Package leaflet: Information for the user

Alitrecare 10 mg, 30 mg

Alitretinoin
Equivalent medicine
WARNING
CAN SERIOUSLY HARM THE UNBORN BABY
Women must use effective contraception
Do not use if you are or think you may be pregnant
This medicine is under 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 all of this leaflet carefully before you start 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 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Alitrecare is and what it is used for
What you need to know before taking Alitrecare
How to take Alitrecare
Possible side effects
How to store Alitrecare
Contents of the pack and other information

1. What Alitrecare is and what it is used for

The active substance 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 hand eczema that has not responded to other topical treatments, including steroids. Treatment with Alitrecare should be carried out under the supervision of a specialist doctor in skin diseases (dermatologist).

2. What you need to know before using Alitrecare

Do not use Alitrecare:

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 have liver disease.
If you have severe kidney disease.
If you have high levels of fats in the blood (such as high cholesterol or elevated triglycerides).
If you have thyroid disorders that have not been adequately treated.
If you have very high levels of vitamin A in your body (hypervitaminosis A).
If you are allergic to 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 take Alitrecare.

Warnings and precautions
Pregnancy Prevention Programme
Women who are pregnant must not use Alitrecare
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 possibly cause miscarriage. This can occur even if Alitrecare
is used for only a short time during pregnancy.

Do not use Alitrecare if you are pregnant or think you might be pregnant.
Do not use Alitrecare if you are breastfeeding. The medicine may pass into breast milk and harm the newborn.
Do not use Alitrecare if you could become pregnant during treatment.
Do not become pregnant for one month after stopping this treatment, as some medicines can remain in your body.
Women who could become pregnant
Alitrecare is prescribed under very strict rules due to the risk of fetal harm. These rules are:
Your doctor must explain the risk of fetal harm to you. 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 and may refer you to a specialist for contraceptive counselling.
Before starting treatment, your doctor will instruct you to take a pregnancy test. The test must confirm that you are not pregnant when starting Alitrecare treatment.

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

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. a hormonal contraceptive pill and a condom). Discuss with your doctor which method may be suitable for you.
You must use contraception for one month before starting Alitrecare, 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 tells you otherwise).

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

You must agree to attend regular check-ups, preferably every month.
You must agree to undergo regular pregnancy tests, preferably every month during treatment and one month after stopping Alitrecare (since some medicines may remain in your body), unless your doctor decides otherwise in your case.
You must agree to take additional pregnancy tests if requested by your doctor.
• You must not become pregnant during treatment or in the month following treatment, 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 family member/guardian) to sign it. This document confirms that the risks have been explained to you and that you agree to follow the above rules.

If you become pregnant while taking Alitrecare, 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 Alitrecare, 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 Alitrecare are too low to harm their
partner's unborn baby. However, you must never share your medicine with anyone else.

Additional precautions
Never give this medicine to anyone else. Return any unused capsules to the
pharmacist at the end of treatment.
Do not donate blood during treatment with this medicine or for 1 month after
stopping Alitrecare, as if a pregnant patient were to receive your blood, it could
harm her unborn baby.

Talk to your doctor or pharmacist before using Alitrecare if:

You have had mental health problems, including depression, aggressive tendencies, or mood changes. This also includes thoughts of self-harm or suicide. This is because Alitrecare may affect your mood.
You have kidney disease. Alitrecare is not recommended for people with moderate kidney disease. If you have kidney disease, check with your doctor whether Alitrecare is suitable for you.
You have high levels of fats in the blood. You may need more frequent blood tests. Alitrecare usually increases blood fat levels, such as cholesterol or triglycerides. If blood fat levels remain high, your doctor may reduce the dose or stop treatment with Alitrecare.
You have high blood sugar (diabetes). Your blood sugar levels may need to be monitored more frequently, and your doctor may start Alitrecare at a low dose.
You have ever had thyroid disorders. Alitrecare may lower thyroid hormone levels. If your thyroid hormone level is low, your doctor may prescribe replacement therapy.

During treatment, be alert to the following:

If you experience vision problems, inform your doctor immediately. Treatment with Alitrecare may need to be stopped, and an eye examination may be required.
If you develop 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 immediately and contact your doctor as soon as possible.
In case of bloody diarrhoea, stop taking the capsules immediately and contact your doctor as soon as possible.
Minimise exposure to sunlight and avoid using sunbeds. Your skin may become more sensitive to sunlight. Before sun exposure, use a high-protection sunscreen (SPF 15 or higher). If your skin and lips become dry during treatment, use a moisturising lotion or cream and a lip balm.
Reduce intense physical activity: alitretinoin may cause muscle and joint pain.
In case of dry eyes, applying a lubricating eye ointment or artificial tears may be helpful. If you wear contact lenses, you may need to wear glasses during treatment with alitretinoin. Dry eyes and vision problems usually resolve after stopping treatment.
Alitrecare may increase liver enzyme levels. Your doctor will perform blood tests during treatment to monitor these levels. If they remain elevated, your doctor may reduce the dose or stop treatment with Alitrecare.

Mental health problems

You may notice 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 identify problems that need to be discussed with your doctor. If you develop mental health problems, including depression, aggression, mood changes, or thoughts of self-harm or suicide, stop taking Alitrecare and contact your doctor as soon as possible.

Children and adolescents
Alitrecare is not recommended for people under 18 years of age. It is not known how it works
in individuals in 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
unwanted side effects.
Inform your doctor or pharmacist if:

you are taking amiodarone (a medicine used to regulate heart rhythm). 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 may reduce 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 cancer), rosiglitazone, or repaglinide (used to treat diabetes). Alitrecare may increase the levels of these medicines in your body.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal medicines.

Pregnancy, breastfeeding and fertility
For further information on pregnancy and contraception, see section 2 of the “Pregnancy
Prevention Programme”.

Driving and using machines
During treatment, your night vision may be reduced. If this occurs, do not drive or operate
machinery.

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

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

3. How to use Alitrecare

Always take this medicine exactly as instructed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
When to take the capsules
The capsule should 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 daily. If you are intolerant to the recommended dose of 30 mg, your doctor may prescribe the lower dose of 10 mg.
How long to take the capsules
A treatment cycle usually lasts from 12 to 24 weeks, depending on the degree of disease improvement. If the first treatment cycle was successful, your doctor may prescribe an additional cycle in case symptoms reappear.
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 nearest hospital immediately.
If you forget to take Alitrecare
If you forget to take a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue as normal. Do not take a double dose to make up for the forgotten capsule.

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

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

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

Blood cell disorders: increase in the number of platelets (cells that help blood clotting), decrease in the number of red and white blood cells in blood tests
Thyroid disorders: decrease in thyroid hormone levels
Eye disorders: inflammation of the eyes (conjunctivitis) and eyelids; sensation of dryness and irritation of the eyes.
Ask your pharmacist for a suitable eye drop. If you wear contact lenses and notice dry eyes, you may need to switch to 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 physical exercise leads to high blood levels of muscle metabolism products.
Skin and hair disorders: dry skin, especially of the face, dry and inflamed lips, skin redness, 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 disorders including blurred vision, distorted vision, clouding of the eye surface (corneal opacity, cataract).
If your vision is affected by these problems, stop using Alitrecare immediately and contact your doctor.
Skin disorders: itchy skin, skin peeling, skin rashes, eczema due to dry skin
Ear, nose and throat disorders: nosebleeds
Intestinal and stomach disorders: indigestion (dyspepsia)
Bone disorders: abnormal bone growth, including a spinal disorder called ankylosing spondylitis.

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

Persistent headache, accompanied by nausea, vomiting and vision disturbances including blurred vision. These may be signs of benign intracranial hypertension.
If you experience these symptoms, stop using Alitrecare immediately and 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 people):

Depression or related disorders. Symptoms include sadness or mood changes, anxiety, feelings of emotional distress.
Worsening of pre-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 thoughts ), have attempted to end their life ( suicide attempt ), or have ended their life ( 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 problems. Your doctor may tell you to stop taking Alitrecare. This may not be enough to stop 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:
Severe allergic reactions
Symptoms include:

itchy skin rash (urticaria)
swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
collapse.
If you have these symptoms, contact your doctor immediately. Stop taking Alitrecare.

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

Stop taking Alitrecare immediately and contact your doctor. These may be signs of serious intestinal problems.

Night vision problems
Vision problems usually return to normal once treatment is stopped.
Blood and circulation
Swelling of the hands, lower legs and feet (peripheral oedema).
Side effects of other medicines in the same class as Alitrecare
These side effects have not been observed so far with Alitrecare, but cannot be ruled out. They are very rare and may affect fewer than 1 in 10,000 patients.
Diabetes
Excessive thirst; frequent need to urinate; blood tests show increased blood sugar levels. These may all be signs of diabetes.
Bone disorders
Arthritis; bone disorders (delayed growth, changes in bone density); bone growth may stop.
Eye and vision disorders
Colour blindness and worsening of colour vision; intolerance to contact lenses.
In rare cases, soybean oil may cause severe allergic reactions.
Reporting of side effects
If you get 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
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 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 special storage conditions.
Do not dispose of medicines via 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 Alitrecare contains

The active substance is alitretinoin.
10 mg capsules: Each soft capsule contains 10 mg of alitretinoin.
30 mg capsules: Each soft capsule contains 30 mg of alitretinoin.
The other ingredients are:
Capsule contents: partially hydrogenated refined soybean oil, hydrogenated vegetable oil, glycerol monostearate, medium-chain triglycerides, alpha-tocopherol.
Capsule shell: gelatin, glycerol, liquid sorbitol (non-crystalline) (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 contents of the pack:
Alitrecare is available as soft capsules.
10 mg capsules:
Alitrecare 10 mg capsules are soft gelatin capsules, oval-shaped, light brown in colour, 10 mm x 6 mm, containing an opaque yellow/orange viscous suspension.
30 mg capsules:
Alitrecare 30 mg capsules are soft gelatin capsules, oval-shaped, yellow in colour, containing an opaque yellow/orange viscous suspension.
The capsules are contained in an aluminium/PVC/PVDC blister.
Pack contents: 30 capsules

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

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

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

10 mg dosage
Denmark: Alitretinoïne IFC 10 mg zachte capsules
Spain: Alitretinóna IFC 10 mg cápsulas blandas EFG
Italy: Alitrecare 10 mg
Portugal: Alitretinoína cantabria 10 mg cápsulas moles mg

30 mg dosage
Denmark: Alitretinoïne IFC 30 mg zachte capsules
Spain: Alitretinóna IFC 30 mg cápsulas blandas EFG
Italy: Alitrecare 30 mg
Portugal: Alitretinoína cantabria 30 mg cápsulas moles mg

Detailed and updated information on this medicinal product is available at the following URL:
https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home