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. See section 4 for how to report side effects.
You should carefully read the leaflet before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later if you need to.
• 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 symptoms 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 section 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 type of irregular heartbeat called atrial fibrillation that is 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 of the legs and/or 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 and lungs, after at least 5 days of initial treatment with injectable medicines that prevent 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 section 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 ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes),
• if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to this 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 breast-feeding. 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 medicine or when heparin is given to keep a line or device in a vein or artery open (see section "Varodoax and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease with treatment,
• stomach or bowel disease that may cause bleeding, e.g. inflammation of the bowel or stomach, or cancer in the stomach, bowel, genital or urinary system,
• eye disease (retinopathy),
• lung disease with enlarged airways and filled with pus (bronchiectasis) or previous bleeding in the lungs,
• if you have artificial heart valves,
• if you have a condition called antiphospholipid syndrome (a disease of the immune system 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 a surgical procedure 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 need to be kept under closer medical supervision.

If you need to have surgery:

• you must carefully follow your doctor's instructions about taking Varodoax in the time period before or after surgery,
• if a procedure to inject a dye into your spinal cord (e.g. for epidural or spinal anaesthesia or puncture) is planned:
• it is very important that you take Varodoax before and after the procedure, as instructed by your doctor,
• you must immediately inform your doctor if you experience any of the following symptoms after the procedure: numbness, weakness of the legs, problems with bowel or urinary function. In such cases, immediate treatment is necessary.

Children and adolescents

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

Varodoax and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take, including those you can buy without a prescription.

• If you are taking:
• certain medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied locally to the skin,
• ketokonazole tablets (used to treat Cushing's syndrome, where the body produces too much cortisol),
• certain medicines for bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines for HIV or AIDS (e.g. ritonavir),
• other medicines that 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 for irregular heartbeat,
• certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline 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 need to be kept under closer medical supervision.
If your doctor thinks you are at increased risk of stomach or duodenal ulcers, he may prescribe a medicine to prevent these conditions.

• If you are taking:
• certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum), a herbal medicine used for depression,
• rifampicin, an antibiotic.

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 need to be kept under closer medical supervision.

Pregnancy and breast-feeding

Do not take Varodoax if you are pregnant or breast-feeding. 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 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 use machines.

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 is essentially sodium-free.

3. How to take Varodoax

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take Varodoax with food.
Swallow the tablet(s) whole, with water. If you have difficulty swallowing the tablet, talk to your doctor about other ways to take Varodoax. The tablet can be crushed and mixed with water or apple sauce just before taking. After taking the mixture, you should eat a meal immediately. If necessary, your doctor may also give you the crushed tablet through a nasogastric tube.

How much 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 widen the blood vessels in the heart (called percutaneous coronary intervention or PCI with stent placement), there is limited evidence to support the use of a reduced dose of one 15 mg Varodoax tablet once daily (or one 10 mg Varodoax tablet once daily in case of kidney problems) in combination with an anti-platelet 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. 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 will depend on body weight and will be calculated by your doctor.
• The recommended dose for children and adolescents weighing 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 dose of Varodoax should be taken with food, with a drink (e.g. water or juice). The tablets should be taken at the same time every day. It is a good idea to set an alarm 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 according to changes in body weight.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose. Do not divide the tablet to get a smaller dose. If a smaller dose is needed, you should use another rivaroxaban medicine that comes in a granule form for oral suspension.
For children and adolescents who are unable to swallow whole tablets, you should use another rivaroxaban medicine that comes in a granule form for oral suspension. If the oral suspension is not available, you can crush the Varodoax tablet and mix it with water or apple sauce just before taking. After taking the mixture, you should eat a meal immediately. If necessary, your doctor may also give you the crushed tablet through a nasogastric tube.

If you spit out or vomit the dose

• 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 or vomit the dose or have vomiting after taking Varodoax.

When to take Varodoax

Take the tablet(s) every day until your doctor tells you to stop. It is best to take the tablet(s) at the same time every day, as this will help you to remember to take them.
Your doctor will decide how long you should take Varodoax.
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, you should take Varodoax as instructed by your doctor.

Missed dose of Varodoax

• Adults, children and adolescents: If you take one 20 mg or one 15 mg tablet once daily and miss a dose, take it as soon as possible. Do not take more than one tablet in a 24-hour period 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 take one 15 mg tablet twice daily and miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in a 24-hour period. If you miss a dose, you can take two 15 mg tablets at the same time to get a total daily dose of two tablets (30 mg) in a 24-hour period. The next day, continue taking one 15 mg tablet twice daily.

Taking more Varodoax than prescribed

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

Stopping Varodoax treatment

Do not stop taking Varodoax without talking to your doctor first, as Varodoax treats and prevents serious conditions.
If you have any further questions on the use of this medicine, 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 may not be visible.

You should tell your doctor immediately if you experience any of the following side effects:

• Signs of bleeding:
• bleeding into the brain or spinal cord (symptoms can include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness and stiff neck. This is a serious medical emergency. You should seek medical help immediately!),
• 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 keep you under closer medical supervision or change your treatment.
• Signs of severe skin reactions:
• widespread, severe skin rash, blistering or peeling of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction that causes rash, fever, swelling of internal organs, blood abnormalities and allergic reactions (DRESS syndrome). The frequency of these side effects is very rare (may affect 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; 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 oedema may occur in up to 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 can make you pale and tired and increase the risk of infections,
• bleeding from the stomach or bowel, bleeding from the urinary tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding into the eyelid),
• bleeding into tissues or body cavities (haematoma, bruising),
• blood in the sputum when coughing (haemoptysis),
• 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 blood tests),
• fever,
• stomach pain, nausea (feeling sick), vomiting, constipation, diarrhoea,
• low blood pressure (symptoms can include dizziness or fainting when standing up),
• general weakness and lack of energy (fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of some liver enzymes, which can be seen in blood tests.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or spinal cord (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• low platelet count (thrombocytopenia),
• allergic reactions, including skin allergic reactions,
• liver problems (which may be seen in blood tests),
• blood tests may show increased levels of bilirubin, liver 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,
• liver problems, including liver damage (cholestasis, liver injury),
• yellowing of the skin and eyes (jaundice),
• local swelling,
• collection of blood (haematoma) in the groin as a complication of a procedure to inject a dye into the blood vessels (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 caused by anticoagulant medicines),
• 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).

Side effects in children and adolescents

Overall, 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 tests may show increased levels of bilirubin
• low platelet count (thrombocytopenia)
• heavy menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact details for reporting side effects" section below.
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 on each blister after "EXP". The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Crushed tablets
The 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. 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 a single-sided imprint "15".
Varodoax 20 mg is a brown-red, round, biconvex film-coated tablet with a single-sided imprint "20".
Cartons containing 14 or 28 film-coated tablets in PVC/PVDC 90/Aluminium blisters.

Marketing Authorisation 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 Warszawa
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet: 31.01.2024