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TOCTINO 30 MG SOFT CAPSULES

Active substance(s): ALITRETINOIN / ALITRETINOIN

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Toctino® 30 mg soft capsules

2994
30.01.17[2]

(alitretinoin)
PATIENT INFORMATION LEAFLET
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.
This medicine is available using the above name but will be referred to as
Toctino throughout the 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).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOCTINO
Do not take Toctino
- If you are pregnant or if you can become pregnant and are not using
effective birth control measures (see below, “Pregnancy and breastfeeding”).
- 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 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.
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 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
You may not see as well at night during your treatment. If this happens to
you, you should not drive or operate machinery.
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 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

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.

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. Store in the original package. 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.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Toctino contains
The active substance is alitretinoin.
Each soft capsule contains 30 mg of alitretinoin.
The other ingredients are: soya bean oil (refined), partially hydrogenated
soya bean oil, medium chain triglycerides, yellow beeswax, all-rac-αtocopherol, gelatin, glycerol, sorbitol liquid (non-crystallising), water purified,
red iron oxide (E172), yellow iron oxide (E172).
What Toctino looks like and contents of the pack
The capsules are oval shaped, red-brown in colour and marked with “A3”.
Available in blister packs of 30 soft capsules.

Manufacturer and Product license holder
Manufactured by SwissCaps GmbH, Grassingerstrasse 9, D-83043 Bad
Aibling, Germany. Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2994

Leaflet revision and issue date (Ref) 30.01.17[2]
Toctino is a trademark of Glaxo Group Ltd.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

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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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