Sorafenib Accord 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sorafenib Accord 200 mg film-coated tablets

sorafenib

Read the entire leaflet carefully before you start taking this medicine, because 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Sorafenib Accord is also used in the treatment of advanced renal cell cancer (advanced renal cell carcinoma) when standard treatment has not been effective in halting the disease or is considered inappropriate.

Sorafenib Accord is a multikinase inhibitor. It works by slowing down the growth rate of cancer cells and interrupting the blood supply that supports the growth of cancer cells.

2. What you need to know before taking Sorafenib Accord

Do not take Sorafenib Accord

If you are allergic to 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 starting treatment with Sorafenib Accord.

Take special care with Sorafenib Accord

• If you experience skin problems. Sorafenib Accord may cause rashes and skin reactions, especially on the hands and feet. Your doctor can usually manage these conditions. Otherwise, your doctor may temporarily or permanently discontinue treatment.
• If you have high blood pressure. Sorafenib Accord may increase blood pressure. Your doctor will monitor your blood pressure and may prescribe medication to treat hypertension.
• If you have or have had an aneurysm (a bulge and weakening in 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 monitored regularly to assess whether an adjustment in antidiabetic medication dosage is needed to minimize the risk of low blood sugar levels.
• If you have bleeding disorders 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 an increased risk of bleeding.
• If you have chest pain or heart problems. Your doctor will decide whether to temporarily or permanently discontinue treatment.
• If you have a heart disorder, such as an abnormal electrical signal known as "QT interval prolongation."
• If you are scheduled for surgery or have recently undergone surgery. Sorafenib Accord may affect wound healing. You should usually stop taking Sorafenib Accord before undergoing surgery. Your doctor will decide when it is safe to restart treatment.
• If you are taking irinotecan or docetaxel, which are also anticancer medicines. Sorafenib Accord may enhance the effects and, in particular, the adverse effects of these drugs.
• If you are taking neomycin or other antibiotics. The effect of Sorafenib Accord may be reduced.
• If you have severe hepatic impairment. You may experience more severe adverse effects when taking this medicine.
• If you have renal impairment. 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, gastrointestinal perforations (holes in the intestinal wall) may occur (see section 4: Possible side effects). In such cases, your doctor will discontinue treatment.
• If you have thyroid cancer. Your doctor will monitor blood levels of calcium and thyroid hormones.
• If you experience any of the following symptoms, contact your doctor immediately, as this may be a potentially life-threatening condition: nausea, difficulty breathing, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue. These may be caused by a group of metabolic complications that can occur during cancer treatment due to the breakdown products of dying cancer cells [tumor lysis syndrome (TLS)], which may lead to changes in kidney function and acute kidney failure (see also section 4: Possible side effects).

Talk to your doctor if any of these situations apply to you. You may require treatment for these conditions, or your doctor may decide to adjust your dose of Sorafenib Accord or discontinue treatment completely (see also section 4: Possible side effects).

Children and adolescents

Sorafenib has not yet been studied in children and adolescents.

Taking Sorafenib Accord with other medicines

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

• Rifampicin, neomycin, or other medicines used to treat infections (antibiotics)
• St. John’s wort, a herbal remedy used 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 clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, which are cancer treatments
• Digoxin, a treatment for mild to moderate heart failure

Pregnancy and breastfeeding

Avoid becoming pregnant during treatment with Sorafenib Accord. If you are able to become pregnant, use adequate contraception during treatment. If you become pregnant while taking Sorafenib Accord, inform your doctor immediately; your doctor will decide whether to continue treatment.

You must not breastfeed during treatment with Sorafenib Accord, as this medicine may interfere with your baby's growth and development.

Driving and using machines

There are no indications that Sorafenib Accord affects the ability to drive or operate machinery.

Sorafenib Accord contains sodium

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

3. How to take Sorafenib Accord

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

This corresponds to a daily dose of 800 mg, or four tablets per day.

Sorafenib Accord tablets should be taken with a glass of water on an empty stomach or with a low- or moderate-fat meal. Do not take this medicine with a high-fat meal, as this reduces the effectiveness of Sorafenib Accord. If you plan to eat a high-fat meal, you should take the sorafenib tablets at least 1 hour before or 2 hours after the meal.

Always follow exactly the instructions provided by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

It is important to take this medicine at the same time each day to maintain a stable level in the bloodstream.

You will usually continue taking this medicine for as long as you are obtaining clinical benefit and do not experience unacceptable side effects.

If you take more Sorafenib Accord than you should

Contact your doctor immediately if you (or anyone else) have taken more than the prescribed dose. Taking too much Sorafenib Accord increases the likelihood of side effects occurring, or of them being more severe, particularly diarrhea or skin problems. Your doctor may instruct you to stop taking this medicine.

If you forget to take Sorafenib Accord

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

4. Possible adverse effects

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

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

• diarrhea
• nausea
• feeling of weakness or tiredness (fatigue)
• pain (including mouth sores, abdominal pain, headache, bone pain, tumor pain)
• hair loss (alopecia)
• redness or pain in palms and soles (hand–foot skin reaction)
• itching or rash
• vomiting
• bleeding (including bleeding in the brain, intestinal wall, and 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 adverse effects: (may affect up to 1 in 10 patients)

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

Uncommon adverse 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
• yellowing of the skin or eyes (jaundice) due to high levels of bile pigments (hyperbilirubinemia)
• allergic-type reactions (including skin rashes and hives)
• dehydration
• breast enlargement (gynecomastia)
• difficulty breathing (lung disease)
• eczema
• overactive thyroid gland (hyperthyroidism)
• multiple skin rashes (erythema multiforme)
• abnormally high blood pressure
• perforation in the intestinal wall (gastrointestinal perforation)
• reversible inflammation of the back part of the brain, which may be associated with headache, altered consciousness, seizures, and visual symptoms including loss of vision (reversible posterior leukoencephalopathy syndrome)
• sudden severe allergic reaction (anaphylactic reaction)

Rare adverse 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)
• liver inflammation that may lead to nausea, vomiting, abdominal pain, and yellowing of the skin (drug-induced hepatitis)
• a sunburn-like rash, which may occur on skin previously exposed to radiotherapy and can be severe (radiation recall dermatitis)
• severe skin and/or mucous membrane reactions, which may include painful blisters or fever, including extensive skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle breakdown that may lead to kidney problems (rhabdomyolysis)
• kidney damage causing loss of large amounts of protein (nephrotic syndrome)
• inflammation of blood vessels in the skin that may cause a rash (leukocytoclastic vasculitis)

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sorafenib Accord

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

Do not use this medicine after the expiry date which is stated on the carton and on each blister after CAD and EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sorafenib Accord

• The active substance is sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
• The other components are:

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), iron oxide red (E172).

Appearance of the product and contents of the pack

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

Aluminium/aluminium perforated unit dose blisters in pack size of 112 x 1 film-coated tablets in a carton.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6a Planta

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

The Netherlands

Date of the most recent revision of this leaflet:

Other sources of information

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