Cotelllic

Package leaflet: Information for the patient

Cotellic 20 mg film-coated tablets

cobimetinib
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Cotellic is and what it is used for

What Cotellic is
Cotellic is an anticancer medicine that contains the active substance cobimetinib.
What Cotellic is used for
Cotellic is used to treat adult patients with a type of skin cancer called melanoma, which has
spread to other parts of the body or cannot be removed by surgery.

• It is used in combination with another anticancer medicine known as vemurafenib.
• It can only be used in patients whose tumour has a specific change (mutation) in a protein called “BRAF”. Before starting treatment, your doctor will perform a test for this mutation. This change may have contributed to the development of the melanoma.

How Cotellic works
Cotellic targets a protein called “MEK”, which plays an important role in controlling the growth of
cancer cells. Using Cotellic in combination with vemurafenib (which targets the mutated “BRAF” protein) further slows down or stops the growth of the tumour.

2. What you should know before taking Cotellic

Do not take Cotellic:

• if you are allergic to cobimetinib or to any of the other ingredients of this medicine (listed in section 6). If you are unsure, consult your doctor, pharmacist, or nurse before taking Cotellic.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Cotellic if you have:

• Bleeding Cotellic can cause serious bleeding, especially in the brain or stomach (see also "Severe bleeding" in section 4). Immediately inform your doctor if you experience unusual bleeding or any of the following symptoms: headache, dizziness, feeling weak, blood in your stools or black stools, or vomiting blood.
• Eye problems Cotellic can cause eye problems (see also "Eye problems" in section 4). Immediately inform your doctor if you develop any of the following symptoms: blurred vision, distorted vision, partial loss of vision, or any other changes in vision during treatment. Your doctor should perform an eye examination if you develop new vision problems or if existing ones worsen during treatment with Cotellic.
• Heart problems Cotellic may reduce the amount of blood pumped by the heart (see also "Heart problems" in section 4). Your doctor will perform certain tests before and during treatment with Cotellic to monitor how well your heart is pumping blood. Immediately inform your doctor if you experience palpitations, a faster or irregular heartbeat, or if you develop dizziness, lightheadedness, shortness of breath, fatigue, or swollen legs.
• Liver problems Cotellic may increase the levels of certain liver enzymes in the blood during treatment. Your doctor will perform blood tests to monitor liver function.
• Muscle problems Cotellic may increase levels of creatine phosphokinase, an enzyme found mainly in muscles, the heart, and the brain. This effect may be a sign of muscle damage (rhabdomyolysis) (see also "Muscle problems" in section 4). Your doctor will perform blood tests to monitor this increase. Immediately inform your doctor if you experience any of the following symptoms: muscle pain, muscle spasms, weakness, or dark or reddish urine.
• Diarrhea Immediately inform your doctor if you develop diarrhea. Severe diarrhea may lead to fluid loss (dehydration). Follow your doctor's instructions on how to help prevent or treat diarrhea.

Children and adolescents
Cotellic must not be given to children or adolescents. The safety and efficacy of Cotellic have not been established in individuals under 18 years of age.
Other medicines and Cotellic
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Cotellic may affect the action of certain medicines. In addition, other medicines may interfere with the action of Cotellic.
Consult your doctor before taking Cotellic if you are taking:

Cotellic with food and beverages
Avoid taking Cotellic with grapefruit juice, as this may increase the amount of Cotellic in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

• The use of Cotellic is not recommended during pregnancy. Although the effects of Cotellic have not been studied in pregnant women, the medicine could cause permanent harm to the fetus or congenital defects.
• If you become pregnant during treatment with Cotellic or within 3 months after the last dose, inform your doctor immediately.
• It is not known whether Cotellic is excreted in breast milk. If you are breastfeeding, your doctor will discuss with you the benefits and risks associated with taking Cotellic.

Contraception
Women of childbearing potential must use two effective contraceptive methods, such as a condom or another barrier method (with spermicide, if available), during treatment and for at least 3 months after completion of treatment. Ask your doctor which contraceptive method is best for you.

Driving and using machines
Cotellic may affect your ability to drive or operate machinery. Avoid driving or operating machinery if you experience vision problems or other symptoms that could impair your abilities, such as dizziness or fatigue. Consult your doctor if you have any concerns.

Cotellic contains lactose and sodium
The tablets contain lactose (a type of sugar). If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.

3. How to take Cotellic

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
How much medicine to take
The recommended dose is 3 tablets (totaling 60 mg) once daily.

• Take the tablets every day for 21 days (a "treatment cycle").
• After the 21 days, do not take any Cotellic tablets for 7 days. During these 7 days of treatment break with Cotellic, continue taking vemurafenib as instructed by your doctor.
• After the 7-day break, start the next 21-day treatment cycle with Cotellic.
• If you experience any adverse effects, your doctor may decide to reduce the dose, temporarily interrupt or permanently discontinue treatment. Always take Cotellic exactly as instructed by your doctor or pharmacist.

How to take the medicine

• Swallow the tablets whole with water.
• Cotellic may be taken with or without food.

In case of vomiting
If you vomit after taking Cotellic, do not take an additional dose of the
medicine on the same day. Continue taking Cotellic as usual the next day.
If you take more Cotellic than you should
If you take more Cotellic than prescribed, contact your doctor immediately. Bring the medicine pack and this patient information leaflet with you.
If you forget to take Cotellic

• If more than 12 hours remain before your next scheduled dose, take the missed dose as soon as you remember.
• If less than 12 hours remain before your next scheduled dose, skip the missed dose. Then take your next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Cotellic
It is important that you continue taking Cotellic for as long as your doctor prescribes it.
If you have any questions about using this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you experience any side effects, your doctor may decide to reduce the dose, or to temporarily or permanently stop treatment.
See also the vemurafenib patient information leaflet, which is used in combination with Cotellic.

Serious side effects
Contact your doctor immediately if you notice any of the following side effects listed below, or if they worsen during treatment.

Severe bleeding (common: may affect up to 1 in 10 people)
Cotellic can cause severe bleeding, especially in the brain or stomach. Depending on the site of bleeding, symptoms may include:

• headache, dizziness or weakness
• vomiting blood
• abdominal pain
• stools that are red or black in colour

Eye problems (vision) (very common: may affect more than 1 in 10 people)
Cotellic can cause eye problems. Some of these eye problems may be due to a condition called "serous retinopathy" (fluid accumulation beneath the retina of the eye).
Symptoms of serous retinopathy include:

• blurred vision
• distorted vision
• partial loss of vision
• any other changes in vision

Heart problems (common: may affect up to 1 in 10 people)
Cotellic can reduce the amount of blood pumped by the heart. Symptoms may include:

• feeling dizzy
• feeling lightheaded
• shortness of breath
• feeling tired
• palpitations, fast or irregular heartbeat
• swollen legs

Muscle problems (uncommon: may affect up to 1 in 100 people)
Cotellic may cause muscle damage (rhabdomyolysis). Symptoms may include:

• muscle pain
• muscle spasms and weakness
• dark or reddish urine

Diarrhoea (very common: may affect more than 1 in 10 people)
Contact your doctor immediately if you develop diarrhoea and follow your doctor’s instructions on what to do to help prevent or treat it.

Other side effects
If you notice any of the following side effects, inform your doctor, pharmacist or nurse:

Very common (may affect more than 1 in 10 people)

• increased skin sensitivity to sunlight
• rash
• feeling unwell (nausea)
• fever
• chills
• increased liver enzymes (detected by blood tests)
• abnormal blood test results for creatine phosphokinase, an enzyme mainly found in the heart, brain and skeletal muscle
• vomiting
• skin rash with smooth areas showing colour changes or raised acne-like bumps
• high blood pressure
• anaemia (low red blood cell levels)
• bleeding
• abnormal thickening of the skin
• swelling, usually in the legs (peripheral oedema)
• pimpled or dry skin
• sore mouth or mouth ulcers, inflammation of mucous membranes (stomatitis)

Common (may affect up to 1 in 10 people)

• certain types of skin tumours such as basal cell carcinoma, cutaneous squamous cell carcinoma and keratoacanthoma
• dehydration, which means having insufficient fluid in the body
• decreased levels of phosphate or sodium (detected by blood tests)
• increased levels of sugar (detected by blood tests)
• increased levels of a pigment produced by the liver (called "bilirubin") in the blood. Signs include yellowing of the skin or eyes
• lung inflammation that may cause breathing difficulties and can be potentially life-threatening (called "pneumonitis")

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cotellic

• 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 carton and blister after EXP/Scad. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cotellic contains

• The active substance is cobimetinib. Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg of cobimetinib.
• The other components are (see section 2 "Cotellic contains lactose and sodium"):
• in the tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate; and
• in the coating film: polyvinyl alcohol, titanium dioxide, macrogol, and talc.

Description of the appearance of Cotellic and package contents
White, round, film-coated tablets with the imprint “COB” on one side. Available in the following pack size: 63 tablets (3 blisters of 21 tablets).
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
Grenzach-Wyhlen
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799
България Luxembourg/Luxemburg
Рош България ЕООД (See/siehe Belgique/Belgien)
Тел: +359 2 818 44 44
Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 1 279 4500
Danmark Malta
Roche Pharmaceuticals A/S (see Ireland)
Tlf: +45 - 36 39 99 99
Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050
Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00
Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739
España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88
France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00
Hrvatska România
Roche d.o.o. Roche România S.R.L.
Tel: +385 1 4722 333 Tel: +40 21 206 47 01
Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00
Ísland Slovenská republika
Roche Pharmaceuticals A/S Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000
Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500
Kύπρος Sverige
Γ.Α.Σταμάτης & Σια Λτδ. Roche AB
Τηλ: +357 - 22 76 62 76 Tel: +46 (0) 8 726 1200
Latvija United Kingdom (Northern Ireland)
Roche Latvija SIA Roche Products (Ireland) Ltd.
Tel: +371 - 6 7039831 Tel: +44 (0) 1707 366000
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.