Rivaxar

Package leaflet: Information for the user

Rivaxar, 10 mg, film-coated tablets
Rivaroxabanum
Read the entire leaflet before taking this medicine, as it contains important information
for the patient

• Keep this leaflet for future reference.
• If you have any further questions, please consult 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Rivaxar is and what it is used for

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

• prevent blood clots in 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 recurrence of blood clots in the blood vessels of the legs and (or) lungs.

Rivaxar 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 Rivaxar

When not to take Rivaxar

• 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. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes),
• if the patient is taking other anticoagulant medicines (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 take Rivaxar, and inform your doctor if you suspect that any of the above-mentioned conditions apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaxar.
When to exercise special caution when taking Rivaxar

• if the patient has an increased risk of bleeding, such as in the following conditions:
• 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 anticoagulant medicines (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 "Rivaxar with 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 intestine and stomach or oesophagitis (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus),
• blood vessel disease at the back of the eye (retinopathy),
• lung disease with bronchiectasis (enlarged airways filled with pus) 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 needs to be changed,
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you suspect that any of the above-mentioned conditions apply to you, inform your doctor
before taking Rivaxar. The doctor will decide whether to use this medicine and whether the patient needs to be under particularly close observation.
If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of taking Rivaxar before or after surgery,
• If during surgery the patient is scheduled to undergo a 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 Rivaxar,
• immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness in the lower limbs, or problems with bowel or bladder function, as immediate treatment is required in such cases.

Children and adolescents
Rivaxar is not recommended for patients under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.
Rivaxar with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.

• 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 antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If you suspect that any of the above-mentioned conditions apply to you, inform your doctor
before taking Rivaxar, because the effect of Rivaxar may be enhanced when taken together with the above-mentioned medicines. The doctor will decide whether to use this medicine and whether the patient needs to be under particularly close observation.
If the doctor believes the patient is at increased risk of developing stomach or duodenal ulcers, they may prescribe treatment to prevent peptic ulcer disease.

• If the patient is taking
• certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital),
• St John's wort ( Hypericum perforatum ), a herbal remedy used for depression,
• rifampicin, which belongs to the group of antibiotics.

If you suspect that any of the above-mentioned conditions apply to you, inform your doctor
before taking Rivaxar, because the effect of Rivaxar may be reduced when taken together with the above-mentioned medicines. The doctor will decide whether to use Rivaxar and whether the patient needs to be under particularly close observation.
Pregnancy and breastfeeding
Do not use Rivaxar 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 Rivaxar. If the patient becomes pregnant while taking this medicine, she should inform the doctor immediately, who will decide on further management.
Driving and operating machinery
Rivaxar 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 or operate machinery.
Rivaxar 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 tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaxar

This medicine should always be taken as directed by your doctor. If you are unsure, you should
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 Rivaxar 10 mg tablet taken once daily.

• For the treatment of blood clots in the leg veins, 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 you Rivaxar 10 mg once daily.

The tablet should be swallowed whole, preferably with water.
Rivaxar may be taken with or without food.
If you have difficulty swallowing the whole tablet, speak with your doctor about alternative
ways of taking Rivaxar. The tablet can be crushed and mixed with water or soft food such as apple
purée, immediately before administration.
If necessary, your doctor may administer crushed Rivaxar tablets via a gastric tube.
When to take Rivaxar
You should 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 leg 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.
Taking more Rivaxar than prescribed
If you have taken more Rivaxar than prescribed, you should contact your doctor immediately.
Taking too high a dose of Rivaxar increases the risk of bleeding.
Missed dose of Rivaxar
If you forget to take a dose, take the tablet as soon as you remember. 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 missed tablet.
Stopping Rivaxar treatment
Do not stop taking Rivaxar without first discussing it with your doctor, as Rivaxar helps prevent
serious illness.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Like other medicines with a similar action (anticoagulant medicines), Rivaxar may cause
bleeding, which potentially can be life-threatening. Excessive bleeding may lead to
a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.

Possible adverse reactions which may indicate bleeding:
Contact your doctor immediately if you experience any of the following adverse reactions:

• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris, which may be signs of bleeding. Your doctor may decide that close monitoring of your condition or a change in treatment is necessary.

Possible adverse reactions which may indicate a skin reaction:
Contact your doctor immediately if you experience any of the following skin reactions such as:

• extensive, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these adverse reactions is very rare (may occur in less than 1 in 10,000 patients),
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) characterized by rash, fever, internal organ inflammation, hematological disorders and systemic involvement. The frequency of these adverse reactions is very rare (may occur in less than 1 in 10,000 patients).

Possible adverse reactions which may indicate a serious allergic reaction:
Contact your doctor immediately if you experience any of the following adverse reactions:

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing, urticaria (hives) and breathing difficulties; sudden drop in blood pressure. The frequency of these reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in less than 1 in 100 patients).

General list of possible adverse reactions:
Common (may occur in 1 in 10 patients)

• decrease in red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath,
• gastrointestinal bleeding (including bleeding from the stomach or intestines), 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 conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin 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, itching of the skin,
• increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon (may occur in 1 in 100 patients)

• bleeding into the brain or intracranial hemorrhage,
• bleeding into joints causing pain and swelling,
• thrombocytopenia (low platelet count, the blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• 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,
• liver function disorders (may be observed in tests performed by a doctor).

Rare (may occur in 1 in 1,000 patients)

• 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 area as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Frequency not known (frequency cannot be estimated from the available data)

• kidney failure following severe bleeding,
• increased pressure in the muscles of the arms or legs occurring after bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Rivaxar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry
and on each blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Rivaxar contains

• The active substance is rivaroxaban. One coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose 2910, sodium croscarmellose, magnesium stearate. See section 2 "Rivaxar contains lactose and sodium".
  Tablet coating: hypromellose 2910, titanium dioxide (E 171), macrogol 3350, iron oxide red (E 172).

What Rivaxar looks like and contents of the pack
Rivaxar 10 mg film-coated tablets are pink, round, biconvex (6 mm in diameter), with the number "10" embossed on one side and smooth on the other.
Clear blisters made of PVC/PVDC/Aluminum in cardboard boxes.
Pack sizes containing 5, 10, 14, 15, 20, 28, 30, 42, 45, 50, 56, 90, 98, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
e-mail: [email protected]

Manufacturer:
S.C. Labormed-Pharma S.A.
44B Theodor Pallady Blvd, 3 District
032266 Bucharest
Romania

Adalvo Ltd
Malta Life Sciences Park
Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann SGN 3000
Malta

This medicinal product is authorised in EEA Member States under the following names:
Iceland: Rivaroxaban AdAlvo 10 mg filmuhúðaðar töflur
Estonia: Rivaroxaban Auxilia
Finland: Rivaroxaban Avansor 10 mg tabletit, kalvopäällysteiset
Latvia: Rivaroxaban Auxilia 10 mg apvalkotās tablets
Lithuania: Rivaroxaban Auxilia 10 mg plėvele dengtos tabletės
Poland: Rivaxar
Sweden: Rivaroxaban Avansor 10 mg filmdragerade tabletter