ISOTIORGA 10 mg Soft Capsule

Зміст інструкції

1. Isotiorga 10 mg soft capsules, 20 mg soft capsules
   1. What is Isotiorga and what is it used for
   2. What you need to know before taking Isotiorga
   3. How to take Isotiorga
   4. Possible side effects
   5. How to store Isotiorga
   6. Contents of the pack and other information

Isotiorga 10 mg soft capsules, 20 mg soft capsules

Isotretinoin

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

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

1. What is Isotiorga and what is it used for

Isotiorga contains isotretinoin, an active ingredient similar to vitamin A, belonging to a
class of medicines known as retinoids(for the treatment of acne).

Isotiorga is indicated for the treatment of severe forms of acne(such as nodular acne and acne

conglobata or acne with a risk of permanent scarring)in adults and adolescents
starting from 12 years of age and only after puberty. Isotiorga must be taken when acne
does not improve with anti-acne treatments, including antibiotics and topical treatments.

Treatment with Isotiorga must be taken under the supervision of a dermatologist
(a doctor specializing in the treatment of skin problems).

2. What you need to know before taking Isotiorga

Do not take Isotiorga

• If you are pregnant or breastfeeding
• If there is any possibility that you may become pregnant, you must take the precautions described in the "Pregnancy Prevention Program" in the "Warnings and precautions" section
• If you are allergic to isotretinoin, peanuts, soy or any of the other ingredients of this medicine (listed in section 6)
• If you have liver problems
• If you have high levels of lipids in your blood (cholesterol, triglycerides)
• If you have excessively high levels of vitamin A in your body (hypervitaminosis A)
• If you are taking tetracyclines (a type of antibiotic) (see "Other medicines and Isotiorga")

If any of these apply to you, return to your doctor before taking Isotiorga.

Warnings and precautions
Talk to your doctor before taking Isotiorga.

• If you have suffered from any 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 you are taking Isotiorga.

Pregnancy Prevention Program
Pregnant women must not use Isotiorga
This medicine can seriously harm the fetus (it is said to be "teratogenic") – it can
cause abnormalities in the unborn baby to the brain, face, ear, eye, heart and some
glands (thymus and parathyroid glands). It can also likely induce abortion. This
can happen even if Isotiorga is used for a short time during pregnancy.

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

For women who can become pregnant, Isotiorga is prescribed with very
strict rules. This is due to the risk of 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 get 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 Isotiorga.

Women must use effective contraception before, during and after
using Isotiorga

• 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 contraception for one month before using Isotiorga, during treatment and for one month after the end of treatment.
• You must use contraception even if you do not have your period or 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 Isotiorga

• You must agree to undergo regular check-ups, 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 Isotiorga (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 following month 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 Isotiorga, stop taking
this medicine immediatelyand see your doctor. The doctor may send you to a specialist
for a consultation.
Also, if you become pregnant within one month of stopping Isotiorga, you should
contact your doctor. The doctor may send you to a specialist for a consultation.

The doctor has written information on pregnancy prevention for
users of Isotiorga that they should provide to you.
For further treatment, a new prescription is required. Each prescription is valid for 7
days.

Advice for men
Levels of oral retinoids in the semen of men usingIsotiorga are 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 Isotiorga as if a pregnant patient were to receive your
blood, it could harm her fetus.
Mental health problems
You may 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
may notice these changes and help you identify problems that need to be discussed with the doctor.

Advice for all patients

• Tell your doctor if you suffer or have suffered from any mental illness(including depression, suicidal behavior or psychosis) or if you are taking medicines for any of these conditions.
• Severe skin reactions(e.g. erythema multiforme (EM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported with the use ofIsotiorga.The skin rash may develop into widespread blisters or peeling of the skin. Ulcers may also appear in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
• Rarely, Isotiorga can cause severe allergic reactions,some of which may affect the skin in the form of eczema, hives and bruises or red spots on arms and legs. If you develop an allergic reaction, stop taking Isotiorga, seek medical attention urgently and tell them that you are taking this medicine.
• Reduce exercise or intense physical activity.Isotiorga can cause muscle and joint pain, especially in children and adolescents who engage in intense physical activity.
• See your doctor if you experience persistent pain in the lower back or buttocks during treatment with Isotiorga. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. The doctor may stop the therapy with Isotiorga and refer you to a specialist for treatment of inflammatory back pain. Further assessments may be necessary, including the use of imaging such as magnetic resonance imaging (MRI).
• Isotiorga has been associated with inflammatory bowel disease.Your doctor will stop taking Isotiorga if you experience severe diarrhea with blood without having suffered from gastrointestinal disorders in the past.
• Isotiorga can cause dry eyes, contact lens intolerance andvisual disturbances, including reduced night vision.Cases of dry eyes that have not resolved after discontinuation of therapy have been reported .Tell your doctor if you experience any of these symptoms. The doctor may ask you to apply an eye ointment to moisturize or artificial tears. If you wear contact lenses and have developed contact lens intolerance, you may be advised to wear glasses during the duration of treatment. The doctor may refer you to a specialist for a consultation if you experience visual disturbances and you may be asked to stop treatment with Isotiorga.
• Benign intracranial hypertension has been reported with the use of Isotiorgaand in some cases of concomitant therapy of Isotiorga with tetracyclines (a type of antibiotic). Stop taking Isotiorga and see your doctor as soon as possible if you develop symptoms such as headache, nausea, vomiting and visual disturbances. The doctor may refer you to a specialist to check for swelling of the optic disc (papilledema).
• Isotiorga can increase liver enzyme levels.The doctor will perform blood tests before, during and at the end of treatment with Isotiorga to check liver values. If they remain high, the doctor may reduce the dose or stop Isotiorga therapy.
• Isotiorga increases commonly the levels of fats in the blood,such as cholesterol or triglycerides. The doctor will monitor these levels before, during and after therapy with

Isotiorga. During treatment, it is advisable not to drink alcoholic beverages or at
least reduce the amount usually consumed. Tell your doctor if you have high
levels of fats in the blood, if you suffer from diabetes (high blood sugar), if you are overweight or if you are
a heavy drinker. The doctor may prescribe you more frequent blood tests. If the levels of fats in the blood remain high, the doctor can
reduce the dose or stop Isotiorga therapy.

• Tell your doctor if you have kidney problems.The doctor may start treatment with a lower dose of Isotiorga and then increase it to the maximum tolerated dose.
• Tell your doctor if you suffer from fructose intolerance.The doctor will not prescribe Isotiorga if you have been diagnosed with fructose or sorbitol intolerance.
• Isotiorga can increase blood sugar levels.Rarely, new cases of diabetes have been reported. The doctor may monitor blood sugar levels during treatment, especially if you already have diabetes, are overweight or are a heavy drinker.
• Skin dryness can occur.Use a moisturizer or cream for the skin and a lip balm during treatment. Avoid using exfoliating or anti-acne products to avoid skin irritation.
• Avoid prolonged exposure to the sun and avoid using sun lamps or tanning beds.The skin may be more sensitive to sunlight. Before sun exposure, use a sunscreen with a high protection factor (15 SPF or higher).
• Avoid dermatological cosmetic treatments.Isotiorga may increase the fragility of the skin. Avoid waxing (hair removal). Also avoid dermabrasion or laser treatments (removal of calloused skin or scars) during treatment and for at least 6 months after discontinuation. These procedures may cause scarring, skin irritation or, rarely, changes in skin pigmentation. Children and adolescentsIsotiorga is not recommended in children under the age of 12. This is because it is not known whether it is safe or effective in this age group. Use in children over 12 years of age only after puberty.Other medicines and IsotiorgaTell your doctor or pharmacist if you are taking, have recently taken or may take any other medicine.
• Do not take vitamin A supplements or tetracyclines(a type of antibiotic)
• Do notuse any medicine with anti-acne action during Isotiorga therapy. Moisturizing and emollient creams (creams or preparations for the skin that prevent water loss and have a softening effect on the skin) can be applied. Pregnancy, breastfeeding and fertilityIf you are or think you may be pregnant, if you are breastfeeding or if you are planning a pregnancy, ask your doctor for advice before taking this medicine. For further information on pregnancy and contraception, see section 2 "Pregnancy Prevention Program". Driving and using machinesNight vision may be affected during treatment. This may occur without warning. In rare cases, this problem can persist after the end of treatment. Very rarely, dizziness and visual disturbances have been reported. If these disorders have occurred, you should not drive or operate machinery.

have occurred,
you should not drive or operate machinery.

Isotiorga contains

• soybean 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 diagnosed you (or your child) with an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which a person cannot break down fructose, consult your doctor before taking (or before your child receives) this medicine.
• Isotiorga 10 mg: this medicine contains up to 5 mg of sorbitol per soft capsule.
• Isotiorga 20 mg:this medicine contains up to 7 mg of sorbitol per soft capsule.
• Isotiorga 10 mg: Ponceau 4R.May cause allergic reactions.
• Isotiorga 20 mg: FCF Yellow Sunset.May cause allergic reactions.

3. How to take Isotiorga

Always take this medicine exactly as your doctor has instructed. If you have any doubts, ask your doctor or pharmacist for advice.
The usual starting doseis 0.5 mg per kilogram of body weight per day (0.5
mg/kg/day). Therefore, if you weigh 60 kg, your starting dose will probably be 30 mg per day.

Take the capsules once or twice a day.Take the capsules with a full stomach.
Swallow the capsules whole, with some liquid or food.

After a few weeks, your doctor may adjust the dose.This depends on your response to
treatment. For most patients, the dose is between 0.5 and 1.0 mg/kg per
day. If you think that the effect of Isotiorga is too strong or too weak, tell your
doctor or pharmacist.

In patients with severe kidney problems,treatment usually starts with a reduced dose
(for example 10 mg/day) which will be increased to the maximum tolerated dose. In patients who
cannot tolerate the recommended dose, your doctor may prescribe treatment at a reduced
dose. In such cases, the treatment will be longer and there will be a higher risk of relapse.

The duration of treatment is typically 16-24 weeks.Most patients
only need a single course of treatment. Acne may continue to improve for up to 8
weeks after the end of treatment. Therefore, you should not start a new course of
treatment before at least this period has elapsed.
Some people experience a worsening of acne during the first few weeks of
treatment. The situation usually improves with continued treatment.

If you take more Isotiorga than you should
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 take Isotiorga
If you forget a dose, take it as soon as possible. However, if it is close to the time of the next
dose, skip the missed dose and continue your treatment as normal. Do not take a double dose
(two doses one after the other) to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some of the side effects associated with the use of isotretinoin are dose-related. Side effects are generally reversible after dose modification or discontinuation of treatment, however, some may persist after
stopping therapy. Some side effects can be serious and require immediate medical attention. The doctor can help you cope with the situation.

Side effects that require immediate medical care:
Skin problems
Frequency not known(cannot be defined based on available data)

• Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), which are potentially life-threatening and require immediate medical intervention. These initially appear as circular patches often with blisters in the center, usually 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. Further symptoms such as eye infections (conjunctivitis) or ulcers in the mouth, throat or nose may occur. Severe forms of rashes can evolve into very extensive peeling which can be life-threatening. These severe skin rashes are often preceded by headache, fever, body aches (flu-like symptoms). If you develop a rash or these skin symptoms, stop therapywith Isotiorga and contact your doctor immediately.Mental problemsRare 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 and 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 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.The doctor may tell you to stop taking Isotiorga. This may not be enough to end the effects: you may need further help and your doctor can arrange this. Allergic reactionsRare effects(may affect up to 1 in 1,000 people)
• Severe (anaphylactic)reactions: difficulty breathing or swallowing caused by sudden swelling of the throat, face, lips and mouth. Sudden swelling also of hands, feet and ankles. Very rare effects(may affect up to 1 in 10,000 people)
• Sudden chest tightness with shortness of breath and dyspnea, especially in patients with asthma. If you experience a severe reaction, go to the emergency room immediately.In case of an allergic reaction, stop taking Isotiorga and contact your doctor. Bones and musclesFrequency not known(cannot be defined based on available data)
• Muscle weakness potentially life-threatening, may be associated with difficulty moving arms or legs, sore, swollen or bruised areas of the body, dark urine, decreased or absent urination, confusion or dehydration. These are signs of rhabdomyolysis, an injury to muscle tissue that can lead to kidney failure. This can occur if you engage in strenuous physical activity during therapy with Isotiorga. Liver and kidney problemsVery rare effects(may affect up to 1 in 10,000 people)
• Yellowing of the skin or eyes and drowsiness. These may be signs of hepatitis. Stop taking Isotiorga immediately and contact your doctor.
• Difficulty urinating (passing urine), swollen eyelids, severe fatigue. These may be signs of kidney inflammation. Stop taking Isotiorga immediately and contact your doctor.Nervous system problemsVery rare effects(may affect up to 1 in 10,000 people)
• Persistent headache, accompanied by feeling unwell (nausea), being sick (vomiting)and changes in vision including blurred vision. These may be signs of benign intracranial hypertension,especially if Isotiorga is taken together with antibiotics called tetracyclines. Stop takingIsotiorga immediately and contact your doctor.Intestinal and stomach problemsVery rare effects(may affect up to 1 in 10,000 people)
• Severe abdominal pain (stomach ache), with or without severe bloody diarrhea, feeling unwell (nausea)and being sick (vomiting). These may be signs of serious intestinal diseases. Stop taking Isotiorga immediately and contact your doctor.Eye disordersVery rare effects(may affect up to 1 in 10,000 people)
• Blurred vision. If you have blurred vision, stop taking Isotiorga immediately and contact yourdoctor.If your vision is altered in any other way, contact a doctor as soon as possible. Other side effects:Very common side effects associated with Isotiorga:(may affect more than 1person in 10)
• Dry skin, especially on the lips and face, skin inflammation, chapped and inflamed lips, rash, mild itching and mild flaking. Apply a moisturizing cream from the start of treatment.
• The skin becomes more fragile and red than usual, especially on the face.
• Back pain; muscle pain; joint pain, especially in children and adolescents. To avoid worsening any bone or muscle problems,reduce intense physical activity during therapy with Isotiorga.
• Inflammation of the eye (conjunctivitis) and the eyelid area; eyes are dry and irritated. Ask your pharmacist for a suitable eye drop. If you suffer from dry eyes and wear contact lenses, you may need to wear glasses.
• Increased liver enzymes observed in blood tests.
• Altered levels of fats in the blood (including HDL or triglycerides).
• More prone to bruising, bleeding or clotting - if platelets are affected.
• Anemia - weakness, dizziness, paleness - if red blood cells are affected. Common side effects associated with Isotiorga:(may affect up to 1 in 10 people)
• Headache.
• Increased cholesterol in the blood.
• Excretion of blood or protein in the urine.
• More prone to infections if white blood cells are affected.
• The nasal mucosa becomes dry and crusty, causing mild nosebleeds.
• Irritation or inflammation of the throat and nose.
• Allergic reactions such as rash, itching. In case of an allergic reaction, stop taking Isotiorga and contact your doctor. Rare side effects associated with Isotiorga:(may affect up to 1 in
• 1,000)
• Hair loss (alopecia). This is usually a temporary effect. Hair should return to normal at the end of treatment. Very rare side effects associated with Isotiorga:(may affect up to 1 in10,000)
• Night vision may be impaired, worsening of color blindness and color vision.
• May increase sensitivity to light; you may need to wear sunglasses to protect your eyes from too much sunlight.
• Other vision problems, including blurred vision, distorted vision, cloudy eye surface (corneal opacity, cataracts).
• Excessive thirst; frequent urination; blood tests reveal increased blood sugar levels. These may be signs of diabetes.
• Worsening of acne in the first few weeks, but symptoms should subside over time.
• Inflamed, swollen and more pigmented skin than usual, especially on the face.
• Excessive sweating or itching.
• Arthritis; bone disorders (delayed growth, excessive growth and changes in bone density); bone growth may stop in forming bones.
• Calcium deposits in soft tissues, tendon pain, high levels of muscle breakdown products in the blood in case of intense physical activity.
• Increased sensitivity to light.
• Bacterial infections at the base of the nail, nail changes.
• Swelling, secretions, pus.
• Thickening of scars after surgery.
• Increased body hair.
• Convulsions, drowsiness, dizziness.
• Lymph nodes may swell.
• Dry throat, hoarseness.
• Hearing impairment.
• General feeling of unwellness.
• High levels of uric acid in the blood.
• Bacterial infections.
• Inflammation of blood vessels (sometimes with bruising, red spots).

Frequency not known:Frequency not known (cannot be defined based on the data

available)

• Dark or the-colored urine.
• Problems getting or maintaining an erection
• Decreased libido
• Enlargement of the breasts with or without tenderness in men
• Vaginal dryness
• Sacroiliitis, a type of inflammatory back pain that causes pain in the buttocks or lower back
• Inflammation of the urethra

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 help provide more information on
the safety of this medicine.

5. How to store Isotiorga

Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the packaging next to EXP. The expiry date refers to the last day of that month.
• Do not use this medicine if you observe damage or signs of tampering on the packaging.
• Do not store at a temperature above 25 °C.
• Store in the original packaging and keep the blister in the box to protect it from light.
• 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. Return any unused capsules to the pharmacist.Store them only as directed by your doctor.

6. Contents of the pack and other information

What Isotiorga contains
The active ingredient is isotretinoin.
The other excipients are: all-rac-alpha-tocopheryl acetate, hydrogenated vegetable oil (type II), hydrogenated
soybean oil, yellow beeswax, refined soybean oil, gelatin, glycerol,
partially dehydrated liquid sorbitol, titanium dioxide (E-171), Patent Blue V (E-131) and
Ponceau 4R (E-124) for the 10 mg capsule, Yellow Sunset FCF (E-110) for the
20 mg capsule & purified water.

Description of Isotiorga and contents of the pack
Isotiorga is available in soft capsules containing 10 mg or 20 mg of isotretinoin.
Isotiorga 10 mg: oval, purple soft capsules, size 3. The capsule is approximately 11.1 mm long and 6.8 mm wide.
Isotiorga 20 mg: oval, off-white soft capsules, size 6. The capsule is approximately 13.8
mm long and 8.1 mm wide.
PVC/TE/PVdC blister /orange aluminum foil.

Soft capsules 10 mg
Packs: 30, 50, 60 and 100 capsules

Soft capsules 20 mg
Packs: 30, 50, 60 and 100 capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Laboratoires Bailleul S.A.
10-12 Avenue Pasteur
L-2310 Luxembourg
LUXEMBOURG

Manufacturer
GAP S.A.
46, Agissilaou str.,
173 41 Agios Dimitrios, Attiki,
Greece

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
Austria Isotiorga 10 mg, 20 mg, 40 mg Weichkapseln
Belgium Isotiorga 10 mg, 20 mg soft capsules/Weichkapseln/zachte capsules
Czech
Republic
Asotiorga
Estonia Isotiorga
Germany Isotiorga 10 mg, 20 mg Weichkapseln
Greece Isotretinoin/Bailleul 20 mg, 40 mg καψάκιο, μαλακό
Hungary Isotiorga 20 mg lágy kapszula
Italy Isotiorga
Luxembourg Isotiorga 20 mg soft capsules
Portugal Isotiorga 10 mg, 20 mg cápsulas molle
Romania Isotiorga 10 mg, 20 mg caps moi
Slovak
Republic
Isotiorga 20 mg mäkké kapsuly
Spain Isotiorga 20 mg, 40 mg cápsulas blandas