VESANOID 10 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Vesanoid 10 mg Soft Capsules

Tretinoin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Vesanoid and what is it used for
2. What you need to know before you take Vesanoid
3. How to take Vesanoid
4. Possible side effects
5. Storage of 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 known as retinoids, structurally related to vitamin A.

Vesanoid is indicated for the treatment of a type of blood problem called "acute promyelocytic leukemia". This medicine works by reducing the growth of a certain type of diseased blood cells.

2. What you need to know before you take Vesanoid

Do not take Vesanoid if you are allergic to:

• tretinoin or any of the other ingredients of this medicine (listed in section 6)
• other "retinoid" medicines. This includes isotretinoin, acitretin, and tazarotene
• peanuts or soy, as Vesanoid contains soybean oil.

Do not take Vesanoid if:

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

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Vesanoid.

Warnings and precautions

Consult your doctor or pharmacist before taking Vesanoid if:

• you have any other illness
• you have ever had any mental health problems, such as depression, aggressive tendencies, or mood changes. This is because taking Vesanoid can affect your mood.
• you have allergies
• your doctor has told you that you have an intolerance to certain sugars, as Vesanoid contains sorbitol

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking Vesanoid.

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 this medicine could affect your mood and behavior. They may notice these changes and help you identify any problems you need to discuss with your doctor.

Monitor important side effects

Vesanoid can cause side effects, including:

• severe headache with nausea or vomiting,
• difficulty breathing,
• fever,
• dizziness,
• chest or back pain.

You will need to monitor all these side effects while taking Vesanoid. For more details, see "Important side effects" in section 4. Your doctor may decide to change the dose of your medicine or prescribe an additional medicine.

Children

Information on the safety and efficacy of tretinoin in children is limited.

Using Vesanoid with other medicines

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

This is important because using more than one medicine at the same time can increase or decrease the effect of the medicines. You should not take Vesanoid with other medicines unless you have informed your doctor and obtained their consent.

While taking Vesanoid, do not take:

• tetracyclines (a type of antibiotic)
• vitamin A
• low-dose progestogens for birth control (mini-pill). If you are taking low-dose progestogens for birth control, your doctor will stop this treatment and prescribe a different oral contraceptive.

Medicines that require special care when taken with Vesanoid:

• rifampicin and erythromycin (antibiotics)
• glucocorticoids (for allergies and inflammation)
• phenobarbital (for epilepsy)
• pentobarbital (for insomnia)
• azole antifungals (e.g., ketoconazole, fluconazole, itraconazole, posaconazole)
• protease inhibitors or macrolides (e.g., clarithromycin)
• ketoconazole (antifungal)
• cimetidine (for stomach ulcers)
• verapamil and diltiazem (for heart problems or hypertension)
• cyclosporin (used after organ or bone marrow transplants)
• tranexamic acid, aminocaproic acid, and aprotinin (medicines used to reduce bleeding).

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Before starting treatment with Vesanoid

Tell your doctor immediately if

• you are pregnant
• you think you are pregnant
• you plan to become pregnant.

You should not become pregnant during treatment with Vesanoid and for up to one month (four weeks) after stopping treatment. If you become pregnant while taking Vesanoid, it is likely that your baby will be born with birth defects.

During treatment with Vesanoid

• During treatment with Vesanoid and for up to four weeks after stopping treatment, you and your partner should use effective and continuous contraceptive methods.Your doctor will tell you which contraceptive methods you can use. If you are taking low-dose progestogens for birth control, your doctor will stop this treatment and prescribe a different oral contraceptive.
• Women taking Vesanoid should have a pregnancy test every month during treatment with Vesanoid.
• Tell your doctor immediately if you become pregnant while taking Vesanoid.You and your doctor will decide the best treatment for you if you are pregnant and have acute promyelocytic leukemia.

Do not breastfeed while taking Vesanoid.Vesanoid may pass into breast milk and harm your baby.

Driving and using machines

Your ability to drive or use machines may be affected while taking Vesanoid, especially if you feel dizzy or have severe headaches.

Vesanoid contains soybean oil, sorbitol, and sodium

This medicine contains soybean oil. Do not use this medicine if you are allergic to peanuts or soy.

This medicine contains 1.93 - 2.94 mg of sorbitol in each soft capsule.

This medicine contains less than 1 mmol of sodium (23 mg) per soft capsule, i.e., it is essentially "sodium-free".

3. How to take Vesanoid

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much to take

Depending on the nature of your illness, your reaction to Vesanoid, your body weight, and height, your doctor will prescribe the dose that is right for you. Do not change the dose yourself. If you think the action of Vesanoid is too strong or too weak, tell your doctor or pharmacist.

Adults

The daily dose is 45 mg/m2, which is equivalent to about 8 capsules per day, divided into two equal doses.

Children

The daily dose will be 45 mg/m2 divided into two equal doses. For children who suffer from severe headaches during treatment, a lower daily dose of 25 mg/m² may be considered.

Adults with renal or hepatic impairment

The daily dose is 25 mg/m2 divided into two equal doses.

Treatment with Vesanoid may last 3 months or more. Your doctor will tell you how long you should take Vesanoid.

Taking this medicine

Swallow the capsules whole with water, preferably during meals or shortly after. Do not chew the capsules.

If you take more Vesanoid than you should

If you or anyone else has taken more Vesanoid than they should, consult your doctor, pharmacist, or the nearest hospital immediately.

In case of overdose or accidental ingestion, call the Toxicology Information Service, Telephone (91) 562 04 20, indicating the medicine and the amount taken.

If you forget to take Vesanoid

If you forget a dose, take it as soon as you remember and inform your doctor immediately.

Do not take a double dose to make up for forgotten doses.

If you have any other questions 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. In addition to the benefits, almost all people experience undesirable side effects during treatment. This happens even when Vesanoid is used correctly.

Important side effects

Tell your doctor immediately if you notice any of the following side effects:

• fever, especially with difficulty breathing, cough, dizziness, chest pain, and abdominal pain
• severe headache with nausea or vomiting, difficulty breathing, fever, dizziness, or chest or back pain. Your doctor may decide to change the dose of your medicine or prescribe an additional medicine
• severe stomach pain that spreads to the back (possible sign of pancreatitis)
• fever with dark, raised spots on the skin, more likely on the face and neck (possible sign of "Sweet's syndrome" or acute febrile neutrophilic dermatosis)
• painful swelling in the leg, sudden chest pain, or difficulty breathing (possible sign of a blood clot)
• chest pain that spreads to the arm or neck (possible sign of a heart attack)
• double vision and dizziness, especially with a feeling of discomfort, ringing in the ears, and headache (possible sign of high pressure in the head)
• unexplained headache or migraine, which may include vision changes (possible sign of a stroke).

Contact your doctor immediately if you notice any of the above side effects.

Other side effects

Very common (may affect more than 1 in 10 people) are:

• hair loss
• irregular heartbeat
• changes in vision and hearing
• bone or joint pain, chest or abdominal pain
• rash, itching, redness, peeling, and inflammation of the skin
• dry skin, mouth, and nose; swelling, dryness, and cracking of the lips
• breathing difficulties, such as asthma, which may worsen (respiratory failure)
• conjunctivitis or dry eyes, which may be a problem if you wear contact lenses
• difficulty sleeping
• excessive sweating
• headache or dizziness
• feeling tired, cold, or unwell
• feeling confused, worried, or depressed
• tingling and numbness of the hands and feet
• loss of appetite, feeling unwell, stomach upset, stomach pain, pancreatitis, lip inflammation, vomiting, diarrhea, or constipation
• changes in blood tests, such as increased levels of transaminases, creatinine in blood, fats in the blood (triglycerides and cholesterol)

Not known (frequency cannot be estimated from the available data):

• genital ulcers
• severe bacterial infections (necrotizing fasciitis)
• kidney problems (renal infarction)
• muscle inflammation or inflammation of the blood vessels (vasculitis)
• painful red lumps under the skin, more common on the legs (erythema nodosum)
• loss of appetite, feeling unwell, with headache, drowsiness, and feeling weak (possible sign of high calcium levels in the blood)
• other changes in blood tests, such as a high number of platelets (thrombocytosis), a change in the number of white blood cells (basophilia), or increased levels of histamine
• inflammation of the heart muscle (myocarditis) or inflammation of the pericardium outside the heart (pericarditis), which may cause shortness of breath, palpitations, or chest pain.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vesanoid

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 label after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

Keep the bottle tightly closed to protect it from moisture.

Keep the bottle in the outer carton to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused capsules to a pharmacy for disposal. 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

Composition of Vesanoid

• The active substance is tretinoin. Each soft capsule contains 10 mg of tretinoin.
• The other ingredients (excipients) of the soft capsule filling are: yellow beeswax, hydrogenated soybean oil, partially hydrogenated soybean oil, and soybean oil (see section 2).
• The other ingredients of the soft capsule shell are: gelatin, glycerol (E 422), karion 83 which contains sorbitol (see section 2), mannitol, and maize starch, and the colorants titanium dioxide (E 171), yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance of the product and pack contents

Vesanoid is presented as soft capsules of two colors: orange-yellow / reddish-brown.

Each pack contains a glass bottle with 100 soft capsules.

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

or

CHEPLAPHARM Arzneimittel GmbH

Bahnhofstr. 1a,

17498 Mesekenhagen

Germany

or

CENEXI SAS

52, rue M. et J. Gaucher

94120 Fontenay-sous-Bois

France

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Laboratorios Rubió, S.A.

Industria, 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Vesanoid,

Tretinoin

Date of last revision of this leaflet: June 2023.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.