Sorafenib Sandoz

Leaflet attached to the packaging: patient information

Sorafenib Sandoz, 200 mg, film-coated tablets

Sorafenib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sorafenib Sandoz and what is it used for
• 2. Important information before taking Sorafenib Sandoz
• 3. How to take Sorafenib Sandoz
• 4. Possible side effects
• 5. How to store Sorafenib Sandoz
• 6. Contents of the packaging and other information

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

Sorafenib Sandoz is used to treat liver cancer (hepatocellular carcinoma).
Sorafenib Sandoz is also used to treat kidney cancer in advanced stages
(advanced renal cell carcinoma) in patients who have not responded to standard therapy or for whom it is not indicated.
Sorafenib Sandoz is used to treat thyroid cancer (differentiated thyroid carcinoma).
Sorafenib Sandoz is a so-called multi-kinase inhibitor. It works by reducing the growth rate of cancer cells and cutting off the blood supply that supports the development of cancer cells.

2. Important information before taking Sorafenib Sandoz

When not to take Sorafenib Sandoz

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

Warnings and precautions

Before starting treatment with Sorafenib Sandoz, discuss it with your doctor or pharmacist.

When to exercise special caution when taking Sorafenib Sandoz:

• If skin changes occur. Sorafenib Sandoz may cause rash and skin reactions, especially on the hands and feet. These changes can usually be treated by the attending physician. If they do not disappear, the doctor may temporarily discontinue treatment with Sorafenib Sandoz or stop it completely.
• If the patient has high blood pressure. Sorafenib Sandoz may increase blood pressure. The attending physician will monitor blood pressure and may prescribe medications to lower it.
• If the patient has or has had an aneurysm(enlargement and weakening of the blood vessel wall) or rupture of the blood vessel wall.
• If the patient has diabetes.In diabetic patients, blood sugar levels should be regularly checked to assess whether the dose of antidiabetic medication needs to be adjusted to minimize the risk of hypoglycemia.
• If there are any bleeding disorders or if the patient is taking warfarin or phenprocoumon.Treatment with Sorafenib Sandoz may increase the risk of bleeding. If the patient is taking warfarin or phenprocoumon, anticoagulant medications to prevent blood clots, there may be an increased risk of bleeding.
• If chest pain or heart problems occur, the doctor may decide to temporarily discontinue treatment with Sorafenib Sandoz or stop it completely.
• If there are heart problems, such as abnormal electrical activity, called "QT interval prolongation".
• If the patient is scheduled for surgery or has recently undergone surgery. Sorafenib Sandoz may affect wound healing. Usually, Sorafenib Sandoz is discontinued in the event of surgery. The attending physician will decide when to resume treatment with Sorafenib Sandoz.
• If the patient is taking irinotecan or receiving docetaxel, which are also anticancer medications. Sorafenib Sandoz may enhance their effect, especially adverse reactions.
• If the patient is taking neomycin or other antibiotics, the effectiveness of Sorafenib Sandoz may be reduced.
• If the patient has severe liver dysfunction, more serious adverse reactions may occur during treatment.
• If the patient has kidney dysfunction, the doctor will monitor fluid and electrolyte balance.
• Fertility.Sorafenib Sandoz may reduce fertility in both men and women. Any fertility issues should be discussed with the doctor.
• Gastrointestinal perforationmay occur during treatment (see section 4: Possible side effects). In this case, the doctor will recommend discontinuing treatment.
• If the patient has thyroid cancer, the doctor will monitor calcium and thyroid hormone levels in the blood.
• If the patient experiences any of the following symptoms, they should contact their doctor immediately, as it may be a life-threatening condition:nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue. Such symptoms may be caused by a group of metabolic complications that can occur during cancer treatment, caused by the breakdown products of dying cancer cells [tumor lysis syndrome (TLS)] and can lead to kidney dysfunction and acute kidney failure (see also section 4. Possible side effects).

If any of these situations apply to the patient, they should inform their doctor. Treatment or a change in the dose of Sorafenib Sandoz or complete discontinuation of treatment with this medicine may be necessary (see also section 4: Possible side effects)

Children and adolescents

So far, no studies have been conducted on the use of Sorafenib Sandoz in children and adolescents.

Sorafenib Sandoz and other medicines

Some medicines may affect the action of Sorafenib Sandoz, or their action may be changed by Sorafenib Sandoz. The doctor or pharmacist should be informed about any medicines on this list that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take and any other medicines, including those available without a prescription:

• Rifampicin, neomycin, or other antibiotics used to treat infections
• St. John's Wort, used to treat depression
• Phenytoin, carbamazepine, or phenobarbital, used to treat epilepsy and other conditions
• Dexamethasone, a corticosteroid used in various diseases
• Warfarin or phenprocoumon, anticoagulant medications used to prevent blood clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan - anticancer medications
• Digoxin, used to treat mild and moderate heart failure

Pregnancy and breastfeeding

Patients should avoid becoming pregnant while taking Sorafenib Sandoz.If there is a risk that the patient may become pregnant while taking Sorafenib Sandoz, they should use an effective method of contraception during treatment. If the patient becomes pregnant while taking Sorafenib Sandoz, they should immediately inform their doctor, who will decide whether treatment can be continued.
Patients should not breastfeed while taking Sorafenib Sandoz,as this medicine may affect the growth and development of the child.

Driving and operating machines

There is no data on the effect of Sorafenib Sandoz on the ability to drive and operate machines.

Sorafenib Sandoz contains sodium.

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Sorafenib Sandoz

This medicine should always be taken as directed by the doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose of Sorafenib Sandoz for adults is 2 tablets x 200 mg, twice a day.

This corresponds to a daily dose of 800 mg or 4 tablets.
Sorafenib Sandoz should be swallowed, washed down with a glass of water, on an empty stomach or with meals with low or moderate fat content. The medicine should not be taken with high-fat meals, as this may reduce the effectiveness of Sorafenib Sandoz. If a high-fat meal is planned, the tablets should be taken at least 1 hour before or 2 hours after the meal.
It is essential to take this medicine at approximately the same time every day to ensure a constant amount of the medicine in the bloodstream.
This medicine is usually taken for as long as it provides clinical benefits and as long as the person taking it does not experience unacceptable side effects.

Taking a higher dose of Sorafenib Sandoz than recommended

The doctor should be informed immediatelyif the patient (or anyone else) has taken a dose larger than recommended. Taking Sorafenib Sandoz in excess may increase the likelihood of side effects or worsen them, especially diarrhea and skin reactions. The doctor may recommend discontinuing treatment with this medicine.

Missing a dose of Sorafenib Sandoz

If the patient misses a dose, they should take it as soon as they remember. If the time for the next dose is near, the missed dose should be skipped, and treatment should continue as usual. A double dose should not be taken to make up for missed single doses.

4. Possible side effects

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

Very common:

May occur in more than 1 in 10 people

• diarrhea
• nausea (vomiting)
• feeling of weakness or fatigue (fatigue)
• pain (including pain in the mouth, abdominal pain, headache, bone pain, cancer pain)
• hair loss (alopecia)
• redness or pain in the hands or feet (hand-foot syndrome)
• itching or rash
• vomiting
• bleeding (including cerebral hemorrhage, gastrointestinal bleeding, respiratory bleeding, hemorrhage)
• high blood pressure or periodic increases in blood pressure (hypertension)
• infections
• loss of appetite (anorexia)
• constipation
• joint pain (arthralgia)
• fever
• weight loss
• dry skin

Common:

May occur in up to 1 in 10 people

• flu-like symptoms
• indigestion (dyspepsia)
• difficulty swallowing (dysphagia)
• inflammation or dryness in the mouth, tongue pain (stomatitis and mucositis)
• low calcium levels in the blood (hypocalcemia)
• low potassium levels in the blood (hypokalemia)
• low blood sugar levels (hypoglycemia)
• muscle pain (myalgia)
• nerve damage in the fingers and toes, including numbness or tingling (peripheral sensory neuropathy)
• depression
• erectile dysfunction (impotence)
• voice changes (dysphonia)
• acne
• skin inflammation, dry and flaky skin (dermatitis and 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)
• low white blood cell count (leukopenia and neutropenia)
• low red blood cell count (anemia)
• low platelet count (thrombocytopenia)
• folliculitis
• underactive thyroid (hypothyroidism)
• low sodium levels in the blood (hyponatremia)
• taste disorders
• redness of the face and often other skin areas (flushing)
• runny nose (rhinitis)
• heartburn (gastroesophageal reflux disease)
• skin cancer (squamous cell carcinoma/skin carcinoma)
• thickening of the outer layer of the skin (hyperkeratosis)
• sudden, involuntary muscle contractions (muscle spasms)

Uncommon:
May occur in up to 1 in 100 people

• gastritis
• abdominal pain caused by pancreatitis, inflammation of the gallbladder, and (or) bile ducts
• yellowing of the skin or eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinemia)
• allergic reactions (including skin reactions and hay fever)
• dehydration
• breast enlargement (gynecomastia)
• breathing difficulties (lung disease)
• eczema
• overactive thyroid (hyperthyroidism)
• multiple skin eruptions (erythema multiforme)
• high blood pressure
• perforation of the gastrointestinal tract (gastrointestinal perforation)
• reversible posterior leukoencephalopathy, which may be associated with headache, changes in consciousness, seizures, and vision disturbances, including loss of vision (reversible posterior leukoencephalopathy syndrome)
• sudden, severe allergic reaction (anaphylactic reaction)

Rare:

May occur in up to 1 in 1000 people

• allergic reaction with skin swelling (e.g., face, tongue), which can cause breathing or swallowing difficulties (angioedema)
• abnormal heart rhythm (QT interval prolongation)
• liver inflammation, which can cause nausea, vomiting, abdominal pain, and jaundice (drug-induced liver inflammation)
• rash similar to sunburn, which can occur on skin previously exposed to radiation, and its severity can be severe (radiation-induced skin inflammation)
• severe skin and (or) mucous membrane reactions, which can include painful blisters and fever, including widespread skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal breakdown of muscle tissue, which can lead to kidney dysfunction (rhabdomyolysis)
• kidney damage causing large amounts of protein loss (nephrotic syndrome)
• inflammation of the blood vessels in the skin, which can cause a rash (leukocytoclastic vasculitis)

Frequency not known:
Frequency cannot be estimated from available data

• brain disorders, which can be associated with drowsiness, changes in behavior, or disorientation (encephalopathy)
• enlargement and weakening of the blood vessel wall or rupture of the blood vessel wall (aneurysm and arterial dissection).
• nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue [ tumor lysis syndrome (TLS)] (see section 2).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301/fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Sorafenib Sandoz

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry datestated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Aluminum/OPA/Aluminum/PVC blisters:
No special precautions for storage of the medicinal product.
Aluminum/PVC/PE/PVDC blisters:
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sorafenib Sandoz contains

• The active substance is sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as sorafenib tosylate).
• Other ingredients are: hypromellose 2910, sodium croscarmellose, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate. Coating:hypromellose 2910, titanium dioxide, macrogol, iron oxide red (E 172).

What Sorafenib Sandoz looks like and what the pack contains

Red-brown, round, biconvex film-coated tablets with the symbol "200" embossed on one side and smooth on the other, with a diameter of 12.0 mm ± 5%.
The medicine is available in packs containing 112 film-coated tablets in Aluminum/PVC/PE/PVDC blisters in a carton.
The medicine is available in packs containing 112 x 1 film-coated tablets in perforated unit-dose Aluminum/PVC/PE/PVDC blisters in a carton.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

LEK Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus