Vesanoid 10 mg soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Vesanoid 10 mg soft capsules

Tretinoin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, 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, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

2. What you need to know before starting to 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 soya, as Vesanoid contains soya oil.

Do not take Vesanoid if:

• you are pregnant, planning to become pregnant, or 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 apply to you. 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 illness
• 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 any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking Vesanoid.

Mental health problems

You may not notice certain changes in your mood and behavior, so it is very important to inform your friends and family that this medicine could affect your mood and behavior. They may notice these changes and help you identify any problems that you need to discuss with your doctor.

Monitor for serious adverse effects

Vesanoid can cause adverse effects including:

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

You must monitor for all of these adverse effects while taking Vesanoid. For more details, see “Serious adverse effects” in section 4. Your doctor may decide to change the dose of your medicine or prescribe an additional drug.

Children

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

Taking Vesanoid with other medicines

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

This is important because taking more than one medicine at the same time may increase or decrease their effects. You should not take Vesanoid with other medicines unless you have informed your doctor and obtained their approval.

While taking Vesanoid, do not take:

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

Medicines that require special caution 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)
• cyclosporine (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

Inform your doctor immediately if

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

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

During treatment with Vesanoid

• During treatment with Vesanoid and for four weeks after stopping treatment, you and your partner should use effective and continuous contraceptive methods (birth control). Your doctor will advise you which contraceptive methods are suitable. If you are taking low-dose progestogens for contraception (mini-pill), your doctor will discontinue this treatment and prescribe a different oral contraceptive.
• Women receiving treatment with 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 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 soya oil, sorbitol, and sodium

This medicine contains soya oil. It should not be used if you are allergic to peanuts or soya.

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 administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage to be taken

Depending on the nature of your illness, your response to Vesanoid, your body weight and height, your doctor will prescribe the dose appropriate for you. Do not change the prescribed dose yourself. If you feel that the effect of Vesanoid is too strong or too weak, inform your doctor or pharmacist.

Adults

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

Children

The daily dose is 45 mg/m², divided into two equal doses. For children experiencing severe headaches during treatment, a lower daily dose of 25 mg/m² should 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 longer. Your doctor will inform you how long you should take Vesanoid.

How to take this medicine

Swallow the capsules whole with water, preferably during or shortly after meals. 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, contact your doctor, pharmacist, or nearest hospital immediately.

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

If you forget to take Vesanoid

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

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. In addition to its benefits, almost everyone undergoing treatment will experience some undesirable adverse effects. This occurs even when Vesanoid is used correctly.

Important adverse effects

Contact your doctor immediately if you notice any of the following adverse effects:

• fever, especially with difficulty breathing, cough, dizziness, chest pain, or abdominal pain
• severe headache with nausea or vomiting, difficulty breathing, fever, dizziness, or chest or back pain. Your doctor may decide to adjust your medicine dose or prescribe an additional drug
• severe stomach pain spreading to the back (possible sign of pancreatitis)
• fever with raised, dark skin lesions, most 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 spreading to the arm or neck (possible sign of a heart attack)
• double vision and dizziness, especially with malaise, ringing in the ears, and headache (possible sign of high pressure in the head)
• unexplained headache or migraine, which may include visual disturbances (possible sign of a stroke).

Contact your doctor immediately if you experience any of the adverse effects listed above.

Other adverse effects

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

• hair loss
• irregular heartbeat
• changes in vision and hearing
• bone or joint pain, chest pain, or abdominal pain
• skin rash, itching, redness, peeling, and skin inflammation
• dry skin, dry mouth, and dry 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 problematic if you wear contact lenses
• difficulty sleeping
• excessive sweating
• headache or dizziness
• feeling tired, cold, or generally unwell
• feelings of confusion, anxiety, or depression
• tingling and numbness in the hands and feet
• loss of appetite, malaise, stomach discomfort, stomach pain, inflammation of the pancreas (pancreatitis), inflammation of the lips, vomiting, diarrhea, or constipation
• blood changes (shown in blood tests), such as increased levels of transaminases, creatinine in blood, blood fats (triglycerides and cholesterol)

Frequency not known (cannot be estimated from available data):

• genital ulcers
• severe bacterial infections (necrotizing fasciitis)
• kidney problems (renal infarction)
• muscle inflammation or inflammation of blood vessels (vasculitis)
• painful red lumps under the skin, most commonly on the legs (erythema nodosum)
• loss of appetite, malaise, accompanied by headache, drowsiness, and weakness (possible sign of high calcium levels in the blood)
• other blood changes (shown in blood tests), such as increased platelets (thrombocytosis), change in white blood cell count (basophilia), or increased histamine levels
• inflammation of the myocardial muscle (myocarditis) or inflammation of the pericardium surrounding the heart (pericarditis), which may cause shortness of breath, palpitations, or chest pain.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the packaging and on the label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Keep the bottle tightly closed to protect it from moisture.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 components (excipients) in the soft capsule filling are: yellow beeswax, hydrogenated soybean oil, partially hydrogenated soybean oil, and soybean oil (see section 2).
• The remaining ingredients in the soft capsule shell are: gelatin, glycerol (E 422), Karion 83 containing sorbitol (see section 2), mannitol and starch (corn), and the colouring agents titanium dioxide (E 171), yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance of the product and contents of the pack

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

Each pack contains one amber glass bottle with 100 capsules.

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

or

CHEPLAPHARM Arzneimittel GmbH

Bahnhofstr. 1a,

17498 Mesekenhagen

Germany

or

CENEXI SAS

52, rue M. et J. Gaucher

94120 Fontenay-sous-Bois

France

Further information on this medicinal product is available upon request 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Vesanoid,

Tretinoin

Date of the most recent review of this leaflet: June 2023.

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