Patient Information

Sorafenib Accord 200 mg Film-Coated Tablets

sorafenib

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Sorafenib Accord is used in the treatment of liver cancer (hepatocellular carcinoma).

Sorafenib Accord is also used in the treatment of advanced kidney cancer (advanced renal cell carcinoma) when standard treatment has not been able to slow down the disease or is considered inappropriate.

Sorafenib Accord is a multi-tyrosine kinase inhibitor. It acts by slowing down the growth rate of cancer cells and interrupting the blood supply that allows cancer cells to grow.

Do not take Sorafenib Accord

If you are allergic to sorafenib or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sorafenib Accord.

Be especially careful with Sorafenib Accord

• If you experience skin problems. Sorafenib Accord may cause rashes and skin reactions, especially on hands and feet. Your doctor may normally treat these conditions. Otherwise, your doctor may temporarily or completely stop treatment.
• If you have hypertension. Sorafenib Accord may increase blood pressure. Your doctor will monitor your blood pressure and prescribe medication to treat hypertension.
• If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall)or a tear in the wall of a blood vessel.
• If you have diabetes. Blood sugar levels in diabetic patients should be regularly monitored to evaluate if a dose adjustment of the antidiabetic medication is necessary to minimize the risk of low blood sugar levels.
• If you have bleeding problems or are taking warfarin or fenprocumon. Treatment with Sorafenib Accord may increase the risk of bleeding. If you are taking warfarin or fenprocumon, medications that thin the blood to prevent blood clots, you may have a higher risk of bleeding.
• If you have chest pain or heart problems. Your doctor will decide whether to temporarily or completely stop treatment.
• If you have a heart condition, such as an abnormal electrical signal called "prolongation of the QT interval."
• If you are about to undergo surgery or have recently undergone surgery. Sorafenib Accord may affect wound healing. Normally, you should stop taking Sorafenib Accord before surgery. Your doctor will decide when to restart treatment with Sorafenib Accord.
• If you are taking irinotecan or docetaxel, which are also anticancer medications. Sorafenib Accord may increase the effects and, in particular, the adverse effects of these medications.
• If you are taking neomicin or other antibiotics. The effect of Sorafenib Accord may be reduced.
• If you have severe liver failure. You may experience more severe side effects when taking this medication.
• If you have kidney failure. Your doctor will monitor your fluid and electrolyte balance.
• Fertility. Sorafenib Accord may reduce male and female fertility. If this applies to you, consult your doctor.
• During treatment, perforations in the walls of the intestine (gastrointestinal perforation) may occur (see section 4: Possible side effects). In this case, your doctor will stop treatment.
• If you have thyroid cancer. Your doctor will monitor your blood calcium and thyroid hormone levels.
• If you experience the following symptoms, contact your doctor immediately, as it may be a potentially life-threatening situation: nausea, difficulty breathing, irregular heartbeats, muscle cramps, seizures, cloudy urine, and fatigue. The cause may be a set of metabolic complications that may occur during cancer treatment as a result of the breakdown products of dying cancer cells [tumor lysis syndrome (TLS)] and may cause changes in kidney function and acute kidney failure (see also section 4: Possible side effects).

Consult your doctor if any of these aspects affect you. It may be necessary to treat them or your doctor may decide to modify your Sorafenib Accord dose or completely stop treatment (see also section 4: Possible side effects).

Children and adolescents

No clinical trials have been conducted with Sorafenib in children and adolescents.

Taking Sorafenib Accord with other medications

Some medications affect Sorafenib Accord or may be affected by it. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication:

• Rifampicin, neomicin, or other medications used to treat infections (antibiotics)
• St. John's Wort, a herbal remedy fordepression
• Phenobarbital, carbamazepine, or phenytoin, treatments forepilepsyand other conditions
• Dexamethasone, acorticosteroidused in various conditions
• Warfarin or fenprocumon, anticoagulants used toprevent blood clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, which areanticancer medications
• Digoxin, a treatment formild to moderate heart failure

Pregnancy and breastfeeding

Avoid becoming pregnant during treatment with Sorafenib Accord. If you can become pregnant, use suitable contraceptive methods during treatment. If you become pregnant during treatment with Sorafenib Accord, inform your doctor immediately, who will decide whether to continue treatment.

Do not breastfeed your baby during treatment with Sorafenib Accordas this medication may interfere with your baby's growth and development.

Driving and operating machinery

There is no indication that Sorafenib Accord affects your ability to drive or operate machinery.

Sorafenib Accord contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free."

The recommended dose of Sorafenib Accord in adults is two 200 mg tablets, taken twice a day.

This is equivalent to a daily dose of 800 mg or four tablets a day.

Sorafenib Accord tablets should be taken with a glass of wateroutside of meals or with a meal low or moderate in fat. Do not take this medication with a meal high in fat, as this reduces the effectiveness of Sorafenib Accord. If you plan to take a meal high in fat, you should take the Sorafenib tablets at least 1 hour before or 2 hours after the meal.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is important to take this medication at the same time every day to maintain a stable amount in the bloodstream.

Normally, you will continue to take this medication as long as it provides clinical benefits and you do not experience unacceptable side effects.

If you take more Sorafenib Accord than you should

Consult your doctor immediatelyif you (or anyone else) have taken a dose higher than prescribed. Taking too much Sorafenib Accord increases the likelihood of side effects or that they will be more severe, especially diarrhea or skin problems. Your doctor may instruct you to stop taking this medication.

If you forgot to take Sorafenib Accord

If you have missed a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for the missed dose.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. This medicine may also affect some laboratory test results.

Very common side effects:(may affect more than 1 in 10 patients)

• diarrhea
• nausea
• feeling of weakness or fatigue (fatigue)
• pain (including mouth pain, abdominal pain, headache, bone pain, tumor pain)
• hair loss (alopecia)
• redness or pain on palms and soles of feet (hand-foot reaction)
• pruritus or exanthema
• vomiting
• bleeding (including cerebral hemorrhage, intestinal wall hemorrhage, and respiratory tract hemorrhage)
• high blood pressure or increased blood pressure (hypertension)
• infections
• loss of appetite (anorexia)
• constipation
• joint pain (arthralgias)
• fever
• weight loss
• dry skin

Common side effects:(may affect up to 1 in 10 patients)

• flu-like illness
• indigestion (dispepsia)
• difficulty swallowing (dysphagia)
• inflamed or dry mouth, tongue pain (stomatitis and mucosal inflammation)
• low calcium levels in the blood (hypocalcemia)
• low potassium levels in the blood (hypokalemia)
• low blood sugar levels (hypoglycemia)
• muscle pain (mialgias)
• alterations in sensitivity in fingers of hands and feet, including numbness or tingling (peripheral sensory neuropathy)
• depression
• erectile dysfunction (impotence)
• voice alteration (hoarseness)
• acne
• inflamed, dry, or scaly skin that peels (dermatitis, skin peeling)
• heart failure
• heart attack (myocardial infarction) or chest pain
• tinnitus (ringing in the ears)
• kidney insufficiency
• abnormally high levels of protein in the urine (proteinuria)
• general weakness or loss of strength (asthenia)
• decrease in the number of white blood cells (leucopeniaandneutropenia)
• decrease in the number of red blood cells (anemia)
• low platelet count in the blood (thrombocytopenia)
• inflammation of hair follicles (foliculitis)
• underactive thyroid gland (hypothyroidism)
• low sodium levels in the blood (hyponatremia)
• distortion of taste (ageusia)
• flushing of the face and often other areas of the skin (flushing)
• nasal secretion (rhinorrhea)
• pyrosis (gastroesophageal reflux disease)
• skin cancer (squamous cell carcinoma)
• thickening of the outer layer of the skin (hyperkeratosis)
• sudden, involuntary muscle contractions (muscle spasms)

Uncommon side effects:(may affect up to 1 in 100 patients)

• inflammation of the stomach lining (gastritis)
• abdominal pain caused by pancreatitis, inflammation of the gallbladder and/or bile ducts.
• yellow skin or eyes (jaundice) caused by elevated levels of bile pigments (bilirubinemia)
• allergic reactions (including skin reactions and rashes)
• dehydration
• breast enlargement (gynecomastia)
• difficulty breathing (pulmonary disease)
• eczema
• hyperthyroidism (hyperthyroidism)
• multiple skin eruptions (erythema multiforme)
• abnormally high blood pressure
• perforation of the intestinal wall (gastrointestinal perforation)
• reversible inflammation of the back of the brain, which may be associated with headache, altered consciousness, seizures, and visual symptoms including loss of vision (reversible posterior leukoencephalopathy)
• severe anaphylactic reaction (anaphylactic reaction)

Rare side effects:(may affect up to 1 in 1,000 patients)

• allergic reaction with skin swelling (e.g. face, tongue) that may cause difficulty breathing or swallowing (angioedema)
• abnormal heart rhythm (QT prolongation)
• inflammation of the liver that may lead to nausea, vomiting, abdominal pain, and yellowing of the skin (drug-induced hepatitis)
• sunburn-like rash that may occur on skin that has been exposed to radiation and may be severe (radiation dermatitis)
• severe skin and/or mucous membrane reactions that may include painful blisters or fever, including extensive skin detachment (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle breakdown that may lead to kidney problems (rhabdomyolysis)
• kidney damage that causes large amounts of protein to be lost (nephrotic syndrome)
• inflammation of the skin blood vessels that may cause a rash (leucocytoclastic vasculitis)

Side effects of unknown frequency:the frequency cannot be estimated from the available data.

• brain damage that may be associated with, for example, drowsiness, changes in behavior, or confusion (encephalopathy)
• increase and weakening of the wall of a blood vessel or tearing of the wall of a blood vessel (aneurysms and arterial dissections).
• nausea, difficulty breathing, irregular heartbeats, muscle cramps, seizures, cloudy urine, and fatigue (tumor lysis syndrome [TLS]) (see section 2).

Reporting of side effects

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

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

Do not use this medication after the expiration datethat appears on the box and on each blister pack after CAD and EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Sorafenib Accord

• The active principle is sorafenib. Each film-coated tablet contains 200 mg of sorafenib (in the form of tosilate)
• The other components are:

Tablet core: sodium croscarmellose, microcrystalline cellulose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 “Sorafenib Accord contains sodium”.

Tablet coating: hypromellose (E464), macrogol (E1521), titanium dioxide (E171), iron oxide red (E172).

Appearance of the product and content of the container

Sorafenib Accord 200 mg film-coated tablets are red, round, biconvex, and bisected with a diameter of 12.0 mm, engraved with “H1” on one face and smooth on the other.

Single-dose, perforated aluminum/aluminum blisters in a container size of 112 x 1 film-coated tablets in a box

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6th Floor

08039 Barcelona

Spain

Responsible for manufacturing

Accord Healthcare Polska Sp. z.o.o.

ul. Lutomierska 50

95-200, Pabianice

Poland

Pharmadox Healthcare Limited

KW20A Kordin Industrial Estate

Paola PLA 3000

Malta

Accord Healthcare B.V.

Winthontlaan 200,

3526 KV Utrecht

Netherlands

Last revision date of this leaflet:

Other sources of information

The detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.