Prospect: information for the user

Sorafenib Dr. Reddys 200 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed only for you, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to 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 additional information

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

Sorafenib is also used in the treatment of advanced kidney cancer (advanced renal cell carcinoma) when standard treatment has not been able to slow down the disease or is considered inappropriate.

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

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

Do not take Sorafenib Dr. Reddys

-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 Dr. Reddys.

Be especially careful with Sorafenib Dr. Reddys

-If you experience skin problems.Sorafenib may cause rashes and skin reactions, especially on hands and feet. Your doctor may normally treat these conditions. Otherwise, your doctor may temporarily or completely stop treatment.

-If you have hypertension.Sorafenib may increase blood pressure. Your doctor will monitor your blood pressure and prescribe medication to treat hypertension.

-If you have or have had an aneurysm(an enlargement and weakening of the wall of a blood vessel)or a tear in the wall of a blood vessel.

-If you have diabetes.Patients with diabetes should have their blood sugar levels regularly monitored to assess whether a dose adjustment of the antidiabetic medication is necessary to minimize the risk of low blood sugar levels.

-If you have bleeding problems or are taking warfarin or fenprocumona.Treatment with Sorafenib may increase the risk of bleeding. If you are taking warfarin or fenprocumona, medications that thin the blood to prevent blood clots, you may be at a higher risk of bleeding.

-If you have chest pain or heart problems.Your doctor will decide whether to temporarily or completely stop treatment.

-If you have a heart disorder,such as an abnormal electrical signal called “prolongation of the QT interval”.

-If you are about to undergo surgery or have recently undergone surgery.Sorafenib may affect wound healing. Normally, you should stop taking sorafenib before surgery. Your doctor will decide when to restart treatment with sorafenib.

-If you are taking irinotecan or docetaxel,which are also anticancer medications. Sorafenib may increase the effects and, in particular, the adverse effects of these medications.

-If you are taking neomicina 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 medication.

-If you have kidney problems.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, perforation of the intestinal walls(gastrointestinal perforation)may occur (see section 4: Possible side effects). In this case, your doctor will stop treatment.

• If you have thyroid cancer, your doctor will monitor your blood calcium levels and thyroid hormone levels.
• If you experience the following symptoms, contact your doctor immediately, as they may be potentially fatal: nausea, difficulty breathing, irregular heartbeats, muscle cramps, seizures, 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 may cause changes in kidney function and acute kidney failure (see also section 4: Possible side effects).

Consult your doctor if any of these aspects affect you.You may need to undergo treatment for them or your doctor may decide to modify your sorafenib dose or completely stop treatment (see also section 4: Possible side effects).

Children and adolescents

No clinical trials have been conducted with sorafenib in children and adolescents.

Other medications and Sorafenib Dr. Reddys

Some medications affect Sorafenib Dr. Reddys or may be affected by it. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the medications listed below or any other medication, including those purchased without a prescription:

-Rifampicin, neomicina, or other medications used to treat infections(antibiotics)

-St. John's Wort, a herbal remedy fordepression

-Phenobarbital, carbamazepine, or phenytoin, treatments forepilepsyand other conditions

-Dexamethasone, acorticosteroidused in various conditions

-Warfarin or fenprocumona, anticoagulants used toprevent blood clots

-Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, which areanticancer medications

-Digoxin, a treatment formild to moderate heart failure

Pregnancy and breastfeeding

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

Do not breastfeed your baby during treatment with Sorafenib Dr. Reddys, as this medication may interfere with your baby's growth and development.

Driving and operating machinery

There is no indication that sorafenib affects your ability to drive or operate machinery.

Sorafenib Dr. Reddys contains sodium

This medication contains less than 1 mmolof sodium (23 mg) per dose; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

This is equivalent to a daily dose of 800 mg or four 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 medication with a high-fat meal, as this reduces the effectiveness of Sorafenib Dr. Reddys. If you plan to take a high-fat meal, take the Sorafenib tablets at least 1 hour before or 2 hours after the meal.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of 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 as long as it provides clinical benefits 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 dose higher than prescribed. Taking too much Sorafenib Dr. Reddys increases the likelihood of experiencing side effects or more severe side effects, especially diarrhea or skin problems. Your doctor may instruct you to stop taking this medication.

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 medication and the amount ingested.

If you forgot 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 as usual. Do not take a double dose to compensate for the missed dose.

Like all medications, this medication may cause side effects, although not everyone will experience them. This medication may also affect some laboratory test results.

Very common:

may affect more than 1 in 10 patients

• diarrhea
• nausea
• feeling of weakness or fatigue(fatigue)
• pain (including mouth pain, abdominal pain, headache, bone pain, tumor pain)
• hair loss(alopecia)
• red or painful palms and soles of the feet(hand-foot syndrome)
• pruritus or exanthema
• vomiting
• bleeding (including intracranial hemorrhage, intestinal wall hemorrhage, and respiratory tract hemorrhage)
• hypertension or increased blood pressure(hypertension)
• infections
• loss of appetite(anorexia)
• constipation
• joint pain(arthralgias)
• fever
• weight loss
• dry skin

Common::

may affect up to 1 in 10 patients

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

(peripheral neuropathy)

• depression
• erectile dysfunction(impotence)
• voice changes(dysphonia)
• acne
• inflamed, dry, or scaly skin that peels(dermatitis, skin peeling)
• heart failure
• heart attack(myocardial infarction)or chest pain
• tinnitus (ringing in the ears).
• kidney insufficiency
• abnormally high levels of protein in the urine(proteinuria)
• general weakness or loss of strength(asthenia)
• decreased white blood cell count(leukopenia and neutropenia)
• decreased red blood cell count(anemia)
• low platelet count in the blood(thrombocytopenia)
• inflammation of hair follicles(folliculitis)
• underactive thyroid gland(hypothyroidism)
• low sodium levels in the blood(hyponatremia)
• distortion of taste(dysgeusia)
• redness of the face and often other areas of the skin(flushing)
• nasal secretion(rhinorrhea)
• pyrosis(gastroesophageal reflux disease)
• skin cancer(squamous cell carcinoma)
• thickening of the outer layer of the skin(hyperkeratosis)
• sudden, involuntary muscle contractions(muscle spasms)

Uncommon::

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.
• yellow skin or eyes(jaundice)caused by elevated levels of bile pigments

(hyperbilirubinemia)

• allergic reactions (including skin rashes and hives)
• dehydration
• breast enlargement(gynecomastia)
• difficulty breathing(pulmonary disease)
• eczema
• hyperactivity of the thyroid gland(hyperthyroidism)
• multiple skin eruptions(erythema multiforme)
• abnormally high blood pressure
• perforation of the intestinal wall(gastrointestinal perforation)
• reversible inflammation of the posterior part of the brain, which may be associated with headache, altered consciousness, seizures, and visual symptoms including loss of vision(reversible posterior leukoencephalopathy)
• severe, sudden allergic reaction(anaphylactic reaction)

Rare:

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(prolonged QT interval)
• inflammation of the liver that may lead to nausea, vomiting, abdominal pain, and yellowing of the skin(drug-induced hepatitis)
• sunburn-like eruption, which may occur on skin that has been exposed to radiation therapy and may be severe(radiation dermatitis)
• severe skin and/or mucous membrane reactions that may include painful blisters or fever, including extensive skin detachment(Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle degradation that may lead to kidney problems(rhabdomyolysis)
• kidney damage that causes them to lose large amounts of protein(nephrotic syndrome)
• inflammation of the skin blood vessels that may cause a rash(leukocytoclastic vasculitis)

Frequency not known:

the frequency cannot be estimated from the available data.

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

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

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

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of your pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Sorafenib Dr. Reddys

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

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

Film coating of the tablet: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), iron oxide red (E172)

Appearance of the product and contents of the package

Sorafenib Dr. Reddys 200 mg film-coated tablets are brownish-red, round, biconvex, with a diameter of 12 mm, with "200" engraved on one side and smooth on the other, with a tablet diameter of 12.0 mm ± 5%.

They are presented in blisters of Aluminio-PVC/PE/PVDC containing 112 film-coated tablets or in blisters of Aluminio-PVC/PE/PVDC containing 112 x 1 film-coated tablets in single-dose perforated blisters.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Telephone: 93.355.49.16

Fax: 93.355.49.61

Responsible for manufacturing

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

Limassol 3056

Cyprus

Phone number: +357 25553000

Fax number: +357 25390192

or

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

Birzebbugia BBG3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this prospectus: March 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).