RIVAROXABAN DR REDDYS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Dr. Reddys 10 mg Film-Coated Tablets EFG

rivaroxaban

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 and other information

1. What is Rivaroxaban Dr. Reddys and what is it used for
2. What you need to know before you take Rivaroxaban Dr. Reddys
3. How to take Rivaroxaban Dr. Reddys
4. Possible side effects
5. Storage of Rivaroxaban Dr. Reddys

1. Contents of the pack and further information

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

Rivaroxaban contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because after an operation you have a higher risk of forming blood clots.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent these blood clots from happening again in the blood vessels of the legs and/or lungs.

Rivaroxaban belongs to a group of medicines called antithrombotic agents. It works by blocking a factor in the blood clotting process (factor Xa) and thus reducing the tendency of the blood to form clots.

2. Before taking Rivaroxaban Dr. Reddys

Do not take Rivaroxaban Dr. Reddys

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you have bleeding problems
• if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, recent injury or bleeding in the brain, or recent brain or eye surgery)
• if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching from one anticoagulant treatment to another or when being treated with heparin through a venous or arterial catheter to prevent it from becoming blocked
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding

Do not take Rivaroxaban Dr. Reddys and inform your doctorif any of these apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting Rivaroxaban Dr. Reddys.

Be careful with Rivaroxaban Dr. Reddys

• if you have an increased risk of bleeding, such as in the following situations:

• moderate or severe kidney failure, as kidney function may affect the amount of medicine that works in your body
• if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter to prevent it from becoming blocked (see section "Other medicines and Rivaroxaban Dr. Reddys")
• bleeding disorders
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as stomach or intestinal inflammation, esophageal inflammation (e.g. due to gastroesophageal reflux disease) or tumors in the stomach, intestines, genital or urinary tract
• a problem in the blood vessels of the back of the eyes (retinopathy)
• a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding

• if you have a heart valve prosthesis
• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor who will decide if it is necessary to change the treatment.
• if your doctor determines that your blood pressure is unstable or if you are scheduled to receive another treatment or undergo surgery to remove a blood clot from your lungs.

Tell your doctor if you have any of these situationsbefore taking Rivaroxaban Dr. Reddys. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

If you need surgery

• It is very important to take Rivaroxaban Dr. Reddys before and after surgery, exactly at the times your doctor indicates.
• If your operation requires the placement of a catheter or injection in the spine (e.g. for epidural or spinal anesthesia, or pain relief):

• It is very important to take Rivaroxaban Dr. Reddys exactly at the times your doctor indicates.
• Tell your doctor immediately if you experience numbness or weakness in your legs or problems in your intestines or bladder after anesthesia, as urgent attention is needed.

Children and adolescents

Rivaroxaban 10 mg is not recommended for children under 18 years of age.There is not enough information on its use in children and adolescents.

Other medicines and Rivaroxaban Dr. Reddys

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription.

• If you are taking

• any medicine for a fungal infection (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless it is only applied to the skin
• tablets with ketoconazole (used to treat Cushing's syndrome, in which the body produces too much cortisol)
• any medicine for bacterial infections (e.g. clarithromycin, erythromycin)
• any antiviral medicine for HIV/AIDS (e.g. ritonavir)
• other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol)
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine for treating irregular heartbeat
• certain medicines for treating depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of the above applies to you, tell your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be increased. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

If your doctor considers that you have a higher risk of developing stomach or intestinal ulcers, they will recommend that you also use a preventative treatment for ulcers.

• If you take

• any medicine for treating epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum), a herbal medicine for treating depression
• rifampicin, an antibiotic

If any of the above applies to you, tell your doctorbefore taking rivaroxaban, as the effect of Rivaroxaban Dr. Reddys may be reduced. Your doctor will decide if you should be treated with Rivaroxaban Dr. Reddys and if you should be kept under closer observation.

Pregnancy and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking rivaroxaban. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban may cause dizziness (a frequent side effect) or fainting (an uncommon side effect) (see section 4, "Possible side effects"). You should not drive or ride a bicycle, use tools or machines if you are affected by these symptoms.

Rivaroxaban Dr. Reddys contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. it is essentially "sodium-free"

.

3. How to take Rivaroxaban Dr. Reddys

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

What dose to take

• To prevent the formation of blood clots in the veins after hip or knee replacement surgery.

The recommended dose is one 10 mg rivaroxaban tablet once a day.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent the recurrence of blood clots. After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed one 10 mg tablet once a day.

Swallow the tablet with water.

This medicine can be taken with or without food.

If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take rivaroxaban. The tablet can be crushed and mixed with water or apple puree immediately before taking it.

If necessary, your doctor may also administer the crushed rivaroxaban tablet through a nasogastric tube.

When to take Rivaroxaban Dr. Reddys

Take one tablet every day, until your doctor tells you to stop.

Try to take one tablet at the same time every day, to help you remember. The doctor will decide how long you should continue treatment.

To prevent the formation of blood clots in the veins after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after the operation.

If you have had major hip surgery, you will usually take tablets for 5 weeks.

If you have had major knee surgery, you will usually take tablets for 2 weeks.

If you take more Rivaroxaban Dr. Reddys than you should

Call your doctor immediately if you have taken too many rivaroxaban tablets. Taking too much rivaroxaban increases the risk of bleeding.

If you forget to take Rivaroxaban Dr. Reddys

If you forget to take a dose, take it as soon as you remember. Take the next tablet the next day and then continue taking one tablet every day, as usual.

Do not take a double dose to make up for forgotten doses.

If you stop taking Rivaroxaban Dr. Reddys

Do not stop taking rivaroxaban without talking to your doctor first, because rivaroxaban prevents the development of a serious condition.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Like other similar medicines to reduce blood clotting, rivaroxaban can cause bleeding, which can be life-threatening. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be visible.

Tell your doctor immediatelyif you experience any of the following side effects:

Signs of bleeding

• bleeding in the brain or inside the skull (symptoms can include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness and stiff neck. A serious medical emergency. Seek medical attention immediately!)
• prolonged or excessive bleeding
• exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina.

Your doctor will decide to keep you under closer observation or modify your treatment.

Signs of severe skin reaction

• severe skin rash that spreads, blisters or lesions on the mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities and systemic disease (DRESS syndrome).

The frequency of these side effects is very rare (may affect up to 1 in 10,000 people)

Signs of severe allergic reaction:

Tell your doctor immediatelyif you experience any of the following side effects:

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure.

The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

General list of possible side effects

Common(may affect up to 1 in 10 patients)

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• stomach or intestinal bleeding, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into a tissue or cavity of the body (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling of the limbs
• pain in the limbs
• kidney function disorder (can be seen in tests performed by the doctor)
• fever
• stomach pain, indigestion, dizziness or feeling of dizziness, constipation, diarrhea
• low blood pressure (symptoms can include dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, tiredness), headache, dizziness
• rash, itching of the skin
• blood tests may show an increase in some liver enzymes

Uncommon(may affect up to 1 in 100 patients)

• bleeding in the brain or inside the skull
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• liver function disorder (can be seen in tests performed by the doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or platelet count
• fainting
• feeling unwell
• increased heart rate
• dry mouth
• hives

Rare(may affect up to 1 in 1,000 patients)

• bleeding into a muscle
• cholestasis (decreased bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• accumulation of blood (hematoma) in the groin as a complication after heart surgery in which a catheter is inserted into the leg artery (pseudoaneurysm)

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white blood cell granulocytes that cause inflammation in the lung (eosinophilic pneumonia)

Frequency not known(cannot be estimated from the available data)

• kidney failure after severe bleeding.
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome due to bleeding)

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 through 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 Rivaroxaban Dr. Reddys

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 packaging and on each blister, after "EXP" or "CAD". The expiry date is the last day of the month shown.

No special storage conditions are required.

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

6. Package Contents and Additional Information

Composition of Rivaroxaban Dr. Reddys

• The active ingredient is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other components are:

Core of the tablet: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 "Rivaroxaban Dr. Reddys contains lactose and sodium"

Coating of the tablet: macrogol 3350, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172).

Appearance of the Product and Package Contents

The film-coated tablets of Rivaroxaban Dr. Reddys 10 mg are pale pink, round, biconvex (approximately 6 mm in diameter) and bear the imprint "10" on one side.

They are packaged in blisters, in boxes of 5, 10, 30 or 100 film-coated tablets

Only some package 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 Number: 93.355.49.16

Fax Number: 93.355.49.61

Manufacturer

Betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

This Medicinal Product is Authorized in the Member States of the European Economic Area under the following Names:

Date of the Last Revision of this Leaflet: September 2023

Detailed and updated 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)