Vesanoid

Package Leaflet: Information for the Patient

Vesanoid, 10 mg, Soft Capsules

Tretinoin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Vesanoid and what is it 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 is Vesanoid and what is it used for

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

2. Important information before taking Vesanoid

Do not take Vesanoid if you are 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 soy, as Vesanoid contains soybean oil.

When not to take Vesanoid

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

Do not take Vesanoid if any of the above situations apply to you.

In case of doubts, consult a doctor or pharmacist before taking the medicine.

Warnings and precautions

Before starting to take Vesanoid, discuss the following with your doctor or pharmacist:

• If you have any other illnesses.
• If you have ever had mental health problems, including depression, aggression, or mood swings. This is because Vesanoid may affect your mood.
• If you have allergies.
• If you have been diagnosed with intolerance to certain sugars, as Vesanoid contains sorbitol. If any of the above apply to you, discuss this with your doctor or pharmacist before starting to take Vesanoid.

Mental health problems
The patient may not notice certain changes in their mood and behavior, so it is essential to tell friends and family members that this medicine may cause changes in behavior and mood. These individuals may notice such changes and help identify problems that need to be discussed with a doctor.

Pay special attention to the following side effects

Vesanoid may cause side effects, including:

• severe headache or nausea
• breathing difficulties
• fever
• dizziness
• chest pain or back pain. Pay special attention to the above side effects. See section 4, "Important side effects". Your doctor may adjust the dose of the medicine or prescribe additional medicines.

Children

There is limited data on the efficacy and safety of Vesanoid in children.

Vesanoid and other medicines

Tell your doctor or pharmacist about all medicines you are taking, including those obtained without a prescription, and those you plan to take.
This is extremely important, as taking more than one medicine at the same time may enhance or weaken their effects.
Therefore, do not take Vesanoid with any other medicine without informing your doctor and obtaining their consent.
Do not take the following medicines while taking Vesanoid:

• tetracyclines (a type of antibiotic)
• vitamin A
• progestogen-only contraceptives (mini-pills). Your doctor will recommend other contraceptive methods.

Be cautious when taking Vesanoid with the following medicines:

• rifampicin or erythromycin (antibiotics)
• glucocorticosteroids (anti-allergic and anti-inflammatory medicines)
• phenobarbital (anti-epileptic medicine)
• pentobarbital (sleeping pill)
• antifungal imidazole and triazole derivatives (used to treat fungal infections, e.g., ketoconazole)
• cimetidine (anti-ulcer medicine)
• verapamil or diltiazem (used in cardiovascular diseases)
• cyclosporin (used after organ or bone marrow transplants)
• tranexamic acid, aminocaproic acid, and aprotinin (antifibrinolytic medicines).

Pregnancy, breastfeeding, and fertility

Before taking any medicine, consult a doctor.
Before taking Vesanoid
contact your doctor immediately if:

• you are pregnant
• you plan to become pregnant
• you may become pregnant

Do not take Vesanoid if you are pregnant or may become pregnant during treatment or within one month (four weeks) after its completion. If you become pregnant while taking Vesanoid, there is a high risk of birth defects in the child.
While taking Vesanoid

• You and your partner agree to use effective contraception methods, i.e., use effective contraceptive methods continuously during the entire treatment period with tretinoin and for one month (four weeks) after its completion. Your doctor will recommend the appropriate contraceptive method. If you are using progestogen-only contraceptives (mini-pills), your doctor will recommend other contraceptive methods.
• Pregnancy tests must be performed at monthly intervals throughout the treatment period.
• Tell your doctor immediately if you become pregnant while taking Vesanoid. Your doctor will discuss the appropriate treatment for acute promyelocytic leukemia during pregnancy.

Do not breastfeed while taking Vesanoid. Vesanoid passes into breast milk and may harm the breastfed child.

Driving and using machines

Do not drive or operate machinery while being treated with Vesanoid, especially if you experience dizziness or severe headaches.

Important information about some ingredients of Vesanoid

The medicine contains soybean oil. Do not take if you are hypersensitive to peanuts or soy.
The medicine contains 1.93 - 2.94 mg of sorbitol in each soft capsule.

3. How to take Vesanoid

Take Vesanoid as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will prescribe the appropriate dose of Vesanoid based on the type of disease, patient response, body weight, and height. Do not change the prescribed dosage.
If you feel that the prescribed dose is too high or too low, tell your doctor or pharmacist.

Adults

The recommended daily dose of the medicine is 45 mg/m² of body surface area, divided into two equal doses (this is approximately 8 capsules per day for adults).

Use in children

The recommended daily dose of the medicine is 45 mg/m² of body surface area, divided into two equal doses. In children who experience headaches during treatment, the doctor may recommend a lower daily dose of 25 mg/m² of body surface area.

Kidney and liver diseases in adults

It is recommended to use a dose of 25 mg/m² of body surface area, divided into two equal doses.
Treatment should be continued for a maximum of 90 days. During or immediately after treatment with Vesanoid, the doctor will use another type of treatment.

Taking Vesanoid

Swallow the capsules whole with water. Do not chew the capsules. It is recommended to take the capsules during or shortly after a meal.

Overdose of Vesanoid

If you have taken more than the recommended dose of the medicine, contact your doctor, pharmacist, or the nearest hospital immediately.

Missing a dose of Vesanoid

If you miss a dose of Vesanoid, take it as soon as possible and contact your doctor immediately. Do not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vesanoid can cause side effects, although not everybody gets them.
Along with the benefits, the treatment also has side effects, which occur in almost every patient, even when the medicine is used correctly.

Important side effects

If you experience any of the following side effects, 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, usually 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 the arms and neck (possible symptoms of a 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, vision disturbances (possible symptoms of a stroke) Contact your doctor immediately if you experience any of the above side effects.

Other side effects

Very common (more than 1 in 10 patients):

• hair loss
• heart rhythm disturbances
• vision or hearing disturbances
• bone or joint pain, chest pain, abdominal pain
• flushing, rash, itching, skin peeling, and inflammation
• dry skin, dry mouth, dry nasal mucosa; swelling, dryness of the lip vermilion
• breathing difficulties, such as worsening asthma (respiratory failure)
• conjunctival disturbances, which may cause problems when wearing contact lenses
• sleep disturbances
• excessive sweating
• headache, dizziness
• fatigue, cold, or malaise
• confusion, anxiety, depression
• paresthesia (e.g., tingling, prickling, numbness of hands and feet)
• decreased appetite, nausea, indigestion, diarrhea or constipation, abdominal pain, pancreatitis, cheilitis, vomiting
• changes in blood test results, e.g., increased aminotransferase activity, creatinine or triglyceride and cholesterol levels in the blood.

Frequency not established ("frequency not known"):

• genital ulcers
• severe bacterial infections (necrotizing fasciitis)
• kidney diseases (renal infarction)
• muscle or vascular edema (vasculitis)
• red, painful spots under the skin, mainly on the lower limbs (erythema nodosum)
• decreased appetite, nausea, vomiting, headache, fatigue, drowsiness (symptoms of hypercalcemia)
• blood abnormalities, e.g., increased platelet count (thrombocytosis), increased count of one type of white blood cell (basophilia), or increased histamine levels
• inflammation of the heart muscle or the sac surrounding the heart (pericarditis) manifested by shortness of breath, palpitations, or chest pain.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Vesanoid

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

6. Contents of the pack and other information

What Vesanoid contains

• The active substance of the medicine is tretinoin. Each soft capsule contains 10 mg of tretinoin.
• The other ingredients of the medicine 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), cornstarch, 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: orange-yellow and reddish-brown.
The capsules are packed in glass bottles of orange glass, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization 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
To obtain more detailed information, contact:
Komtur Polska Sp. z o.o.
phv@komtur.com

Date of last revision of the package leaflet: