ZORIAS 10 mg Hard Capsules

Зміст інструкції

1. Zorias 10 mg capsule, 25 mg capsule
   1. WHAT ZORIAS IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING ZORIAS
   3. HOW TO TAKE ZORIAS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ZORIAS
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Zorias 10 mg capsule, 25 mg capsule

Acitretina
Equivalent Medicinal Product

WARNING
MAY CAUSE SERIOUS HARM TO THE FETUS
Women must use effective contraceptive methods
Do not use if you are or think you may 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 encountered during
taking this medicine. See the end of section 4 for information on how to report adverse effects.

Read this leaflet carefully before taking the 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 give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If any side effects occur, ask your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. WHAT ZORIAS IS AND WHAT IT IS USED FOR

Acitretin belongs to a group of medicines known as retinoids. Retinoids are derivatives of vitamin A.
This medicine is used to treat severe skin problems, characterized by thickening or
scaling, that do not respond satisfactorily to other conventional treatments.
Zorias is used to treat:

• extensive and severe forms of various skin diseasesresulting from alterations of the superficial layer of the skin (epidermis), such as psoriasis, accompanied by a dry, scaly and waxy rash;
• specific skin diseases characterized by dry scalingresulting from marked keratinization (ichthyosis, an organic process whereby keratin is deposited in cells making them as thick as nails and hair) and similar diseases that present with rashes (pityriasis) or small elevations of the skin and mucous membranes (lichen ruber).

2. WHAT YOU NEED TO KNOW BEFORE USING ZORIAS

Do not take Zorias

• If you are pregnant or breastfeeding.
• If there is any possibility that you might become pregnant, you must take the precautions described in the “Pregnancy Prevention Program” section, under “Warnings and precautions”.
• if your liveris not functioning properly
• if your kidneysare not functioning properly
• if you have very high levels of fat or cholesterolin your blood (a condition also known as “hyperlipidemia”)
• if you are taking other retinoid medicinesor medicines, vitamin supplements, or foods containing high levels of vitamin A. See section “Do not take Zorias with”
• if you are taking tetracycline-based antibiotics(for an infection). See section “Do not take Zorias with”
• if you are being treated with methotrexate(a medicine used to treat cancer, psoriasis, and rheumatic diseases). See section “Do not take Zorias with”
• if you are using the so-called minipill(a contraceptive pill with a low content of progesterone) the contraceptive effect of the minipill may be reduced by Zorias and therefore reliable contraceptive protection is no longer guaranteed. See section “Do not take Zorias with”
• 7. if you are allergic(hypersensitive) to the active ingredient, to any of the other ingredients of the medicine (listed in section 6: “Contents of the pack and other information”) or to other “retinoid” medicines. Hypersensitivity normally manifests itself in the form of skin reactions, such as rashes, hives and/or itching. Warnings and precautionsTalk to your doctor or pharmacist before taking acitretin. Warning for all patients Acitretin commonly increases fats in the blood, such as cholesterol or triglycerides, which have been associated with pancreatitis. Tell your doctor if you experience severe abdominal and back pain (this may be a sign of inflammation of the pancreas).

Pregnancy Prevention Program
Pregnant women must not use Zorias
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 Zorias is
used for only a short time during pregnancy.

• You must not use Zorias if you are pregnant or think you might be.
• You must not use Zorias if you are breastfeeding. The medicine can pass into the milk and harm the newborn.
• You must not use Zorias if you could become pregnant during treatment.
• You must not become pregnant for 3 years after finishing this treatment because some medicines can remain in your body. Women who can become pregnant are prescribed Zorias with very strict rules. This is due to therisk 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 get pregnant. The doctor may refer you to a specialist for contraceptive counseling.
• Before starting treatment, the doctor will ask you to take a pregnancy test. The test must show that you are not pregnant when you start treatment with Zorias

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

• 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 Zorias, during treatment and for 3 years 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 after using Zorias
• You must agree to have regular check-up visits, preferably every month
• You must agree to have regular pregnancy tests, preferably every month during treatment and, as some medicines can remain in your body, from 1 to 3 months for 3 years after stopping Zorias
• You must agree to perform additional pregnancy tests if your doctor asks you to.
• You must not become pregnant during treatment or within the next 3 years because some medicines can remain in your body.
• The doctor will discuss all these points with you, using a checklist and will ask you (or a relative/guardian) to sign it. This document will serve to confirm that you have been informed of the risks and that you will have to follow the above rules. If you become pregnant while taking Zorias, stop taking this medicine immediately, and see your doctor. The doctor may refer you to a specialist for a consultation. Also, if you become pregnant within 3 years of stopping Zorias, you should contact your doctor. The doctor may refer you to a specialist for a consultation.

Advice for men
Levels of oral retinoids in the semen of men usingZorias are too low to harm the
fetus of their partner. However, you should never share your medicines with anyone.

Further precautions
You should never give this medicine to anyone else. At the end of treatment return the unused capsules
to the pharmacist.
You must not donate blood during treatment with this medicine and for 3 years after stopping using
Zorias as if a pregnant patient were to receive your blood it could harm her fetus.
Talk to your doctor before taking Zorias:

• If you have not had mental health problems. This includes depression, aggressive tendencies or mood swings. This is because Zorias can interfere with your mood.

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 this medicine can interfere with mood and behavior. They may notice
these changes and help you identify problems that need to be discussed with your doctor.

Pay particular attention with Zorias

• if you are a woman of childbearing potentialand the doctor decides to use this medicine, you must strictly adhere to a series of instructions (see “Instructions for women of childbearing potential” in the “Pregnancy, breastfeeding and fertility” section)
• if you suffer from high blood sugar levels (diabetes),if you drink a lot of alcohol, if you are overweight, if you suffer from lipid metabolism disorders or high blood pressure. In this case, when you start taking this medicine, you will need to have more frequent checks of your serum levels.
• if you notice problems with your vision, especially in the dark (see “Driving and using machines”)
• if you wear contact lenses.Zorias causes dry eyes and therefore you should wear glasses during the treatment period.
• if Zorias is to be used in children.Growth and bone development must be checked at regular intervals. In long-term treatment of children, the doctor must carefully weigh the possible serious side effects against the benefit of therapy with this medicine.
• if you are exposed to intense sunlightor intend to use tanning beds. Zorias can intensify the effects of UV light on the skin. In this case, avoid excessive exposure to the sun and do not use tanning beds. Before exposing yourself to the sun, make sure to apply adequate sun protection (at least SPF 15).
• If you suffer from severe headache, nausea, vomiting and visual disturbances, if there have been rare cases of increased benign pressure in the brain.

Tests before starting treatment

• The doctor will need to perform a blood test before starting treatment to check your liver function.The blood test should be repeated every 1-2 weeks for 2 months after starting treatment. After this period, the tests should be repeated at least every 3 months during treatment. If abnormal values are found, your liver function should be monitored weekly. If the abnormality in liver function determines premature discontinuation of treatment, liver function should be monitored for at least 3 months after stopping Zorias therapy.
• Cholesterol and triglyceride levels in the blood (fasting values) must be checked before starting treatment, one month after starting and then every 3 months during treatment. In diabetics, retinoids can improve or worsen glucose tolerance. Blood sugar levels should therefore be checked more frequently than usual in the early stages of treatment.
• For all patients at high risk where cardiovascular risk indicators fail to return to normal or worsen further, a dose reduction or discontinuation of acitretin treatment should be considered.
• The doctor may check your blood pressure.
• Before treatment with Zorias and during long-term therapy, the doctor will subject you to further examinations of your bones at regular intervals (e.g. once a year) as this medicine can cause bone changes (see section 4 “Possible side effects”). If this is the case, the doctor will discuss with you the advantages and disadvantages of continuing therapy.
• Tell your doctor if you notice the following signs of possible bone changes:bone, joint or muscle pain, limited mobility. There have been occasional reports of bone changes in children after long-term treatment with etretinate (another “retinoid” drug). Therefore, in children, growth parameters and bone development must be carefully monitored.

Very rarely, a serious condition has been reported that causes increased permeability of
small blood vessels (capillaries) (capillary leak syndrome / retinoic acid syndrome).
This can cause severe hypotension (low blood pressure), edema (fluid accumulation that
leads to swelling) and shock (collapse).
Very rarely, a serious skin reaction has been reported with symptoms such as rashes,
blisters or peeling skin (exfoliative dermatitis).

Other medicines and Zorias
Tell your doctor or pharmacist if you are taking/using or have recently taken/used any
other medicines, including those available without a prescription.
The effect of phenytoin (a medicine for epilepsy) may be increased when taking Zorias. Therefore, the
dosage of phenytoin may require adjustment.

Do not take Zorias with:

• tetracycline-based antibioticsbecause they can cause an increase in pressure in the brain.
• methotrexate(a medicine used in the treatment of cancer, psoriasis and rheumatic diseases), because this combination can cause liver inflammation.
• the so-called minipill(a contraceptive pill with a low content of progesterone). The contraceptive effect of the minipill may be reduced by Zorias, so the reliability of contraceptive protection is no longer guaranteed.
• medicines or vitamin A supplements containing high levels of vitamin A(more than 5000 IU per day).
• other retinoid medicines, such as isotretinoin.

Zorias with food and drink
During treatment with Zorias you should not drink alcohol as this would increase the risk of side effects.
Women of childbearing potential should absolutely not drink alcohol during treatment with acitretin and for the 2 months
following discontinuation of treatment (see “Instructions for women of childbearing potential”).
The concomitant intake of Zorias and alcohol can lead to the formation of a compound (etretinate), which can
be harmful to the fetus, and if formed, takes some time to be completely removed from the body.

Pregnancy, breastfeeding and fertility
Pregnancy
Do not take Zorias if you are pregnant or there is a possibility of becoming pregnant at any time during treatment and for 3 years after stopping.
If you become pregnant during treatment with Zorias, stop taking the medicine immediately and contact your doctor; if pregnancy occurs within 3 years of stopping treatment, contact your doctor immediately.
Acitretin, the active ingredient of this medicine, is likely to cause birth defects. If, despite the precautions described (see "Instructions for women of childbearing potential", see below and “Pregnancy Prevention Program” in the “Warnings and precautions” section), pregnancy occurs during treatment with Zorias or within 2 years of its discontinuation, there is a high risk of serious birth defects.

Instructions for women of childbearing potential
Zorias is highly teratogenic. This means that it is likely to seriously harm the unborn child.
Typical malformations produced by acitretin include, for example, damage to the central nervous system, heart and major blood vessels, skull and face, skeleton and thymus gland.
The percentage of malformations is high, even if the medicine has been taken for a short period during pregnancy or if pregnancy begins within 3 years of stopping treatment.

If you are a woman of childbearing potential, you can only take Zorias if:

• you suffer from a very severe or disabling skin disease that has shown no improvement with other treatments
• you strictly observe the following precautions to prevent pregnancyduring treatment with Zorias and for 2 years after stopping it:
• your doctor has explainedthe teratogenic risk (very serious fetal malformation) associated with the use of Zorias and you understand the reasons why you should not become pregnant and how to prevent it
• you must use an effective method of birth control(contraception), preferably 2 complementary methods (hormonal contraceptive or an intrauterine device and a condom or diaphragm) without interruption, for at least 1 month before starting to take the medicine,

during treatment and for 3 years after stopping treatment. Discuss with your doctor the precautionary measures to be taken for effective contraception. Contact your doctor immediately if you suspect you are pregnant.

• you have undergone a supervised pregnancy test(which must be negative) up to 3 days before starting the first dose of Zorias to ensure you are not pregnant. You may also be asked to have regular pregnancy tests during the intake of this medicine. After stopping treatment, the pregnancy test must be performed every 1-3 months for a period of 3 years after the administration of the last dose of Zorias.
• you start taking Zorias after the negative result of the pregnancy test, on the second or third day of your next menstrual cycle
• you understand and accept the need to undergo monthly follow-up visitsand possibly further pregnancy tests, at the doctor's discretion
• you strictly adhere to these precautions in case of repeated treatment with Zorias
• you do not consume alcohol (in beverages, food or medicines) during the treatment period with Zorias and for 2 months after stopping it because alcohol can increase the risk of malformations. Women of childbearing potential should not receive blood from patients treated with acitretin.

The doctor may ask you (or your legal guardian) to sign a declaration confirming that you have been informed about the risks of treatment with Zorias and that you accept the necessary precautionary measures.
If you have questions about these instructions, ask your doctor or pharmacist before taking this medicine.
For more information on pregnancy and contraception, see section 2 of the “Pregnancy Prevention Program”.
Breastfeeding
You must not take Zorias if you are breastfeeding, as acitretin passes into breast milk and can harm the newborn.
Prescription based on diagnosis and therapeutic plan of the dermatology specialist. Based on the therapeutic plan of a maximum duration of 6 months, prescriptions can also be issued by the attending physician. The prescription of Zorias to women of childbearing potential is limited to 30 days of therapy and continuation of therapy requires a new prescription. The pregnancy test, delivery of the prescription and dispensing of Zorias should preferably take place on the same day. Zorias will be dispensed to you by the pharmacist within a maximum of seven days from the date of the prescription. After this period, the pharmacist will only dispense Zorias to you upon presentation of a new prescription.

Driving and operating machinery
Night vision may worsen during treatment. This phenomenon can occur suddenly.
In rare cases, this phenomenon has continued even after stopping treatment. Be careful if you drive or use any type of tool or machinery at night or in tunnels. (see “Pay particular attention with Zorias”).
Zorias contains glucose (as maltodextrin from corn). If your doctor has told you that you have an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE ZORIAS

Zorias must only be prescribed by doctors, preferably dermatologists, who have experience in
treatment with systemic retinoids and who correctly assess the risk of taking acitretin in case of
pregnancy.
Always take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts
ask your doctor or pharmacist.

• Take Zorias with meals or with a glass of milk.
• Swallow each capsule whole. The dose varies depending on the patient. The doctor will calculate the dose appropriate for your case.

For individual treatment, Zorias capsules are available with a content of 10 or 25 mg of acitretin.

Adult and elderly patients

• The usual initial dose for adults and the elderly is 25 mg or 30 mg once a day.
• After 2 or 4 weeks, the doctor may increase or decrease the dose. The decision will depend on the effectiveness of the medicine and the effects it produces on you.
• The maximum dose is 75 mg per day.
• Most patients take Zorias for a maximum period of 3 months. However, the doctor may decide to extend the treatment further in your case.

If you take more Zorias than you should
If you take more Zorias than you should, you may experience headache, nausea or vomiting, drowsiness, irritability and itching. In
this case, stop taking the medicine and seek immediate medical attention or go to hospital.
If you forget to take Zorias
Do not take a double dose of Zorias to make up for a missed dose. If you should forget a
dose, take it as soon as you remember and continue to follow the prescribed dosage schedule. However, if it is
almost time to take the next dose, skip the missed dose.

If you stop taking Zorias
The doctor will best assess the opportunity and method of stopping treatment with Zorias.
Always consult your doctor before stopping taking the medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

• The side effects of Zorias are related to the dose. The higher the dose, the greater the risk of side effects.
• Treatment with high doses can cause mood changes including irritability, aggressiveness and depression.
• Most side effects occur at the beginning of treatment, when the dose has not yet been adjusted. Most adverse effects are reversible following dose modification or discontinuation of treatment.
• Occasionally, skin symptoms may worsen at the beginning of treatment.
• Since Zorias is a vitamin A derivative, most side effects are similar to the symptoms that occur in case of excessive use of vitamin A.

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

• Dryness or inflammation of the lips
• Dryness, irritated or runny nose, nosebleeds, skin scaling, especially at the level of the palms of the hands and soles of the feet
• inflammation of the nasal mucosa
• itching
• hair loss
• dry mouth, feeling more thirsty than usual
• changes in liver function (indicated by blood tests)
• increased levels of fats (triglycerides, cholesterol) in the blood (indicated by blood tests)
• Dry, irritated or swollen eyes, which can lead to intolerance of contact lenses

Using moisturizers or ‘emollients’ from the beginning of treatment can help to relieve problems related to
skin or lip dryness.
Adverse effects on the skin and mucous membranes occur rather early (after a few days)
from the start of treatment, while hair loss tends to occur after many weeks.
These adverse effects are reversible following dose modification or discontinuation of treatment. However, the
regrowth of hair may take several months, due to their growth cycle.

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

• Headache
• Muscle and joint pain
• Swelling of the hands, ankles and feet
• Inflammation of the oral mucosa
• Gastro-intestinal problems (e.g., nausea, vomiting, abdominal pain, diarrhea, digestive disorders)
• Fragile skin, sticky feeling on the skin or skin rashes, skin inflammation, changes in hair structure, brittle nails, skin infections around a nail, skin redness.

Uncommon side effects(may affect up to 1 in 100 people)

• dizziness
• blurred vision
• Inflammation of the gums
• Inflammation of the liver (hepatitis)
• Fissures, cracks or thin linear scars on the skin, for example, around the mouth (cheilitis), blisters and skin inflammation (bullous dermatitis)
• Increased sensitivity of the skin to sunlight

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

• Damage to the peripheral nervous system, which may include symptoms such as muscle weakness, numbness and tingling in the hands and feet or burning or stabbing pain

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

• Increased pressure in the skull
• Altered night vision, inflammation of the cornea (ulcerative keratitis)
• Yellowing of the skin or whites of the eyes (jaundice)
• bone pain, changes in bone growth

Side effects of unknown frequency(frequency cannot be estimated from available data)

• Vaginal infection (also known as candidaor thrush)
• Severe itchy rash with pale or reddish raised irregular patches (urticaria)
• Partial hearing loss, ringing in the ears (tinnitus)
• hot flashes
• A serious condition causing increased permeability of small blood vessels (capillaries) (capillary leak syndrome / retinoic acid syndrome). This can cause severe hypotension (low blood pressure), edema (fluid accumulation leading to swelling) and shock (collapse)
• Changes in taste perception; rectal bleeding
• Swelling or small, reddish nodules on the skin that can bleed easily (pyogenic granuloma)
• Loss of eyelashes and eyebrows (madarosis)
• A severe skin reaction with symptoms such as skin rashes, blisters or peeling skin (exfoliative dermatitis)
• Immediate allergic reaction with symptoms such as skin rashes, swelling or itching of the skin, red and swollen eyes, severe nasal congestion, asthma or shortness of breath. The reaction can range from mild to life-threatening.
• Alteration of voice sound (dysphonia)

Children
Occasionally, bone changes may occur. Growth and bone development parameters must be
monitored.
Diabetics
Improvement or worsening of glucose tolerance may occur

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. HOW TO STORE ZORIAS

Keep this medicine out of the sight and reach of children.
Do not use the medicine after the expiry date which is stated on the packaging and on the blister pack after the wording SCAD.
or EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C. Store in the original packaging to protect the
medicine from humidity.
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 Zorias contains
The active ingredient is acitretin.
Zorias 10 mg capsule: each hard capsule contains 10 mg of acitretin.
Zorias 25 mg capsule: each hard capsule contains 25 mg of acitretin.
The other ingredients are:
Zorias 10 mg capsules
Capsule content:

• Glucose (as maltodextrin from corn)
• Sodium ascorbate
• Microcrystalline cellulose Capsule shell:
• Gelatin
• Propylene glycol
• Sodium lauryl sulfate
• Titanium dioxide (E 171)
• Black iron oxide (E172)
• Red iron oxide (E172)
• Shellac
• Purified water

Zorias 25 mg capsules
Capsule content:

• Glucose (as maltodextrin from corn)
• Sodium ascorbate
• Microcrystalline cellulose Capsule shell:
• Gelatin
• Propylene glycol
• Sodium lauryl sulfate
• Titanium dioxide (E 171)
• Yellow iron oxide (E172)
• Black iron oxide (E172)
• Red iron oxide (E172)
• Shellac
• Purified water

Description of the appearance of Zorias and package contents
Zorias 10 mg consists of a body from white to off-white and a brown cap, with the inscription “A10” printed in
black on the capsule body, and containing a yellow powder.
Zorias 25 mg consists of a body from yellow to light yellow and a brown cap, with the inscription “A25” printed in
black on the capsule body, and containing a yellow powder.
The capsules are packaged in PVC/PVDC and aluminum blisters.
Package sizes:
20, 30 and 50 hard capsules
Not all pack sizes may be marketed.

Marketing authorisation holder
Difa Cooper S.p.A.
Via Milano 160
21042 Caronno Pertusella (VA)

Manufacturers
Industrial Farmacéutica Cantabria S.A.
C/ Pirita, 9
28850 Torrejón de Ardoz (Madrid) - Spain
Laboratorios Edefarm, S.L.
Polígono Industrial Enchilagar del Rullo, 117

• 46191 – Villamarchante, Valencia Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
ES: Acitretina IFC
IT: Zorias
NL: Acitretine IFC
Detailed and updated information on this medicinal product is available at the following URL:
https://www.aifa.gov.it/hu/trova-farmaco