SORAFENIB ACCORD 200 mg FILM-COATED TABLETS

Introduction

Prospective: Information for the User

Sorafenib Accord 200 mg Film-Coated Tablets

sorafenib

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the Prospectus

1. What is Sorafenib Accord and what is it used for
2. What you need to know before taking Sorafenib Accord
3. How to take Sorafenib Accord
4. Possible adverse effects
5. Storage of Sorafenib Accord
6. Package contents and additional information

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

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 served to slow down the disease or is considered inappropriate.

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

2. What you need to know before taking Sorafenib Accord

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 particularly careful with Sorafenib Accord

• If you experience skin problems. Sorafenib Accord may cause skin rashes and reactions, especially on hands and feet. Your doctor can usually treat these conditions. Otherwise, your doctor may interrupt treatment temporarily or completely.
• If you have high blood pressure. Sorafenib Accord may increase blood pressure. Your doctor will monitor your blood pressure and may administer medication to treat high blood pressure.
• If you have or have had an aneurysm (enlargement and weakening of the wall of a blood vessel) 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 it is necessary to adjust the dose of the anti-diabetic medication to minimize the risk of low blood sugar levels.
• If you have bleeding problems or are taking warfarin or phenprocoumon. Treatment with Sorafenib Accord may increase the risk of bleeding. If you are taking warfarin or phenprocoumon, 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 interrupt treatment temporarily or completely.
• If you have a heart disorder, such as an abnormal electrical signal called "prolonged QT interval".
• If you are going to undergo surgery or have recently undergone surgery. Sorafenib Accord may affect wound healing. You should usually interrupt your treatment with Sorafenib Accord if you are going to undergo surgery. Your doctor will decide when to restart treatment with Sorafenib Accord.
• If you are taking irinotecan or docetaxel, which are also anti-cancer medications. Sorafenib Accord may increase the effects and, in particular, the adverse effects of these medications.
• If you are taking neomycin or other antibiotics. The effect of Sorafenib Accord may decrease.
• If you have severe liver failure. You may experience more severe adverse 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 is your case, consult your doctor.
• During treatment, holes in the walls of the intestine(gastrointestinal perforation) may occur (see section 4: Possible adverse effects). In this case, your doctor will interrupt 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, convulsions, cloudy urine, and fatigue. The cause may be a set of metabolic complications that can occur during cancer treatment as a result of the breakdown products of dying cancer cells [tumor lysis syndrome (TLS)] and may cause changes in renal function and acute renal failure (see also section 4: Possible adverse 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 dose of Sorafenib Accord or interrupt treatment completely (see also section 4: Possible adverse effects).

Children and adolescents

Tests with Sorafenib have not yet been conducted 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 recently taken, or may need to take any other medication:

• Rifampicin, neomycin, or other medications used to treat infections (antibiotics)
• St. John's Wort, a herbal remedy for depression
• Phenytoin, carbamazepine, or phenobarbital, treatments for epilepsy and other conditions
• Dexamethasone, a corticosteroid used in various conditions
• Warfarin or phenprocoumon, anticoagulants used to prevent blood clot formation
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, which are anti-cancer treatments
• Digoxin, a treatment for mild or moderate heart failure

Pregnancy and breastfeeding

Avoid becoming pregnant during treatment with Sorafenib Accord. If you can become pregnant, use adequate 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 during treatment with Sorafenib Accord, as this medication may interfere with the growth and development of your baby.

Driving and using machines

There is no indication that Sorafenib Accord affects the ability to drive or use machines.

Sorafenib Accord contains sodium

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

3. How to take Sorafenib Accord

The recommended dose of Sorafenib Accord in adults is 2 tablets of 200 mg, twice a day.

This is equivalent to a daily dose of 800 mg or 4 tablets per day.

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

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

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

Normally, you will continue taking this medication while it provides clinical benefits and does not cause unacceptable adverse 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 adverse effects or makes them more severe, especially diarrhea or skin problems. Your doctor may instruct you to suspend taking this medication.

If you forget to take Sorafenib Accord

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone experiences them. This medication can also affect some laboratory test results.

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

• diarrhea
• nausea
• feeling of weakness or fatigue
• pain (including mouth pain, abdominal pain, headache, bone pain, tumor pain)
• hair loss
• redness or pain on the palms of the hands and soles of the feet
• itching or rash
• vomiting
• bleeding (including bleeding in the brain, intestinal wall, and respiratory tract)
• high blood pressure or increased blood pressure
• infections
• loss of appetite
• constipation
• joint pain
• fever
• weight loss
• dry skin

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

• flu-like illness
• indigestion
• difficulty swallowing
• inflamed mouth or dry mouth, tongue pain
• low calcium levels in the blood
• low potassium levels in the blood
• low blood sugar levels
• muscle pain
• altered sensitivity in fingers and toes, including tingling or numbness
• depression
• erectile dysfunction
• voice changes
• acne
• inflamed, dry, or scaly skin
• heart failure
• heart attack or chest pain
• ringing in the ears
• kidney failure
• abnormally high protein levels in the urine
• general weakness or loss of strength
• decreased white blood cell count
• decreased red blood cell count
• low platelet count
• inflamed hair follicles
• underactive thyroid gland
• low sodium levels in the blood
• distorted sense of taste
• redness of the face and often other areas of the skin
• nasal discharge
• heartburn
• skin cancer
• thickening of the outer layer of the skin
• sudden, involuntary muscle contractions

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

• inflammation of the stomach wall
• abdominal pain caused by pancreatitis, inflammation of the gallbladder, and/or bile ducts
• yellowing of the skin and eyes
• allergic reactions
• dehydration
• breast enlargement
• difficulty breathing
• eczema
• overactive thyroid gland
• multiple skin rashes
• abnormally high blood pressure
• holes in the walls of the intestine
• reversible inflammation of the back of the brain, which may be associated with headache, altered consciousness, seizures, and visual symptoms, including loss of vision
• severe allergic reaction

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

• allergic reaction with swelling of the skin
• abnormal heart rhythm
• inflammation of the liver
• skin rash that may occur in skin that has been previously exposed to radiation
• severe skin reactions
• abnormal muscle breakdown
• kidney damage
• inflammation of the blood vessels

Adverse effects with unknown frequency:the frequency cannot be estimated from the available data.

• brain damage
• enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel
• nausea, difficulty breathing, irregular heartbeats, muscle cramps, convulsions, cloudy urine, and fatigue

Reporting adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. 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 medication.

5. Storage of Sorafenib Accord

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions.

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

6. Package contents and additional information

Composition of Sorafenib Accord

• The active ingredientis sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as tosylate)
• The other ingredientsare:

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

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

Appearance of the product and package contents

Sorafenib Accord 200 mg film-coated tablets are red, round, biconvex, and beveled, 12.0 mm in diameter, engraved with "H1" on one side and smooth on the other.

Single-dose aluminum/aluminum blisters in a package size of 112 x 1 film-coated tablets

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Manufacturer

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

Date of the last revision of this prospectus:

Other sources of information

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