Patient Information Leaflet: Information for the User

NOIDAK 10 mg soft capsules, 20 mg soft capsules

Isotretinoin
Generic medicine
WARNING
CAN CAUSE SEVERE HARM TO THE UNBORN BABY
Women must use effective contraception
Do not use if you are or think you may be pregnant
This medicine is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

What NOIDAK is and what it is used for
What you need to know before taking NOIDAK
How to take NOIDAK
Possible side effects
How to store NOIDAK
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 to treat severe forms of acne (such as nodular or conglobate acne or
acne that may lead to permanent scarring) in adults and adolescents aged 12 years and older
only after puberty. You will use NOIDAK when acne does not improve with other anti-acne treatments,
including antibiotics and topical therapies.
Treatment with NOIDAK must be supervised by a dermatologist (a doctor
specialized in treating skin conditions).

2. What you need to know before taking NOIDAK

Do not use NOIDAK:

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, soybeans, or to any of the excipients of this medicine (listed in section 6)
if you have liver disease
if you have high levels of cholesterol or triglycerides in your blood
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 NOIDAK”)

Warnings and precautions
Talk to your doctor before taking NOIDAK:

If you have ever had mental health problems, including depression, aggressive tendencies, or mood changes. This also includes thoughts of harming yourself or ending your life. This is because your mood may change while taking NOIDAK.

Mental health problems
You may not notice certain changes in your mood and behaviour. 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 promptly identify any problems that need to be discussed with your doctor.
Below are important recommendations, first for women, then for men, and finally for all patients.

Important advice for women
Pregnancy Prevention Programme
Women who are pregnant must not use NOIDAK
This medicine can severely harm the unborn baby (it is said to be "teratogenic") – it may cause birth defects affecting the brain, face, ears, eyes, heart, and certain glands (thymus and parathyroid glands). It may also likely cause miscarriage. This can occur even if NOIDAK is used only briefly during pregnancy.

You must not use NOIDAK if you are pregnant or think you might be pregnant.
You must not use NOIDAK if you are breastfeeding. The medicine can pass into breast 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 stopping this treatment, as some medicines may remain in your body.

For women who could become pregnant, NOIDAK is prescribed under very strict rules
due to the risk of harm to the unborn baby.
These are the rules:

Your doctor must explain the risk of harm to the unborn baby – you must understand that you must not become pregnant and what is required to prevent pregnancy.
Your doctor must have discussed contraception (birth control) with you. Your doctor will provide information on how to avoid pregnancy. Your doctor may refer you to a specialist for contraceptive counselling.
Before starting treatment, your doctor will require you to take a pregnancy test. The test must confirm that you are not pregnant when you begin treatment with NOIDAK.

Women must use an effective method of contraception before, during, and after using NOIDAK

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 oral contraceptive and condom). Discuss with your doctor which method may be suitable for you.
You must use contraception for one month before starting NOIDAK, throughout treatment, and for one month after stopping treatment.
You must use contraception even if you do not have periods or are not sexually active (unless your doctor advises otherwise).

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

You must agree to regular follow-up visits, preferably every month.
You must agree to undergo regular pregnancy tests, preferably monthly during treatment and, since some medicines may remain in your body, one month after stopping NOIDAK (unless your doctor decides this is not necessary in your case).
You must agree to additional pregnancy tests if requested by your doctor.
You must not become pregnant during treatment or in the month following, 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 agree to follow the above rules.

If you become pregnant while taking NOIDAK, stop taking this medicine immediately and contact your doctor. Your doctor may refer you to a specialist for consultation.
Additionally, if you become pregnant within one month after stopping NOIDAK, you must contact your doctor. Your doctor may refer you to a specialist for consultation.

Advice for men
Levels of oral retinoids in the semen of men taking NOIDAK are too low to harm their partner's unborn baby. However, you must never share your medicine 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. Skin rash may rapidly progress to widespread blistering or skin peeling. Conjunctivitis (red, swollen eyes), mouth ulcers, and ulcers in the throat, nose, or genital area may also occur.
Rarely, NOIDAK can cause severe allergic reactions, some of which may affect the skin as eczema, hives, or bruising or red patches on arms and legs. If you develop an allergic reaction, stop taking NOIDAK, seek immediate medical help, and tell the doctor you are taking this medicine.
Avoid intense physical exercise and strenuous 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. Your doctor will stop your treatment with NOIDAK if you develop severe, unexplained diarrhoea or gastrointestinal disturbances.
NOIDAK can cause dry eyes, problems wearing contact lenses, and visual difficulties including reduced night vision. Inform your doctor if you experience any of these symptoms. Your doctor may recommend using an eye lubricant or artificial tears. If you wear contact lenses and develop intolerance, you may be advised to wear glasses during treatment. Your doctor may refer you to a specialist if you develop visual problems and may ask you to stop treatment with NOIDAK.
Benign intracranial hypertension has been reported with NOIDAK use, and in some cases when NOIDAK was used together with tetracyclines (a type of antibiotic). Stop taking NOIDAK and seek immediate medical help 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).
NOIDAK may increase liver enzyme levels. Your doctor will perform blood tests before, during, and after treatment with NOIDAK to monitor these levels. If levels remain elevated, your doctor may reduce the dose or stop NOIDAK.
NOIDAK commonly increases levels of fats, such as cholesterol or triglycerides. Your doctor will test these levels before and during treatment with NOIDAK. It is best not to drink alcoholic beverages during treatment. Inform your doctor if you already have high blood fat levels, diabetes (high blood sugar), are overweight, or have alcohol dependence. You may need more frequent blood tests. If blood fat levels remain high, your doctor may reduce your dose or stop NOIDAK.
Inform your doctor if you have any kidney problems. Your doctor may start you on a lower dose of NOIDAK and then increase it to the maximum tolerated dose.
NOIDAK 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 moisturizing 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 tanning beds. 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. NOIDAK may make your skin more fragile. Do not wax (hair removal), 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 discoloration.

Additional precautions
Never give this medicine to anyone else. After treatment, return any unused capsules to your pharmacist.
Do not donate blood during treatment with this medicine and for 1 month after stopping NOIDAK, as if a pregnant woman received your blood, it could harm her unborn baby.

Children and adolescents
The use of NOIDAK 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.
Use in adolescents above 12 years of age only after puberty.

Other medicines and NOIDAK
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 NOIDAK. Moisturizers and emollients (skin creams or preparations that prevent water loss and soften the skin) may be used.
Avoid using topical anti-acne keratolytic or exfoliating agents while taking NOIDAK.

Pregnancy, breastfeeding, and fertility
Pregnancy
NOIDAK must not be used during pregnancy. If you could become pregnant, you must use effective contraception during treatment and for one month after stopping NOIDAK.
If you become pregnant while taking NOIDAK or within one month after stopping treatment, stop taking the medicine immediately and contact your doctor. They may refer you to a specialist for advice.
If used during pregnancy, NOIDAK is likely to harm the unborn child. It may also increase the risk of miscarriage.
NOIDAK may cause severe abnormalities in the unborn child’s brain, face, ears, eyes, heart, and certain glands (called thymus and parathyroid glands).

Breastfeeding
You must not take NOIDAK if you are breastfeeding. The medicine is likely to pass into breast milk and may harm the baby.

For further information on pregnancy and contraception, see section 2 of the "Pregnancy Prevention Programme".

Driving and using machines
You may have reduced night vision during treatment. This may occur suddenly. Rarely, this persists after treatment has ended. Very rarely, drowsiness and dizziness have been reported. If this happens, you must not drive or operate machinery.

NOIDAK contains soybean seed oil.

If you are allergic to peanuts or soybeans, do not take this medicine.

3. How to take NOIDAK

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 milligrams per kilogram of body weight per day (0.5 mg/kg/day).
Therefore, if you weigh 60 kg, your starting dose will usually be 30 mg per day.
Take the capsules once or twice daily.
Take them with food. Swallow the capsules whole with some water. Do not chew the capsules.
After a few weeks, your doctor may adjust the dose. This depends on how you respond to the medicine.
For many patients, the dose ranges between 0.5 and 1.0 mg/kg per day. If you think NOIDAK is too strong or too weak, speak to your doctor or pharmacist.
If you have severe kidney problems, you will start on 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 treatment lasts longer and that your acne is more likely to return.
Normally, a course of treatment lasts from 16 to 24 weeks. Most patients require only one course of treatment. Your acne may continue to improve for up to 8 weeks after finishing treatment. Usually, a new treatment course will not begin until this time has passed.
Some people find that their acne worsens during the first few weeks of treatment. Usually, it improves as treatment continues.
If you take more NOIDAK than you should
If you take too many capsules or if 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 remember. However, if less than 4 hours remain before your 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 the use of this medicine, consult 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 requiring immediate medical attention.
Following that, you will find an overview of other side effects. These side effects usually improve or disappear over time at the end of treatment.

SIDE EFFECTS REQUIRING IMMEDIATE MEDICAL ATTENTION

Skin problems
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, 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 may include eye inflammation (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 reactions are often preceded by headache, fever, and body aches (flu-like symptoms).

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

Mental 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 discomfort.
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 died by suicide. These people 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 symptoms of any of these mental health problems. Your doctor may tell you to stop taking NOIDAK. This may not be enough 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, especially if you have asthma.

If you have a severe allergic reaction, seek immediate medical help.
If you have an allergic reaction, stop taking NOIDAK 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, possibly associated with difficulty moving arms or legs, painful, swollen, and bruised areas of the body, dark or cola-coloured urine, reduced or absent urine flow, confusion, or dehydration. These are signs of muscle tissue breakdown that may lead to kidney failure. This may occur if you are engaging in intense physical activity during treatment with NOIDAK.

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 unusually tired. These may be signs of hepatitis. Stop taking NOIDAK immediately and contact your doctor.
Difficulty urinating (urinary retention), swollen eyelids, feeling excessively tired. These may be signs of kidney inflammation. Stop taking NOIDAK 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 visual disturbances. These may be signs of benign intracranial hypertension, particularly if NOIDAK is taken with antibiotics called tetracyclines. Stop taking NOIDAK immediately and contact your doctor.

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

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

Eye problems
Very rare side 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, particularly on the lips and face; inflamed skin, chapped and inflamed lips, mild itching, and slight 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, avoid intense physical activity during treatment with NOIDAK.
Eye inflammation (conjunctivitis) and eyelid area; dry, irritated eyes. Ask your pharmacist for suitable eye drops. If your eyes become dry and you wear contact lenses, you may need to switch to glasses.
Increased liver enzymes observed in blood tests.
Altered blood lipid levels (including HDL cholesterol or triglycerides).
Bruising, bleeding, or clotting more easily—if blood clotting cells are affected.
Anaemia—weakness, dizziness, paleness—if red blood cells are affected.

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

Headache.
Elevated blood cholesterol levels.
Protein or blood in the urine.
Increased tendency to infections—if white blood cells are affected.
Dryness inside the nose, with crusting, causing slight nosebleeds.
Allergic reactions such as skin 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 a temporary reaction. Your hair will return to normal once treatment is completed.

Very rare side effects with NOIDAK ( 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.
Other vision problems include blurred vision, distorted vision, clouding of the eye surface (corneal opacity, cataract).
Excessive thirst; frequent need to urinate; blood tests showing increased sugar levels. These may be signs of diabetes.
Worsening acne in the first few weeks, but symptoms improve over time.
Skin inflammation, swelling, or darkening, especially on the face.
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, tendon pain, elevated levels of muscle breakdown products in the blood—especially if engaging in intense exercise.
Increased light sensitivity.
Inflammation at the base of the nails, nail changes.
Swelling, discharge, pus.
Thickening of scars after surgery.
Increased body hair growth.
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 spots).
Rhabdomyolysis.

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

Dark or cola-coloured urine.
Problems achieving or maintaining an erection.
Decreased libido.
Enlargement of the breasts with or without tenderness in men.
Vaginal dryness.

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 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 stated on the carton 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 packaging. Keep the blister in the carton 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 no longer required. This will help protect the environment.

6. Package contents and other information

What NOIDAK contains

The active substance is isotretinoin.
The other components are hydrogenated soybean seed oil, hydrogenated vegetable oil, white beeswax, disodium edetate, butylated hydroxyanisole (E320), refined soybean oil, polysorbate 80, gelatin, glycerol (E422), iron oxide red (E172), titanium dioxide (E171), light liquid paraffin, printing ink containing shellac, iron oxide black (E172), propylene glycol (E1520).

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

Marketing Authorization Holder
Velit Biopharma S.r.l.
Piazza Cavour, 3
Milan 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
The Netherlands

This medicinal product is authorized in the European Economic Area countries under the following names:
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
The 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

This Patient Information Leaflet was last approved on:
Detailed and up-to-date information on this medicinal product is available by scanning the QR code included in the PIL with a smartphone. The same information is also available at the following URL: http://www.aifa.gov.it/content/medicinali-base-di-retinoidi

Square QR code made of small black modules on a white background with three large positioning squares at the corners

Noidak