The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 00031/0849.
Cotellic 20 mg film-coated tablets
Cotellic 20 mg film-coated tablets
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 pack and other information
Cotellic is an anti-cancer medicine that contains the active substance cobimetinib.
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.
Cotellic targets a protein called “MEK” that is important in controlling cancer cell growth. When Cotellic is used in combination with vemurafenib (which targets the changed “BRAF” protein), it further slows down or stops the growth of your cancer.
If you are not sure, talk to your doctor, pharmacist or nurse before taking Cotellic.
Talk to your doctor, pharmacist or nurse before taking Cotellic if you have:
Cotellic can cause severe bleeding, especially in your brain or stomach (see also “Severe bleeding” in Section 4). Tell your doctor straight away if you have any unusual bleeding or any of these symptoms: headaches, dizziness, feeling weak, blood in the stools or black stools and vomiting blood.
Cotellic can cause eye problems (see also “Eye (vision) problems” in Section 4). Tell your doctor straight away if you get the following symptoms: blurred vision, distorted vision, partly missing vision, or any other changes to your sight during treatment. Your doctor should examine your eyes if you have any new or worsening problems with your sight while you are taking Cotellic.
Cotellic can lower the amount of blood pumped by your heart (see also “Heart problems” in Section 4). Your doctor should do tests before and during your treatment with Cotellic to check how well your heart can pump blood. Tell your doctor straight away if it feels like your heart is pounding, racing or beating unevenly, or if you experience dizziness, lightheadedness, shortness of breath, tiredness, or swelling in the legs.
Cotellic can increase the amount of some liver enzymes in your blood during treatment. Your doctor will do blood tests to check these amounts and monitor how well your liver is working.
Cotellic can cause increased levels of creatine phosphokinase, an enzyme that is found mainly in the muscle, heart, and brain. This can be a sign of muscle damage (rhabdomyolysis) (see also “Muscle problems” in Section 4). Your doctor will do blood tests to monitor for this. Tell your doctor straight away if you get any of these symptoms: muscle aches, muscle spasms, weakness, or dark- or red-coloured urine.
Tell your doctor straight away if you get diarrhoea. Severe diarrhoea can cause loss of body fluid (dehydration). Follow your doctor’s instructions for what to do to help prevent or treat diarrhoea.
Cotellic is not recommended for children and adolescents. The safety and efficacy of Cotellic in people younger than 18 years old have not been established.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Cotellic can affect the way some other medicines work. Also, some other medicines can affect the way Cotellic works.
Talk to your doctor before taking Cotellic if you are taking:
Medicine Purpose of the medicine
itraconazole, clarithromycin, erythromycin, telithromycin, voriconazole, rifampicin, posaconazole, fluconazole, miconazole for some fungal and bacterial infections
ritonavir, cobicistat, lopinavir, delavirdine, amprenavir, fosamprenavir for HIV infection
telaprevir for hepatitis C
nefadozone for depression
amiodarone for an uneven heartbeat
diltiazem, verapamil for high blood pressure
imatinib for cancer
carbamazepine, phenytoin for fits (seizures)
St John’s Wort a herbal medicine, used to treat depression. This is available without prescription.
Avoid taking Cotellic with grapefruit juice. This is because it could increase the amount of Cotellic in your blood.
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women of childbearing potential should use two effective methods of contraception, such as a condom or other barrier method (with spermicide, if available) during treatment and for at least 3 months after treatment has finished. Ask your doctor about the best contraception for you.
Cotellic can affect your ability to drive or use machines. Avoid driving or using machines if you have problems with your vision or other problems that might affect your ability e.g. if you feel dizzy or tired. Talk to your doctor if you are not sure.
The tablets contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 3 tablets (a total of 60 mg) once a day.
If you are sick (vomit) after taking Cotellic, do not take an extra dose of Cotellic on that day. Continue to take Cotellic as normal, the next day.
If you take more Cotellic than you should, talk to a doctor straight away. Take the medicine package and this leaflet with you.
It is important to keep taking Cotellic for as long as your doctor prescribes it.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get side effects your doctor may decide to lower your dose, stop treatment temporarily or permanently.
Please also refer to the Package Leaflet for vemurafenib, which is used in combination with Cotellic.
Tell your doctor straight away if you notice any of the side effects listed below or if these get worse during treatment.
Severe bleeding (common: may affect up to 1 in 10 people)
Cotellic can cause severe bleeding, especially in your brain or stomach. Depending on the area of the bleeding, symptoms may include:
Eye (vision) problems (very common: may affect more than 1 in 10 people)
Cotellic can cause eye problems. Some of these eye problems may be a result of “serous retinopathy” (a build-up of fluid under the retina in the eye). Symptoms of serous retinopathy include:
Heart problems (common: may affect up to 1 in 10 people)
Cotellic can lower the amount of blood pumped by your heart. Symptoms may include:
Muscle problems (uncommon: may affect up to 1 in 100 people)
Cotellic can result in the breakdown of muscle (rhabdomyolysis), symptoms may include:
Diarrhoea (very common: may affect more than 1 in 10 people)
Tell your doctor straight away if you get diarrhoea and follow your doctor’s instructions for what to do to help prevent or treat diarrhoea.
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
Cotellic film-coated tablets are white, round with “COB” debossed on one side. One pack size is available: 63 tablets (3 blisters of 21 tablets).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in January 2023