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TOCTINO 10MG SOFT CAPSULES

Active substance(s): ALITRETINOIN

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6

Pharma code Ref. No. 9970
11016063
11016063
Package leaflet: Information for the user

2 What you need to know
before you take Toctino
Do not take Toctino

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 any further questions, ask your doctor or
pharmacist.
■ This medicine has been prescribed for you only. 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 side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Toctino is and what it is used for
2. What you need to know before you take Toctino
3. How to take Toctino
4. Possible side effects
5. How to store Toctino
6. Contents of the pack and other information

1 What Toctino is and
what it is used for
The active substance in Toctino is alitretinoin. It belongs to a
group of medicines known as retinoids which are related to
Vitamin A. Toctino capsules come in two strengths, containing
10 mg or 30 mg of alitretinoin.
Toctino is used to treat adults with severe chronic hand
eczema that has not got better after any other topical
treatments, including steroids. Treatment with Toctino must be
supervised by a specialist skin doctor (a dermatologist).

Warnings and precautions

Talk to your doctor before taking Toctino:
■ If you have ever had any mental health problems,
including depression, suicidal behaviour or psychosis, or if
you take medicines for any of these conditions.
■ If you have kidney disease. Toctino is not recommended
for people with moderate kidney disease. If you have kidney
disease – check with your doctor that Toctino is suitable for
you.
■ If you have high blood fats, you may need blood tests
more often. Toctino commonly increases blood fats, such as
cholesterol or triglycerides. If your blood fats stay high, your
doctor may lower your dose, or take you off Toctino.
■ If you have high blood sugar (diabetes), your blood sugar
levels may need to be checked more often and your doctor
may start you on a lower dose of Toctino.
■ If you have been suffering from thyroid disease.
Toctino may lower your thyroid hormone levels. If your
thyroid hormone level is low, your doctor may prescribe
supplements.

■ If you experience any problems with your sight, tell your
doctor immediately.
Toctino may need to be stopped and your sight monitored.
■ If you get a persistent headache, nausea or vomiting
(feeling or being sick) and blurred vision, these may be signs
of a condition called benign intracranial hypertension.
Stop the capsules immediately and contact your doctor
as soon as possible.
■ If you develop any mental health problems including
depression, suicidal behaviour or psychosis you must stop
the capsules immediately and contact your doctor as soon
as possible.
■ If you have bloody diarrhoea stop the capsules
immediately and contact your doctor as soon as possible.
■ Minimise your exposure to sunlight and avoid sun lamps.
Your skin may become more sensitive to sunlight. Before
you go out in the sun, use a sun protection product with
a high protection factor (SPF 15 or higher). If you get dry
skin and lips during treatment, use a moisturising ointment
or cream and a lip balm.
■ Cut down on intensive physical exercise: alitretinoin can
cause muscle and joint pain.
■ If you develop dry eyes, lubricating eye ointment or tear
replacement drops can help. If you wear contact lenses,
you may need to wear glasses during alitretinoin treatment.
Dry eyes and sight problems normally return to normal once
treatment is stopped.
■ Toctino may increase liver enzyme levels. Your doctor will
do blood tests during treatment to check these levels. If they
stay high, your doctor may lower your dose or take you off
of Toctino.
Children and adolescents
Toctino is not recommended for people aged under 18 years
old. It is not known how well it works in this age group.

Other medicines and Toctino

Do not take other retinoid medicines (e.g. isotretinoin),
vitamin A supplements or tetracyclines (a type of antibiotic)
while taking Toctino. This increases the risk of side effects.
Tell your doctor or pharmacist if:
➤ you are taking amiodarone (a medicine that helps to
regulate heart rate). Amiodarone is not recommended to
be taken together with Toctino.
➤ you are taking ketoconazole, fluconazole, miconazole
(medicines used to treat infections). Your doctor may
decide to reduce your dose of Toctino.

➤ you are taking simvastatin (a medicine used to lower
cholesterol). Toctino may decrease the amount of this
medicine in your body.
➤ you are taking gemfibrozil (another medicine used to
lower cholesterol) or oxandrolone (an anabolic steroid).
Your doctor may decide to reduce your dose of Toctino.
➤ you are taking paclitaxel (used to treat cancer),
rosiglitazone or repaglinide (used to treat diabetes).
Toctino may increase the amount of these medicines in
your body.
Tell your doctor or a pharmacist if you are taking, or have
recently taken or might take any other medicines. This
includes medicines obtained without a prescription, and herbal
medicines.

Pregnancy and breast-feeding
Important advice for women
Do not take Toctino if you are breast-feeding

■ The medicine is likely to pass into your milk and may harm
your baby.

Do not take Toctino if you are pregnant

Toctino is likely to cause severe birth defects (in medical
language it is teratogenic). It also increases the risk of
miscarriage.
■ You must not take Toctino when you are pregnant.
■ You must not get pregnant during treatment with
Toctino, or during the month after treatment.

If you are a woman and could get pregnant:

You must not use Toctino because of the risk of birth
defects (damage to the unborn baby), unless you meet
the following STRICT rules:
■ Your doctor must have explained the risk of birth
defects: you understand why you must not get pregnant
and what you need to do to prevent it.
■ You must have discussed contraception (birth control)
with your doctor. They will give you information on
preventing pregnancy. He or she may refer you to a
specialist for contraceptive advice.
■ You must agree to use one or preferably two effective
methods of contraception, including condoms or a
cap plus spermicide, for a month before taking Toctino,
during treatment and for a month afterwards. One month
before you start treatment and at the start of treatment your
doctor will ask you to take a pregnancy test, which must be
negative.

■ You must use contraception even if you do not have
periods or are not currently sexually active unless your
doctor decides, that there is absolutely no risk of pregnancy
(for example because your womb has been removed).
■ You must agree to monthly visits and more pregnancy
tests during and around 5 weeks after stopping treatment,
as decided by your doctor. These tests should be performed
in the first 3 days of the menstrual cycle. You must not get
pregnant during treatment and for a month afterwards.
■ Your doctor may ask you (or a guardian) to sign a form
that confirms that you have been told about the risks, and
that you accept the necessary precautions.
Prescriptions for women who could get pregnant are for no
more than 30 days treatment.
A new prescription is needed for more treatment. Each
prescription is only valid for 7 days.
➤ If you do get pregnant or think you might be pregnant
while taking Toctino, or in the month after treatment
has stopped, stop taking the medicine straight away, and
contact your doctor. He or she may refer you to a specialist
for advice.
Your doctor will show you written information on
pregnancy and contraception for the users of Toctino.
If you haven’t seen this material already, ask your doctor for it.

Advice for men

Very low amounts of alitretinoin are present in the semen
of men taking Toctino, but too little to harm the unborn
baby of your partner. You must remember not to share your
medication with anyone, particularly not women.

Advice for both sexes

Do not donate blood while you are taking Toctino or for
one month afterwards. If someone who is pregnant is given
your blood, the baby may be born with birth defects. Never
share your medicine with anybody else. Return any unused
medicine to your pharmacist at the end of treatment.

Driving and using machines

3 How to take Toctino
When to take the capsules

The capsule should be taken with a main meal, preferably at
the same time each day. The capsules should be swallowed
whole and not chewed.

How much to take

The dose is either 10 or 30 mg once daily. If your body can’t
tolerate the recommended 30 mg dose, you may be prescribed
the lower 10 mg dose.
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

How long should you take the capsules

A course of treatment usually lasts for 12 to 24 weeks
depending how your disease gets better. If your first treatment
was successful, your doctor may prescribe another course of
treatment if symptoms return.

If you take more than you should

If you take too many capsules or someone else accidentally
takes your medicine, contact your doctor, pharmacist or
nearest hospital immediately.

If you forget to take a capsule

If you miss a dose take it as soon as you can. However, if it
is nearly time for your next dose, skip the missed dose and
carry on as before. Do not take a double dose to make up for a
forgotten capsule.
➤ If you have any further questions on 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 everybody gets them.
very common:

affects more than 1 user in 10

You may not see as well at night during your treatment. If this
happens to you, you should not drive or operate machinery.

common:

affects 1 to 10 in 100

Toctino contains soya oil and sorbitol

uncommon:

affects 1 to 10 in 1,000

rare:

affects 1 to 10 in 10,000

If you are allergic to peanut or soya, do not use this medicinal
product. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
Toctino.

Very common effects

■ Headache.
■ Raised blood fats: higher levels of fats (triglycerides) and
cholesterol in the blood.

Common effects

■ Depression and other mental problems: depression,
including sad or empty mood.
➤ You should tell a family member or close friend that you can
become depressed, or have significant changes in mood or
behaviour with Toctino, and ask them to read this leaflet. You
might ask them to look after you if they are worried about
your depression or other changes in your behaviour.
■ Blood cell disorders: increase in the number of blood
platelets (cells that help blood to clot), decrease in the
number of red and white blood cells seen in blood tests.
■ Thyroid problems: decreased levels of thyroid hormones.
■ Eye problems: inflammation of the eye (conjunctivitis) and
eyelid area; eyes feel dry and irritated.
➤ Ask a pharmacist for suitable eye drops. If you wear
contact lenses and get dry eyes, you may need to wear
glasses instead.
■ Ear problems: persistent noise in the ears (tinnitus).
■ Dizziness
■ Blood and circulation: flushing, high blood pressure
(hypertension).
■ Gut and stomach problems: feeling sick (nausea), being
sick (vomiting), dry mouth.
■ Muscle and joint pain: muscle pain, joint pain, lack of
energy (fatigue). High levels of muscle breakdown products
in your blood if you exercise vigorously.
■ Skin and hair problems: dryness of the skin, especially of
the face, dry and inflamed lips, redness of the skin, itchy
skin rash, inflamed skin, hair loss.
■ Liver problems: raised liver enzymes seen in blood tests.

Uncommon effects

■ Sight problems including blurred vision, distorted vision,
cloudy surface on the eye (corneal opacity, cataracts).
➤ If your sight is affected, stop taking Toctino immediately
and contact your doctor.
■ Skin problems: itchy skin, skin peeling, rash, dry skin
eczema.
■ Ear, nose and throat problems: nose bleeding.
■ Gut and stomach problems: indigestion (dyspepsia).
■ Bone disorders: extra growth of bone, including the spine
disorder ankylosing spondylitis.

Rare effects

■ Lasting headache, along with feeling sick (nausea), being
sick (vomiting) and changes in your eyesight including
blurred vision. These may be signs of benign intracranial
hypertension.
➤ If you experience these symptoms, stop taking Toctino
immediately and contact your doctor.
■ Blood and circulation: inflammation of blood vessels.

Other side effects

Other side effects have occurred in a very small number of
people but their exact frequency is unknown:
Severe allergic reactions. Signs include:
■ raised and itchy rash (hives).
■ swelling, sometimes of the face or mouth (angioedema),
causing difficulty in breathing.
■ collapse.
➤ Contact a doctor immediately if you get these
symptoms. Stop taking Toctino.
Gut and stomach disorders. Severe stomach (abdominal)
pain, with or without bloody diarrhoea, feeling sick (nausea)
and being sick (vomiting).
➤ Stop taking Toctino immediately and contact your
doctor. These can be signs of serious gut conditions.
Mood changes or thoughts of committing suicide.
Tearfulness, and emotional disorder.
Some people have had thoughts about harming themselves
or ending their lives, have attempted suicide or committed
suicide. These people may not appear to be depressed.
➤ Contact your doctor immediately if you get signs of
any of these mental problems. Your doctor may tell you to
stop taking Toctino. That may not be enough to stop the
effects: you may need more help, and your doctor can
arrange this.
Problems seeing at night. Sight problems normally return to
normal once treatment is stopped.
Blood and circulation: swelling of the hands, lower legs and
feet (peripheral oedema).

Side effects of other medicines in the same
family as Toctino.
These effects haven’t been seen in Toctino so far, but they
can’t be ruled out.
They are very rare and may affect less than 1 user in 10,000.
Diabetes. Excessive thirst; frequent need to urinate; blood
tests show an increase in your blood sugar. These can all be
signs of diabetes.

Bone disorders. Arthritis; bone disorders (delayed growth,
changes to bone density); growing bones may stop growing.
Eye and visual disorders. Colour blindness and colour vision
gets worse; intolerance to contact lenses.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information
on the safety of this medicine.

5 How to store Toctino
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 blister after EXP. The expiry date refers to
the last day of that month.
Do not store above 30°C. Keep the blister in the outer carton in
order to protect from light.
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.

6 Contents of the pack and
other information
What Toctino contains

The active substance is alitretinoin.
Each capsule, soft contains 10 mg or 30 mg of alitretinoin.
The other ingredients are: soya bean oil (refined), partially
hydrogenated soya bean oil, medium chain triglycerides,
yellow beeswax, all-rac-α-tocopherol, gelatin, glycerol, sorbitol
liquid (non-crystallising), water purified, iron oxide, red (E172),
iron oxide, black (E172) (10 mg) or iron oxide, yellow (E172)
(30 mg).

Marketing Authorisation Holder

GSK-ContractMfg-Eur-UK-Germany-Swiss Caps-Bad Aibling

GlaxoSmithKline UK Ltd
Stockley Park West
Uxbridge
Middlesex
UB11 1BT

United Kingdom-GBR

Manufacturer

Toctino

SwissCaps GmbH
Grassingerstrasse 9
D-83043 Bad Aibling
Germany
This medicinal product is authorised in the Member States
of the EEA under the following names:
Austria, Bulgaria, Czech Republic, Denmark, Finland, France,
Germany, Hungary, Iceland, Italy, Latvia, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
United Kingdom: Toctino
Greece: Cehado
This leaflet was last revised in September 2015
Other formats:
To listen to or request a copy of this leaflet in Braille, large print
or audio please call, free of charge:

N/A
720 X 168 mm

Information not available
Information not available

0800 198 5000 (UK Only)

1

Please be ready to give the following information:
Product name
Toctino 10 mg capsules, soft

Toctino 30 mg capsules, soft
Reference number 19494/0252
This is a service provided by the Royal National Institute of
Blind People.
Toctino is a registered trade mark of Stiefel Laboratories, Inc.
© 2015 Stiefel Laboratories, Inc. All rights reserved.

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What Toctino looks like and contents of the
pack
Toctino comes in capsules, soft. The capsules are about
11 mm long and 7 mm wide, oval, opaque, coloured brown
and marked with “A1” (10 mg) or about 13 mm long and
8 mm wide, oval, coloured red-brown and marked with “A3”
(30 mg). The capsules come in blister packs of 30.

Pharma code Ref. No. 9970

Toctino 10 mg capsules, soft
Toctino 30 mg capsules, soft

■ If you are pregnant or if you can become pregnant and are
not using effective birth control measures
(see below, “Pregnancy and breast-feeding”).
■ If you are breast-feeding.
■ If you have liver disease.
■ If you have severe kidney disease.
■ If you have high blood fats (such as high cholesterol or
raised triglycerides).
■ If you have untreated thyroid disease.
■ If you have very high levels of vitamin A in your body
(hypervitaminosis A).
■ If you are allergic to alitretinoin, to other retinoids (such
as isotretinoin), to peanut or soya or any of the other
ingredients of this medicine (listed in section 6).
■ If you are taking tetracycline (a type of antibiotic).
➤ If any of these apply to you, go back to your doctor.
You must not take Toctino.

You need to take care during treatment:

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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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