Rivaroxaban olimp

Package leaflet: Information for the user

Rivaroxaban OLIMP, 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 as 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Rivaroxaban OLIMP contains the active substance rivaroxaban and 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 further recurrence of blood clots in the blood vessels of the legs and (or) lungs.

Rivaroxaban OLIMP 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. Information before using Rivaroxaban OLIMP

When not to use Rivaroxaban OLIMP

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if the patient has 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 catheter patency in a vein or artery
• 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 OLIMP and inform the doctor if the patient suspects that any of the above circumstances apply.

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

• 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), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery (see section "Rivaroxaban OLIMP and other medicines")
  • blood clotting 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 gastro-oesophageal 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 in the back of the eye (retinopathy)
  • lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs
• in patients with heart valve prostheses
• 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 treatment needs to be changed
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs. If the patient suspects that any of the above conditions apply, inform the doctor before taking Rivaroxaban OLIMP. The doctor will decide whether to use this medicine and whether the patient needs particularly close monitoring.

If the patient needs surgery

• strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban OLIMP before or after surgery
• if during surgery the patient is scheduled to undergo lumbar puncture or spinal catheter placement (e.g. for epidural or spinal anaesthesia or for pain relief):
  • strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban OLIMP
  • inform the doctor immediately if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness in the lower limbs, disturbances in bowel movements or bladder function, because immediate treatment is required in such cases.

Children and adolescents
Rivaroxaban OLIMP 10 mg tablets are not recommended for patients under 18 years of age.
There is insufficient data on the use of this medicine in children and adolescents.
Rivaroxaban OLIMP and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 - 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 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 any of the above situations apply to the patient, inform the doctor before taking Rivaroxaban OLIMP, because the effect of Rivaroxaban OLIMP may be enhanced. The doctor will decide whether to use this medicine and whether the patient needs particularly close monitoring. If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, he may prescribe treatment to prevent ulcer formation.
• If the patient is taking
  • certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St John's wort ( Hypericum perforatum ), an herbal medicine used for depression
  • rifampicin, which belongs to the group of antibiotics. If the patient suspects that any of the above conditions apply, inform the doctor before taking Rivaroxaban OLIMP, because the effect of Rivaroxaban OLIMP may be reduced. The doctor will decide whether to use Rivaroxaban OLIMP and whether the patient needs particularly close monitoring.

Pregnancy and breastfeeding
Do not use Rivaroxaban OLIMP 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 OLIMP. If the patient becomes pregnant while taking this medicine, inform the doctor immediately, who will decide on further treatment.
Driving and operating machinery
Rivaroxaban OLIMP 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 OLIMP contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaroxaban OLIMP

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

How many tablets to take

• To prevent blood clots in veins after hip or knee replacement surgery: The recommended dose is one tablet of Rivaroxaban OLIMP 10 mg 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 tablet of 10 mg once daily or one tablet of 20 mg once daily. Your doctor has prescribed Rivaroxaban OLIMP 10 mg once daily for you.

Swallow the tablet whole, preferably with water.
Rivaroxaban OLIMP may be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways of taking Rivaroxaban OLIMP. The tablet can be crushed and mixed with water or apple puree immediately before administration.
If necessary, your doctor may administer crushed Rivaroxaban OLIMP tablets via a gastric tube.

When to take Rivaroxaban OLIMP
Take one tablet every day until your 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.
Your doctor will decide how long treatment should continue.

To prevent blood clots in the legs after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.

If you take more Rivaroxaban OLIMP than you should
If you take more Rivaroxaban OLIMP than prescribed, contact your doctor immediately. Taking too high a dose of Rivaroxaban OLIMP increases the risk of bleeding.

If you forget to take Rivaroxaban OLIMP
If you forget to take a dose, take the tablet as soon as you remember. Take the next tablet the following day, then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a forgotten tablet.

Stopping Rivaroxaban OLIMP
Do not stop taking Rivaroxaban OLIMP without first talking to your doctor, as Rivaroxaban OLIMP helps prevent serious illness.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Rivaroxaban OLIMP may cause adverse effects, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban OLIMP may cause bleeding, which potentially could 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 paralysis, 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
  • extensive, 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 illness. The frequency of these adverse effects is very rare (occurring in no more than 1 in 10,000 people).
• Signs of severe allergic reactions
  • swelling of the face, lips, mouth, oral cavity, tongue, or throat; difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe hypersensitivity reactions is very rare (anaphylactic reactions, including anaphylactic shock; may occur in no more than 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in no more than 1 in 100 people).

General list of possible adverse effects
Common (may occur in up to 1 in 10 people)

• reduction in red blood cell count, which may cause paleness of the skin and lead to weakness or shortness of breath
• gastrointestinal bleeding or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from gums
• bleeding into the eye (including bleeding from the sclera)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood
• bleeding from the skin or subcutaneous bleeding
• postoperative bleeding
• oozing of blood or fluid from 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 reduction 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 people)

• bleeding into the brain or inside the skull (see above, signs of bleeding)
• bleeding into a joint causing pain and swelling
• thrombocytopenia (low platelet count, platelets being 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
• dry mouth
• urticaria

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

• 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 up to 1 in 10,000 people):

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

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

• kidney failure following severe bleeding
• bleeding in the kidneys, sometimes with presence of blood in urine, leading to inability of the kidneys to function properly (anticoagulant-related 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 after bleeding).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 to provide more information on the safety of the medicine.

5. How to store Rivaroxaban OLIMP

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister
after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply 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 packaging and other information

What Rivaroxaban OLIMP contains

• The active substance is rivaroxaban. Each coated tablet contains 10 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, hypromellose 2910, magnesium stearate, sodium lauryl sulphate.
  Tablet coating: hypromellose 2910, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Rivaroxaban OLIMP looks like and contents of the pack
Rivaroxaban OLIMP 10 mg coated tablets are orange, round, biconvex, with an embossed mark "10" on one side and "RH" on the other side.
Supplied in transparent PVC/PVDC/Aluminium blisters in cardboard packaging.
Pack sizes: 10 or 30 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
OLIMP Laboratories Sp. z o.o.
Pustynia 84 F
39-200 Dębica
tel.: +48 14 690 32 02
e-mail: [email protected]
{OLIMP Laboratories logo}

Manufacturer/Importer:
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta