VESANOID 10MG SOFT CAPSULES

Active substance: TRETINOIN

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Genisys-No.

10136676

Printing Colour:

Pantone Black

Format:

148x594 mm

Folding Format:

148x297 mm

Type Size

12 pt

Drawing Norm

NP9344

make-up code

GB

97.4.3524

Checked and
approved

11.08.10

Signature

226

Date

KAU-Nr.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

10136676 GB 1201.1073

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 further questions, ask
your doctor or pharmacist.
● This medicine has been prescribed
for you. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same
as yours.
● If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet.

While you are 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 tell
you to stop and prescribe a
different oral contraceptive.
Medicines which may require
particular care when taken with
Vesanoid include:
● rifampicin and erythromycin
(antibiotics)
● glucocorticoids (for allergies and
inflammation)
● phenobarbital (for epilepsy)
● pentobarbital (for insomnia)
● ketoconazole (an antifungal)
● cimetidine (for stomach ulcers)
● verapamil and diltiazem (for heart
conditions or high blood pressure)
● ciclosporin (used following organ
or bone marrow transplants)
● tranexamic acid, aminocaproic
acid and aprotinin (used to reduce
bleeding).

What is in 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

Contraception, pregnancy and
breast-feeding
Ask your doctor or pharmacist for
advice before taking any medicine.

1. What Vesanoid is and what
it is used for
Vesanoid contains a medicine called
tretinoin. This belongs to a group of
medicines called ‘retinoids’. These
medicines are similar to vitamin A.

Before starting treatment with
Vesanoid
Tell your doctor immediately if:
● you are pregnant,
● you think you are pregnant,
● you intend to become pregnant.
You should not become pregnant
during and within one month (four
weeks) after stopping treatment
with Vesanoid. If you do become
pregnant while taking Vesanoid,
it is very likely that your baby
will be born deformed.

Vesanoid is used to treat a type of
blood problem called ‘acute
promyelocytic leukaemia’. It 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 Vesanoid (listed in
Section 6)
● other ‘retinoid’ medicines. These
include isotretinoin, acitretin and
tazarotene
● peanuts or soya.
This is because
Vesanoid contains
soya-bean oil.

During treatment with Vesanoid
● During treatment with
Vesanoid and four weeks after
stopping, you and your
partner should practice
effective and continued
contraception (birth control).
Your doctor will
tell you what
methods of
contraception
you can use. If
you are taking
low-dose progestogens (minipill) for birth control, your
doctor will tell you to stop and
prescribe a different oral
contraceptive for you.
● Women taking Vesanoid should
take 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 discuss the right
treatment for you if you are
pregnant and have acute
promyelocytic leukaemia.

Do not take Vesanoid if:
● you are pregnant, planning to
become pregnant or breast-feeding
(see Section 2, Contraception,
pregnancy and breast-feeding)
● you are taking a tetracycline
(a type of antibiotic)
● you are taking vitamin A.
Do not take this medicine if any of
the above apply to you. If you are
not sure, talk to your doctor or
pharmacist before taking
Vesanoid.
Warnings and precautions

Do not breast-feed your baby
while taking Vesanoid. Vesanoid
enters the breast milk, and could
therefore harm your baby.

Talk to your doctor or pharmacist
before taking Vesanoid if:
● you have any other illness
● you have allergies
● you have been told by your doctor
that you have an intolerance to
some sugars. This is because
Vesanoid contains sorbitol.

Driving and using machines
Your ability to drive or operate
machinery might be impaired while
you are taking Vesanoid, especially if
you are feeling dizzy or have a
severe headache.

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

Vesanoid contains soya-bean oil
and sorbitol
Vesanoid contains soya-bean oil. If
you are allergic to peanut or soya, do
not take this medicine.

Look out for important side effects
Vesanoid can cause side effects
including:
● a severe headache with feeling or
being sick
● difficulty in breathing
● fever
● feeling dizzy
● chest or back pain.
You will need to look out for these
while you are taking Vesanoid. See
“Important side effects” in
Section 4 for more details. Your
doctor may decide to change the
dose of your medicine or to prescribe
an additional medicine.

Vesanoid contains sorbitol (a type of
sugar). If you have been told by your
doctor that you have an intolerance
to some sugars, contact your doctor
before taking this medicine.

3. How to take Vesanoid
Always take Vesanoid exactly as
your doctor or pharmacist has told
you. Check with your doctor or
pharmacist if you are not sure.
How much to take
Depending on the nature of your
illness, your reaction to Vesanoid,
your body weight and body height,
your doctor will prescribe a dose that
is right for you. Do not change the
prescribed dose yourself. If you feel
that the effect of Vesanoid is too
strong or too weak, talk to your
doctor or pharmacist.

Other medicines and Vesanoid
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines. This
includes medicines obtained without
a prescription and herbal medicines.
This is extremely important, as using
more than one medicine at the same
time can strengthen or weaken the
effect of the medicines. Therefore
you should not take Vesanoid with
any other drug unless you have told
your doctor and they have agreed.

Adults
The daily dose will be 45 mg/m2 and
will be about 8 capsules a day
divided into two equal doses.
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Genisys-No.

10136676

Printing Colour:

Pantone Black

Format:

148x594 mm

Folding Format:

148x297 mm

Type Size

12 pt

Drawing Norm

NP9344

make-up code

GB

97.4.3524

Checked and
approved

11.08.10

Signature

226

Date

KAU-Nr.

Children
The daily dose will be 45 mg/m2
divided into two equal doses.
Children who suffer from bad
headaches during treatment might
receive a lower dose.

Not known (frequency cannot be
estimated from the available data):
● genital ulcers
● serious bacterial infections
● kidney problems (renal infarct)
● swollen muscles or swollen blood
vessels (vasculitis)
● red painful lumps under the skin,
most likely on your legs (erythema
nodosum)
● loss of appetite, feeling or being
sick, with a headache, feeling
drowsy or weak (possible sign of
too much calcium in your blood)
● other changes to your blood
(shown in tests) such as too many
platelets (thrombocythaemia), a
change in the number of white
blood cells (basophilia) or
increased histamine levels.

Adults with kidney or liver
diseases
The daily dose will be 25 mg/m2
divided into two equal doses.
You will take Vesanoid for up to a
maximum of 90 days. During therapy
with Vesanoid or immediately after,
your doctor will start treatment with
other medicines.
Taking this medicine
Swallow the capsules whole with
water, preferably with a meal or
shortly thereafter. Do not chew the
capsules.

If you get any of the side effects, talk
to your doctor or pharmacist. This
includes any side effects not listed in
this leaflet.

If you take more Vesanoid than
you should
If you or another person have taken
an overdose of Vesanoid, you must
contact your doctor, pharmacist or
the nearest hospital immediately.

5. How to store Vesanoid
Keep out of the sight and reach of
children.
Do not use this medicine after the
expiry date which is stated on the
carton and bottle label after EXP.
The expiry date refers to the last day
of that month.

If you forget to take Vesanoid
If you forget to take one dose, take
your capsules as soon as you
remember and tell your doctor
immediately. Do not take a double
dose to make up for a forgotten dose.

Glass bottles:
Do not store above 30°C.
Keep the bottle tightly closed in
order to protect from moisture.
Keep the bottle in the outer carton in
order to protect from light.

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

Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.

4. Possible side effects
Like all medicines, this medicine can
cause side effects although not
everybody will get them. In addition
to the benefits, nearly everyone will
get some undesirable effects during
treatment. This is true, even when
Vesanoid is used correctly.

6. Contents of the pack and
other information
What Vesanoid contains

Important side effects
Tell your doctor immediately, if
you notice any of the following:
● fever, especially with breathing
difficulties, coughing, feeling
dizzy, chest pain and abdominal
pain
● a severe headache with feeling or
being sick, difficulty in breathing,
fever, feeling dizzy, or chest or
back pain. Your
doctor may decide to
change the dose of
your medicine or to
prescribe an
additional medicine
● severe stomach pain which spreads
to your back (possible sign of
pancreatitis)
● fever with dark lumpy markings on
your skin, most likely on your face
and neck (possible sign of
“Sweet’s syndrome” or acute
febrile neutrophilic dermatosis)
● a painful swelling in your leg,
sudden chest pain or difficulty
breathing (possible sign of a blood
clot)
● a pain in your chest that spreads to
your arm or neck (possible sign of
a heart attack)
● double vision and feeling dizzy,
especially with feeling or being
sick, ringing in your ears and
headache (possible sign of
increased pressure in your head)
● an unexplained headache or
migraine, which can include
disturbed vision (possible sign of a
stroke).
Tell your doctor immediately if you
notice any of the side effects listed
above.

● The active substance is tretinoin.
Each capsule contains 10 mg
tretinoin.
● The other ingredients in the
capsule contents are yellow
beeswax, hydrogenated soya-bean
oil, partially hydrogenated soyabean oil and soya-bean oil.
● The other ingredients in the
capsule shell are
gelatin, glycerol
(E 422), karion
83 containing
sorbitol, mannitol
and starch (maize), and the
colorants titanium dioxide (E 171),
iron oxide yellow (E 172) and iron
oxide red (E 172).
What Vesanoid looks like and
contents of the pack
Vesanoid soft capsules are bicoloured, orange-yellow and reddishbrown. They are packed in glass
bottles containing 100 capsules.
Marketing Authorisation Holder
Roche Products Limited
6 Falcon Way, Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Manufacturer (UK only)
Roche Products Limited
6 Falcon Way, Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Manufacturer (Ireland only)
Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany

Other side effects
Very common (may affect more
than 1 in 10 people):
● hair loss
● an irregular heartbeat
● changes to your eyesight or
hearing
● bone or joint pain, chest pain or
abdominal pain
● skin rash, itching, redness, peeling
or inflammation
● dry skin, mouth or nose, swollen,
dry or cracked lips
● breathing difficulties such as
asthma, which may get worse
● conjunctivitis or dry eyes, which
may be a problem if you wear
contact lenses
● difficulty sleeping
● sweating more than usual
● headache or feeling dizzy
● feeling tired, cold or generally
unwell
● feeling confused, worried or
depressed
● pins and needles or numbness of
your hands or feet
● loss of appetite, feeling or being
sick, stomach upset, diarrhoea or
constipation
● changes to your blood (shown in
tests) such as higher levels of
blood fats (triglycerides and
cholesterol).

This medicinal product is
authorised in the Member States of
the EEA under the following
names:
Vesanoid
This leaflet was last revised in
April 2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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