NOIDAK 10 mg Kapsułka Miękka

Treść ulotki

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

NOIDAK 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

Medicinal product subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects you experience
while taking 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 could 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 NOIDAK is and what it is used for
• 2. What you need to know before you take NOIDAK
• 3. How to take NOIDAK
• 4. Possible side effects
• 5. How to store NOIDAK
• 6. Contents of the pack and other information

1. What NOIDAK is and what it is used for

NOIDAK contains isotretinoin- a medicine related to vitamin A, belonging to a group
of medicines called retinoids.

NOIDAK is used for the treatment of severe types of acne(such as nodular or conglobate acne or
acne with a risk of causing permanent scarring) in adults and adolescents starting from 12 years
old only after puberty. You will use NOIDAK when acne does not improve with other anti-acne treatments,
including antibiotics and skin treatments.

Treatment with NOIDAK must be supervised by a dermatologist(a doctor
specialized in the treatment of skin problems).

2. What you need to know before taking NOIDAK

Do not use NOIDAK:

• If you are pregnant or breastfeeding with breast milk.
• 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” paragraph.
• if you are allergic toisotretinoin, to peanuts or soy or to any of the excipientsof this medicine (listed in paragraph 6)
• if you have a liver disease
• if you have high levels of cholesterol or triglycerides in the blood
• if you have high levels of vitamin Ain the body (hypervitaminosis A)
• ifyou are simultaneously being treated with tetracyclines(a type of antibiotic) (see “Other medicines and NOIDAK”)

Warnings and precautions
Talk to your doctor before taking NOIDAK:

• If you have ever 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 you are taking NOIDAK.

Mental health problems
You may not 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.
Below you will find important advice, first for women, then for men and finally for all patients.

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

• You must not use NOIDAK if you are pregnant or if you think you may be.
• You must not use NOIDAK if you are breastfeeding with breast milk. The medicine can pass into the milk and harm the newborn.
• You must not use NOIDAK 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.

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

• The doctor must explain the risk of harm to the fetus - you must understand that you must not become pregnant and what you need to do to prevent pregnancy.
• The doctor must have spoken to you about contraception (birth control). The doctor will give you information on how not to become pregnant. The doctor may 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 NOIDAK.

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

• 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 NOIDAK, 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 NOIDAK

• 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 NOIDAK (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 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 NOIDAK, stop taking this
medicine immediately, and see your doctor. The doctor may send you to a specialist for a consultation.
Also, if you become pregnant within one month of stopping NOIDAK, 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 semen of men using NOIDAK are too low to
harm the fetus of their partner. However, you should never share your medicines with anyone.

Advice for all patients

• Severe skin reactions(e.g. erythema multiforme (EM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported with the use of NOIDAK. The rash may rapidly progress to widespread blistering or peeling of the skin. Conjunctivitis (red and swollen eyes), ulcers in the mouth, throat, nose and genitals may also occur.
• Rarely, NOIDAK may 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 NOIDAK, seek immediate medical attention and tell them you are taking this medicine.
• Eliminate intense exercise and physical activity.NOIDAK can cause muscle and joint pain, especially in children and adolescents who engage in intense physical activity.
• NOIDAK has been associated with inflammatory bowel disease.The doctor will stop you from taking NOIDAK if you have severe diarrhea with unprecedented gastrointestinal disorders.
• NOIDAK can cause dry eyes, problems using contact lenses and visual difficultiesincluding reduced night vision.Tell your doctor if you have any of these symptoms. The doctor may ask you to use a lotion to lubricate your eyes or tear replacement therapy. If you wear contact lenses and have developed contact lens intolerance, you may be advised to wear glasses during treatment. The doctor may refer you to a specialist for advice if you develop visual difficulties and may ask you to stop treatment with NOIDAK.
• Benign intracranial hypertension has been reported with the use of NOIDAKand in some cases where NOIDAK was used together with tetracyclines (a type of antibiotic). Stop taking NOIDAK and seek immediate medical attention 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 your eye (papilledema).
• NOIDAK can increase liver enzyme levels.The doctor will have you do blood tests before, during and after treatment with NOIDAK to check these levels. If they remain elevated, the doctor may reduce the dose or stop NOIDAK.
• NOIDAK increases commonly levels of fats,such as cholesterol or triglycerides. The doctor will test these levels before, during and treatment with NOIDAK. It is best not to drink alcoholic beverages during treatment. Tell your doctor if you know you already have high levels of fats in the blood, diabetes (high blood sugar), if you are overweight, or if you have an alcohol addiction. You may need to have blood tests more often. If the fats in the blood remain elevated, the doctor may reduce your dose, or stop NOIDAK.
• Tell your doctor if you have any kidney problems.The doctor may start you on a lower dose of NOIDAK and then increase it to the maximum tolerated dose.
• NOIDAK can increase blood sugar levels.In rare cases people become diabetic. The doctor may monitor blood sugar levels after treatment, especially if you already have diabetes, if you are overweight or if you have an alcohol addiction.
• Your skin may become drier.Use a lotion or moisturizing cream and lip balm during treatment. To prevent skin irritation, you should avoid using exfoliating or anti-acne products.
• Avoid excessive exposure to the sun and do not use sunlamps or tanning beds.Your skin may become more sensitive to light. Before going out in the sun, use a sunscreen product with a high protection factor (SPF 15 or higher).
• Do not undergo any cosmetic skin treatments.NOIDAK can make your skin more fragile. Do not wax (hair removal), dermabrasion (to remove calloused skin or scars) during treatment, or for at least 6 months after treatment. They may cause scarring, skin irritation, or rarely alteration of skin color.

Further precautions
You should never give this medicine to anyone else. At the end of the treatment return the
unused capsules to the pharmacist.
You should not donate blood during treatment with this medicine and for 1 month after
stopping NOIDAK as if a pregnant patient were to receive your
blood it could harm the fetus.
Children and adolescents
The use of NOIDAK in children under 12 years of age is not recommended. This is because it is
not known if it is safe or effective in this age group.

Use in adolescents over 12 years of age only after puberty.
Other medicines and NOIDAK
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including herbal products and those available without a prescription.

• Do not take vitamin A supplements or tetracycline(an antibiotic), or use skin treatments for acne during the intake of NOIDAK. Moisturizers and emollients (skin creams or preparations that prevent water loss and have a softening effect on the skin) can be used.
• Avoid the use of keratolytic or exfoliating anti-acne agents for topical useduring the intake of NOIDAK.

Pregnancy, breastfeeding and fertility
Pregnancy
NOIDAK must not be used during pregnancy. If you could become pregnant, you must use
effective contraception during and up to one month after treatment with NOIDAK.

If you become pregnant while taking NOIDAK, or in the month following the interruption of
treatment, stop taking the medicine immediatelyand contact your doctor. He or
she may refer you to a specialist for advice.

If used during pregnancy, NOIDAK is likely to harm the unborn
child. It can also increase the risk of miscarriage.
NOIDAK can cause serious abnormalities of the brain, face, ears, eyes, heart and some
glands (called thymusand parathyroid glands) of the unborn child.
Breastfeeding

You must not takeNOIDAK if you are breastfeeding. The medicine is likely to pass into
breast milk and can harm the baby.
For further information on pregnancy and contraception, see paragraph 2 of the "Pregnancy
Prevention Program".

Driving and operating machinery
You may not see well at night during treatment. This can happen suddenly. Rarely
persists once treatment is finished. Very rarely drowsiness and dizziness have been reported.
If this happens to you, you should not drive or operate machinery.

NOIDAK contains soybean oil.

• If you are allergic to peanuts or soy, you should not take this medicine.

3. How to take NOIDAK

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 per kilogram of body weight per day (0.5 mg/kg per day).
Therefore, 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 with a full stomach. Swallow them whole with a little water. Do not chew the capsules.

After a few weeks, your doctor may adjust the dose.This depends on how you react to the
medicine. For many patients, the dose is between 0.5 and 1.0 mg/kg per day. If you think that NOIDAK is too
strong or too weak, talk to your doctor or pharmacist.

If you have severe kidney problems,you will start with a lower dose (such as 10 mg per day) which will
be increased to the highest dose your body can tolerate. If your body cannot
tolerate the recommended dose, you may be prescribed a lower dose: this may mean that
you are treated for longer and that your acne is likely to recur.

Normally a treatment cycle lasts from 16 to 24 weeks. Most patients
need only one treatment cycle. Your acne may continue to improve for up to 8 weeks
after the end of treatment. As a rule, you will not start a new treatment until then.
Some people find that acne worsens during the first few weeks of treatment. It usually improves
with continued treatment.

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

If you forget to take NOIDAK
If you miss a dose, take it as soon as you can. However, if less than 4 hours remain until the next dose,
skip the missed dose and continue as before. Do not take a double dose (two doses together).
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Below you will first find a list of serious side effects that require immediate medical attention.
Below is an overview of other side effects. Over time these side effects usually improve or disappear by the end of treatment.

SIDE EFFECTS REQUIRING IMMEDIATE MEDICAL ATTENTION
Skin problems
Frequency not known (the frequency cannot be defined based on available data ):

• Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), potentially life-threatening and requiring immediate medical attention. These initially appear as dark spots often with central blisters usually on arms and hands or on legs and feet, more severe rashes may include blisters on the chest and back. Additional symptoms such as eye inflammation (conjunctivitis), or ulcers of the mouth, throat or nose may occur. Severe skin rashes can progress to widespread skin peeling which can be life-threatening. These serious skin reactions are often preceded by headache, fever, aches and pains (flu-like symptoms).

If you develop a severe rash or these skin symptoms, stop taking
NOIDAK and contact your doctor immediately.
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 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: a 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 NOIDAK. This may not be enough to end the effects: you may need further help, and your doctor can arrange for this
to happen.

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

• Severe (anaphylactic) reactions: difficulty breathing or swallowing caused by a sudden swelling of the throat, face, lips and mouth. Also sudden swelling of hands, feet and ankles.

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

• Sudden tightness of the chest, shortness of breath and wheezing, especially if you have asthma.

If you have a severe allergic reaction, seek immediate medical attention.
If you have an allergic reaction, stop taking NOIDAK and contact your doctor.

Bones and muscles
Frequency not known (the frequency cannot be defined based on available data):

• Muscle weakness that can be potentially life-threatening can be associated with problems moving your arms or legs, sore, swollen and bruised areas of the body, dark-colored urine, reduced or absent urine flow, confusion or dehydration. These are signs of a

breakdown of muscle tissue that can lead to kidney failure. This can occur if you are
doing intense physical activity while being treated with NOIDAK .

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

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

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

• Persistent headache with feeling unwell (nausea), feeling sick (vomiting) or changes in vision including visual disturbances. These can be signs of benign intracranial hypertension, especially if NOIDAK is taken with antibiotics called tetracyclines. Stop taking NOIDAK immediately and contact your doctor.

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

• Severe abdominal (stomach) pain, with or without bloody diarrhea, feeling unwell (nausea) and feeling sick (vomiting). These can be signs of a serious condition of the intestine. Stop taking NOIDAK immediately and contact your doctor.

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

• Blurred vision.

If your vision becomes blurred, stop taking NOIDAK 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 NOIDAK: (may affect more than 1 in 10 people):

• Dry skin, especially on the lips and face; inflamed skin, inflamed and cracked lips, mild itching and slight flaking. Use a moisturizer from the start of treatment.
• Skin becoming more fragile and reddened than usual, especially on the face.
• Back pain; muscle or joint pain, especially in children and adolescents .To avoid worsening bone or muscle problems,stop intense physical activity during treatment with NOIDAK.
• Inflammation of the eyes (conjunctivitis) and the eyelid area; feeling of dry and irritated eyes. Ask your pharmacist for a suitable eye drop. If your eyes become dry and you wear contact lenses, you may need to replace them with glasses.
• Increased liver enzymes observed in the blood.
• Altered levels of fats in the blood (including HDL cholesterol or triglycerides).
• Bruising, bleeding or clotting more easily - if blood clotting cells are affected.
• Anemia - weakness, dizziness, paleness - if red blood cells are affected.

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

• Headache.
• High levels of cholesterol in the blood.
• Protein or blood in the urine.
• Increased susceptibility to infections if white blood cells are affected.
• Inside of the nose becoming dry, with crusting, causing slight nosebleeds.
• Allergic reactions such as rash, itching. If you have an allergic reaction, stop taking NOIDAK and contact your doctor.

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

• Hair loss (alopecia). This is only a temporary reaction. Your hair will return to normal when treatment is finished.

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

• You may see less well at night; color blindness and worsening of color vision.
• You may become more sensitive to light you may need to wear sunglasses to protect your eyes from too much sunlight.
• Other eye problems include blurred vision, distorted vision, cloudy corneal surface (cataracts).
• Excessive thirst; frequent need to urinate; blood tests showing increased sugars. These can be signs of diabetes.
• Acne that gets worse in the first few weeks, but symptoms improve over time.
• Inflamed skin, swollen, or darker than usual, especially on the face.
• Excessive sweating or itching
• Arthritis; bone disorders (delayed growth, excessive growth and changes in bone density); growing bones may stop growing.
• Calcium deposits in soft tissues, pain in tendons, high levels of muscle breakdown products in the blood, especially if you exercise intensely.
• Increased sensitivity to light.
• Inflammation at the base of the nails, changes in the nails.
• Swelling, discharge, pus.
• Thickening of scars following surgery.
• Increased hair growth on the body.
• Convulsions, drowsiness, dizziness.
• Swollen lymph nodes.
• Dry throat, hoarseness.
• Difficulty hearing.
• General feeling of being unwell.
• High levels of uric acid in the blood.
• Bacterial infections.
• Inflammation of blood vessels (sometimes with bruising, red spots)
• Rhabdomyolysis.

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

• Dark or cola-colored urine
• Problems getting or maintaining an erection
• Decreased libido
• Enlargement of the breasts with or without tenderness in men
• Vaginal dryness

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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store NOIDAK

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 pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original package. Keep the blister in the carton to protect the medicine 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.

6. Package contents and other information

What NOIDAK contains

• The active substanceis isotretinoin.
• The other ingredientsare hydrogenated soybean oil, hydrogenated vegetable oil, white beeswax, disodium edetate, butylated hydroxyanisole (E320), refined soybean oil, polysorbate 80, gelatin, glycerol (E422), red iron oxide (E 172), titanium dioxide (E171), light liquid paraffin, printing ink containing shellac, black iron oxide (E 172), propylene glycol (E1520).

Description of the appearance of NOIDAK and package contents
NOIDAK is available in soft capsules containing 10 mg or 20 mg of isotretinoin.
The 10 mg capsules are oval-shaped, light pink, opaque soft gelatin capsules with
“RR” printed in black edible ink, approximately 9.30±0.5 mm in length and 6.60±0.5 mm in width,
containing an oily yellow-orange suspension.
The 20 mg capsules are oval-shaped, orange to reddish, opaque soft gelatin capsules with
“RR” printed in black edible ink, approximately 13.20±0.5 mm in length and 7.80±0.5 mm
in width, containing an oily yellow-orange suspension.
The capsules are packaged in blisters of 20, 30, 50, 60, 90 or 100 capsules.
Not all pack sizes may be marketed

Marketing Authorisation Holder
Velit Biopharma S.r.l.
Piazza Cavour, 3
Milano 20121
Italy

Batch Release
Terapia S.A.
Str. Fabricii nr. 124
400 632 Cluj-Napoca
Romania
Alkaloida Chemical Company Zrt
Kabay János u.29.
H-4440 Tiszavasvári
Hungary
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany: Isotretinoin Basics 10 mg Weichkapseln
Isotretinoin Basics 20 mg Weichkapseln
Spain: Isotretinoína SUN 10 mg cápsulas blandas EFG
Isotretinoína SUN 20 mg cápsulas blandas EFG
Hungary: Sotret Neo 10 mg lágy kapszula
Sotret Neo 20 mg lágy kapszula
Italy: NOIDAK 10 mg capsule molli
NOIDAK 20 mg capsule molli
Netherlands: Isotretinoïne SUN 10 mg, zachte capsules
Isotretinoïne SUN 20 mg, zachte capsules
Poland : Sotret 10 mg
Sotret 20 mg
Romania: Sotret 10 mg capsule moi
Sotret 20 mg capsule moi
United Kingdom: Isotretinoin 10 mg soft capsules
Isotretinoin 20 mg soft capsules
Detailed and up-to-date information on this medicine is available by scanning the QR code
included in the package leaflet with a smartphone. The same information is also available at the following
URL: http://www.aifa.gov.it/content/medicinali-base-di-retinoidi