Rivaroxaban olpha

Package leaflet: Information for the user

Rivaroxaban Olpha, 10 mg, coated tablets
Rivaroxabanum
Please read this leaflet carefully before taking this medicine, because it contains important information
for the patient.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform 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

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

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the 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 the recurrence of blood clots in the blood vessels of the legs and/or lungs.

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 has active bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g., peptic ulcer, trauma or bleeding in 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 leading 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 conditions apply.

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

• if the patient has an increased risk of bleeding, such as:
   moderate or 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 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., inflammatory bowel disease or gastritis, 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, intestines, genital or urinary tract,
   vascular disease of the posterior part of the eyeball (retinopathy),
   lung disease with bronchiectasis (dilated bronchi filled with pus) or previous pulmonary bleeding,
• in patients with prosthetic heart valves,
• if the patient has a condition 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 another treatment to remove a pulmonary embolism is planned.

If any of the above 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 requires particularly close monitoring.
If the patient needs 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 intrathecal anesthesia or pain relief) is planned during surgery:
   the doctor’s instructions regarding the timing of Rivaroxaban Olpha administration must be strictly followed,
   the doctor must be informed immediately if, after anesthesia ends, the patient experiences numbness or weakness in the legs, or bowel or bladder dysfunction, as immediate treatment is required in such cases.

Children and adolescents
Rivaroxaban Olpha 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 Olpha and other medicines
Inform the doctor or pharmacist about all medicines currently 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),
   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, 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 requires 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 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, 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 requires 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 must 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 the 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 instructed by the doctor. In case of doubt, consult the 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 Rivaroxaban Olpha 10 mg tablet 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 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed Rivaroxaban Olpha 10 mg once daily.

The tablet should be swallowed whole, preferably with water.
Rivaroxaban Olpha may be taken with or without food.
If a patient has difficulty swallowing the whole tablet, discuss alternative methods 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.

When to take Rivaroxaban Olpha
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 veins 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 Olpha than you should
If a patient takes more than the prescribed dose of Rivaroxaban Olpha, contact the doctor immediately. Taking too high a dose of Rivaroxaban Olpha increases the risk of bleeding.

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

Stopping Rivaroxaban Olpha
Do not stop taking Rivaroxaban Olpha without first consulting your doctor, as Rivaroxaban Olpha 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 any medicine, Rivaroxaban Olpha may cause adverse effects, although not everyone will experience them.
As with other medicines of similar 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 may not always be obvious or visible.
You should immediately contact your doctor 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 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 causing rash, fever, internal organ inflammation, hematological disorders and systemic symptoms (DRESS syndrome). The frequency of these adverse effects is very rare (occurring in up to 1 in 10,000 people).
• Signs of serious allergic reactions
  • swelling of the face, lips, mouth, 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 effects:
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,
• bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• bleeding into the eye (including bleeding from the white part of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, feeling of nausea or vomiting, constipation, diarrhoea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general reduction in 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 affect 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, 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,
• dryness of the mouth,
• urticaria.

Rare ( may affect up to 1 in 1000 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 affect up to 1 in 10,000 people )

• accumulation of eosinophils, a type of granulocyte 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 the urine, leading to impaired kidney function (drug-induced 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).

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform 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
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects 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 outer carton after "Expiry date (EXP)" and on the blister after "EXP". The expiry date refers to the last day of the stated month.
No special temperature storage precautions 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 the sewage system 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 pack and other information

What Rivaroxaban Olpha contains

• The active substance is rivaroxaban. One coated tablet contains 10 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: microcrystalline cellulose (E460i), monohydrate lactose, 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 10 mg coated tablets are light red, round, biconvex,
with the imprint “A” on one side and the number “10” on the other side (diameter: 5.10 ± 0.20 mm, thickness: 2.40 ± 0.30 mm).
Transparent blisters made of PVC/PVdC/Aluminum or oPa/Aluminum/PVC/Aluminum containing 10 or 14 coated tablets in a cardboard box.
Each cardboard box contains either 30 coated tablets (3 blisters) or 98 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 marketing in the Member States of the European Economic Area under the following names: