Sorafenib Medac

Package leaflet: Information for the user

Sorafenib medac 200 mg film-coated tablets

Sorafenib
Generic medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Sorafenib medac is used for the treatment of liver cancer (hepatocellular carcinoma).
Sorafenib medac 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 effective in stopping it or is considered
inappropriate.
Sorafenib medac is a so-called multikinase inhibitor. It works by slowing down the rate of growth of tumor
cells and by blocking the blood supply that enables tumor cells to grow.

2. What you should know before taking Sorafenib medac

Do not take Sorafenib medac

• 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 taking Sorafenib medac.
Exercise special caution with Sorafenib medac:

• If you develop skin problems. Sorafenib medac may cause rashes and skin reactions, especially on the hands and feet. These effects can usually be managed by your doctor. Otherwise, your doctor may suspend or completely stop treatment.

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• If you have high blood pressure. Sorafenib medac may cause an increase in blood pressure; your doctor will regularly monitor your blood pressure and may prescribe medications to treat high blood pressure.
• If you have or have had an aneurysm (a bulging 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 must be monitored regularly to assess whether adjustment of antidiabetic medication dosage is needed, in order to minimize the risk of low blood sugar.
• If you have bleeding problems or are taking warfarin or phenprocoumon. Treatment with Sorafenib medac may increase the risk of bleeding. If you are taking warfarin or phenprocoumon, which are blood-thinning medicines used to prevent blood clots, there may be an increased 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 disorder, such as an electrical conduction abnormality called "QT interval prolongation".
• If you are scheduled for or have recently undergone surgery. Sorafenib medac may affect wound healing. If you are due to have surgery, your treatment with Sorafenib medac will likely be stopped temporarily. Your doctor will decide when to restart it.
• If you are receiving treatment with irinotecan or docetaxel, which are also anticancer medicines. Sorafenib medac may increase the effects, and in particular the side effects, of these medicines.
• If you are taking neomycin or other antibiotics. The effectiveness of Sorafenib medac may be reduced.
• If you have severe liver impairment. You may experience 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. Sorafenib medac may reduce fertility in both men and women. If this is a concern for you, discuss it with your doctor.
• Gastrointestinal perforation may occur during treatment (see section 4: Possible side effects). In such a case, your doctor will stop treatment.
• If you have thyroid cancer, your doctor will monitor calcium and thyroid hormone levels in your blood.
• If you experience any of the following symptoms, contact your doctor immediately, as they may indicate a potentially life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue. These symptoms may be caused by a series of metabolic complications that can occur during cancer treatment due to the breakdown products of dying tumor cells (tumor lysis syndrome, TLS), which may lead to changes in kidney function and acute kidney failure (see also section 4: Possible side effects).

Inform your doctor if any of these conditions apply to you. You may require treatment for these conditions, or your doctor may adjust the dose of Sorafenib medac or stop treatment altogether (see also section 4: Possible side effects).
Children and adolescents
Sorafenib medac has not yet been studied in children and adolescents.
Other medicines and Sorafenib medac
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Some medicines may affect Sorafenib medac or be affected by it. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular:

• 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 for various diseases
• Warfarin or phenprocoumon, anticoagulants used to prevent blood clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, used in cancer treatment
• Digoxin, used to treat mild to moderate heart failure

Pregnancy and breastfeeding
Avoid becoming pregnant while being treated with Sorafenib medac. If you are of childbearing age, you must use an effective method of contraception during treatment with Sorafenib medac. If you become pregnant while receiving Sorafenib medac, inform your doctor immediately; your doctor will decide whether treatment should continue or be stopped.
You must not breastfeed during treatment with Sorafenib medac, as this medicine may interfere with the child's growth and development.
Driving and using machines
There are no known reasons to believe that sorafenib may affect the ability to drive vehicles or operate machinery.
Sorafenib medac contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take Sorafenib medac

The recommended dose of Sorafenib medac in adults is two 200 mg tablets twice daily.
This corresponds to a daily dose of 800 mg, or four tablets per day.
Take the Sorafenib medac tablets with a glass of water, on an empty stomach or with food low to medium in fat. Do not take this medicine with high-fat meals, as they may reduce its effectiveness. If you plan to eat a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal. Always take this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
It is important to take this medicine at approximately the same time each day to maintain a constant concentration in the blood.
This medicine is usually taken as long as clinical benefit is observed and no intolerable side effects occur.
If you take more Sorafenib medac than you should
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Contact your doctor immediately if you or anyone else has taken more than the prescribed dose. Taking too much Sorafenib medac increases the likelihood or severity of side effects, especially diarrhea and skin reactions. Your doctor may instruct you to stop taking this medicine.
If you forget to take Sorafenib medac
If you forget to take a dose, take it as soon as you remember. 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 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 certain blood tests.

Very common (may affect more than 1 in 10 people):

• diarrhoea
• feeling unwell (nausea)
• feeling weak or tired (fatigue)
• pain (including mouth, abdominal pain, headache, bone pain, oncological pain)
• hair loss (alopecia)
• redness or pain on the palms of the hands or soles of the feet (hand-foot skin reaction)
• itching or rash
• vomiting
• bleeding (including brain haemorrhage, intestinal wall haemorrhage, respiratory tract haemorrhage)
• high blood pressure, or increase in 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)
• sensory disturbances in fingers and toes, including tingling and numbness (peripheral sensory neuropathy)
• depression
• problems with erection (impotence)
• voice changes (dysphonia) 4/7
• acne
• inflamed, dry or peeling skin (dermatitis, skin desquamation)
• 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 (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 sensation (dysgeusia)
• redness of the face and often other areas of the skin (flushing)
• runny nose (rhinorrhoea)
• heartburn (gastroesophageal reflux disease)
• skin tumour (keratoacanthoma/squamous cell carcinoma of the skin)
• thickening of the outer layer of the skin (hyperkeratosis)
• sudden involuntary muscle contractions (muscle spasms)

Uncommon (may affect up to 1 in 100 people):

• inflammation of the stomach (gastritis)
• stomach (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
• breast enlargement (gynaecomastia)
• difficulty breathing (lung disease)
• eczema
• overactivity of the thyroid gland (hyperthyroidism)
• multiple skin rashes (erythema multiforme)
• high blood pressure
• gastrointestinal perforation
• reversible swelling in the back part of the brain which may be associated with headache, altered consciousness, seizures and visual symptoms including loss of vision (posterior reversible encephalopathy syndrome)
• 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) which may cause difficulty breathing and swallowing (angioedema)
• abnormal heart rhythm (QT prolongation)
• liver inflammation, which may lead to nausea, vomiting, abdominal pain and jaundice (drug-induced hepatitis)
• appearance of a sunburn-like rash on skin previously exposed to radiotherapy, which may be severe (radiation-like dermatitis)

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• severe skin and/or mucosal membrane reactions which may include painful blisters and fever, with shedding of large areas of skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle damage which may lead to kidney problems (rhabdomyolysis)
• kidney damage causing loss of large amounts of protein in the urine (nephrotic syndrome)
• inflammation of blood vessels in the skin which may appear as a rash (leucocytoclastic vasculitis)

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

• impaired brain function which may be associated with, for example, 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)
• nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine and fatigue [tumour lysis syndrome (TLS)] (see section 2)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://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 medac

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater 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 Sorafenib medac contains

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

Description of the appearance of Sorafenib medac and package contents
The 200 mg film-coated tablets of Sorafenib medac are pink, round, and biconvex, with the imprint
“TV” on one side and “S3” on the other side. They are packed in cartons containing 112 tablets.

Marketing Authorization Holder
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medac pharma s.r.l.
Via Viggiano 90,
00178 Rome, Italy

Manufacturer
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.)
Prilaz baruna Filipovica 25
HR-10000 Zagreb
Croatia
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