0.5 and 2 mg film-coated tablets
trametinib
What Mekinist is and what it is used for
Mekinist is a medicine that contains the active substance trametinib. It is used either alone or in combination with another medicine containing dabrafenib to treat melanoma, a type of skin cancer, which has spread to other parts of the body or which cannot be removed by surgery.
Machinist in combination with dabrafenib is also used to prevent melanoma from returning after surgery.
Machinist 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 change ( mutation ) in a gene called BRAF at the V600 position. This gene mutation may be the cause of cancer development. This drug targets proteins produced by this mutated gene and delays or stops the development of cancer.
What you need to know before taking Mekinist
Mechanics should only be used to treat melanoma and NSCLC with BRAF mutation one. Therefore, before starting your treatment, your doctor will test if you have this mutation.
If your doctor prescribes combination therapy with Mekinist and dabrafenib, read the dabrafenib package leaflet carefully, as well as this leaflet.
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
Do not take Mekinist
- if you are allergic to trametinib or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor if you think this applies to you.
Warnings and cautions
Talk to your doctor before taking your medicine. Your doctor needs to know if you:
- have liver problems . Your doctor may take blood samples to check your liver function while you are taking this medicine.
- have or have had kidney problems .
- have or have had problems with the lungs or breathing.
- have heart problems such as heart failure (which can cause shortness of breath, difficulty breathing when lying down, swollen feet or legs) or problems with how the heart beats. Your doctor should check your heart function before and during treatment.
- have eye problems including blockage of the vein that drains the eye (retinal vein occlusion) or swelling in the eye that may be caused by fluid leakage (chorioretinopathy).
Before taking Mekinist in combination with dabrafenib, your doctor needs to know if you:
- have had any type of cancer other than melanoma or NSCLC , as you may be at greater risk of developing other types of cancer than skin cancer when you take Mekinist.
Talk to your doctor if you think any of these problems may apply to you.
Symptoms you need to be aware of
Some people who take Mekinist get other problems that can be serious. You need to know what important symptoms you need to be aware of.
Bleeding
Taking Mekinist or combination therapy with Mekinist and dabrafenib can cause severe bleeding in your brain, digestive system (such as stomach, rectum, and intestines), lungs, and other organs, and can be fatal. Symptoms of bleeding may be:
- headache, dizziness or feeling tired
- blood in the stool or black stools
- blood in the urine
- abdominal pain
- blood in vomiting / vomiting
Tell your doctor as soon as possible if you get any of these symptoms.
Fever
Taking Mekinist or combination therapy with Mekinist and dabrafenib may cause fever, although you are more likely to take the combination therapy (see also section 4). In some cases, people with fever may have low blood pressure, dizziness, or other symptoms.
Tell your doctor immediately if you get a temperature above 38 ºC or if you feel feverish while taking this medicine.
Heart problems
Mekinist may cause heart problems or aggravate existing heart problems (see also “Heart problems” in section 4), in people taking Mekinist in combination with dabrafenib.
Tell your doctor if you have any heart disease. Your doctor will perform various tests to check that your heart is functioning properly, both before and during your treatment with the medicine. Tell a doctor immediately if it feels like the heart is pounding hard, the heartbeat is fast or irregular, or if you feel dizzy, tired or dizzy, short of breath, or if your legs are swollen. The doctor may decide to pause the treatment or stop it altogether if necessary.
Changes in your skin that may indicate new skin cancer
Your doctor will check your skin before you start taking this medicine and at regular intervals while you are taking it. Tell your doctor immediately if you notice any skin changes while you are taking this medicine or after treatment (see also section 4).
Eye problems
Your doctor should examine your eyes while you are taking this medicine.
Tell your doctor immediately if your eyes become red and irritated, if you experience blurred vision, eye pain, or other vision changes during treatment (see also section 4).
Mechanics can cause eye problems, including blindness. Mekinist is not recommended if you have had a clot in the vein that carries blood from the eye (retinal vein occlusion). Tell your doctor immediately if you get the following eye symptoms: blurred vision, vision loss or other vision changes, colored dots in your field of vision, or halophenoma (light rings around objects) during your treatment. The doctor may decide to pause the treatment or stop it altogether if necessary.
Liver problem
Machinist, or the combination with dabrafenib, can cause problems with your liver that can develop into serious conditions such as hepatitis (liver inflammation) and liver failure, which can be fatal. Doctors will check you at regular intervals. Signs that your liver is not working properly can be:
- loss of appetite
- nausea
- vomiting
- stomach ache (abdomen)
- yellowish color on the skin or whites of the eyes (jaundice)
- dark-colored urine
- skin itching
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 breathing problems often accompanied by dry cough, shortness of breath, and fatigue. Your doctor may order an examination of your lung function before you start taking your medicine.
Muscle pain
The mechanism can result in muscle breakdown ( rhabdomyolysis ). Tell your doctor as soon as possible if you get any of these symptoms:
- muscle aches
- dark-colored urine due to kidney damage
If necessary, your doctor may need to temporarily discontinue or discontinue your treatment altogether.
- Read the information under “Possible serious side effects” in section 4 of this leaflet.
Holes in the stomach or intestine (perforation)
Taking Mekinist or the combination of Mekinist and dabrafenib may increase the risk of developing cavities in the intestinal wall. Tell your doctor as soon as possible if you have severe abdominal pain.
Severe 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 in your skin (see section 4 for symptoms to be aware of).
An inflammatory disease that mainly affects the skin, lungs, eyes, and lymph nodes
An inflammatory disease that mainly affects the skin, lungs, eyes, and lymph nodes ( sarcoidosis ). Common symptoms of sarcoidosis can be cough, shortness of breath, swollen lymph nodes, visual disturbances, fever, fatigue, pain, swelling in the joints, and sore lumps in the skin. Tell your doctor if you get any of these symptoms.
Children and young people
Mekinist is not recommended for children and adolescents as the effects of Mekinist in people under 18 years of age are not known.
Other medicines and Mekinist
Before starting treatment, tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines.
Make a list of which medicines you are taking so you can show it to your doctor, nurse, or pharmacist when you receive a new medicine.
Mechanic with food and drink
You must take Mekinist on an empty stomach, as food affects how the medicine is absorbed into the body (see section 3).
Pregnancy, breastfeeding and fertility
Mekinist is not recommended 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. Mechanics can harm the unborn baby.
- If you are a woman and could become pregnant, you must use a reliable contraceptive while you are taking Mekinist and for at least 16 weeks after the end of treatment.
- Contraceptives that contain hormones (such as pills , syringes and patches ) may not work well if you take Mekinist in combination with dabrafenib. You must use another effective method of contraception so that you do not become pregnant while taking this combination of medicines. Consult a doctor, nurse or pharmacist.
- If you become pregnant while taking Mekinist, tell your doctor immediately.
Mekinist is not recommended during breast-feeding
It is unknown whether the ingredients in Mekinist can pass into breast milk.
If you are breastfeeding or planning to breastfeed, tell your doctor. It is recommended that you do not breastfeed while taking Mekinist. You and the doctor decide whether to take Mekinist or breastfeed.
Fertility – refers to both men and women
Mechanics can impair fertility in both men and women.
Taking Mekinist with dabrafenib: Dabrafenib may permanently reduce male fertility. In addition to this, men taking dabrafenib may have a reduced sperm count and it is uncertain whether the sperm count will return to normal levels after stopping treatment.
Talk to your doctor before starting treatment about what opportunities there are to improve your chances of having children in the future.
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
Driving and using machines
Mechanics can have side effects that can affect your ability to drive and use machines. Avoid driving a vehicle or using machines if you feel tired or weak, if you have vision problems or if you feel powerless.
Descriptions of these effects can be found in other sections (see sections 2 and 4).
Read all information in this leaflet for guidance.
If you have any further questions, ask your doctor, nurse, or pharmacist. Your disease symptoms and treatment situation can also affect your ability to drive and use machines.
Mekinist contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to take Mekinist
Always take this medicine exactly as your doctor, nurse or pharmacist has told you. If you are not sure, talk to your doctor, nurse, or pharmacist.
How much to take
The usual dose of Mekinist either alone or in combination with dabrafenib is a 2 mg tablet once daily. The recommended dose is one of dabrafenib, in combination with Mekinist, 150 mg twice daily.
Your doctor may decide to reduce your dose if you experience side effects.
Do not take more Mekinist than your doctor recommends, as it may increase the risk of side effects.
How to take Mekinist
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 meal or 2 hours after a meal). It means:
- you must wait at least 1 hour after taking Mekinist before eating anything, or
- you must wait at least 2 hours after eating before taking Mekinist.
Take Mekinist at about the same time each day.
If you take more Mekinist than you should
If you have taken too many Mekinist tablets, consult your doctor, nurse, or pharmacist. If possible, show them the package with Mekinist and this leaflet.
If you forget to take Mekinist
If it has been less than 12 hours since you should have taken a dose, take it as soon as you remember.
If it has been more than 12 hours since you should have taken one dose, skip it and take the next dose at the usual time. Then continue to take your tablets regularly 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 tells you to.
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
How to take Mekinist in combination with dabrafenib
- Take Mekinist in combination with dabrafenib according to your doctor’s, nurse’s or pharmacist’s instructions. Do not change dose or stop taking Mekinist or dabrafenib unless your doctor, nurse or pharmacist tells you to.
- Take Mekinist once daily and dabrafenib twice daily. It may be helpful for you to get into the habit of taking both of your 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. The dose of dabrafenib should be taken at intervals of approximately 12 hours.
- Take Mekinist and dabrafenib on an empty stomach, at least 1 hour before and 2 hours after a meal. The capsules and tablets should be swallowed whole with a full glass of water.
- If you forget to take a dose of Mekinist or dabrafenib, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose , but take your next dose at your usual time:
- If it is less than 12 hours until your next scheduled dose of Mekinist, taken once daily.
- If it is less than 6 hours until your next scheduled dose of dabrafenib, taken twice daily.
- If you take more Mekinist or dabrafenib than you should, contact a doctor, nurse or pharmacist immediately. If possible, take your Mekinist tablets and dabrafenib capsules with you. If possible, show Mekinist and dabrafenib drug packs with package leaflets.
- If you get side effects , your doctor may decide to take lower doses of Mekinist and dabrafenib. Take the doses of Mekinist and dabrafenib exactly according to your doctor’s, nurse’s or pharmacist’s instructions.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Any serious side effects ar
Heart problems
A mechanic can affect your heart’s pumping ability. This is more likely to affect people who already have heart problems. While taking Mekinist you will be checked for heart problems. Signs and symptoms of heart problems include:
- feeling that your heart is beating hard, fast or irregularly
- dizziness
- fatigue
- you feel dizzy
- shortness of breath
- swollen legs.
Tell your doctor as soon as possible if you get any of these symptoms, whether it’s your first time or if they get worse.
High blood pressure
Mechanics can cause or worsen high blood pressure ( hypertension ). Your doctor or nurse should check your blood pressure during treatment with Mekinist. Contact a doctor or nurse immediately if you develop high blood pressure, your blood pressure drops, or if you experience severe headaches, dizziness or dizziness.
Problems with bleeding
Mekinist can cause severe bleeding, especially in your brain or stomach. Contact your doctor or nurse for immediate medical attention if you experience any signs of bleeding, such as:
- headache, dizziness or feeling weak
- you cough up blood or clotted blood
- vomiting that contains blood or that looks like coffee grounds
- red feces or feces that are black as tar.
Eye/vision problems
The mechanic can cause eye problems. Mekinist is not recommended if you have had a clot in the vein that carries blood from the eye (retinal vein occlusion). Your doctor may recommend an eye examination before taking Mekinist and while you are taking it. Your doctor may recommend that you stop taking Mekinist or refer you to a specialist if you experience signs and symptoms related to your vision, such as:
- vision loss
- red and irritated eyes
- colored dots in the field of view et
- halofenomen (light rings around objects)
- dimsyn.
Skin changes
Serious skin reactions have been reported in people taking Mekinist in combination with dabrafenib (occurs in an unknown number of users). If you notice any of the following:
- reddish spots on the torso that are round or target-like, with blisters in the middle. Skin detachment. Sores in the mouth, throat, nose, around the genitals and in the eyes. These severe skin rashes may 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 contact a doctor immediately or see the nearest emergency department.
Up to 3 out of 100 people treated with Mekinist in combination with dabrafenib can get a form of skin cancer called cutaneous squamous cell carcinoma (SCC). Others can get a form of skin cancer called basal cell carcinoma (BCC). Usually, these forms of skin cancer are 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 melanoma has developed. These melanomas are usually removed with surgery and treatment with Mekinist and dabrafenib can be continued without interruption.
Your doctor will examine your skin before you start taking dabrafenib, then your skin will be examined every month during the entire dabrafenib treatment and for 6 months after it has been stopped. This is done to detect any new skin cancer.
Your doctor will also examine your head, neck, mouth and your lymph nodes and your chest and abdomen will be regularly x-rayed ( computed tomography ). Blood samples may also be taken. The tests are to find out if any other type of cancer, including squamous cell carcinoma, is developing in your body. Examination of the pelvis (for women) and rectum is also recommended before and after treatment.
Machinists, as monotherapy or in combination with dabrafenib, may cause a rash or acne-like rash. Follow your doctor’s instructions on how to 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 rash with any of the following symptoms: blisters on the skin, blisters or sores in the mouth, skin flaking, fever, redness or swelling of the face or soles of the feet.
Tell your doctor or nurse as soon as possible if you get a rash or if the existing rash gets worse.
Muscle pain
Mechanics can cause muscles to break down ( rhabdomyolysis ). Tell your doctor or nurse if you have any new or worsening symptoms such as:
- muscle pain
- dark-colored urine due to kidney damage.
Problems with the lungs or breathing
Mechanics can cause inflammation of the lungs ( pneumonitis or interstitial lung disease). Tell your doctor or nurse if you have any new symptoms of lung or respiratory problems or worsening of previous symptoms, such as:
- shortness of breath
- cough
- fatigue.
Possible side effects are in patients taking Mekinist alone
Side effects that you may notice 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 in various places in the body, which can be mild or severe
- Cough
- Shortness of breath
- Diarrhea
- Nausea and vomiting
- Constipation
- Stomach pain
- Dry mouth
- Skin rash, acne-like rash, flushing, dry or itchy skin (see also “Skin changes” earlier in section 4)
- Unusual hair loss or thinning hair
- Lack of energy, feeling weak or tired
- Swollen hands or feet (peripheral edema )
- Fever
Very common side effects can be seen in blood tests
- Abnormal liver values
Common side effects (may affect up to 1 in 10 people):
- Inflammation of the skin hair follicles
- Nail problems such as changes in the nail bed , nail pain, infected and swollen cuticles
- Skin infection ( cellulite )
- Skin rash with blisters (see also “Skin changes” earlier in section 4)
- Allergic reaction (hypersensitivity)
- Dehydration (low water or liquid content)
- Dimsyn
- Swelling around the eyes
- Vision problems (see also “Eye / vision problems” earlier in section 4)
- Altered pumping capacity of the heart (left ventricular dysfunction) (see also “Heart problems” earlier in section 4)
- Pulse that is lower than the normal range and / or a decrease in heart rate
- Local tissue swelling
- Inflammation of the lungs ( pneumonitis or interstitial lung disease)
- Soreness in the oral cavity or sores in the mouth, inflamed mucous membranes
- Redness , chapped or cracked skin
- Reddened, painful hands and feet
- Swelling of the face
- Inflammation of the mucous membrane
- Feeling weak
Common side effects can be seen in blood tests
- Decreased red blood cell count ( anemia ), abnormal test value for creatine phosphokinase, an enzyme found mainly in the heart, brain and skeletal muscles
Uncommon side effects (may affect up to 1 in 100 people)
- Swollen eye due to fluid leakage (chorioretinopathy) (see also “Eye / vision problems” earlier in section 4)
- Swollen nerves in the back of the eye (papillary edema) (see also “Eye / vision problems” earlier in section 4)
- Release of the photosensitive layer at the back of the eye (retina) from the underlying layers (retinal detachment) (see also “Eye / vision problems” earlier in section 4)
- Clot in the vein that carries blood from the eye (retinal vein occlusion) (see also “Eye / vision problems” earlier in section 4)
- Impaired pumping capacity of the heart, leading to shortness of breath, pronounced fatigue and swollen ankles and legs ( heart failure )
- A hole (perforation) in the stomach or intestines
- Inflammation of the intestines ( colitis )
- Muscle breakdown, which can cause muscle pain and kidney damage ( rhabdomyolysis )
If you get any side effects, talk to your doctor, nurse, or pharmacist. This also applies to side effects that are not mentioned in this information.
Side effects are when Mekinist and dabrafenib are taken together
When you take Mekinist and dabrafenib together you can get all of the side effects listed above but the frequency may change (increase or decrease).
You may also get additional side effects due to taking dabrafenib at the same time as Mekinist, see the listed side effects below.
Tell your doctor as soon as possible if you get any of these symptoms, whether it is the first time you have them or if they have worsened.
Please read the package leaflet for dabrafenib for details on the side effects that may occur when taking this medicine.
The side effects that you may experience while taking Mekinist in combination with dabrafenib are as follows:
Very common side effects (may affect more than 1 user in 10):
- Nasal and throat inflammation
- Decreased appetite
- Headache
- Dizziness
- High blood pressure
- Bleeding in various places in the body, which can be mild or severe
- Cough
- Stomach pain
- Constipation
- Diarrhea
- Nausea, vomiting
- Rash, dry skin, itching , reddening of the skin
- Joint pain, muscle aches or pain in the hands or feet
- Muscle twitching
- Lack of energy, feeling of weakness
- Overindulge
- Swollen hands or feet (peripheral edema )
- Fever
- Flu-like symptoms
Very common side effects can be seen in blood tests
- Abnormal liver values
Common side effects (may affect up to 1 in 10 people )
- Urinary tract infection
- Skin changes including skin infection ( cellulite ), inflammation of the hair follicles in the skin, nail side effects such as changes in the nail bed , pain in the nails, infection and swelling in the cuticles, skin rash with swollen blisters, cutaneous squamous cell carcinoma (a type of skin cancer), papilloma (a form of skin tumor usually harmless), wart-like growths, increased sun sensitivity of the skin (see also “Skin changes” earlier in section 4)
- Dehydration (low levels of water or liquid)
- Blurred vision, vision problems, inflammation of the eye ( uveitis )
- Reduced efficiency in the heart’s pumping ability
- Low blood pressure
- Localized tissue swelling
- Shortness of breath
- Dry mouth
- Cold sores or sores in the mouth, inflammation of the mucous membranes
- Acne-like problems
- Thickening of the outer layer of the skin ( hyperkeratosis ), patches of thick, scaly or rough skin ( actinic keratosis ), chapped skin or cracking of the skin
- Heavy sweating including night sweats
- Abnormal hair loss or thinning hair
- Reddened, painful hands and feet
- Inflammation of the fat layer under the skin (panniculitis)
- Inflammation of the mucous membrane
- Facial swelling
Common side effects can be seen in blood tests
- Low concentrations of white blood cells
- Decreased number of red blood cells ( anemia ), platelets (cells that help the blood to coagulate) and a type of white blood cell ( leukopenia )
- Low levels of sodium ( hyponatremia ) or phosphate ( hypophosphatemia ) in the blood
- Increased blood sugar levels
- Increase in creatine phosphokinase, an enzyme commonly found in the heart, brain and skeletal muscles
- Increase in certain substances ( enzymes ) produced by the liver
Uncommon side effects (may affect up to 1 in 100 people)
- Emergence of new skin cancer (malignant melanoma )
- Shafted skin flaps
- Allergic reactions (hypersensitivity)
- Changes in the eye including swelling of the eye caused by fluid leakage (chorioretinopathy), the photosensitive membrane in the back of the eye ( retina ) detaching from its supporting layer (retinal detachment) and swelling around the eyes
- Pulse that is lower than the normal range and / or a decrease in heart rate
- Pneumonia _ _ _
- Pancreatitis inflammation
- Inflammation of the intestines ( colitis )
- Kidney failure
- Kidney inflammation
- Inflammatory disease that mainly affects the skin, lungs, eyes and lymph nodes ( sarcoidosis )
Rare side effects (may affect up to 1 in 1,000 people)
- A hole (perforation) in the stomach or intestines
Has been reported (occurs in an unknown number of users)
- Inflammation of the heart muscle ( myocarditis ) which can result in shortness of breath, fever, palpitations and chest pain
- Severe dermatitis with dandruff (exfoliative dermatitis )
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 can and carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Store in the original package. Sensitive to light. Moisture sensitive.
Close the jar tightly with the desiccant inside (small cylindrical container).
Once opened, the jar can be stored at a maximum of 30 ° C for a maximum of 30 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is trametinib. One film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg or 2 mg trametinib.
- Other ingredients are:
- Tablet: mannitol (E421), microcrystalline cellulose (E460), hypromellose (E464), croscarmellose sodium (E468), magnesium stearate (E470b), sodium lauryl sulphate and colloidal silica (E551).
- Film coating: hypromellose (E464), titanium dioxide (E171), polyethylene glycol, yellow iron oxide (E172) (for 0.5 mg tablets), polysorbate 80 (E433) and red iron oxide (E172) (for 2 mg tablets).
What the medicine looks like and contents of the pack
Mekinist 0.5 mg film-coated tablets are yellow, modified oval, and biconvex, with the company logo embossed on one side and “TT” on the other.
Mekinist 2 mg film-coated tablets are pink, round, and biconvex, with the company logo embossed on one side and “LL” on the other.
The film-coated tablets are packaged in opaque white plastic jars, with plastic screw caps. One can contain either 7 or 30 tablets.
The jars also contain silica gel desiccant in a small cylindrical container. The desiccant must not be removed from the jar and must not be eaten.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Lek Pharmaceuticals dd
Verovskova Ulica 57
1526, Ljubljana
Slovenia
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Glaxo Wellcome, SA
Avda. Extremadura, 3
09400, Aranda de Duero
Burgos
Spain
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50 |
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| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600 |
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| .ΠροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 | SwedenNovartis Sverige ABTel: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsTel: +371 67 887 070 | United Kingdom (Northern Ireland) |