Rivahib

Package Leaflet: Information for the Patient

Varodoax, 15 mg, Film-Coated Tablets

Varodoax, 20 mg, Film-Coated Tablets

Rivaroxaban
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. To find out how to report side effects, see point 4.
You should carefully read the leaflet before taking the medicine, as it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See point 4.

Contents of the Pack

• 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 pack and other information

1. What is Varodoax and what is it used for

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

• prevent blood clots in the brain (stroke) and other blood vessels in the body, if you have a form of irregular heartbeat called atrial fibrillation not caused by a heart valve problem.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood clots in the lungs (pulmonary embolism) and prevent new blood clots from forming in the veins and lungs. Varodoax is used in children and adolescents aged below 18 years and weighing 30 kg or more to:
• treat and prevent blood clots in the veins or lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Varodoax belongs to a group of medicines called anticoagulants. Its action is to block a clotting factor in the blood (factor Xa) and reduce the tendency to form blood clots.

2. Important information before taking Varodoax

When not to take Varodoax

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in point 6),
• if you have bleeding that is not under control,
• if you have a disease or condition of an organ that increases the risk of serious bleeding (e.g. stomach or intestinal ulcer, injury or bleeding in the brain, recent brain or eye surgery),
• if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to this type of medicine or when heparin is given to keep a line or device in a vein or artery open,
• if you have a liver disease that increases the risk of bleeding,
• if you are pregnant or breastfeeding. Do not take Varodoax and inform your doctorif you think any of the above applies to you.

Warnings and precautions

Before taking Varodoax, discuss this with your doctor or pharmacist.

When to be extra careful while taking Varodoax

• if you have an increased risk of bleeding, such as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine that works in the body,
• if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to this type of medicine or when heparin is given to keep a line or device in a vein or artery open (see "Varodoax and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease with treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) due to acid reflux disease or tumors in the stomach, intestines, genital or urinary system,
• blood vessel disease in the back of the eye (retinopathy),
• lung disease where the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if you have artificial heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment,
• if you have abnormal blood pressure or if surgery is planned to remove a blood clot from the lungs.

If you think any of the above applies to you, tell your doctor

before taking Varodoax. Your doctor will decide whether to prescribe this medicine and whether you should be closely monitored.

If you need to have surgery:

• you must carefully follow your doctor's instructions regarding the intake of Varodoax at a specific time before or after surgery,
• if spinal or epidural injection or catheter placement is planned during surgery (e.g. for spinal or epidural anesthesia or pain relief):
• it is very important to take Varodoax before and after the injection or catheter removal, as instructed by your doctor,
• you must immediately inform your doctor if, after the anesthesia is finished, you experience symptoms such as: numbness, weakness of the legs, disturbances in bowel or bladder function. In such a case, immediate treatment is necessary.

Children and adolescents

Varodoax tablets are not recommended for children weighing less than 30 kg.
There is not enough data on the use of Varodoax in children and adolescents for the same indications as in adults.

Varodoax and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

• If you are taking:
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally 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 you think any of the above applies to you, tell your doctor

before taking Varodoax, as the effect of Varodoax may be increased. Your doctor will decide whether to prescribe this medicine and whether you should be closely monitored.
If your doctor thinks you are at increased risk of stomach or duodenal ulcers, they may prescribe a medicine to prevent this condition.

• If you are taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression,
• rifampicin, which belongs to a group of antibiotics.

If you think any of the above applies to you, tell your doctor

before taking Varodoax, as the effect of Varodoax may be reduced. Your doctor will decide whether to prescribe Varodoax and whether you should be closely monitored.

Pregnancy and breastfeeding

Do not take Varodoax if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Varodoax. If you become pregnant while taking this medicine, you should inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Varodoax may cause dizziness (common side effects) and fainting (uncommon side effects) (see point 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 you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol sodium (23 mg) per tablet, which means that it is essentially "sodium-free".

3. How to take Varodoax

This medicine should always be taken exactly as your doctor has instructed. If you are not sure, ask your doctor or pharmacist.
Varodoax should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If you have difficulty swallowing whole tablets, you should talk to your doctor about other ways to take Varodoax. The tablet can be crushed and mixed with water or apple puree immediately before taking. After such a mixture, you should eat a meal immediately.
If necessary, your doctor may also give you a crushed Varodoax tablet through a nasogastric tube.

How many tablets to take

• Adults
• In preventing blood clots in the brain (stroke) and other blood vessels in the body. The recommended dose is one 20 mg Varodoax tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Varodoax tablet once daily.

If you need a procedure to open up the blood vessels in the heart (called percutaneous coronary intervention or PCI with stent placement), there is limited evidence to support a dose reduction to one 15 mg Varodoax tablet once daily (or one 10 mg Varodoax tablet once daily in case of kidney function impairment) in combination with an antiplatelet medicine such as clopidogrel.

• In treating blood clots in the veins of the legs, blood clots in the lungs, and preventing new blood clots from forming. The recommended dose is one 15 mg Varodoax tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Varodoax 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 you have kidney problems and are taking one 20 mg Varodoax tablet once daily, your doctor may decide to reduce the dose to one 15 mg Varodoax tablet once daily after 3 weeks of treatment, if the risk of bleeding is higher than the risk of new blood clots.
• Children and adolescentsThe dose of Varodoax depends on body weight and will be calculated by your doctor.
• The recommended dose for children and adolescents weighing from 30 kg to less than 50 kgis one 15 mg Varodoax tabletonce daily.
• The recommended dose for children and adolescents weighing 50 kg or moreis one 20 mg Varodoax tabletonce daily.

Each Varodoax dose should be taken with food, with a drink (e.g. water or juice). The tablets should be taken every day at approximately the same time. It is a good idea to set an alarm as a reminder.
For parents or caregivers: you should check that the child has taken the whole dose.
The dose of Varodoax is based on body weight, so it is important to come to scheduled doctor's appointments, as the dose may need to be adjusted depending on changes in body weight.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose.
Do not divide the tablet to achieve a smaller dose. If a smaller dose is needed, you should use another rivaroxaban-containing medicine in the form of granules for oral suspension.
For children and adolescents who are unable to swallow whole tablets, you should use another rivaroxaban-containing product in the form of granules for oral suspension.
If the oral suspension is not available, you can crush the Varodoax tablet and mix it with water or apple puree immediately before taking. After such a mixture, you should eat a meal immediately. If necessary, your doctor may also give you a crushed Varodoax tablet through a nasogastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking Varodoax, you should take a new dose.
• more than 30 minutes after taking Varodoax, do not take a new dose. In this case, take the next dose of Varodoax at the usual time.

You should contact your doctor if you spit out the dose or vomit repeatedly after taking Varodoax.

When to take Varodoax

The tablet(s) should be taken every day until your doctor decides to stop the treatment.
It is best to take the tablet(s) at the same time every day, as this will help you to remember to take it.
Your doctor will decide how long you should continue the treatment.
Preventing blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored to normal using a procedure called cardioversion, Varodoax should be taken as instructed by your doctor.

Missing a dose of Varodoax

• Adults, children and adolescents: If you are taking one 20 mg or one 15 mg tablet once daily and you miss a dose, you should take it 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 at the usual time the next day and then continue taking one tablet once daily.
• Adults: If you are taking one 15 mg tablet twice daily and you miss a dose, you should take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in one day. The next day, continue taking one 15 mg tablet twice daily.

Taking more Varodoax than prescribed

If you have taken more Varodoax tablets than prescribed, you should contact your doctor immediately.
Taking more Varodoax than prescribed may increase the risk of bleeding.

Stopping Varodoax treatment

You should not stop taking Varodoax without first talking to your doctor, as Varodoax treats and prevents serious conditions.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Varodoax can cause side effects, although not everybody gets them.
As with other medicines that prevent blood clots, Varodoax may cause bleeding, which can be life-threatening. Severe bleeding may lead to a sudden drop in blood pressure (shock). Not all bleeding may be obvious or external.

You must immediately inform 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 stiff neck. This is a serious medical emergency. You should immediately seek medical attention!),
• prolonged or excessive bleeding,
• unusual weakness, tiredness, paleness, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina. Your doctor may decide to closely monitor you or change your treatment.
• Signs of severe skin reactions:
• widespread, severe skin rash, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders and systemic symptoms (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; a 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 in adults, children and adolescents:

Common(may affect up to 1 in 10 people)

• reduced red blood cell count, which may cause paleness and be the reason for 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 from the gums,
• bleeding into the eye (including bleeding into the white of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum when coughing,
• bleeding from the skin or bleeding under the skin,
• bleeding after surgery,
• oozing of blood or fluid from a wound after surgery,
• swelling of a limb,
• limb pain,
• kidney problems (which may be seen in tests performed by your doctor),
• fever,
• stomach pain, nausea (feeling sick), vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, tiredness), headache, dizziness,
• rash, itching of the skin,
• increased activity of some liver enzymes, which may be seen 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 a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, which are cells that help the blood to clot),
• allergic reactions, including allergic skin reactions,
• liver problems (which may be seen in tests performed by your doctor),
• blood test results may show increased levels of bilirubin, some liver or pancreatic enzymes, or platelet count,
• fainting,
• feeling unwell,
• rapid heartbeat,
• dry mouth,
• hives.

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

• bleeding into a 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 a heart catheterization procedure, when a catheter is inserted into an 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 (drug-induced nephropathy),
• increased pressure in the muscles of the legs and arms after bleeding, which can lead to pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Generally, the side effects seen in children and adolescents treated with Varodoax were similar in type to those seen in adults and were mostly mild to moderate.
Side effects seen 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 test results may show increased levels of bilirubin
• thrombocytopenia (low platelet count, which are cells that help the blood to clot)
• excessive menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased levels of a bilirubin subtype (direct bilirubin).

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly to the Pharmacovigilance Department, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Varodoax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines should not be disposed of via wastewater 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 Varodoax contains

• The active substance is rivaroxaban. Each tablet contains 15 or 20 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, 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)], iron oxide red (E 172).

What Varodoax looks like and contents of the pack

Varodoax 15 mg is a pink, round, biconvex film-coated tablet with one-sided engraving "15".
Varodoax 20 mg is a brown-red, round, biconvex film-coated tablet with one-sided engraving "20".
Cartons containing 14 or 28 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 further information on this medicine, please contact:

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