Isotretinoin Doc Generici: detailed information

Package leaflet: Information for the user

ISOTRETINOINA DOC 10 mg soft capsules, 20 mg soft capsules

Generic medicine
WARNING
CAN CAUSE SEVERE HARM TO THE UNBORN CHILD
Women must use effective contraception
Do not use if you are or think you may be pregnant
Read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What ISOTRETINOINA DOC is and what it is used for
What you need to know before taking ISOTRETINOINA DOC
How to take ISOTRETINOINA DOC
Possible side effects
How to store ISOTRETINOINA DOC
Contents of the pack and other information

1. What ISOTRETINOINA DOC is and what it is used for

ISOTRETINOINA DOC contains isotretinoin – a medicine related to vitamin A, belonging to a group of medicines called retinoids (for the treatment of acne).
ISOTRETINOINA DOC is used to treat severe forms of acne (such as nodular acne or conglobate acne, or acne that may lead to permanent scarring) in adults and adolescents aged 12 years and older, but only after puberty. You will use ISOTRETINOINA DOC when acne does not improve with other anti-acne treatments, including antibiotics and topical skin treatments.
Treatment with ISOTRETINOINA DOC must be supervised by a dermatologist (a doctor specialized in treating skin conditions).

2. What you should know before taking ISOTRETINOINA DOC

Do not use ISOTRETINOINA DOC:

If you are pregnant or breastfeeding.
If there is any possibility that you could become pregnant, you must follow the precautions outlined in the “Pregnancy Prevention Programme” described in the section “Warnings and precautions”.
If you are allergic to isotretinoin, peanuts, or soy, or to any of the excipients of this medicine (listed in section 6).
If you have liver disease.
If you have high levels of fat in your blood (e.g. high cholesterol or triglycerides).
If you have high levels of vitamin A in your body (hypervitaminosis A).
If you are currently being treated with tetracyclines (a type of antibiotic) (see “Other medicines and ISOTRETINOINA DOC”).
If you have previously developed severe skin irritation, skin peeling, blisters, and/or mouth ulcers after using isotretinoin.

If any of these situations apply to you, consult your doctor before taking ISOTRETINOINA DOC.
Warnings and precautions
Talk to your doctor or pharmacist before taking ISOTRETINOINA DOC:
If you have ever had mental health problems, including depression, aggressive tendencies, or mood changes. This also includes thoughts of self-harm or ending your life. This is because your mood may change while you are taking ISOTRETINOINA DOC.
This medicine may cause serious skin reactions. Stop using isotretinoin and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Pregnancy Prevention Programme
Pregnant women must not use ISOTRETINOINA DOC
This medicine can severely harm the unborn baby (it is said to be "teratogenic") – it may cause serious birth defects affecting the brain, face, ears, eyes, heart, and certain glands (thymus and parathyroid glands). It may also likely cause spontaneous abortion. This can occur even if ISOTRETINOINA DOC is used for only a short time during pregnancy.

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

ISOTRETINOINA DOC is prescribed to women who could become pregnant under very strict rules.
This is due to the risk of harm to the unborn baby.
These rules are:

Your doctor must explain the risk of harm to the unborn baby – you must understand that you must not become pregnant and what steps you need to take to avoid pregnancy.
Your doctor must have discussed contraception (birth control) with you. Your doctor will give you information on how to avoid pregnancy. Your doctor may refer you to a specialist for contraceptive counselling.
Before starting treatment, your doctor will instruct you to have a pregnancy test. The test must confirm that you are not pregnant when you start treatment with ISOTRETINOINA DOC.

Women must use an effective contraceptive method before, during, and after using ISOTRETINOINA DOC.

You must agree to use at least one highly reliable contraceptive method (e.g. an intrauterine device or contraceptive implant), or two effective methods that work in different ways (e.g. hormonal contraceptive pill and a condom). Discuss with your doctor which method may be suitable for you.

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You must use contraception for one month before starting ISOTRETINOINA DOC, during treatment, and for one month after treatment ends.
You must use contraception even if you do not have menstrual periods or are not sexually active (unless your doctor tells you it is not necessary).

Women must agree to undergo pregnancy tests before, during, and after using ISOTRETINOINA DOC

You must agree to regular check-ups, preferably every month.
You must agree to regular pregnancy tests, preferably every month during treatment and, since some medicines may remain in your body, one month after stopping ISOTRETINOINA DOC (unless your doctor decides this is not necessary in your case).
You must agree to additional pregnancy tests if your doctor requests them.
You must not become pregnant during treatment or within one month after treatment ends, as some medicines may remain in your body.
Your doctor will discuss all these points with you using a checklist and will ask you (or a relative/guardian) to sign it. This document confirms that you have been informed of the risks and that you will follow the rules outlined above.

If you become pregnant while taking ISOTRETINOINA DOC, stop taking this medicine immediately and contact your doctor. Your doctor may refer you to a specialist for counselling.
Additionally, if you become pregnant within one month after stopping ISOTRETINOINA DOC, you must contact your doctor. Your doctor may refer you to a specialist for counselling.
Your doctor has provided information on pregnancy prevention for users of ISOTRETINOINA DOC, which must be given to you at the time of prescription.
Advice for men: The levels of oral retinoids in the semen of men taking ISOTRETINOINA DOC are too low to harm their partner's unborn baby. However, you must never share your medicine with anyone.
Additional precautions
Never give this medicine to another person. Return any unused capsules to your pharmacist at the end of treatment.
Do not donate blood during treatment with this medicine and for 1 month after stopping ISOTRETINOINA DOC, because it could harm the unborn baby if a pregnant patient receives your blood.
Mental health issues
You may not notice some changes in your mood and behaviour, so it is very important that you inform your friends and family that you are taking this medicine. They may notice these changes and help you quickly identify any problems that you need to discuss with your doctor.
Advice for all patients

Inform your doctor if you have ever had a mental illness (including depression, suicidal behaviour, or psychosis), or if you are taking medicines for any of these conditions.
Serious skin reactions (e.g. erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN)) have been reported with the use of ISOTRETINOINA DOC. The skin rash may rapidly progress to widespread blistering or skin peeling. Also look for mouth, throat, nose, genital ulcers, and conjunctivitis (red and swollen eyes).
Rarely, ISOTRETINOINA DOC may cause severe allergic reactions, some of which may affect the skin in the form of eczema, hives, bruising, or red spots on arms and legs.

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If you develop an allergic reaction, stop taking ISOTRETINOINA DOC, consult a doctor immediately, and inform them that you are taking this medicine.

Reduce intense exercise and physical activity. ISOTRETINOINA DOC may cause muscle and joint pain, particularly in children and adolescents who engage in intense physical activity.
Contact your doctor if you experience persistent lower back or buttock pain during treatment with ISOTRETINOINA DOC. These symptoms may indicate sacroiliitis, an inflammatory back pain. Your doctor may stop treatment with ISOTRETINOINA DOC and refer you to a specialist for management of inflammatory back pain. Some evaluations may be needed, including imaging diagnostics such as magnetic resonance imaging (MRI).
ISOTRETINOINA DOC has been associated with inflammatory bowel disease. Your doctor will stop your treatment with ISOTRETINOINA DOC if you develop severe diarrhoea without prior gastrointestinal problems.
ISOTRETINOINA DOC may cause dry eyes, intolerance to contact lenses, and visual difficulties, including reduced night vision. Cases of dry eyes that did not resolve after stopping treatment have been reported. Inform your doctor if you experience any of these symptoms. Your doctor may recommend using an eye lubricating ointment or artificial tear therapy. If you wear contact lenses and have developed intolerance, you may be advised to wear glasses during treatment. Your doctor may refer you to a specialist if you develop visual difficulties and may ask you to stop treatment with ISOTRETINOINA DOC.
Benign intracranial hypertension has been reported with the use of ISOTRETINOINA DOC, and in some cases when ISOTRETINOINA DOC was used together with tetracyclines (a type of antibiotic). Stop taking ISOTRETINOINA DOC and contact your doctor urgently if you develop symptoms such as headache, nausea, vomiting, or visual disturbances. Your doctor may refer you to a specialist to check for swelling of the optic disc in your eye (papilledema).
ISOTRETINOINA DOC may increase liver enzyme levels. Your doctor will perform blood tests before, during, and after treatment with ISOTRETINOINA DOC to monitor these levels. If they remain elevated, your doctor may reduce the dose or stop ISOTRETINOINA DOC.
ISOTRETINOINA DOC commonly increases levels of fats, such as cholesterol or triglycerides. Your doctor will test these levels before, during, and after treatment with ISOTRETINOINA DOC. It is best not to drink alcoholic beverages or at least reduce your usual intake during treatment. Inform your doctor if you already have high fat levels in your blood, diabetes (high blood sugar), are overweight, or have alcohol dependence. You may need more frequent blood tests. If fat levels remain high, your doctor may reduce your dose or stop ISOTRETINOINA DOC.
Inform your doctor if you have any kidney problems. Your doctor may start you on a lower dose of ISOTRETINOINA DOC and then increase it to the maximum tolerated dose.
Inform your doctor if you have fructose intolerance. Your doctor will not prescribe ISOTRETINOINA DOC if you have fructose or sorbitol intolerance.
ISOTRETINOINA DOC may increase blood sugar levels. In rare cases, people may develop diabetes. Your doctor may monitor your blood sugar levels after treatment, especially if you already have diabetes, are overweight, or have alcohol dependence.
Your skin may become drier. Use moisturising lotions or creams and a lip balm during treatment. To prevent skin irritation, avoid using exfoliating or anti-acne products.
Avoid excessive sun exposure and do not use sunlamps or sunbeds. Your skin may become more sensitive to light. Before going out in the sun, use a sunscreen with a high protection factor (SPF 15 or higher).
Do not undergo any cosmetic skin treatments. ISOTRETINOINA DOC may make your skin more fragile. Do not wax (depilate), or undergo dermabrasion (to remove calloused skin or scars) during treatment or for at least 6 months after treatment. These procedures may cause scarring, skin irritation, or rarely, skin colour changes.

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Children and adolescents
The use of ISOTRETINOINA DOC in children under 12 years of age is not recommended. This is because it is not known whether it is safe or effective in this age group.
ISOTRETINOINA DOC must not be used to treat acne in children under 12 years of age.
Other medicines and ISOTRETINOINA DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal products and those without a prescription.

Do not take vitamin A supplements or tetracyclines (an antibiotic), or use topical acne treatments while taking ISOTRETINOINA DOC. Moisturisers and emollients (skin creams or preparations that prevent water loss and soften the skin) may be used.
Avoid topical keratolytic or exfoliating anti-acne agents while taking ISOTRETINOINA DOC.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to have a baby, ask your doctor for medical advice before taking this medicine.
For further information on contraception, pregnancy, and breastfeeding, see section 2 “Pregnancy Prevention Programme”.
Driving and using machines
You may have poor night vision during treatment. This may occur suddenly. Rarely, this persists after treatment ends. Very rarely, drowsiness and dizziness have been reported. If this happens to you, do not drive or operate machinery.
ISOTRETINOINA DOC contains

soybean seed oil. If you are allergic to peanuts or soy, do not use this medicine.
Sorbitol: sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which a person cannot metabolise fructose, talk to your doctor before you (or your child) take or receive this medicine. ISOTRETINOINA DOC 10 mg: this medicine contains up to 5 mg of sorbitol in each soft capsule. ISOTRETINOINA DOC 20 mg: this medicine contains up to 7 mg of sorbitol in each soft capsule.
ISOTRETINOINA DOC 10 mg: Ponceau 4R. May cause allergic reactions.
ISOTRETINOINA DOC 20 mg: Sunset Yellow FCF. May cause allergic reactions.

3. How to use ISOTRETINOINA DOC

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual starting dose is 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day).
Therefore, if you weigh 60 kg, your usual starting dose will be 30 mg per day.
Take the capsules once or twice daily.
Take them with food. Swallow the capsules whole with a drink or a portion of food.
After a few weeks, your doctor may adjust the dose. This depends on how the treatment progresses. For most patients, the dose ranges between 0.5 and 1.0 mg/kg per day. If you think that ISOTRETINOINA DOC is too strong or too weak, speak to your doctor or pharmacist.
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If you have severe kidney problems, you will start with a lower dose (such as 10 mg per day), which will then be increased to the highest dose your body can tolerate.
If your body cannot tolerate the recommended dose, a lower dose may be prescribed: this may mean that your treatment lasts longer and that acne is more likely to recur.
Normally, a treatment cycle lasts from 16 to 24 weeks. Most patients require only one treatment cycle. Your acne may continue to improve for up to 8 weeks after treatment ends. Usually, a new treatment cycle will not begin until this time has passed.
Some people find that acne worsens during the first few weeks of treatment. Usually, it improves as treatment continues.
If you take more ISOTRETINOINA DOC than you should
If you take too many capsules or if someone accidentally takes the medicine, contact your doctor, pharmacist, or nearest hospital immediately.
If you forget to take ISOTRETINOINA DOC
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue as before. Do not take a double dose (two doses together) to make up for a forgotten dose.
If you have any questions 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 experiences them.
Some of the side effects associated with isotretinoin use are dose-related. Side effects are generally reversible after dose adjustment or discontinuation of treatment; however, some may persist after treatment has been stopped.
Some side effects can be serious and require immediate medical attention.

Side effects requiring immediate medical attention:

Skin problems
Stop using isotretinoin and contact your doctor immediately if you notice any of the following symptoms of severe skin reactions:
Frequency not known (frequency cannot be estimated from the available data):

Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), potentially life-threatening conditions requiring immediate medical attention. These initially appear as flat, red patches, target-shaped or circular, often with central blisters, typically on arms and hands or legs and feet. More severe rashes may include blisters on the chest and back. Additional symptoms may include eye infections (conjunctivitis), or mouth, throat, or nose ulcers. Severe forms of skin rash may progress to widespread skin peeling, which can be life-threatening. These severe skin rashes are often preceded by headache, fever, and body aches (flu-like symptoms).
A widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. These symptoms usually occur early in treatment (generalized pustular eruption (GPP)).

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If you develop a severe skin rash or these skin symptoms, stop taking ISOTRETINOINA DOC and contact your doctor immediately.

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

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

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

Some people have had thoughts or intentions of harming themselves or ending their life (suicidal ideation), have attempted suicide, or have died by suicide. These individuals may not appear depressed.
Unusual behaviour.
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 any of these mental health symptoms. Your doctor may instruct you to stop taking ISOTRETINOINA DOC. This may not be sufficient to stop the effects—you may need further help, and your doctor can ensure this is provided.

Allergic reactions
Rare side effects (may affect up to 1 in 1,000 people):

Severe (anaphylactic) reactions: difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, and mouth. Sudden swelling of hands, feet, and ankles may also occur.

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

Sudden chest tightness, shortness of breath, and wheezing, particularly if you have asthma.

If you experience a severe allergic reaction, seek immediate medical help. If you have an allergic reaction, stop taking ISOTRETINOINA DOC and contact your doctor.

Bones and muscles
Frequency not known (frequency cannot be estimated from the available data):

Muscle weakness, which may be potentially life-threatening, may be associated with difficulty moving arms or legs, painful, swollen, and bruised areas of the body, dark-coloured urine, reduced or absent urine output, confusion, or dehydration. These are signs of rhabdomyolysis, a breakdown of muscle tissue that may lead to kidney failure. This may occur if you engage in intense physical activity during treatment with ISOTRETINOINA DOC.
Sacroiliitis, a type of inflammatory back pain causing buttock or lower back pain.

Liver or kidney problems
Very rare side effects (may affect up to 1 in 10,000 people):

Yellowing of the skin or eyes and feeling tired. These may be signs of hepatitis. Stop taking ISOTRETINOINA DOC immediately and contact your doctor.
Difficulty urinating (passing urine), swollen eyelids, feeling excessively tired. These may be signs of kidney inflammation. Stop taking ISOTRETINOINA DOC immediately and contact your doctor.

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

Persistent headache with nausea, vomiting, or changes in vision including blurred vision. These may be signs of benign intracranial hypertension, especially if ISOTRETINOINA DOC is taken with antibiotics called tetracyclines. Stop taking ISOTRETINOINA DOC immediately and contact your doctor.

Stomach and intestinal problems
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Very rare side effects (may affect up to 1 in 10,000 people):

Severe abdominal pain, with or without severe bloody diarrhoea, nausea, and vomiting. These may be signs of a serious intestinal condition. Stop taking ISOTRETINOINA DOC immediately and contact your doctor.

Frequency not known (frequency cannot be estimated from the available data):

Anal fissure (a small tear in the thin, moist tissue lining the anus).

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

Blurred vision. If you experience this, stop taking ISOTRETINOINA DOC immediately and contact your doctor. If your vision is affected in any other way, inform your doctor as soon as possible.

Other side effects

Very common side effects with ISOTRETINOINA DOC (may affect more than 1 in 10 people):

Dry skin, particularly on the lips and face; inflamed skin, chapped and inflamed lips, skin rash, mild itching, and mild peeling. Use a moisturising cream from the start of treatment.
Skin becoming more fragile and reddened than usual, especially on the face.
Back pain; muscle or joint pain, particularly in children and adolescents. To avoid worsening bone or muscle problems, reduce intense physical activity during treatment with ISOTRETINOINA DOC.
Inflammation of the eyes (conjunctivitis) and eyelid area; dry, irritated eyes. Ask your pharmacist for a suitable eye drop. If your eyes become dry and you wear contact lenses, you may need to switch to glasses.
Increased liver enzymes detected in blood tests.
Altered blood fat levels (including HDL cholesterol or triglycerides).
Bruising, bleeding, or clotting more easily—if blood clotting cells are affected.
Anaemia—weakness, dizziness, pale skin—if red blood cells are affected.

Common side effects with ISOTRETINOINA DOC (may affect up to 1 in 10 people):

Headache.
Elevated cholesterol levels in the blood.
Protein or blood in the urine.
Increased risk of infections if white blood cells are affected.
Dry, crusted nasal lining, causing mild nosebleeds.
Allergic reactions such as skin rash, itching. If you have an allergic reaction, stop taking ISOTRETINOINA DOC and contact your doctor.

Rare side effects with ISOTRETINOINA DOC (may affect up to 1 in 1,000 people):

Hair loss (alopecia). This is a temporary reaction. Your hair will return to normal after treatment ends.
Allergic skin reactions such as rashes and itching. If you have an allergic reaction, stop taking ISOTRETINOINA DOC and contact your doctor.

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

Reduced night vision; colour blindness and worsening of colour vision.
Increased sensitivity to light—you may need to wear sunglasses to protect your eyes from strong sunlight.

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Other vision problems include blurred vision, distorted vision, cloudy surface of the eye (corneal opacity, cataract), intolerance to contact lenses, and inflammation of the cornea (keratitis).
Excessive thirst; frequent need to urinate. These may be signs of diabetes.
Worsening of acne in the first few weeks, although symptoms improve over time.
Inflamed, swollen, or darker-than-usual skin, especially on the face, skin rash (exanthema), discoloured skin, easily bleeding red bumps on the skin (pyogenic granuloma).
Excessive sweating or itching.
Arthritis; bone disorders (growth delay, excessive growth, and changes in bone density); growing bones may stop growing.
Calcium deposits in soft tissues, painful tendons, elevated levels of muscle breakdown products in the blood, especially if engaging in intense exercise.
Increased light sensitivity.
Bacterial infection at the base of the nails, nail changes.
Swelling, discharge, pus.
Thickening of scars following surgery.
Increased body hair.
Seizures, drowsiness, dizziness.
Swollen lymph glands.
Dry throat, hoarseness.
Hearing difficulties.
General feeling of being unwell.
Elevated uric acid levels in the blood.
Bacterial infections.
Inflammation of blood vessels (sometimes with bruising, red patches).

Frequency not known (frequency cannot be estimated from the available data):

Dark or cola-coloured urine.
Problems achieving or maintaining an erection.
Decreased libido.
Breast enlargement with or without tenderness in men.
Vaginal dryness.
Inflammation of the urethra.

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

5. How to store ISOTRETINOIN DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Store below 30°C.
Store in the original packaging and keep the blisters in the box to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Return unused capsules to the pharmacist. Store them only if instructed by your doctor.
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6. Package contents and other information

What ISOTRETINOINA DOC contains

The active substance is isotretinoin.
The other ingredients are: all-rac-alpha-tocopheryl acetate, hydrogenated vegetable oil (type II), hydrogenated soybean oil, yellow beeswax (E901), refined soybean oil. Capsule shell: gelatin (E441), glycerol (E422), partially dehydrated liquid sorbitol, titanium dioxide (E171) and purified water. For the 10 mg capsule: Patent Blue V (E131) and Ponceau 4R (E124). For the 20 mg capsule: Sunset Yellow FCF (E110).

Description of the appearance of ISOTRETINOINA DOC and package contents
ISOTRETINOINA DOC is available in soft capsules containing 10 mg or 20 mg of isotretinoin.
ISOTRETINOINA DOC 10 mg: soft oval, violet capsules, size 3. The capsule length is approximately 11.1 mm and the width approximately 6.8 mm.
ISOTRETINOINA DOC 20 mg: soft oval capsules, colour ranging from off-white to cream, size 6. The capsule length is approximately 13.8 mm and the width approximately 8.1 mm.
Orange PVC/TE/PVdC-aluminum blister.
Soft capsules 10 mg
Pack sizes: 30 capsules
Soft capsules 20 mg
Pack sizes: 0 capsules
Not all pack sizes may be marketed.
Marketing Authorization Holder:
DOC Generici Srl - Via Turati 40, 20121 Milan - Italy
Manufacturers:
GAP S.A. - Agissilaou 46 - 173 41 Agios Dimitrios - Greece
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Netherlands: Isotretinoïne DOC 10 mg, 20 mg zachte capsules
Italy: ISOTRETINOINA DOC
Detailed and updated information on this medicinal product is available at the following website
https://www.aifa.gov.it/-/nota-informativa-importante-sui-retinoidi-orali-acitretina-alitretinoina-e-
isotretinoina-.
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