TOCTINO 10 mg Soft Capsule

Зміст інструкції

1. TOCTINO 10 mg soft capsules, 30 mg soft capsules
   1. What is TOCTINO and what is it used for
   2. What you need to know before using TOCTINO
   3. How to use TOCTINO
   4. Possible side effects
   5. How to store TOCTINO
   6. Package contents and other information

TOCTINO 10 mg soft capsules, 30 mg soft capsules

Alitretinoin

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
This medicine is subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects you experience during
taking this medicine. See the end of section 4 for information on how to report adverse effects.

Read this leaflet carefully before using this 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 pass it on to others, even if they have the same symptoms as you, as it may 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 TOCTINO is and what it is used for
• 2. What you need to know before you use TOCTINO
• 3. How to use TOCTINO
• 4. Possible side effects
• 5. How to store TOCTINO
• 6. Contents of the pack and other information

1. What is TOCTINO and what is it used for

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

2. What you need to know before using TOCTINO

Do not use TOCTINO

• If you are pregnantor breastfeeding.
• If there is any possibility that you might become pregnant, you must take the precautions outlined in the “Pregnancy Prevention Program” in 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 high triglycerides)
• If you have untreated thyroid disease
• If you have very high levels of vitamin Ain your body (hypervitaminosis A)
• If you are allergicto alitretinoin, other retinoids (such as isotretinoin), peanuts or soy, or 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 TOCTINO.

Warnings and precautions
Pregnancy Prevention Program
Pregnant women should not use TOCTINO
This medicine can seriously harm the fetus (it is said to be “teratogenic”) – it can cause
birth defects affecting the brain, face, ear, eye, heart, and certain glands (thymus and
parathyroid glands). It can also likely induce abortion. This can happen even if TOCTINO
is used for only a short time during pregnancy.

• Do not use TOCTINO if you are pregnant or think you might be.
• Do not use TOCTINO if you are breastfeeding. The medicine can pass into the milk and harm the newborn.
• Do not use TOCTINO if you could become pregnant during treatment.
• Do not become pregnant for one month after you have finished this treatment, as some medicines can remain in your body.

For women who could become pregnant, TOCTINO is prescribed with very strict rules. This is because of the risk of harm that can be caused to the fetus.
These are the rules:

• The doctor must have explained the risk of harm to the fetus to you - you must understand that you must not become pregnant and what you need to do to prevent pregnancy.
• The doctor must have talked 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 tell you to take a pregnancy test. The test must show that you are not pregnant when you start treatment with TOCTINO.

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

• 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 pills and a condom). Talk to your doctor about which method may be suitable for you.
• You must use contraception for one month before using TOCTINO, during treatment, and for one month after the end of treatment.
• You must use contraception even if you do not have your period or 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 TOCTINO

• You must agree to regular check-ups, preferably every month.
• You must agree to regular pregnancy tests, preferably every month during treatment and, as some medicines can remain in your body, 1 month after stopping TOCTINO (unless your doctor decides that this is not necessary in your case).
• You must agree to take additional pregnancy tests if your doctor asks you to.
• You must not become pregnant during treatment or in the month following, as some medicines can remain in your body.
• The doctor will discuss all of these points with you, using a checklist, and will ask you (or a relative/guardian) to sign it. This document will confirm that you have been informed of the risks and that you will follow the above rules.

If you become pregnant while taking TOCTINO, 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 TOCTINO, 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 usingTOCTINO are too low to harm the fetus of their partner. However, you should never share your medicines with anyone.

Further precautions
Never give this medicine to anyone else. At the end of treatment, return unused capsules to your pharmacist.
Do not donate blood during treatment with this medicine and for 1 month after stopping TOCTINO, as if a pregnant patient were to receive your blood, it could
harm her fetus.
See your doctor before using TOCTINO:

• If you have ever had mental health problems. This includes depression, aggressive tendencies, or mood swings. This also includes thinking about harming yourself or ending your life. This is because your mood may change while you are taking TOCTINO.
• If you have kidney disease. TOCTINO is not recommended for people with moderate kidney disease. If you have kidney disease - check with your doctor that TOCTINO is suitable for you.
• If you have high levels of fats in the blood, you may need more frequent blood tests. TOCTINO usually 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 TOCTINO.
• If you have high blood sugar (diabetes), your blood sugar levels mayneed to be monitored more frequently, and your doctor may start therapy withTOCTINO at a low dose.
• If you have ever suffered from thyroid disease.TOCTINO can lower levels of thyroid hormone. If your thyroid hormone level is low, your doctor may prescribe replacement therapy.

During treatment, you must be careful:

• If you experience vision problems, tell your doctor immediately.You may need to stop treatment with TOCTINO and have an eye exam.
• If you experience persistent headaches,nausea or vomiting (feeling sick), 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.
• If you experience dry eyes,it may be helpful to apply a 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.
• TOCTINO can increase levels of liver enzymes.The doctor will perform some blood tests during treatment to monitor these levels. If they remain elevated, the doctor may reduce the dosage or stop treatment with TOCTINO.

Mental health problems

• You may not notice some changes in your mood and behavior, so 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 suffer from any mental health problems, including depression, aggressive tendencies, or mood swings, thoughts of harming yourself or ending your life, you must stoptaking TOCTINO immediatelyand see your doctor as soon as possible.

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

Other medicines and TOCTINO
Do not take other retinoid medicines(e.g. isotretinoin), vitamin A supplements, or tetracyclines
(a type of antibiotic) while taking TOCTINO. 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 that you do not takeamiodarone with TOCTINO.
• you are taking ketoconazole, fluconazole, miconazole(medicines used to treat infections). Your doctor may decide to reduce the dose of TOCTINO.
• you are taking simvastatin(a medicine used to lower cholesterol). TOCTINO 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 TOCTINO.
• you are taking paclitaxel(used to treat cancer), rosiglitazoneor repaglinide(used to treat diabetes). TOCTINO can increase the levels of these medicines in your body.

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

Pregnancy and breastfeeding
Do not take TOCTINO if you are breastfeeding

• This medicine can pass into the milk and harm the newborn.

Do not take TOCTINO if you are pregnant
TOCTINO can seriously harm the fetus (it is said to be “teratogenic”). It can also increase
the risk of abortion.

• You must not use TOCTINO when you are pregnant.
• You must not become pregnant during treatment with TOCTINO, or during the month following the end of treatment.

For more information about pregnancy and contraception, see section 2 “Pregnancy prevention
program”.

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

TOCTINO contains soybean oil and sorbitol
If you are allergic to peanuts or soy, do not use this medicine. If your doctor has diagnosed
an intolerance to certain sugars, contact him before taking TOCTINO.

3. How to use TOCTINO

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.

Dosage
The dose is 10 or 30 mg once a day. If you are intolerant to the recommended dose of 30mg, your doctor
may prescribe the lower dose of 10mg.
Always use TOCTINO exactly as your doctor has instructed. If you have any doubts, consult your doctor or
pharmacist.

How long to use the capsules
A treatment cycle usually lasts from 12 to 24 weeks, depending on the degree of improvement of the
condition. If the first treatment cycle has been successful, your doctor may prescribe a further
cycle if symptoms recur.

If you take more TOCTINO 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 takeTOCTINO
If you forget to take a dose, take it as soon as possible. However, if the time of the
next dose is approaching, 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 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: may affect more than 1 in 10 people
common: may affect up to 1 in 10 people
uncommon: may affect up to 1 in 1,000 people
rare: may affect up to 1 in 10,000 people

Very common side effects

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

Common side effects

• 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 thyroid hormone levels
• 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 experience 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 sick (nausea), unwell (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 chapped lips, skin redness, itchy rash, inflamed skin, hair loss.
• Liver disorders:increased liver enzymes in blood tests.

Uncommon side effects

• Vision disordersincluding blurred vision, distorted vision, clouding of the eye surface (corneal opacity, cataracts).
• If your vision is affected by these problems immediately stop using TOCTINOand contact your doctor.
• Skin disorders:itchy skin, skin scaling, rashes, eczema from 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

• 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 using TOCTINOand 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.

Other side effects
Other side effects have occurred in a very small number of people but their exact frequency
is not known:

Serious allergic reactions
Symptoms include:

• itchy, raised skin (urticaria)
• swelling, sometimes of the face or mouth (angioedema), which causes difficulty breathing
• collapse.
• If you have these symptoms contact your doctor immediately. Stop taking TOCTINO.Intestinal and stomach disorders.Severe stomach (abdominal) pain, with or without bloody diarrhea, feeling sick and unwell (vomiting).
• Immediately stop taking TOCTINOand contact your doctor. These may be signs of serious intestinal problems.

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

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

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

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.

Vision and eye disorders.Colour blindness and worsening of colour vision; intolerance to
contact lenses.

Mental problems
Rare 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 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 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 TOCTINO. This may not be enough to end the effects: you may need further help, and your doctor can arrange this.

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
to: “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 TOCTINO

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.
Do not store at a temperature above 30°C. Keep the blister in the outer packaging to protect the
medicine from light.
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 TOCTINO contains
The active ingredient is alitretinoin.
Each soft capsule contains 10 mgof alitretinoin.
The other ingredients are: soybean oil (refined), partially hydrogenated soybean oil, medium
chain triglycerides, yellow beeswax, all-rac-α-tocopherol, gelatin, glycerol, liquid sorbitol (non-crystallized), purified
water, iron oxide, red (E172), iron oxide, black (E172).
Each soft capsule contains 30 mgof alitretinoin.
The other ingredients are: soybean oil (refined), partially hydrogenated soybean oil, medium
chain triglycerides, yellow beeswax, all-rac-α-tocopherol, gelatin, glycerol, liquid sorbitol (non-crystallized), purified
water, iron oxide, red (E172), iron oxide, yellow (E172).

Description of the appearance of TOCTINO and package contents
TOCTINO 10 mg is presented as soft capsules. The capsules are approximately 11 mm long and 7 mm wide,
oval, brownin color and marked with “A1”. The capsules are packaged in blisters of 30
capsules.
TOCTINO 30 mg is presented as soft capsules. The capsules are approximately 13 mm long and 8 mm wide,
oval, red-brownin color and marked with “A3”. The capsules are packaged in blisters of
30 capsules.

Marketing Authorisation Holder and Manufacturer
Stiefel Laboratories Legacy (Ireland) Ltd.
Finisklin Business Park
Sligo, Ireland
Legal Representative: GlaxoSmithKline S.p.A., Via A. Fleming, 2 – 37135 Verona (Italy)

Manufacturer
SwissCaps GmbH,
Grassingerstrasse 9,
D-83043 Bad Aibling,
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Austria, Denmark, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Portugal,
Slovakia, Slovenia, Spain, United Kingdom: Toctino
Greece: Cehado