Rivaroxaban Reddi

Package Leaflet: Information for the User

Rivaroxaban Reddy, 15 mg, film-coated tablets

Rivaroxaban Reddy, 20 mg, film-coated tablets

rivaroxaban
Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• 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 symptoms 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 package leaflet:

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

1. What is Rivaroxaban Reddy and what is it used for

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

• prevent blood clots in the brain (stroke) and other blood vessels in the body, if you have a form of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent blood clots from forming again in the blood vessels of the legs and/or lungs.

Rivaroxaban Reddy is used in children and adolescents under 18 years of age and weighing 30 kg or more to:

• treat and prevent blood clots in the veins or lungs after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Rivaroxaban Reddy belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. Important information before taking Rivaroxaban Reddy

When not to take Rivaroxaban Reddy

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have a disease or condition of an organ that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery),
• if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant treatment or when heparin is given to maintain catheter patency in a vein or artery,

if you have liver disease that increases the risk of bleeding,

• if you are pregnant or breastfeeding.

Do not take Rivaroxaban Reddy and inform your doctorif you think any of the above conditions apply to you.

Warnings and precautions

Before taking rivaroxaban, discuss it with your doctor or pharmacist.

When to be extra careful while taking Rivaroxaban Reddy

• if you have an increased risk of bleeding, such as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine in the body,
• bleeding disorders,
• taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant treatment or when heparin is given to maintain catheter patency in a vein or artery (see "Rivaroxaban Reddy and other medicines"),
• very high blood pressure that does not decrease with medication,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) due to reflux disease or tumors in the stomach, intestines, genital or urinary system,
• vascular disease in the back of the eye (retinopathy),
• pulmonary disease where the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding in the lungs,
• in patients with artificial heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change treatment,
• if you have abnormal blood pressure or if surgery is planned to remove a blood clot from the lungs.

If you think you have any of the above conditions, tell your doctor

before taking Rivaroxaban Reddy. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.

If you need to have surgery:

• you must follow your doctor's instructions regarding the intake of Rivaroxaban Reddy at a specific time before or after surgery,
• if catheterization or spinal puncture is planned (e.g. for spinal anesthesia or pain relief):
• it is very important to take Rivaroxaban Reddy before and after the puncture or catheter removal, at a time specified by your doctor,
• you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban is not recommended for children under 30 kg. There is limited data on the use of rivaroxaban in children and adolescents for indications in adults.

Rivaroxaban Reddy and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

If you are taking:

• certain medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketokonazole tablets (used to treat Cushing's syndrome, where the body produces too much cortisol),
• certain medicines for bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines for HIV or AIDS treatment (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 heart rhythm disorders,
• certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you think you have any of the above conditions, tell your doctor

before taking Rivaroxaban Reddy, as the effect of Rivaroxaban Reddy may be increased. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.

If you are taking

• certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum), a herbal medicine used for depression,
• rifampicin, which belongs to a group of antibiotics.

If you think you have any of the above conditions, tell your doctor

before taking Rivaroxaban Reddy, as the effect of Rivaroxaban Reddy may be reduced. Your doctor will decide whether to use Rivaroxaban Reddy and whether you need to be closely monitored.

Pregnancy and breastfeeding

Do not take Rivaroxaban Reddy if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception during treatment with Rivaroxaban Reddy. If you become pregnant during treatment with this medicine, you should inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaroxaban may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Rivaroxaban Reddy contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, which is essentially "sodium-free".

3. How to take Rivaroxaban Reddy

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Rivaroxaban Reddy should be taken with food. The tablet(s) should be swallowed, preferably with water.
If you have difficulty swallowing whole tablets, talk to your doctor about other ways to take rivaroxaban. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking. After such a mixture, the meal should be taken immediately.
If necessary, your doctor may also give you a crushed Rivaroxaban Reddy tablet through a gastric tube.

How many tablets to take

Adults

• In preventing blood clots in the brain (stroke) and other blood vessels in the body, the recommended dose is one 20 mg tablet once daily. If you have kidney disease, the dose may be reduced to one 15 mg tablet once daily.

If you need a procedure to open up the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one 15 mg tablet once daily (or one 10 mg tablet once daily in case of kidney disease) in combination with an antiplatelet agent such as clopidogrel.

• In treating blood clots in the veins of the legs, blood clots in the lungs, and preventing blood clots from forming again, the recommended dose is one 15 mg tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney disease and are taking one 20 mg tablet once daily, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg tablet once daily, if the risk of bleeding is higher than the risk of further blood clots.

Children and adolescents

The dose of rivaroxaban depends on body weight and will be calculated by your doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one rivaroxaban 15 mgtablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one rivaroxaban 20 mgtablet once daily.

Each dose of rivaroxaban should be taken with food, with a drink (e.g. water or juice). The tablets should be taken daily at about the same time. It's a good idea to set an alarm to remind you. For parents or caregivers: you should watch your child to make sure they take the whole dose.
The dose of rivaroxaban is based on body weight, so it's essential to come to scheduled doctor's appointments, as the dose may need to be adjusted due to changes in body weight.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose.
Do not split the tablet to get a partial dose. If a smaller dose is needed, use rivaroxaban in the form of granules for oral suspension. For children and adolescents who are unable to swallow whole tablets, use rivaroxaban in the form of granules for oral suspension.
If the oral suspension is not available, you can crush the rivaroxaban tablet and mix it with water or apple sauce immediately before taking. After this mixture, take the meal. If necessary, your doctor may also give you a crushed Rivaroxaban Reddy tablet through a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking rivaroxaban, take a new dose.
• more than 30 minutes after taking rivaroxaban, do nottake a new dose. In this case, take the next dose of rivaroxaban at the usual time.

Contact your doctor if you spit out the dose or vomit repeatedly after taking rivaroxaban.

When to start taking Rivaroxaban Reddy

Take the tablet(s) every day until your doctor decides to stop treatment.
It's best to take the tablet(s) at the same time every day, as it's easier to remember.
Your doctor will decide how long you should continue treatment.
Preventing blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored with a procedure called cardioversion, take rivaroxaban as directed by your doctor.

Missing a dose of Rivaroxaban Reddy

• Adults, children, and adolescents: If you take one 20 mg tablet or one 15 mg tablet once daily and miss a dose, take it as soon as possible. Do not take more than one tablet in one day to make up for a missed dose. Take the next tablet the next day, and then take one tablet once daily.
• Adults: If you take one 15 mg tablet twice daily and miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in one day. The next day, continue taking one 15 mg tablet twice daily.

Taking more than the recommended dose of Rivaroxaban Reddy

If you have taken more Rivaroxaban Reddy tablets than recommended, contact your doctor immediately. Taking too much Rivaroxaban Reddy increases the risk of bleeding.

Stopping treatment with Rivaroxaban Reddy

Do not stop taking Rivaroxaban Reddy without first talking to your doctor, as Rivaroxaban Reddy treats and prevents serious diseases.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Reddy can cause side effects, although not everybody gets them.
Like other medicines that reduce blood clotting, rivaroxaban can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These signs of bleeding may not always be obvious or visible.

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

Signs of bleeding

• bleeding into the brain or skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness in the neck. This is a serious medical emergency. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina .Your doctor may decide to monitor you closely or change your treatment.

Signs of severe skin reactions

• widespread, severe skin rash, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic symptoms (DRESS syndrome). The frequency of these side effects is very rare (less than 1 in 10,000 people).

Signs of severe allergic reactions

• swelling of the face, lips, mouth, tongue, or throat; hives and difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible side effects in adults, children, and adolescents

Common(may affect up to 1 in 10 people)

• reduced red blood cell count, which can cause pallor and be the reason for weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding into the white of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum when coughing,
• bleeding from the skin or bleeding under the skin,- bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney problems (which can be seen in tests performed by your doctor),
• fever,
• stomach pain, nausea, feeling sick (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or skull (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver problems (which can be seen in tests performed by your doctor),
• blood test results may show increased bilirubin levels, certain liver or pancreatic enzyme activity, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

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

• bleeding into the muscles,
• cholestasis (bile flow obstruction), liver inflammation, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm).

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

• accumulation of eosinophils, a type of white blood cell, which can cause inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding,
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant therapy),
• increased pressure in the muscles of the legs and arms after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Overall, the side effects seen in children and adolescents treated with rivaroxaban were similar in type to those seen in adults and were mostly mild to moderate.
Side effects seen more frequently in children and adolescents:

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

• headache
• fever
• nosebleeds, vomiting

Common(may affect up to 1 in 10 people)

• rapid heartbeat
• blood test results may show increased bilirubin levels (a bile pigment)
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• excessive menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased direct bilirubin levels (a bile pigment).

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Reddy

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 carton after EXP. and on each blister after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
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. Contents of the pack and other information

What Rivaroxaban Reddy contains

• The active substance is rivaroxaban. One film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 "Rivaroxaban Reddy contains lactose and sodium". Coating: macrogol, hypromellose, titanium dioxide (E 171), iron oxide red (E 172).

What Rivaroxaban Reddy looks like and contents of the pack

15 mg:
Red, round, biconvex (about 6 mm in diameter) with the number "15" on one side.
Pack sizes: 14, 28, 42, or 98 film-coated tablets.
20 mg:
Dark red, round, biconvex (about 6 mm in diameter) with the number "20" on one side.
Pack sizes: 14, 28, or 98 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder

Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Tel.: +49 821 74881 0

Manufacturer

Betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark:
Rivaroxaban Reddy
Germany:
Rivaroxaban beta 15 mg film-coated tablets;
Rivaroxaban beta 20 mg film-coated tablets
France:
RIVAROXABAN REDDY PHARMA 15mg, film-coated tablet;
RIVAROXABAN REDDY PHARMA 20mg, film-coated tablet
Italy:
RIVAROXABAN DR. REDDY'S
Austria:
Rivaroxaban Reddy 15 mg film-coated tablets;
Rivaroxaban Reddy 20 mg film-coated tablets
Netherlands:
Rivaroxaban Reddy 15 mg film-coated tablets;
Rivaroxaban Reddy 20 mg film-coated tablets
Spain:
Rivaroxaban Dr. Reddys 15 mg film-coated tablets EFG;
Rivaroxaban Dr. Reddys 20 mg film-coated tablets EFG
Slovakia:
Rivaroxaban Reddy 15 mg film-coated tablets;
Rivaroxaban Reddy 20 mg film-coated tablets
Czech Republic:
Rivaroxaban Reddy
Poland:
Rivaroxaban Reddy
Sweden:
Rivaroxaban Reddy 15 mg film-coated tablet;
Rivaroxaban Reddy 20 mg film-coated tablet
United Kingdom (Northern Ireland): Rivaroxaban Dr. Reddy’s 15 mg Film-Coated Tablets;
Rivaroxaban Dr. Reddy’s 20 mg Film-Coated Tablets
Date of last revision of the leaflet:10/2023