnant patient
were to receive your blood it could harm the fetus.
Other precautions

• Isotretinoina difa can increase levels of fats such as triglycerides or cholesterol in the blood. The doctor will subject patients to blood tests to monitor these values before the start of therapy, during and at the end of treatment with Isotretinoina difa. Inform your doctor if you already suffer from high levels of these substances in the blood and if you suffer from diabetes, are overweight, or suffer from alcoholism, as blood tests may need to be performed more frequently in these cases.
• Isotretinoina difa can increase levels of liver enzymes. The doctor will subject patients to blood tests before the start of therapy, during and at the end of treatment with Isotretinoina difa, to check liver values. If the levels of liver enzymes remain high, the doctor may reduce the dose or stop therapy with Isotretinoina difa.
• Isotretinoina difa can increase blood sugar levels and in rare cases diabetes mellitus has been diagnosed. The doctor will monitor blood sugar levels during treatment, especially if you suffer from diabetes, are overweight or suffer from alcoholism.
• Use an ointment or emollient cream and lip balm during treatment as dry skin or lips may occur during treatment with Isotretinoina difa.

Talk to your doctor before taking Isotretinoina difa

• If you have had mental health problems including depression, aggressive tendencies or mood changes. This includes also the thought of harming yourself or ending your life. This is because your mood may change while you are taking Isotretinoina difa. Mental health problems You may notice some changes in your mood and behavior and 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.
• If you suffer from kidney failure. In this case, therapy should start with a lower dose.
• Isotretinoina difa affects night vision. Dry eyes or vision problems may occur during treatment with Isotretinoina difa that usually resolve after the end of treatment. Be careful when driving vehicles or using machinery at night as these symptoms may appear suddenly. If you wear contact lenses and experience dry eyes, you may need to wear glasses during the duration of treatment with Isotretinoina difa. If you experience any vision problems, inform your doctor immediately, as it may be necessary to stop treatment with Isotretinoina difa and monitor your vision.

Patients must immediately stop treatment and promptly consult
the doctor if they experience any of the following symptoms:

• Allergic reaction (redness or rash) or a severe anaphylactic reaction
• Persistent headache, nausea, vomiting and visual disturbances. Isotretinoina difa has been very rarely associated with a condition called benign intracranial hypertension.
• Bloody diarrhea (example blood in the stool). Isotretinoina difa has been very rarely associated with inflammatory bowel disorders. What to avoid when taking Isotretinoina difa:
• Avoid prolonged exposure to sunlight and do not use UV radiation lamps or tanning beds. The skin may become more sensitive to light during treatment with Isotretinoina difa. Before exposure to the sun, apply a protective sunscreen product with a high sun protection factor of at least SPF 15.
• Avoid cosmetic procedures such as dermabrasion or laser treatments (removal of moles or scars) and waxing during treatment and for at least 6 months after the end of treatment. Isotretinoina difa can make your skin more fragile and this can cause scarring or irritation.
• Reduce intense physical activity during treatment with Isotretinoina difa as muscle and joint pain has been observed during treatment with Isotretinoina difa.
• Do not donate blood both during and for one month after the end of treatment with Isotretinoina difa. If a pregnant woman were to receive this blood, the child could be born with serious malformations. Taking other medicinesInform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription. Do not take vitamin preparations containing vitamin A or tetracyclines (a type of antibiotic) during therapy with Isotretinoina difa, due to the increased risk of side effects. Do not use any other skin treatment for acne during treatment with Isotretinoina difa to avoid increasing local irritation. Pregnancy and breastfeedingPregnancy

Isotretinoina difa must not be taken during pregnancy, as
isotretinoin, the active ingredient of Isotretinoina difa is highly teratogenic. If
despite these precautions (Pregnancy Prevention Program)
pregnancy occurs during treatment or in the month following it,
there is a high risk of very serious and severe fetal malformations.
Fetal malformations associated with treatment with isotretinoin include
anomalies of the central nervous system (hydrocephalus, malformations/anomalies
cerebellar, microcephaly), facial dysmorphism, palatoschisis, anomalies of the external ear (absence of the external ear, small or absent external auditory canals),
ocular anomalies (microphthalmia), cardiovascular anomalies (cone-trunk malformations such as tetralogy of Fallot, transposition of the great vessels, septal defects),
anomalies of the thymus and parathyroid glands. There is also an increased incidence
of miscarriages.

If pregnancy should occur during treatment with
isotretinoin, treatment must be stopped immediately and the
patientmustbe referred to a specialist doctor.
Breastfeeding
Isotretinoina difa must not be taken during breastfeeding because
isotretinoin probably passes into breast milk and can harm the
child.
For further information on pregnancy and contraception, see paragraph 2 of the
“Pregnancy Prevention Program”

Driving and operating machinery
Isotretinoina difa has a moderate influence on the ability to drive or operate
machinery.
Night vision may be affected during treatment and this can
occur without warning. In rare cases this problem may persist after the end
of treatment. Exercise caution when driving vehicles or operating
machinery.
Confusion and visual disturbances have been reported very rarely. Patients
must be warned that if they experience these undesirable effects, they should not
drive, operate machinery or participate in activities where these
symptoms may expose themselves or others to risk.

Important information about some ingredients of Isotretinoina difa
Isotretinoina difa contains soybean oil. If you are allergic to peanuts or soy, do
not use this medicine.
Isotretinoina difa contains sorbitol. If your doctor has diagnosed you with a
intolerance to certain sugars, contact them before taking this medicine.
Isotretinoina difa contains the sunset yellow (E110) dye which may cause
allergic reactions.

3. How to use Isotretinoina difa

Always use Isotretinoina difa exactly as your doctor has instructed. If you have any doubts, ask your doctor or pharmacist.

• The capsules must be taken with food one or two times a day
• Swallow the capsules whole, do not chew or suck them.

Occasionally, acne may worsen during the first few weeks of treatment, and should improve with continued treatment.

Dosage
The doctor will prescribe an individual dose depending on body weight and other clinical parameters such as renal insufficiency, etc.
Adults including adolescents and the elderly
The usual starting dose is 0.5 mg per kg of body weight per day (0.5 mg/kg/day). After a few weeks, the doctor may adjust the dose. This depends on the response to treatment and the occurrence of undesirable effects. For most patients, the dose is between 0.5 and 1.0 mg/kg per day.
If you feel that the effect of Isotretinoina difa is too strong or too weak, tell your doctor or pharmacist.
Patients with severe renal impairment
In patients with severe renal impairment, treatment with Isotretinoina difa should be started with a reduced dose, for example 10 mg/day. The dose should then be increased to the maximum dose tolerated by the patient.
Children
Isotretinoin is not indicated in children as there is insufficient safety data.
Patients with intolerance
In patients who do not tolerate the recommended dose, the doctor may decide to continue treatment at a reduced dose. In such cases, the treatment will have a longer duration and a higher risk of relapse.

If the recommended dose cannot be reached with 40 mg capsules,
another preparation based on isotretinoin must be chosen.
Duration of treatment
A treatment cycle usually lasts 16-24 weeks.
Acne may continue to improve for up to 8 weeks after the end of treatment.
Therefore, a new treatment cycle should not be started before at least this period has elapsed. Most patients only need a single cycle of treatment.

Remember that this medicine has been prescribed for you!
Only a doctor can prescribe it. Do not give this medicine to others, for other individuals this medicine could be dangerous, even if their symptoms are the same as yours.

If you use more Isotretinoina difa than you should
The following symptoms may occur: severe headache, nausea or vomiting, drowsiness, irritability and redness.
If you use too many capsules or someone else accidentally takes this medicine, contact your doctor or pharmacist immediately or go to the nearest hospital.

If you forget to use Isotretinoina difa
If you forget a dose, take it as soon as possible. If it is close to the time of the next dose, skip the missed dose and continue treatment as normal. Do not take a double dose to make up for the forgotten dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Isotretinoina difa can cause side effects,
although not everybody gets them.
Some of the side effects associated with the use of isotretinoin are dose-related. Side effects are generally reversible after dose reduction or
discontinuation of treatment, however, some may persist after
treatment is stopped.
The following frequency data are the basis for the evaluation of side effects:

very common: may affect more than 1 in 10 people

common: may affect up to 1 in 10 people

uncommon: may affect up to 1 in 100 people

rare: may affect up to 1 in 1,000 people

very rare: may affect up to 1 in 10,000 people

not known:frequency cannot be estimated from the available data
The following symptoms are the most commonly reported side effects of isotretinoin: dryness of the skin, dryness of the mucous membranes for example of the
lips, nasal mucosa and eyes.
The following side effects may also occur.

Laboratory tests

Very commonIncreased levels in the blood of fatty substances (triglycerides),
reduction of HDL cholesterol (high-density lipoproteins)

CommonIncreased cholesterol in the blood, increased blood sugar
(glycemia), blood in the urine, protein excretion in the urine.

Very rareIncreased blood levels of creatine phosphokinase.

Blood and lymphatic system disorders

Very common
Red blood cell deficiency, increased erythrocyte sedimentation rate, increase or decrease in the number of platelets.

Commondecrease in neutrophil leukocytes (a type of white blood cells)

Very raredisease of the lymph nodes (lymphadenopathy)

Nervous system disorders

CommonHeadache

Very rareBenign intracranial hypertension, seizures, confusion
Eye disorders

Very commoninflammation of the periocular area, eye inflammation,
dry eyes, eye irritation

Very rareNight blindness, clouding of the eye surface (cataract),
color blindness (color vision deficiency), intolerance to contact lenses,
corneal opacity, reduced night vision, keratitis, swelling of the pupil
(papilledema, as a sign of benign intracranial hypertension), light sensitivity,
visual disturbances

Ear and labyrinth disorders

Very rareHearing loss

Respiratory, thoracic and mediastinal disorders

Commonnosebleeds, nasal dryness, inflammation of the nasal mucosa, in particular pharyngeal mucosa.

Very rareairway closure (Bronchospasm), especially in patients
with asthma, hoarseness

Gastrointestinal disorders

Very rareinflammation of the colon and intestinal mucosa,
dry throat, gastrointestinal bleeding, hemorrhagic diarrhea, inflammatory bowel disease, nausea, pancreatitis (see section 2 Before using
Isotretinoina difa)

Renal and urinary disorders

Very rarekidney inflammation

Frequency not knowndark urine

Skin and subcutaneous tissue disorders

Very commoninflammation of the lips, skin inflammation, dry skin, localized flaking, itching, redness, skin fragility (risk
of friction trauma)

Rarehair loss

Very rareSevere acne (fulminant acne), worsening of acne (acne exacerbation), skin redness, especially of the face, skin rash, hair disorders, increased body hair, changes in nails, infection of the tissue
around the nail base, light sensitivity, pus-forming eruptions
(pyogenic granuloma), increased skin pigmentation, increased
sweating

Skin and hair disorders
Frequency not known:
Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) which are potentially life-threatening and require
immediate medical attention. These symptoms initially appear as
circular patches, often with central blisters, usually on the arms and hands or legs
and feet, more severe rashes may include blisters on the chest and neck.
Additional symptoms such as eye infections (conjunctivitis) or
ulcers in the mouth, throat or nose may appear. Severe forms of rash can progress to widespread exfoliation
of the skin, which can be fatal. These are often preceded by
headache, fever, muscle pain (flu-like symptoms).
If a rash or these skin symptoms appear, stop treatment with
Isotretinoina difa and contact your doctor immediately.

Musculoskeletal and connective tissue disorders

Very commonjoint pain, muscle pain, back pain
(particularly in children and adolescents)

Very rare
Joint inflammation, calcification of soft tissues (ligaments and
tendons), premature fusion of growing bones, excessive bone tissue formation (exostosis/hyperostosis), reduced bone density, tendinitis, muscle rupture
(rhabdomyolysis).

Metabolism and nutrition disorders

Very rareincreased blood sugar levels (diabetes mellitus), increased
uric acid in the blood

Infections

Very rareBacterial skin and mucous membrane infections

Vascular disorders

Very rare
Inflammation of blood vessels (e.g. Wegener's granulomatosis, allergic vasculitis)

Systemic disorders and administration site conditions

Very rareincreased formation of tissue that can cause scar hyperplasia
after surgery, malaise

Immune system disorders

RareAllergic skin reaction, severe allergic reactions that can cause
shock (anaphylactic reactions), hypersensitivity

Hepatobiliary disorders

Very commonIncreased levels of liver enzymes (see section 2. Before
using Isotretinoina difa)

Very rareliver inflammation

Psychiatric disorders

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

Very rare• Some people have had thoughts or intentions of harming themselves or ending their lives (suicidal ideas), have tried 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 problems.
Your doctor may tell you to stop taking Isotretinoina difa. This may not
be enough to end the effects: you may need further help, and
your doctor can arrange this.

Reproductive system and breast disorders

Frequency not knownproblems achieving or maintaining an erection, decreased libido
Soybean oil can very rarely cause allergic reactions.

Reporting of side effects
If you get any side effects, even those not listed in
this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. r
By reporting side effects you can help provide more information
on the safety of this medicine

5. How to store Isotretinoina difa

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Isotretinoina difa after the expiry date which is stated on the
outer packaging and on the blister. The expiry date refers to the last day of the
month.
Do not store at a temperature above 25°C. Store in the original
packaging to protect the medicine from moisture and light.

IMPORTANT!Return any unused capsules to the pharmacist at the end of
treatment. Store them only if instructed by your doctor.
Medicines should be disposed of through appropriate containers in order to
protect the environment.

6. Other information

What Isotretinoina difa contains
The active ingredient is isotretinoin.
Each capsule contains 40 mg of isotretinoin.

Other ingredients are:
Capsule content:
yellow wax, refined soybean oil, hydrogenated soybean oil, partially hydrogenated soybean oil,
DL-alpha-tocopherol, disodium edetate, butylhydroxytoluene
Capsule shell:
gelatin, glycerol, non-crystallizing liquid sorbitol (E420), sunset yellow (E110),
titanium dioxide (E171)

Description of the appearance of Isotretinoina difa and contents of the
pack:
The soft gelatin capsules are light orange, oval, containing a viscous liquid
of opaque yellow/orange color.
The capsules are contained in blisters of 15, 20, 30, 50 and 60 capsules.
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER
Difa Cooper S.p.A.
Via Milano 160
21042 Caronno Pertusella (Varese)

MANUFACTURER
TOLL MANUFACTURING SERVICES SL CALLE DE LOS ARAGONESES (P I
ALCOBENDAS) 2 28108 ALCOBENDAS (MADRID) SPAIN
Detailed and updated information on this medicine is available at the following
URL address: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home