Label: information for the patient

Odomzo 200mg hard capsules

sonidegib

Odomzo may cause severe congenital anomalies. It may cause fetal or neonatal death. Do not become pregnant while taking this medication. You must follow the contraception instructions included in this label.

Read this label carefully before starting to take this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist,even if they do not appear in this label. See section4.

What isOdomzo

Odomzo contains the active ingredient sonidegib. It is a cancer medication.

What is Odomzo used for

Odomzo is used to treat adults with a type of skin cancer called basal cell carcinoma. It is used when the cancer has spread to the local area and cannot be treated with surgery or radiation.

How Odomzo works

The normal growth of cells is controlled by different chemical signals. In patients with basal cell carcinoma, changes occur in genes that control a part of this process known as the “hedgehog pathway”. These changes in the signals cause cancer cells to grow out of control. Odomzo works by blocking this process, interrupting the growth of cancer cells and preventing new cells from forming.

Read the specific instructions provided by your doctor, mainly about the effects of Odomzo on the fetus.

Read carefully and follow the instructions in the patient information leaflet and the reminder card provided by your doctor.

Do not take Odomzo

• if you are allergic to sonidegib or any of the other ingredients in this medication (listed in section 6).
• if you are pregnant or think you may be pregnant. This is because Odomzo may cause harm or death to your fetus (see section “Pregnancy”).
• if you are breastfeeding. This is because it is unknown whether Odomzo can pass into breast milk and cause harm to the newborn (see section “Breastfeeding”).
• if you may become pregnant but cannot or do not want to follow the necessary pregnancy prevention measures listed in the Odomzo Pregnancy Prevention Program.

Do not take Odomzo if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Odomzo.

Additional information can be found in the sections “Pregnancy”, “Breastfeeding”, “Fertility”, and “Contraception in women and men”.

Warnings and precautions

• Odomzo may cause muscle problems. Inform your doctor before taking Odomzo if you have a history of muscle cramps or weakness, or if you are taking other medications. Some medications (e.g. cholesterol-lowering medications) may increase the risk of muscle problems. Inform your doctor or pharmacist immediately if your muscles cause pain or if you experience unexplained muscle cramps or weakness during treatment with Odomzo. Your doctor may need to change your dose, or temporarily or permanently discontinue your treatment.
• You should not donate blood while taking Odomzo or during the 20 months after completing treatment.
• Men should not donate semen at any time during treatment and for 6 months after the last dose.
• Your doctor will regularly check your skin for another type of cancer called basal cell carcinoma (BCC). It is unknown whether BCC may be related to treatment with Odomzo. Normally, this type of cancer appears on sun-damaged skin, does not spread, and can be cured. Inform your doctor if you notice any changes in your skin.
• Never give this medication to anyone else. You should return any unused capsules at the end of your treatment. Consult your doctor or pharmacist about where to return the capsules.

Blood tests during Odomzo treatment

Your doctor will perform blood tests before treatment and possibly during treatment. These tests will check the health of your muscles by determining the levels of an enzyme in your blood called creatine phosphokinase.

Children and adolescents (under 18 years of age)

Odomzo should not be used in children and adolescents under 18 years of age. Problems with teeth and bone growth have been observed with this medication. Odomzo may cause bones to stop growing in children and adolescents. This can also occur after stopping treatment.

Taking Odomzo with other medications

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication. This includes over-the-counter medications and herbal medications. This is because Odomzo may affect the way other medications work. Additionally, some medications may affect the way Odomzo works, or increase the risk of adverse reactions.

Specifically, inform your doctor or pharmacist if you are taking any of the following:

• medications, such as statins and fibrates, used to treat high cholesterol and lipid levels.
• vitamin B3, also known as niacin
• medications, such as methotrexate, mitoxantrone, irinotecan, or topotecan, used to treat certain types of cancer, as well as other conditions such as severe arthritis (rheumatoid arthritis) and psoriasis.
• medications, such as telithromycin, rifampicin, or rifabutin, used to treat bacterial infections
• medications, such as ketoconazole (not including shampoos or creams), itraconazole, posaconazole, or voriconazole, used to treat fungal infections
• medications, such as chloroquine or hydroxychloroquine, used to treat parasitic infections, as well as other conditions such as rheumatoid arthritis or lupus erythematosus
• medications, such as ritonavir, saquinavir, or zidovudine, used to treat HIV or AIDS
• medications, such as carbamazepine, phenytoin, or phenobarbital, used to treat seizures
• a medication called nefazodone used to treat depression
• a medication called penicillamine used to treat severe arthritis (rheumatoid arthritis)
• a herbal medication called St. John's Wort (also known as Hypericum perforatum) used to treat depression.

If any of the above applies to you or if you are unsure, consult your doctor or pharmacist before taking Odomzo.

These medications should be used with caution or may need to be discontinued during treatment with Odomzo. If you are taking any of them, your doctor may need to prescribe an alternative medication.

During treatment with Odomzo, you should inform your doctor or pharmacist if you are prescribed any other medication that you have not taken before.

Pregnancy

Do not take Odomzo if you are pregnant, think you may be pregnant, or plan to become pregnant during treatment or for 20 months after completing treatment. You should discontinue treatment with Odomzo and inform your doctor immediately if you become pregnant or suspect you may be pregnant. Odomzo may cause severe congenital anomalies or lead to fetal death. The specific instructions (the Odomzo Pregnancy Prevention Program) provided by your doctor contain information mainly about the effects of Odomzo on the fetus.

Breastfeeding

Do not breastfeed during treatment or for 20 months after completing treatment. It is unknown whether Odomzo can pass into breast milk and cause harm to the newborn.

Fertility

Odomzo may have an impact on male and female fertility. Inform your doctor if you plan to become pregnant in the future.

Contraception in women and men

Women

Before starting treatment with Odomzo, consult your doctor if you may become pregnant, even if your periods have stopped (menopause). It is essential to check with your doctor if there is a risk that you may become pregnant.

If you may become pregnant:

• you must take precautions to avoid becoming pregnant while taking Odomzo,
• you must use 2 effective methods of contraception, one highly effective method and a barrier method (see examples below) while taking Odomzo,
• you must continue to use these contraceptive methods for 20 months after discontinuing treatment with Odomzo because traces of the medication remain in the body for a long time.

Your doctor will discuss the best contraceptive method for you.

You must use a highly effective method, such as:

• a intrauterine device (IUD)
• surgical sterilization

In addition, you must use a barrier method, such as:

• a condom (with spermicide, if available)
• a diaphragm (with spermicide, if available)

Your doctor will perform a pregnancy test:

• at least 7 days before starting treatment – to ensure you are not already pregnant
• every month during treatment

During treatment and for 20 months after completing treatment, inform your doctor immediately if:

• you think your contraceptive method has failed for any reason
• your periods have stopped
• you have stopped using contraceptives
• you need to change your contraceptive method

Men

While taking Odomzo, always use a condom (with spermicide, if available) when having sex with a female partner, even if you have had a vasectomy. You should continue to use a condom for 6 months after completing treatment.

Inform your doctor immediately if your partner becomes pregnant while you are taking Odomzo and for 6 months after completing treatment.

You should not donate semen during treatment and for 6 months after completing treatment.

Driving and operating machinery

Odomzo is unlikely to affect your ability to drive or use any tools or machinery. If in doubt, consult your doctor.

Odomzo contains lactose

Odomzo contains lactose (milk sugar). If your doctor has indicated that you have an intolerance to certain sugars, consult them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again..

Medication Intake

The recommended dose is 200mg (1capsule) per day.

• Do not eat for 2hours before taking Odomzo or for 1hour after taking it.
• Take your capsule at approximately the same time every day. This will help you remember when to take your medication.
• Swallow the capsule whole. Do not open, chew, or crush the capsule. You should avoid any contact with the contents of the capsules, as it may be harmful.

Do not change your dose without consulting your doctor. Do not exceed the recommended dose prescribed by your doctor. If you vomit after swallowing the capsule, do not take more capsules until your next dose.

For How Long Should You Take Odomzo

Continue taking Odomzo for the time your doctor tells you to. If you have doubts about the time you should take Odomzo, consult your doctor or pharmacist.

If You Take More Odomzo Than You Should

If you take more Odomzo than you should, or if someone else accidentally takes your medication, consult a doctor or go to the hospital immediately. Bring the medication, your packaging, and your leaflet with you..

If You Forget to Take Odomzo

If you forget to take a dose of Odomzo, take it as soon as you remember. If more than six hours have passed since you should have taken the dose, skip the missed dose and take the next dose according to the established schedule. Do not take a double dose to make up for the missed doses.

If You Interrupt Treatment with Odomzo

Do not interrupt treatment with Odomzo without first consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist..

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Odomzo can cause severe congenital anomalies, do not become pregnant while taking this medicine (for more information see “Pregnancy”, “Breastfeeding”, “Fertility”” and “Contraception in women and men” in section2).

Interrupt your treatment with Odomzo and immediately inform your doctor if you observe any of the following effects, as they may be signs of an allergic reaction:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• severe skin itching, with a red rash or protuberances.

Some side effects can be severe

Immediately inform your doctor or pharmacist if you observe any of the following:

• severe muscle cramps, muscle pain, or muscle weakness. These may be signs of a condition called rhabdomyolysis, which consists of muscle tissue breakdown.
• dark urine, decreased urine output, or no urine production. These may be signs of muscle rupture, which is harmful to the kidneys.

Other possible side effects

If any of these side effects become severe, consult with your doctor or pharmacist.

Very common:can affect more than1 in 10patients

• muscle cramps, muscle pain, bone pain, ligament pain, and tendon pain
• absence of menstrual periods
• diarrhea or stomach acid
• decreased appetite
• headache
• alteration of taste or strange taste in the mouth
• abdominal pain
• uncomfortable feeling
• vomiting
• itching
• hair loss
• fatigue
• pain
• weight loss.

Common:can affect up to1 in 10patients

• stomach discomfort or indigestion
• constipation
• skin rash
• abnormal hair growth
• thirst, decreased urine output, weight loss, dry and red skin, irritability (possible symptoms of low fluid levels in the body, known as dehydration).

During treatment with Odomzo, you may also experienceabnormal blood test results. This may alert your doctor to possible changes in the function of some parts of your body, for example:

• elevated levels of the following enzymes: creatine phosphokinase (muscle function), lipase and/or amylase (pancreatic function), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (liver function)
• elevated creatinine level (renal function)
• elevated blood sugar level (known as hyperglycemia)
• low hemoglobin level (necessary for transporting oxygen in the blood)
• low white blood cell count.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging and blister after CAD/EXP. The expiration date is the last day of the month indicated.
• Do not store above 86°F (30°C).
• Store in the original packagingto protect it from moisture.
• Medications should not be disposed of through drains or trash.Ask your pharmacist how to dispose ofthe packaging and medications that you no longerneed.This will help protect the environment.

Composition of Odomzo

• The active ingredient is sonidegib (as phosphate). Each capsule contains 200mg of sonidegib.
• The other components are:

• Filler of the capsule: crospovidone type A, lactose monohydrate (see section 2, “Odomzo contains lactose”), magnesium stearate, poloxamer 188, anhydrous colloidal silica, sodium lauryl sulfate.
• Capsule coating: gelatin, red iron oxide (E172), titanium dioxide (E171).
• Printing ink: black iron oxide (E172), propylene glycol (E1520), shellac.

Appearance of Odomzo and contents of the pack

Odomzo 200mg capsules are opaque and pink. They are printed with “SONIDEGIB 200MG” and “NVR”.

Odomzo is provided in perforated unit dose blisters containing 10x1capsule. It is available in packs of 10 and 30capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu

As part of the Odomzo pregnancy prevention program, all patients will receive:

• Patient leaflet
• Patient reminder card

For additional information, please refer to these documents.