InfoCons Consumer Protection informs you – Mekinist – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor , pharmacist or nurse . This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Mekinist is and what it is used for

Mekinist is a medicine that contains the active substance trametinib. It is used either on its own or in combination with another medicine containing dabrafenib in adults and adolescents aged 12 years and older 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 in adults and adolescents aged 12 years and older to prevent melanoma from coming back after it has been removed by surgery.

Mekinist in combination with dabrafenib is also used in adults to treat a type of lung cancer called non-small cell lung cancer (NSCLC).

Mekinist in combination with dabrafenib is also used in adults to treat a type of thyroid cancer called differentiated thyroid cancer (DTC).

These cancers have a particular change (mutation) in a gene called BRAF at the V600 position . This mutation in the gene may have caused the cancer to develop. Your medicine targets proteins made from this mutated gene and slows down or stops the development of your cancer.

⚠️ 2. What you need to know before you take Mekinist

Mekinist should only be used to treat cancers with the BRAF mutation. Therefore, before starting treatment your doctor will tes t for this mutation.

If your doctor decides that you will receive treatment with the combination of Mekinist and dabrafenib, read the dabrafenib leaflet carefully as well as this leaflet .

If you have any further questions on the use of th is medicine, ask your doctor, pharmacist or nurse .

57 Do not take Mekinist

• if you are allergic to trametinib or 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 your medicine . Your doctor needs to know if you :

• have any liver problems . Your doctor may take bloo d samples to monitor your liver function while you are taking this medicine.
• have or have ever had kidney problems .
• have or have ever had lung or breathing problems .
• have heart problems such as heart failure (which can cause shortness of breath, difficulty in breathing when lying down, swelling of the feet or legs ) or problems with the way your heart beats. Your doctor should check your heart function before and during treatment.
• have eye problems including blockage of the vein draining the eye (retinal vein occlusion) or swelling in the eye which may be caused by fluid blockage (chorioretinopathy).

Before you take Mekinist in combination with dabrafenib your doctor need s to know if you :

• have had a different type of cancer other than melanoma , NSCLC or DTC , as you may be at greater risk of developing non -skin cancers when taking Mekinist .

Check with your doctor if you think any of these may app ly to you.

Conditions you need to look out for Some people taking Mekinist develop other conditions which can be serious. You need to know about important symptoms to look out for.

Bleeding Taking Mekinist or the combination of Mekinist and dabrafenib can cause serious bleeding including in your brain, the digestive system (such as stomach, rectum or intestine), lungs, and other organs, and can lead to death. Symptoms may include:

• headaches, dizziness, or feeling weak
• passing blood in the stools or passing black stools
• passing blood in the urine
• stomach pain
• coughing / vomiting up blood Tell your doctor as soon as possible if you get any of these symptoms.

Fever Taking Mekinist or the combination of Mekinist and dabrafenib may cause fever, although it is more likely if you are taking the combination treatment (see also section 4). In some cases, people with fever may develop low blood pressure, dizziness or other symptoms.

Tell your doctor immediately if you get a temperature above 38 °C or if you feel a fever coming on while you are taking this medicine.

Heart disorder Mekinist can cause heart problems, or make existing heart problems worse (see also “Heart conditions ” in section 4) in people taking Mekinist in combination with dabrafenib .

Tell your doctor if you have a heart disorder. Your doctor will run tests to check that your heart is working properly before and during your treatment with this medicine . Tell your doctor immediately if it feels like your heart is pounding, racing, or beating irregularly, or if you experience dizziness, tiredness, light -headed ness, shortness of breath or swelling in the legs. If necessary, your doctor may decide to interrupt your treatment or to stop it altogether.

58 Changes in your skin which may indicate new skin cancer Your doctor will check your skin before you start taking this medicine and regularly while you are taking it . Tell your doctor immediately if you notice any changes to your skin while taking this medicine or after treatment (see also section 4).

Eye problems You should have your eyes examined by your doctor while you are taking this medicine.

Tell your doctor immediately if you get eye redness and irritation, blurred vision, eye pain or other vision changes during your treatment (see also section 4).

Mekinist can cause eye problems including blindness. Mekinist is not recommended if you have ever had blockage of the vein draining the eye (retinal vein occlusion). Tell your doctor immediately if you get the following symptoms of eye problems: blurred vision, loss of vision or other vision changes, coloure d dots in your vision or halos (seeing blurred outline around objects) during your treatment. If necessary, your doctor may decide to interrupt your treatment or to stop it altogether.

Liver problems Mekinist, or the combination with dabrafenib, can cause problems with your liver which may develop into 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 may include:

• loss of appetite
• feeling sick (nausea)
• being sick (vomiting)
• pain in your stomach (abdomen)
• yellowing of your skin or the whites of your eyes (jaundice)
• dark-coloured urine
• itching of your skin Tell your doctor as soon as possible if you get any of these symptoms.

Lung or breathing problems Tell your doctor if you have any lung or breathing problems , including difficulty in breathing often accompanied by a dry cough, shortness of breath and fatigue. Your doctor may arrange to check your lung function before you start taking your medicine.

Muscle pain Mekinist can result in the breakdown of muscle (rhabdomyolysis), Tell your doctor as soon as possible if you get any of these symptoms :

• muscle pain
• dark urine due to kidney damage If necessary, your doctor may decide to interrupt your treatment or to stop it altogether.

→ Read the information “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 gut wall. Tell your doctor as soon as possible if you have severe abdominal pain.

Serious skin reactions Serious skin reactions have been reported in people taking Mekinist in combination with dabrafenib.

Tell your doctor immediately if you notice any changes to your skin (see section 4 for symptoms to be aware of).

Inflammatory disease mainly affecting the skin, lung, eyes and lymph nodes An inflammatory disease mainly affecting the skin, lung, eyes and lymph nodes (sarcoidosis).

Common symptoms of sarcoidosis may include coughing, shortness of breath, swollen lymph nodes, visual disturbances, fever, fatigue, pain and swelling in the joints and tender bumps on your skin. Tell your doctor if you get any of these symptoms.

Immune system disorders Mekinist in combination with dabrafenib may in rare instances cause a condition (haemophagocytic lymphohistiocytosis or HLH) in which the immune system makes too many infection -fighting cells, called histiocytes and lymphocytes. Symptoms may include enlarged liver and/or spleen, skin rash, lymph node enlargement, breathing problems, easy bruising, kidney abnormalities, and heart problems. Tell your doctor immediately if you exper ience multiple symptoms such as fever, swollen lymph glands, bruising or skin rash, at the same time.

Tumour lysis syndrome If you experience the following symptoms, tell your doctor immediately as this can be a life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscular cramps, seizures, clouding of urine, decrease in urine output and tiredness. These may be caused by a group of metabolic complications that can occur during treatment of cancer that are caused by t he breakdown products of dying cancer cells ( tumour lysis syndrome or TLS) and can lead to changes in kidney function (see also section 4).

Children and adolescents

Mekinist is not recommended for children and adolescents under 18 years of age , except for adolescents aged 12 years and older with melanoma .

Other medicines and Mekinist

Before starting treatment, t ell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. Keep a list of the medicines you take, so you can show it to your doctor, pharmacist or nurse when you get a new medicine.

Mekinist with food and drink It is important to take Mekinist on an empty stomach because food affects the way the medicine is absorbed into your body (see section 3).

Pregnancy, breast -feeding and fertility Mekinist is not recommended for use during pregnancy.

• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Mekinist can harm the unborn baby.
• If you are a woman who could become pregnant, you must use reliable birth control (contraception) while you are taking Mekinist and for at least 16 weeks after you stop taking it.
• Birth control using hormones (such as pills, injections or patches) may not work as well if you are taking Mekinist in combination with dabrafenib . You need to use another effective method of birth control so you do not become pregnant while you are taking this combination of medicine s. Ask your doctor, pharmacist or nurse for advice.
• If you do become pregnant while you are taking Mekinist, tell your doctor immediately.

Mekinist is not recommended while breast -feeding It is not known whether the ingredients of Mekinist can pass into breast milk.

If you are breast -feeding, or planning to breast -feed, you must tell your doctor. It is recommended that you do not breast -feed while you are taking Mekinist. You and your doctor will decide whether you will take Mekinist or breast -feed.

Fertility – both 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 who are taking dabrafenib may have a reduced sperm count , and their sperm count may not return to normal levels after they stop taking this medicine.

Prior to starting treatment with dabrafenib, talk to your doctor about options to improve your chances to have children in the future.

If you have any further questions on the effect of this medicine on fertility , ask your doctor, pharmacist or nurse.

Driving and using machines

Mekinist can have side effects that may affect your ability to drive or use machines. Avoid driving or using machines if you feel tired or weak, if you have problems with your vision or if your energy levels are low.

Descriptions of these effects can be found in other sections (see section s 2 and 4). Read all the informatio n in this leaflet for guidance.

Discuss with your doctor, pharmacist or nurse if you are unsure about anything. Your disease symptoms and treatment situation may also affect your ability to drive or use machines.

Mekinist contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium – free’.

💊 3. How to take Mekinist

Always take this medicine exactly as your doctor , pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to take Adults

• The usual dose of Mekinist is one 2 mg tablet once a day regardless of body weight .

Adolescents ( 12 to less than 18 years of age )

• Your doctor will decide on the correct dose of Mekinist for you based on your body weight .

Your doctor may decide to lower the dose if you get side effects .

Don’t take more Mekinist than your doctor has recommended , since this may increase the risk of side effects .

How to take it Swallow the tablet whole , with a full glass of water .

Take Mekinist once a day, on an empty stomach (at least 1 hour before a m eal 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 about the same time each day.

61 If you take more Mekinist than you should If you take too many tablets of Mekinist, contact your doctor, pharmacist or nurse for advice. If possible, show them the Mekinist pack and this leaflet.

If you forget to take Mekinist

If the missed dose is less than 12 hours late, take it as soon as you remember.

If the missed dose is more than 12 hours late, skip that dose and take your next dose at the usual time.

Then carry on taking your ta blets at regular times as usual.

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

If you stop taking Mekinist

Take Mekinist for as long as your doctor recommends. Do not stop unless your doctor advises you to.

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

How should you take Mekinist in combination with dabrafenib

• Take Mekinist in combination with dabrafenib exactly as your doctor, pharmacist or nurse tells you. Do not change your dose or stop Mekinist or dabrafenib unless your doctor, pharmacist or nurse tells you to.
• Take Mekinist once daily and take dabrafenib twice daily . It may be good for you to get into the habit of taking both medicines at the same times each day. Mekinist should be taken with either the morning dose of dabrafenib or the evening dose of dabrafenib. The dabrafenib doses should be about 12 hours apart.
• Take Mekinist and dabrafenib on an empty stomach, at least one hour before or two hours after a meal. Take 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 missed doses and just take your next dose at your regular time: o If it is less than 12 hours to your next scheduled dose of Mekinist, which is taken once daily. o If it is less than 6 hours to your next scheduled dose of dabrafenib, which is taken twice daily.
• If you take too much Mekinist or dabrafenib, immediately contact your doctor, pharmacist or nurse . Take Mekinist tablets and dabrafenib capsules with you when possible. If possible, show them the Mekinist and dabrafenib pack with each leaflet.
• If you get side effects your doctor may decide that you should take lower doses of Mekinist and dabrafenib. Take the doses of Mekinist and dabrafenib exactly as your doctor, pharmacist or nurse tells you.

❗ 4. Possible side effects

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

Possible s erious side effects Heart conditions Mekinist can affect how well your heart pumps blood . It is more likely to affect p eople who have an existing heart problem. You will be checked for any heart problems while you are taking Mekinist.

Signs and symptoms of heart problems include:

• feeling like your heart is pounding, racing, or beating irregularly
• dizziness
• tiredness
• feeling lightheaded
• shortness of breath
• swelling in the legs Tell your doctor as soon as possible if you get any of these symptoms, either for the first time or if they get worse.

High blood pressure Mekinist can cause new or worsening high blood pressure (hypertension). Your doctor or nurse should check your blood pressure during treatment with Mekinist. Call your doctor or nurse right away if you develop high blood pressure, your blood pressure worse ns, or you have severe headache, light – headedness, or dizziness.

Bleeding problems Mekinist can cause serious bleeding problems, especially in your brain o r stomach . Call your doctor or nurse and get medical help right away if you have any unusual signs of bleeding, including:

• headaches, dizziness, or weak ness
• cough ing up of blood or blood clots
• vomit containing blood or that looks like “coffee grounds”
• red or black stools that look like tar Eye ( vision) problems Mekinist can cause eye problems. Mekinist is not recommended if you have ever had a blockage of the vein draining the eye (retinal vein occlusion). Your doctor may advise an eye examination before you take Mekinist and while you are taking it. Your doctor may ask you to stop taking Mekinist or refer you to a specialist, if you develop sig ns and symptoms in your vision that include:
• loss of vision
• eye redness and irritation
• colour ed dots in your vision
• halo (seeing a blurred outline around objects)
• blurred vision Changes in your s kin Serious skin reactions have been reported in people taking Mekinist in combination with dabrafenib (frequency not known). If you notice any of the following:
• reddish patches on the trunk that are circular or target -shaped, with central blisters. Skin peeling. Ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu -like symptoms (Stevens -Johnson syndrome).
• widespread rash, fever, and enlarged lymph nodes (DRESS -syndrome or drug hypersensitivity syndrome).

➔ stop using the medicine and seek medical attention 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 local and can be removed with surgery and treatment with Mekinist and dabrafenib can be continued without interruption.

Some people taking Mekinist in combination with dabrafenib may also notice that new melanomas have appeared . These melanomas are usually removed by surgery and treatment with Mekinist and dabrafenib can be continued without interruption .

Your doctor will check your skin before you start taking dabrafenib , then check it again every month while you are taking dabrafenib and for 6 months after you stop taking it. This is to look for any new skin cancers .

Your doctor will also check your head, neck, mouth and lymph glands and you will have scans of your chest and stomach area (called CT scans) regularly. You may also have blood tests. These checks are to detect if any other cancer, including squamous cell carcinoma, develops inside your body. Pelvic examinations (for women) and anal examinations are also recommended before and at the end of your treatment.

Mekinist as monotherapy or in combination with dabrafenib can cause rash or acne -like rash. Follow your doctor’s instructions for what to do to help prevent rash. Tell your doctor or nurse as soon as possible if you get any of these symptoms for the first time or if they get worse.

Contact your doctor immediately if you get a severe skin rash with any of the following symptoms: blisters on your skin, blisters or sores in your mouth, peeling of your skin, fever, redness or swelling of your face, or soles of your feet.

Tell your doctor or nurse as soon as possible if you get any skin rash, or if you have a rash that gets worse.

Muscle pain Mekinist can result in the b reakdown of muscle (rhabdomyolysis) . Tell your doctor or nurse if you have any new or worsening symptoms , including:

• muscle pain
• dark urine due to kidney damage Lung or breathing problems Mekinist can cause i nflammation of the lung (pneumonitis or interstitial lung disease) . Tell your doctor or nurse if you have any new or worsening symptoms of lung or breathing problems, including:
• shortness of breath
• cough
• fatigue Immune system disorders If you experience multiple symptoms such as fever, swollen lymph glands, bruising or skin rash, at the same time, tell your doctor immediately. These may be sign s of a condition where the immune system makes too many infection -fighting cells called histiocytes and lymphocytes that may cause various symptoms (haemophagocytic lymphohistiocytosis), see section 2 (frequency rare).

Tumour lysis syndrome Tell your doctor immediately i f you experience the following symptoms : nausea, shortness of breath, irregular heartbeat, muscular cramps, seizures, clouding of urine, decrease in urine output and tiredness . These may be signs of a condition resulting from a rapid breakdown of cancer cells which in some people may be fatal (tumour lysis syndrome or TLS), see section 2 (frequency not known).

Possible side effects in patients taking Mekinist alone The side effects that you may see when you take Mekinist alone are as follows:

Very common side effects (may affect more than 1 in 10 people )

• High blood pressure (hypertension)
• Bleeding, at various sites in the body, which may be mild or serious
• Cough
• Shortness of breath
• Diarrhoea
• Feeling sick (nausea), being sick (vomiting)
• Constipation
• Stomach ache
• Dry mouth 64 • Skin rash, acne -like rash, redness of the face, dry or itching skin (see also “ Changes in your skin” earlier in section 4)
• Unusual hair loss or thinning
• Lack of energy or feeling weak or tired
• Swelling of the hands or feet (oedema peripheral)
• Fever

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

• Abnormal blood test results related to the liver

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

• Inflammation of hair follicles in the skin
• Nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles
• Infection of the skin (cellulitis)
• Skin rash with pus -filled blisters (see also “Changes in your skin ” earlier in section 4)
• Allergic reaction (hypersensitivity)
• Dehydration (low levels of water or fluid)
• Blurred vision
• Swelling around the eyes
• Eyesight problems (see also “Eye (vision) problems” earlier in section 4)
• Changes in how the heart pumps blood (left ventricular dysfunction) (see also “Heart conditions” earlier in section 4)
• Heart rate that is lower than the normal range and/or a decrease in heart rate
• Localised tissue swelling
• Inflammation of the lung (pneumonitis or interstitial lung disease)
• Sore mouth or mouth ulcers, inflammation of mucous membranes
• Reddening, chapping or cracking of the skin
• Red, painful hands and feet
• Swelling of the face
• Inflammation of the mucosa
• Feeling weak
• Problem with the nerves that can produce pain, loss of sensation or tingling in hands and feet and/or muscle weakness (peripheral neuropathy)

Common side effects that may show up in your blood tests

• Decreased red blood cells (anaemia) , abnormal test related to creatine phosphokinase, an enzyme found mainly in heart, brain, and skeletal muscle

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

• Swelling in the eye caused by fluid leakage (chorioretinopathy) (see also “Eye (vision) problems ” earlier in section 4)
• Swelling of nerves at the back of the eye (papilloedema) (see also “Eye (vision) problems ” earlier in section 4)
• Separation of the light -sensitive membrane in the back of the eye (the retina) from its supporting layers (retinal detachment) (see also “Eye (vision) problems ” earlier in section 4).
• Blockage of the vein draining the eye (retinal vein occlusion) (see also “Eye (vision) problems” earlier in section 4)
• Heart pumping less efficiently, causing shortness of breath, extreme tiredness and swelling in ankles and legs (heart failure)
• A hole (perforation) in the stomach or intestines
• Inflammation of the intestines (colitis)
• Breakdown of muscle which can cause muscle pain and kidney damage (rhabdomyolysis)

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

• Irregular heartbeat (atrioventricular block) Side effects when Mekinist and dabrafenib are taken together When you take Mekinist and dabrafenib together you may get any of the side effects given in the lists above, although the frequency may change (increase or decrease).

You may also get additional side effects due to taking dabrafenib at the same time as Mekinist in the list below.

Tell your doctor as soon as possible if you get any of these symptoms, either for the first time or if they get worse.

Please read the dabrafenib Package Leaflet for details of the side effects you may get when taking this medicine.

The side effects that you may see when you take Mekinist in combination with dabrafenib are as follows:

Very common side effects ( may affect more than 1 in 10 people)

• Nasal and throat inflammation
• Urinary tract infection
• Decreased appetite
• Headache
• Dizziness
• High blood pressure (hypertension)
• Bleeding , at various sites in the body, which may be mild or serious (haemorrhage)
• Cough
• Stomach ache
• Constipation
• Diarrhoea
• Feeling sick (nausea), being sick (vomiting)
• Rash, dry skin, itching, skin reddening
• Acne -like problems (dermatitis acneiform)
• Joint pain, muscle pain, or pain in the hands or feet
• Muscle spasms
• Lack of energy, feeling we ak
• Chills
• Swelling of the hands or feet (oedema peripheral)
• Fever
• Flu-like illness

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

• Abnormal blood test results related to the liver
• Low levels of white blood cells (neutropenia)
• Decrease in number of red blood cells (anaemia)

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

• Skin effects including infection of the skin (cellulitis), inflammation of hair follicles in the skin, nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles, skin rash with pus -filled blisters , cutaneous squamous cell carcinoma (a type of skin cancer), papilloma (a type of skin tumour which is usually not harmful), wart -like growths , increased sensitivity of the skin to sun (see also “ Changes in your skin ” earlier in section 4)
• Dehydration (low levels of water or fluid)
• Blurred vision, eyesight problems , inflammation of the eye (uveitis)
• Heart pumping less efficiently 66 • Heart rate that is lower than the normal range and/or a decrease in heart rate (bradycardia)
• Low blood pressure (hypotension )
• Localised tissue swelling
• Inflammation of the lung (pneumonitis)
• Shortness of breath
• Dry mouth
• Sore mouth or mouth ulcers, inflammation of mucous membranes
• Inflamed, flaky skin (exfoliative dermatitis)
• Thickening of the outer layer of the skin (hyperkeratosis) , patches of thick, scaly, or crusty skin (actinic keratosis), chapping or cracking of the skin
• Increased sweating, n ight sweats
• Unusual hair loss or thinning
• Red, painful hands and feet
• Inflammation of the fatty layer under the skin (panniculitis)
• Kidney failure (renal failure)
• Severely decreased urine output (acute kidney injury)
• Inflammation of the mucosa
• Swelling of the face
• Problem with the nerves that can produce pain, loss of sensation or tingling in hands and feet and/or muscle weakness (peripheral neuropathy)

Common side effects that may show up in your blood tests

• Decrease in blood platelets (cells that help blood to clot) and a type of white blood cells (leukopenia)
• Low levels of sodium (hyponatraemia) or phosphate (hypophosphataemia) in the blood
• Increase in blood sugar level
• Increase in creatine phosphokinase, an enzyme found mainly in heart, brain, and skeletal muscle
• Increase in some substances (enzymes) produced by the liver

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

• Appearance of new skin cancer ( melanoma )
• Skin tags
• Allergic reactions (hypersensitivity)
• Eye changes including swelling in the eye caused by fluid leakage (chorioretinopathy), separation of the light -sensitive membrane in the back of the eye (the retina) from its supporting layers (retinal detachment) and swelling around the eyes
• Breathlessness, difficulty breathing when lying down, swelling of the feet or legs as signs of heart muscle not pumping blood as well as it should (cardiac failure)
• Fatigue, feeling full or bloated, heart palpitations, loss of appetite, nausea, reduced ability to exercise, shortness of breath, swelling as signs of changes in the way that the heart pumps (left ventricular dysfunction)
• Irregular heartbeat (atrioventricular block)
• A hole (perforation) in the stomach or intestines (gastrointestinal perforation)
• Inflammation of pancreas
• Inflammation of the intestines (colitis)
• Inflammatory disease mainly affecting the skin, lung, eyes and lymph nodes (sarcoidosis)
• Raised, painful, red to dark reddish -purple skin patches or sores that appear mainly on the arms, legs, face and neck, with a fever (signs of acute febrile neutrophilic dermatosis)
• Abnormal breakdown of muscle causing pain, fever, red -brown urine (rhabdomyolysis)

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

• Cough, difficulty breathing, painful breathing (interstitial lung disease)
• Inflammation of the kidneys (nephritis) 67 Not known (frequency cannot be estimated from the available data):
• Inflammation of the heart muscle (myocarditis) which can result in breathlessness, fever, palpitations and chest pain.
• Skin reactions localised in tattoos

Additional side effects in adolescents

Very common side effects ( may affect more than 1 in 10 people)

• Increase in w eight (abnormal weight gain)

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.

🌡️ 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 bottle label and carton after EXP .

The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture.

Keep the bottle tightly closed with the dessicant inside (small cylinder -shaped container ).

Before opening: This medicine does not require any special temperature storage conditions.

After opening: Store at not more than 30°C. Use within 30 days of opening.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Mekinist contains

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

What Mekinist looks like and contents of the pack

The Mekinist 0.5 mg film -coated tablets are yellow, modified oval, biconvex, with the company logo debossed on one face and “TT” on the opposing face.

The Mekinist 2 mg film -coated tablets are pink, round, biconvex, with the company logo debossed on one face and “LL” on the opposing face.

The film -coated tablets are supplied in opaque white plastic bottles with threaded plastic closures. One bottle contains either 7 or 30 tablets.

68 The bottles also include a silica gel desiccant in a small cylinder -shaped container. The desiccant must be kept inside the bottle and must not be eaten.

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 Glaxo Wellcome, S.A.

Avda. Extremadura, 3 09400, Aranda de Duero Burgos Spain Novartis Pharma GmbH Sophie -Germain -Strasse 10 90443 Nuremberg Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50 България Novartis Bulgaria EOOD Тел: +359 2 489 98 28 Luxembourg/Luxemburg Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11 Česká republika Novartis s.r.o.

Tel: +420 225 775 111 Magyarország Novartis Hungária Kft.

Tel.: +36 1 457 65 00 Danmark Novartis Healthcare A/S Tlf.: +45 39 16 84 00 Malta Novartis Pharma Services Inc.

Tel: +356 2122 2872 Deutschland Novartis Pharma GmbH Tel: +49 911 273 0 Nederland Novartis Pharma B.V.

Tel: +31 88 04 52 111 69 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810 Norge Novartis Norge AS Tlf: +47 23 05 20 00 Ελλάδα Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12 Österreich Novartis Pharma GmbH Tel: +43 1 86 6570 España Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00 Polska Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888 France Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00 Portugal Novartis Farma – Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600 Hrvatska Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220 România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 Ireland Novartis Ireland Limited Tel: +353 1 260 12 55 Slovenija Novartis Pharma Services Inc.

Tel: +386 1 300 75 50 Ísland Vistor ehf.

Sími : +354 535 7000 Slovenská republika Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439 Italia Novartis Farma S.p.A.

Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200 Κύπρος Novartis Pharma Services Inc.

Τηλ: +357 22 690 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 00 Latvija SIA Novartis Baltics Tel: +371 67 887 070

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu .

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Mekinist (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/14/931).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.