Rivaroxaban olpha

Package leaflet: Information for the user

Rivaroxaban Olpha, 15 mg, coated tablets
Rivaroxaban Olpha, 20 mg, coated tablets
Rivaroxabanum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• Please consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual only. Do not share it with others. This medicine may harm others, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Rivaroxaban Olpha is and what it is used for
2. What you should know 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

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

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body in 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 recurrence of blood clots in the veins of the legs and/or lungs. Rivaroxaban Olpha is used in children and adolescents under 18 years of age and with body weight of 30 kg or more, to:
• treat blood clots and prevent 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 Olpha 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 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, trauma or bleeding into the brain, recent surgery on the brain or eye),
• 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 catheter patency 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. Rivaroxaban Olpha must not be used, and the doctor must be informed if the patient suspects any of the above circumstances apply.

Warnings and precautions
Before starting to take Rivaroxaban Olpha, consult a doctor or pharmacist.
When to exercise special caution when taking Rivaroxaban Olpha

• 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,
  • use of other medicines that prevent blood clots (e.g. warfarin, etexilate dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparan is administered to maintain catheter patency in a vein or artery (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. inflammation of the intestines and stomach or oesophagus (throat and oesophagus), such as due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach, intestines, reproductive or urinary system,
  • blood vessel disease in the back of the eye (retinopathy),
  • lung disease where bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with heart valve prostheses,
• 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 treatment adjustment is needed,
• if the patient has abnormal blood pressure or if surgery or other treatment to remove a blood clot from the lungs is planned.

If the patient suspects any of the above conditions apply, inform the doctor
before taking Rivaroxaban Olpha. 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 the timing of taking Rivaroxaban Olpha before or after surgery,
• if catheterisation or spinal puncture (e.g. for epidural or intrathecal anaesthesia 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,
  • due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia wears off.

Children and adolescents
Rivaroxaban Olpha tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of Rivaroxaban Olpha in children and adolescents for adult indications.

Rivaroxaban Olpha and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, 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, inform the doctor
before taking Rivaroxaban Olpha, as the effect of Rivaroxaban Olpha may be increased. 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 stomach 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), an herbal medicine used for depression,
  • rifampicin, an antibiotic.

If the patient suspects any of the above conditions apply, inform the doctor
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 requires particularly close monitoring.

Pregnancy and breastfeeding
Do not use Rivaroxaban Olpha if the patient is pregnant or breastfeeding. If there is a risk that the patient could become pregnant, an effective method of contraception should be used during treatment with Rivaroxaban Olpha. If the patient becomes pregnant while taking this medicine, inform the doctor immediately, who will decide on further treatment.

Driving and using machines
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, they should consult their 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 exactly as prescribed by your doctor. If you have any doubts,
you should contact your doctor or pharmacist.
Rivaroxaban Olpha should be taken with food.
The tablet should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, they should discuss alternative ways of taking
Rivaroxaban Olpha with their doctor. The tablet may be crushed and mixed with water or apple
purée immediately before administration. After taking this mixture, the patient should promptly
consume a meal.
If necessary, your doctor may administer crushed Rivaroxaban Olpha 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 Rivaroxaban Olpha 20 mg tablet once daily. If the patient has kidney disease, the dose may be reduced to one Rivaroxaban Olpha 15 mg tablet once daily.

If the patient requires a procedure to unblock blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one Rivaroxaban Olpha 15 mg tablet once daily (or one Rivaroxaban Olpha 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 Rivaroxaban Olpha 15 mg tablet twice daily for the first 3 weeks. For treatment beyond 3 weeks, the recommended dose is one Rivaroxaban Olpha 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 Rivaroxaban Olpha 20 mg tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Olpha 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 Olpha depends on body weight and will be calculated by the doctor.  The recommended dose for children and adolescents with body weight from 30 kg to below 50 kg is one Rivaroxaban Olpha 15 mg tablet once daily.  The recommended dose for children and adolescents with body weight of 50 kg or more is one Rivaroxaban Olpha 20 mg tablet once daily. Each dose of Rivaroxaban Olpha should be taken with a meal, accompanied by a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. Consider setting an alarm as a reminder. For parents or caregivers: monitor the child to ensure they have taken the full dose.

The dose of Rivaroxaban Olpha depends on body weight; therefore, it is important to attend scheduled appointments with your doctor, as dose adjustments may be necessary due to weight changes.
Never adjust the dose of Rivaroxaban Olpha on your own. If necessary, your doctor will adjust the dose.
Do not split the tablet to obtain a partial dose. If a lower dose is required, an alternative formulation of rivaroxaban should be used. For children and adolescents who cannot swallow tablets whole, an alternative formulation of rivaroxaban should be used.
If an oral suspension is not available, the Rivaroxaban Olpha tablet may be crushed and mixed with water or apple purée immediately before administration. After this mixture, a meal should be consumed. If necessary, your doctor may also administer crushed Rivaroxaban Olpha tablets via a gastric tube.

If a dose is vomited or expelled

• Within 30 minutes of taking Rivaroxaban Olpha, take a new dose.
• More than 30 minutes after taking Rivaroxaban Olpha, do not take another dose. In this case, take the next dose of Rivaroxaban Olpha at the usual time.

Contact your doctor if you repeatedly vomit or expel the dose after taking Rivaroxaban Olpha.

When to take Rivaroxaban Olpha
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 restoration of normal heart rhythm via a cardioversion procedure is required, Rivaroxaban Olpha should be taken at the time prescribed by your doctor.

Missed dose of Rivaroxaban Olpha

• 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 a 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 forgets 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 Olpha
If a patient has taken more than the recommended dose of Rivaroxaban Olpha, contact your doctor immediately. Taking too high a dose of Rivaroxaban Olpha increases the risk of bleeding.

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

4. Possible adverse reactions

Like all medicines, Rivaroxaban Olpha may cause adverse reactions, although not everyone experiences them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban Olpha 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.
Immediately contact your doctor if you or your child experience any of the following side effects:

• 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, 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 and systemic disorders (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, 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 reactions in adults, children, and adolescents:
Common (may affect 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 bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• 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 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, 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 affect up to 1 in 100 people)

• intracranial bleeding or bleeding within the skull (see bleeding signs 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 affect 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,
• 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 affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granulocyte 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 urine, leading to impaired kidney function (anticoagulant-related nephropathy),
• increased pressure in the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding).

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with Rivaroxaban Olpha were similar in type to those observed in adults and were mostly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may affect more than 1 in 10 people)

• headache
• fever
• nosebleeds
• vomiting

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to gather more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Rivaroxaban Olpha

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 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 apply to 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. This will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Olpha contains
Rivaroxaban Olpha 15 mg, film-coated tablets

• The active substance is rivaroxaban. Each film-coated tablet contains 15 mg of rivaroxaban.
• The 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 red (E172).

Rivaroxaban Olpha 20 mg, film-coated tablets

• The active substance is rivaroxaban. Each film-coated tablet contains 20 mg of rivaroxaban.
• The 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 red (E172).

What Rivaroxaban Olpha looks like and contents of the pack
Rivaroxaban Olpha 15 mg, film-coated tablets
Rivaroxaban Olpha 15 mg film-coated tablets are red, round, biconvex, with the imprint "A" on one side and the number "15" on the other side (diameter: 6.10 ± 0.20 mm, thickness: 2.60 ± 0.30 mm).
Transparent blisters made of PVC/PVdC/Aluminum or oPa/Aluminum/PVC/Aluminum containing 14 film-coated tablets in a cardboard box.
Each cardboard box contains 28 film-coated tablets (2 blisters) or 42 film-coated tablets (3 blisters) or 98 film-coated tablets (7 blisters).

Rivaroxaban Olpha 20 mg, film-coated tablets
Rivaroxaban Olpha 20 mg film-coated tablets are brown-red, round, biconvex, with the imprint "A" on one side and the number "20" on the other side (diameter: 6.10 ± 0.30 mm, thickness: 3.20 ± 0.30 mm).
Transparent blisters made of PVC/PVdC/Aluminum or oPa/Aluminum/PVC/Aluminum containing 14 film-coated tablets in a cardboard box.
Cardboard boxes containing 28 film-coated tablets (2 blisters) or 98 film-coated tablets (7 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 sale in the countries of the European Economic Area under the following names: