ISDIBEN 5 mg Miękkie Kapsułki

Treść ulotki

1. Isdiben 5 mg, 10 mg, 20 mg, 40 mg soft capsules
   1. What Isdiben is and what it is used for
   2. What you need to know before taking Isdiben
   3. How to take Isdiben
   4. Possible side effects
   5. How to store Isdiben
   6. Package Contents and Other Information

Isdiben 5 mg, 10 mg, 20 mg, 40 mg soft capsules

isotretinoin
Generic medicine

WARNING
MAY CAUSE SERIOUS FETAL HARM
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 you start to take 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 could be harmful.
• If you get any side effects, see your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Isdiben is and what it is used for

Isdiben contains isotretinoin.

• Isotretinoin is related to vitamin A.
• It belongs to a group of medicines called “retinoids”.

Isotretinoin is used for the treatment of severe types of acne

• These types of acne can cause permanent scarring
• These types of acne are also called “nodular” acne or “conglobate” acne. Isotretinoin is used when your acne has not improved with other treatments, which include antibiotics and skin treatments.

Your treatment must take place under the supervision of a specialist doctor, called a “dermatologist”,
specialized in the treatment of skin problems.

2. What you need to know before taking Isdiben

Consult your doctor if you experience persistent pain in the lower back or buttocks
during treatment with Isdiben. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may interrupt therapy with Isdiben and refer you
to a specialist for the treatment of inflammatory back pain. Further evaluations may be necessary, including the use of imaging diagnostics, such as
magnetic resonance imaging (MRI).

Do not take Isdiben if:

• you are allergic to peanuts or soy or any of the other ingredients of Isdiben. This medicine contains soy oil, in addition to isotretinoin. See section 6 (further information) at the end of this leaflet for a complete list of ingredients
• there is any possibility that you may become pregnant, you must take the precautions outlined in the “Pregnancy Prevention Program” in the “Warnings and precautions” section
• you are pregnant or breastfeeding
• you have been diagnosed with liver problems
• you have been diagnosed with very high levels of fats in the blood (such as high cholesterol or triglycerides)
• you have been diagnosed with very high levels of vitamin A in the body (a condition called “hypervitaminosis A”)
• you are simultaneously being treated with tetracyclines (a type of antibiotic) (see the “Other medicines and Isdiben” section)

If any of the above points apply to you, return to your doctor and do not take this medicine. Talk to your
doctor before taking it.

Use in young people over 12 years.

• Do not give this medicine to children under 12 years of age. Give it only to young people over 12 years of age if they have completed all the changes of puberty.

Special precautions with Isdiben
Do not take this medicine if you are pregnant.

Pregnancy Prevention Program
Pregnant women should not use Isdiben
This medicine can seriously harm the fetus (it is said to be “teratogenic”), it can cause
birth defects in the baby's brain, face, ear, eye, heart and some glands (thymus and
parathyroid glands). It can also likely induce abortion. This can happen even if
Isdiben is used for only a short time during pregnancy.

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

Isdiben is prescribed to women who may become pregnant 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 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 Isdiben. Women must use an effective contraceptive treatment before, during and afterusing Isdiben
• 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 Isdiben, 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 that it is not necessary). Women must agree to undergo pregnancy tests before, during and afterusing Isdiben
• 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 Isdiben (unless your doctor decides that this is not necessary in your case).
• You must agree to undergo 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 have to follow the above rules.

If you become pregnant while taking Isdiben, 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 Isdiben, you must contact your
doctor. The doctor may refer you to a specialist for consultation.
The doctor will show you written information about pregnancy and contraception. If you have not seen
this information, ask your doctor.
Prescriptions for women of childbearing potential are only for one month at a time. For prolonged treatment a
new prescription is required. You must bring the prescription to the pharmacist within 7 days, if it is later, the
pharmacist cannot give you the medicine.

Advice for men
Oral retinoid levels in the semen of men usingIsdiben 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.
Advice for all patients
Talk to your doctor before taking Isdiben:

• if you have 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 Isdiben. Also tell your doctor if you are taking medicines for any of these conditions, as your mood may be affected while taking isotretinoin.

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 may notice these
changes and help you identify problems that need to be discussed with your doctor.

Isotretinoin often increases fats in the blood, such as cholesterol and triglycerides. The doctor will have your blood tested before, during and after treatment with isotretinoin. It is best that you do not drink alcoholic beverages during treatment or at least reduce the amount you normally drink.
Tell your doctor if you already have high levels of fat in your blood, diabetes, if you are overweight or if you have
a problem with drinking too much alcohol. You may need to have blood tests
more often. If your fat levels in your blood remain high, your doctor may reduce the dose or
stop this medicine.

• Isotretinoin can affect your liverThe doctor will have your blood tested before, during and after treatment with isotretinoin to check how your liver is working. If your liver function is affected, the doctor may reduce the dose or stop this medicine.
• Isotretinoin can increase blood sugar levelsIn rare cases people become diabetic. The doctor will check your blood sugar levels during treatment, this especially if you already have diabetes, if you are overweight or if you have a problem with drinking too much alcohol.
• Your skin may become dry, use a moisturizer and lip balm. To prevent skin irritation it is best not to use so-called “exfoliants” or other anti-acne products.
• Severe skin reactions(e.g. erythema multiforme (EM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported with the use of this medicine. The rash may progress to blistering or peeling of the skin. You should also be careful for ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
• Rarely this medicine can cause severe allergic reactions, some of which can 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 this medicine, seek urgent medical advice and tell them that you are taking this medicine.
• Avoid exposure to the sun as much as possible and do not use sun lamps or tanning beds.Your skin may become more sensitive to sunlight. Before exposure to the sun use a sunscreen with a high protection factor (SPF 50 or more).
• Avoid cosmetic skin treatments.Isotretinoin can make your skin more fragile. Avoid waxing, dermabrasion or laser therapy (removal of corneal skin or scars) during treatment and for at least 6 months after treatment. These can cause scarring, skin irritation or, rarely, changes in skin color.
• Isotretinoin has been associated with inflammatory bowel disease.The doctor will stop isotretinoin if you have severe diarrhea with blood without previous gastrointestinal disorders.
• Isotretinoin can cause dry eyes, intolerance to contact lenses anddifficulty seeing, including decreased night vision.Cases of dry eyes that have not resolved after stopping therapy have been reported. Tell your doctor if you have any of these symptoms. The doctor may ask you to use an ointment to lubricate your eyes or

artificial tear therapy. If you use contact lenses and have developed intolerance to contact lenses, you may be advised to use glasses during treatment. If you develop
visual impairment, the doctor will refer you to a specialist for advice and may ask you to
stop taking isotretinoin.

• Benign intracranial hypertension has been reported with isotretinoinand, in some cases, when isotretinoin was used together with tetracyclines (a class of antibiotics). Stop taking Isdiben and seek urgent medical advice 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 in the eye (papilloedema).
• Reduce the amount of intense exercise.Isdiben can cause muscle and joint pain especially in young people.
• Do not take vitamin A supplementswhile taking this medicine. Taking them together may increase the risk of side effects.
• Tell your doctor if you have kidney problems.The doctor may start with a lower dose of isotretinoin and then increase it to the maximum tolerated dose.
• You must not donate bloodduring treatment with this medicine and for 1 monthafter stopping using Isdiben as, if a pregnant woman were to receiveyour blood, it could harm the fetus.
• You must remember not to share your medicine with anyone.You must return unused capsules to the pharmacist at the end of treatment. Talk to your doctor or pharmacist about how to return the capsules.

Driving and using machines
During treatment you may have problems with your eyes and not see well. This can happen
suddenly. In rare cases, night vision problems have continued after the end of
treatment. Very rarely, drowsiness and dizziness have been reported. If this happens to you, do not
drive, ride a bicycle or use machines.

Other medicines and Isdiben
Do not take vitamin A supplements or tetracyclines(a type of antibiotic) and do not use other
treatments for acne that may dry or peel the skin while taking Isdiben. It is good
to use moisturizers and emollients (skin creams or preparations that prevent water loss and
have a softening effect on the skin).
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines, including herbal products or over-the-counter medicines (including
multivitamin supplements) or if you are using any skin products, or have used them recently.

Pregnancy, breastfeeding and fertility
For more information on pregnancy and contraception, see section 2 of the “Pregnancy Prevention Program”.

Isdiben soft capsules contain soybean oil.If you are allergic to peanuts or soybeans, do not use
this medicine.

3. How to take Isdiben

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

The usual starting doseis 0.5 mg per kg of body weight per day (0.5 mg/kg/day). If you weigh 60
kg, your dose will usually start at 30 mg per day.

Take the capsules once or twice a day.
Take them during or after meals. Swallow the capsules whole with a drink or with a mouthful of
food.

After a few weeks, your doctor may adjust the dose.This depends on how you react
to the medicine. For most people, the dose will be between 0.5 and 1 mg per kg of body weight per
day. If you think the medicine is too strong or too weak, talk to your doctor or pharmacist.

If you have severe kidney problemsyou will usually start with a lower dose (such as 10 mg per day), which
will be increased to the maximum dose your body can take. If your body cannot
take the recommended dose, you will be prescribed a lower dose. This may mean that you will
be treated for a longer period of time and that your acne is more likely to come back.

A treatment cycle usually lasts from 4 to 6 months.Most people only need one
treatment cycle. Your acne may continue to improve for up to 8 weeks after the end of the
treatment. Usually, another cycle is not started before this time.
Some people notice a worsening of acne during the first few weeks of treatment, but this
generally improves with continued treatment.

If you take more Isdibenthan you should
If you take too many capsules or if someone else accidentally takes your medicine, contact
your doctor, pharmacist or the nearest hospital immediately.

If you forget to take Isdiben
If you forget to take a dose, take it as soon as you can. However, if it is close to the time of the next dose,
skip the forgotten dose and take the next dose as usual. Do not take two doses
at the same time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Often side effects disappear or end when treatment is stopped. Your doctor can help you manage them.

Stop taking this medicine and contact your doctor immediately if you experience symptoms
of any of the following side effects.This may not be enough to stop the side effects. You may need more help, and your doctor can arrange this for you.

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 may notice these changes and help you identify problems that need to be discussed with your
doctor.

Mental 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 discomfort.
• 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 of harming themselves or ending their lives (suicidal thoughts), 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 health problems.Your
doctor may tell you to stop taking Isdiben. This may not be enough to stop the effects: you may need further help, and your doctor can arrange this
for you.

Rashes and other skin symptoms
Frequency not known(frequency cannot be estimated from the available data)

• This medicine can cause severe rashes, potentially life-threatening and requiring immediate medical attention. They often start as circular patches on the arms, hands, legs or feet and may have blisters. More severe rashes may appear as blisters on the chest and back. You may also have other symptoms, such as eye infection (conjunctivitis) or ulcers in the mouth, throat or nose.
• If a large portion of skin begins to peel off, this is a dangerous sign and you should go to the hospital immediately. Bring the medicine with you. Severe forms of rash can lead to widespread skin peeling, which can be life-threatening. If you have flu-like symptoms (headache, fever, chills), they may be followed by a rash, so check them carefully and be ready to act quickly.

Very common effects( may affect more than 1 in 10 people):

• Dry skin, especially on the face and lips; red and painful skin, chapped and inflamed lips, rash, mild itching and mild flaking. If you use a moisturizer from the start of treatment, you can reduce the risk of these effects.
• The skin may become more red and fragile than usual, especially on the face.

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

• Hair loss, which is usually only temporary. Your hair will return to normal when treatment is finished.

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

• Acne may worsen in the first few weeks, but symptoms should improve over time.
• Inflamed, swollen and darker skin than usual, especially on the face.
• Feeling of excessive sweating or itching.
• Increased sensitivity to light.
• Bacterial infections in the nail bed and other nail changes.
• Swelling, discharge, pus.
• Thicker scars after surgery.
• Increased body hair.

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

• Severe allergic reactions such as difficulty breathing or swallowing caused by sudden swelling of the throat, face, lips and mouth. Also sudden swelling of hands, feet

and ankles. If you have any allergic reaction, stop taking isotretinoin and
contact your doctor.

• Skin allergic reactions such as rash, itching.

Other problems
Very common effects( may affect more than 1 in 10 people):

• Increased liver enzymes in blood tests.

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

• Yellowing of the skin or eyes, feeling more tired than usual. These can be signs of hepatitis.
• Difficulty urinating, swollen eyelids, feeling more tired than usual. These can be signs of kidney problems.
• Severe abdominal pain, with or without diarrhea with blood, feeling unwell (nausea) and vomiting. These can be signs of serious intestinal conditions.
• Headache that lasts a long time with nausea, vomiting and changes in vision, including blurred vision. These can be signs of benign intracranial hypertension, especially if isotretinoin is taken with antibiotics called tetracyclines.
• Other vision problems, including blurred vision, distorted vision, cloudy cornea (cataract).
• Dark or cola-colored urine.
• Muscle weakness that can be potentially life-threatening, even associated with difficulty moving arms or legs, sore, swollen, bruised areas of the body, dark urine, reduced or absent urine output, confusion or dehydration. These are signs of muscle tissue breakdown that can lead to kidney failure (“rhabdomyolysis”). This can happen if you do intense physical activity while taking this medicine.

Stop taking this medicine and contact your doctor immediately if you experience the
symptoms of any of the side effects reported above.This may not be enough to
stop the side effects. You may need more help, which your doctor can arrange for
you.

If you experience symptoms of any of the following side effects, contact your doctor immediately.
The doctor may tell you to stop taking this medicine.

Very common effects( may affect more than 1 in 10 people):

• You may bleed or bruise more easily - if the number of blood clotting cells decreases.
• Anemia, weakness, dizziness, pale skin - if the number of red blood cells decreases.
• Increased likelihood of getting infections with symptoms such as chills, sudden fever, sore throat or flu-like symptoms - if the number of white blood cells (which help protect the body from infections and diseases) decreases.
• Inflammation of the eyes (conjunctivitis) and the area around the eyelids; dryness and irritation of the eyes. Ask your pharmacist for a suitable eye drop. If you have dry eyes and wear contact lenses, you may need to use glasses.
• Back, muscle or joint pain, especially in adolescents. To avoidworsening bone or muscle problemsreduce intense physical activity while taking isotretinoin.
• Changes in blood fat levels (including HDL or triglycerides).

Common effects( may affect up to 1 in 10 people):

• Headache
• The inside of the nose becomes dry and crusty, causing mild nosebleeds.
• Sore throat or painful or inflamed nose.
• Increased chance of getting infections if white blood cells are affected.
• Increased cholesterol levels in the blood
• Presence of protein or blood in the urine
• Allergic reactions such as rash, itching.

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

• Convulsions, numbness, dizziness
• You may see less well at night, have blurred vision or color blindness and your color vision gets worse
• You may become more sensitive to light and may need to wear sunglasses to protect your eyes from too much sunlight
• Lymph nodes (glands around the neck, armpits and groin) may become swollen.
• Dry throat, hoarseness
• Sudden tightness in the chest and difficulty breathing and wheezing, especially if you have asthma
• Difficulty hearing
• Feeling very thirsty; frequent need to urinate; blood tests show increased sugar in the blood. These can be symptoms of diabetes.
• Feeling generally unwell.
• Increased uric acid levels in the blood.
• Bacterial infections
• Inflammation of blood vessels (sometimes with bruising, red spots)
• Arthritis, bone changes (delayed growth, changes in bone density, abnormal bone growth); bone growth may stop.
• Calcium deposits in soft tissues
• Painful tendons
• Increased levels of creatine phosphokinase in the blood

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

• Problems getting or maintaining an erection
• Decreased libido (sexual desire)
• 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

Contact your doctor immediately if you experience the symptoms of any of the side effects reported
above.The doctor may tell you to stop taking this medicine.

To avoid worsening bone or muscle problemsreduce intense physical activity while
taking this medicine.

If you notice any side effect that worries you,whether it is listed or not in this leaflet,
talk to your doctor.

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
.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Isdiben

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C. Store in the original packaging.
Do not use this medicine after the expiry date which is stated on the box and on the blisters after
EXP. The expiry date refers to the last day of that month.

Return any remaining capsules to the pharmacist at the end of treatment.
Keep this medicine only if your doctor tells you to do so.
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. Package Contents and Other Information

What Isdiben 5 mg, 10 mg, 20 mg, 40 mg soft capsules contain
The active ingredient is isotretinoin
Each 5 mg capsule contains 5 mg of isotretinoin
Each 10 mg capsule contains 10 mg of isotretinoin
Each 20 mg capsule contains 20 mg of isotretinoin
Each 40 mg capsule contains 40 mg of isotretinoin

Other ingredients are: soybean oil, hydrogenated vegetable oil and yellow beeswax.

Composition of the capsule shell for 5 mg, 20 mg and 40 mg capsules:gelatin, glycerol, purified water, red iron oxide (E 172), yellow iron oxide (E 172) and titanium dioxide (E 171).

Composition of the capsule shell for 10 mg capsules:gelatin, glycerol, purified water and iron oxide red (E 172).

Description of the appearance of Isdiben 5 mg, 10 mg, 20 mg and 40 mg soft capsules and package contents
Each Isdiben 5 mg soft capsule has an opaque, two-tone red/brown and cream gelatin shell with a bright yellow/orange content. The oval capsule is printed in black ink on one side with the logo “5”.
Each Isdiben 10 mg soft capsule has an opaque, red/brown gelatin shell with a bright yellow/orange content. The oval capsule is printed in black ink on one side with the logo “I 10”.
Each Isdiben 20 mg soft capsule has an opaque, two-tone red/brown and cream gelatin shell with a bright yellow/orange content. The oval capsule is printed in black ink on one side with the logo “I 20”.
Each Isdiben 40 mg soft capsule has an opaque, orange/brown gelatin shell with a bright yellow/orange content. The oval capsule is printed in black ink on one side with the logo “I 40”.
Isdiben is available in packs of 30, 50 or 100 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ISDIN S.r.l., Via Tito Speri 8, 20154 Milan, Italy.

Manufacturer:
Catalent France Beinheim S.A., 74 rue Principale, 67930 Beinheim, France.
Catalent Germany Eberbach GmbH, Gammelsbacher Str. 2, 69412 Eberbach, Germany.
Catalent Germany Schorndorf GmbH, Steinbeisstrasse 2, 73614 Schorndorf, Germany.

You can obtain more information on this medicinal product from your doctor or pharmacist.