Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cotellic

Document Subject

Generated Narrative: MedicinalProductDefinition mp3a2e83e300727740331b28eb7f2593e4

identifier: http://ema.europa.eu/identifier/EU/1/15/1048/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Cotellic 20 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3a2e83e300727740331b28eb7f2593e4

identifier: http://ema.europa.eu/identifier/EU/1/15/1048/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - cotellic

Attesters

What is 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 pack and other information

What Cotellic is Cotellic is an anti-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, that 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 used in patients whose cancer has a change (mutation) in a protein called BRAF . Before starting treatment, your doctor will test for this mutation. This change may have led to the development of melanoma.

How Cotellic works 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.

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

• Bleeding 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.

• Eye problems 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.

• Heart problems 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.

• Liver problems 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.

• Muscle problems 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.

• Diarrhoea 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.

Children and adolescents 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.

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 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.

Cotellic with food and drink Avoid taking Cotellic with grapefruit juice. This is because it could increase the amount of Cotellic in your blood.

Pregnancy and breast-feeding 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.

• Cotellic is not recommended during pregnancy - although the effects of Cotellic have not been studied in pregnant women, it may cause permanent harm or birth defects to an unborn baby.
• If you become pregnant during treatment with Cotellic or in the 3 months after your last dose, tell your doctor straight away.
• It is not known if Cotellic passes into breast milk. Your doctor will discuss with you the benefits and risks of taking Cotellic, if you are breast-feeding.

Contraception 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.

Driving and using machines 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.

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, 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.

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

• 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 in Cotellic treatment, you should keep taking vemurafenib as told by your doctor.
• Start your next Cotellic 21 day treatment period after the 7 day break.
• If you get side effects, your doctor may decide to lower your dose, stop treatment temporarily or permanently. Always take Cotellic exactly as your doctor or pharmacist has told you.

Taking the medicine

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

If you are sick 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 If you take more Cotellic than you should, talk to a doctor straight away. Take the medicine package and this leaflet with you.
If you forget to take Cotellic

• If it is more than 12 hours before your next dose, take the missed dose as soon as you remember.
• If it is less than 12 hours before your next dose, skip the missed dose. Then take the 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 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.

Serious side effects 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:

• headaches, dizziness, or weakness
• vomiting blood
• abdominal pain
• red or black coloured stools.

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:

• blurred vision
• distorted vision
• partly missing vision
• any other changes to your sight.

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:

• feeling dizzy
• feeling light-headed
• feeling short of breath
• feeling tired
• feeling like your heart is pounding, racing or beating unevenly
• swelling in the legs.

Muscle problems (uncommon: may affect up to 1 in 100 people) Cotellic can result in the breakdown of muscle (rhabdomyolysis), symptoms may include:

• muscle aches
• muscle spasms and weakness
• dark- or red-coloured urine.

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.

Other side effects 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)

• increased skin sensitivity to sunlight
• skin rash
• feeling sick (nausea)
• fever
• chills
• increased liver enzymes (shown in blood tests)
• abnormal blood test results related to creatine phosphokinase, an enzyme found mainly in heart, brain and skeletal muscle
• vomiting
• skin rash with a flat discoloured area or raised bump like acne
• high blood pressure
• anaemia (a low level of red blood cells)
• bleeding
• abnormal thickening of the skin
• swelling usually in the legs (oedema peripheral) itchy or dry skin.
  Common (may affect up to 1 in 10 people)
• some types of skin cancer such as basal cell carcinoma, cutaneous squamous cell carcinoma and keratoacanthoma
• dehydration, when your body does not have enough fluid
• decreased levels of phosphate or sodium (shown in blood tests)
• increased sugar level (shown in blood tests)
• increased liver pigment (called bilirubin ) in the blood. Signs include yellowing of the skin or eyes
• inflammation of the lungs that may cause difficulty breathing, 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• Keep this medicine out of the sight and reach of children.
• Do not take this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Cotellic contains

• The active substance is cobimetinib. Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib.
• The other ingredients are (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 Cotellic looks like and contents of the pack 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).

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien
N.V. Roche S.A.
T l/Tel: +32 (0) 2 525 82 Lietuva
UAB Roche Lietuva
Tel: +370 5 2546

: +359 2 818 44 Luxembourg/Luxemburg
(Voir/siehe Belgique/Belgien)
esk republika
Roche s. r. o.
Tel: +420 - 2 20382Magyarorsz g
Roche (Magyarorsz g) Kft.
Tel: +36 - 1 279 4Danmark
Roche Pharmaceutical A/S
Tlf: +45 - 36 39 99 Malta
(see Ireland)
Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438Eesti
Roche Eesti O
Tel: + 372 - 6 177 Norge
Roche Norge AS
Tlf: +47 - 22 78 90
Roche (Hellas) A.E.
: +30 210 61 66 sterreich
Roche Austria GmbH
Tel: +43 (0) 1 27Espa a
Roche Farma S.A.
Tel: +34 - 91 324 81 Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 France
Roche
T l: +33 (0) 1 47 61 40 Portugal
Roche Farmac utica Qu mica, Lda
Tel: +351 - 21 425 70 Hrvatska
Roche d.o.o.
Tel: +385 1 4722 Rom nia
Roche Rom nia S.R.L.
Tel: +40 21 206 47 Ireland
Roche Products (Ireland) Ltd.
Tel: +353 (0) 1 469 0Slovenija
Roche farmacevtska dru ba d.o.o.
Tel: +386 - 1 360 26 sland
Roche Pharmaceuticals A/S
c/o Icepharma hf
S mi: +354 540 8Slovensk republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638Italia
Roche S.p.A.
Tel: +39 - 039 2Suomi/Finland
Roche Oy
Puh/Tel: +358 (0) 10 554 K
. . & .
: +357 - 22 76 62 Sverige
Roche AB
Tel: +46 (0) 8 726 1Latvija
Roche Latvija SIA
Tel: +371 - 6 7039United Kingdom (Northern Ireland)
Roche Products (Ireland) Ltd.
Tel: +44 (0) 1707 366This leaflet was last revised in {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency web site: