AXALTRA 20 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Axaltra, 15 mg, film-coated tablets
3. Axaltra, 20 mg, film-coated tablets
   1. You should carefully read the contents of this leaflet before taking the medicine because it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Axaltra and what is it used for
5. Important information before taking Axaltra
   1. When not to take Axaltra
   2. Warnings and precautions
   3. When to be particularly careful when taking Axaltra
   4. If you suspect that you have any of the above conditions, you should inform your doctor
   5. If you need to have surgery
   6. Children and adolescents
   7. Other medicines and Axaltra
   8. If you suspect that you have any of the above conditions, you should inform
   9. If you suspect that you have any of the above conditions, you should inform
   10. Pregnancy and breastfeeding
   11. Driving and using machines
   12. Axaltra contains lactose and sodium
6. How to take Axaltra
   1. How many tablets to take
   2. In case of spitting out the dose or vomiting
   3. When to take Axaltra
   4. Missing a dose of Axaltra
   5. Taking more Axaltra than prescribed
   6. Stopping Axaltra treatment
7. Possible side effects
   1. You should immediately inform your doctor if you experience any of the following side effects:
   2. General list of possible side effects in adults, children, and adolescents
   3. Frequency not known (frequency cannot be estimated from available data)
   4. Side effects in children and adolescents
   5. Reporting side effects
8. How to store Axaltra
9. Contents of the pack and other information
   1. What Axaltra contains
   2. What Axaltra looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: patient information

Axaltra, 15 mg, film-coated tablets

Axaltra, 20 mg, film-coated tablets

Rivaroxaban

You should carefully read the contents of this leaflet before taking the medicine because 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 further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Axaltra and what is it used for

Axaltra contains the active substance rivaroxaban.
Axaltra is used in adults to
‐ prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type 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 vessels in the lungs (pulmonary embolism) and prevent the formation of new blood clots in the blood vessels of the legs and (or) lungs.
Axaltra is used in children and adolescents under 18 years of age and weighing 30 kg or more to
‐ treat blood clots and prevent the formation of new blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.
Axaltra 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 Axaltra

When not to take Axaltra

‐ if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
‐ if you have excessive bleeding
‐ if you have 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 surgical procedure on the brain or eyes)
‐ if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter
‐ if you have liver disease that leads to an increased risk of bleeding
‐ if you are pregnant or breastfeeding
Do not take Axaltra, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Axaltra, you should consult your doctor or pharmacist.

When to be particularly careful when taking Axaltra

‐ 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 acting in the patient's body
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Other medicines and Axaltra")
• bleeding disorders
• very high blood pressure that does not decrease despite taking medicines
• 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 the genital or urinary system
• disease of the blood vessels in the back of the eye (retinopathy)
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs ‐ in patients with artificial heart valves ‐ if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation) you should inform your doctor, who will decide whether to change the treatment ‐ if you have been diagnosed with abnormal blood pressure or a surgical procedure is planned to remove a blood clot from the lungs

If you suspect that you have any of the above conditions, you should inform your doctor

before taking Axaltra. Your doctor will decide whether to use this medicine and whether you should be under close observation.

If you need to have surgery

‐ you must strictly follow your doctor's instructions regarding the intake of Axaltra at a precisely specified time before or after surgery
‐ if a procedure to open blood vessels in the heart (called percutaneous coronary intervention with stent placement) is planned:

• it is very important to take Axaltra before and after the procedure, according to your doctor's instructions
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness of the legs, bowel or bladder disorders after anesthesia.

Children and adolescents

Axaltra tablets are not recommended for children weighing less than 30 kg.
There is a lack of sufficient data on the use of Axaltra in children and adolescents for indications in adults.

Other medicines and Axaltra

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
‐ If you are taking

• certain medicines used to treat fungal infections (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 medicines used to treat bacterial infections (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 suspect that you have any of the above conditions, you should inform

your doctorbefore taking Axaltra, as the action of Axaltra may be enhanced if taken with the above medicines. Your doctor will decide whether to use this medicine and whether you should be under close observation.
If your doctor considers that you have an increased risk of developing stomach or duodenal ulcers, they may use a treatment to prevent ulcers.
‐ 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 suspect that you have any of the above conditions, you should inform

your doctorbefore taking Axaltra, as the action of Axaltra may be reduced if taken with the above medicines. Your doctor will decide whether to use Axaltra and whether you should be under close observation.

Pregnancy and breastfeeding

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

Driving and using machines

Axaltra may cause dizziness (frequent side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive vehicles, ride bicycles, or operate tools or machines.

Axaltra contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Axaltra

This medicine should always be taken according to your doctor's instructions. If you have any doubts, you should consult your doctor or pharmacist.
Axaltra should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways to take Axaltra. The tablet can be crushed and mixed with water or apple sauce immediately before taking. After such a mixture, you should take a meal immediately.
If necessary, your doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

• Adults‐ To prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body, the recommended dose is one 20 mg Axaltra tablet once a day. If you have kidney problems, the dose may be reduced to one 15 mg Axaltra tablet once a day.

If you need a procedure to open blood vessels in the heart (called percutaneous coronary intervention with stent placement), there is limited evidence to support a dose reduction to one 15 mg Axaltra tablet once a day (or one 10 mg Axaltra tablet once a day in case of kidney function disorder) in combination with an antiplatelet medicine such as clopidogrel.
‐ To treat blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the formation of new blood clots
The recommended dose is one 15 mg Axaltra tablet twice a day for the first 3 weeks.
For treatment after 3 weeks, the recommended dose is one 20 mg Axaltra tablet once a day.
After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment, using one 10 mg tablet once a day or one 20 mg tablet once a day.
If you have kidney problems and are taking one 20 mg Axaltra tablet once a day, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Axaltra tablet once a day, if the risk of bleeding is greater than the risk of new blood clots.

• Children and adolescentsThe dose of Axaltra 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 Axaltra 15 mgtablet once a day. ‐ The recommended dose for children and adolescents weighing 50 kgor more is one Axaltra 20 mgtablet once a day. Each Axaltra dose should be taken with a meal, with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. It's a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they take the entire dose.

The dose of Axaltra is dependent on body weight, so it's essential to come to scheduled doctor's appointments, as it may be necessary to adjust the dose due to weight changes.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose.
Do not divide the tablet to get a partial dose. If a smaller dose is needed, you should use a different form of Axaltra, a granule for oral suspension.
For children and adolescents who are unable to swallow whole tablets, Axaltra should be used in the form of granules for oral suspension.
If the oral suspension is not available, you can crush the Axaltra tablet and mix it with water or apple sauce immediately before taking. After such a mixture, you should take a meal immediately.
If necessary, your doctor may also administer the crushed tablet through a gastric tube.

In case of spitting out the dose or vomiting

• less than 30 minutes after taking Axaltra, you should take a new dose
• more than 30 minutes after taking Axaltra, do not take a new dose. In this case, take the next Axaltra dose at the usual time. You should contact your doctor in case of repeated spitting out of the dose or vomiting after taking Axaltra.

When to take Axaltra

You should take one tablet every day until your doctor decides to stop the treatment.
It's best to take the tablet at the same time every day, as it's easier to remember.
Your doctor will decide how long to continue the treatment.
To prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body:

Missing a dose of Axaltra

‐ Adults, children, and adolescents
If you take one 20 mg or one 15 mg tablet once a day 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 the missed dose. Take the next tablet the next day, and then take one tablet once a day.
‐ Adults
If you take one 15 mg tablet twice a day 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 forget to take a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day.
Take the next dose the next day, and then continue taking one 15 mg tablet twice a day.

Taking more Axaltra than prescribed

If you have taken too many Axaltra tablets, you should immediately contact your doctor.
Taking too much Axaltra increases the risk of bleeding.

Stopping Axaltra treatment

You should not stop taking Axaltra without first talking to your doctor, as Axaltra prevents serious illnesses.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Axaltra can cause side effects, although not everybody gets them.
Like other medicines with similar action to reduce blood clot formation, Axaltra can cause bleeding, which can potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

You should immediately inform your doctor if you 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. You should immediately seek medical help!). ‐ prolonged or excessive bleeding ‐ unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris Your doctor may decide to monitor you closely or change the treatment.
• Signs of severe skin reactions‐ widespread, severe skin rash, blistering or changes to the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis) ‐ drug reaction causing rash, fever, inflammation of internal organs, blood disorders, and systemic disorders (DRESS syndrome) The frequency of these side effects is very rare (less than 1 in 10,000 people).
• Signs of serious allergic reactions‐ swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; 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 less than 1 in 100 people).

General list of possible side effects in adults, children, and adolescents

Common(may affect up to 1 in 10 people)
‐ reduction in red blood cell count, which may cause paleness and be the cause of weakness or shortness of breath
‐ bleeding from the stomach or intestine, 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 from the sclera)
‐ bleeding into tissues or body cavities (hematoma, bruising)
‐ coughing up blood (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 limbs
‐ limb pain
‐ kidney function disorders (can be observed in tests performed by your 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
‐ increased activity of certain liver enzymes, which can 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, cells involved in blood clotting)
‐ allergic reactions, including allergic skin reactions
‐ liver function disorders (can be observed in tests performed by your 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 muscles
‐ cholestasis (bile stasis), hepatitis, including liver cell damage
‐ jaundice (yellowing of the skin and eyes)
‐ localized swelling
‐ accumulation of blood (hematoma) in the groin as a complication of heart catheterization, when the catheter is inserted into an artery in the leg (pseudoaneurysm)
Very rare(may affect up to 1 in 10,000 people)
‐ accumulation of eosinophils, a type of white granular blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia)

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

‐ kidney failure after severe bleeding
‐ bleeding in the kidneys, 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 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 observed in children and adolescents treated with Axaltra were similar in type to those observed in adults and were mainly mild to moderate.
Side effects observed 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 bilirubin levels
‐ thrombocytopenia (low platelet count, cells involved in blood clotting)
‐ heavy menstrual bleeding
Uncommon(may affect up to 1 in 100 people)
‐ blood test results may show increased direct bilirubin levels (a type of bile pigment)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 Axaltra

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Axaltra contains

‐ The active substance of Axaltra is rivaroxaban. One film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
‐ The other ingredients are:
tablet core:sodium lauryl sulfate, lactose, poloxamer 188, microcrystalline cellulose type 105, microcrystalline cellulose type 102, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, anhydrous, see section 2 "Axaltra contains lactose and sodium"
tablet coating:hypromellose type 2910, titanium dioxide (E 171), macrogol 3350, iron oxide red (E 172)

What Axaltra looks like and contents of the pack

Axaltra, 15 mg, film-coated tabletsare red, round, biconvex tablets with "15" engraved on one side and smooth on the other.
The diameter of the tablet is approximately 5.6 mm ± 0.2 mm.
They are available in blisters in cartons containing 10, 14, 28, 30, 42, 50, 98, or 100 film-coated tablets.
Not all pack sizes may be marketed.
Axaltra, 20 mg, film-coated tabletsare brown-red, round, biconvex tablets with "20" engraved on one side and smooth on the other.
The diameter of the tablet is approximately 6.6 mm ± 0.2 mm.
They are available in blisters in cartons containing 10, 14, 28, 30, 98, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area
41004 Larisa
Greece
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
BBG3000 Birzebbuga
Malta
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Hungary
Xabdu 2.5 mg, 10 mg, 15 mg, 20 mg film tablet
Czech Republic Axaltra
Croatia Cloter 2.5 mg, 10 mg, 15 mg, 20 mg film-coated tablets
Poland
Axaltra
To obtain more detailed information on this medicine, you should contact the representative of the marketing authorization holder in Poland:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel.: +48 12 262 32 36
e-mail: [email protected]
Date of last revision of the leaflet:February 2024