Rivahib

Leaflet included in the packaging: patient information

Varodoax, 2.5 mg, film-coated tablets

Rivaroxaban
This medicinal product will be subject to additional monitoring. This will allow for the rapid identification of new safety information. The user of the medicinal product can also contribute to this by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see section 4.
You should carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicinal product has been prescribed to you for a specific condition. Do not pass it on to others. The medicinal product may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions 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 adverse reactions
• 5. How to store Varodoax
• 6. Contents of the packaging and other information

1. What is Varodoax and what is it used for

The patient has been given Varodoax because

• they have been diagnosed with acute coronary syndrome (a condition that includes myocardial infarction and unstable angina pectoris) and have elevated levels of cardiac biomarkers. Varodoax reduces the risk of another myocardial infarction or reduces the risk of death due to cardiovascular disease in adults. Varodoax will not be given to the patient as the only medicinal product. The doctor will also prescribe the patient to take:
• acetylsalicylic acid or
• acetylsalicylic acid and clopidogrel or ticlopidine.

or

• they have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Varodoax reduces the risk of blood clots (thrombotic events) in adults. Varodoax will not be given to the patient as the only medicinal product. The doctor will also prescribe the patient to take acetylsalicylic acid. In some cases, if the patient is taking Varodoax after a procedure to widen a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel to be taken for a short time in addition to acetylsalicylic acid.

Varodoax contains the active substance rivaroxaban and belongs to a group of medicinal products called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thereby 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 medicinal product (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 medicinal products that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant treatment or when heparin is given to maintain the patency of a catheter in a vein or artery,
• if the patient has been diagnosed with acute coronary syndrome and has had bleeding or a blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and has had bleeding in the brain (stroke) or blockage of small blood vessels that supply blood to the tissues in the deep structures of the brain (sinus thrombosis) or if the patient has had a blood clot in the brain (ischemic stroke) in the last month),
• 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 used, and the doctor should be informedif the patient suspects that any of the above circumstances apply to them.

Warnings and precautions

Before starting treatment with Varodoax, the patient should discuss it with their doctor or pharmacist.
Varodoax should not be used in combination with certain other medicinal products that inhibit blood clotting, such as prasugrel or ticagrelor, other than acetylsalicylic acid, clopidogrel or ticlopidine.

When to exercise special caution when taking Varodoax

• if the patient has an increased risk of bleeding, in conditions such as:
• severe kidney disease, as kidney function may affect the amount of medicinal product that works in the patient's body,
• taking other medicinal products that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban or heparin) when switching anticoagulant treatment or when heparin is given to maintain the patency of a catheter in a vein or artery (see section "Varodoax and other medicinal products"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment with medicinal products,
• 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 (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• eye disease (retinopathy),
• pulmonary disease, in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if the patient is over 75 years old,
• if the patient weighs less than 60 kg,
• coronary artery disease with severe symptoms of heart failure,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide on possible changes to the treatment.

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 medicinal product and whether the patient should be subject to special observation.

If the patient needs to undergo surgery:

• the doctor's instructions regarding the intake of Varodoax at a specific time before or after surgery should be followed very carefully,
• if catheterization or spinal puncture is planned during surgery (e.g., for spinal anesthesia or epidural anesthesia or pain relief):
• it is very important to take Varodoax before and after the puncture or catheter removal, according to the doctor's instructions
• due to the need for special caution, the doctor should be informed immediately if there is numbness or weakness of the legs, bowel or bladder disorders, or back pain after the anesthesia is completed.

Children and adolescents

Varodoax 2.5 mg tablets are not recommended for persons under 18 years of age. There is not enough data on the use of this medicinal product in children and adolescents.

Varodoax and other medicinal products

The patient should tell their doctor or pharmacist about all medicinal products they are currently taking or have recently taken, as well as any medicinal products they plan to take, including those that are available without a prescription.

• If the patient is taking
• certain antifungal medicinal products (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain antibacterial medicinal products (e.g., clarithromycin, erythromycin),
• certain antiviral medicinal products used to treat HIV or AIDS (e.g., ritonavir),
• other medicinal products that prevent the formation of blood clots (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 medicinal products (e.g., naproxen or acetylsalicylic acid),
• dronedarone, a medicinal product used to treat heart rhythm disorders,
• certain medicinal products 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 doctor before taking Varodoax, as the effect of Varodoax may be enhanced. The doctor will decide whether to use this medicinal product and whether the patient should be subject to special observation.
If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use a treatment to prevent ulcers.

• If the patient is taking
• certain antiepileptic medicinal products (e.g., phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum), a herbal medicinal product used to treat depression,
• rifampicin, which belongs to a group of antibiotics. If the patient suspects that any of the above points apply to them, they should inform their doctor before taking Varodoax, as the effect of Varodoax may be reduced. The doctor will decide whether to use Varodoax and whether the patient should be subject to special observation.

Pregnancy and breastfeeding

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

Driving and using machines

Varodoax may cause dizziness (common adverse reactions) and fainting (uncommon adverse reactions) (see section 4, "Possible adverse reactions"). Patients who experience these adverse reactions 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 medicinal product.
The medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicinal product is considered "sodium-free".

3. How to take Varodoax

This medicinal product should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Varodoax should be taken at approximately the same time every day (e.g., one tablet in the morning and one tablet in the evening). The medicinal product can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways to take Varodoax. The tablet can be crushed and mixed with water or apple sauce immediately before taking it.
If necessary, the doctor may administer the crushed Varodoax tablet through a gastric tube.
Varodoax will not be given to the patient as the only medicinal product.
The doctor will also prescribe the patient to take acetylsalicylic acid.
If the patient is taking Varodoax after acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine to be taken.
If the patient is taking Varodoax after a procedure to widen a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel to be taken for a short time in addition to acetylsalicylic acid.
The doctor will inform the patient about the dose of these medicinal products to be taken (usually 75-100 mg of acetylsalicylic acid per day or a daily dose of 75-100 mg of acetylsalicylic acid plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to take Varodoax

Treatment with Varodoax after acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, but no later than 24 hours after hospitalization and at the time when parenteral (by injection) anticoagulant treatment would normally be discontinued.
The doctor will tell the patient when to start treatment with Varodoax if they have been diagnosed with coronary artery disease or peripheral arterial disease.
The doctor will decide how long to continue treatment.

Taking more than the recommended dose of Varodoax

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

Missing a dose of Varodoax

The patient should not take a double dose to make up for a missed dose. If the patient misses a dose, they should take the next dose at the scheduled time.

Stopping treatment with Varodoax

Varodoax should be taken regularly and for the duration prescribed by the doctor.
The patient should not stop taking Varodoax without first consulting their doctor. If the patient stops taking this medicinal product, the risk of another myocardial infarction, stroke, or death due to cardiovascular disease may increase.
If the patient has any further doubts about the use of this medicinal product, they should consult their doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, this medicinal product can cause adverse reactions, although not everybody gets them.
Like other medicinal products with a similar effect that reduce the formation of blood clots, Varodoax may cause bleeding, which can potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). It may not always be obvious or visible signs of bleeding.
The patient should inform their doctor immediately if they experience any of the following adverse reactions:

• Signs of bleeding:
• bleeding into the brain or within the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. A serious and sudden medical condition. Medical help should be sought immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. The doctor may decide on the need for very close monitoring of the patient or changes to the treatment.
• Signs of severe skin reactions:
• widespread, acute skin rash, blistering, or changes to the mucous membranes, e.g., tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a reaction to the medicinal product that causes a rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these adverse reactions is very rare (up to 1 in 10,000 people).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue, or throat; hives, and difficulty breathing; a 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:

Common(may affect up to 1 in 10 people)

• reduction in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, 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 (hemoptysis) while coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the extremities,
• pain in the extremities,
• disorders of kidney function (may be observed in tests performed by the doctor),
• fever,
• stomach pain, nausea (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, itching of the skin,
• 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 within 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 allergic skin reactions,
• disorders of liver function (may be observed in tests performed by the doctor),
• blood test results may show increased levels of bilirubin, certain liver or pancreatic 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 flow obstruction), liver inflammation, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• collection of blood (hematoma) in the groin as a complication of cardiac catheterization, when the 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 the presence of blood in the urine, leading to kidney failure (nephropathy associated with anticoagulants),
• increased blood pressure in the muscles of the legs and arms, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting adverse reactions

If adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Adverse reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicinal product.

5. How to store Varodoax

The medicinal product should be stored out of sight and reach of children.
The medicinal product should not be used after the expiry date stated on the carton and each blister after "EXP". The expiry date refers to the last day of the month stated.
There are no special precautions for storage of the medicinal product.
Crushed tablets
Crushed tablets are stable in water or apple sauce for up to 4 hours.
Medicinal products should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicinal products 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 2.5 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose (E 5), sodium lauryl sulfate, magnesium stearate. Coating: Aqua Polish P white composition: hypromellose (E 5), hypromellose (E 15), hydroxypropylcellulose, macrogol 8000, titanium dioxide (E 171).

What Varodoax looks like and contents of the pack

Varodoax 2.5 mg is a white, round, biconvex tablet with a single-sided imprint "2.5".
The carton contains 28 film-coated tablets in blisters of PVC/PVDC 90/Aluminum.

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

To obtain more detailed information about this medicinal product, 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