Neotigason

Package Leaflet: Information for the User

Neotigason, 10 mg, capsules
Neotigason, 25 mg, capsules
Acitretin

WARNING

MAY CAUSE SERIOUS HARM TO THE UNBORN CHILD
Women must use effective contraception methods.
Do not use during pregnancy or suspected pregnancy.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept to be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Neotigason and what is it used for

Neotigason contains the active substance acitretin. It belongs to a group of medicines called retinoids.
Neotigason is used to treat severe skin diseases, where the skin becomes thick and may flake. These skin diseases include psoriasis, ichthyosis, pityriasis rubra pilaris, and Darier's disease. Acitretin restores normal skin growth.
Neotigason is usually used under the supervision of a dermatologist (a doctor specializing in skin diseases).

2. Important information before taking Neotigason

When not to take Neotigason:

• If the patient is pregnant or breastfeeding.
• If there is a risk that the patient may become pregnant, the precautions listed in the Pregnancy Prevention Program must be followed, see "Warnings and precautions" section.
• If the patient is allergic to the active substance acitretin or any of the other ingredients of this medicine (listed in section 6) or if they are taking other medicines called "retinoids".
• If the patient has severe liver disease.
• If the patient has severe kidney disease.
• If the patient has high levels of lipids (fat) in the blood.
• If the patient is taking medicines called tetracyclines (used to treat infections) or methotrexate (used to treat skin diseases, joint pain, or cancer), see also "Neotigason and other medicines".
• If the patient is taking vitamin A or other retinoids (such as isotretinoin), see the "Neotigason and other medicines" section.

The patient should discuss with their doctor before taking Neotigason if they think any of the above warnings apply to them.

Warnings and precautions

Pregnancy Prevention Program.

Women who are pregnant must not take Neotigason.

This medicine can seriously harm the unborn child (it has a "teratogenic" effect). It can cause serious damage to the brain, face, ear, eye, heart, and some glands (thymus and parathyroid) of the fetus. It also increases the risk of miscarriage. These effects can occur even if Neotigason is taken for a short period during pregnancy.

• Neotigason must not be taken if the patient is pregnant or suspects they may be pregnant.
• Neotigason must not be taken during breastfeeding. The medicine is likely to pass into breast milk and may harm the unborn child.
• Neotigason must not be taken if the patient may become pregnant during treatment.
• The patient must not become pregnant for 3 years after stopping treatment, as the medicine may still be present in the patient's body.

Neotigason may be prescribed to female patients of childbearing age only under strict conditions, due to the risk of serious birth defects.

The following conditions must be met:

• The doctor must explain to the patient the risk of harm to the unborn child (birth defects); the patient must understand why they must not become pregnant and how to prevent it.
• The patient must discuss contraception (birth control methods) with their doctor. The doctor will provide information on birth control methods. The doctor may refer the patient to a specialist for birth control advice.
• Before starting treatment, the doctor will ask the patient to have a pregnancy test. The test must show that the patient is not pregnant at the start of treatment with Neotigason.

Female patients must use effective contraception methods before, during, and after treatment with Neotigason

Neotigason

• The patient must agree to use at least one highly effective contraception method (e.g., an intrauterine device or contraceptive implant) or two effective methods that work in different ways (e.g., oral hormonal contraceptives and condoms). The patient should discuss with their doctor which methods are most suitable for them.
• The patient must use a contraceptive method for 1 month before taking Neotigason, during treatment, and for 3 years after stopping treatment with this medicine.
• The patient must use contraception, even if they do not menstruate or are not currently sexually active (unless the doctor decides it is not necessary).

Female patients must agree to have pregnancy tests before, during, and after treatment with Neotigason

• The patient must agree to have regular check-ups with their doctor, ideally every month.
• The patient must agree to have regular pregnancy tests, ideally every month during treatment and every 1-3 months for 3 years after stopping treatment with Neotigason, as the medicine may still be present in the patient's body (unless the doctor decides it is not necessary for the patient).
• The patient must agree to have additional pregnancy tests as recommended by their doctor.
• The patient must not become pregnant during treatment and for 3 years after stopping treatment, as the medicine may still be present in their body.
• The doctor will discuss all issues with the patient using a checklist and ask the patient (or their parent or legal guardian) to sign it. This form confirms that the patient has been informed of the risks and agrees to follow the above rules.

If the patient becomes pregnant while taking Neotigason, they must stop takingthe medicine immediatelyand contact their doctor. The doctor may refer the patient to a specialist for advice.
Additionally, if the patient becomes pregnant within 3 years after stopping treatment with Neotigason, they should contact their doctor. The doctor may refer the patient to a specialist for advice.

Advice for men

The amount of oral retinoids in the sperm of men taking Neotigason is too small to harm the unborn child of their partner. However, this medicinal product should never be shared with anyone, especially women.

Advice for all patients

Acitretin often increases blood fat levels, such as cholesterol or triglycerides, which has been associated with pancreatitis.
If severe abdominal or back pain occurs, the patient should inform their doctor (these may be symptoms of pancreatitis).

Additional precautions

This medicinal product should never be given to another person. All unused capsules should be returned to the pharmacist after treatment has ended.

Before starting treatment with Neotigason, the patient should discuss the following with their doctor:

• If the patient has diabetes. The patient will need to have their blood sugar levels checked more frequently after starting Neotigason.
• If the patient has high levels of lipids in the blood or is obese. The doctor may order a blood test during treatment with Neotigason to check the patient's blood lipid levels.
• If the patient has cardiovascular disease. The patient may need to be monitored more closely by their doctor, e.g., have their blood pressure checked.
• If the patient consumes large amounts of alcohol.
• If the patient has liver function disorders.
• If the patient has ever had mental health problems, including depression, aggression, mood swings, or psychotic symptoms (altered perception of reality, such as hearing voices or seeing things that are not there).

This is because Neotigason may affect the patient's mood and mental health.

Mental health problems

The patient may not notice certain changes in their mood and behavior, so it is essential to tell friends and family members that this medicine may cause changes in behavior and mood. These people may notice such changes and help identify problems that need to be discussed with the doctor.
Other situations to consider when taking Neotigason:

• Neotigason may cause impaired night vision (see also "Driving and using machines" and section 4).
• Neotigason may cause increased pressure in the skull. If symptoms of increased intracranial pressure occur, such as severe headache, nausea, vomiting, or vision disturbances, the patient should contact their doctor immediately.
• Neotigason may increase the effects of UV radiation on the skin. Before going out in strong sunlight, the patient should protect their skin with a sunscreen with a sun protection factor (SPF) of at least 15. The patient should avoid using sunlamps (solarium) without supervision and excessive exposure to sunlight.
• Liver function and blood lipid levels should be checked before starting treatment and regularly during treatment. The doctor may periodically check the patient's bones, as Neotigason may cause bone changes, especially in children and elderly patients treated long-term.
• Taking high doses of Neotigason may cause mood changes (including irritability, aggression, and depression).
• Very rarely, a severe condition (capillary leak syndrome/retinoic acid syndrome) has been reported, in which small blood vessels (capillaries) leak. This can lead to severe hypotension (low blood pressure), edema (fluid accumulation causing swelling), and shock (collapse).
• Very rarely, a severe skin reaction (exfoliative dermatitis) has been reported, with symptoms such as rash, blisters, or flaking skin. See section 4.
• Due to the risk of harm to the fetus, this medicine must not be given to another person. Unused or expired capsules should be returned to the pharmacy for destruction.

Women of childbearing age:
Neotigason causes birth defects in the unborn child. Pregnancy prevention and pregnancy testing are necessary during treatment and for 3 years after stopping Neotigason, see also "Pregnancy and breastfeeding". Women of childbearing age must not consume alcohol during treatment and for 2 months after stopping treatment, see "Neotigason and alcohol".
Blood donation:

Do not donate blood while taking this medicine or for 3 years after stopping Neotigason. If the patient's blood is given to a pregnant woman, she may give birth to a

child with birth defects.
If any of the above warnings apply to the patient, they should contact their doctor or pharmacist before taking Neotigason.

Neotigason and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.
Metotrexate (used to treat skin diseases, joint pain, or cancer), tetracyclines (used to treat infections), or vitamin A and other retinoids (such as isotretinoin) must not be taken at the same time as Neotigason, see also "When not to take Neotigason".
Before starting treatment with Neotigason, the patient should inform their doctor if they are taking phenytoin (used to treat epilepsy) or oral contraceptives containing low doses of progesterone (minipills).

Neotigason and alcohol

Women of childbearing age must not consume alcohol (in drinks, food, or medicines) while taking Neotigason and for 2 months after stopping treatment. Taking alcohol and Neotigason at the same time may cause the formation of a compound called etretinate, which harms the fetus and is very slowly eliminated from the body. For 3 years after stopping treatment with Neotigason, effective pregnancy prevention methods must be used.

Fertility, pregnancy, and breastfeeding

Neotigason causes birth defects in the unborn child. The following instructions must be strictly followed, even if there are fertility problems.
Do not takeNeotigason if the patient is pregnant, suspects they may be pregnant, or may become pregnant while taking Neotigason or within 3 years of stopping treatment.
Do not takeNeotigason if the patient is breastfeeding.
Birth control:If the patient is of childbearing age, they must use effectivecontraception methods (birth control)without interruption, for at least 4 weeks before starting Neotigason, during treatment, and for 3 years after stopping treatment with acitretin, see also "Pregnancy and breastfeeding". The primary birth control method is a combination of oral contraceptives or an intrauterine device with a condom or diaphragm. Mini-pills (containing low doses of progesterone) are not recommended.
Pregnancy testing:The doctor will require a mandatory pregnancy testwithin 3 days before starting treatment. The test result must be negative. Treatment with Neotigason can only be started after a negative pregnancy test result, ideally on the second or third day of the next menstrual period. The patient will also be asked to have regular pregnancy testsevery 28 days during treatment. Before each prescription renewal, the doctor will ask for a negative pregnancy test result. The test should be performed no earlier than 3 days before the doctor's visit.
After stopping Neotigason, pregnancy tests should be performed at 1-3 month intervals for 3 years after the last dose.
If the patient becomes pregnant or suspects they may be pregnantduring treatment or within 3 years of stopping treatment, they should contact their doctor immediately.
More information on pregnancy and contraception can be found in section 2, "Pregnancy Prevention Program".
If the patient has any questions about the above instructions, they should discuss them with their doctor or pharmacist before taking Neotigason.

Driving and using machines

While taking Neotigason, the patient may have problems with their vision, especially at night.
The patient should be cautious when driving, using tools, and operating machines.

Neotigason contains glucose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking Neotigason.

Neotigason contains sodium

Neotigason contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Neotigason

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should ask their doctor.
The capsules are best taken once a day with food or milk.
The usual dose for adults is 25 mg (i.e., 1 capsule containing 25 mg of acitretin) or 30 mg (3 capsules, each containing 10 mg of acitretin). The doctor may adjust the dose according to the disease and other factors, such as the patient's overall health. The maximum recommended daily dose is 75 mg (i.e., 3 capsules, each containing 25 mg of acitretin).

Women of childbearing age

Treatment with Neotigason can only be started on the second or third day of the next menstrual period. The doctor will require a mandatory pregnancy testwithin 3 days before starting treatment and regular pregnancy testsduring treatment and for 3 years after stopping treatment. The pregnancy test results must be negative. The patient must also use effective contraception methodswithout interruption, for at least 4 weeks before starting Neotigason, during treatment, and for 3 years after stopping treatment with acitretin, see also "Pregnancy and breastfeeding".

Use in children

Neotigason can be given to children only if alternative treatment methods are not suitable. The doctor will decide on the dose, which depends on the disease and the child's weight.

Overdose

If the patient or someone else has taken more Neotigason than prescribed, they should contact their doctor or hospital immediately. Symptoms of overdose include headache, dizziness, nausea, vomiting, drowsiness, irritability, or itching.

Missed dose

The patient should take the missed dose as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. The patient should not take a double dose to make up for the missed dose.

Stopping treatment

The patient should not stop taking Neotigason without consulting their doctor.
If the patient has any further questions about taking Neotigason, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Neotigason can cause side effects, although not everybody gets them.

The patient should stop taking Neotigason and contact their doctor immediately if they experience any of the following side effects:

• Severe headache, nausea, vomiting, and vision disturbances. These may be symptoms of increased intracranial pressure ( very rare).
• Allergic reactions with symptoms such as rash, swelling, or itching of the skin, redness and swelling of the eyes, severe swelling of the nasal mucosa, asthma, or wheezing ( frequency unknown).
• Yellowing of the skin and whites of the eyes - jaundice ( very rare).
• Jaundice and other symptoms such as loss of appetite, fever, general malaise, nausea, dark urine, abdominal discomfort. These may be symptoms of hepatitis ( not very common).
• A severe condition (capillary leak syndrome/retinoic acid syndrome), in which small blood vessels (capillaries) leak. This can lead to severe hypotension (low blood pressure), edema (fluid accumulation causing swelling), and shock (collapse). Symptoms include swelling or edema, difficulty breathing, abdominal cramps, muscle pain, excessive thirst, general feeling of tiredness and weakness ( frequency unknown).
• A severe skin reaction with symptoms such as rash, blisters, or flaking skin ( frequency unknown).

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

• Dry, irritated, or swollen eyes, which may lead to intolerance of contact lenses
• Dryness, irritation, or watery discharge from the nose, nosebleeds
• Dry mouth, thirst
• Dryness or inflammation of the mouth, which can be alleviated by applying a greasy ointment
• Itching, hair loss, flaking skin on the hands or feet or even on the whole body
• Changes in liver function (visible in blood tests)
• Increased blood fat levels (visible in blood tests).

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

• Headache
• Mouth inflammation, abdominal pain, diarrhea, nausea, vomiting
• Sensitive skin, feeling of wet skin, or rash, skin inflammation, abnormal hair structure, weak nails, infection of the skin around the nails, redness of the skin
• Joint pain, muscle pain
• Swelling of the hands, feet, and ankles.

Not very common (may affect up to 1 in 100 people):

• Dizziness
• Blurred vision
• Gingivitis
• Fissures, cracks, or ulcers of the skin, e.g., around the mouth, blisters, or skin inflammation (bullous dermatitis), increased sensitivity of the skin to sunlight (photosensitivity).

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

• Damage to the peripheral nervous system, which may include symptoms such as muscle weakness, numbness, tingling, or burning sensation in the feet, hands, or toes.

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

• Night blindness, corneal inflammation (ulcerative keratitis)
• Bone pain, changes in bone growth.

Frequency unknown (cannot be estimated from available data):

• Vaginal infections (also known as thrush or fungal infections)
• Mood changes, psychotic symptoms: altered perception of reality, such as hearing voices or seeing things that are not there
• Hearing disorders, ringing in the ears (tinnitus)
• Sudden flushing
• Changes in taste; rectal bleeding
• Small, red bumps on the skin that may bleed easily (granuloma), loss of eyebrows and eyelashes, skin swelling, skin rashes (causing itching and redness)
• Thinning of the skin, exfoliative dermatitis
• Improvement or worsening of glucose tolerance in patients with diabetes
• Changes in voice (dysphonia).

Sometimes, at the start of treatment, a worsening of psoriasis symptoms is observed.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Neotigason

The medicine should be kept out of sight and reach of children.
Store in a temperature not exceeding 25°C, in the original packaging.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
Due to the risk of harm to the fetus, this medicine must not be given to another person. Unused or expired capsules mustbe returned to the pharmacy for destruction.

6. Contents of the pack and other information

What Neotigason contains

• The active substance of Neotigason is acitretin. Each capsule contains 10 mg or 25 mg of acitretin.
• Other ingredients of the medicine are:

Neotigason 10 mg capsules:

gelatin, spray-dried glucose, sodium ascorbate, microcrystalline cellulose
capsule shell:
Body of the capsule: titanium dioxide (E 171), gelatin.
Cap of the capsule: iron oxide black (E 172), iron oxide yellow (E 172), iron oxide red (E 172), titanium dioxide (E 171), gelatin.
Ink: shellac, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, iron oxide black (E 172).

Neotigason 25 mg capsules:

gelatin, spray-dried glucose, sodium ascorbate, microcrystalline cellulose
capsule shell:
Body of the capsule: iron oxide yellow (E 172), titanium dioxide (E 171), gelatin.
Cap of the capsule: iron oxide black (E 172), iron oxide yellow (E 172), iron oxide red (E 172), titanium dioxide (E 171), gelatin.
Ink: shellac, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, iron oxide black (E 172).

What Neotigason looks like and contents of the pack:

10 mg: capsules with a brown cap and white body, with "10" printed in black on the body; capsules are size 4.
25 mg: capsules with a brown cap and yellow body, with "25" printed in black on the body; capsules are size 1.
One pack contains 30 or 100 capsules.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer:

CENEXI
52 rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00.

Date of last revision of the leaflet: September 2024

Detailed and up-to-date information about this medicine is available by scanning the QR code on the leaflet with a smartphone
This information is also available on the website: www.retynoidyteva.pl

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