TOCTINO 10MG SOFT CAPSULES
Active substance: ALITRETINOIN
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Package Leaflet Information for the user
2 Before you take Toctino
Do not take Toctino
If you are pregnant or if you can become pregnant and are
Toctino 10 mg capsules, soft Toctino 30 mg capsules, soft
Read all of this leaflet carefully before you start taking this medicine
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. Do not pass it on
to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist:
not using effective birth control measures (see below, Pregnacy 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 (hypersensitive) to alitretinoin, to other retinoids (such as isotretinoin) or any of the other ingredients of Toctino (they are 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.
Stop the capsules, soft immediately and contact your doctor as soon as possible. If you have bloody diarrhoeastop the capsules, soft 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). Cut down on intensive physical exercise: alitretinoin can cause muscle and join 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.
You must have discussed contraception (birth control)
Taking other medicines
Do not take vitamin A supplements or tetracyclines (a type of antibiotic) while taking Toctino. This increases the risk of side effects. Tell your doctor or a pharmacist if you are taking other medicines, or have recently taken any. This includes medicines obtained without a prescription, and herbal medicines such as St. Johns Wort.
In this leaflet:
1 2 3 4 5 6 What Toctino is and what it is used for Before you take Toctino How to take Toctino Possible side effects How to store Toctino Further information
Your doctor needs to know before treatment:
If you have ever had any mental health problems,
! 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
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, soft come in two strengths, containing 10 mg or 30 mg of alitretinoin. Toctino is used for patients 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).
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 been suffering from thyroid disease. Toctino may lower your thyroid hormone levels. If your thyroid hormone level is low, your doctor may prescribe supplements.
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.
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. Before you start 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 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 havent 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.
You need to take care during treatment:
If you experience any problems with your sight, tell your
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.
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.
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.
Section 2 continues over
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11:19
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.
4 Possible side effects
Like all medicines, Toctino can cause side effects, although not everybody gets them. very common: common: uncommon: rare: affects more than 1 user in 10 affects 1 to 10 in 100 affects 1 to 10 in 1,000 affects 1 to 10 in 10,000
Rare effects
Lasting headache, along with feeling sick (nausea), being
5 How to store Toctino
Keep out of the reach and sight of children. Do not use Toctino 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 put medicines into waste water or household rubbish. Ask your pharmacist how to dispose of medicines you no longer need. This will help to protect the environment. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Important information about some of the ingredients of Toctino
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.
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.
3 How to take Toctino
When to take the capsules, soft
The capsule, soft should be taken with a meal. The capsules, soft should be swallowed whole and not chewed.
Very common effects
Headache Raised blood fats: higher levels of fats (triglycerides) and
Side effects of other medicines in the same family as Toctino.
These effects havent been seen in Toctino so far, but they cant be ruled out. They are very rare and may affect less than 1 user in 10,000. 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.
cholesterol in the blood
Common effects
Blood cell disorders: decreased clotting, decrease in the
6 Further information
What Toctino contains
Each capsule, soft contains 10 mg or 30 mg of alitretinoin. The capsules, soft also contain: Soya oil (refined), partially hydrogenated soya oil, medium chain triglycerides, yellow beeswax, all-rac--tocopherol. The capsule shell consists of: gelatin, glycerol, sorbitol liquid (non-crystallising), water purified, iron oxide (E172).
How much to take
The dose will be between 10 mg and 30 mg once daily. If your body cant tolerate the recommended dose, you may be prescribed a lower dose. Always take Toctino 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, soft
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, soft or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital immediately.
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: back 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 lips and face, inflamed skin, hair loss Liver problems: raised liver enzymes seen in blood tests.
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.
Gut and stomach disorders. Severe abdominal (tummy) pain, with or without severe bloody diarrhoea, feeling sick (nausea) and being sick (vomiting).
What Toctino looks like and contents of the pack
Toctino comes in capsules, soft. The capsules, soft are oval, opaque, coloured brown (10 mg) or red-brown (30 mg). The capsules, soft come in blister packs of 30.
Uncommon effects
Sight problems including blurred vision, distorted vision,
If you forget to take a capsule, soft
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, soft. If you have any further questions on the use of this product, ask your doctor or pharmacist.
cloudy surface on the eye (corneal opacity, cataracts).
If your sight is affected, stop taking Toctino immediately and contact your doctor. Skin problems: hair loss, 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.
Stop taking Toctino immediately and contact your doctor. These can be signs of serious gut conditions. 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. Visual disorders. You may see less well at night; colour blindness and colour vision gets worse.
Marketing Authorisation Holder
Basilea Medical, LtD 14/16 Frederick Sanger Road The Surrey Research Park, Guildford, Surrey GU2 7YD, U.K. Tel.: +44(0)1483 600095
Manufacturer
Swisscaps Grassingerstr. 9, 83043 Bad Aibling, Germany 400002 This leaflet was last approved in {09/2010} 87958
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
87958.indd
2
16.09.10
11:19
2 Before you take Toctino
Do not take Toctino
If you are pregnant or if you can become pregnant and are
Toctino 10 mg capsules, soft Toctino 30 mg capsules, soft
Read all of this leaflet carefully before you start taking this medicine
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. Do not pass it on
to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist:
not using effective birth control measures (see below, Pregnacy 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 (hypersensitive) to alitretinoin, to other retinoids (such as isotretinoin) or any of the other ingredients of Toctino (they are 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.
Stop the capsules, soft immediately and contact your doctor as soon as possible. If you have bloody diarrhoeastop the capsules, soft 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). Cut down on intensive physical exercise: alitretinoin can cause muscle and join 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.
You must have discussed contraception (birth control)
Taking other medicines
Do not take vitamin A supplements or tetracyclines (a type of antibiotic) while taking Toctino. This increases the risk of side effects. Tell your doctor or a pharmacist if you are taking other medicines, or have recently taken any. This includes medicines obtained without a prescription, and herbal medicines such as St. Johns Wort.
In this leaflet:
1 2 3 4 5 6 What Toctino is and what it is used for Before you take Toctino How to take Toctino Possible side effects How to store Toctino Further information
Your doctor needs to know before treatment:
If you have ever had any mental health problems,
! 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
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, soft come in two strengths, containing 10 mg or 30 mg of alitretinoin. Toctino is used for patients 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).
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 been suffering from thyroid disease. Toctino may lower your thyroid hormone levels. If your thyroid hormone level is low, your doctor may prescribe supplements.
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.
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. Before you start 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 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 havent 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.
You need to take care during treatment:
If you experience any problems with your sight, tell your
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.
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.
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.
Section 2 continues over
87958.indd
1
16.09.10
11:19
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.
4 Possible side effects
Like all medicines, Toctino can cause side effects, although not everybody gets them. very common: common: uncommon: rare: affects more than 1 user in 10 affects 1 to 10 in 100 affects 1 to 10 in 1,000 affects 1 to 10 in 10,000
Rare effects
Lasting headache, along with feeling sick (nausea), being
5 How to store Toctino
Keep out of the reach and sight of children. Do not use Toctino 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 put medicines into waste water or household rubbish. Ask your pharmacist how to dispose of medicines you no longer need. This will help to protect the environment. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Important information about some of the ingredients of Toctino
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.
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.
3 How to take Toctino
When to take the capsules, soft
The capsule, soft should be taken with a meal. The capsules, soft should be swallowed whole and not chewed.
Very common effects
Headache Raised blood fats: higher levels of fats (triglycerides) and
Side effects of other medicines in the same family as Toctino.
These effects havent been seen in Toctino so far, but they cant be ruled out. They are very rare and may affect less than 1 user in 10,000. 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.
cholesterol in the blood
Common effects
Blood cell disorders: decreased clotting, decrease in the
6 Further information
What Toctino contains
Each capsule, soft contains 10 mg or 30 mg of alitretinoin. The capsules, soft also contain: Soya oil (refined), partially hydrogenated soya oil, medium chain triglycerides, yellow beeswax, all-rac--tocopherol. The capsule shell consists of: gelatin, glycerol, sorbitol liquid (non-crystallising), water purified, iron oxide (E172).
How much to take
The dose will be between 10 mg and 30 mg once daily. If your body cant tolerate the recommended dose, you may be prescribed a lower dose. Always take Toctino 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, soft
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, soft or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital immediately.
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: back 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 lips and face, inflamed skin, hair loss Liver problems: raised liver enzymes seen in blood tests.
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.
Gut and stomach disorders. Severe abdominal (tummy) pain, with or without severe bloody diarrhoea, feeling sick (nausea) and being sick (vomiting).
What Toctino looks like and contents of the pack
Toctino comes in capsules, soft. The capsules, soft are oval, opaque, coloured brown (10 mg) or red-brown (30 mg). The capsules, soft come in blister packs of 30.
Uncommon effects
Sight problems including blurred vision, distorted vision,
If you forget to take a capsule, soft
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, soft. If you have any further questions on the use of this product, ask your doctor or pharmacist.
cloudy surface on the eye (corneal opacity, cataracts).
If your sight is affected, stop taking Toctino immediately and contact your doctor. Skin problems: hair loss, 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.
Stop taking Toctino immediately and contact your doctor. These can be signs of serious gut conditions. 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. Visual disorders. You may see less well at night; colour blindness and colour vision gets worse.
Marketing Authorisation Holder
Basilea Medical, LtD 14/16 Frederick Sanger Road The Surrey Research Park, Guildford, Surrey GU2 7YD, U.K. Tel.: +44(0)1483 600095
Manufacturer
Swisscaps Grassingerstr. 9, 83043 Bad Aibling, Germany 400002 This leaflet was last approved in {09/2010} 87958
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
87958.indd
2
16.09.10
11:19
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
