Cotellic 20 mg comprimidos recubiertos con pelicula

Package Insert: Information for the Patient

Cotellic 20Film-Coated Tablets

cobimetinib

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

What is Cotellic

Cotellic is a cancer medication that contains the active ingredient cobimetinib.

How is Cotellic used

Cotellic is used to treat adult patients with a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery.

• It is used in combination with another cancer medication called vemurafenib.
• It can only be used in patients whose cancer has a change (mutation) in a protein called "BRAF". Before starting treatment, your doctor will perform a test for this mutation. This change may cause melanoma to develop.

How Cotellic works

Cotellic acts on a protein called "MEK", which is important for controlling the growth of cancer cells. When Cotellic is used in combination with vemurafenib (which acts on the changed "BRAF" protein), it slows down or stops the growth of your cancer even further.

Do not take Cotellic:

• if you are allergic to cobimetinib or any of the other ingredients in this medication (listed in section6).

If you have any doubts, consult your doctor, pharmacist, or nurse before taking Cotellic.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Cotellic if you have:

• Bleeding

Cotellic may cause severe bleeding, especially in your brain or stomach(see also “Severe bleeding” in section 4).Inform your doctor immediately if you experience any unusual bleeding or any of the following symptoms: headaches, dizziness, weakness, blood in your stool or black stools, and vomiting with blood.

• Visual problems

Cotellic may cause visual problems(see also “Visual problems” in section 4).Inform your doctor immediately if you experience any of the following symptoms: blurry, distorted, or partially impaired vision, or any other change in your vision during treatment. Your doctor should examine your eyes if you experience any new visual problems or worsening of existing ones while taking Cotellic.

• Cardiac problems

Cotellic may decrease the amount of blood pumped by your heart(see also “Cardiac problems” in section4).Your doctor should perform tests before and during Cotellic treatment to ensure your heart can pump blood properly. Inform your doctor immediately if you experience any of the following symptoms: rapid, irregular, or pounding heartbeat, dizziness, lightheadedness, shortness of breath, fatigue, or swelling in your legs.

• Liver problems

Cotellic may increase the levels of certain liver enzymes in your blood during treatment. Your doctor will perform blood tests to monitor these levels and ensure your liver is functioning properly.

• Muscle problems

Cotellic may cause elevated levels of creatine phosphokinase, an enzyme primarily found in muscle, heart, and brain. This may be a sign of muscle damage (rhabdomyolysis)(see also “Muscle problems” in section 4).Your doctor will perform blood tests to monitor this. Inform your doctor immediately if you experience any of the following symptoms: muscle pain, muscle spasms, weakness, dark or reddish urine.

• Diarrea

Inform your doctor immediately if you experience diarrhea. Severe diarrhea can cause dehydration. Follow your doctor's instructions on how to prevent or treat diarrhea.

Children and adolescents

Cotellic is not recommended for children and adolescents. The efficacy and safety of Cotellic have not been established in children under 18years.

Other medications and Cotellic

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because Cotellic may affect the functioning of other medications. Other medications may also affect the functioning of Cotellic.

Consult your doctor before taking Cotellic if you are taking:

Use of Cotellic with food and drinks

Avoid taking Cotellic with grapefruit juice. This is because it may increase the levels of Cotellic in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• Cotellic is not recommended during pregnancy. Although the effects of Cotellic on pregnant women have not been studied, it may cause permanent damage or congenital defects in the fetus.
• If you become pregnant during Cotellic treatment or within 3months after your last dose, inform your doctor immediately.
• The safety of Cotellic during breastfeeding is unknown. If you are breastfeeding, your doctor will inform you of the benefits and risks of taking Cotellic.

Contraceptives

Women of childbearing age should use two effective contraceptive methods, such as a condom or another barrier method (with spermicide, if possible) during treatment and for at least 3months after treatment. Consult your doctor about the best contraceptive method for you.

Driving and operating machinery

Cotellic may affect your ability to drive or operate machinery. Avoid driving or operating machinery if you experience any visual problems or other issues that may affect your ability, e.g., if you feel dizzy or tired. Consult your doctor if you are unsure.

Cotellic contains lactose and sodium

Cotellic tablets contain lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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.

How much to take

The recommended dose is 3tablets (a total of 60mg) once a day.

• Take the tablets every day for 21days (what is called a "treatment period").
• After 21days, do not take any Cotellic tablets for 7days. During this 7day pause in Cotellic treatment, you must continue taking vemurafenib as instructed by your doctor.
• Start your 21day treatment period with Cotellic after the 7day pause.
• If you experience any adverse effect, your doctor may consider reducing the dose, interrupting treatment temporarily or permanently.Follow exactly the administration instructions for Cotellic as indicated by your doctor.

Medication intake

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

If you feel nauseous

If you feel nauseous (vomit) after taking Cotellic, do not take an additional dose of Cotellic that day. Continue taking Cotellic normally the next day.

If you take more Cotellic than you should

If you take more Cotellic than you should, inform your doctor immediately. Bring the medication packaging and this leaflet with you.

If you forget to take Cotellic

• If more than 12 hours remain until the next dose, take the missed dose as soon as you remember.
• If less than 12 hours remain until the next dose, skip the missed dose and continue taking Cotellic according to the usual schedule.
• Do not take a double dose to compensate for the missed dose.

If you interrupt Cotellic treatment

It is essential to take Cotellic during the prescribed treatment period.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, your doctor may consider reducing the dose, temporarily or permanently stopping treatment.

Also see the vemurafenib prospect, which is used in combination with Cotellic.

Severe side effects

Inform your doctor immediately if you experience any of the following side effects or if any of these worsen during treatment.

Severe bleeding(frequent: may affect up to 1 in 10 people)

Cotellic may cause severe bleeding, especially in the brain or stomach.

Depending on the bleeding area, symptoms may include:

• headaches, dizziness, or weakness
• vomiting with blood
• abdominal pain
• stools that are red or black.

Visual problems(very frequent: may affect more than 1 in 10 people)

Cotellic may cause visual problems. Some of these visual problems may lead to "serous retinopathy" (fluid accumulation under the retina of the eye). Symptoms of serous retinopathy include:

• blurred vision
• distorted vision
• partial vision loss
• any other change in vision.

Cardiac problems(frequent: may affect up to 1 in 10 people)

Cotellic may decrease the amount of blood pumped by the heart. Symptoms may include:

• sensation of dizziness
• sensation of fainting
• sensation of shortness of breath
• sensation of fatigue
• sensation of irregular heartbeat, rapid, or vibrating heartbeat
• swelling in the legs.

Muscle problems(rare: may affect up to 1 in 100 people)

Cotellic may increase the level of an enzyme in your blood (creatine phosphokinase), which is found in muscles. This may be a sign of muscle damage (rhabdomyolysis). Symptoms may include:

• muscle pain
• muscle spasms and weakness
• ordark or reddish-colored urine.

Dyspepsia(very frequent: may affect more than 1 in 10 people)

Inform your doctor immediately if you have diarrhea and follow your doctor's instructions to know what to do to help prevent or treat diarrhea.

Other side effects

Inform your doctor, pharmacist, or nurse if you experience any of the following side effects:

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

• increased skin sensitivity to sunlight
• skin rash
• sensation of dizziness (nausea)
• fever
• chills
• increase in liver enzymes (shown in blood tests)
• alterations in blood test results related to creatine phosphokinase, an enzyme mainly found in the heart, brain, and skeletal muscle.
• vomiting
• skin rash with a flat, discolored, or bumpy area like acne
• high blood pressure
• anemia (low red blood cell count in blood)
• bleeding
• abnormal skin thickening
• generalized swelling in the legs (peripheral edema)
• itching or dryness in the skin
• mouth pain or ulcers, inflammation of mucous membranes (stomatitis)

Frequent(may affect up to 1 in 10 people)

• some types of skin cancer such as basal cell carcinoma, squamous cell carcinoma, and keratoacanthoma
• dehydration, a condition in which your body does not have as much fluid as it should
• decrease in phosphate and sodium levels (shown in blood tests)
• increase in blood sugar levels (shown in blood tests)
• increase in a liver pigment (called bilirubin) in the blood. Symptoms include yellowing of the skin and eyes
• inflammation of the lungs that may cause difficulty breathing and may be fatal (called "pneumonitis").

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a side effect that does not appear in this prospectus. You can also report them directly through theAppendix Vnational notification system included in the

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the blister and box after CAD. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.
• Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cotellic

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

Appearance of Cotellic and contents of the pack

Cotellic film-coated tablets are white, round and have the inscription "COB" engraved on one face. There is one pack size available: 63 tablets (3 blisters of 21 tablets).

Responsible for manufacturing

Roche Pharma AG

Emil-Barell-Strasse 1

79639

Grenzach-Wyhlen

Germany

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:

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.