Toctino 10 mg 30 capsules

What is Toctino and when is it used?

The active ingredient in Toctino is alitretinoin. It belongs to a group of medicines called retinoids , which are related to vitamin A. Toctino capsules are available in two strengths containing 10 mg or 30 mg alitretinoin.

Toctino is used in patients with refractory, severe chronic hand eczema who have received intensive local treatment for at least 4 weeks and have not responded. Pretreatment includes avoidance of contact with the causative agent, skin protection, and potent topical corticosteroids. Treatment with Toctino must be supervised by a dermatologist.

Toctino can lead to serious malformations of the unborn child during pregnancy, which is why special precautionary measures are necessary, which require strict medical control.

Toctino is only available with a doctor's prescription.

Toctino is prescribed according to criteria that may vary from patient to patient. It is prescribed for you personally and you must under no circumstances give the medicine or the instructions that apply to you to anyone else.

When should Toctino not be taken?

• If you are pregnant you must not take Toctino under any circumstances .
• if you are able to become pregnant and are not practicing effective methods of contraception .
• if you are breastfeeding.
• if you suffer from liver disease.
• if you suffer from severe kidney disease.
• if your blood fat levels are too high (for example high cholesterol or elevated triglycerides).
• if you suffer from untreated thyroid disease.
• if you have very high levels of vitamin A in your body (hypervitaminosis A).
• if you are allergic (hypersensitive) to alitretinoin or any of the other ingredients of Toctino. Toctino contains soybean oil. It should not be taken if you are hypersensitive (allergic) to peanut or soy.
• if you suffer from fructose intolerance.
• if you are taking tetracycline (a type of antibiotic ) or methotrexate (a type of cytostatic ).

If any of these apply to you, please talk to your doctor and do not take Toctino.

Toctino capsules must not be administered to children or adolescents under 18 years of age.

When should you be careful when taking Toctino?

Toctino is only prescribed under strict conditions for women who can become pregnant due to the risk of birth defects (harm to the unborn child).

• Before starting treatment, you must ensure that you are not pregnant. Your doctor will therefore carry out two separate pregnancy tests, the results of which must be negative.
• Your doctor must have explained to you the risk of birth defects: you must understand why you should not become pregnant and what you must do to prevent pregnancy.
• You must have spoken to your doctor about contraceptives. He will give you information about preventing pregnancy. He can refer you to a specialist who can advise you on contraception.
• You must agree to use two effective methods of contraception, including a barrier method (condoms or a cap plus spermicide), for one month before taking Toctino, during treatment and for one month afterwards .
• You must use contraceptive methods even if you do not have your period or are not currently sexually active (unless your doctor thinks this is not necessary).
• You must agree to a monthly check-up and further pregnancy tests if your doctor decides. A test will be performed one month after stopping Toctino. You must not become pregnant during treatment or for one month afterwards.
• Your doctor may ask you (or a guardian) to sign a form confirming that you have been informed of the risks and that you agree to the necessary safety measures.
• The amount of Toctino prescribed per prescription is limited to a 30-day supply. Continued treatment requires re-prescription every 30 days. Your pharmacist may only give you Toctino within 7 days of the prescription date. After 7 days, the prescription is considered expired and Toctino will only be given to you again at the pharmacy if you present a new prescription.

If you become pregnant or suspect that you are pregnant despite strict contraception while taking Toctino or in the month following the end of treatment, you must stop taking the medicine immediately and contact your doctor. He can refer you to a specialist who will advise you.

Your doctor will show you written information about pregnancy and pregnancy prevention intended for patients being treated with Toctino. If your doctor has not shown you this information material, ask him or her to do so.

Advice for men

Very small amounts of alitretinoin are present in the semen of men taking Toctino. These small amounts are not expected to endanger the unborn child if the partner is pregnant.

Please remember that you must not give your medicine to anyone, especially women.

Advice for both genders

• You should not donate blood while taking Toctino or for one month afterwards. If a pregnant woman receives your blood, the baby may be born with birth defects.
• Limit exposure to sunlight to a minimum and avoid UV lamps or UV beds unless under medical supervision and when indicated for medical reasons. Your skin may be more sensitive to sunlight. Use a sunscreen with a high SPF (SPF 15 or higher) before exposure to the sun.
• If you notice dry skin and lips during treatment, use a moisturizer and lip balm.
• Reduce intense physical activities: Alitretinoin can cause muscle and joint pain.
• Dry eyes can be relieved by applying eye ointment to moisten the eye or tear replacement drops. If you wear contact lenses and dry eyes occur, you may need to wear glasses for the duration of treatment with alitretinoin. Dry eyes and vision problems usually return to normal after treatment is stopped.
• If you have vision problems, please inform your doctor immediately. Toctino may need to be stopped and your vision monitored.

You may have difficulty seeing in the dark during your treatment. In this case, you must not drive a vehicle or operate machines.

• If persistent headaches, nausea or vomiting, and blurred vision occur, these may be signs of a condition called benign intracranial hypertension (benign increased intracranial pressure).
  Stop taking the capsules immediately and contact your doctor as soon as possible.
• If bloody diarrhea occurs, stop taking the capsules immediately and contact your doctor as soon as possible.
• Liver enzymes: Toctino may cause an increase in liver enzymes. Your doctor will therefore carry out blood tests to monitor liver enzymes during treatment. If liver enzymes remain elevated, your doctor may reduce the dosage of Toctino or stop treatment.

You must inform your doctor before treatment if:

• You have ever suffered from mental health problems , including depression, suicidal thoughts or psychosis, or are taking medication for any of these conditions.
• If you have high blood fat levels, you may need more frequent blood tests. Toctino often increases blood lipid levels, such as cholesterol or triglycerides. If your blood fat levels remain elevated, your doctor may lower your dose or stop taking Toctino.
• If you have suffered from thyroid disease. Toctino can lower your thyroid hormone levels. If your thyroid hormone levels are low, your doctor may prescribe supplements.
• If you suffer from diabetes. Toctino can increase your blood sugar levels. Your doctor may want to monitor your blood sugar levels during treatment, especially if you already have diabetes or are overweight.
• If you are using ketoconazole, fluconazole or miconazole (medicines used to treat infections).
• If you are using gemfibrozil (a medicine used to lower cholesterol), diosmin (a medicine used to treat hemorrhoids) or valproic acid (a medicine used to treat epilepsy).

In these cases, your doctor may adjust the dose of Toctino.

• If you use St. John's wort (a plant extract used to treat depression), protease inhibitors (used to treat HIV or hepatitis C), or medications used to treat epilepsy or convulsions. These can reduce the effectiveness of the contraceptive pill
• If you suffer from liver dysfunction. Toctino must not be taken if you have liver dysfunction.
• If you suffer from kidney dysfunction. Toctino must not be taken if you have severe kidney dysfunction. If you have a kidney disorder, you should check with your doctor whether Toctino is right for you.

This medicine contains 20.08 mg sorbitol per Toctino 10 mg soft capsule or 25.66 mg sorbitol per Toctino 30 mg soft capsule.

You must not take vitamin A supplements while taking Toctino . This increases the risk of side effects. You must also not take other retinoids such as isotretinoin or tazaroton while taking Toctino.

It is not recommended to use Toctino with amiodarone (a medicine used to regulate heart rate).

Toctino can also affect how some other medications work. This includes:

• Paclitaxel (a drug used to treat cancer),
• Rosiglitazone or repaglinide (medicines used to treat diabetes).

Tell your doctor or pharmacist if you suffer from other illnesses, have allergies or are taking other medicines (including those you have bought yourself) or using them externally!

Can Toctino be taken during pregnancy or while breastfeeding?

Important note for women

Toctino can cause severe deformities in the unborn child and, as a result, lead to the birth of a severely deformed child (in medical terms it is teratogenic ). It also increases the risk of miscarriage.

• If you are pregnant, you should not take Toctino under any circumstances (see “When should you not take Toctino?”).
• You must not take Toctino if you are breast-feeding. The medicine can pass into breast milk and harm your baby.

How do you use Toctino?

Adult:

Take the capsules with a main meal, preferably at the same time every day. Swallow the capsules whole without chewing them.

The dose is 10 mg or 30 mg per day. If your body cannot tolerate the recommended 30 mg dose, you may be prescribed the lower 10 mg dose.

How long should you take the capsules?

A course of treatment usually lasts 12 to 24 weeks, depending on how your disease improves. If your first treatment was successful, your doctor may prescribe further treatment if symptoms return.

If you have taken more Toctino than you should

If you have taken too many capsules or if someone else has accidentally taken your medicine, please contact your doctor, pharmacist or nearest hospital immediately.

If you forget to take Toctino

If you miss a dose, please take it as soon as possible. However, if it is almost time for your next dose, please skip the missed dose and take the medicine at the usual times. Do not take a double dose if you forget a capsule.

Do not change the prescribed dosage on your own. If you think the medicine is too weak or too strong, talk to your doctor or pharmacist.

What side effects can Toctino have?

The following side effects were observed in clinical trials with Toctino:

Very common side effects (affects more than 1 in 10 users)

• Increased blood lipid levels: increased levels of blood lipids (triglycerides) and cholesterol.
• Headache.

Common side effects (affects 1 to 10 users in 100)

• Disturbances of the blood system: increase in the number of platelets, lack of red and white blood cells.
• Thyroid problems: Decreased thyroid hormone levels.
• Depression, including a feeling of sadness or emptiness.
• Dizziness.
• Eye problems: Inflammation of the eye (conjunctivitis) and the eyelid area; Eye dryness and irritation.

Please ask the pharmacist about suitable eye drops. If you wear contact lenses and experience dry eyes, you may need to wear glasses instead.

• Constant noise in the ears (tinnitus).
• Blood and circulation: hot flashes, high blood pressure (hypertension).
• Nausea, dry mouth, vomiting.
• Liver problems : Elevated liver enzymes in blood tests.
• Skin and hair problems: dry skin, especially on the lips and face, inflamed skin, redness of the skin, itchy rash, hair loss.
• Muscle and joint pain: back pain, muscle pain, joint pain. High levels of muscle breakdown products in the blood after intense physical exercise.
• Fatigue.

Uncommon side effects (affects 1 to 10 users in 1,000)

• Visual disturbances: blurred vision, clouding on the surface of the eye (cataract). If your vision is affected, stop taking Toctino immediately and contact your doctor.
• Ear, nose and throat problems: nosebleeds.
• Digestive disorders (dyspepsia).
• Skin problems: itching, rash, peeling skin, dry skin eczema.
• Bone Disorders: Additional bone growth, including the spinal disorder ankylosing spondylitis.

Rare side effects (affects 1 to 10 in 10,000 users)

• Persistent headache, with nausea, vomiting and changes in vision, including blurred vision. These symptoms can be indications of benign increased intracranial pressure. If your vision is affected, stop taking Toctino immediately and contact your doctor.
• Blood and circulation: Inflammation of the blood vessels.

Post-marketing side effects (frequency not known):

The following side effects have been observed following the marketing of Toctino, the frequency of which cannot be reliably estimated:

• Severe allergic reactions and hypersensitivity.
• Mood swings, suicidal thoughts (see below).
• Problems seeing in the dark.
• Severe stomach or abdominal pain with or without severe bloody diarrhea, nausea, and vomiting.
• Changes in nails.
• Abnormal hair structure (e.g. hair frizz).
• Increased skin sensitivity to sunlight.
• Accumulation of water in the tissues of the arms and legs (peripheral edema).

Other possible side effects:

Side effects of other medicines that belong to the same family as Toctino.

These side effects have not yet been observed with Toctino, but cannot be ruled out.

They are very rare and affect fewer than 1 in 10,000 users.

• Mental disorders

Some patients have had the desire to harm or kill themselves (suicidal ideation), attempted suicide (attempted suicide), or committed suicide (suicide). These patients may not appear depressed.

Please contact your doctor immediately if you experience signs of any of these mental health problems. Your doctor may tell you to stop taking Toctino. However, it may be that this measure is not enough to stop the effects. You may need further help and your doctor can make appropriate arrangements.

Talk to a member of your family or a close friend about the possibility of depression or significant changes in mood or behavior caused by treatment with Toctino. Ask them to read this leaflet. Also ask them to care for you if they are concerned about your depression or other changes in your behavior.

• diabetes

Excessively strong thirst; frequent urge to urinate; Blood tests show elevated blood sugar levels. These could be signs of diabetes.

• Bone disorders

Arthritis; Bone disorders (delayed growth, changes in bone density); Bones that are still growing can no longer grow.

• Vision problems

Your vision may be impaired in the dark, color blindness may occur, and color vision may deteriorate.

Talk to your doctor if a side effect gets worse.

If you notice any side effects, contact your doctor or pharmacist. This applies in particular to side effects that are not stated in this leaflet.

What should also be noted?

The medicine may only be used until the date marked “EXP” on the container.

Storage instructions

Store at room temperature (15 – 25°C) in the original container.

Store the blister in the folding box protected from light.

Toctino must be kept out of the reach of children.

More information

Medicines must not be disposed of in wastewater or household waste. Please return unused or expired medicines to your pharmacy for disposal.

At the end of treatment, please return any unused capsules to your pharmacist and only keep them if your doctor expressly tells you to do so.

Your doctor or pharmacist can provide you with further information. These people have the detailed information for specialists.

What is included in Toctino?

One soft capsule contains:

Active ingredients

Alitretinoin 10 mg or 30 mg.

Excipients

Capsule contents:

Refined soybean oil, partially hydrogenated soybean oil, medium chain triglycerides, yellow wax, DL-α-tocopherol.

Capsule shell:

Gelatin, glycerol, sorbitol solution 70% (non-crystallizing) E 420, purified water, iron oxide red (E 172).

Additionally for Toctino 10 mg soft capsules

Black iron oxide (E 172).

Additionally for Toctino 30 mg soft capsules

Iron oxide yellow (E 172).

Approval number

58711 (Swissmedic)

Where can you get Toctino? Which packs are available?

In pharmacies against a doctor's prescription, which only entitles you to a one-time purchase.

• Toctino 10 mg, packs of 30 soft capsules.
• Toctino 30 mg, packs of 30 soft capsules.

Authorization holder

GlaxoSmithKline AG, Münchenbuchsee.