SORAFENIB DR. REDDYS 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sorafenib Dr. Reddys 200 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Sorafenib Dr. Reddys is and what it is used for

Sorafenib is used to treat liver cancer (hepatocellular carcinoma).

Sorafenib is also used to treat advanced kidney cancer (advanced renal cell carcinoma) when standard treatment has not helped to control your disease or is considered inappropriate.

Sorafenib is used to treat thyroid cancer (differentiated thyroid carcinoma).

Sorafenib 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 you take Sorafenib Dr. Reddys

Do not take Sorafenib Dr. Reddys

• If you are allergic to sorafenib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Sorafenib Dr. Reddys.

Be careful with Sorafenib Dr. Reddys

• If you have skin problems. Sorafenib may cause skin reactions and rashes, especially on the 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 may increase blood pressure. Your doctor will monitor your blood pressure and may give you a medicine 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 in order to assess whether a dose adjustment of the anti-diabetic medication is necessary to minimize the risk of low blood sugar levels.
• If you have bleeding problems or are taking warfarin or phenprocoumon. Treatment with Sorafenib may increase the risk of bleeding. If you are taking warfarin or phenprocoumon, medicines 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 have surgery or have recently had surgery. Sorafenib may affect wound healing. You should normally stop taking sorafenib if you are going to have surgery. Your doctor will decide when to restart treatment with sorafenib.
• If you are taking irinotecan or docetaxel, which are also anti-cancer medicines. Sorafenib may increase the effects and, in particular, the side effects of these medicines.
• If you are taking neomycin or other antibiotics. The effect of sorafenib may be reduced.
• If you have severe liver failure. You may experience more severe side effects when taking this medicine.
• If you have kidney failure. Your doctor will monitor your fluid and electrolyte balance.
• Fertility. Sorafenib may reduce male and female fertility. If this applies to you, consult your doctor.
• During treatment, gastrointestinal perforation (a hole in the wall of the intestine) may occur (see section 4: Possible side 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 they can be life-threatening: nausea, difficulty breathing, irregular heartbeats, muscle cramps, convulsions, cloudy urine, and fatigue. These may be caused by a group of metabolic complications that can occur during cancer treatment and are caused by the breakdown products of dying cancer cells (tumor lysis syndrome [TLS]) and can lead to changes in kidney function and acute kidney failure (see also section 4: Possible side effects).

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

Children and adolescents

There is limited experience with sorafenib in children and adolescents.

Other medicines and Sorafenib Dr. Reddys

Some medicines affect Sorafenib Dr. Reddys or may be affected by it. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the medicines listed in the following list or any other medicine, including those obtained without a prescription:

• Rifampicin, neomycin, or other medicines 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 clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, which are anti-cancer treatments
• Digoxin, a treatment for mild to moderate heart failure

Pregnancy and breastfeeding

Avoid becoming pregnant during treatment with Sorafenib Dr. Reddys.If you can become pregnant, use adequate contraceptive methods during treatment. If you become pregnant during treatment with sorafenib, inform your doctor immediately, who will decide whether you should continue treatment.

Do not breastfeed during treatment with Sorafenib Dr. Reddysas this medicine may interfere with the growth and development of your baby.

Driving and using machines

There are no indications that sorafenib affects the ability to drive or use machines.

Sorafenib Dr. Reddys contains sodium

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

3. How to take Sorafenib Dr. Reddys

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

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

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

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, 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.

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

If you take more Sorafenib Dr. Reddys than you should

Consult your doctor immediatelyif you (or anyone else) have taken a higher dose than prescribed. Taking too much Sorafenib Dr. Reddys increases the likelihood of side effects or makes them more severe, especially diarrhea or skin problems. Your doctor may instruct you to stop taking this medicine.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Sorafenib Dr. Reddys

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 with your normal schedule. Do not take a double dose to make up for the individual dose missed.

4. Possible side effects

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

Very common:

may affect more than 1 in 10 people

• diarrhea
• nausea
• feeling weak or tired (fatigue)
• pain (including mouth pain, abdominal pain, headache, bone pain, tumor 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 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:

may affect up to 1 in 10 people

• flu-like illness
• indigestion (dyspepsia)
• difficulty swallowing (dysphagia)
• inflamed mouth or dry mouth, pain in the tongue (stomatitis and mucosal inflammation)
• low calcium levels in the blood (hypocalcemia)
• low potassium levels in the blood (hypokalemia)
• low blood sugar (hypoglycemia)
• muscle pain (myalgia)
• altered sensitivity in fingers and toes, including tingling or numbness (peripheral sensory neuropathy)

• depression
• erectile dysfunction (impotence)
• voice changes (dysphonia)
• acne
• inflamed, dry, or scaly skin that sheds (dermatitis, skin exfoliation)
• heart failure
• heart attack (myocardial infarction) or chest pain
• ringing in the ears (tinnitus)
• kidney failure
• abnormally high protein levels 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 in the blood (thrombocytopenia)
• inflammation of the hair follicles (folliculitis)
• underactive thyroid gland (hypothyroidism)
• low sodium levels in the blood (hyponatremia)
• distortion of the sense of taste (dysgeusia)
• redness of the face and often other areas of the skin (flushing)
• nasal discharge (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:

may affect up to 1 in 100 people

• inflammation of the stomach lining (gastritis)
• abdominal pain caused by pancreatitis, inflammation of the gallbladder, and/or the bile ducts.
• yellowing of the skin or eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinemia)

• allergic reactions (including skin reactions and hives)
• dehydration
• breast enlargement (gynecomastia)
• difficulty breathing (lung disease)
• eczema
• overactive thyroid gland (hyperthyroidism)
• multiple skin rashes (erythema multiforme)
• abnormally high blood pressure
• hole in the wall of the intestine (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 syndrome)
• 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) that can cause difficulty breathing or swallowing (angioedema)
• abnormal heart rhythm (prolonged QT interval)
• inflammation of the liver that can lead to nausea, vomiting, abdominal pain, and yellowing of the skin (drug-induced hepatitis)
• a rash that looks like a sunburn, which can occur on skin that has been exposed to radiation before and can be severe (radiation recall dermatitis)
• severe skin reactions and/or mucous membranes that can include painful blisters or fever, including widespread skin shedding (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle breakdown that can lead to kidney problems (rhabdomyolysis)
• kidney damage that causes large amounts of protein to be lost (nephrotic syndrome)
• inflammation of the blood vessels in the skin that can cause a rash (leukocytoclastic vasculitis)

Frequency not known:

frequency cannot be estimated from the available data.

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sorafenib Dr. Reddys

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

Do not use this medicine after the expiry datestated on the carton and on each blister after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Sorafenib Dr. Reddys

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

Core of the tablet: hypromellose 2910 (E464), sodium croscarmellose (E468), microcrystalline cellulose (E460), magnesium stearate (E470b), sodium lauryl sulfate (E514)

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

Appearance of the product and packaging content

The film-coated tablets of Sorafenib Dr. Reddys 200 mg are reddish-brown, round, biconvex, with a diameter of 12 mm, which has "200" engraved on one face and is smooth on the other, with a tablet diameter of 12.0 mm ± 5%.

They are presented in packs of 112 film-coated tablets in aluminum-PVC/PE/PVDC blisters or packs of 112 x 1 film-coated tablets in perforated unit-dose aluminum-PVC/PE/PVDC blisters.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Phone: 93.355.49.16

Fax: 93.355.49.61

Manufacturer

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

Limassol 3056

Cyprus

Phone No: +357 25553000

Fax No: +357 25390192

or

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

Birzebbugia BBG3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of thisleaflet:March 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).