Rivaroxaban reddy

Package leaflet: Information for the user

Rivaroxaban Reddy, 2.5 mg, film-coated tablets
rivaroxabanum
Please read all of this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Rivaroxaban Reddy is and what it is used for
2. What you need to know before you take 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 Rivaroxaban Reddy is and what it is used for

You have been prescribed Rivaroxaban Reddy because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been confirmed. Rivaroxaban Reddy reduces the risk of subsequent heart attack or the risk of death due to heart- or blood vessel-related disease in adults. Rivaroxaban Reddy will not be given to you as a single treatment. Your doctor will also prescribe:
  • acetylsalicylic acid, or
  • acetylsalicylic acid and clopidogrel or ticlopidine.

or

• You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease causing symptoms. Rivaroxaban Reddy reduces the risk of blood clots (atherosclerotic thrombotic events) in adults. Rivaroxaban Reddy will not be given to you as a single treatment. Your doctor will also prescribe acetylsalicylic acid. In some cases, if you are receiving Rivaroxaban Reddy after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken in addition to acetylsalicylic acid for a short period.

Rivaroxaban Reddy contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

2. Important information before taking Rivaroxaban Reddy

When not to take Rivaroxaban Reddy

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient is experiencing excessive bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent surgery on the brain or eyes),
• if the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously experienced brain bleeding (hemorrhagic stroke), blockage of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had a blood clot in the brain (ischemic non-lacunar stroke) within the last month,
• if the patient has a liver disease that increases the risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Rivaroxaban Reddy and inform your doctor if you suspect any of the above-mentioned conditions apply.
Warnings and precautions
Before starting rivaroxaban, discuss this with your doctor or pharmacist.
Rivaroxaban should not be used in combination with anticoagulant medicines other than acetylsalicylic acid, clopidogrel, or ticlopidine, such as prasugrel or ticagrelor.
When to exercise special caution when taking Rivaroxaban Reddy

• if the patient has an increased risk of bleeding, such as in the following conditions:

• severe kidney disease, as kidney function may affect the amount of drug acting in the patient's body,

• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Rivaroxaban Reddy and other medicines"),

• coagulation disorders,

• very high blood pressure that does not decrease despite medication,

• diseases of the stomach or intestines that may cause bleeding, e.g., inflammatory bowel disease or gastritis, or esophagitis (inflammation of the throat and esophagus), e.g., due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus), or tumors located in the stomach, intestines, genital or urinary system,

• vascular disease of the posterior segment of the eyeball (retinopathy),

• lung disease with bronchiectasis (enlarged bronchi filled with pus) or previous lung bleeding,

• if the patient is over 75 years of age,

• if the patient weighs less than 60 kg,

• coronary artery disease with severe symptomatic heart failure,

• in patients with prosthetic heart valves,

• if the patient has a disorder called antiphospholipid syndrome (an autoimmune disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is needed.
  If you suspect any of the above-mentioned conditions apply, you should
  inform your doctor before taking Rivaroxaban Reddy. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
  If the patient requires surgery:

• strictly follow the doctor's instructions regarding the timing of rivaroxaban administration before or after surgery,

• if catheterization or spinal puncture (e.g., for epidural or spinal anesthesia or pain relief) is planned during surgery:

• it is very important to take rivaroxaban before and after the puncture or catheter removal as directed by the doctor,

• due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, or bowel or bladder dysfunction occurs after the anesthesia wears off.

Children and adolescents
Rivaroxaban Reddy 2.5 mg is not recommended for patients under 18 years of age. There is insufficient data on its use in children and adolescents.
Rivaroxaban Reddy and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

• If the patient is taking:
• certain antifungal medicines (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
• certain antibiotics (e.g., clarithromycin, erythromycin),
• certain antiviral medicines used in HIV infection or AIDS treatment (e.g., ritonavir),
• other medicines used to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin or acenocoumarol, prasugrel and ticagrelor (see section "Warnings and precautions")),
• anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid),
• dronedarone, a medicine used to treat heart rhythm disorders,
• certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

If you suspect any of the above-mentioned conditions apply, inform your doctor before taking Rivaroxaban Reddy, as the effect of the medicine may be enhanced.
The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers the patient to be at increased risk of developing stomach or intestinal ulcers, preventive treatment may be prescribed.

• If the patient is taking:
• certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital),
• St. John's wort ( Hypericum perforatum ), a herbal remedy used for depression,
• rifampicin, an antibiotic.

If you suspect any of the above-mentioned conditions apply, inform your doctor before taking Rivaroxaban Reddy, as the effect of the medicine may be reduced.
The doctor will decide whether to use rivaroxaban and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not take rivaroxaban if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use an effective method of contraception during treatment with rivaroxaban. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on further management.
Driving and operating machinery
Rivaroxaban Reddy may cause dizziness (common side effects) or fainting (uncommon side effects) (see section 4, "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Reddy contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaroxaban Reddy

This medicine should always be taken as directed by the physician. If in doubt, consult your
doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet taken twice daily. Rivaroxaban should be taken at
approximately the same time each day (for example, one tablet in the morning and one in the evening).
This medicine may be taken with or without food.
If a patient has difficulty swallowing the whole tablet, discuss alternative ways of taking rivaroxaban
with the doctor. The tablet may be crushed and mixed with water or soft food such as apple puree,
immediately before administration.
If necessary, the doctor may administer crushed rivaroxaban tablets through a gastric tube.
Rivaroxaban will not be given to the patient as the only medication. The doctor will prescribe
acetylsalicylic acid to be taken concomitantly.
If a patient is receiving Rivaroxaban Reddy after an acute coronary syndrome, the doctor may also
prescribe clopidogrel or ticlopidine.
If a patient is receiving Rivaroxaban Reddy after a procedure to restore blood flow through a narrowed
or blocked artery in the lower limb, the doctor may additionally prescribe clopidogrel to be taken
for a short period alongside acetylsalicylic acid.
The doctor will inform the patient about the dosage of these medications (usually 75–100 mg of
acetylsalicylic acid per day, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of
75 mg clopidogrel, or the standard daily dose of ticlopidine).
When to start taking Rivaroxaban Reddy
Treatment with rivaroxaban after acute coronary syndrome should be initiated as soon as possible
after stabilization of the acute coronary syndrome, no earlier than 24 hours after hospital admission
and at the time when parenteral (by injection) anticoagulant therapy would normally be discontinued.
The doctor will inform the patient when to start treatment with Rivaroxaban Reddy if coronary artery
disease or peripheral arterial disease has been diagnosed.
The doctor will decide how long treatment should continue.
Taking more Rivaroxaban Reddy than prescribed
If a patient has taken more tablets than prescribed, contact the doctor immediately. Taking too high
a dose of rivaroxaban increases the risk of bleeding.
Missing a dose of Rivaroxaban Reddy
Do not take a double dose to make up for a missed dose. If a dose is missed, take the next dose at
the scheduled time.
Stopping Rivaroxaban Reddy
Rivaroxaban should be taken regularly and for the duration prescribed by the doctor.
Do not stop taking rivaroxaban without first consulting the doctor. Discontinuation of this medicine
may increase the risk of another heart attack, stroke, or death due to heart or blood vessel disease.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
As with other medicines that have a similar effect in reducing blood clot formation, rivaroxaban
can cause bleeding, which potentially may be life-threatening. Excessive bleeding may
lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should contact your doctor immediately if any of the following adverse effects occur:

Signs of bleeding

• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, reduced level of consciousness and neck stiffness. This is a serious medical emergency. Seek immediate medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina.

Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.

Signs of severe skin reactions

• widespread, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, internal organ inflammation, hematological disorders and systemic symptoms (DRESS syndrome). The frequency of these adverse effects is very rare (occurring in up to 1 in 10,000 people).

Signs of severe allergic reactions

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

General list of possible adverse effects

Common (may occur in 1 in 10 patients)

• reduction in red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the white part of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) when coughing,
• bleeding from the skin or under the skin,
• bleeding after surgery,
• oozing of blood or fluid from a surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low arterial blood pressure (symptoms may include dizziness or fainting upon standing),
• general loss of strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon (may occur in 1 in 100 patients)

• bleeding into the brain or inside the skull (see signs of bleeding above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low number of platelets, blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (may be observed in tests performed by a doctor),
• blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dryness of the mouth,
• hives.

Rare (may occur in 1 in 1,000 patients)

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

Very rare (may occur in 1 in 10,000 patients)

• accumulation of eosinophils, a type of granulocyte white blood cells, causing lung inflammation (eosinophilic pneumonia).

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

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with blood in the urine, leading to the kidneys' inability to function properly (anticoagulant-related nephropathy),
• increased pressure within the muscles of the arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects
not listed in this leaflet, consult your doctor or pharmacist. Adverse effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder. By reporting
adverse effects, additional information on the safety of the medicine's use can be collected.

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 stated on the outer carton after:
Expiry date (EXP) and on each blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Reddy contains

• The active substance is rivaroxaban. One coated tablet contains 2.5 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".
  Tablet coating: macrogol, hypromellose, titanium dioxide (E 171), iron oxide yellow (E 172).

What Rivaroxaban Reddy looks like and contents of the pack
Light yellow, round, biconvex coated tablets (approximately 6 mm in diameter) marked with "2.5" on one side.
Pack sizes of 28, 56 or 196 coated tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Denmark Rivaroxaban Reddy
Germany Rivaroxaban beta 2.5 mg Filmtabletten
France RIVAROXABAN REDDY PHARMA 2.5 mg, comprimé pelliculé
Italy RIVAROXABAN DR. REDDY’S
Austria Rivaroxaban Reddy 2.5 mg Filmtabletten
Netherlands Rivaroxaban Reddy 2.5 mg filmomhulde tabletten
Spain Rivaroxaban Dr. Reddys 2.5 mg comprimidos recubiertos con película EFG
Slovakia Rivaroxaban Reddy 2.5 mg filmom obalené tablety
Czech Republic Rivaroxaban Reddy
Poland: Rivaroxaban Reddy
Sweden Rivaroxaban Reddy 2.5 mg filmdragerad tablett
United Kingdom (Northern Ireland): Rivaroxaban Dr. Reddy’s 2.5 mg Film-Coated Tablets