FINLEE 10 mg DISPERSIBLE TABLETS

2. What you need to know before giving Finlee

Do not give Finlee

• to dabrafenib or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Consult your doctor before giving Finlee. The doctor needs to know if your child:

• has eye problems, such as blockage of the veins that supply the eye (retinal vein occlusion) or swelling of the eye that may be due to a blockage of fluid (chorioretinopathy).
• has heart problems, such as heart failure or problems with the way the heart beats.
• has or has had kidney problems.
• has or has had liver problems.
• has or has had lung or breathing problems, such as difficulty breathing, often accompanied by dry cough, shortness of breath, and fatigue.
• has or has had gastrointestinal problems, such as diverticulitis (inflamed pouches in the colon) or metastases in the gastrointestinal tract.

Before your child starts taking Finlee, during, and after treatment, the doctor will perform checks to prevent complications.

Skin Examination

Finlee may cause skin cancer. In general, these skin changes remain localized and can be removed by surgery, and treatment with Finlee can continue without interruption. The doctor may examine your child's skin before and regularly during treatment.

Check your child's skin monthly during treatment and for 6 months after stopping this medicine. Tell the doctoras soon as possible if you notice any changes in your child's skin, such as a new wart, skin sore, or a red lump that bleeds or does not heal, or a change in the size or color of a mole.

Tumor Lysis Syndrome

If your child experiences the following symptoms, tell the doctor immediately, as it may be a life-threatening condition: nausea, difficulty breathing, irregular heartbeats, muscle cramps, seizures, cloudy urine, decreased urine production, and fatigue. These may be caused by a group of metabolic complications that can occur during cancer treatment and are caused by the breakdown products of dying cancer cells (tumor lysis syndrome or TLS) and can cause changes in kidney function (see also section 4).

Children under 1 year of age

The effects of Finlee in children under 1 year of age are unknown. Therefore, Finlee is not recommended in this age group.

Patients over 18 years of age

Information on treatment in patients over 18 years of age with glioma is limited, so the doctor must assess the continuation of treatment until adulthood.

Other Medicines and Finlee

Before starting treatment, tell the doctor, pharmacist, or nurse if your child is taking, has recently taken, or might take any other medicines. This includes medicines bought without a prescription.

Some medicines may affect the way Finlee works or make it more likely that your child will have side effects. Finlee may also affect the way other medicines work. These include:

• medicines used for birth control (contraceptives) that contain hormones, such as the pill, injections, or patches
• medicines used to make the blood thinner, such as warfarin and acenocoumarol
• medicines used to treat heart conditions, such as digoxin
• medicines used to treat fungal infections, such as itraconazole, voriconazole, and posaconazole
• medicines used to treat Cushing's disease, such as ketoconazole
• certain medicines called calcium channel blockers used to treat high blood pressure, such as diltiazem, felodipine, nicardipine, nifedipine, or verapamil
• medicines used to treat cancer, such as cabazitaxel
• certain medicines used to lower fat (lipid) levels in the blood, such as gemfibrozil
• certain medicines used to treat certain psychiatric conditions, such as haloperidol
• certain medicines called antibiotics, such as clarithromycin, doxycycline, and telithromycin
• certain medicines used to treat tuberculosis, such as rifampicin
• certain medicines used to lower cholesterol levels, such as atorvastatin and simvastatin
• certain medicines called immunosuppressants, such as cyclosporin, tacrolimus, and sirolimus
• certain medicines called anti-inflammatory medicines, such as dexamethasone and methylprednisolone
• certain medicines used to treat HIV, such as ritonavir, amprenavir, indinavir, darunavir, delavirdine, efavirenz, fosamprenavir, lopinavir, nelfinavir, tipranavir, saquinavir, and atazanavir
• certain medicines used to help with sleep, such as diazepam, midazolam, zolpidem
• certain medicines used for pain relief, such as fentanyl or methadone
• medicines used to treat seizures (epileptic fits), such as phenytoin, phenobarbital, primidone, valproic acid, or carbamazepine
• medicines called antidepressants, such as nefazodone and St. John's Wort (Hypericum perforatum).

Consult your doctor, pharmacist, or nurseif your child is taking any of these medicines (or if you are not sure). Your doctor may consider adjusting the dose.

Pregnancy, Breast-feeding, and Fertility

Pregnancy

• If your daughter is pregnant or thinks she may be pregnant, consult a doctor or nurse before using this medicine. Finlee may harm the fetus.
• If your daughter becomes pregnant while taking this medicine, consult a doctor immediately.

Breast-feeding

It is not known if Finlee can pass into breast milk. If your daughter is breast-feeding or plans to breast-feed, she should inform her doctor. You, your daughter, and the doctor will decide whether to take Finlee or breast-feed.

Fertility

Finlee may reduce sperm count and may not return to normal levels until after stopping treatment with Finlee.

Taking Finlee with trametinib oral solution: Trametinib may affect fertility in both males and females.

Before starting treatment with Finlee, talk to the doctor about options to improve the chances of your child having children in the future.

Contraception

• If your daughter can become pregnant, she must use a reliable method of birth control (contraceptive) while taking Finlee in combination with trametinib oral solution and for at least 16 weeks after the last dose of Finlee and trametinib.
• Hormonal birth control methods (such as the pill, injections, or patches) may not be as effective when taking Finlee in combination with trametinib oral solution. Therefore, while taking this combination of medicines, your daughter needs to use another effective birth control method to avoid becoming pregnant. Consult a doctor or nurse.

Driving and Using Machines

Finlee may cause side effects that can affect your child's ability to drive, ride a bike, use machines, or participate in other activities that require being alert. If your child has vision problems or feels tired, weak, or lacks energy, they should avoid these types of activities.

The description of side effects can be found in section 4. For more information, read the entire package leaflet.

If you are not sure, talk to a doctor, pharmacist, or nurse. Your child's ability to perform these types of activities may also be affected by their own illness, symptoms, or treatment.

Finlee contains potassium

This medicine contains potassium, less than 1 mmol (39 mg) per maximum daily dose; this is essentially "potassium-free".

Finlee contains benzyl alcohol

This medicine contains less than 0.00078 mg of benzyl alcohol in each dispersible tablet.

Benzyl alcohol may cause allergic reactions.

Consult a doctor or pharmacist if your daughter is pregnant or breast-feeding. This is because large amounts of benzyl alcohol can accumulate in your daughter's body and cause side effects (metabolic acidosis).

Consult a doctor or pharmacist if your child has liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your child's body and cause side effects (metabolic acidosis).

3. How to give Finlee

Follow the instructions for giving this medicine to your child exactly as told by the doctor, pharmacist, or nurse. If you are unsure, consult the doctor, pharmacist, or nurse again.

How much to give

The doctor will decide the correct dose of Finlee based on your child's body weight.

The doctor will decide if your child needs to take a lower dose based on the side effects they experience.

How to give it

Read the instructions for use at the end of this leaflet for more information on how to prepare and give the dispersible tablet solution.

• Give Finlee twice a day. Giving Finlee at the same time every day will help you remember when to give the medicine. The doses of Finlee should be given 12 hours apart. Trametinib oral solution is only taken once a day. Give trametinib oral solution with either the morning or evening dose of Finlee.
• Give Finlee on an empty stomach, at least 1 hour before or 2 hours after a meal, which means:
• • after taking Finlee, your child must wait at least 1 hourbefore eating.
  • after eating, your child must wait at least 2 hoursbefore taking Finlee.
  • if necessary, breast milk and/or formula can be given on demand.

If you give too much Finlee

If you give too much Finlee, contact a doctor, pharmacist, or nurse immediately. If possible, show them the Finlee packaging with the package leaflet.

If you forget to give Finlee

If it has been less than 6 hours since the missed dose, give it as soon as you remember.

If it has been 6 hours or more since the missed dose, do not make up for the missed dose. Give the next dose at the usual time and then continue giving Finlee at the usual time.

Do not give a double dose to make up for missed doses.

If your child vomits after taking Finlee

If your child vomits after taking Finlee, do not give another dose until the next scheduled dose.

If you stop treatment with Finlee

Give Finlee for the time the doctor has told you. Do not stop treatment unless the doctor tells you to.

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

4. Possible Adverse Effects

Like all medicines, this medicine may cause adverse effects, although not all people suffer from them.

Stop giving this medicine and seek urgent medical attention if your child has any of the following symptoms:

• coughing up blood, blood in the urine, vomiting blood or if the vomit has the appearance of "coffee grounds", if they have red or black stools with a tar-like appearance. These may be signs of bleeding.
• fever (temperature of 38 °C or higher).
• chest pain or difficulty breathing, sometimes with fever or cough. These may be signs of pneumonitis or inflamed lungs (interstitial lung disease).
• blurred vision, loss of vision or other changes in vision. These may be signs of retinal detachment.
• redness of the eyes, eye pain, increased sensitivity to light. These may be signs of uveitis.
• unexplained muscle pain, muscle cramps or muscle weakness, dark urine. These may be signs of rhabdomyolysis.
• severe abdominal pain. This may be a sign of pancreatitis.
• fever, swelling of the lymph nodes, bruising or rash at the same time. These may be signs of a condition in which the immune system produces too many cells that fight infections, which can cause various symptoms (hemophagocytic lymphohistiocytosis).
• nausea, difficulty breathing, irregular heartbeats, muscle cramps, seizures, cloudy urine, decreased urine production and fatigue. These may be signs of a condition resulting from the rapid breakdown of cancer cells that in some people can be fatal (tumor lysis syndrome or TLS).
• red patches on the trunk, circular or target-like, with or without central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These may be signs of severe skin rashes, which can be life-threatening and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome), generalized rash, fever and swollen lymph nodes (DRESS).

Other possible adverse effects

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

• headache
• dizziness
• cough

• diarrhea, feeling of dizziness (nausea), discomfort (vomiting), constipation, stomach pain

• skin problems such as rash, acne-like rash, dry or itchy skin, redness of the skin
• wart-like growths (cutaneous papilloma)
• skin infection under the nails
• pain in arms or legs or joints
• lack of energy or feeling weak or tired
• weight gain
• upper respiratory tract infections with symptoms such as sore throat and nasal congestion (nasopharyngitis)

• increased liver enzymes in blood tests

• low levels of white blood cells (neutropenia, leucopenia)
• low levels of red blood cells (anemia)

Common(may affect up to 1 in 10 people)

• frequent urination with pain or burning sensation (urinary tract infection)
• skin effects including skin infection (cellulitis), inflammation of the hair follicles in the skin, inflamed and peeling skin (generalized exfoliative dermatitis), thickening of the outer layer of the skin (hyperkeratosis)
• decreased appetite
• low blood pressure (hypotension)
• high blood pressure (hypertension)
• shortness of breath
• mouth ulcers or mouth pain, inflammation of the mucous membranes
• inflammation of the fatty layer under the skin (panniculitis)
• unusual hair loss or thinning hair
• redness and pain in the hands and feet (hand-foot syndrome)
• muscle spasms
• chills
• allergic reaction (hypersensitivity)
• dehydration
• vision problems including blurred vision

• decreased heart rate (bradycardia)
• fatigue, chest discomfort, feeling of dizziness, palpitations (reduced ejection fraction)
• swelling of the tissues (edema)

• muscle pain (myalgia)
• fatigue, chills, sore throat, joint or muscle pain (flu-like illness)
• abnormal results of tests related to creatine phosphokinase, an enzyme found mainly in the heart, brain and skeletal muscle
• increased blood sugar levels
• low levels of sodium or phosphate in the blood
• decreased platelet count in the blood (cells that help blood clotting)
• increased sensitivity of the skin to the sun

Uncommon(may affect up to 1 in 100 people)

• irregular heartbeats (atrioventricular block)
• inflammation of the intestines (colitis)
• cracked skin
• night sweats
• excessive sweating
• raised, painful, red to dark purple skin patches or sores that appear mainly on the arms, legs, face and neck, with fever (signs of acute febrile neutrophilic dermatosis)

In addition to the adverse effects described above, the following adverse effects have only been reported in adult patients so far, although they may also occur in children:

• nervous system problems that can cause pain, numbness or tingling in the hands and feet and/or muscle weakness (peripheral neuropathy)
• dry mouth
• kidney failure
• benign skin tumor (acrocordon)
• inflammatory disease that mainly affects the skin, lungs, eyes and lymph nodes (sarcoidosis)
• kidney inflammation
• hole (perforation) in the stomach or intestines
• inflammation of the heart muscle that can cause difficulty breathing, fever, palpitations and chest pain

Reporting of adverse effects

If your child experiences any type of adverse effect, consult a doctor, pharmacist or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Finlee

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date that appears on the label of the bottle and on the packaging, after CAD. The expiry date is the last day of the month indicated.

Administer the solution no later than 30 minutes after the tablets have been dissolved.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Container Contents and Additional Information

Composition ofFinlee

• The active ingredient is dabrafenib. Each dispersible tablet contains dabrafenib mesylate equivalent to 10 mg of dabrafenib.
• The other ingredients are: mannitol (E 421), microcrystalline cellulose (E 460), crospovidone (E 1202), hypromellose (E 464), potassium acesulfame (E 950) (see section 2), magnesium stearate (E 470b), artificial berry flavor (maltodextrin, propylene glycol [E 1520], artificial flavors, triethyl citrate [E 1505], benzyl alcohol [E 1519] [see section 2]) and anhydrous colloidal silica (E 551).

Appearance of the Product and Container Contents

The Finlee 10 mg dispersible tablets are white to slightly yellow, round, 6 mm, marked with a "D" on one face and "NVR" on the other.

The bottles are made of plastic, white in color with plastic screw caps.

The bottles also include a silica gel desiccant in a small cylindrical container. These desiccants should be left inside the bottle and should not be ingested.

Finlee 10 mg dispersible tablets are available in containers containing 1 or 2 bottles (210 or 420 dispersible tablets) and 2 dosing cups.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526, Ljubljana

Slovenia

Novartis Pharmaceutical Manufacturing LLC

Verovškova ulica 57

1000, Ljubljana

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website: https://www.ema.europa.eu.

INSTRUCTIONS FOR USE