Axaltra

Package leaflet: Information for the patient

Axaltra, 2.5 mg, film-coated tablets
Rivaroxaban
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• 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 personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Axaltra is and what it is used for
2. What you need to know 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

You have been prescribed Axaltra because:
‐ You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been confirmed.
Axaltra reduces the risk of subsequent heart attack or the risk of death due to heart or blood vessel disease in adults.
Axaltra will not be given to you as the only medication. Your doctor will also prescribe you to take:

• acetylsalicylic acid, or
• acetylsalicylic acid and clopidogrel or ticlopidine

or
‐ You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease causing symptoms.
Axaltra reduces in adults the risk of blood clots (atherosclerotic thrombotic events).
Axaltra will not be given to you as the only medication. Your doctor will also prescribe you to take acetylsalicylic acid.
In certain cases, if you are receiving Axaltra after a procedure to open a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken for a short time in addition to acetylsalicylic acid.
Axaltra contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

2. Important information before using 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 an organ that leads to an increased risk of
serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery
on the brain or eyes)
‐ if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran,
apixaban or heparin), except when switching anticoagulant therapy or if heparin
is administered to maintain the patency of a catheter in a vein or artery
‐ if the patient has been diagnosed with acute coronary syndrome and previously experienced
bleeding or blood clot in the brain (stroke)
‐ if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously experienced brain haemorrhage (stroke) or occlusion of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had an ischaemic non-lacunar stroke within the last month
‐ if the patient has a liver disease that leads to an increased risk of bleeding
‐ if the patient is pregnant or breastfeeding

Do not use Axaltra and inform your doctor if you suspect any of the above-mentioned circumstances apply to you.

Warnings and precautions
Before starting to take Axaltra, consult your doctor or pharmacist.
Axaltra should not be used together with other medicines that inhibit blood clotting such as
prasugrel or ticagrelor (exceptions are medicines containing acetylsalicylic acid, clopidogrel or
ticlopidine).

When to exercise special caution when using Axaltra
‐ if the patient has an increased risk of bleeding, such as in the following conditions:

• 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 switching anticoagulant therapy or when heparin is administered to maintain the patency of a catheter in a vein or artery (see section "Other medicines and Axaltra")
• blood clotting disorders
• very high blood pressure that does not decrease despite medication
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach or intestines, or in the genital or urinary system
• blood vessel disease of the posterior part of the eyeball (retinopathy)
• lung disease in which bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding
• 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 heart valve prostheses
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment needs to be changed.

If you suspect any of the above-mentioned conditions apply to you, inform your doctor
before taking Axaltra. The doctor will decide whether to use this medicine and whether the patient
requires particularly close monitoring.

If the patient needs to undergo surgery:
‐ strictly follow the doctor's instructions regarding the timing of taking Axaltra before or after surgery
‐ if catheterisation or spinal puncture (e.g. for epidural or intrathecal anaesthesia or pain relief) is planned during surgery:

• it is very important to take Axaltra before and after the puncture or removal of the catheter, as directed by the doctor
• due to the need for special caution, immediately inform the doctor if numbness or weakness of the legs, or disturbances in bowel or bladder function occur after the anaesthesia wears off.

Children and adolescents
Axaltra 2.5 mg tablets are not recommended for patients under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.

Other medicines and Axaltra
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription.

‐ If the patient is taking

• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin
• ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol)
• certain antibiotics used for bacterial infections (e.g. clarithromycin, erythromycin)
• certain antiviral medicines used for HIV infection or AIDS treatment (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 section "Warnings and precautions"))
• 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI))

If you suspect any of the above-mentioned conditions apply to you, inform your 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 requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, they may prescribe treatment to prevent ulcer formation.

‐ If the patient is taking

• certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital)
• St John's wort ( Hypericum perforatum ), a herbal remedy used for depression
• rifampicin, an antibiotic

If you suspect any of the above-mentioned conditions apply to you, inform your doctor
before taking Axaltra, as the effect of Axaltra may be reduced when taken together with the above-mentioned medicines. The doctor will decide whether to use Axaltra and whether the patient requires particularly close monitoring.

Pregnancy and breastfeeding
Do not use Axaltra if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use an effective method of contraception during treatment with 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 (common side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.

Axaltra contains lactose and sodium
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Axaltra

This medicine should always be taken as directed by the doctor. In case of doubt, consult the doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Axaltra should be taken at approximately the same time each day (for example, one tablet in the morning and one in the evening). This medicine may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, discuss alternative ways of taking Axaltra with the doctor. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, the doctor may administer crushed Axaltra tablets through a gastric tube.
Axaltra will not be given to the patient as the only medicine.
The doctor will prescribe acetylsalicylic acid to be taken by the patient. If the patient is receiving Axaltra after an acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine.
If the patient is receiving Axaltra after a procedure to restore blood flow in a narrowed or blocked artery of the lower limb, the doctor may also prescribe clopidogrel to be taken for a short period in addition to acetylsalicylic acid.
The doctor will inform the patient of the dose to take (usually 75–100 mg of acetylsalicylic acid per day, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg clopidogrel, or the standard daily dose of ticlopidine).
When to take Axaltra
Treatment with Axaltra after an acute coronary syndrome should be initiated as soon as possible after stabilization of the acute coronary syndrome, no earlier than 24 hours after hospital admission and at the time when parenteral (injected) anticoagulant treatment would normally be discontinued.
The doctor will inform the patient when to start treatment with Axaltra if coronary artery disease or peripheral arterial disease has been diagnosed.
The doctor will decide how long treatment should continue.
Taking more than the recommended dose of Axaltra
If the patient has taken more than the recommended dose of Axaltra, contact the doctor immediately. Taking too high a dose of Axaltra increases the risk of bleeding.
Missing a dose of Axaltra
Do not take a double dose to make up for a missed dose. If a dose is missed, the patient should take the next dose at the scheduled time.
Stopping Axaltra
Axaltra should be taken regularly and for the duration recommended by the doctor.
Do not stop taking Axaltra without first consulting the doctor. If treatment with this medicine is stopped, the risk of another heart attack, stroke, or death due to heart or blood vessel disease may increase.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Axaltra may cause adverse effects, although not everyone will experience them.
As with other medicines with a similar anticoagulant effect, Axaltra may cause bleeding, which could potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should contact your doctor immediately if you experience any of the following adverse effects:

• Signs of bleeding – bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness and neck stiffness. This is a serious medical emergency. Seek immediate medical help!). – prolonged or excessive bleeding – unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.
• Signs of severe skin reactions – widespread acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis) – drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), presenting with rash, fever, internal organ inflammation, hematological disorders and systemic involvement. The frequency of these adverse effects is very rare (occurring in up to 1 in 10,000 people).
• Signs of serious allergic reactions – swelling of the face, lips, oral cavity, tongue or throat; difficulty swallowing; urticaria and breathing difficulties; 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 adverse effects
Common (may occur in up to 1 in 10 people)
– reduction in red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath
– gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding
– bleeding into the eye (including conjunctival bleeding)
– bleeding into tissues or body cavities (hematoma, bruising)
– presence of blood in sputum (hemoptysis) during coughing
– skin bleeding or subcutaneous bleeding
– postoperative bleeding
– oozing of blood or fluid from a surgical wound
– limb swelling
– limb pain
– kidney function disorders (may be observed in tests performed by a doctor)
– fever
– stomach pain, indigestion, nausea or vomiting, constipation, diarrhea
– low blood pressure (symptoms may include dizziness or fainting upon standing)
– general loss of strength and energy (weakness, fatigue), headache, dizziness
– rash, skin itching
– increased activity of certain liver enzymes, which may be evident in blood test results

Uncommon (may occur in up to 1 in 100 people)
– bleeding into the brain or inside the skull (see signs of bleeding above)
– bleeding into a joint causing pain and swelling
– thrombocytopenia (low platelet count, blood cells involved in clotting)
– allergic reactions, including allergic skin reactions
– liver function disorders (may be observed in tests performed by a doctor)
– blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count
– fainting
– malaise
– rapid heartbeat
– dry mouth
– urticaria

Rare (may occur in 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)
– local swelling
– blood collection (hematoma) in the groin as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm)

Very rare (may occur in up to 1 in 10,000 people)
– accumulation of eosinophils, a type of granulocytic white blood cells, causing lung inflammation (eosinophilic pneumonia)

Frequency not known (frequency cannot be estimated from available data)
– kidney failure following severe bleeding
– bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy)
– increased pressure in the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding)

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Axaltra

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Axaltra contains
‐ The active substance is rivaroxaban. One coated tablet contains 2.5 mg of rivaroxaban.
‐ Other ingredients are:
tablet core: sodium lauryl sulfate, lactose, poloxamer 188, microcrystalline cellulose type 105, microcrystalline cellulose type 102, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica, see section 2 "Axaltra contains lactose and sodium"
tablet coating: hypromellose type 2910, titanium dioxide (E 171), macrogol 400, iron oxide yellow (E 172).

What Axaltra looks like and contents of the pack
Axaltra 2.5 mg, coated tablets are light yellow, round, biconvex tablets, with the inscription "2.5" embossed on one side and smooth on the other.
The tablet diameter is approximately 8.6 mm ± 0.2 mm.
Available in blister packs within cardboard boxes containing 10, 14, 28, 30, 56, 60, 98, 100, 168 or 196 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation 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]