TOCTINO 10MG SOFT CAPSULES

Active substance: ALITRETINOIN

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11014831
Package leaflet: Information for the user

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

Toctino 10 mg capsules, soft
Toctino 30 mg capsules, soft
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.
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).

■ 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.

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 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.

You need to take care during treatment:

■ 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 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 ketoconazole (a
medicine used to treat infections), or simvastatin (a medicine used
to lower cholesterol). Your doctor may decide to adjust your dose.
➤ 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
such as St. John’s Wort.

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

Section 2 continues over ➔

➔ Toctino contains soya oil and sorbitol

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.

3 How to take Toctino
When to take the capsules
The capsule should be taken with a meal. The capsules should be
swallowed whole and not chewed.

How much to take
The dose will be between 10 and 30 mg once daily. If your body can’t
tolerate the recommended dose, you may be prescribed a lower 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

Common effects

■ Blood cell disorders: decreased clotting, 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.
■ Blood and circulation: flushing.
■ Muscle and joint pain: muscle pain, joint pain. 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

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

■ 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.
■ Bone disorders: extra growth of bone, including the spine disorder
ankylosing spondylitis.

If you forget to take a capsule

Rare effects

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 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
common:
affects 1 to 10 in 100
uncommon:
affects 1 to 10 in 1,000
rare:
affects 1 to 10 in 10,000

Very common effects

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

■ 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 severe 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.

Depression and other mental problems. Depression, including sad or
empty mood, mood changes, 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.

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).

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.

Marketing Authorisation Holder
GlaxoSmithKline UK Ltd
Stockley Park West
Uxbridge
Middlesex
UB11 1BT

Manufacturer
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, Estonia, Finland, France,
Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, United Kingdom: Toctino
Cyprus, Greece: Cehado
This leaflet was last revised in 04/2014
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Toctino 10 mg and 30 mg capsules, soft
Reference number PL 19494/0252 (10 mg) and PL 19494/0253
(30 mg)
This is a service provided by the Royal National Institute of Blind People.
Toctino is a registered trade mark of Stiefel Laboratories, Inc.
© 2014 Stiefel Laboratories, Inc. All rights reserved.

11014831

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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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