Vesanoid

Package leaflet: Information for the patient

Vesanoid, 10 mg, soft capsules
Tretinoinum
Please read all of this leaflet carefully before taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Vesanoid is and what it is used for
2. Important information before taking Vesanoid
3. How to take Vesanoid
4. Possible side effects
5. How to store Vesanoid
6. Contents of the pack and other information

1. What Vesanoid is and what it is used for

Vesanoid contains tretinoin, which belongs to a group of medicines called retinoids, structurally similar to vitamin A.
Vesanoid is prescribed by doctors for the treatment of acute promyelocytic leukemia.
Tretinoin inhibits the growth of certain types of abnormal blood cells.

2. Important information before using Vesanoid

Do not use Vesanoid if the patient is allergic to:

• the active substance – tretinoin, or any of the other ingredients of this medicine (listed in section 6)
• other retinoids, including isotretinoin, acitretin, and tazarotene
• peanuts or soya, because Vesanoid contains soya oil.

When not to use Vesanoid

• if the patient is pregnant, planning to become pregnant, or breastfeeding (see section 2, "Pregnancy, breastfeeding and fertility")
• if the patient is taking vitamin A, tetracyclines, or retinoids.

Do not use Vesanoid if any of the above situations apply to the patient.
If in doubt, consult a doctor or pharmacist before using this medicine.
Warnings and precautions
Before starting treatment with Vesanoid, discuss the following with your doctor or pharmacist:

• If the patient has any other medical conditions.
• If the patient has ever had mental health problems, including depression, aggressive tendencies, or mood swings. This is important because Vesanoid may affect the patient's mood.
• If the patient has allergies.
• If the patient has been diagnosed with intolerance to certain sugars, as Vesanoid contains sorbitol. If any of the above apply, discuss them with a doctor or pharmacist before starting Vesanoid.

Mental health problems
The patient may not notice certain changes in mood and behaviour; therefore, it is important to
inform friends and family members that this medicine may cause changes in behaviour and
mood. These individuals may notice such changes and help identify problems that need to be
discussed with a doctor.
Particular attention should be paid to the following adverse effects:
Vesanoid may cause adverse effects, including:

• severe headache or nausea
• breathing difficulties
• fever
• dizziness
• chest or back pain
  Pay special attention to the above-mentioned adverse effects. See section 4, "Important adverse effects". The doctor may adjust the dose or recommend additional medication.

Children
Data on the efficacy and safety of Vesanoid in children are limited.

Vesanoid with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.
This is extremely important because taking more than one medicine at the same time may increase or reduce their effects.
Therefore, Vesanoid must not be taken in combination with any other medicine without first informing and obtaining approval from the treating doctor.
The following medicines must not be taken during treatment with Vesanoid:

• tetracyclines (a type of antibiotic)
• vitamin A
• progestogen-only contraceptives containing very low doses of progesterone, known as "minipills". The doctor will recommend alternative contraceptive methods.

Exercise particular caution if Vesanoid is used concomitantly with the following medicines:

• rifampicin or erythromycin (antibiotics)
• glucocorticosteroids (anti-allergic and anti-inflammatory medicines)
• phenobarbital (an anticonvulsant)
• pentobarbital (a sedative)
• antifungal agents of the imidazole and triazole group (used to treat fungal infections, e.g. ketoconazole)
• cimetidine (an anti-ulcer medicine)
• verapamil or diltiazem (used in cardiovascular diseases)
• cyclosporine (used after organ or bone marrow transplantation)
• tranexamic acid, aminocaproic acid, and aprotinin (antifibrinolytic medicines).

Pregnancy, breastfeeding and fertility
Before using any medicine, consult a doctor.
Before using Vesanoid
contact your doctor immediately if:

• the patient is pregnant
• the patient is planning pregnancy
• the patient may become pregnant

Vesanoid must not be used in women who are pregnant or who may become pregnant
during treatment or within one month (four weeks) after its completion. If the patient becomes
pregnant while taking Vesanoid, there is a high probability of developmental abnormalities
in the child.
During treatment with Vesanoid

• The patient and her partner agree to follow required methods of effective pregnancy prevention, i.e. to use effective contraceptive methods continuously throughout the entire treatment period with tretinoin and for one month (four weeks) after treatment ends. The doctor will recommend the appropriate contraceptive method. If the patient uses low-dose progestogen-only contraceptives (so-called "minipills"), the doctor will recommend alternative contraceptive methods.
• Pregnancy tests must be performed monthly throughout the treatment period.
• Inform the doctor immediately if pregnancy occurs during treatment with Vesanoid. The doctor will discuss appropriate management of acute promyelocytic leukaemia during pregnancy.

Breastfeeding must not be performed during treatment with Vesanoid. Vesanoid passes into
human milk and could harm the breastfed infant.

Driving and operating machinery
During treatment with Vesanoid, patients should not drive or operate machinery,
particularly if they experience dizziness or severe headaches.

Important information about some ingredients of Vesanoid
This medicine contains soya oil. Do not use if hypersensitivity to peanuts or soya has been diagnosed.
This medicine contains 1.93 – 2.94 mg of sorbitol in each soft capsule.

3. How to use Vesanoid

Vesanoid should be taken according to the doctor's instructions. If in doubt, consult your
doctor or pharmacist.
The treating physician should prescribe the appropriate dose of Vesanoid depending on the type
of disease, the patient's response, body weight and height. The prescribed dosage must not be changed.
If you feel the prescribed dose is too high or too low, inform your doctor or pharmacist.
Adults
The recommended daily dose of the drug is 45 mg/m^2 of body surface area, given in two equal
divided doses (this is on average 8 capsules per day for adults).
Use in children
The recommended daily dose of the drug is 45 mg/m^2 of body surface area, given in two equal
divided doses. In children experiencing headaches during treatment, the doctor may recommend a lower
daily dose of 25 mg/m^2 of body surface area.
Kidney and liver diseases in adults
A dose of 25 mg/m^2 of body surface area, given in two equal divided doses, is recommended.
Treatment should continue for a maximum of 90 days. During or immediately after completion of Vesanoid treatment,
the doctor will initiate another type of therapy.
How to take Vesanoid
Capsules should be swallowed whole with water. Capsules must not be chewed. It is recommended
to take the capsules during or shortly after a meal.
Accidental overdose of Vesanoid
If you take more than the prescribed dose, seek immediate medical advice from your doctor,
pharmacist, or nearest hospital.
Missed dose of Vesanoid
If you miss a dose of Vesanoid, take it as soon as possible and immediately consult your doctor.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
Alongside the benefits of treatment, adverse reactions may occur in almost every patient, even when the medicine is used correctly.

Important adverse reactions
If any of the following adverse reactions occur, contact your doctor immediately:

• fever, especially with difficulty breathing, cough, dizziness, chest pain, abdominal pain
• severe headache with nausea, difficulty breathing, fever, dizziness, chest pain or back pain. Your doctor may recommend reducing the dose of the medicine or using additional medicines
• severe abdominal pain radiating to the back (possible symptoms of pancreatitis)
• fever with the appearance of dark spots on the skin, most commonly on the face and neck (possible symptoms of Sweet's syndrome, dermatosis neutrophilica febrilis)
• painful swelling of the lower limbs, sudden chest pain or difficulty breathing (possible symptoms of thrombosis)
• chest pain radiating to arms and neck (possible symptoms of heart attack)
• double vision and dizziness, especially with nausea, ringing in the ears and head (possible symptoms of increased intracranial pressure)
• sudden headache or migraine, visual disturbances (possible symptoms of stroke). Contact your doctor immediately if any of the above adverse reactions occur.

Other adverse reactions
Very common (in more than 1 out of 10 patients):

• hair loss
• heart rhythm disorders
• visual or hearing disturbances
• bone or joint pain, chest pain, abdominal pain
• redness, rash, itching, skin peeling and inflammation
• dryness of the skin, mouth, nasal mucosa; swelling, dryness and redness of the lips
• breathing disorders such as worsening asthma (respiratory failure)
• eye disorders which may cause problems when wearing contact lenses
• sleep disturbances
• excessive sweating
• headache, dizziness
• feeling of fatigue, cold-like symptoms or general malaise
• confusion, anxiety, depression
• paresthesia (e.g. tingling, pricking, numbness of hands and feet)
• decreased appetite, nausea, indigestion, diarrhoea or constipation, abdominal pain, pancreatitis, inflammation of the lips, vomiting
• changes in blood tests, e.g. increased activity of aminotransferases, creatinine levels, or triglycerides and cholesterol in blood.

Frequency not known:

• ulceration of genital organs
• serious bacterial infections (necrotizing fasciitis)
• kidney disorders (renal infarction)
• muscle or vascular swelling (vasculitis)
• red, painful subcutaneous spots, mainly on lower limbs (erythema nodosum)
• decreased appetite, nausea, vomiting, headache, feeling of fatigue, drowsiness (symptoms of hypercalcaemia)
• blood count abnormalities, e.g. increased number of platelets (thrombocytosis), increased number of one type of white blood cells (basophilia) or increased histamine levels
• myocarditis or pericarditis (inflammation of the pericardium) manifesting as shortness of breath, palpitations or chest pain.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vesanoid

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton, indicated by EXP. The expiry date refers to the last day of the month.
Store below 30°C, in the original packaging to protect from light.
Store in a tightly closed bottle to protect from moisture.
The bottle should be kept in the outer packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Vesanoid contains

• The active substance is tretinoin. Each soft capsule contains 10 mg of tretinoin.
• The other ingredients are: yellow beeswax, hydrogenated soybean oil, partially hydrogenated soybean oil, soybean oil (see section 2).
• The other ingredients in the soft capsule shell are: gelatin, glycerol (E 422), sorbitol (E 420), mannitol (E 421), starch (corn), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Vesanoid looks like and contents of the pack
Vesanoid capsules consist of two parts: yellow-orange and red-brown.
Vesanoid capsules are packed 100 capsules in glass bottles made of amber glass, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany
CENEXI S.A.S.
52 rue Marcel et Jacques Gaucher
94120 Fontenay sous Bois
France

For more detailed information, please contact:
Komtur Polska Sp. z o.o.
[email protected]