Patient Information Leaflet: Information for the Patient

Mekinist 0.5 mg film-coated tablets, 2 mg film-coated tablets

trametinib
Please read all of this leaflet carefully before you start taking this medicine, as 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Mekinist is and what it is used for
What you need to know before taking Mekinist
How to take Mekinist
Possible side effects
How to store Mekinist
Contents of the pack and other information

1. What Mekinist is and what it is used for

Mekinist is a medicine that contains the active substance trametinib. It is used alone or in combination with another medicine containing dabrafenib to treat a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery.
Mekinist in combination with dabrafenib is also used to prevent recurrence of melanoma following surgical removal.
Mekinist in combination with dabrafenib is also used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
Both cancers have a specific alteration (mutation) in a gene called BRAF at position V600. This gene mutation may have caused the development of the cancer. The medicine targets the proteins produced by this mutated gene and slows down or blocks cancer growth.

2. What you need to know before taking Mekinist

Mekinist should only be used to treat BRAF-mutated melanomas and NSCLC. Therefore,
before starting treatment, your doctor will check for the presence of this mutation.
If your doctor decides that you will receive Mekinist in combination with dabrafenib,
please read carefully the package leaflet for dabrafenib and this leaflet.
If you have further questions about the use of this medicine, please consult your doctor, pharmacist, or
nurse.
Do not take Mekinist

if you are allergic to trametinib or to any of the other ingredients of this medicine (listed in section 6). Check with your doctor if you think this applies to you.

Warnings and precautions
Talk to your doctor before taking this medicine. Your doctor needs to know:

if you have any liver problems. Your doctor may take blood samples to monitor liver function while you are taking this medicine.
if you have or have had any kidney problems
if you have or have had lung or breathing problems
if you have heart problems such as heart failure (which may cause shortness of breath, difficulty breathing when lying down, swelling of the feet or legs), or irregular heartbeat. Your doctor must check your heart function before and during treatment.
if you have eye problems, including blockage of the vein draining the eye (retinal vein occlusion) or eye swelling caused by fluid retention (chorioretinopathy).

Before taking Mekinist in combination with dabrafenib, your doctor needs to know if:

you have had types of cancer other than melanoma or NSCLC, as you may be at increased risk of developing other non-skin tumors while taking Mekinist.

Check with your doctor if you think any of these conditions may apply to you.
Conditions requiring caution
Some people taking Mekinist develop other conditions that may be serious. You should be aware of the important symptoms to watch for.
Bleeding
Taking Mekinist or the combination of Mekinist and dabrafenib may cause severe bleeding, including bleeding in the brain, gastrointestinal tract (such as stomach, rectum, or intestine), lungs, and other organs, which may be fatal. Symptoms may include:

headache, dizziness, or feeling weak
blood in the stool or black stools
blood in the urine
stomach pain
coughing or vomiting blood

Contact your doctor as soon as possible if you experience any of these symptoms.
Fever
Taking Mekinist or the combination of Mekinist and dabrafenib may cause fever, although fever is more likely when you are taking the combination treatment (see also section 4). In some cases, people with fever may also experience low blood pressure, dizziness, or other symptoms.
Contact your doctor immediately if you develop a fever above 38°C or feel feverish while taking this medicine.
Heart problems
Mekinist may cause heart problems or worsen pre-existing heart conditions (see also ‘Heart conditions’ in section 4), especially when taken in combination with dabrafenib.
Inform your doctor if you have a heart condition. Your doctor will perform tests to assess heart function before and during treatment with this medicine. Contact your doctor immediately if you experience a fast, irregular, or pounding heartbeat, dizziness, fatigue, fainting, shortness of breath, or leg swelling. If necessary, your doctor may decide to interrupt or stop treatment.
Skin changes that may indicate the development of a new skin cancer
Your doctor will examine your skin before you start taking this medicine and regularly during treatment. Contact your doctor immediately if you notice any skin changes during or after treatment (see also section 4).
Eye problems
An eye examination by your doctor is required while you are taking this
medicine.
Contact your doctor immediately if you experience eye redness, irritation, blurred vision, eye pain, or other vision changes during treatment (see also section 4).
Mekinist may cause eye problems, including blindness. Mekinist is not recommended if you have had a blockage of the vein draining the eye (retinal vein occlusion). Contact your doctor immediately if you experience any of the following symptoms of eye problems: blurred vision, vision loss, other vision changes, colored spots in your vision, or halos (blurred edges around objects) during treatment. If necessary, your doctor may decide to interrupt or stop treatment.
Liver problems
Taking Mekinist or the combination of Mekinist and dabrafenib may cause liver problems that can progress to serious conditions such as hepatitis and liver failure, which may be fatal. Your doctor will monitor you periodically. Signs that your liver may not be working properly include:

loss of appetite
feeling unwell (nausea)
vomiting
stomach (abdominal) pain
yellowing of the skin or whites of the eyes (jaundice)
dark-colored urine
skin itching

Contact your doctor as soon as possible if you experience any of these symptoms.
Lung or breathing problems
Inform your doctor if you have lung or breathing problems, including difficulty breathing, often accompanied by a dry cough, shortness of breath, and fatigue. Your doctor may arrange a lung function test before starting treatment.
Muscle pain
Mekinist may cause muscle breakdown (rhabdomyolysis). Contact your doctor as soon as possible if you experience any of the following symptoms:

muscle pain
dark urine due to kidney damage

If necessary, your doctor may decide to interrupt or stop treatment.
→ Read the information under ‘Possible serious side effects’ in section 4 of this
leaflet.
Hole in the stomach or intestine (perforation)
Taking Mekinist or the combination of Mekinist and dabrafenib may increase the risk of developing holes in the intestinal wall. Contact your doctor as soon as possible if you experience severe abdominal pain.
Severe skin reactions
Severe skin reactions have been observed in people taking Mekinist in combination with dabrafenib. Contact your doctor immediately if you notice any skin changes (see section 4 for symptoms you should be aware of).
Inflammatory disease affecting mainly the skin, lungs, eyes, and lymph nodes
An inflammatory disease that mainly affects the skin, lungs, eyes, and lymph nodes. Common symptoms of sarcoidosis may include cough, shortness of breath, swollen lymph nodes, vision problems, fever, fatigue, joint pain and swelling, and painful skin lumps. Inform your doctor if you experience any of these symptoms.
Immune system disorders
Mekinist in combination with dabrafenib may, in rare cases, cause a condition (hemophagocytic lymphohistiocytosis or HLH) in which the immune system produces an excessive number of infection-fighting cells called histiocytes and lymphocytes. Symptoms may include: enlarged liver and/or spleen, skin rash, swollen lymph nodes, breathing problems, easy bruising, kidney abnormalities, and heart problems. Contact your doctor immediately if you experience several of the following symptoms at the same time: fever, swollen lymph nodes, bruising, or skin rash.
Tumor lysis syndrome
If you experience any of the following symptoms, contact your doctor immediately, as this may be a life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, reduced urine output, and fatigue. These may be caused by a group of metabolic complications that can occur during cancer treatment due to the breakdown products of dying cancer cells (tumor lysis syndrome or TLS), and may lead to changes in kidney function (see also section 4).
Children and adolescents
Mekinist is not recommended for children and adolescents, as the effects of Mekinist in people under 18 years of age are unknown.
Other medicines and Mekinist
Before starting treatment, inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines. Keep a list of all medicines you are taking to show your doctor, pharmacist, or nurse when starting a new medicine.
Mekinist with food and drink
It is important to take Mekinist on an empty stomach due to the effect of food on the absorption of the medicine into the body (see section 3).
Pregnancy, breastfeeding, and fertility
Mekinist is not recommended during pregnancy.

If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. Mekinist may harm the unborn baby.
If you are a woman of childbearing potential, you must use a reliable method of contraception (birth control) while taking Mekinist and for at least 16 weeks after stopping it.
Hormonal contraceptives (such as pills, injections, or patches) may be less effective while taking Mekinist in combination with dabrafenib. You should use another effective method of contraception if you do not wish to become pregnant while taking this combination. Consult your doctor, pharmacist, or nurse.
If you become pregnant while taking Mekinist, inform your doctor immediately.

Mekinist is not recommended during breastfeeding.
It is not known whether the components of Mekinist pass into breast milk.
If you are breastfeeding or planning to breastfeed, you must inform your doctor. Breastfeeding is not recommended while taking Mekinist. You and your doctor will decide whether to take Mekinist or breastfeed.
Fertility – men and women
Mekinist may impair fertility in both men and women.
Taking Mekinist with dabrafenib: Dabrafenib may permanently reduce male fertility. In addition, men taking dabrafenib may have reduced sperm count, which may not return to normal after treatment is stopped.
Before starting treatment with dabrafenib, discuss with your doctor options to preserve your future ability to have children.
If you have further questions about the effects of this medicine on fertility, talk to your doctor, pharmacist, or nurse.
Driving and using machines
Mekinist may cause side effects that could affect your ability to drive or operate machinery. Avoid driving or operating machinery if you feel tired or weak, have vision problems, or have low energy levels.
Descriptions of these effects can be found in other sections (see sections 2 and 4). Read all information in this leaflet carefully.
Discuss with your doctor, pharmacist, or nurse if you are unsure about anything. Your illness, symptoms, and treatment status may also affect your ability to drive or use machinery.
Mekinist contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Mekinist

Take this medicine exactly as prescribed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, nurse, or pharmacist.

Dosage

The recommended dose of Mekinist, either alone or in combination with dabrafenib, is one 2 mg tablet once daily. The recommended dose of dabrafenib, when used in combination with Mekinist, is 150 mg twice daily.

Your doctor may decide to reduce your dose if you experience adverse effects.

Do not take more Mekinist than prescribed by your doctor, as this may increase the risk of adverse effects.

How to take it

Swallow the tablet whole with a full glass of water.

Take Mekinist once daily on an empty stomach (at least 1 hour before or 2 hours after a meal). This means that:

after taking Mekinist, you must wait at least 1 hour before eating
after eating, you must wait at least 2 hours before taking Mekinist.

Take Mekinist at approximately the same time each day.

If you take more Mekinist than you should

If you take too many Mekinist tablets, contact your doctor, pharmacist, or nurse for advice. If possible, show them the Mekinist packaging and this leaflet.

If you forget to take Mekinist

If you forget a dose and less than 12 hours have passed, take it as soon as you remember.

If you forget a dose and more than 12 hours have passed, skip that dose and take the next dose at your usual time. Then continue taking the tablets at regular intervals as usual.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Mekinist

Take Mekinist for the entire duration recommended by your doctor. Do not stop unless your doctor advises you to do so.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

How to take Mekinist in combination with dabrafenib

Take Mekinist in combination with dabrafenib exactly as directed by your doctor, pharmacist, or nurse. Do not change the dose or stop treatment with Mekinist or dabrafenib unless your doctor, pharmacist, or nurse tells you to do so.
Take Mekinist once daily and dabrafenib twice daily. It may be helpful for you to take both medicines at the same time each day. Mekinist should be taken either with the morning dose of dabrafenib or with the evening dose of dabrafenib. Doses of dabrafenib should be taken approximately 12 hours apart.
Take Mekinist and dabrafenib on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the tablet or capsules whole with a full glass of water.
If you miss a dose of Mekinist or dabrafenib, take it as soon as you remember. Do not make up for the missed dose; instead, take the next scheduled dose as planned:
o If less than 12 hours remain before the next scheduled dose of Mekinist (taken once daily).
o If less than 6 hours remain before the next scheduled dose of dabrafenib (taken twice daily).
If you take too many Mekinist tablets or dabrafenib capsules, contact your doctor, pharmacist, or nurse immediately. If possible, bring the Mekinist tablets and dabrafenib capsules with you. If possible, show them the Mekinist and dabrafenib packaging, including the package leaflets.
If you experience adverse effects, your doctor may decide to reduce your dose of Mekinist and dabrafenib. Always take the doses of Mekinist and dabrafenib exactly as instructed by your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible serious side effects
Heart conditions
Mekinist can affect how the heart pumps blood. This is more likely to affect people who already have an existing heart problem. You will be monitored for any heart problems while taking Mekinist. Signs and symptoms of heart problems include:

feeling your heart beating strongly, rapidly, or irregularly
dizziness
tiredness
feeling mentally confused
shortness of breath
swelling in the legs

Tell your doctor as soon as possible if you experience any of these symptoms, whether they occur for the first time or worsen.
High blood pressure
Mekinist can cause new-onset high blood pressure (hypertension) or worsening of existing high blood pressure. Your doctor or nurse must monitor your blood pressure during treatment with Mekinist. Contact your doctor or nurse immediately if you have high blood pressure or worsening blood pressure, or if you experience severe headache, dizziness, or lightheadedness.
Bleeding problems
Mekinist can cause serious bleeding problems, especially in the brain or stomach. Contact your doctor or nurse immediately for medical assistance if you experience any unusual signs of bleeding, including:

headache, dizziness, or weakness
coughing up blood or blood clots
vomiting blood or material that looks like coffee grounds
red or black, tarry stools

Eye (vision) problems
Mekinist can cause eye problems. Mekinist is not recommended if you have previously had a blockage in the vein that drains the eye (retinal vein occlusion). Your doctor may recommend an eye examination before starting Mekinist and during treatment. Your doctor may ask you to stop taking Mekinist or refer you to a specialist if you develop vision symptoms, including:

loss of vision
redness and irritation of the eye
colored spots in your vision
halos (seeing blurred edges around objects)
blurred vision

Skin changes
Severe skin reactions have been observed in people taking Mekinist in combination with dabrafenib (frequency not known). If you notice any of the following reactions:

red, circular or target-shaped patches on the trunk, with central blisters. Skin peeling. Mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
widespread rash, fever, and swollen lymph nodes (DRESS syndrome or drug reaction with eosinophilia and systemic symptoms). ➔ Stop taking the medicine and contact your doctor immediately.

Up to 3 in 100 people taking Mekinist in combination with dabrafenib may develop a different type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). Others may develop a type of skin cancer called basal cell carcinoma (BCC). Usually, these skin changes remain localized and can be removed surgically, and treatment with Mekinist and dabrafenib can continue uninterrupted.
Some people taking Mekinist in combination with dabrafenib may also develop new melanomas. These melanomas are usually removed surgically, and treatment with Mekinist and dabrafenib can continue without interruption.
Your doctor will examine your skin before starting treatment with dabrafenib, and then monthly during dabrafenib treatment and for 6 months after stopping it, to check for any new skin cancers.
Your doctor will also examine your head, neck, mouth, and lymph nodes, and you will undergo regular chest and abdominal scans (called CT scans). You will also have laboratory tests. These tests help identify any cancers, including squamous cell carcinoma, that may develop in your body. A pelvic (for women) and anal examination before and after treatment are also recommended.
Mekinist used alone or in combination with dabrafenib may cause rash or acne-like rash. Follow your doctor’s instructions on how to help prevent skin rash.
Tell your doctor or nurse as soon as possible if you experience any of these symptoms for the first time or if they worsen.
Contact your doctor immediately if you develop a severe skin rash with any of the following symptoms: blisters on the skin, blisters or sores in the mouth, skin peeling, fever, redness or swelling of the face or soles of the feet.
Tell your doctor or nurse as soon as possible if you develop any skin rash or if your rash worsens.
Muscle pain
Mekinist can cause muscle breakdown (rhabdomyolysis). Inform your doctor or nurse if you develop new symptoms or if existing ones worsen, including:

muscle pain
dark urine due to kidney damage

Lung or breathing problems
Mekinist can cause inflammation of the lung (pneumonitis or interstitial lung disease). Inform your doctor or nurse if you develop new or worsening lung symptoms or breathing problems, including:

shortness of breath
cough
fatigue

Immune system disorders
Inform your doctor immediately if you experience several symptoms together, such as fever, swollen lymph nodes, bruising, or skin rash. These may be signs of a condition (hemophagocytic lymphohistiocytosis) in which the immune system produces an excessive number of infection-fighting cells called histiocytes and lymphocytes, which can cause various symptoms; see section 2 (rare frequency).
Tumor lysis syndrome
Inform your doctor immediately if you experience the following symptoms: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, decreased urine output, and fatigue. These may be signs of a condition caused by the rapid breakdown of cancer cells, which can be fatal in some people (tumor lysis syndrome or TLS); see section 2 (frequency not known).

Possible side effects in patients taking Mekinist alone
The side effects you may experience when taking Mekinist alone are the following:
Very common side effects (may affect more than 1 in 10 people):

High blood pressure (hypertension)
Bleeding in various parts of the body, which can be mild or severe
Cough
Shortness of breath
Diarrhea
Nausea, vomiting
Constipation
Stomach pain
Dry mouth
Rash, acne-like rash, facial redness, dry or itchy skin (see 'Skin changes' at the beginning of section 4)
Unusual hair loss or thinning
Lack of energy or feeling weak or tired
Swelling of hands or feet (peripheral edema)
Fever

Very common side effects that may show up in blood tests:

Abnormal liver blood tests

Common side effects (may affect up to 1 in 10 people):

Inflammation of hair follicles (folliculitis)
Nail changes such as nail bed changes, nail pain, nail infections, and cuticle swelling or infection
Skin infection (cellulitis)
Rash with pus-filled blisters (see also 'Skin changes' at the beginning of section 4)
Allergic reaction (hypersensitivity)
Dehydration (low levels of water or fluids)
Blurred vision
Swelling around the eyes
Vision problems (see also 'Eye (vision) problems' at the beginning of section 4)
Changes in the way the heart pumps blood (left ventricular dysfunction) (see also 'Heart conditions' at the beginning of section 4)
Lower than normal heart rate and/or decreased heart rate
Localized tissue swelling
Lung inflammation (pneumonitis or interstitial lung disease)
Mouth pain or mouth ulcers, inflammation of mucous membranes
Red, cracked, or fissured skin
Red, painful hands and feet
Facial swelling
Mucosal inflammation
Feeling weak
Condition affecting the nerves that may cause pain, loss of sensation, or tingling in the hands and feet and/or muscle weakness (peripheral neuropathy)

Common side effects that may show up in blood tests:

Decrease in red blood cells (anemia), abnormal blood tests related to creatine phosphokinase, an enzyme found mainly in the heart, brain, and skeletal muscles

Uncommon side effects (may affect up to 1 in 100 people):

Eye swelling due to fluid leakage (chorioretinopathy) (see also 'Eye (vision) problems' at the beginning of section 4)
Swelling of nerves at the back of the eye (papilledema) (see also 'Eye (vision) problems' at the beginning of section 4)
Separation of the light-sensitive membrane at the back of the eye (retina) from its supporting layers (retinal detachment) (see also 'Eye (vision) problems' at the beginning of section 4)
Blockage of the vein draining the eye (retinal vein occlusion) (see also 'Eye (vision) problems' at the beginning of section 4)
Heart pumping less efficiently, causing shortness of breath, extreme tiredness, and swelling of ankles and legs (heart failure)
A hole (perforation) in the stomach or intestine
Inflammation of the intestine (colitis)
Muscle breakdown that may cause muscle pain and kidney damage (rhabdomyolysis)

Not known (frequency cannot be estimated from available data):

Irregular heartbeat (atrioventricular block)

Side effects when Mekinist and dabrafenib are taken together
When taking Mekinist and dabrafenib together, you may experience one of the side effects listed above, although the frequency may change (increase or decrease).
You may also experience additional side effects due to dabrafenib taken together with Mekinist, listed below.
Inform your doctor as soon as possible if you experience any of these side effects, whether for the first time or if they worsen.
Read the dabrafenib package leaflet for details on side effects you may experience while taking this medicine.
The side effects you may experience when taking Mekinist in combination with dabrafenib are the following:
Very common side effects (may affect more than 1 in 10 people):

Inflammation of the nose and throat
Decreased appetite
Headache
Dizziness
High blood pressure (hypertension)
Bleeding in various parts of the body, ranging from mild to severe (hemorrhage)
Cough
Stomach pain
Constipation
Diarrhea
Nausea, vomiting
Skin rash, dry skin, itching, skin redness
Joint pain, muscle pain, or pain in hands and feet
Muscle spasms
Lack of energy, feeling weak
Chills
Swelling of hands or feet (peripheral edema)
Fever
Flu-like illness

Very common side effects that may be detected in blood tests:

Abnormal laboratory results related to the liver

Common side effects (may affect up to 1 in 10 people):

Urinary tract infection
Skin-related effects including skin infection (cellulitis), hair follicle inflammation, nail disorders such as nail bed changes, nail pain, nail infections, and cuticle swelling, rash with pus-filled blisters, cutaneous squamous cell carcinoma (a type of skin cancer), papilloma (a usually non-dangerous skin tumor), wart-like growths, increased skin sensitivity to sunlight (see also 'Skin changes' at the beginning of section 4)
Dehydration (low levels of water or fluids)
Blurred vision, vision problems, eye inflammation (uveitis)
Heart pumping less efficiently
Low blood pressure (hypotension)
Localized tissue swelling
Shortness of breath
Dry mouth
Mouth pain or mouth ulcers, mucosal inflammation
Acne-like problems
Thickening of the outer skin layer (hyperkeratosis), areas of thickened or scaly, crusted skin (actinic keratosis), cracked or damaged skin
Increased sweating, night sweats
Unusual hair loss or thinning
Red, painful hands and feet
Inflammation of the fat layer under the skin (panniculitis)
Mucosal inflammation
Facial swelling
Condition affecting the nerves that may cause pain, loss of sensation, or tingling in the hands and feet and/or muscle weakness (peripheral neuropathy)

Common side effects that may be detected in blood tests:

Low levels of white blood cells
Decreased number of red blood cells (anemia), platelets (cells that help blood to clot), and a type of white blood cells (leukopenia)
Low levels of sodium (hyponatremia) or phosphate (hypophosphatemia) in the blood
Increased blood sugar levels
Increased creatine phosphokinase, an enzyme found mainly in the heart, brain, and skeletal muscles
Increased levels of certain substances (enzymes) produced by the liver

Uncommon side effects (may affect up to 1 in 100 people):

Development of a new skin tumor (melanoma)
Skin tags (acrochordons)
Allergic reactions (hypersensitivity)
Eye changes including eye swelling due to fluid leakage (chorioretinopathy), separation of the light-sensitive retina from its supporting layer (retinal detachment), and swelling around the eyes
Lower than normal heart rate and/or decreased heart rate
Lung inflammation (pneumonitis)
Pancreas inflammation
Intestinal inflammation (colitis)
Kidney failure
Kidney inflammation
Inflammatory disease mainly affecting the skin, lungs, eyes, and lymph nodes (sarcoidosis)
Irregular heartbeat (atrioventricular block)
Raised, painful, red to dark red skin spots or ulcers mainly on arms, legs, face, and neck, accompanied by fever (signs of acute febrile neutrophilic dermatosis)

Rare side effects (may affect up to 1 in 1,000 people):

A hole (perforation) in the stomach or intestine

Not known (frequency cannot be estimated from available data):

Inflammation of the heart muscle (myocarditis), which may cause shortness of breath, fever, palpitations, and chest pain
Inflamed, scaly skin (exfoliative dermatitis)

Reporting of side effects
If you experience any side effects, 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 Mekinist

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 label of the bottle and on the
carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original packaging to protect the medicine from light and moisture.
Keep the bottle tightly closed and containing a desiccant (small cylindrical container).
After first opening, the bottle can be stored for up to 30 days at a temperature not exceeding 30 °C.
Do not dispose of any medicine 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 Mekinist contains

The active substance is trametinib. Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg or 2 mg of trametinib.
The other components are:
- Tablet core: mannitol (E421), microcrystalline cellulose (E460), hypromellose (E464), sodium croscarmellose (E468), magnesium stearate (E470b), sodium lauryl sulfate, and colloidal silicon dioxide (E551).
- Coating: hypromellose (E464), titanium dioxide (E171), polyethylene glycol, yellow iron oxide (E172) (for the 0.5 mg tablets), polysorbate 80 (E433), and red iron oxide (E172) (for the 2 mg tablets).

Description of the appearance of Mekinist and contents of the pack
The 0.5 mg film-coated tablets of Mekinist are yellow, modified oval-shaped, biconvex tablets, with the company logo imprinted on one side and 'TT' on the opposite side.
The 2 mg film-coated tablets of Mekinist are pink, round-shaped, biconvex tablets, with the company logo imprinted on one side and 'LL' on the opposite side.
The film-coated tablets are supplied in white, opaque plastic bottles with a screw cap. Each bottle contains 7 or 30 tablets.
The bottles also contain a silica desiccant gel in a small cylindrical container.
The desiccant must be kept inside the bottle and must not be ingested.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Lek Pharmaceuticals d.d.
Verovskova ulica 57
1526, Ljubljana
Slovenia
Novartis Pharmaceutical Manufacturing LLC
Verovskova ulica 57
1000, Ljubljana
Slovenia
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Glaxo Wellcome, S.A.
Avda. Extremadura, 3
09400, Aranda de Duero
Burgos
Spain
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 555

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.