NEXAVAR 200 mg Фильм-Coated Таблетки

Содержание инструкции

1. Nexavar 200 mg film-coated tablets
   1. What is Nexavar and what it is used for
   2. What you need to know before taking Nexavar
   3. How to take Nexavar
   4. Possible side effects
   5. How to store Nexavar
   6. Package contents and other information

Nexavar 200 mg film-coated tablets

sorafenib

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Nexavar is and what it is used for
• 2. What you need to know before you take Nexavar
• 3. How to take Nexavar
• 4. Possible side effects
• 5. How to store Nexavar
• 6. Contents of the pack and other information

1. What is Nexavar and what it is used for

Nexavar is used for the treatment of hepatocellular carcinoma.
Nexavar is also used in the treatment of kidney cancer (advanced renal cell carcinoma) when
it is in an advanced stage and when standard therapy has not been helpful in stopping it or is
considered unsuitable.
Nexavar is used for the treatment of thyroid cancer (differentiated thyroid carcinoma).
Nexavar is a so-called multikinase inhibitor. It works by slowing down the rate of growth of cancer cells
and blocking the blood supply that allows cancer cells to grow.

2. What you need to know before taking Nexavar

Do not take Nexavar

• if you are allergicto sorafenib or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Nexavar.

Pay particular attention with Nexavar, especially

• If you develop skin problems. Nexavar can cause rashes and skin reactions, especially on the hands and feet. These effects can usually be treated by your doctor. If not, your doctor may suspend or completely stop treatment.
• If you have high blood pressure.Nexavar can cause an increase in blood pressure; your doctor will check your blood pressure regularly and may prescribe medicines to treat high blood pressure.
• If you have or have had an aneurysm(bulging and weakening of a blood vessel wall) or a tear in a blood vessel wall.
• If you have diabetes.In diabetic patients, blood glucose levels should be checked regularly in order to assess whether the dosage of the anti-diabetic medicine needs to be

modified to minimize the risk of having a low blood glucose level.
blood.

• If you have bleeding problems or if you are taking warfarin or phenprocoumone.Treatment with Nexavar can lead to an increased risk of bleeding. If you are taking warfarin or phenprocoumone, medicines that thin the blood to prevent blood clots, there may be a greater risk of bleeding.
• If you have chest pain or heart problems.Your doctor may decide to suspend or completely stop treatment.
• If you have a heart condition, such as an alteration of the electrical signal called “QT prolongation”.
• If you are about to undergo or have just undergone surgery.Nexavar can affect wound healing. If you are about to undergo surgery, your treatment with Nexavar will probably be suspended. The doctor will then decide when to restart it.
• If you are being treated with irinotecan or docetaxel,which are also medicines against cancer. Nexavar may increase the effects and, in particular, the side effects of these medicines.
• If you are taking neomycin or other antibiotics.The effectiveness of Nexavar may be reduced.
• If you have severe liver failure.You may have a worsening of side effects when taking this medicine.
• If you have reduced kidney function.Your doctor will monitor your fluid and electrolyte balance.
• Fertility.Nexavar can reduce fertility in both men and women. If this is a concern for you, talk to your doctor.
• Gastrointestinal perforationcan occur during treatment (see section 4: Possible side effects). In this case, your doctor will stop treatment.
• If you have a thyroid tumor, your doctor will check the levels of calcium and thyroid hormone in your blood.
• If you experience the following symptoms, contact your doctor immediately as it may bea potentially life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue. These symptoms may be caused by a number of metabolic complications that can occur during cancer treatment and are caused by the breakdown products of tumor cells in the terminal stage (tumor lysis syndrome, TLS) and can lead to impaired kidney function and acute kidney failure (see also section 4: Possible side effects).

Tell your doctor if any of these problems apply to you.You may need treatment
for these problems, or your doctor may change your dose of Nexavar, or stop treatment altogether (see also section 4: Possible side effects ).

Children and adolescents
Nexavar has not yet been studied in children and adolescents.

Other medicines and Nexavar
Some medicines can affect Nexavar or be affected by it. Tell your doctor or pharmacist
if you are taking, have recently taken or might take any of the medicines listed
below or any other medicines, including those available without a prescription:

• Rifampicin, neomycin or other medicines used to treat infections (antibiotics)
• Hypericum perforatum, also known as “St John’s Wort”, a herbal treatment for depression
• Phenytoin, carbamazepine or phenobarbital, treatments for epilepsyand other conditions
• Dexamethasone, a corticosteroidused for various diseases
• Warfarin or phenprocoumone, anticoagulants used to prevent blood clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel and irinotecan, used in the treatment of tumors.
• Digoxin, used in the treatment of mild or moderate heart failure

Pregnancy and breastfeeding
Avoid becoming pregnant if you are being treated with Nexavar.If you are of childbearing potential, you should
use an effective method of contraception during treatment with Nexavar. If you become
pregnant while being treated with Nexavar, tell your doctor immediately who
will decide whether the treatment should be continued or stopped.

Do not breastfeed your baby during treatment with Nexavar, as this medicine
may interfere with the growth and development of the baby.

Driving and using machines
There is no reason to believe that Nexavar will affect your ability to drive and operate
machines.

Nexavar contains sodium
This medicine contains less than 1 mmol (23mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to take Nexavar

The recommended dose of Nexavar in adults is two 200 mg tablets twice a day.
This corresponds to a daily dose of 800 mg, or four tablets a day.

Take Nexavar tablets with a glass of water, away from meals or with low- to medium-fat foods. Do not take this medicine with very fatty foods, because these
may reduce its effectiveness. If you intend to eat very fatty foods, take the tablets
at least 1 hour before or 2 hours after the meal. Take this medicine exactly as
directed by your doctor, always. If you have any doubts, ask your doctor or pharmacist.
It is important to take this medicine at about the same time each day, in order to maintain
a constant concentration in the blood. Usually this medicine is taken as long as clinical benefits are noticed, and you do not experience
intolerable side effects.

If you take more Nexavar than you should
Tell your doctor immediatelyif you, or anyone else, has taken more than the
prescribed dose. Taking too much Nexavar makes side effects more likely or more severe,
especially diarrhea and skin reactions. Your doctor may tell you to stop taking
this medicine.

If you forget to take Nexavar
If you have forgotten to take a dose, take it as soon as you remember. If it is almost time
for the next dose, skip the missed dose and continue with your usual schedule.
Do not take a double dose to make up for a missed tablet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
This medicine may also alter the results of some blood tests.

Very common:
may affect more than 1 in 10 people

• diarrhea
• discomfort (nausea)
• feeling weak or tired ( fatigue)
• pain (including mouth pain, abdominal pain, headache, bone pain, cancer pain)
• hair loss ( alopecia)
• redness or pain in the palms of the hands or soles of the feet ( hand-foot skin reaction)
• itching or rash
• vomiting
• bleeding (including brain hemorrhage, in the intestinal wall and in the respiratory tract)
• high blood pressure, or increased blood pressure ( hypertension)
• infections
• loss of appetite (anorexia)
• constipation
• joint pain (arthralgia)
• fever
• weight loss
• dry skin

Common:
may affect up to 1 in 10 people

• flu-like illness
• indigestion ( dyspepsia)
• difficulty swallowing ( dysphagia)
• inflammation or dryness of the mouth, tongue pain ( stomatitis and inflammation of themucosa)
• low levels of calcium in the blood ( hypocalcemia)
• low levels of potassium in the blood (hypokaliemia)
• low levels of glucose in the blood (hypoglycemia)
• muscle pain (myalgia)
• numbness or tingling in the fingers and toes, including tingling and numbness ( peripheral sensory neuropathy)
• depression
• erection problems (impotence)
• voice changes (dysphonia)
• acne
• inflamed, dry or flaky skin ( dermatitis, skin peeling)
• heart failure
• heart attack (myocardial infarction) or chest pain
• tinnitus (ringing in the ears)
• kidney failure
• high levels of protein in the urine (proteinuria)
• general weakness or loss of strength (asthenia)
• reduced number of white blood cells (leukopenia and neutropenia)
• reduced number of red blood cells (anemia)
• low number of platelets in the blood (thrombocytopenia)
• inflammation of hair follicles (folliculitis)
• reduced thyroid activity (hypothyroidism)
• low levels of sodium in the blood (hyponatremia)
• changes in taste (dysgeusia)
• flushing of the face and often other areas of the skin (hot flashes)
• runny nose (rhinorrhea)
• heartburn (gastroesophageal reflux disease)
• skin tumor (keratoacanthoma/squamous cell carcinoma of the skin)
• thickening of the outer layer of the skin (hyperkeratosis)
• sudden, involuntary muscle contraction (muscle spasms)

Uncommon:
may affect up to 1 in 100 people

• inflammation of the stomach (gastritis)
• stomach pain (abdomen) due to pancreatitis, inflammation of the gallbladder and/or bile ducts
• yellowing of the skin or eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinemia)
• allergic-type reactions (including skin reactions and hives)
• dehydration
• enlargement of the breasts ( gynecomastia)
• difficulty breathing (lung disease)
• eczema
• overactive thyroid ( hyperthyroidism)
• multiple skin rashes (erythema multiforme)
• high blood pressure
• gastrointestinal perforation
• reversible swelling in the back of the brain that can be associated with headache, altered state of consciousness, seizures and visual symptoms, including vision loss (reversible posterior leukoencephalopathy)
• sudden, severe allergic reaction (anaphylactic reaction)

Rare:
may affect up to 1 in 1,000 people

• allergic reaction with swelling of the skin (e.g. face, tongue) that can cause difficulty breathing and swallowing (angioedema)
• abnormal heart rhythm (QT prolongation)
• Inflammation of the liver, which can lead to nausea, vomiting, abdominal pain and jaundice (drug-inducedhepatitis)
• appearance on previously irradiated skin of a rash similar to a sunburn and may be severe (radiation-like dermatitis)
• severe skin and/or mucous membrane reactions that can include blistering and fever, with detachment of large areas of skin (Stevens-Johnson syndrome and toxicepidermal necrolysis)
• abnormal muscle injury that can lead to kidney problems (rhabdomyolysis)
• kidney damage causing loss of large amounts of protein with the urine (nephrotic syndrome)
• inflammation of the skin blood vessels that can manifest as a rash (leucocytoclasticvasculitis)

Not known:
the frequency cannot be estimated from the available data

• impaired brain function that can be associated with for example drowsiness, behavioral changes, or confusion (encephalopathy)
• Dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections).
• nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine and fatigue [ tumor lysis syndrome (TLS)] (see section 2).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nexavar

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

Do not use this medicine after the expiry datewhich is stated on the pack after Scad. and on
each blister after EXP. The expiry date refers to the last day of that month.
Do not store this medicine at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nexavar contains

• The activesubstance is sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
• The otheringredients are: Tablet core: sodium croscarmellose, microcrystalline cellulose, hypromellose, sodium lauryl sulfate and magnesium stearate. Tablet coating: hypromellose, macrogol, titanium dioxide (E 171) and red iron oxide (E 172)

Description of Nexavar and package contents
The 200 mg film-coated tablets of Nexavar are faceted, red and round, with the Bayer cross
on one side and “200” on the other side. They are presented in packs of 112 tablets, containing
four transparent calendar blisters of 28 tablets each.

Marketing authorisation holder
Bayer AG
51368 Leverkusen
Germany

Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Lietuva
UAB Bayer
Tel. +37 05 23 36 868

България
Байер България ЕООД
Тел.: +359 (0)2 424 72 80

Luxembourg/Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Česká republika
Bayer s.r.o.
Tel: +420 266 101 111

Magyarország
Bayer Hungária KFT
Tel:+36 14 87-41 00

Danmark
Bayer A/S
Tlf: +45 45 23 50 00

Malta
Alfred Gera and Sons Ltd.
Tel: +35 621 44 62 05

Deutschland
Bayer Vital GmbH
Tel: +49 (0)214-30 513 48

Nederland
Bayer B.V.
Tel: +31-(0)23-799 1000

Eesti
Bayer OÜ
Tel: +372 655 8565

Norge
Bayer AS
Tlf: +47 24 11 18 00

Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30 210 61 87 500

Österreich
Bayer Austria Ges.m.b.H.
Tel: +43-(0)1-711 46-0

España
Bayer Hispania S.L.
Tel: +34-93-495 65 00

Polska
Bayer Sp. z o.o.
Tel: +48 22 572 35 00

France
Bayer HealthCare
Tél (N° vert): +33-(0)800 87 54 54

Portugal
Bayer Portugal, Lda.
Tel: +351 21 416 42 00

Hrvatska
Bayer d.o.o.
Tel: +385-(0)1-6599 900

România
SC Bayer SRL
Tel: +40 21 529 59 00

Ireland
Bayer Limited
Tel: +353 1 216 3300

Slovenija
Bayer d. o. o.
Tel: +386 (1) 58 14 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Bayer spol. s r.o.
Tel. +421 2 59 21 31 11

Italia
Bayer S.p.A.
Tel: +39 02 397 81

Suomi/Finland
Bayer Oy
Puh/Tel: +358 20 785 21

Κύπρος
NOVAGEM Limited
Τηλ: +357 22 48 38 58

Sverige
Bayer AB
Tel: +46 (0) 8 580 223 00

Latvija
SIA Bayer
Tel: +371 67 84 55 63

United Kingdom (Northern Ireland)
Bayer AG
Tel: +44-(0)118 206 3000
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .