VESANOID 10 mg Soft Capsule

Зміст інструкції

1. Vesanoid 10 mg soft capsules
   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. How to store Vesanoid
   6. Contents of the pack and other information

Vesanoid 10 mg soft capsules

Tretinoin

Read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others even if their
symptoms are the same as yours, as it could be harmful.
If any side effects occur, including those not listed in this leaflet,
tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Vesanoid is and what it is used for
• 2. What you need to know before you take 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 a medicine called tretinoin, which belongs to a group of medicines known
as "retinoids" and similar to vitamin A.
Vesanoid is used to treat a type of blood disease called "acute promyelocytic leukemia" and
works by slowing the growth of certain types 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, including isotretinoin, acitretin and tazarotene.
• peanuts or soy, because Vesanoid contains soybean oil.

Do not take Vesanoid if:

• you are pregnant, planning a pregnancy or breastfeeding (see section 2, Pregnancy, breastfeeding and fertility)
• you are taking vitamin A, tetracyclines or retinoids.

If any of these conditions apply to you, do not take this medicine. If you have any doubts,
consult your doctor or pharmacist before taking Vesanoid.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Vesanoid if:
you have any other illness.
you have had mental health problems including depression, aggressive tendencies or changes
in mood. This is because Vesanoid can interfere with your mood.
you have allergies.
You have been told by your doctor that you suffer from an intolerance to certain sugars, as Vesanoid
contains sorbitol.
If any of these conditions apply to you (or if you have any doubts), consult your doctor or pharmacist
before taking Vesanoid.
Mental health problems
You may notice some changes in your mood and behavior and it is very important that you tell your
friends and family that this medicine can interfere with mood and behavior.
They may notice these changes and help you identify problems that need to be
discussed with your doctor.

Pay attention to the following side effects
Vesanoid can cause side effects such as:

• severe headache with a feeling of illness or malaise
• difficulty breathing
• fever
• feeling dizzy
• back or chest pain You should pay attention to these effects during treatment with Vesanoid. For more details see section 4 “Important side effects”. Your doctor may decide to change the dose of your medicine or prescribe an additional medicine.

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

Other medicines and Vesanoid
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription and herbal medicines.
This is extremely important, because the simultaneous use of multiple medicines can strengthen or
limit the effect of the medicines themselves. Therefore, do not take Vesanoid with other drugs unless
you have informed your doctor and your doctor agrees.
While you are taking Vesanoid, do not take:

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

The medicines that may require particular attention when taken with Vesanoid
include:

• 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)
• cimetidine (for stomach ulcers)
• verapamil and diltiazem (for heart problems or high blood pressure)
• cyclosporine (used after organ or bone marrow transplantation)
• tranexamic acid, aminocaproic acid and aprotinin (used to reduce bleeding).

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.

Before starting treatment with Vesanoid
Tell your doctor immediately
if you are pregnant
if you think you may be pregnant
if you are planning to become pregnant.
You must not become pregnant during treatment with Vesanoid and for one month
(four weeks) after stopping it. 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 the four weeks followingstopping, you and your partner must use effective and continuous contraception. Your doctor will advise you on which method of contraception to use. If you are taking low-dose progestins for birth control (mini-pill), your doctor will tell you to stop the 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 during treatmentwith Vesanoid.Your doctor will explain the correct treatment for you if you are pregnant and suffer from acute promyelocytic leukemia.

Do not breastfeed during therapy with Vesanoid. Vesanoid passes into breast milk and may therefore
be harmful to the baby.

Driving and using machines
Your ability to drive vehicles or use machines may be impaired during the period of taking
Vesanoid, especially if you experience dizziness or severe headache.

Vesanoid contains soybean oil, sorbitol and sodium
Vesanoid contains soybean oil. If you are allergic to peanuts or soy, do not use this
medicine.
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. essentially
“sodium-free”.

3. How to take Vesanoid

Always take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts
consult your doctor or pharmacist.

Recommended dose
The doctor will prescribe the right dose, according to the nature of your illness, your response to Vesanoid,
your body weight and your height. Do not change the prescribed dose on your own initiative. If you feel that
the effect of Vesanoid is too strong or too weak, consult your doctor or pharmacist.

Adults
The daily dose will be 45 mg/m, which is approximately 8 capsules per day divided into 2 equal doses.

Children
The daily dose will be 45 mg/m divided into 2 equal doses. For children who suffer from severe
headaches during treatment, a lower daily dose of 25 mg/m should be
considered.

Adults with kidney or liver disease
The daily dose will be 25 mg/m divided into 2 equal doses.
Treatment with Vesanoid may last 3 months or even longer. Your doctor will tell you how long
you need to take Vesanoid.

Taking 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 another person has taken an excessive dose of Vesanoid, you should contact your doctor, your
pharmacist or go to the nearest hospital immediately.

If you forget to take Vesanoid
If you forget to take a dose, take the capsules as soon as you remember the omission and
inform your doctor immediately. Do not take a double dose to make up for the missed dose.
If you have any doubts 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 everyone will experience them.
In addition to the beneficial effects, almost all patients will experience some side effects during
treatment. This happens even when Vesanoid is used correctly.

Important side effects
Immediately inform your doctorif you experience the following symptoms:

• fever, especially with difficulty breathing, cough, feeling dizzy, chest and abdominal pain.
• severe headache with feeling unwell or being unwell, difficulty breathing, cough, feeling dizzy, or
  chest or abdominal pain. Your doctor may decide to change the dose of the medicine or to
  prescribe you another medicine in addition.
• severe stomach pain that extends to the back (possible sign of pancreatitis)
• fever with dark skin nodules, most likely on the face and neck (possible sign of “Sweet’s
  syndrome” or acute febrile neutrophilic dermatosis)
• painful swelling of the legs, sudden chest pain or difficulty breathing (possible sign of a blood
  clot)
• chest pain that extends to the arms or neck (possible sign of a heart attack)
• double vision and dizziness, accompanied especially by feeling unwell or being unwell, ringing in the
  ears and headache (possible sign of increased pressure in the head)
• unexplained headache or migraine, including vision problems (possible sign of stroke).

Immediately inform your doctor if you notice any of the above-listed side effects.

Other side effects
Very common (affect more than 1 in 10 people):
hair loss
irregular heartbeat
changes in vision or hearing
bone or joint pain, chest or abdominal pain
skin rash, itching, redness, flaking or inflammation of the skin
dryness of the skin of the nose or mouth; swollen, dry or cracked lips
difficulty breathing including asthma, with possible worsening (respiratory failure)
conjunctivitis or dry eyes, which may be a problem if you wear contact lenses
difficulty sleeping
unusual increase in sweating
headache or dizziness
feeling tired, cold or generally unwell
feeling confused, worried or depressed
tingling or numbness in the hands or feet
loss of appetite, feeling unwell or being unwell, stomach upset, stomach pain,
inflammation of the pancreas (pancreatitis), inflammation of the lips, vomiting, diarrhea or
constipation
blood changes (visible in tests) such as increased levels of transaminases, creatinine
hematocrit or blood fats (triglycerides and cholesterol).

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

• severe bacterial infections (necrotizing fasciitis)
• kidney problems (renal infarction)
• swelling of muscles or inflammation of blood vessels (vasculitis)
• red, painful nodules under the skin, more often observed on the legs (erythema nodosum)
• loss of appetite, feeling unwell or being unwell, with headache, feeling sleepy or weak (possible
  sign of excess calcium in the blood)
• other blood abnormalities (shown in tests) such as excess platelets (thrombocytosis), an
  alteration of white blood cells (basophilia) or increased levels of histamine.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 on the label of the
bottle after Scad. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Keep the bottle tightly closed to protect the medicine from moisture.
Keep the bottle in the outer packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This 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 excipients contained in the soft capsule are yellow wax, hydrogenated soybean oil, partially hydrogenated soybean oil and soybean oil (see section 2).
• The excipients in the soft capsule shell are gelatin, glycerol (E 422), karion 83 containing sorbitol (see section 2), mannitol and starch (corn), and the colorants titanium dioxide (E 171), yellow iron oxide (E 172) and red iron oxide (E 172).

Description of the appearance of Vesanoid and contents of the pack
Vesanoid 10 mg soft capsules are two-tone yellow-orange/brownish-red capsules. One
amber glass bottle contains 100 capsules.

Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer responsible for batch release
CHEPLAPHARM Arzneimittel GmbH
Bahnhofstr. 1a
17498 Mesekenhagen
Germany
CENEXI SAS
52, rue M. et J. Gaucher
94120 Fontenay-sous-Bois
France

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Vesanoid, Tretinoin

This leaflet was last updated on