SORAFENIB 200 mg Фильм-Coated Таблетки

Содержание инструкции

1. Sorafenib Teva 200 mg film-coated tablets
   1. What is Sorafenib Teva and what is it used for
   2. What you need to know before taking Sorafenib Teva
   3. How to take Sorafenib Teva
   4. Possible side effects
   5. How to store Sorafenib Teva
   6. Contents of the pack and other information

Sorafenib Teva 200 mg film-coated tablets

sorafenib

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Sorafenib Teva and what is it used for

Sorafenib Teva is used for the treatment of liver cancer (hepatocellular carcinoma).
Sorafenib Teva is also used for the treatment of kidney cancer (advanced renal cell carcinoma)
in an advanced stage when standard therapy has not helped to stop the disease or is considered
unsuitable.
Sorafenib Teva is a so-called multikinase inhibitor. It works by slowing down the rate of
proliferation of cancer cells and blocking the blood supply that allows cancer cells
to grow.

2. What you need to know before taking Sorafenib Teva

Do not take Sorafenib Teva

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

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

Be particularly careful with Sorafenib Teva

• If you develop skin problems.Sorafenib Teva 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.Sorafenib Teva 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 sugar levels should be checked regularly to assess whether it is necessary to adjust the dose of the antidiabetic drug to minimize the risk of hypoglycemia.
• If you have bleeding problems or if you are taking warfarin or phenprocoumon.Treatment with Sorafenib Teva may involve an increased risk of bleeding. If you are taking warfarin or phenprocoumon, 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 “prolongation of the QT interval”.
• If you are about to undergo or have just undergone surgery.Sorafenib Teva may affect wound healing. If you are about to undergo surgery, treatment with Sorafenib Teva will probably be suspended. Your doctor will then decide when to restart it.
• If you are being treated with irinotecan or docetaxel,which are also anticancer medicines. Sorafenib Teva may increase the effects and, in particular, the side effects of these medicines.
• If you are taking neomycin or other antibiotics.The effect of Sorafenib Teva may be reduced.
• If you have severe liver impairment.You may experience more serious side effects during treatment with this medicine.
• If you have reduced kidney function.Your doctor will monitor your fluid and electrolyte balance.
• Fertility.Sorafenib Teva may reduce fertility in both men and women. If you are concerned, talk to your doctor.
• Gastrointestinal perforationsmay develop during treatment (see section 4: Possible side effects). In this case, your doctor will suspend treatment.

Tell your doctor if any of these problems apply to you.You may need to be subjected to
therapy or your doctor may decide to change the dose of Sorafenib Teva or to completely stop
treatment (see also section 4: Possible side effects).

Children and adolescents
Sorafenib Teva has not yet been studied in children and adolescents.

Other medicines and Sorafenib Teva
Some medicines can affect Sorafenib Teva 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 medicine, including those available without a prescription:

• Rifampicin, neomycin or other medicines used to treat infections (antibiotics)
• St John's Wort, a herbal remedy for depression
• Phenytoin, carbamazepine or phenobarbital, treatments for epilepsyand other conditions
• Dexamethasone, a corticosteroidused for various diseases
• Warfarin or phenprocoumon, anticoagulants used to prevent blood clot formation
• Doxorubicin, capecitabine, docetaxel, paclitaxel and irinotecan, used in the treatment of tumors
• Digoxin, used to treat mild to moderate heart failure

Pregnancy and breastfeeding
Avoid becoming pregnant if you are being treated with Sorafenib Teva.If you are of childbearing
potential, use an adequate method of contraception during treatment. If you become pregnant
while being treated with Sorafenib Teva, contact your doctor immediately, who will decide whether
to continue or stop therapy.

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

Driving and using machines
There is no reason to believe that sorafenib can affect the ability to drive vehicles or
use machines.

Sorafenib Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is equivalent to
essentially “sodium-free”.

3. How to take Sorafenib Teva

The recommended dose of Sorafenib Teva in adults is 2 tablets of 200 mg twice a day.
This corresponds to a daily dose of 800 mg or four tablets a day.

Swallow the Sorafenib Teva tablets with a glass of water, away from meals or with a
meal low or moderate in fat. Do not take this medicine with high-fat meals, as these may reduce its
effectiveness. If you intend to consume a high-fat meal, take the tablets at least 1 hour before or 2
hours after the meal. Take this medicine exactly as your doctor has instructed. If you have any
questions, consult 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 observed and unacceptable side effects do
not occur.

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

If you forget to take Sorafenib Teva
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 as usual. Do not take a double dose to make up for a
missed dose.

4. Possible side effects

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

Very common:
may affect more than 1 in 10 people

• diarrhoea
• discomfort (nausea)
• feeling of weakness or fatigue (asthenia)
• pain (including mouth pain, abdominal pain, headache, bone pain, cancer pain)
• hair loss (alopecia)
• redness or pain on the palms of the hands or soles of the feet (hand-foot reaction)
• itching or rash
• vomiting
• bleeding (including brain bleeding, in the intestinal wall and in the airways; haemorrhage)
• 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 mucosal inflammation)
• low levels of calcium in the blood (hypocalcaemia)
• low levels of potassium in the blood (hypokalaemia)
• low levels of sugar in the blood (hypoglycaemia)
• muscle pain (myalgia)
• numbness or tingling in the fingers of the hands and feet, including pins and needles (peripheral sensory neuropathy)
• depression
• erection problems (impotence)
• changes in voice (dysphonia)
• acne
• inflamed, dry or flaky skin (dermatitis, skin scaling)
• heart failure
• heart attack (myocardial infarction) or chest pain
• tinnitus (ringing in the ears)
• kidney failure
• unusually high levels of protein in the urine (proteinuria)
• general weakness or loss of strength (asthenia)
• reduced number of white blood cells (leucopenia and neutropenia)
• reduced number of red blood cells (anaemia)
• low number of platelets in the blood (thrombocytopenia)
• inflammation of hair follicles (folliculitis)
• reduced thyroid activity (hypothyroidism)
• low levels of sodium in the blood (hyponatraemia)
• changes in taste (dysgeusia)
• flushing of the face and often other areas of the skin (hot flushes)
• runny nose (rhinorrhoea)
• heartburn (gastro-oesophageal reflux disease)
• skin cancer (keratoacanthoma/squamous cell carcinoma of the skin)
• thickening of the outer layer of the skin (hyperkeratosis)
• sudden involuntary muscle contraction (muscle spasms)

Not common:
may affect up to 1 in 100 people

• inflammation of the stomach lining (gastritis)
• abdominal pain (abdominal pain) 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 (hyperbilirubinaemia)
• allergic-type reactions (including skin reactions and urticaria)
• dehydration
• enlargement of the breasts (gynaecomastia)
• difficulty breathing (lung disease)
• eczema
• excessive thyroid activity (hyperthyroidism)
• multiple skin rashes (erythema multiforme)
• unusually high blood pressure
• gastrointestinal perforation
• reversible swelling at the back of the brain that may be associated with headache, altered state of consciousness, seizures and visual symptoms, including vision loss (reversible posterior leukoencephalopathy)
• severe, sudden allergic reactions (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 (prolongation of the QT interval)
• inflammation of the liver, which may involve nausea, vomiting, abdominal pain and jaundice (drug-induced hepatitis)
• appearance on previously irradiated skin of a rash similar to a sunburn, potentially severe (radiation recall dermatitis)
• severe skin and/or mucous membrane reactions that may include painful blisters and fever, with detachment of large areas of skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle injury that may 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 may manifest as a rash (leucocytoclastic vasculitis)

Frequency not known:
the frequency cannot be estimated from the available data

• impaired brain function that may be e.g. associated with drowsiness, behavioural 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).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through the national reporting system www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sorafenib Teva

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.
This medicine does not require special storage conditions regarding temperature.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sorafenib Teva contains

• The active substanceis sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
• The otheringredients are: Tablet core:microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, hypromellose, magnesium stearate [vegetable]. Tablet coating:hypromellose, macrogol, titanium dioxide (E171) and red iron oxide (E172).

Description of the appearance of Sorafenib Teva and contents of the pack
Sorafenib Teva 200 mg film-coated tablets consist of pink, round, biconvex tablets,
marked with the words “TV” on one side and “S3” on the other. The tablets have a diameter of approximately 11 mm.
Sorafenib Teva is available in blisters containing 28, 30, 56 and 112 film-coated tablets and in
unit dose perforated blisters containing 112 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan

Manufacturer
Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.), Prilaz baruna Filipovića 25, Zagreb, 10000 – Croatia
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg, 89143 – Germany
Teva Operations Poland Sp. z.o.o, ul. Mogilska 80, Kraków, 31-546 – Poland
Teva Pharma B.V., Swensweg 5, Haarlem, 2031GA – Netherlands