ALITRECARE 10 mg Soft Capsules

Зміст інструкції

1. Alitrecare 10 mg, 30 mg
   1. What is Alitrecare and what is it used for
   2. What you need to know before using Alitrecare
   3. How to use Alitrecare
   4. Possible side effects
   5. How to store Alitrecare
   6. Package Contents and Other Information

Alitrecare 10 mg, 30 mg

Alitretinoin
Generic medicine

WARNING
MAY 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 experienced during the use of this medicinal product. See
the end of section 4 for information on how to report adverse effects.

Read this leaflet carefully before using 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 other people, 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 Alitrecare is and what it is used for
• 2. What you need to know before you use Alitrecare
• 3. How to use Alitrecare
• 4. Possible side effects
• 5. How to store Alitrecare
• 6. Contents of the pack and other information

1. What is Alitrecare and what is it used for

The active ingredient of Alitrecare is alitretinoin. It belongs to a group of medicines known
as retinoids which are related to vitamin A. Alitrecare capsules are available
in two strengths, containing 10 mg or 30 mg of alitretinoin.
Alitrecare is used to treat adults with severe chronic eczema of the hands that is resistant
to other topical treatments, including steroids. Treatment with Alitrecare must be
carried out under the supervision of a doctor specializing in skin diseases (dermatologist).

2. What you need to know before using Alitrecare

Do not use Alitrecare:

• If you are pregnantor breastfeeding.
• If there is any possibility that you may become pregnant, you must take the precautions described in the “Pregnancy Prevention Program”, in the “Warnings and precautions” section.
• If you have liver disease
• If you have severe kidney disease
• If you have high levels of fats in the blood(such as high cholesterol or high triglycerides)
• If you have thyroid disease, which has not been sufficientlytreated
• If you have very high levels of vitamin Ain your body ( hypervitaminosisA)
• If you are allergicto alitretinoin, to other retinoids (such as isotretinoin), to peanuts or soy, or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking tetracyclines(a type of antibiotic).
• If any of these conditions apply to you, consult your doctor. Do not takeAlitrecare.

Warnings and precautions
Pregnancy Prevention Program
Pregnant women must not use Alitrecare
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
miscarriage. This can happen even if Alitrecare is used for a short time during
pregnancy.

• You must not use Alitrecare if you are pregnant or think you might be.
• You must not use Alitrecare if you are breastfeeding. The medicine can pass into the milk and harm the newborn.
• You must not use Alitrecare if you could become pregnant during treatment.
• You must not become pregnant for one month after finishing this treatment because some medicines can remain in your body. Women who can become pregnant Alitrecare is prescribed with veryrestrictive rules. This is due to the risk of harm that can be caused to the fetus.These are the rules:
• The doctor must explain the risk of harm to the fetus. You must understand that you must not become pregnant and what you need to do to prevent pregnancy.
• The doctor must have spoken to you about contraception (birth control). The doctor will give you information on how not to become pregnant. The doctor may refer you to a specialist for contraceptive counseling.
• Before starting treatment, the doctor will tell you to take a pregnancy test. The test must show that you are not pregnant when you start treatment with Alitrecare.

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

• 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 Alitrecare, during treatment and for one month after the end of treatment.
• You must use contraception even if you do not have your period or if you are not sexually active (unless your doctor tells you that it is not necessary).

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

• You must agree to undergo regular check-ups, preferably every month
• You must agree to undergo regular pregnancy tests, preferably every month during treatment and, as some medicines can remain in your body, 1 month after stopping Alitrecare (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 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 Alitrecare, 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 one month of stopping Alitrecare, you must
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 using Alitrecare 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 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 Alitrecare because if a pregnant patient
were to receive your blood it could harm her fetus.
See your doctor or pharmacist before using Alitrecare:

• If you have had mental health problems, including depression, aggressive tendencies or mood swings. This also includes thoughts of harming yourself or ending your life. This is because Alitrecare can interfere with your mood.
• If you have kidney disease. Alitrecare is not recommended for people with moderate kidney disease. If you have kidney disease - check with your doctor that Alitrecare is suitable for you.
• If you have high levels of fats in the blood, you may need more frequent blood tests. Usually Alitrecare increases fats in the blood, such as cholesterol or triglycerides. If blood fats remain high, your doctor may reduce the dose or stop treatment with Alitrecare.
• If you have a lot of sugar in your blood (diabetes), your blood sugar levels may need to be monitored more frequently and your doctor may start therapy with a low dose of Alitrecare.
• If you have ever suffered from thyroid disease. Alitrecare can lower the levels of thyroid hormone. If your thyroid hormone level is low, your doctor may prescribe replacement therapy.

During treatment, you must pay attention:

• If you experience vision problems, report them immediately to your doctor. It may be necessary to stop treatment with Alitrecare and have an eye exam.
• If you experience persistent headaches, nausea or vomiting (feeling unwell) and blurred vision, these may be signs of a condition called benign intracranial hypertension. Stop taking the capsules immediatelyand contact your doctor as soon as possible.
• If you experience bloody diarrhea, stop taking the capsules immediatelyand contact your doctor as soon as possible.
• Minimize exposure to sunlightand avoid using tanning beds. Your skin may become more sensitive to sunlight. Before exposure to the sun, use a sunscreen product with a high protection factor (SPF 15 or higher ).If your skin and lips become dryduring treatment, use a moisturizing lotion or cream and lip balm.
• Reduce intense physical activity: alitretinoin can cause muscle and joint pain.
• In case of dry eyes, it may be helpful to apply a lubricating eye ointment or artificial tears. If you wear contact lenses, you may need to use glasses during treatment with alitretinoin. Dry eyes and vision problems usually resolve with discontinuation of treatment.
• Alitrecare can increase levels of liver enzymes. The doctor will perform some blood tests during treatment to monitor these levels. If they remain high, the doctor may reduce the dosage or stop treatment with Alitrecare.

Mental health problems

• You may notice some changes in your mood and behavior and it is very important that you tell your friends and family that you are taking this medicine. They may notice these changes and help you identify problems that need to be discussed with your doctor. If you develop mental health problemsincluding depression, aggression, mood swings, thoughts of harming yourself or ending your life, stop taking Alitrecareand contact your doctor as soon as possible.

Children and adolescents
Alitrecare is not recommended for people under the age of 18. It is not known how
it works in subjects belonging to this age group.

Other medicines and Alitrecare
Do not take other retinoid medicines(e.g. isotretinoin), vitamin A supplements or tetracyclines(a type of antibiotic) while taking Alitrecare. This
increases the risk of side effects.

Tell your doctor or pharmacist if:

• you are taking amiodarone(a medicine that helps regulate your heartbeat). It is recommended not to take amiodarone together with Alitrecare.
• you are taking ketoconazole, fluconazole, miconazole(medicines used to treat infections). Your doctor may decide to reduce the dose of Alitrecare.
• you are taking simvastatin(a medicine used to lower cholesterol). Alitrecare can decrease the level of this medicine in your body.
• you are taking gemfibrozil(another medicine used to lower cholesterol) or oxandrolone(an anabolic steroid). Your doctor may decide to reduce the dose of Alitrecare.
• you are taking paclitaxel(used to treat tumors), rosiglitazone orrepaglinide(used to treat diabetes). Alitrecare can increase the levels of these medicines in your body.

Tell your doctor or pharmacistif you are taking, have recently taken or may
take any other medicines, including over-the-counter medicines and
herbal medicines.

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

Driving and using machines
During treatment, you may experience reduced night vision. If this happens
do not drive and do not use machinery.

Alitrecare contains soybean oil
If you are allergic to peanuts or soy, do not use this medicine.

Alitrecare contains sorbitol
Each Alitrecare 10 mg capsule contains 13.28 mg of sorbitol
Each Alitrecare 30 mg capsule contains 25.55 mg of sorbitol

3. How to use Alitrecare

Always take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.

When to take the capsules
The capsule must be taken with a main meal, preferably at the same time each day. The capsules must be swallowed whole and not chewed.

Dose
The dose is 10 or 30 mg once a day. If you are intolerant to the recommended dose of 30 mg, your doctor may prescribe you the lower dose of 10mg.

For how long to use the capsules
A treatment cycle usually lasts from 12 to 24 weeks, depending on the degree of improvement of the disease. If the first treatment cycle was positive, your doctor may prescribe you a further cycle in case of recurrence of symptoms.

If you take more Alitrecare than you should
If you have taken too many capsules or if other people have accidentally taken your medicine, contact your doctor, pharmacist or the nearest hospital immediately.

If you forget to take Alitrecare
If you forget to take a dose, take it as soon as possible. However, if the time for the next dose is approaching, skip the forgotten dose and continue as usual. Do not take a double dose to make up for the forgotten capsule.

• If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• Headache
• Increased blood fats: higher levels of fats (triglycerides) and cholesterol in the blood

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

• Blood and blood disorders:increased number of platelets (cells that help blood clotting), decreased number of red blood cells and white blood cells in blood tests
• Thyroid disorders:decrease in the levels of thyroid hormones
• Eye disorders:inflammation of the eyes (conjunctivitis) and eyelids; feeling of dryness and irritation of the eyes.
• Ask your pharmacist for a suitable eye drop. If you wear contact lenses and notice eye dryness, you may need to switch to wearing glasses.
• Ear disorders: persistent noises in the ears (tinnitus)
• Dizziness
• Blood and circulation:hot flushes, high blood pressure (hypertension)
• Intestinal and stomach disorders:feeling unwell (nausea), discomfort (vomiting), dry mouth
• Muscle and joint pain:muscle pain, joint pain, lack of energy (fatigue). Intense exercise results in high concentrations in the blood of muscle metabolism products.
• Skin and hair disorders:dry skin, especially on the face, dry and inflamed lips, redness of the skin, itchy rash, inflamed skin, hair loss.
• Liver disorders:increased liver enzymes in blood tests.

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

• Vision disordersincluding blurred vision, distorted vision, clouding of the eye surface (corneal opacity, cataract).
• If your vision is affected by these problems immediately stop usingAlitrecareand contact your doctor.
• Skin disorders:itching of the skin, skin peeling, rashes, eczema from dry skin
• Ear, nose and throat disorders:nosebleeds
• Intestinal and stomach disorders:indigestion (dyspepsia)
• Bone disorders:abnormal bone growth, including a disorder of the spine called ankylosing spondylitis.

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

• Persistent headache,accompanied by nausea, vomiting and changes in vision including blurred vision. These may be signs of benign intracranial hypertension.
• If you experience these symptoms, immediately stop usingAlitrecareand contact your doctor.
• Blood and circulation:inflammation of blood vessels.
• Skin and hair problems:nail disorders, increased sensitivity of the skin to sunlight, changes in hair structure

Mental problems
Rare side effects (may affect up to 1 in 1,000):

• Depression or related disorders. Symptoms of this include sadness or altered mood, anxiety, feelings of emotional distress.
• Worsening of existing depression
• Becoming violent or aggressive

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

• 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: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 Alitrecare. This may not be enough to end the effects: you may need further help, and your doctor can arrange this.

Other side effects
Other side effects have occurred in a very small number of people but their
exact frequency is unknown:

Serious allergic reactions
Symptoms include:

• itchy skin rash (urticaria)
• swelling, sometimes of the face or mouth (angioedema), which causes difficulty breathing
• collapse.
• If you have these symptoms contact your doctor immediately. Stop takingAlitrecare.

Intestinal and stomach disorders
Severe stomach (abdominal) pain, with or without bloody diarrhea, feeling
unwell and discomfort (vomiting).

• Immediately stop taking Alitrecareand contact your doctor. These may be signs of serious intestinal problems.

Problems with night vision
Vision problems usually return to normal once treatment is stopped.

Blood and circulation
Swelling of the hands, lower legs and feet (peripheral edema).

Side effects of other medicines belonging to the same family as Alitrecare
These effects have not yet been observed with Alitrecare, but it cannot be excluded that they
may occur. They are very rare and may affect less than 1 in 10,000 patients.

Diabetes
Excessive thirst; frequent need to urinate; blood tests show an increase
in blood sugar. These may all be signs of diabetes.

Bone disorders
Arthritis; bone disorders (delayed growth, changes in bone density); bone growth
may be interrupted.

Visual and eye disorders
Color blindness and worsening of color vision; intolerance to contact lenses.
In rare cases, soybean oil can cause serious allergic reactions.

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. . You can also report side effects
directly through the national reporting system at
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 Alitrecare

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 carton and blister after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Alitrecare contains

• The active ingredient is alitretinoin. 10 mg Capsules Each soft capsule contains 10 mg of alitretinoin. 30 mg Capsules Each soft capsule contains 30 mg of alitretinoin.
• Other ingredients are: Capsule content: soybean oil (refined) partially hydrogenated, hydrogenated vegetable oil, glycerol monostearate, triglycerides (medium chain), alpha-tocopherol. Capsule shell content: gelatin, glycerol, sorbitol liquid (non-crystallized) (E420), titanium dioxide (E171), purified water. 10 mg Capsules Iron oxide red (E172), Iron oxide yellow (E172), Iron oxide black (E172) 30 mg Capsules Iron oxide yellow (E172)

Description of the appearance of Alitrecare and package contents:
Alitrecare is presented as soft capsules.
10 mg Capsules:
Alitrecare 10 mg capsules are soft gelatin capsules, oval in shape, light brown in color, 10 mm x 6 mm, containing an opaque yellow/orange viscous suspension.
30 mg Capsules:
Alitrecare 30 mg capsules are soft gelatin capsules, oval in shape, yellow in color, containing an opaque yellow/orange viscous suspension.
The capsules are contained in an Aluminum/PVC/PVDC blister.
Package contents: 30 capsules

Marketing Authorisation Holder
Difa Cooper S.p.A.
Via Milano 160
21042 Caronno Pertusella (Varese)

Manufacturer
Industrial Farmacéutica Cantabria, S.A.
C/ Pirita, 9
Torrejón de Ardoz (Madrid), 28850, Spain

This medicinal product is authorised in the Member States of the European Economic
Area under the following denominations:
10 mg Dosage
Denmark Alitretinoïne IFC 10 mg soft capsules
Spain Alitretinóna IFC 10 mg soft capsules EFG
Italy Alitrecare 10 mg
Portugal Alitretinoína cantabria 10 mg soft capsules mg

30 mg Dosage
Denmark Alitretinoïne IFC 30 mg soft capsules
Spain Alitretinóna IFC 30 mg soft capsules EFG
Italy Alitrecare 30 mg
Portugal Alitretinoína cantabria 30 mg soft capsules mg
Detailed and up-to-date information on this medicinal product is available at the
following URL:
https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home