50 mg and 75 mg hard capsules
dabrafenib
What Tafinlar is and what it is used for
Tafinlar is a medicine that contains the active substance dabrafenib. It is used either alone or in combination with another medicine containing trametinib in adults to treat melanoma, a type of skin cancer, that has spread to other parts of the body or cannot be removed by surgery.
Tafinlar in combination with trametinib is also used to prevent melanoma from coming back after it has been surgically removed.
Tafinlar in combination with trametinib is also used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
Both cancers have a particular change ( mutation ) in a gene called BRAF at the V600 position. This gene mutation may be the reason why cancer has developed. This drug targets protein made by this mutated gene and delays or stops the development of cancer.
What you need to know before you take Tafinlar
Tafinlar should only be used to treat melanoma and NSCLC with a BRAF mutation. Before you start your treatment, the doctor will therefore test whether you have this mutation.
If the doctor prescribes combination therapy with Tafinlar and trametinib, read the package leaflet for trametinib carefully, as well as this leaflet.
If you have any further questions about this medicine, ask your doctor, nurse, or pharmacist.
Do not take Tafinlar
- if you are allergic to dabrafenib or any of the other ingredients of this medicine (listed in section 6).
Consult your doctor if you think this applies to you.
Warnings and precautions
Talk to your doctor before taking Tafinlar. The doctor needs to know if you:
- have some liver problems.
- have or have had any kidney problems. The doctor may need to take blood tests to check your liver and kidney function while you are taking Tafinlar.
- have had a type of cancer other than melanoma or NSCLC, as you may be at increased risk of developing other types of cancer while taking Tafinlar.
Before taking Tafinlar in combination with trametinib, your doctor needs to know if you:
- have heart problems such as heart failure or problems with the way the heart beats.
- have eye problems including blockage of the vein that drains the eye (retinal vein occlusion) or swelling of the eye which may be caused by fluid leakage (chorioretinopathy).
- have or have had problems with your lungs or breathing, including difficulty breathing often accompanied by a dry cough, shortness of breath, and tiredness.
- have or have had any problems with the stomach and intestines such as diverticulitis (inflamed pockets in the large intestine) or metastasis in the gastrointestinal tract.
Consult your doctor if you think any of these apply to you.
Symptoms you may need to watch out for
Some people who take Tafinlar develop other problems, which can be serious. You need to know important signs and symptoms to look out for while taking this medicine. Some of these symptoms (bleeding, fever, skin changes, and eye problems) are mentioned briefly in this section, but there is more detailed information in section 4, “Possible side effects”.
Bleeding
Taking Tafinlar in combination with trametinib can cause serious bleeding in your brain, digestive system (such as stomach, rectum, and intestine), lungs, and other organs, and can be fatal. Symptoms of bleeding can be:
- headache, dizziness, or feeling tired
- blood in the stool or black stools
- blood in the urine
- stomach pain
- blood in coughing up/vomiting
Tell your doctor as soon as possible if you get any of these symptoms.
Fever
Taking Tafinlar or combination therapy with Tafinlar and trametinib can cause fever, although this is more likely if you are taking the combination therapy (see also section 4). In some cases, people with a fever may experience low blood pressure, dizziness, or other symptoms.
Tell your doctor immediately if you develop a temperature above 38ºC or if you feel feverish while taking this medicine.
Heart problems
Tafinlar can cause heart problems or make heart problems worse (see also “Heart problems” in section 4), in people taking Tafinlar in combination with trametinib.
Tell the doctor if you have any heart disease. The doctor will do various tests to check that your heart is working properly, both before and while you are being treated with Tafinlar in combination with trametinib. Tell your doctor right away if you feel like your heart is racing, your heartbeat is fast or irregular, or if you feel dizzy, tired or dizzy, short of breath, or if your legs swell. The doctor can decide to pause the treatment or stop it altogether if necessary.
Changes to your skin that may indicate new skin cancer
The doctor will check your skin before you start taking this medicine and periodically while you are taking it. Tell your doctor immediately if you notice any skin changes while taking this medicine or after treatment (see also section 4).
Eye problems
The doctor should examine your eyes while you are taking this medicine.
Tell your doctor immediately if your eyes become red and irritated, or if you experience blurred vision, eye pain, or other vision changes during treatment (see also section 4).
Tafinlar, when given in combination with trametinib, can cause eye problems, including blindness. Trametinib is not recommended if you have had a clot in the vein that brings blood from the eye (retinal vein occlusion). Tell your doctor immediately if you experience the following eye symptoms: blurred vision, vision loss or other vision changes, colored dots in your field of vision, or halo phenomena (rings of light around objects) during your treatment. The doctor can decide to pause the treatment or stop it altogether if necessary.
- Read the information about fever, skin changes, and eye problems in section 4 of this leaflet. Tell your doctor, pharmacist, or nurse if you get any of the signs and symptoms described here.
Liver problems
Tafinlar in combination with trametinib can cause problems with your liver that can develop into serious conditions such as hepatitis (inflammation of the liver) and liver failure, which can be fatal. Doctors will periodically check you. Signs that your liver is not working properly may include:
- loss of appetite
- nausea
- vomiting
- stomach ache (abdomen)
- yellowish color in 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
Muscle pain
Tafinlar in combination with trametinib can result in muscle breakdown ( rhabdomyolysis ). Tell your doctor as soon as possible if you get any of these symptoms:
- muscle pain
- dark colored urine due to kidney damage
If necessary, your doctor may need to temporarily interrupt or stop your treatment altogether.
Hole in the stomach or intestine (perforation)
Taking the combination of Tafinlar and trametinib may increase the risk of developing holes in the intestinal 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 Tafinlar in combination with trametinib. 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 ( sarcoid ). Common symptoms of sarcoid can be cough, shortness of breath, swollen lymph nodes, visual disturbances, fever, fatigue, pain, and swelling in the joints, and tender nodules in the skin. Tell your doctor if you get any of these symptoms.
Children and young people
Tafinlar is not recommended for children and adolescents. The effect of Tafinlar on people under 18 years of age is unknown.
Other medicines and Tafinlar
Before starting the treatment, you must tell the doctor, pharmacist, or nurse if you are taking, have recently taken, or maybe taking other medicines. This also applies to over-the-counter medicines.
Some medicines can affect how Tafinlar works, or increase the risk of side effects. Tafinlar can also affect some other medicines. These medicines are:
- contraceptives that contain hormones, such as birth control pills, birth control syringes, and birth control patches
- warfarin and acenocoumarol, medicines that thin the blood
- digoxin used to treat heart problems
- medicines against fungal infections , e.g. ketoconazole , itraconazole, voriconazole and posaconazole
- certain calcium channel blockers, used for high blood pressure, e.g. diltiazem, felodipine, nicardipine, nifedipine, and verapamil
- anticancer drugs, such as cabazitaxel
- certain medicines to lower blood fats (lipids ), e.g. gemfibrozil
- some medicines used in certain psychiatric conditions, e.g. haloperidol
- certain antibiotics, e.g. clarithromycin, doxycycline, and telithromycin
- certain anti- tuberculosis medicines , e.g. rifampicin
- certain medicines that lower the cholesterol level, e.g. atorvastatin and simvastatin
- certain medicines that inhibit the immune system, e.g. ciclosporin, tacrolimus, and sirolimus
- certain anti-inflammatory drugs, e.g. dexamethasone and methylprednisolone
- certain medicines against HIV , e.g. ritonavir, amprenavir, indinavir, darunavir, delavirdine, efavirenz, fosamprenavir, lopinavir, nelfinavir, tipranavir, saquinavir and atazanavir
- certain medicines that are pain relievers, e.g. fentanyl and methadone
- medicines against seizures ( epilepsy ), e.g. phenytoin, phenobarbital, primidone, valproic acid, and carbamazepine
- antidepressants such as nefazodone and the herbal remedy St. John’s wort ( Hypericum perforatum).
- Tell your doctor, pharmacist, or nurse if you are taking any of these medicines (or if you are not sure). The doctor may decide to change your dose.
Make a list of the medicines you are taking so that you can show it to the doctor, pharmacist, or nurse.
Pregnancy, breastfeeding, and fertility
Tafinlar is not recommended during pregnancy.
- If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine. Tafinlar is not recommended during pregnancy as there is a risk of harm to the unborn baby.
- If you are a woman and could become pregnant, you must use reliable contraception while taking Tafinlar and for at least 2 weeks after you stop taking it and for at least 16 weeks after the last dose of trametinib when given in combination with Tafinlar.
- Contraceptives that contain hormones ( birth control pills, birth control injections, or birth control patches ) may not work as they should while you are taking Tafinlar or the combination therapy (Tafinlar and trametinib). You must use another effective method of contraception so that you do not become pregnant while taking this medicine. Consult a doctor, pharmacist, or nurse.
- If you become pregnant while taking this medicine, you must tell your doctor immediately.
Tafinlar is not recommended during breastfeeding.
It is unknown whether the ingredients of this medicine can be excreted in breast milk.
If you are breastfeeding or plan to breastfeed, you must tell the doctor. You and the doctor decide whether you should take this medicine or breastfeed.
Fertility – refers to both men and women
Animal studies have shown that the active substance dabrafenib permanently reduces fertility in men. In addition, men taking Tafinlar may experience a decrease in sperm count while taking the drug, and it is not certain that sperm count will return to normal after they stop taking this drug.
Taking Tafinlar with trametinib: trametinib can impair fertility in both men and women.
Before you start treatment with Tafinlar, you should talk to the doctor about different options to increase the chances of having children in the future.
If you have any further questions about how this medicine may affect sperm count, ask your doctor, pharmacist or nurse.
Driving ability and use of machinery
Tafinlar may have side effects that may affect your ability to drive and use machines. Avoid driving any vehicle or using machinery if you have vision problems or feel tired and weak, or lack energy. Descriptions of these effects can be found in sections 2 and 4. Talk to your doctor, pharmacist, or nurse if you are not sure. Your illness, the symptoms, and the treatment situation can also affect your ability to drive and use machines.
How to take Tafinlar
Always take this medicine exactly as your doctor, nurse or pharmacist has told you. Consult a doctor, nurse, or pharmacist if you are unsure.
How much to take
The usual dose of Tafinlar either as a single treatment or in combination with trametinib is two 75 mg capsules twice a day (equivalent to a daily dose of 300 mg). The recommended dose of trametinib in combination with Tafinlar is 2 mg once daily.
If you experience side effects, the doctor may decide that you should take a lower dose.
Tafinlar is also available in 50 mg capsules if the dose needs to be reduced.
Do not take more Tafinlar than your doctor has recommended, as this may increase the risk of side effects.
How to take Tafinlar
Swallow the capsules whole with a little water, one at a time.
The capsules must not be chewed or crushed. Then they lose their effect.
Take Tafinlar twice daily on an empty stomach. It means
- you must wait at least 1 hour after taking Tafinlar before eating or drinking anything
- you must wait at least 2 hours after you have eaten before taking Tafinlar.
Take Tafinlar in the morning and the evening. Approximately 12 hours should pass between times. Take your morning and evening dose of Tafinlar at about the same time each day. Then it will be easier to remember to take the capsules.
Do not take the morning and evening doses of Tafinlar at the same time.
If you have taken too much Tafinlar
If you take too many Tafinlar capsules, consult a doctor, pharmacist, or nurse. If possible, show the Tafinlar package and the package leaflet.
If you forget to take Tafinlar
If it has not been more than 6 hours since you should have taken your dose, take it as soon as you remember.
If it has been more than 6 hours since you should have taken your dose, skip it and take your next dose at the usual time. Then continue taking your capsules regularly as usual.
Do not take a double dose to make up for a missed dose.
If you stop taking Tafinlar
Take Tafinlar for as long as your doctor recommends. Do not stop unless your doctor, pharmacist, or nurse advises you to do so.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
How to take Tafinlar in combination therapy with trametinib
- Take Tafinlar in combination with trametinib as directed by your doctor, nurse, or pharmacist. Do not change your dose or stop taking Tafinlar or trametinib unless your doctor, nurse, or pharmacist tells you to.
- Take Tafinlar twice daily and trametinib once daily. It may be good for you to get into the habit of taking both of your medicines at the same time each day. Tafinlar doses should be taken approximately 12 hours apart. When trametinib is given in combination with Tafinlar, it should be taken either with the morning dose of Tafinlar or with the evening dose of Tafinlar.
- Take Tafinlar and trametinib on an empty stomach, at least 1 hour before or 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 Tafinlar or trametinib, take it as soon as you remember. Do not take a double dose to make up for a missed dose, but take your next dose at your usual time:
- If it is less than 6 hours until your next scheduled dose of Tafinlar, which is taken twice daily.
- If it is less than 12 hours until your next scheduled dose of trametinib, which is taken once daily.
- If you take too much Tafinlar or trametinib, contact your doctor, nurse, or pharmacist immediately. If possible, take your Tafinlar capsules and trametinib tablets with you. If possible, show the Tafinlar and trametinib drug packages with package leaflets.
- If you experience side effects, the doctor may decide that you should take a lower dose of Tafinlar and/or trametinib. Take the doses of Tafinlar and trametinib exactly as your doctor, nurse or pharmacist has told you.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Any serious side effects are
Problems with bleeding
Tafinlar can cause serious bleeding, especially in your brain, when taken in combination with trametinib. Contact a doctor or nurse for immediate medical help if you experience any signs of bleeding such as:
- headache, dizziness, or feeling weak
- you cough up blood or clotted blood
- vomit that contains blood or looks like coffee grounds
- red stools or stools that are black like tar.
Fever
More than 1 in 10 people taking Tafinlar may develop a fever. Tell your doctor, pharmacist, or nurse immediately if you develop a fever (38ºC or more) or if you feel feverish while taking this medicine. They will take samples to see if there are other causes of the fever and treat the problem.
In some cases, people with a fever may experience low blood pressure and dizziness. In case of a high fever, the doctor may recommend that you stop taking Tafinlar, or Tafinlar, and trametinib, while the fever is treated with other medicines. As soon as the fever has gone down, the doctor may recommend that you start taking Tafinlar again.
Heart problems
Tafinlar can affect the pumping ability of your heart when taken in combination with trametinib. This is more likely to affect people who already have heart problems. While you are taking Tafinlar in combination with trametinib, you will be checked for heart problems. Signs and symptoms of heart problems may 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 the first time you’ve had them or if they’ve gotten worse.
Skin changes
Serious skin reactions have been reported in people taking Tafinlar in combination with trametinib (occurring in an unknown number of users). If you notice any of the following:
- reddish spots on the trunk that are round or target-like, with blisters in the center. Skin shedding. Sores in the mouth, throat, nose, around the genitals, and 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 immediately contact a doctor or go to the nearest emergency department.
Patients taking Tafinlar may commonly (may affect up to 1 in 10 users) develop another type of skin cancer called cutaneous squamous cell carcinoma. Others may develop a type of skin cancer called basal cell carcinoma. These skin changes are usually limited and can be surgically removed. Treatment with Tafinlar can then continue without interruption.
Some people taking Tafinlar may also find that they have new melanomas. These melanomas are usually surgically removed and treatment with Tafinlar can be continued without interruption.
The doctor will examine your skin before you start taking Tafinlar and then your skin will be examined every month while you are taking this medicine and for 6 months after you stop taking it. These checks are done to make sure you don’t get any new skin cancer.
The doctor will also examine your head, neck, mouth, and lymph nodes and your chest and abdomen will be regularly X-rayed ( computed tomography ). You may also have a blood test. These checks are carried out to detect if any other cancer, including squamous cell carcinoma, is developing inside your body. Pelvic (for women) and rectal examinations are also recommended before and after your treatment.
Check your skin regularly while taking Tafinlar
If you notice any of the following:
- a new wart
- sores or red bumps on the skin that bleed or won’t heal
- a birthmark that changes size or color
- tell your doctor, pharmacist, or nurse as soon as possible if you get these symptoms either if they are new or if they get worse.
Skin reactions (rash) may occur when you take Tafinlar in combination with trametinib. Talk to your doctor if you get a rash while taking Tafinlar in combination with trametinib.
Eye problems
Patients taking Tafinlar alone may uncommonly (may affect up to 1 in 100 users) develop an eye problem called uveitis, which can damage vision if left untreated. This may be common (may affect up to 1 in 10 people) in patients taking Tafinlar in combination with trametinib.
Uveitis can develop quickly and the symptoms are:
- red and irritated eyes
- blurred vision
- sore eyes
- increased sensitivity to light
- dots moving before the eyes.
- Contact a doctor, pharmacist, or nurse immediately if you get these symptoms.
Tafinlar can cause eye problems when taken in combination with trametinib. Trametinib is not recommended if you have had a clot in the vein that brings blood from the eye (retinal vein occlusion). Your doctor may recommend an eye exam before and while you take Tafinlar in combination with trametinib. The doctor may recommend that you stop taking trametinib or refer you to a specialist if you develop signs and symptoms affecting your vision, such as:
- vision loss
- red and irritated eyes
- colored dots in the field of vision et
- halo phenomenon (rings of light around objects)
- blurred vision
- Contact a doctor, pharmacist, or nurse immediately if you experience these symptoms.
You must tell your doctor, pharmacist, or nurse if you get these symptoms, especially if your eyes become red and painful and do not go away quickly. They can arrange for you to see an eye specialist for a full eye examination.
Possible side effects in patients taking Tafinlar alone
Side effects that you may notice when taking Tafinlar alone are as follows:
Very common (may affect more than 1 in 10 users)
- Papilloma (a form of skin tumor that is usually harmless)
- Reduced appetite
- Headache
- Cough
- Nausea, vomiting
- Diarrhea
- Thickened outer skin
- Unusual hair loss or thinning hair
- Rash
- Redness or swelling of the palms, fingers, and soles of the feet (see ‘Skin changes’ earlier in section 4)
- Joint pain, muscle pain, or pain in the hands or feet
- Fever (see “Fever” earlier in section 4)
- Lack of energy
- Overindulge
- Feeling of weakness
Common (may affect up to 1 in 10 users)
- Skin changes such as cutaneous squamous cell carcinoma (a type of skin cancer), wart-like growths, stalked skin flaps, uncontrolled skin growths or lesions ( basal cell carcinoma), patches of thick, scaly, or rough skin ( actinic keratosis ), cracking of the skin, redness of the skin, increased skin sensitivity to the sun
- Constipation
- Influenza-like illness
Common side effects that can be seen in blood tests
- Low phosphorus content in the blood
- The increased amount of sugar ( glucose ) in the blood
Uncommon (may affect up to 1 in 100 users)
- New melanoma
- Allergic reaction (hypersensitivity)
- Eye inflammation ( uveitis, see “Eye problems” earlier in section 4)
- Inflammation of the pancreas (causes severe abdominal pain)
- Inflammation of the fatty layer under the skin (panniculitis)
- Kidney problems, kidney failure
- Inflammation of the kidneys
Possible side effects when Tafinlar and trametinib are taken together
When you take Tafinlar and trametinib together, you may experience all of the side effects listed above, but the frequency may change (increase or decrease).
You may also have additional side effects due to taking trametinib at the same time as Tafinlar.
Tell your doctor as soon as possible if you get any of these symptoms, whether it’s the first time you’ve had them or if they’ve gotten worse.
Please also read the package leaflet for trametinib for details on side effects that may occur when taking trametinib.
The side effects that you may experience when taking Tafinlar in combination with trametinib are as follows:
Very common side effects (may affect more than 1 in 10 users):
- Nose and throat inflammation
- Decreased appetite
- Headache
- Dizziness
- High blood pressure
- Bleeding in various parts of the body, which can be mild or severe
- Cough
- Stomach pains
- Constipation
- Diarrhea
- Nausea, vomiting
- Rash, dry skin, itching, skin redness
- Joint pain, muscle pain, or pain in the hands or feet
- Muscle twitching
- Lack of energy, feeling of weakness
- Overindulge
- Swollen hands or feet (peripheral edema )
- Fever
- Influenza-like illness
Very common side effects that can be seen in blood tests
- Abnormal liver values
Common side effects (may affect up to 1 in 10 users )
- Urinary tract infection
- Skin changes include skin infection ( cellulitis ), inflammation of hair follicles in the skin, nail side effects such as changes in the nail bed, pain in the nails, infection, and swelling of the cuticles, skin rash with wart-filled blisters, cutaneous squamous cell carcinoma (a type of skin cancer), papilloma (a type of skin tumor that is 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 fluids)
- Blurred vision, vision problems, inflammation of the eye ( uveitis )
- Decreased efficiency in the heart’s pumping ability
- Low blood pressure
- Localized tissue swelling
- Shortness of breath
- Dry mouth
- Mouth ulcers 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 ), scaly skin, or cracking of the skin
- Heavy sweating including night sweats
- Abnormal hair loss or thinning hair
- Red, painful hands and feet
- Inflammation of the fat layer under the skin (panniculitis)
- Inflammation of the mucous membrane
- Facial swelling
Common side effects that can be seen in blood tests
- Low concentrations of white blood cells
- Decreased number of red blood cells ( anemia ), platelets (cells that help blood clot), 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 normally found in the heart, brain, and skeletal muscle
- Increase in certain substances ( enzymes ) produced by the liver
Uncommon side effects (may affect up to 1 in 100 users)
- The appearance of new skin cancer (malignant melanoma )
- Stemmed skin flaps
- Allergic reactions (hypersensitivity)
- Changes in the eye include swelling the eye caused by fluid leakage (chorioretinopathy), the light-sensitive membrane at the back of the eye ( retina ) detaching from its supporting layer (retinal detachment), and swelling around the eyes
- A heart rate that is lower than the normal range and/or a decrease in heart rate
- Pneumonia ( pneumonitis )
- Pancreatitis
- Inflammation of the intestines ( colitis )
- Kidney failure
- Kidney inflammation
- An inflammatory disease that mainly affects the skin, lungs, eyes, and lymph nodes ( sarcoid )
Rare side effects (may affect up to 1 in 1,000 users)
- A hole (perforation) in the stomach or intestines
Has been reported (occurring in an unknown number of users)
- Inflammation of the heart muscle ( myocarditis ) which can result in shortness of breath, fever, palpitations, and chest pains.
- Severe skin inflammation with scaling (exfoliative dermatitis )
How to store Tafinlar
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the can label and on the carton after EXP.
The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is dabrafenib. One hard capsule contains dabrafenib mesylate equivalent to 50 mg or 75 mg dabrafenib.
- Other ingredients are microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, red iron oxide (E172), titanium dioxide (E171), and hypromellose (E464). The print on the capsule consists of black ink of black iron oxide (E172), shellac and propylene glycol.
Appearance and package sizes of the medicine
Tafinlar 50 mg hard capsules are opaque, dark red, imprinted with “GS TEW” and “50 mg”.
Tafinlar 75 mg hard capsules are opaque, dark pink, with the text “GS LHF” and “75 mg”.
The jars are made of opaque white plastic with plastic screw caps.
The cans also contain desiccant in the form of silica gel in a small cylinder-shaped container. The desiccant must remain in the jars and must not be eaten.
Tafinlar 50 mg and 75 mg hard capsules are available in packs containing 28 or 120 capsules. Not all pack sizes are to be marketed in your country.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Glaxo Wellcome, SA
Abda. Extremadura, 3
09400 Aranda De Duero
Burgos
Spain
Lek Pharmaceuticals dd
Verovskova street 57
1526, Ljubljana
Slovenia
Novartis Pharma GmbH
Roonstraße 25
D‑90429 Nuremberg
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienNovartis Pharma NVTél/Tel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lietuvos filialasPhone: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODPhone: +359 2 489 98 28 | Luxembourg/LuxembourgNovartis Pharma NVTél/Tel: +32 2 246 16 11 |
| Czech RepublicNovartis s.r.oPhone: +420 225 775 111 | MagyarországNovartis Hungária Kft.Tel.: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A/SPhone: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Phone: +356 2122 2872 |
| DeutschlandNovartis Pharma GmbHPhone: +49 911 273 0 | The NetherlandsNovartis Pharma BVPhone: +31 88 04 52 555 |
| EstoniaSIA Novartis Baltics Eesti branchPhone: +372 66 30 810 | NorwayNovartis Norway iPhone: +47 23 05 20 00 |
| GreeceNovartis (Greece) AEBEPhone: +30 210 281 17 12 | AustriaNovartis Pharma GmbHPhone: +43 1 86 6570 |
| SpainNovartis Farmacéutica, SAPhone: +34 93 306 42 00 | PolishNovartis Poland Sp. z o. iPhone: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Produtos Farmacêuticos, SAPhone: +351 21 000 8600 |
| HrvatskaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLPhone: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedPhone: +353 1 260 12 55 | Slovenija Novartis Pharma Services Inc.Phone: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovenian RepublicNovartis Slovakia s.r.oPhone: +421 2 5542 5439 |
| ItalyNovartis Pharma SpAPhone: +39 02 96 54 1 | Finland/FinlandNovartis Finland OyTel: +358 (0)10 6133 200 |
| CyprusNovartis Pharma Services Inc.Phone: +357 22 690 690 | SwedenNovartis Sweden ABPhone: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsPhone: +371 67 887 070 | United Kingdom (Northern Ireland)Novartis Ireland LimitedPhone: +44 1276 69837 |