20 mg film-coated tablets 
cobimetinib

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

1. What Cotellic is and what it is used for

What Cotellic is 
Cotellic is a cancer 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 anti-cancer medicine called vemurafenib. 
  • It can only be given to patients whose cancer has a change ( mutation ) in a protein called “BRAF”. Before starting treatment, your doctor will test if your melanoma has this mutation. This change may have led to the development of melanoma.

How Cotellic works 
Cotellic affects a protein called “MEK”, which is important for the growth of cancer cells. When Cotellic is used in combination with vemurafenib (which affects the altered “BRAF” protein ), it further slows down or stops, the growth of your cancer.

What you need to know before taking Cotellic

Do not take Cotellic:

  • if you are allergic to cobimetinib or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, talk to your doctor, pharmacist, or nurse before taking Cotellic.

Warnings and cautions

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

  • Bleeding

Cotellic can cause severe bleeding, especially in the brain or stomach ( see also Severe bleeding in section 4 ). Contact your doctor immediately if you have any unusual bleeding or any of these symptoms; headache, dizziness, feeling weak, blood in the stool or black stools, and bloody vomiting.

  • Eye problems

Cotellic can cause eye problems ( see also ” Eye problems  in section 4 ). Contact your doctor immediately if you experience the following symptoms: blurred vision, distorted vision, loss of vision, or other vision changes during treatment. Your doctor should examine your eyes if you experience any new or worsening problems with your vision while taking Cotellic.

  • Heart problems

Cotellic may reduce the amount of blood pumped by your heart ( see also ” Heart problems  in section 4 ). Your doctor should perform tests before and during treatment with Cotellic to check how well your heart can pump blood. Contact your doctor immediately if you have a feeling that your heart is beating, rushing, or beating irregularly, or if you experience dizziness, shortness of breath, fatigue, or swelling in your legs.

  • Liver problem

Cotellic may increase the level of certain liver enzymes in your blood during treatment. Your doctor will take blood samples to check these levels and how well your liver is working.

  • Muscle problem

Cotellic can cause elevated levels of creatine phosphokinase, which is an enzyme found primarily in muscle, heart, and brain. This may be a sign of muscle damage ( rhabdomyolysis ) (see also Muscle problems in section 4). Your doctor will take blood samples to check this. Contact your doctor immediately if you get any of these symptoms; muscle pain, muscle spasm, weakness, or dark or red urine.

Contact your doctor immediately if you get diarrhea. Severe diarrhea can cause loss of body fluid ( dehydration ). Follow your doctor’s instructions for what to do to prevent or treat diarrhea.

Children and young people

Cotellic is not recommended for children and adolescents. The effects of Cotellic in people under 18 years of age are not known.

Other medicines and Cotellic

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is because Cotellic may affect the way some other medicines work. Other medicines can also affect the way Cotellic works.

Drug Purpose of the drug
itraconazole, clarithromycin, erythromycin, telithromycin, voriconazole, rifampicin, posaconazole, fluconazole, miconazole against certain fungal and bacterial infections
ritonavir, cobicistat, lopinavir, delavirdine, amprenavir, fosamprenavir against HIV – infection
telaprevir against hepatitis C
nefazodone against depression
amiaridon against irregular heartbeats
diltiazem , verapamil against high blood pressure
imatinib against cancer
carbamazepine, phenytoin against seizures
St. John’s wort herbal medicine used to treat mild depression

Cotellic with food and drink

Avoid taking Cotellic with grapefruit juice. The reason is that it could increase the amount of Cotellic in the blood.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

  • Cotellic is not recommended during pregnancy. Although the effects of Cotellic have not been studied in pregnant women, it can lead to permanent damage or malformations in the fetus.
  • If you become pregnant during treatment with Cotellic or within 3 months of your last dose, contact your doctor immediately.
  • It is not known if Cotellic passes into breast milk. If you are breast-feeding, your doctor will discuss the benefits and risks of taking Cotellic with you.

Contraceptives 
Women of childbearing potential should use two effective methods of contraception, e.g. condom or another barrier method (with spermicide, if available) during treatment and for at least 3 months after treatment has ended. Ask your doctor about the best contraceptive methods for you.

Driving and using machines

Cotellic may affect your ability to drive and use machines. Avoid driving and using machines if you feel that your vision is affected or other problems that may affect your ability, e.g. if you feel dizzy or tired. Contact your doctor if you are unsure.

Cotellic contains lactose and sodium

The tablets contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to take Cotellic

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How many tablets to take

The recommended dose is 3 tablets once daily (total 60 mg)

  • Take the tablets every day for 21 days (called a “treatment period”).
  • After the 21 days, do not take any Cotellic tablets for 7 days. During this 7-day break from Cotellic treatment, you should continue to take vemurafenib according to your doctor’s instructions.
  • Start your next 21-day treatment period after a 7-day break.
  • If you experience side effects, your doctor may decide to lower your dose, temporarily or permanently discontinue treatment. Always take Cotellic exactly as your doctor or pharmacist has told you.

How to take your tablets

  • Swallow the tablets whole with a glass of water
  • Cotellic can be taken with or without food

If you vomit 
If you vomit after taking Cotellic, do not take an extra dose of Cotellic that day. Continue to take Cotellic, as usual, the next day.

If you take more Cotellic then you should

If you take more Cotellic than you should, contact a doctor immediately. Bring the medicine pack and this leaflet.

If you forget to take Cotellic

  • If there are more than 12 hours left until your next dose, take your dose as soon as you remember.
  • If there are less than 12 hours left until your next dose, skip the missed dose. Take the next dose at the usual time.
  • Do not take a double dose to make up for a forgotten dose.

If you stop taking Cotellic

It is important that you continue to take Cotellic for as long as your doctor prescribes it.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience side effects, your doctor may decide to lower your dose, temporarily or permanently discontinue treatment.


Also read the package leaflet for vemurafenib, which is used in combination with Cotellic.

Serious side effects are

Contact your doctor immediately if you experience any of the side effects listed below or if they get worse 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 bleeding site, symptoms may include:

  • headache, dizziness, or weakness
  • bloody vomiting
  • abdominal pain
  • red or black stools

Eye (vision) problems (very common: may affect more than 1 user in 10)

Cotellic can cause eye problems. Some of these eye problems can occur due to something called “serous retinopathy” (an accumulation of fluid under the retina of the eye). Symptoms of serious retinopathy include:

  • Tamsyn
  • distorted vision
  • vision loss
  • all other changes in your vision

Heart problems (common: may affect up to 1 in 10 people)

Cotellic can reduce the amount of blood pumped by your heart. Symptoms of this may include:

  • feeling dizzy
  • the feeling of shortness of breath
  • feeling of tiredness
  • feeling that your heart is beating, rushing, or beating irregularly
  • swelling in the legs

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

Cotellic may result in the degradation of muscle tissue ( rhabdomyolysis ). Symptoms of this may include:

  • muscle pain
  • muscle spasm or weakness
  • dark or red urine.

Diarrhea (very common: may affect more than 1 user in 10)

Contact your doctor immediately if you get diarrhea. Follow your doctor’s instructions for what to do to prevent or treat diarrhea.

Other side effects are 
, tell your doctor, pharmacist, or nurse if you notice any of the following side effects:

Very common: may affect more than 1 user in 10

  • increased sensitivity to sunlight
  • rash
  • nausea
  • fever
  • overindulge
  • increase in liver enzymes (shown in blood tests)  
  • abnormal results of blood tests related to creatine phosphokinase, an enzyme found mainly in the heart, brain, and skeletal muscle
  • vomiting
  • skin rash with a flat, discolored, or raised area-like acne.
  • high blood pressure
  • anemia (low red blood cell count )
  • bleeding
  • abnormal thickening of the skin

Common: may affect up to 1 in 10 users

  • different types of skin cancer such as basal cell carcinoma, squamous cell carcinoma of the skin, and keratoacanthoma
  • dehydration, when the body does not have enough fluid
  • reduced amount of phosphate or sodium (shown in a blood test)
  • the increased amount of sugar (shown in a blood test)
  • the increased amount of liver pigment (called “bilirubin”) in the blood. Signs include yellowing of the skin or eyes
  • inflammation of the lungs that can cause breathing difficulties and can be life-threatening (called “pneumonitis”)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

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 blister and carton after EXP. The expiration date is the last day of the specified month.
  • This medicine does not require any special storage instructions.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and the contents of the pack

Cotellic film-coated tablets are white and round with “COB” engraved on one side. There is one available pack size: 63 tablets (3 blisters with 21 tablets each).

Marketing Authorisation Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Strasse 1

79639

Grenzach-Wyhlen

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNV Roche SATel: +32 (0) 2 525 82 11 LithuaniaUAB “Roche Lietuva”Tel: +370 5 2546799
BulgariaRosh BULGARIA LOODETel: +359 2 818 44 44 Luxembourg / Luxemburg(See / See Belgium / Belgium)
Czech RepublicRoche sroTel: +420 – 2 20382111 Magyarorsz ágRoche (Hungary) Kft.Tel: +36 – 23 446 800
DenmarkRoche a / sTel: +45 – 36 39 99 99 Malta(See Ireland)
GermanyRoche Pharma AGTel: +49 (0) 7624 140 The NetherlandsRoche Nederland BVTel: +31 (0) 348 438050
EestiRoche Eesti OÜTel: + 372 – 6 177 380 NorwayRoche Norge ASTel: +47 – 22 78 90 00
GreeceRoche (Hellas) AE:Ηλ: +30 210 61 66 100 AustriaRoche Austria GmbHTel: +43 (0) 1 27739
SpainRoche Farma SATel: +34 – 91 324 81 00 PolandRoche Polska Sp.z ooTel: +48 – 22 345 18 88
FranceRocheTel: +33 (0) 1 47 61 40 00 PortugalRoche Pharmacêutica Chemica, LdaTel: +351 – 21 425 70 00
CroatiaRoche dooTel: + 385 1 47 22 333 RomaniaRoche România SRLTel: +40 21 206 47 01
IrelandRoche Products (Ireland) Ltd.Tel: +353 (0) 1 469 0700 SloveniaRoche pharmacevtska družba dooTel: +386 – 1 360 26 00
IcelandRoche a / sc / o Icepharma hfPhone: +354 540 8000 Slovak RepublicRoche Slovensko, sroTel: +421 – 2 52638201
ItalyRoche SpATel: +39 – 039 2471 Finland / FinlandRoche Oy Puh / Tel: +358 (0) 10 554 500
ύπρος Γ.Α.Σταμάτης & Σια Λτδ.:Ηλ: +357 – 22 76 62 76 Roche ABTel: +46 (0) 8 726 1200
LatviaRoche Latvija SIATel: +371 – 6 7039831 United KingdomRoche Products Ltd.Tel: +44 (0) 1707 366000

Muhammad Nadeem

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