ODOMZO 200 mg HARD CAPSULES

2. What you need to know before taking Odomzo

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 reminder card provided by your doctor.

Do not take Odomzo

• if you are allergic to sonidegib or any of the other components of 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 "Pregnancy" section).
• if you are breastfeeding. This is because it is unknown if Odomzo can pass into breast milk and cause harm to the newborn (see "Breastfeeding" section).
• if you can 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 on the above points can be found in the "Pregnancy", "Breastfeeding", "Fertility", and "Contraception in Women and Men" sections.

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 immediately if your muscles hurt or if you experience muscle cramps or unexplained weakness during treatment with Odomzo. Your doctor may need to change your dose or interrupt your treatment temporarily or permanently.
• You should not donate blood while being treated with Odomzo or for 20 months after treatment ends.
• If you are male, you should not donate semen at any time during treatment or for 6 months after the last dose.
• Your doctor will regularly check your skin for another type of cancer called squamous cell carcinoma (SCC). It is unknown if SCC is related to treatment with Odomzo. This type of cancer usually 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 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 measuring 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 growing bones have been observed with this medication. Odomzo may cause bones to stop growing in children and adolescents. This can also occur after treatment is stopped.

Taking Odomzo with Other Medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This includes medications obtained without a prescription and herbal medications. This is because Odomzo may affect the functioning of other medications. Similarly, some medications may affect the functioning of Odomzo or make it more likely for you to experience side effects.

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

• medications, such as statins and fibric acid derivatives, 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 diseases like severe joint problems (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 and hydroxychloroquine, used to treat parasitic infections, as well as other diseases like rheumatoid arthritis or lupus erythematosus
• medications, such as ritonavir, saquinavir, or zidovudine, used to treat AIDS or HIV
• 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 joint problems (rheumatoid arthritis)
• a herbal remedy 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 interrupted during your treatment with Odomzo. If you are taking any of them, your doctor may need to prescribe an alternative medication.

During your treatment with Odomzo, 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 treatment ends. You must stop treatment with Odomzo and inform your doctor immediately if you become pregnant or suspect you may be pregnant. Odomzo may cause serious birth defects 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 treatment ends. It is unknown if Odomzo can pass into breast milk and cause harm to the newborn.

Fertility

Odomzo may affect 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 can 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 can become pregnant:

• you must take precautions to avoid becoming pregnant while taking Odomzo,
• you must use 2 contraceptive methods, a 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 stopping treatment with Odomzo, as 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:

• an 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 pregnant
• every month during treatment.

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

• you think your contraceptive method has not worked 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 sexual intercourse with a female partner, even if you have had a vasectomy. You must continue to use a condom for 6 months after treatment ends.

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

You should not donate semen during treatment or for 6 months after treatment ends.

Driving and Using Machines

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

Odomzo ContainsLactose

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

3. How to Take Odomzo

Follow the exact instructions for administering this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Taking this Medication

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

• Do not eat for 2 hours before taking Odomzo or for 1 hour 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 they may have harmful effects.

Do not change your dose without discussing it with 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.

How Long to Take Odomzo

Continue taking Odomzo for the time indicated by your doctor. If you have doubts about how long to 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, its packaging, and the package 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 6 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 missed doses.

If You Stop Treatment with Odomzo

Do not stop treatment with Odomzo without discussing it with your doctor first.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Odomzo may cause serious birth defects; you should not become pregnant while taking this medication (for more information, see "Pregnancy", "Breastfeeding", "Fertility", and "Contraception in Women and Men" in section 2).

Stop your treatment with Odomzo and inform your doctor immediately 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-colored rash or bumps.

Some Side Effects can be Serious

Inform your doctor or pharmacist immediately if you observe any of the following:

• severe muscle cramps, muscle pain, or muscle weakness. These can be signs of a problem called rhabdomyolysis, which involves the breakdown of muscle tissue.
• dark-colored urine, decreased urine output, or no urine production. These can be signs of muscle breakdown, which can harm the kidneys.

Other Possible Side Effects

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

Very Common:may affect more than 1 in 10 patients

• muscle cramps, muscle pain, bone, ligament, 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
• discomfort
• vomiting
• itching
• hair loss
• fatigue
• pain
• weight loss.

Common:may affect up to 1 in 10 patients

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

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

• high 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)
• high creatinine level (kidney function)
• high blood sugar level (known as hyperglycemia)
• low hemoglobin level (necessary for carrying oxygen in the blood)
• low white blood cell count.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Odomzo

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date stated on the packaging and blister after CAD/EXP. The expiration date is the last day of the month indicated.
• Do not store above 30°C.
• Store in the original packaging to protect from moisture.
• Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Odomzo Composition

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

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

Appearance of Odomzo and Package Contents

The Odomzo 200 mg capsules are opaque and pink in color. They are printed with "SONIDEGIB 200MG" and "NVR".

Odomzo is provided in perforated unit-dose blisters containing 10 x 1 capsule. It is available in packs of 10 and 30 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

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

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: 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, refer to these documents.