AXALTRA 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Axaltra, 10 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine because it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Axaltra and what is it used for
4. 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, 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, inform your doctor
   9. If you suspect that you have any of the above conditions, inform your doctor
   10. Pregnancy and breastfeeding
   11. Driving and using machines
   12. Axaltra contains lactose and sodium
5. How to take Axaltra
   1. How many tablets to take
   2. When to take Axaltra
   3. Taking more Axaltra than prescribed
   4. Missing a dose of Axaltra
   5. Stopping Axaltra treatment
6. Possible side effects
   1. Tell your doctor immediately if you experience any of the following side effects:
   2. General list of possible side effects
   3. Frequency not known (frequency cannot be estimated from the available data)
   4. Reporting side effects
7. How to store Axaltra
8. 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 attached to the packaging: patient information

Axaltra, 10 mg, film-coated tablets

Rivaroxaban

Read the leaflet carefully before taking the medicine because it contains important information for the patient.

• Keep this leaflet, so you can read it again 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 experience any side effects, including those not listed in this leaflet, 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 and is used in adults to
‐ prevent the formation of blood clots in the veins, after hip or knee replacement surgery. Your 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.
Axaltra belongs to a group of medicines 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 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 brain or eye surgery)
‐ if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching 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, consult your doctor or pharmacist.

When to be particularly careful when taking Axaltra

‐ if you have an increased risk of bleeding, such as:
‐ moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in your body
‐ if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching 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 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 the genital or urinary system
‐ disease of the blood vessels in the back of the eye (retinopathy)
‐ lung disease in which the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs ‐ in patients with heart valve prostheses ‐ 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 your treatment ‐ if you have been diagnosed with abnormal blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

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

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

If you need to have surgery:

‐ you must follow your doctor's instructions carefully regarding the intake of Axaltra at a strictly defined time before or after surgery
‐ if catheterization or spinal puncture is planned during surgery (e.g. for epidural or spinal anesthesia or pain relief):

• you must follow your doctor's instructions carefully regarding the intake of Axaltra at a strictly defined time
• you should immediately inform your doctor if, after the anesthesia is finished, you experience: numbness or weakness of the lower limbs, disorders of bowel or bladder function, as immediate treatment is necessary in such cases.

Children and adolescents

Axaltra 10 mg tablets are not recommended for persons under 18 years of age. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Other medicines and Axaltra

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take, including those that are 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 locally 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 noradrenaline reuptake inhibitors (SNRIs))

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

before taking Axaltra, as the effect of Axaltra may be enhanced if taken with the above medicines. Your doctor will decide whether to prescribe this medicine and whether you should be closely monitored.
If your doctor considers that you have an increased risk of developing stomach or duodenal ulcers, he may prescribe preventive treatment for stomach 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, inform your doctor

before taking Axaltra, as the effect of Axaltra may be reduced if taken with the above medicines. Your doctor will decide whether to prescribe Axaltra and whether you should be closely monitored.

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, inform your doctor immediately, 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, ride a bicycle, 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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your 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 Axaltra 10 mg tablet taken once a day.
‐ 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 a day or one 20 mg tablet once a day. Your doctor has prescribed Axaltra 10 mg once a day for you.
Swallow the tablet whole, preferably with water.
Axaltra can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Axaltra. The tablet can be crushed and mixed with water or apple sauce just before taking it.
If necessary, your doctor may administer the crushed Axaltra tablet through a gastric tube.

When to take Axaltra

Take one tablet every day until your doctor decides to stop the treatment.
It is best to take the tablet at the same time every day, as it will be easier to remember.
Your doctor will decide how long you should continue the treatment.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:
Take the first tablet 6 to 10 hours after surgery.
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 Axaltra than prescribed

If you have taken more Axaltra than prescribed, contact your doctor immediately. Taking too much Axaltra increases the risk of bleeding.

Missing a dose of Axaltra

If you forget to take a dose, take the tablet as soon as you remember. Take the next tablet the next day, and then take the tablets as usual, once a day.
Do not take a double dose to make up for a missed tablet.

Stopping Axaltra treatment

Do not stop taking Axaltra without consulting your doctor first, as Axaltra prevents a serious disease.
If you have any further questions about taking this medicine, 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 a similar effect of reducing blood clot formation, Axaltra may cause bleeding, which can potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Not all of these will be obvious or visible signs of bleeding.

Tell your doctor immediately 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. Seek medical help immediately!).

‐ 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 your treatment.

• Signs of severe skin reactions‐ widespread, acute 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, hematological and systemic disorders (DRESS syndrome) The frequency of these side effects is very rare (maximum 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 up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in up to 1 in 100 people).

General list of possible side effects

Common(may affect up to 1 in 10 people)
‐ reduction in red blood cell count, which may cause paleness of the skin 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, gum bleeding
‐ bleeding into the eye (including bleeding from the white of the eye)
‐ bleeding into tissues or body cavities (hematoma, bruising)
‐ presence of blood in sputum (hemoptysis) 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 (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
‐ skin rash, itching
‐ increased activity of some 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 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 some 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 muscles
‐ cholestasis (bile stasis), hepatitis, including liver cell damage
‐ yellowing of the skin and eyes (jaundice)
‐ localized swelling
‐ blood accumulation (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 granular white blood cell, which can cause inflammation in the lungs (eosinophilic pneumonia)

Frequency not known (frequency cannot be estimated from the 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 drugs)
‐ 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 you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Axaltra

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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 10 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, 10 mg, film-coated tabletsare light red, round, biconvex tablets with the inscription "10" on one side and smooth on the other side.
The diameter of the tablet is approximately 8.6 mm ± 0.2 mm.
They are available in blisters in cartons containing 5, 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-coated tablets
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, 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