Alitretinoin IFC 30 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alitretinoin IFC 30 mg soft capsules EFG

WARNING IF PREGNANT, THIS MEDICATION MAY SERIOUSLY HARM THE UNBORN BABY. Women must use effective contraception throughout treatment. Do not use if you are pregnant or think you may be pregnant.

?This medicine is subject to additional monitoring, which will help speed up the detection of new safety information. You can help by reporting any adverse reactions you may experience. The end of section 4 includes information on how to report these adverse reactions.

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Alitretinoin IFC 30 mg soft capsules EFG is and what it is used for
2. What you need to know before taking Alitretinoin IFC 30 mg soft capsules EFG
3. How to take Alitretinoin IFC 30 mg soft capsules EFG
4. Possible adverse effects
5. Storage of Alitretinoin IFC 30 mg soft capsules EFG
6. Contents of the pack and other information

1. What Alitretinoin IFC 30 mg soft capsules EFG is and what it is used for

The active substance in Alitretinoin IFC is alitretinoin. It belongs to a group of medicines known as retinoids, which are derived from Vitamin A. Alitretinoin IFC is available in two strengths containing either 10 mg or 30 mg of alitretinoin.

Alitretinoin IFC is used to treat severe chronic hand eczema in adult patients that has not improved with any other topical treatments, including corticosteroids. Treatment with Alitretinoin IFC should be supervised by a specialist skin doctor (dermatologist).

2. What you need to know before taking Alitretinoin IFC 30 mg soft capsules EFG

Do not take Alitretinoin IFC:

• If you are pregnant or breastfeeding.
• If there is any possibility you could become pregnant, you must follow the precautions outlined in the “Pregnancy Prevention Programme”; see 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 untreated thyroid disease.
• 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, to 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 the above apply to you, consult your doctor. You must not take Alitretinoin IFC.

Warnings and precautions

Pregnancy Prevention Programme

Pregnant women must not take Alitretinoin IFC

This medicine can severely harm the unborn baby (the medicine is considered "teratogenic") – it may cause serious abnormalities in the baby’s brain, face, ears, eyes, heart, and certain glands (thymus and parathyroid). It also increases the risk of miscarriage. This can occur even if Alitretinoin IFC is taken for only a short time during pregnancy.

• You must not take Alitretinoin IFC if you are pregnant or think you might be pregnant.
• You must not take Alitretinoin IFC if you are breastfeeding. The medicine is likely to pass into your milk and may harm your baby.
• You must not take Alitretinoin IFC if you could become pregnant during treatment.
• You must not become pregnant during the month following discontinuation of treatment, as the medicine may still remain in your body.

Women who could become pregnant must be prescribed Alitretinoin IFC under strict rules due to the risk of serious harm to the unborn baby

These rules are:

• Your doctor must explain the risk of harm to the unborn baby – you must understand why you must not become pregnant and what steps you need to take to prevent pregnancy.

• You must have discussed contraception (birth control) with your doctor. Your doctor will provide information on how to avoid pregnancy. Your doctor may refer you to a specialist for contraceptive advice.

• Before starting treatment, your doctor will require you to take a pregnancy test. The test must confirm that you are not pregnant when starting Alitretinoin IFC treatment.

Women must use effective contraception before, during, and after taking Alitretinoin IFC

• 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 methods are suitable for you.
• You must use contraception for one month before starting Alitretinoin IFC, 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 decides it is not necessary).

Women must agree to undergo pregnancy tests before, during, and after taking Alitretinoin IFC

You must agree to attend regular follow-up visits, ideally every month.

• You must agree to undergo regular pregnancy tests, ideally every month during treatment and one month after stopping Alitretinoin IFC (due to the possibility of residual medicine in your body), unless your doctor decides otherwise.
• You must agree to undergo additional pregnancy tests if requested by your doctor.
• You must not become pregnant during treatment or within one month after stopping, as the medicine may still be present in your body.
• Your doctor will discuss all these points with you using a checklist and will ask you (or a parent/guardian) to sign it. This checklist confirms that you have been informed of the risks and will follow the rules above.

If you become pregnant while taking Alitretinoin IFC, stop taking the medicine immediately and consult your doctor. Your doctor may refer you to a specialist for advice.

Additionally, if you become pregnant within one month after stopping Alitretinoin IFC, you must consult your doctor. Your doctor may refer you to a specialist for advice.

Advice for men

Levels of oral retinoids in semen of men taking Alitretinoin IFC are too low to harm a partner’s unborn baby. However, you must never share your medicine with anyone.

Additional precautions

Never give this medicine to anyone else. Please return any unused capsules to your pharmacist at the end of treatment.

You must not donate blood during treatment with this medicine or for one month after stopping Alitretinoin IFC, as a developing baby could be harmed if a pregnant woman receives your blood.

Consult your doctor before starting Alitretinoin IFC:

• If you have ever had any mental health problems. This includes depression, aggressive tendencies, or mood changes. Also included are thoughts about self-harm or ending your life. This is because your mood may be affected while taking Alitretinoin IFC.
• If you have kidney disease. Alitretinoin IFC is not recommended in patients with moderate kidney disease. If you have kidney disease, consult your doctor to determine whether Alitretinoin IFC is suitable for you.
• If you have high levels of fats in the blood; you may need more frequent blood tests. Alitretinoin IFC generally increases blood fat levels, such as cholesterol or triglycerides. If blood fat levels remain high, your doctor may reduce your dose or stop treatment with Alitretinoin IFC.
• If you have high blood sugar levels (diabetes); you may need to monitor your blood sugar levels more frequently, and your doctor may reduce your dose of Alitretinoin IFC.
• If you have had thyroid disease. Alitretinoin IFC may reduce thyroid hormone levels. If thyroid hormone levels are low, your doctor may prescribe supplements.

Take special care during treatment:

• If you experience any vision problems; inform your doctor immediately. You may need to stop taking Alitretinoin IFC and have your vision monitored.
• If you experience persistent headache, nausea or vomiting (feeling sick or actually vomiting), and blurred vision, as these may be signs of a condition called benign intracranial hypertension. Stop taking the capsules immediately and contact your doctor as soon as possible.
• If you develop bloody diarrhoea. Stop taking the capsules immediately and contact your doctor as soon as possible.
• Reduce exposure to sunlight and avoid sunlamps. Your skin may become more sensitive to sunlight. Before sun exposure, use a sunscreen with a high protection factor (SPF 15 or higher). If you experience dry skin and lips during treatment, use moisturizing creams or ointments and lip balm.
• Reduce intense physical activity. Alitretinoin may cause muscle and joint pain.
• If you develop dry eyes; this can be relieved with lubricating eye ointment or artificial tears. If you wear contact lenses, you may need to wear glasses during treatment with alitretinoin. Dry eyes and vision problems usually resolve when treatment is stopped.
• Alitretinoin IFC may increase liver enzyme levels. Your doctor will perform blood tests during treatment to monitor these levels. If levels remain high, your doctor may reduce the dose or discontinue treatment with Alitretinoin IFC.

Mental health problems

• You may not notice changes in your mood or behavior, so it is very important to inform your friends and family that you are taking this medicine. They may notice changes and help you identify any problems quickly so you can discuss them with your doctor.

• If you develop any mental health problems, including depression, aggressive tendencies, mood changes, or thoughts of self-harm or ending your life, you must stop taking Alitretinoin IFC immediately and contact your doctor as soon as possible.

Children and adolescents

Use of Alitretinoin IFC is not recommended in individuals under 18 years of age. Efficacy is unknown in this age group.

Taking Alitretinoin IFC with other medicines

Do not take other medicines containing retinoids (e.g., isotretinoin), vitamin A supplements, or tetracyclines (a type of antibiotic) while taking Alitretinoin IFC, as this increases the risk of adverse effects.

Inform your doctor or pharmacist if:

• you are taking amiodarone (a medicine used to regulate heart rhythm). Taking amiodarone with Alitretinoin IFC is not recommended.
• you are taking ketoconazole, fluconazole, or miconazole (medicines used to treat infections). Your doctor may decide to reduce the dose of Alitretinoin IFC.
• you are taking simvastatin (a medicine used to lower cholesterol levels). Alitretinoin IFC may reduce the amount of this medicine in your body.
• you are taking gemfibrozil (another medicine used to lower cholesterol) or oxandrolone (an anabolic agent). Your doctor may decide to reduce the dose of Alitretinoin IFC.
• you are receiving paclitaxel (used to treat cancer), taking rosiglitazone, or repaglinide (used to treat diabetes). Alitretinoin IFC may increase the amount of these medicines in your body.

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription. This also includes herbal medicines.

Pregnancy, breastfeeding, and fertility

For more information about pregnancy and contraception, see the “Pregnancy Prevention Programme” in the section “Warnings and precautions”.

Driving and using machines

Your vision may be impaired at night during treatment. If this occurs, you must not drive or operate machinery.

Alitretinoin IFC contains soya oil

Do not use this medicine if you are allergic to peanuts or soya.

Alitretinoin IFC contains sorbitol

This medicine contains 25.55 mg of sorbitol in each Alitretinoin IFC 30 mg capsule.

3. How to take Alitretinoin IFC

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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.

How much to take

The dose is either 10 mg or 30 mg once daily. If your body cannot tolerate 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 between 12 and 24 weeks, depending on how your condition improves. If your first treatment has been successful, your doctor may prescribe another treatment cycle if symptoms reappear.

If you take more capsules than you should

If you take too many capsules or if someone accidentally takes your medicine, contact your doctor, pharmacist, or go to the nearest hospital immediately. In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone: 91 562 04 20. It is recommended to bring the medicine’s packaging and package leaflet to the healthcare professional.

If you forget to take Alitretinoin IFC

If you forget to take a dose, take it as soon as you can. However, if it is almost time for your next dose, do not take the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common 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 effects (may affect up to 1 in 10 people)

• Blood cell disorders: increase in the number of blood platelets (cells that help with clotting), decrease in the number of red and white blood cells observed in blood tests.
• Thyroid problems: decrease in thyroid hormone levels.
• Eye problems: inflammation of the eye (conjunctivitis) and of the eyelid area, causing dryness and irritation of the eyes.

? Ask a pharmacist for a suitable eye drop. If you wear contact lenses and experience dry eyes, you may need to wear glasses instead.

• Ear problems: persistent noise in the ears (tinnitus).
• Dizziness.
• Blood and circulation disorders: hot flushes, high blood pressure (hypertension).
• Intestinal and stomach problems: nausea, vomiting, dry mouth.
• Muscle and joint pain: muscle pain, joint pain, lack of energy (fatigue). High blood levels of muscle breakdown products if you exercise vigorously.
• Skin and hair problems: dry skin, especially of the face, dryness and inflammation of the lips, skin redness, itchy skin rash, inflamed skin, hair loss.
• Liver problems: elevated liver enzymes observed in blood tests.

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

• Vision problems, including blurred vision, distorted vision, cloudy area in the eye (corneal opacity, cataracts).

??If your vision is affected**, stop taking Alitretinoin IFC immediately** and contact your doctor.

• Skin problems: itchy skin, skin peeling, rash, eczema with dry skin.
• Ear, nose and throat problems: nosebleeds.
• Intestinal and stomach problems: indigestion (dyspepsia).
• Bone disorders: abnormal bone growth, including the spinal disorder called ankylosing spondylitis.

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

• Persistent headache, with general discomfort (nausea), vomiting and changes in vision, including blurred vision. These may be signs of benign intracranial hypertension.

??If you experience these symptoms, stop taking Alitretinoin IFC immediately and contact your doctor.

• Blood and circulation disorders: inflammation of blood vessels.
• Skin and hair problems: nail abnormalities, increased sensitivity of the skin to sunlight, changes in hair texture.

Mental health problems

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

• Depression or related disorders. These signs include sad or altered mood, anxiety, feelings of emotional distress.
• Worsening of existing depression.
• Becoming violent or aggressive.

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

• Some people have had feelings or thoughts about harming themselves or ending their lives (suicidal thoughts), have attempted to end their lives (suicide attempt), or have died by suicide. These people may not appear to be 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 signs of any of these mental health problems. Your doctor may advise you to stop taking Alitretinoin IFC. This may not be enough to stop the effects: you may need further help, which your doctor can provide.

Other adverse effects

In a very small number of people, other adverse effects have occurred, the exact frequency of which is unknown:

Severe allergic reactions

Signs include:

• itchy raised rash (hives).
• swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing.
• collapse.

??If you have these symptoms, contact your doctor immediately. Stop taking Alitretinoin IFC.

Intestinal and stomach disorders

Severe abdominal (stomach) pain, with or without bloody diarrhoea, general discomfort (nausea) and vomiting.

??Stop taking Alitretinoin IFC immediately and contact your doctor. These may be signs of serious intestinal conditions.

Night vision problems

Vision problems usually return to normal after stopping treatment.

Blood and circulation disorders

Swelling of the hands, lower legs and feet (peripheral oedema).

Adverse effects of other medicines in the same class as Alitretinoin IFC

These effects have not been observed with Alitretinoin IFC so far, but cannot be ruled out.

They are very rare and may affect fewer than 1 in 10,000 people.

Diabetes

Excessive thirst, frequent need to urinate, blood tests showing increased blood sugar levels.

All of these may be signs of diabetes.

Bone disorders

Arthritis, bone disorders (growth delay, changes in bone density). Growing bones may stop growing.

Eye and vision disorders

Worsening of colour blindness and colour vision, intolerance to contact lenses.

In rare cases, soya bean oil may cause severe allergic reactions.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alitretinoin IFC

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alitretinoin IFC

• The active substance is alitretinoin.

Each soft capsule contains 30 mg of alitretinoin.

• The other components are:

Capsule contents: soybean oil (refined), partially hydrogenated soybean oil, hydrogenated vegetable oil, glyceryl monostearate, medium-chain triglycerides, all-rac-α tocopherol.

Capsule shell: gelatin, glycerol, liquid sorbitol (non-crystalline) (E420), titanium dioxide (E171), purified water and yellow iron oxide (E172).

Appearance of the medicinal product and contents of the pack

Alitretinoin IFC 30 mg soft capsules are oval-shaped, yellow, 13 mm x 8 mm in size, and contain a viscous, opaque, yellow-orange suspension.

The capsules are packaged in PVC/PVDC/Aluminium blisters.

Pack size: 30 capsules.

Marketing Authorization Holder

Industrial Farmacéutica Cantabria, S.A.

Ctra. Cazoña-Adarzo, s/n

39011 Santander

Spain

Manufacturer

Industrial Farmacéutica Cantabria, S.A.

C/ Pirita, 9

28850 Torrejón de Ardoz (Madrid)

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands: ALITRETINOÏNE IFC 30 mg capsules, zacht

Spain: Alitretinoína IFC 30 mg cápsulas blandas EFG

Italy: ALITRECARE

Portugal: ALITRETINOÍNA CANTABRIA 30 mg cápsulas moles

Date of the most recent revision of this leaflet: April 2021

Detailed and up-to-date information about this product is available by scanning the QR code included in the leaflet using a smartphone. The same information is also available at the following link: http://www.aemps.gob.es