Rivaroxaban reddy

Package leaflet: Information for the user

Rivaroxaban Reddy, 10 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, 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, 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

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

• prevent blood clots from forming in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots is increased after surgery.
• 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 the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Reddy 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, trauma 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 the patency of a catheter in a vein or artery,
• if the patient has a liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not use Rivaroxaban Reddy, and inform your doctor if you suspect any of the above conditions apply.

Warnings and precautions
Before starting rivaroxaban, discuss it with your doctor or pharmacist.
When to exercise special caution when using Rivaroxaban Reddy

• if the patient has an increased risk of bleeding, such as in the following conditions:
• moderate or severe kidney disease, because kidney function may affect the amount of medicine acting in the patient's body,
• if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or if heparin is administered to maintain the patency of a catheter in a vein or artery (see section "Rivaroxaban Reddy and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite medication,
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagus (throat and oesophagus), e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach or intestines or in the genital or urinary system,
• blood vessel disease of the back of the eyeball (retinopathy),
• lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary,
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a pulmonary embolism.

If the patient suspects any of the above conditions apply, they should inform their doctor
before taking rivaroxaban. The doctor will decide whether to use this medicine and whether the
patient requires particularly close monitoring.
If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding taking rivaroxaban at a precisely defined time before or after surgery,
• if during the surgical procedure a lumbar puncture or placement of a catheter into the spine is planned (e.g. for epidural or spinal anaesthesia or for pain relief):
• strictly follow the doctor's instructions regarding taking rivaroxaban at a precisely defined time,
• immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness of the lower limbs, disturbances in bowel movements or bladder function, as immediate treatment will be necessary.

Children and adolescents
Rivaroxaban 10 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),
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid),
• dronedarone, a medicine used to treat heart rhythm disorders,
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects any of the above conditions apply, they should inform their doctor
before taking rivaroxaban, because the effect of rivaroxaban may be enhanced.
The doctor will decide whether to use this medicine and whether the patient requires particularly close
monitoring.
If the doctor considers that the patient has an increased risk of developing gastric or duodenal ulcer,
they may prescribe treatment to prevent peptic ulcer disease.

• If the patient is taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St John's wort ( Hypericum perforatum ), a herbal remedy used for depression,
• rifampicin, which belongs to the group of antibiotics.

If the patient suspects any of the above conditions apply, they should inform their doctor
before taking rivaroxaban, because the effect of rivaroxaban may be reduced. The doctor will decide
whether to use rivaroxaban and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use rivaroxaban if the patient is pregnant or breastfeeding. If there is a risk that the patient
may become pregnant, an effective method of contraception should be used during treatment with
rivaroxaban. If the patient becomes pregnant while taking this medicine, inform the doctor
immediately, who will decide on further treatment.
Driving and operating machinery
Rivaroxaban 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, they should contact their 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 doctor. If in doubt, consult the doctor or pharmacist.

How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgery: The recommended dose is one 10 mg tablet once daily.
• For the treatment of blood clots in the legs, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. The doctor has prescribed one 10 mg tablet once daily for the patient.

The tablet should be swallowed whole, preferably with water.
This medicine can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, discuss alternative methods 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 via a gastric tube.

When to start taking Rivaroxaban Reddy
Take the tablet every day until the doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.
To prevent blood clots after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
In patients undergoing major hip surgery, treatment usually lasts 5 weeks.
In patients undergoing major knee surgery, treatment usually lasts 2 weeks.

Taking more Rivaroxaban Reddy than prescribed
If the 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
If the patient forgets to take a dose, take the tablet as soon as remembered. Take the next tablet the following day, and then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a missed tablet.

Stopping Rivaroxaban Reddy
Do not stop taking rivaroxaban without first discussing it with the doctor, as rivaroxaban helps prevent serious illness.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, rivaroxaban
can cause bleeding, which may potentially 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 reactions occur:

Signs of bleeding

• Bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased 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, formation of blisters 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 reactions 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; urticaria 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 reactions
Common (may occur in up to 1 in 10 patients)

• Decrease in red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath,
• Gastrointestinal or intestinal bleeding, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• Bleeding into the eye (including bleeding from the sclera),
• Bleeding into tissues or body cavities (hematoma, bruising),
• Presence of blood in sputum (hemoptysis) when coughing,
• Bleeding from the skin or subcutaneous bleeding,
• Postoperative bleeding,
• 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, feeling of nausea (nausea) or vomiting, constipation, diarrhea,
• Low blood pressure (symptoms may include dizziness or fainting upon standing),
• General decrease in 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 up to 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 platelet count, blood cells involved in blood clotting),
• Allergic reactions, including allergic skin reactions,
• 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,
• Urticaria,
• Liver function disorders (may be observed in tests performed by a doctor).

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

• Bleeding into muscles,
• Cholestasis (bile stasis), hepatitis including liver cell damage,
• Yellowing of the skin and eyes (jaundice),
• Localized swelling,
• Collection 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 up to 1 in 10,000 patients)

• Eosinophilia, a type of white granulocytic 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 impaired kidney function (anticoagulant-associated nephropathy),
• Increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet,
you should contact your doctor or pharmacist. Adverse reactions 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, phone: +48 22 49 21 301,
fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse
reactions helps provide more information on the safety of the 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 stated on the carton after: Expiry (EXP) and on each blister after: EXP. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must 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 10 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, 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

Light pink, round, biconvex tablets (approximately 6 mm in diameter) marked with the number "10" on one side.
Pack sizes of 10 or 30 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 the United Kingdom (Northern Ireland) under the following names:
Denmark: Rivaroxaban Reddy
Germany: Rivaroxaban beta 10 mg Filmtabletten
France: RIVAROXABAN REDDY PHARMA 10 mg, comprimé pelliculé
Italy: RIVAROXABAN DR. REDDY’S
Austria: Rivaroxaban Reddy 10 mg Filmtabletten
Netherlands: Rivaroxaban Reddy 10 mg filmomhulde tabletten
Spain: Rivaroxaban Dr. Reddys 10 mg comprimidos recubiertos con película EFG
Slovakia: Rivaroxaban Reddy 10 mg filmom obalené tablety
Czech Republic: Rivaroxaban Reddy
Poland: Rivaroxaban Reddy
Sweden: Rivaroxaban Reddy 10 mg filmdragerad tablett
United Kingdom (Northern Ireland): Rivaroxaban Dr. Reddy’s 10 mg Film-Coated Tablets