Rivaroxaban reddy: detailed information

Package leaflet: Information for the user

Rivaroxaban Reddy, 15 mg, coated tablets
Rivaroxaban Reddy, 20 mg, coated tablets
rivaroxabanum
Please read 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 experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

What Rivaroxaban Reddy is and what it is used for
What you need to know before taking Rivaroxaban Reddy
How to take Rivaroxaban Reddy
Possible side effects
How to store Rivaroxaban Reddy
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 and is used in adults to:

prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body of patients who have a type of irregular heartbeat called non-valvular atrial fibrillation.
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 veins and/or lungs.

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

treat blood clots and prevent the recurrence of blood clots in veins or in the blood vessels of the 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. 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 clots (e.g. warfarin,
dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if
heparin is administered to maintain the patency of a venous or arterial catheter,
if the patient has 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 that any of the above circumstances apply to you.
Warnings and precautions
Before starting treatment with rivaroxaban, discuss this 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:
severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient’s body,
coagulation disorders,
taking other medicines that prevent blood clots (e.g. warfarin, etexilate dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a venous or arterial catheter (see section “Rivaroxaban Reddy with other medicines”),
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 oesophagitis (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach or intestines, or in the reproductive or urinary system,
vascular disease of the posterior part of the eyeball (retinopathy),
lung disease with dilated bronchi filled with pus (bronchiectasis) or previous pulmonary haemorrhage,
in patients with prosthetic heart valves,
if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an 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 if surgery or another treatment to remove a pulmonary clot is planned.

If you suspect that any of the above conditions apply to you, inform your doctor
before taking rivaroxaban. 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 catheterisation or spinal puncture (e.g. for epidural or spinal anaesthesia or pain relief) is planned during surgery:
it is very important to take rivaroxaban at the specified times before and after the puncture or catheter removal, as directed by the doctor,
immediately inform the doctor if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia wears off, as immediate treatment will be required.

Children and adolescents
Rivaroxaban is not recommended for children weighing less than 30 kg.
There is insufficient data on the use of rivaroxaban in children and adolescents for adult indications.
Rivaroxaban Reddy with other medicines
Inform 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 topically on the skin only,
oral ketoconazole (used in the treatment of Cushing’s syndrome, a condition 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 you suspect that any of the above conditions apply to you, inform your doctor
before taking rivaroxaban, as 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 ulceration, preventive treatment for peptic ulcer disease may be prescribed.

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 you suspect that any of the above conditions apply to you, inform your doctor
before taking rivaroxaban, as 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 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 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 exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Rivaroxaban Reddy should be taken with food. Swallow the tablet(s) whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, discuss alternative ways of taking rivaroxaban with your doctor. The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration. After consuming this mixture, a meal should be taken immediately.
If necessary, your doctor may administer crushed rivaroxaban tablets through a gastric tube.

How many tablets to take

Adults
For prevention of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one 20 mg tablet once daily. If the patient has kidney disease, the dose may be reduced to one 15 mg tablet once daily.

If a procedure to open blocked blood vessels in the heart is required (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one 15 mg tablet once daily (or one 10 mg tablet once daily if kidney function is impaired), in combination with an antiplatelet medicine such as clopidogrel.

For treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots: The recommended dose is one 15 mg tablet twice daily for the first 3 weeks. After 3 weeks of treatment, 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 either one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has kidney disease and is taking one 20 mg tablet once daily, the 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 greater than the risk of further blood clots.
Children and adolescents The dose of rivaroxaban depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents with a body weight from 30 kg to below 50 kg is one 15 mg rivaroxaban tablet once daily.
The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg rivaroxaban tablet once daily.

Each dose of rivaroxaban should be taken with a meal and with a drink (e.g. water or juice). Tablets should be taken every day at approximately the same time. Consider setting an alarm to remind you. For parents or caregivers: observe the child to ensure the full dose has been taken.
The dose of rivaroxaban depends on body weight, so it is important to attend scheduled doctor’s appointments, as dose adjustments may be needed due to changes in body weight.
Never adjust the dose on your own. Your doctor will adjust the dose if necessary.
Do not split the tablet to achieve partial doses. If a lower dose is required, use rivaroxaban oral suspension granules. For children and adolescents who cannot swallow whole tablets, rivaroxaban oral suspension granules should be used.
If the oral suspension is not available, the rivaroxaban tablet may be crushed and mixed with water or apple puree immediately before administration. After consuming this mixture, a meal should be taken. If necessary, your doctor may also administer crushed rivaroxaban tablets through a gastric tube.

If a dose is vomited or spat out

within 30 minutes of taking rivaroxaban, take a new dose.
more than 30 minutes after taking rivaroxaban, do not take another dose. In this case, take the next dose at the usual time.

Contact your doctor if you repeatedly vomit or spit out rivaroxaban after administration.

When to start taking Rivaroxaban Reddy
Take the tablet(s) every day until your doctor decides to stop treatment. It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If restoring normal heart rhythm by cardioversion is required, rivaroxaban should be taken as directed by your doctor.

Missed dose of Rivaroxaban Reddy

Adults, children and adolescents: If the patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.
Adults: If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient forgot to take a dose, they may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.

Taking more than the recommended dose of Rivaroxaban Reddy
If the patient has taken too many rivaroxaban tablets, contact your doctor immediately. Taking too high a dose of rivaroxaban increases the risk of bleeding.

Stopping Rivaroxaban Reddy
Do not stop taking rivaroxaban without first consulting your doctor, as rivaroxaban treats and prevents serious medical conditions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.
As with other medicines with a similar mechanism of action that reduce 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, 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 or a change in treatment is necessary.

Signs of severe skin reactions

widespread, acute skin rash, blistering or mucosal lesions, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological abnormalities and systemic involvement. 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, oral cavity, 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 effects in adults, children and adolescents
Common (may occur in 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 bleeding or bleeding from the urinary and genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
bleeding into the eye (including conjunctival hemorrhage),
bleeding into tissues or body cavities (hematoma, bruising),
presence of blood in sputum (hemoptysis) during coughing,
skin bleeding 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, 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 evident 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 platelet count, blood cells involved in 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,
dry mouth,
urticaria.

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),
localized 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 granular white blood cells, causing inflammation in the lungs (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 inability of the kidneys to function properly (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).

Adverse effects in children and adolescents
In general, adverse effects observed in children and adolescents treated with rivaroxaban were
similar in type to those observed in adults and were mainly mild to moderate in severity.
Adverse effects observed more frequently in children and adolescents:
Very common (may occur in more than 1 in 10 patients)

headache
fever
nosebleeds, vomiting

Common (may occur in 1 in 10 patients)

rapid heartbeat
blood tests may show increased bilirubin levels (a bile pigment)
thrombocytopenia (low platelet count, blood cells that help in clotting)
excessive menstrual bleeding

Uncommon (may occur in 1 in 100 patients)

blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

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 of Adverse Drug Reactions at 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. Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Rivaroxaban Reddy

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after:
Expiry (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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 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 tablets (approximately 6 mm in diameter) marked with the number "15" on one side.
Pack sizes of 14, 28, 42 or 98 coated tablets.
20 mg:
Dark red, round, biconvex tablets (approximately 6 mm in diameter) marked with the number "20" on one side.
Pack sizes of 14, 28 or 98 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 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 Filmtabletten;
Rivaroxaban beta 20 mg Filmtabletten
France: RIVAROXABAN REDDY PHARMA 15mg, comprimé pelliculé;
RIVAROXABAN REDDY PHARMA 20mg, comprimé pelliculé
Italy: RIVAROXABAN DR. REDDY’S
Austria: Rivaroxaban Reddy 15 mg Filmtabletten;
Rivaroxaban Reddy 20 mg Filmtabletten
Netherlands: Rivaroxaban Reddy 15 mg filmomhulde tabletten;
Rivaroxaban Reddy 20 mg filmomhulde tabletten
Spain: Rivaroxaban Dr. Reddys 15 mg comprimidos recubiertos con película EFG;
Rivaroxaban Dr. Reddys 20 mg comprimidos recubiertos con película EFG
Slovakia: Rivaroxaban Reddy 15 mg filmom obalené tablety;
Rivaroxaban Reddy 20 mg filmom obalené tablety
Czech Republic: Rivaroxaban Reddy
Poland: Rivaroxaban Reddy
Sweden: Rivaroxaban Reddy 15 mg filmdragerad tablett;
Rivaroxaban Reddy 20 mg filmdragerad tablett
United Kingdom (Northern Ireland): Rivaroxaban Dr. Reddy’s 15 mg Film-Coated Tablets;
Rivaroxaban Dr. Reddy’s 20 mg Film-Coated Tablets