InfoCons Consumer Protection informs you – Odomzo – Package Leaflet

Before anything else

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 possible side effects not list ed in this leaflet. See section 4.

ℹ️ 1. What Odomzo is and what it is used for

What Odomzo is Odomzo contains the active substance sonidegib. It is an anti -cancer medicine.

What Odomzo is 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 locally and cannot be treated with surgery or radiation.

How Odomzo works

The normal growth of cells is controlled by various che mical signals. In patients with basal cell carcinoma, changes occur to genes controlling a part of this process known as the “hedgehog pathway”. This switches on signals that make the cancer cells grow out of control. Odomzo works by blocking this process, stopping cancer cells from growing and making new cells.

⚠️ 2. What you need to know before you take Odomzo

Read the specific instructions given to you by your doctor, particularly on the effects of Odomzo on unborn babies.

Read carefully and follow the instructions of the patient brochure and reminder card given to you by your doctor.

31 Do not take Odomzo

• if you are allergic to sonidegib or any of the other ingredients of this medicine (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 unborn baby (see section “ Pregnancy ”).
• if you are breast -feeding. This is because it is not known whether Odomzo can pass into your breast milk and cause harm to your baby (see section “Breast -feeding ”).
• if you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the Odomzo Pregnancy Prevention Programme.

Do not take Odomzo if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Odomzo.

Additional information on the above points can be found in the sections “Pregnancy ”, “Breast -feeding ”, “Fertility” and “Contraception for women and men” .

Warnings and precautions

• Odomzo ma y cause muscle problems. Tell your doctor before taking Odomzo if you have a history of muscle cramps or weakness or if you are taking other medicines. Some medicines (e.g. medicines used to treat high cholesterol) might increase the risk for muscle problems. Tell your doctor or pharmacist immediately if your muscles hurt or you have unexplained muscle cramps or weakness during treatment with Odomzo. Your doctor may need to change your dose, or stop your treatment temporarily or permanently .
• You should not donate blood while on treatment with Odomzo and for 20 months after ending your treatment.
• If you are male, you should not donate semen at any time during treatment and for 6 months after the final dose.
• Your doctor will check your skin regularly for another type of cancer called cutaneous squamous cell carcinoma (SCC). It is not known whether SCC can be related to treatment with Odomzo. Usually this type of cancer appears on sun- damaged skin, does not spread and can be cured. Tell your doctor if you notice any changes in your skin.
• Never give this medicine to anyone else. You should return unused capsules at the end of your treatment. Talk to your doctor or pharmacist regarding where to return the capsules.

Blood tests during treatment with Odomzo Your doctor will perform blood tests before treatment , and possibly during treatment as well . 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 below the age of 18. Problems with growing teeth and bones were seen with this medicine. Odomzo may cause bones to stop growing in children and adolescents. This can also happen after discontinuation of the treatment.

Other medicines and Odomzo

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Odomzo can affect the way some medicines work. Some other medicines can also affect how Odomzo works, or make it more likely that you will have side effects.

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

• medicines such as statins and fibric acid derivatives used to treat high cholesterol and lipids
• vitamin B3 , also known as niacin
• medicines such as methotrexate, mitoxantrone, irinotecan, or topotecan used to treat certain types of cancers or other diseases such as severe joint problems (rheumatoid arthritis) and psoriasis
• medicines such as telithromycin, rifampi cin or rifabutin used to treat bacterial infections
• medicines such as ketoconazole (not inc luding shampoos and creams), itraconazole, posaconazole or voriconazole used to treat fungal infections 32 • medicines such as chloroquine and hydroxychloroquine used to treat parasitic infections as well as other diseases such as rheumatoid arthritis or lupus erythematosus
• medicines such as ritonavir, saquinavir or zidovudine used to treat AIDS or HIV
• medicines such as carbamazepine, phenytoin or phenobarbital used to treat acute seizures
• a medicine called nefazodone used to treat depression
• a medicine called p enicillamine used to treat rheumatoid arthritis
• a herbal medicine called St. John’s wort ( also known as Hypericum perforatum ) used to treat depression.

If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking Odomzo.

These medicines should be used with caution or may need to be avoided during your treatment with Odomzo. If you are taking any of these, your doctor might need to prescribe an alternative medicine for you.

During your treatment with Odomzo, you s hould also tell your doctor or pharmacist if you are prescribed another medicine that you were not taking before .

Pregnancy

Do not take Odomzo if you are pregnant, think you may be pregnant, or are planning to become pregnant during your treatment or duri ng the 20 months after your treatment has finished. You must stop taking Odomzo and talk to your doctor immediately if you become pregnant or suspect you could be pregnant. Odomzo may cause your baby to have severe birth defects or lead to the death of you r unborn baby. Specific instructions (the Odomzo Pregnancy Prevention Programme) given to you by your doctor contain information particularly on the effects of Odomzo on unborn babies .

Breast -feeding Do not breast -feed during your treatment or during the 20 months after your treatment has finished. It is not known whether Odomzo can pass into your breast milk and cause harm to your baby.

Fertility

Odomzo may have an impact on fertility in men and women. Talk to your doctor if you plan to have children in the future.

Contraception for women and men Women Before starting Odomzo treatment, ask your doctor if you are able to become pregnant , even if your periods have stopped (menopause) . It is important to check with your doctor whether there is a risk that you could become pregnant.

If you are able to become pregnant:

• you must take precautions so that you do not become pregnant while taking Odomzo,
• you must use 2 methods of contraception, one highly effective method and one barrier method (see the examples below) while you are taking Odomzo,
• you must keep using this contraception for 20 months after you have stopped taking Odomzo because traces of the medicine remain in the body for a long time .

Your doctor will discuss with you the best method of contraception for you.

You must use one highly effective method, such as:

• an intra -uterine device (“the coil” or IUD)
• surgical sterilisation.

You must also use one barrier method, such as:

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

Your doctor will test you for pregnancy:

• at least 7 days before starting treatment – to make sure that you are not already pregnant 33 • every month during treatment.

During treatment and during the 20 months after your treatment has finished , tell your doctor straight away if:

• you think your contraception has not worked for any reason
• your periods stop
• you stop using contraception
• you need to change contraception Men While you are taking Odomzo, always use a condom (with spermicide, if available) when you have sex with a female partner, even if you have had a vasectomy. You must keep doing this for 6 months after your treatment has finished.

Tell your doctor straight away if your partner becomes pregnant while you are taking Odomzo and for 6 months after your treatment has finished.

You should not donate semen during your treatment and for 6 months after your treatment has finished .

Driving and using machines

Odomzo is not likely to affect your ability to drive or use any tools or machines. Talk to your doctor if you are un sure.

Odomzo contains lactose

Odomzo contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine .

💊 3. How to take Odomzo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine The recommended dose is 200 mg (1 capsule) a day.

• Do not eat for 2 hours before taking Odomzo and for 1 hour after wards .
• Take your capsule at about the same time each day. This will help you to remember when to take your medicine.
• Swallow the capsule whole. Do not open, chew or crush the capsule. Any contact with the content of the capsules should be avoided, as it may have harmful effects.

Do not change your dose without talking to your doctor. Do not exceed the recommended dose prescribed by your doctor. If you vomit after you swallow the capsule, do not take any more capsules until your next scheduled dose.

How long to take Odomzo Keep taking Odomzo for as long as your doctor tells you. If you have questions about how long to take Odomzo, talk to 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 medicine, talk to a doctor or go to a hospital straight away . Take the medicine and its packaging and leaflet with you.

If you forget to take Odomzo

If you forget to take a dose of Odomzo, take i t as soon you reali se. If more than six hours have passed since the dose was due to be taken, skip the missed dose, then take the next dose at the scheduled time. Do not take 34 a double dose to make up for a forgotten dose.

If you stop taking Odomzo

Do not stop taking Odomzo without talking to your doctor first.

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.

Odomzo may cause severe birth defects, Y ou must not become pregnant while taking this medicine (see “Pregnancy ”, “Breast -feeding ”, “F ertility” and “Contraception for women and men” in section 2 for more information) .

Stop taking Odomzo and tell your doctor straight away if you notice any of the following as these could be signs of an allergic reaction:

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

Some side effects could be serious Tell your doctor or pharmacist straight away if you notice any of the following:

• severe muscle cramps, muscle pain or muscle weakness. These could be signs of a problem called rhabdomyolysis, which involves the breakdown of muscle tissue .
• dark urine, decreased urine output or no urine output. These could be signs that your m uscle fibre is breaking down, which is harmful to your kidneys.

Other possible side effects If any of these side effects become severe, tell your doctor or pharmacist.

Very common: may affect more than 1 in 10 people

• muscle cramps, muscle pain, pain in the bones, ligaments and tendons
• absence of menstrual periods
• diarrhoea or heartburn
• decreased appetite
• headache
• disturbed sense of taste or strange taste in the mouth
• pain in the belly
• feeling sick
• vomiting
• itching
• hair loss
• tiredness
• pain
• weight loss .

Common: may affect up to 1 in 10 people

• upset stomach or indigestion
• constipation
• rash
• abnormal hair growth
• thirst, not passing much urine , weight loss, dry flushed skin, irritability (possible symptoms of low level of fluids in the body , known as dehydration) .

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

• high levels of the following enzymes: creatine phosphokina se (muscle function), lipase and/or amylase (pancreas function), alanine aminotransferase (ALT) and/or aspartat e aminotransferase (AST) (liver function)
• high level of creatinine (kidney function)
• high level of sugar in the blood (known as hyperglycaemia)
• low level of haemoglobin (needed to transport oxygen in the blood)
• low level of white blood cells.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Odomzo

• 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 pack and the 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 in order to protect from moisture .
• 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.

📦 6. Contents of the pack and other information

What Odomzo contains

• The active substance is sonidegib (as phosphate). Each capsule contains 200 mg sonidegib.
• The other ingredients are:
• Capsule contents: crospovidone type A , lactose monohydrate (see section 2, ‘ Odomzo contains lactose ’), magnesium stearate, poloxamer 188, silica, colloidal anhydrous, sodium laurilsulfate.
• Capsule shell: gelatin, iron oxide red (E172), titanium dioxide (E171).
• Printing ink: iron oxide black (E172), propylene glycol (E1520) , shellac.

What Odomzo looks like and contents of the pack

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

Odomzo is provided in perforated u nit-dose blisters containing 10 x 1 capsule. It is available in pack sizes of 10 and 30 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87 2132JH Hoofddorp Netherlands 36 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Sun Pharmaceutical Industries Europe B.V.

Tél/Tel: +31 23 568 55 01 Lietuva Sun Pharmaceutical Industries Europe B.V.

Tel: +31 23 568 55 01 България Sun Pharmaceutical Industries Europe B.V.

Тел: +31 23 568 55 01 Luxembourg/Luxemburg Sun Pharmaceutical Industries Europe B.V.

Tél/Tel: +31 23 568 55 01 Česká republika Sun Pharmaceutical Industries Europe B.V.

Tel: +31 23 568 55 01 Magyarország Sun Pharmaceutical Industries Europe B.V.

Tel.: +31 23 568 55 01 Danmark Sun Pharmaceutical Industries Europe B.V.

Tlf: +31 23 568 55 01 Malta Sun Pharmaceutical Industries Europe B.V.

Tel: +31 23 568 55 01 Deutschland Sun Pharmaceuticals Germany GmbH Tel: +49 21 440 39 90 E-mail: [email protected] Nederland Sun Pharmaceutical Industries Europe B.V.

Tel: +31 23 568 55 01 Eesti Sun Pharmaceutical Industries Europe B.V.

Tel: +31 23 568 55 01 Norge Sun Pharmaceutical Industries Europe B.V.

Tlf: +31 23 568 55 01 Ελλάδα Sun Pharmaceutical Industries Europe B.V.

Τηλ: +31 23 568 55 01 Österreich Astro -Pharma GmbH Tel: +43 (1) 97 99 860 España Sun Pharma Laboratorios S.L.

Tel: +34 93 342 78 90 Polska Ranbaxy (Poland) Tel.: +48 22 642 07 75 France Sun Pharma France Tél:+33 1 41 44 44 50 Portugal Sun Pharmaceutical Industries Europe B.V.

Tel: +31 23 568 55 01 Hrvatska Sun Pharmaceutical Industries Europe B.V.

Tel.: +31 23 568 55 01 România Terapia S.A.

Tel:+40 264 50 15 00 Ireland Sun Pharmaceutical Industries Europe B.V.

Tel: +31 23 568 55 01 Slovenija Sun Pharmaceutical Industries Europe B.V.

Tel: +31 23 568 55 01 Ísland Sun Pharmaceutical Industries Europe B.V.

Sími : +31 23 568 55 01 Slovenská republika Sun Pharmaceutical Industries Europe B.V.

Tel: +31 23 568 55 01 Italia Sun Pharma Italia S.r.l.

Tel: +39 02 33 49 07 93 Suomi/Finland Sun Pharmaceutical Industries Europe B.V.

Puh/Tel: +31 23 568 55 01 37 Κύπρος Sun Pharmaceutical Industries Europe B.V.

Τηλ: +31 23 568 55 01 Sverige Sun Pharmaceutical Industries Europe B.V.

Tel: +31 23 568 55 01 Latvija Sun Pharmaceutical Industries Europe B.V.

Tel: +31 23 568 55 01 United Kingdom (Northern Ireland) Ranbaxy UK Ltd Tel: +44 (0) 208 848 8688

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu As part of the Odomzo Pregnancy Prevention Programme, all patients will receive a:

• Patient Brochure
• Patient Reminder Card Please refer to these documents for further information.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Odomzo (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/15/1030).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.