Rivahib

Leaflet included in the packaging: patient information

Varodoax, 10 mg, film-coated tablets

Rivaroxaban
This medicinal product will be subject to additional monitoring. This will allow for quick identification of new safety information. The patient can also help by reporting any side effects they experience while taking this medicine. To find out how to report side effects, see section 4.
It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The patient should keep this leaflet to be able to read it again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to the patient for a specific condition. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Varodoax and what is it used for
• 2. Important information before taking Varodoax
• 3. How to take Varodoax
• 4. Possible side effects
• 5. How to store Varodoax
• 6. Contents of the packaging and other information

1. What is Varodoax and what is it used for

Varodoax 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. The doctor has prescribed this medicine because the risk of blood clot formation 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 prevent the recurrence of blood clots in the veins of the legs and/or lungs.

Varodoax belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thus reducing the tendency to form blood clots.

2. Important information before taking Varodoax

When not to take Varodoax

• 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 the body that leads to an increased risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant treatment or when 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.

Varodoax should not be taken, and the doctor should be informedif the patient suspects that any of the above conditions apply to them.

Warnings and precautions

Before starting treatment with Varodoax, the patient should discuss it with their doctor or pharmacist.

When to be particularly careful when taking Varodoax

• 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,
• if the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant treatment or when heparin is administered to maintain catheter patency in a vein or artery (see "Varodoax and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g., due to reflux disease of the esophagus (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• disease of the blood vessels in the back of the eye (retinopathy),
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with artificial heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform their doctor, who will decide on possible treatment changes,
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If the patient suspects that any of the above conditions apply to them, they should

inform their doctorbefore taking Varodoax. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.

If the patient needs to undergo surgery:

• the patient should carefully follow the doctor's instructions regarding the intake of Varodoax at a specific time before or after surgery,
• if a spinal puncture or catheter insertion into the spinal cord is planned during the surgical procedure (e.g., for spinal anesthesia or pain relief):
• the patient should carefully follow the doctor's instructions regarding the intake of Varodoax at a specific time,
• the patient should immediately inform their doctor if they experience symptoms such as numbness, weakness, difficulty urinating or defecating, or breathing difficulties after the anesthesia is completed, as immediate treatment may be necessary.

Children and adolescents

Varodoax 10 mg tablets are not recommended for persons under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.

Varodoax and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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,
• ketokonazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain antibacterial medicines (e.g., clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV or AIDS (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 (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects that any of the above points apply to them, they should

inform their doctorbefore taking Varodoax, as the effect of Varodoax may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use a medicine to prevent this condition.

• If the patient is taking:
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression,
• rifampicin, an antibiotic.

If the patient suspects that any of the above points apply to them, they should

inform their doctorbefore taking Varodoax, as the effect of Varodoax may be reduced when taken with these medicines. The doctor will decide whether to use Varodoax and whether the patient should be closely monitored.

Pregnancy and breastfeeding

Varodoax should not be taken if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use effective contraception while taking Varodoax. If the patient becomes pregnant while taking this medicine, they should immediately inform their doctor, who will decide on further treatment.

Driving and operating machinery

Varodoax may cause dizziness (common side effect) and fainting (uncommon side effect) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive, ride a bicycle, or operate machinery.

Varodoax 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 of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Varodoax

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgery. The recommended dose is one Varodoax 10 mg tablet taken once daily.
• To treat blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the 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. The doctor has prescribed Varodoax 10 mg once daily for the patient.

The tablet should be swallowed whole, preferably with water.
Varodoax can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should discuss other ways of taking Varodoax with their doctor. The tablet can be crushed and mixed with water or apple sauce immediately before intake.
If necessary, the doctor may administer the crushed Varodoax tablet through a nasogastric tube.

When to take Varodoax

The patient should take one tablet every day until the doctor decides to stop the treatment.
It is best to take the tablet at the same time every day, as it is easier to remember.
The doctor will decide how long the treatment should be continued.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:

The first tablet should be taken 6 to 10 hours after the surgical procedure.
In patients after major hip replacement surgery, treatment usually lasts 5 weeks.
In patients after major knee replacement surgery, treatment usually lasts 2 weeks.

Taking more Varodoax than prescribed

If the patient has taken more Varodoax than prescribed, they should immediately consult their doctor. Taking too much Varodoax increases the risk of bleeding.

Missing a dose of Varodoax

If the patient forgets to take a dose, they should take the tablet as soon as they remember.
The next tablet should be taken the next day, and then the tablets should be taken as usual, one tablet once daily.
The patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Varodoax

The patient should not stop taking Varodoax without first discussing it with their doctor, as Varodoax prevents the development of a serious condition.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Varodoax can cause side effects, although not everybody gets them. Like other medicines that reduce blood clotting, Varodoax may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). The signs of bleeding may not always be obvious or visible.
The patient should immediately inform their doctor if they 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 stiffness of the neck. This is a serious medical emergency. The patient should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. The doctor may decide to closely monitor the patient or change the treatment.
• Signs of severe skin reactions:
• widespread, severe skin rash, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• drug reaction that causes a rash, fever, inflammation of internal organs, hematologic disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (less than 1 in 10,000 people).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue, or throat; hives and difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible side effects:

Common(may affect up to 1 in 10 people)

• decrease in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum when coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney function disorders (may be observed in tests performed by the doctor),
• fever,
• stomach pain, nausea, vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, skin itching,
• increased activity of certain liver enzymes, which may be visible in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above signs of bleeding),
• bleeding into the joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including skin allergic reactions,
• liver function disorders (may be observed in tests performed by the doctor),
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

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

• bleeding into the muscle,
• cholestasis (bile stasis), liver inflammation, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of cardiac catheterization, when a catheter is inserted into the artery in the leg (pseudoaneurysm).

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

• kidney failure after severe bleeding,
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant therapy),
• increased pressure in the muscles of the legs and arms, occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Varodoax

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month stated.
There are no special storage instructions for this medicine.
Crushed tablets

Crushed tablets are stable in water or apple sauce for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Varodoax contains

• The active substance of Varodoax is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• Other ingredients are: tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose (E 5), sodium lauryl sulfate, magnesium stearate. Coating: Aqua Polish P white [containing: hypromellose (E 5), hypromellose (E 15), hydroxypropylcellulose, macrogol 8000, titanium dioxide (E 171)], iron oxide red (E 172).

What Varodoax looks like and contents of the pack

Varodoax 10 mg is a light pink, round, biconvex tablet with a single-sided imprint "10".
A carton box containing: 10 film-coated tablets in PVC/PVDC 90/Aluminum blisters.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

For more information about this medicine, the patient should contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw
Tel: 022/ 636 52 23; 636 53 02
[email protected]

Date of last revision of the leaflet: 31.01.2024