ODOMZO 200 mg Hard Capsule

Содержание инструкции

1. Odomzo 200 mg hard capsules
   1. What is Odomzo and what is it used for
   2. What you need to know before taking Odomzo
   3. How to take Odomzo
   4. Possible side effects
   5. How to store Odomzo
   6. Contents of the pack and other information

Odomzo 200 mg hard capsules

sonidegib
Odomzo may cause serious birth defects. It may lead to the death of the baby before
birth or shortly after. You must not become pregnant while taking this medicine. You must
follow the contraception instructions contained in this leaflet.

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Odomzo is and what it is used for
• 2. What you need to know before you take Odomzo
• 3. How to take Odomzo
• 4. Possible side effects
• 5. How to store Odomzo
• 6. Contents of the pack and other information

1. What is Odomzo and what is it used for

What is Odomzo
Odomzo contains the active substance sonidegib. It is an antitumoural medicine.

What is Odomzo used for
Odomzo is used to treat adult patients with a type of skin cancer called basal cell carcinoma.
It is used when the tumour has spread locally and cannot be treated with
surgery or radiotherapy.

How Odomzo works
Normal cell growth is controlled by various chemical signals. In patients with basal cell carcinoma,
changes occur in the genes that control part of this process known
as the "hedgehog pathway". This activates signals that cause tumour cells to grow
uncontrollably. Odomzo works by blocking this process, interrupting the growth and formation
of new cancer cells.

2. What you need to know before taking Odomzo

Read the specific instructions provided by your doctor, particularly regarding the effects of Odomzo on the
fetus.
Read carefully and follow the instructions in the leaflet and the reminder card for the patient that
you received from your doctor.

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 can harm or cause the death of the fetus (see section “Pregnancy”).
• if you are breastfeeding. This is because it is not known whether Odomzo can pass into breast milk and cause harm to the baby (see section “Breastfeeding”).
• if you are of childbearing potential but are unable or unwilling to follow the necessary measures of pregnancy prevention that are listed in the Odomzo Pregnancy Prevention Program. Do not take Odomzo if any of the above conditions apply to you. If you are unsure, ask your doctor or pharmacist before taking Odomzo.

Further information on the points above can be found in the sections “Pregnancy”,
“Breastfeeding”, “Fertility” and “Contraception in women and men”.

Warnings and precautions

• Odomzo can cause muscle problems. Tell your doctor before taking Odomzo if you have had cramps or muscle weakness in the past or if you are taking other medicines. Some medicines (e.g. medicines used for high cholesterol) can increase the risk of muscle problems. Tell your doctor or pharmacist immediatelyif you experience muscle pain or unexplained muscle cramps or muscle weakness while taking Odomzo. Your doctor may need to adjust the dose, or stop treatment permanently or temporarily.
• Do not donate blood during treatment with Odomzo and for 20 months after the end of treatment.
• If you are a man, you should never donate sperm during treatment and for 6 months after taking the last dose.
• Your doctor will regularly check your skin for the appearance of another type of cancer called squamous cell carcinoma (SCC). It is not known whether SCC is related to treatment with Odomzo. Generally, this type of cancer occurs on skin damaged by the sun, 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. Unused capsules at the end of treatment must be returned. Talk to your doctor or pharmacist about where to return the capsules.

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

Children and adolescents (under 18 years)
Odomzo should not be used in children and adolescents under 18 years of age. Problems related to the growth of teeth and bones have been observed. Odomzo may cause the interruption of
bone growth in children and adolescents. This can happen even after stopping the
treatment.

Other medicines and Odomzo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those without a prescription and herbal medicines. This is because Odomzo can affect the way some medicines work, and in turn
some other medicines can affect the action of Odomzo, or increase the likelihood of
side effects.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines such as statins and fibric acid derivatives used for high cholesterol and lipid levels
• vitamin B3, also known as niacin
• medicines, such as methotrexate, mitoxantrone, irinotecan, or topotecan used for the treatment of some types of cancer or other diseases such as severe joint problems (rheumatoid arthritis)

and psoriasis

• medicines such as telithromycin, rifampicin or rifabutin used for the treatment of bacterial infections
• medicines such as ketoconazole (excluding shampoos and creams), itraconazole, posaconazole or voriconazole used for the treatment of fungal infections
• medicines such as chloroquine and hydroxychloroquine used for the treatment of parasitic infections and other diseases such as rheumatoid arthritis or lupus erythematosus
• medicines such as ritonavir, saquinavir or zidovudine used for the treatment of AIDS or HIV
• medicines such as carbamazepine, phenytoin or phenobarbital used for the treatment of seizures
• a medicine called nefazodone used for the treatment of depression
• a medicine called penicillamine used for the treatment of rheumatoid arthritis
• an herbal medicine called St. John's wort (also known as Hypericumperforatum) used for the treatment of depression. If any of these conditions apply to you or if you are unsure, tell your doctor or pharmacist before taking Odomzo.

These medicines should be used with caution or may need to be avoided during treatment
with Odomzo. If you are taking any of these medicines, your doctor may need to prescribe you
an alternative medicine.
During treatment with Odomzo, you must tell your doctor or pharmacist if you have been prescribed
another medicine that you have not already been taking.

Pregnancy
Do not take Odomzo if you are pregnant, if you suspect you may be pregnant or are planning a
pregnancy during treatment or during the 20 months after the end of treatment. You must stop
taking Odomzo and tell your doctor immediately if you become pregnant or suspect you
are. Odomzo can cause serious birth defects or lead to the death of the baby before
birth (fetus). The specific instructions (Odomzo Pregnancy Prevention Program)
that your doctor has given you contain information in particular about the effects of Odomzo on the fetus.

Breastfeeding
Do not breastfeed during treatment or during the 20 months after the end of treatment. It is
not known whether Odomzo can pass into breast milk and cause harm to the baby.

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

Contraception for women and men

Women
Before starting treatment with Odomzo, ask your doctor if you are able to become pregnant, even
if your menstrual cycle has stopped (menopause). It is important to check with your doctor if there is a risk
that you may become pregnant.
If you can become pregnant:

• you must take precautions so as not to become pregnant during treatment with Odomzo,
• you must use 2 methods of contraception, one highly effective and one barrier method (see examples below) while taking Odomzo,
• you must continue this contraception for 20 months after stopping Odomzo because traces of this medicine remain in the body for a long time. Your doctor will discuss with you the best method of contraception.

You should use a highly effective method, such as:

• an intrauterine device (“coil” or IUD)
• surgical sterilization.

You should also 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 make sure you are not already pregnant
• every month during treatment.

During treatment and during the 20 months after the end of treatment, tell your doctor immediately if:

• you think, for any reason, that the contraceptive method has failed
• your menstrual cycle has stopped
• you have stopped using contraceptive methods
• you need to change your contraceptive method

Men
While taking Odomzo, always use a condom (with spermicide, if available)
during sexual intercourse with a female partner, even if you have had a vasectomy. You must
continue to use it for 6 months after the end of treatment.
Tell your doctor immediately if your partner becomes pregnant while you are taking Odomzo
and within 6 months after the end of treatment.
You should not donate semen during treatment and within 6 months after the end of
treatment.

Driving and using machines
It is unlikely that Odomzo will affect your ability to drive and use machines. Tell your
doctor if you have any doubts.

Odomzo contains lactose
Odomzo contains lactose (milk sugar). If your doctor has diagnosed you with intolerance to
some sugars, contact him before taking this medicine.

3. How to take Odomzo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

How to take this medicine
The recommended dose is 200 mg (1 capsule) per day.

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

Do not change the 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 any more capsules until your next
scheduled dose.

How long to take Odomzo
Continue to take Odomzo for as long as your doctor tells you. If you have any doubts about how long to
take Odomzo, ask 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,
contact a doctor or go to a hospital immediately. Take the medicine and its packaging 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 were supposed to take it, skip the dose and take the next one at the
scheduled time. Do not take a double dose to make up for a missed dose.

If you stop taking Odomzo
Do not stop taking Odomzo without first consulting your doctor.
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 can cause serious birth defects. You must not become pregnant while taking this medicine (see “Pregnancy”, “Breast-feeding”, “Fertility” and “Contraception for women and
men” in section 2 for further information).
Stop taking Odomzo and tell your doctor immediately if you notice any of the following
side effects which may 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 bumps.

Some side effects can be serious
Tell your doctor or pharmacist immediately if you experience any of the following side
effects:

• severe muscle cramps, muscle pain or muscle weakness. These may be signs of a condition called rhabdomyolysis, which involves the breakdown of muscle tissue.
• dark urine, decreased or no urine output. These may be signs that muscle fibres are breaking down, a condition harmful to the 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, bone, ligament and tendon pain
• absence of menstrual periods
• diarrhoea or heartburn
• decreased appetite
• headache
• taste disturbance or strange taste in the mouth
• abdominal pain
• feeling unwell
• vomiting
• itching
• hair loss
• fatigue
• pain
• weight loss.

Common:may affect up to 1 in 10 people

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

During treatment with Odomzo, you may also have some abnormal blood test resultsthat can alert the doctor to possible functional changes in some parts of the 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 levels of creatinine (kidney function)
• high levels of sugar in the blood (known as hyperglycemia)
• low levels of hemoglobin (needed to carry oxygen in the blood)
• low levels of white blood cells in the blood.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through
the reporting system mentioned in Annex V. By reporting side effects you can help to 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 that is stated on the box and on the blister after “EXP”/“Scad”. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.
• Store in the original package to protect the medicine from moisture.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This 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 of sonidegib.
• The other ingredients are:
• Capsule contents: crospovidone type A, lactose monohydrate (see section 2, “Odomzo contains lactose”), magnesium stearate, poloxamer 188, anhydrous colloidal silicon dioxide, sodium lauryl sulfate.
• Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171).
• Printing ink: black iron oxide (E172), propylene glycol (E1520), shellac glaze.

Description of the appearance of Odomzo and contents of the pack
Odomzo 200 mg capsules are pink and opaque, with the inscription “SONIDEGIB 200MG” and
“NVR” imprinted on them.
Odomzo is supplied in divisible blister packs containing 10 x 1 capsule. It is available in
packs 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
For further information on this medicine, 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

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

Other sources of information
More detailed information on this medicine 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 any information, please refer to these documents.