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VESANOID 10MG SOFT CAPSULES

Active substance(s): TRETINOIN

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koepcke.publishing
stand (datum): 10.06.2014
format: 180 x 315 mm
farben: 1/1-farbig schwarz
mat.-nr.: GB 9000695/11
schriftgröße: 9 pt

PACKAGE LEAFLET:
INFORMATION FOR THE USER

taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Tretinoin

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 Tretinoin with any other
drug unless you have told your doctor and they have agreed.

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.
What is in this leaflet:
1. What Tretinoin is and what it is used for
2. What you need to know before you take Tretinoin
3. How to take Tretinoin
4. Possible side effects
5. How to store Tretinoin
6. Contents of the pack and other information
1. W
 hat Tretinoin is and what it is used for
Tretinoin 10 mg soft capsules contains a medicine called
tretinoin. This belongs to a group of medicines called
‘retinoids’. These medicines are similar to vitamin A.
Tretinoin 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.

While you are taking Tretinoin 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 Tretinoin 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).
Contraception, pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
Before starting treatment with Tretinoin
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 Tretinoin.
If you do become pregnant while taking Tretinoin, it is
very likely that your baby will be born deformed.

2. What you need to know before you take Tretinoin

Do not take Tretinoin if you are allergic to:
• tretinoin or any of the other ingredients of Tretinoin 10 mg soft
capsules (listed in Section 6)
• other ‘retinoid’ medicines. These include isotretinoin,
acitretin and tazarotene
• peanuts or soya. This is because Tretinoin contains soyabean oil.
Do not take Tretinoin if:
• you are pregnant, planning to become pregnant or breastfeeding (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 Tretinoin.
Warnings and precautions

Talk to your doctor or pharmacist before taking Tretinoin 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 Tretinoin contains sorbitol.
If any of the above apply to you (or you are not sure), talk to
your doctor or pharmacist before taking Tretinoin.
Look out for important side effects
Tretinoin 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
Tretinoin. 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.
Other medicines and Tretinoin
Tell your doctor or pharmacist if you are taking, have recently

During treatment with Tretinoin
• During treatment with Tretinoin 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 Tretinoin should take a pregnancy test
every month during treatment with Tretinoin.
• Tell your doctor immediately if you become pregnant
while taking Tretinoin. You and your doctor will discuss the right treatment for you if you are pregnant and
have acute promyelocytic leukaemia.
Do not breast-feed your baby while taking Tretinoin.
Tretinoin enters the breast milk, and could therefore harm
your baby.

Driving and using machines
Your ability to drive or operate machinery might be impaired
while you are taking Tretinoin, especially if you are feeling
dizzy or have a severe headache.
Tretinoin contains soya-bean oil and sorbitol
Tretinoin contains soya-bean oil. If you are allergic to peanut
or soya, do not take this medicine.
Tretinoin 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 Tretinoin
Always take Tretinoin 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

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Tretinoin, 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 Tretinoin is
too strong or too weak, talk to your doctor or pharmacist.

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).

Adults
The daily dose will be 45 mg/m2 and will be about 8 capsules
a day divided into two equal doses.
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 Tretinoin for up to a maximum of 90 days. During therapy with Tretinoin 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 take more Tretinoin than you should
If you or another person have taken an overdose of Tretinoin,
you must contact your doctor, pharmacist or the nearest
hospital immediately.

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 forget to take Tretinoin
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.

5. How to store Tretinoin
Keep out of the sight and reach of children.

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

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.

4. Possible side effects

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.

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 Tretinoin is used
correctly.

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.

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.
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

6. C
 ontents of the pack and other information
What Tretinoin contains
• 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
soya-bean 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 Tretinoin looks like and contents of the pack
Tretinoin soft capsules are bicoloured, orange-yellow and
reddishbrown. They are packed in glass bottles containing
100 capsules.
Marketing Authorisation Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Bahnhofstr. 1a, 17498 Mesekenhagen
Germany
Distributor in the UK
Intrapharm Laboratories Limited
The Courtyard Barns, Choke Lane
Cookham Dean, Maidenhead, Berks SL6 6PT
United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
Tretinoin
Vesanoid
2

This leaflet was last revised in April 2014

GB 9000695/11

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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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