Label: Information for the User

Vesanoid 10 mg Soft Capsules

Tretinoin

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, 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 who have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Vesanoid contains tretinoin, which belongs to a group of medications known as retinoids, structurally related tovitamin A.

Vesanoid is indicated for the treatment of a type of blood disorder called “acute promyelocytic leukemia”. This medication acts by reducing the growth of certain types of diseased blood cells.

Do not take Vesanoid if you are allergic to:

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

Do not take Vesanoid if:

• you are pregnant, intend 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 medication if you experience any of the above. If you are unsure, consult your doctor or pharmacist before taking Vesanoid.

Warnings and precautions

Consult your doctor or pharmacist before taking Vesanoid if:

- you have any other medical condition

- you have ever had any mental health problems, such as depression, aggressive tendencies, or mood changes. This is because taking Vesanoid may affect your mood.

- you have allergies

- your doctor has told you that you have an intolerance to certain sugars, as Vesanoid contains sorbitol

If you experience any of the above (or are unsure), 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 to tell your friends and family that this medication may affect your mood and behavior. They may notice these changes and help you identify any problems you need to discuss with your doctor.

Watch for important side effects

Vesanoid may cause side effects, including:

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

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

Children

The safety and efficacy information for the use of tretinoin in children is limited.

Use of Vesanoid with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication. This includes medications purchased without a prescription, including herbal medications.

This is important, as taking multiple medications at the same time may increase or decrease their effects. Do not take Vesanoid with other medications unless you have informed your doctor and obtained their consent.

While taking Vesanoid, do not take:

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

Medications 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)
• ciclosporin (used after organ or spinal cord transplants)
• tranexamic acid, aminocaproic acid, and aprotinin (medications used to reduce bleeding)

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Before starting treatment with Vesanoid

Inform your doctor immediately if:

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

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

During treatment with Vesanoid

• During treatment with Vesanoid and for four weeks after completing treatment, you and your partner should use effective and continuous birth control methods.Your doctor will tell you which birth control methods you can use. If you are taking low doses of progestogens for birth control (mini-pill), your doctor will discontinue this treatment and prescribe a different oral contraceptive.
• Women taking Vesanoid should have a pregnancy test every month during treatment with Vesanoid.
• Inform your doctor immediately if you become pregnant while taking Vesanoid.You and your doctor will decide on 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 operating machinery

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

Vesanoid contains soy oil, sorbitol, and sodium

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

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

This medication contains less than 1 mmol of sodium (23 mg) per soft capsule, making it essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Amount to Take

Depending on the nature of your illness, your reaction to Vesanoid, your body weight, and height, your doctor will prescribe the appropriate dose for you. Do not change the prescribed dose yourself. If you estimate that the action of Vesanoid is too strong or weak, inform 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/m2divided into two equal doses. For children who experience severe headaches during treatment, consider a daily dose of 25 mg/m².

Adults with Renal or Hepatic Insufficiency

The daily dose is 25 mg/m2divided into two equal doses.

Vesanoid treatment can last 3 months or more. Your doctor will tell you how long you should take Vesanoid.

Taking This Medication

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 you should, consult your doctor, pharmacist, or the nearest hospital immediately.

In case of overdose or accidental ingestion, call the Toxicological Information Service, Phone (91) 562 04 20, indicating the medication and the amount ingested.

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 compensate for missed doses.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. In addition to the benefits, almost everyone experiences unwanted side effects during treatment. This can occur even when Vesanoid is used correctly.

Important side effects

Inform 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 your medication dose or prescribe an additional medication
• intense stomach pain that extends to the back (possible sign of pancreatitis)
• fever with dark, swollen patches on the skin, more likely on the face and neck (possible sign of "Sweet 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 extends to the arm or neck (possible sign of a heart attack)
• double vision and dizziness, especially with discomfort, ringing in the ears, and headache (possible sign of high blood pressure)
• headache or migraine without explanation, which may include vision changes (possible sign of a stroke).

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

Other side effects

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

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

Unknown (frequency cannot be calculated from available data):

• genital ulcers
• severe bacterial infections (necrotizing fasciitis)
• kidney problems (renal infarction)
• muscle inflammation or inflammation of blood vessels (vasculitis)
• red, painful bumps 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 (shown in blood tests) such as many 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) that may cause shortness of breath, palpitations, or chest pain.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the bottle label after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above30 °C.

Keep the bottle tightly closed to protect it from moisture.

Store the bottle inside the outer carton to protect it from light.

Medicines should not be disposed of through drains or in the trash.Depositthe packaging and unused medications at the SIGRE collection pointofthe pharmacy.Incase of doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Vesanoid

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

Appearance of the product and contents of the packaging

Vesanoid is presented in the form of two-colored soft capsules: orange-yellow / reddish-brown.

Each package contains an amber-colored glass vial with 100 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing

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 request more information about this medication by contacting the local representative of the marketing authorization holder:

Laboratorios Rubió, S.A.

Industria, 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Vesanoid,

Tretinoin

Last review date of this leaflet: June 2023.

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.