Rivaroxaban olpha

Package leaflet: Information for the user

Rivaroxaban Olpha, 2.5 mg, coated tablets
Rivaroxabanum
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else 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 Olpha is and what it is used for
2. Important information before taking Rivaroxaban Olpha
3. How to take Rivaroxaban Olpha
4. Possible side effects
5. How to store Rivaroxaban Olpha
6. Contents of the pack and other information

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

You have been prescribed Rivaroxaban Olpha 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 detected. Rivaroxaban Olpha reduces the risk of further heart attack or the risk of death due to heart or blood vessel disease in adult patients. Rivaroxaban Olpha will not be given to you as a single treatment. Your doctor will also prescribe you:
  • acetylsalicylic acid, or
  • acetylsalicylic acid and clopidogrel or ticlopidine.

or

• You are at high risk of developing blood clots due to coronary artery disease or peripheral arterial disease causing symptoms. Rivaroxaban Olpha reduces the risk of blood clots (atherothrombotic events) in adult patients. Rivaroxaban Olpha will not be given to you as a single treatment. Your doctor will also prescribe you acetylsalicylic acid. In some cases, if you are receiving Rivaroxaban Olpha 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 for a short time in addition to acetylsalicylic acid.

Rivaroxaban Olpha 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 to form blood clots.

2. Important information before taking Rivaroxaban Olpha

When not to take Rivaroxaban Olpha
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 the patency of a venous or arterial catheter,
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 bleeding in the brain (stroke) or occlusion 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 past month,
if the patient has a liver disease that leads to an increased risk of
bleeding,
if the patient is pregnant or breastfeeding.
Rivaroxaban Olpha must not be used, and the doctor must be informed if the patient
suspects that any of the above-mentioned circumstances apply.

Warnings and precautions
Before starting to take Rivaroxaban Olpha, consult a doctor or
pharmacist.
Rivaroxaban Olpha should not be used in combination with other blood-thinning medicines besides acetylsalicylic acid, clopidogrel or ticlopidine, such as
prasugrel or ticagrelor.

When to exercise particular caution when taking Rivaroxaban Olpha
if the patient has an increased risk of bleeding, in conditions such as:

• severe kidney disease, as kidney function may affect the amount of medicine
  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 the patency of a venous or arterial catheter
  (see section "Rivaroxaban Olpha and other medicines"),
• blood clotting disorders,
• very high blood pressure that does not decrease despite medication,
• stomach or intestinal diseases that may cause bleeding, e.g., intestinal and
  gastric inflammation 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 or intestines or in the genital or urinary system,
• blood vessel disease in the posterior part of the eyeball (retinopathy),
• lung disease with dilated bronchi filled with pus (bronchiectasis)
  or previous bleeding from the lungs,
• 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 immune system disorder causing increased risk of clot formation), the patient should
  inform the doctor, who will decide whether treatment adjustment is necessary.
  If any of the above-mentioned conditions apply to the patient, the doctor must be informed
  before taking Rivaroxaban Olpha. The doctor will decide whether to use this medicine and whether the patient
  should be subjected to particularly close monitoring.

If the patient needs to undergo surgery:
the doctor's instructions regarding the timing of Rivaroxaban Olpha administration
immediately before or after surgery must be strictly followed,
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 Olpha before and after the puncture or
  catheter removal, as directed by the doctor,
• the doctor must be informed immediately if, after anesthesia ends, numbness or weakness in the legs, or disturbances in bowel or bladder function occur,
  as immediate treatment may be required in such cases.

Children and adolescents
Rivaroxaban Olpha 2.5 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 Olpha and other medicines
Inform the doctor or pharmacist about all medicines currently taken or 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, 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).
  If the patient suspects that any of the above conditions apply, the doctor must be informed
  before taking Rivaroxaban Olpha, as the effect of Rivaroxaban
  Olpha may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be subjected to particularly close monitoring.
  If the doctor considers that the patient has an 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 the patient suspects that any of the above conditions apply, the doctor must be informed
  before taking Rivaroxaban Olpha, as the effect of Rivaroxaban
  Olpha may be reduced. The doctor will decide whether to use Rivaroxaban Olpha and whether the patient should be subjected to particularly close monitoring.

Pregnancy and breastfeeding
Rivaroxaban Olpha must not be used 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 Olpha. If the patient becomes pregnant while taking this medicine, she must inform the doctor immediately, who will decide on further management.

Driving and operating machinery
Rivaroxaban Olpha may cause dizziness (common side effects) and 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 Olpha 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 (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaroxaban Olpha

This medicine should always be taken as advised by the doctor. If in doubt, contact the
doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Rivaroxaban Olpha should be taken at
approximately the same time each day (for example, one tablet in the morning and one in the
evening). This medicine can be taken with or without food.
If a patient has difficulty swallowing the whole tablet, discuss alternative ways of taking Rivaroxaban
Olpha 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 Olpha tablets via a gastric tube.
Rivaroxaban Olpha will not be given to the patient as the only medicine.
The doctor will prescribe acetylsalicylic acid for the patient to take.
If the patient is receiving Rivaroxaban Olpha after an acute coronary syndrome, the doctor may also
prescribe clopidogrel or ticlopidine.
If the patient is receiving Rivaroxaban Olpha after a procedure to restore blood flow in a narrowed or
blocked artery of 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 of the dosage (usually 75–100 mg 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 take Rivaroxaban Olpha
Treatment with Rivaroxaban Olpha after an acute coronary syndrome should be started 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 treatment would normally be
discontinued. The doctor will inform the patient when to start treatment with Rivaroxaban Olpha if
coronary artery disease or peripheral artery disease has been diagnosed.
The doctor will decide how long treatment should continue.
Taking more than the recommended dose of Rivaroxaban Olpha
If the patient has taken more than the recommended dose of Rivaroxaban Olpha, contact the doctor
immediately. Taking too high a dose of Rivaroxaban Olpha increases the risk of bleeding.
Missing a dose of Rivaroxaban Olpha
Do not take a double dose to make up for a missed dose. If a dose is missed, the patient should take
the next dose at the scheduled time.
Stopping Rivaroxaban Olpha
Rivaroxaban Olpha should be taken regularly and for the duration recommended by the doctor.
Do not stop taking Rivaroxaban Olpha without first consulting the doctor.
Stopping 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 reactions

Like any medicine, Rivaroxaban Olpha may cause adverse reactions, although not everyone experiences them.
As with other medicines with a similar anticoagulant effect, Rivaroxaban Olpha may cause bleeding, which can potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Bleeding may not always be 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 paralysis, vomiting, seizures, reduced level of consciousness and neck stiffness. This is a serious, acute 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. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • drug reaction with rash, fever, internal organ inflammation, hematological disorders and systemic involvement (DRESS syndrome). The frequency of these adverse reactions is very rare (occurring in up to 1 in 10,000 people).
• Signs of serious allergic reactions
  • swelling of the face, lips, oral cavity, tongue or throat; difficulty swallowing, 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 up to 1 in 100 people).

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

• reduction in red blood cells, which may cause pale 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) during coughing,
• bleeding from or under the skin,
• 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 loss of strength and energy (weakness, fatigue), headache, dizziness,
• rash, skin itching,
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon ( may occur in up to 1 in 100 people )

• 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,
• liver function disorders (may be observed in tests performed by a doctor),
• blood tests may show increased bilirubin levels, 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),
• local swelling,
• blood collection (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 granulocytic white 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 blood in urine, leading to impaired kidney function (drug-induced 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 following bleeding).

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the responsible entity.

5. How to store Rivaroxaban Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after "Expiry date (EXP)" and on the blister after "EXP". The expiry date refers to the last day of the stated month.
No special precautions regarding storage temperature are required for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Olpha contains

• The active substance is rivaroxaban. One coated tablet contains 2.5 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose (E468), sodium lauryl sulfate (E487), hypromellose 2910 (E464), magnesium stearate (E470b). See section 2 “Rivaroxaban Olpha contains lactose and sodium”.
  Coating: hypromellose 2910 (E464), titanium dioxide (E171), macrogol 3350 (E1521), iron oxide yellow (E172).

What Rivaroxaban Olpha looks like and contents of the pack
Rivaroxaban Olpha 2.5 mg coated tablets are light yellow, round, biconvex,
with the imprint “A” on one side and the number “2.5” on the other side (diameter: 6.10 ± 0.20 mm, thickness: 3.20 ± 0.30 mm).
Clear blisters made of PVC/PVdC/Aluminum or oPa/Aluminum/PVC/Aluminum containing 14 coated tablets in a cardboard box.
Each cardboard box contains either 56 coated tablets (4 blisters) or 196 coated tablets (14 blisters).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [email protected]

Manufacturer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [email protected]

This medicinal product is authorised for marketing in the European Economic Area Member States under the following names: