- RIVAROX® is an anticoagulant and the first orally active direct factor Xa inhibitor.

- Unlike warfarin, routine lab monitoring of INR is not necessary. Only the

  10 mg tablet can be taken without regard to food. The 15 mg and 20 mg

  tablet should be taken with food.

Indications, dosage and administration:


- Each film-coated tablet of RIVAROX® contains:

   Rivaroxaban       2.5 mg.

   Rivaroxaban        10 mg.

   Rivaroxaban                       15 mg.

   Rivaroxaban                       20 mg.


- Active pathological bleeding [see Warnings and Precautions].

- Severe hypersensitivity reaction to RIVAROX® (e.g., anaphylactic reactions).

Drug interactions:

- Avoid concomitant administration of RIVAROX® with known combined P-gp and

  strong CYP3A inhibitors (e.g., ketoconazole and ritonavir).

- Avoid concomitant use of RIVAROX® with drugs that are combined P-gp and

  strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s wort).

- Coadministration of RIVAROX® with enoxaparin, warfarin, aspirin, clopidogrel

  and chronic NSAID may increase the risk of bleeding.

- Risk of Pregnancy-Related Hemorrhage:

  Use RIVAROX® with caution in pregnant women due to the potential for obstetric

  hemorrhage and/or emergent delivery.

- Patients with Prosthetic Heart Valves:

  RIVAROX® use not recommended.

- Acute PE in Hemodynamically Unstable Patients or Patients Who Require

Adverse reactions:

  Like all medicines, Rivaroxaban can cause side effects, although not everyone gets

  them. Like other similar medicines (antithrombotic agents), Rivaroxaban may cause

  bleeding which may potentially be life threatening. Excessive bleeding may lead to

  a sudden drop in blood pressure (shock). In some cases, the bleeding may not be


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

• long or excessive bleeding

• Exceptional weakness, tiredness, paleness, dizziness, headache, unexplained

  swelling, breathlessness, chest pain or angina pectoris, which may be signs of


- Increased Risk of Thrombotic Events after Premature


  If RIVAROX®  is discontinued for a reason other than pathological bleeding or

  completion of a course of therapy, consider coverage with another anticoagulant.

- Risk of Bleeding: and can cause serious or fatal bleeding.

• Concomitant use of other drugs that impair hemostasis increases the risk of bleeding

  (e.g. aspirin, antiplatelet; fibrinolytic therapy and NSAIDs).

• the following conditions are at increased risk of bleeding with the use of

  RIVAROX® for primary VTE prophylaxis: history of bronchiectasis, pulmonary

  cavitation, or pulmonary hemorrhage, active cancer (i.e. undergoing acute,

  in-hospital cancer treatment), active gastroduodenal ulcer in the three months prior

  to treatment, history of bleeding in the three months prior to treatment, or dual

  antiplatelet therapy.

- Spinal/Epidural Anesthesia or Puncture: is employed, patients are at risk of

  developing an epidural or spinal hematoma which can result in long-term or

  permanent paralysis.

Tell your doctor immediately if you experience skin reactions such as:

• Spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes

  (Stevens Johnson syndrome/toxic epidermal necrolysis).

• A drug reaction that causes rash, fever, inflammation of internal organs, hematologic

  abnormalities and systemic illness (DRESS syndrome).

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

• Swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and

  breathing difficulties; sudden drop in blood pressure.

Overall list of possible side effects:

• reduction in red blood cells which can make the skin pale and cause weakness or


• bleeding in the stomach or bowel, urogenital bleeding, nose bleed, bleeding in the


• bleeding into the eye (including bleeding from the whites of the eyes)

• bleeding into tissue or a cavity of the body (hematoma, bruising)

• coughing up blood.

• bleeding from the skin or under the skin.

• bleeding following an operation.

• oozing of blood or fluid from surgical wound.

• swelling in the limbs.

• pain in the limbs.

• impaired function of the kidneys (may be seen in tests performed by your doctor).

• fever.

• stomach ache, indigestion, feeling or being sick, constipation, diarrhea.

• low blood pressure (symptoms may be feeling dizzy or fainting when standing up).

• decreased general strength and energy (weakness, tiredness), headache, dizziness

• rash, itchy skin.

• blood tests may show an increase in some liver enzymes.

• fainting.

  this includes any possible side effects not listed in this leaflet. you can report side   

  effect directly via the: hhttp\\www.modernpharmaye.com\adrs.pdf

  and send to us on: adrs@modernpharmaye.com


- Use in Patients with Renal Impairment:

  Periodically assess renal function as clinically indicated (i.e., more frequently in

  situations in which renal function may decline) and adjust therapy accordingly [see

  indications, Dosage and Administration table].

- Use in Patients with Hepatic Impairment:

  No clinical data are available for patients with severe hepatic impairment.

- Use with P-gp and Strong CYP3A Inhibitors or Inducers:

  Avoid concomitant use of RIVAROX®  with known combined P-gp and

  strong CYP3A inhibitors (e.g. ketoconazole and ritonavir) or strong CYP3A inducer

  (e.g., carbamazepine, phenytoin, rifampin, St. John’s wort).


- RIVAROX® 2.5 Tablets (Blister of 10 Tablets, Pack of three blisters).

- RIVAROX® 10 Tablets (Blister of 10 Tablets, Pack of three blisters).

- RIVAROX® 15 Tablets (Blister of 10 Tablets, Pack of three blisters).

- RIVAROX® 20 Tablets (Blister of 10 Tablets, Pack of three blisters).


- Store in a dry place at a temperature not exceeding 25 ºC.

- Keep out of the reach of children.