AXALTRA 2.5 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Axaltra, 2.5 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What Axaltra is and what it is used for
4. Important information before taking Axaltra
   1. When not to take Axaltra
   2. Warnings and precautions
   3. When to exercise special caution when taking Axaltra
   4. If the patient suspects that they have the above conditions, they should inform their doctor
   5. If the patient needs to undergo surgery:
   6. Children and adolescents
   7. Other medicines and Axaltra
   8. If the patient suspects that they have the above conditions, they should inform their doctor
   9. If the patient suspects that they have the above conditions, they should inform their 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 a higher dose of Axaltra than recommended
   4. Missing a dose of Axaltra
   5. Stopping Axaltra
6. Possible side effects
   1. General list of possible side effects
   2. Frequency not known (frequency cannot be estimated from the available data)
   3. 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 what the pack contains
   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, 2.5 mg, film-coated tablets

Rivaroxaban

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

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Axaltra is and what it is 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 Axaltra is and what it is used for

The patient has been given Axaltra because they have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, acute chest pain) and have elevated levels of cardiac biomarkers. Axaltra reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Axaltra will not be given to the patient as the only medicine. The doctor will instruct the patient to take aspirin as well.

• aspirin or
• aspirin and clopidogrel or ticlopidine

or

‐ the patient has been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease, which causes symptoms. Axaltra reduces the risk of blood clots (atherothrombotic events) in adults. Axaltra will not be given to the patient as the only medicine. The doctor will instruct the patient to take aspirin as well. In some cases, if the patient is taking Axaltra after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for the patient to take for a short time in addition to aspirin. Axaltra contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. Important information before taking Axaltra

When not to take Axaltra

‐ if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (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 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 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 artery disease and has had bleeding in the brain (stroke) or blockage of small arteries supplying 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 liver disease that leads to an increased risk of bleeding ‐ if the patient is pregnant or breastfeeding

Warnings and precautions

Before starting to take Axaltra, the patient should consult their doctor or pharmacist. Axaltra should not be taken with other medicines that prevent blood clotting, such as prasugrel or ticagrelor (except for medicines containing aspirin, clopidogrel or ticlopidine).

When to exercise special caution when taking Axaltra

‐ if the patient has increased risk of bleeding, in such conditions as:

• severe kidney disease, 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 gastroesophageal reflux disease (stomach acid flowing back into the esophagus), or tumors located in the stomach or intestines, or 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
• if the patient is over 75 years old
• if the patient weighs less than 60 kg
• coronary artery disease with severe symptomatic heart failure ‐ in patients with valve prostheses ‐ if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots) the patient should inform the doctor, who will decide on possible changes to the treatment.

If the patient suspects that they have the above conditions, they should inform their doctor

before taking Axaltra. The doctor will decide whether to use this medicine 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 Axaltra at a strictly defined time before or after surgery should be followed very carefully ‐ if catheterization or spinal puncture is planned during surgery (e.g. for epidural or spinal anesthesia or pain relief):

• it is very important to take Axaltra 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 numbness or weakness of the legs, bowel or bladder disorders occur after anesthesia.

Children and adolescents

Axaltra 2.5 mg tablets are not recommended for people 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

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

• certain medicines used to treat fungal infections (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 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, prasugrel and ticagrelor (see "Warnings and precautions"))
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin)
• 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 the patient suspects that they have the above conditions, they should inform their doctor

before taking Axaltra, as the effect of Axaltra may be enhanced. The doctor will decide whether to use this medicine 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 preventive treatment. ‐ If the patient is 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 the patient suspects that they have the above conditions, they should inform their doctor

before taking Axaltra, as the effect of Axaltra may be reduced if taken with the above medicines. The doctor will decide whether to use Axaltra and whether the patient should be subject to special observation.

Pregnancy and breastfeeding

Axaltra should not be taken if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use effective contraception while taking Axaltra. If the patient becomes pregnant while taking this medicine, they should inform their 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 the patient has previously been diagnosed with intolerance to some sugars, they should contact their 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 the doctor's instructions. In case of doubts, the doctor or pharmacist should be consulted.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Axaltra should be taken at approximately the same time every day (e.g. one tablet in the morning and one in the evening). The medicine 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 Axaltra. The tablet can be crushed and mixed with water or apple sauce just before taking. If necessary, the doctor may give the crushed Axaltra tablet through a gastric tube. Axaltra will not be given to the patient as the only medicine. The doctor will instruct the patient to take aspirin as well. If the patient is taking Axaltra after acute coronary syndrome, the doctor may also instruct them to take clopidogrel or ticlopidine. If the patient is taking Axaltra after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for the patient to take for a short time in addition to aspirin. The doctor will tell the patient what dose of the medicine to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel, or a standard daily dose of ticlopidine).

When to take Axaltra

Treatment with Axaltra after acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the latest 24 hours after hospitalization and when parenteral (by injection) anticoagulant treatment would normally be discontinued. The doctor will tell the patient when to start treatment with Axaltra if they have been diagnosed with coronary artery disease or peripheral artery disease. The doctor will decide how long to continue treatment.

Taking a higher dose of Axaltra than recommended

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

Missing a dose of Axaltra

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

Stopping Axaltra

Axaltra should be taken regularly and for the time prescribed by the doctor. The patient should not stop taking Axaltra without first consulting their doctor. If the patient stops taking this medicine, the risk of another heart attack, stroke or death due to heart or blood vessel disease may increase. In case of any further doubts about the use of the medicine, the doctor or pharmacist should be consulted.

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 be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). Not all of these will be obvious or visible signs of bleeding. The doctor should be informed immediately if any of the following side effects occur:

• 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. A serious medical emergency. 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 The doctor may decide to monitor the patient very closely or change the treatment.
• Signs of severe skin reactions‐ widespread, acute skin rash, blistering or changes on 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 (up to 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 pallor and be the cause of weakness or shortness of breath ‐ bleeding from the stomach or intestine, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding ‐ bleeding into the eye (including bleeding from the sclera)
‐ bleeding into tissues or body cavities (hematoma, bruising)
‐ blood in the 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 limbs
‐ limb pain
‐ kidney disorders (can be observed in tests performed by the doctor)
‐ fever
‐ stomach pain, nausea, feeling of nausea (nausea) or 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 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 disorders (can be observed in tests performed by the 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 the muscles
‐ cholestasis (bile stasis), hepatitis, including liver cell damage
‐ yellowing of the skin and eyes (jaundice)
‐ localized swelling
‐ blood collection (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 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 side effects occur, including those not listed in this leaflet, the doctor, pharmacist or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, more information can be gathered on the safety of the medicine.

5. How to store Axaltra

The medicine should be stored in a place that is out of sight and reach of children. This medicine should not be taken after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. 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 2.5 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 400, yellow iron oxide (E 172).

What Axaltra looks like and what the pack contains

Axaltra, 2.5 mg, film-coated tabletsare light yellow, round, biconvex tablets with the inscription "2.5" on one side and smooth on the other. The diameter of the tablet is approximately 8.6 mm ± 0.2 mm. They are available in blisters in cartons containing 10, 14, 28, 30, 56, 60, 98, 100, 168 or 196 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 filmtabletta Czech Republic Axaltra Croatia Cloter 2.5 mg, 10 mg, 15 mg, 20 mg film-coated tablets Poland Axaltra For more information about this medicine, please 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