Xabanel 20 mg. 28 tablets

1. What Xabanel is and what it is used for
Xabanel contains the active substance rivaroxaban and is used in adults to:

prevent blood clots from forming in the brain (stroke) and in other blood vessels in your body if you have a type of heart rhythm disorder called non-valvular atrial fibrillation;
treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent them from re-forming in the blood vessels of your legs and/or lungs.
Xabanel belongs to a group of medicines called antithrombotic agents. It works by blocking a blood clotting factor (factor Xa), thereby reducing the blood's tendency to form clots.

2. What you need to know before you take Xabanel
Do not take Xabanel
if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6);
if you are bleeding excessively;
if you have a disease or condition of an organ in your body that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent surgery on the brain or eyes); if you are taking medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant treatment or while receiving heparin via a venous or arterial catheter to keep it open;
if you have a liver disease that leads to an increased risk of bleeding;
if you are pregnant or breastfeeding.
Do not take Xabanel and inform your doctor if any of these circumstances apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Xabanel.

Take special care with Xabanel
if you have an increased risk of bleeding, such as in the case of:
severe kidney disease, as your kidney function may affect the amount of the medicine that acts in your body;
if you are taking other medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin) when switching anticoagulant treatment or while receiving heparin via a venous or arterial catheter to keep it open (see section "Other medicines and Xabanel");
bleeding disorders;
very high blood pressure that is not controlled by medication; stomach or bowel disorders that may lead to bleeding, e.g., inflammation of the stomach or bowel, or inflammation of the oesophagus due to, for example, gastro-oesophageal reflux disease (a condition where stomach acid moves up into the oesophagus);
a problem with the blood vessels in the back of the eyes (retinopathy);
a lung disease where your bronchi are widened and filled with pus (bronchiectasis), or a history of bleeding from the lungs;
if you have a prosthetic heart valve.
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that causes an increased risk of blood clots), tell your doctor, who will decide whether your treatment needs to be changed.
if your doctor determines that your blood pressure is unstable, or if another treatment or a surgical procedure to remove a clot from your lungs is planned.
If any of these apply to you, talk to your doctor before taking Xabanel. Your doctor will decide whether to treat you with this medicine and whether you need to be monitored more closely.

If you are due to have surgery
It is very important to take rivaroxaban before and after the operation at the exact times specified by your doctor. If the procedure involves the placement of a catheter or an injection into the spine (e.g., for epidural or spinal anesthesia, or for pain relief):
It is very important to take rivaroxaban before and after the injection or catheter removal, exactly as instructed by your doctor.
Tell your doctor immediately if you experience numbness or weakness in your legs, or bowel or bladder problems after the anesthesia wears off, as urgent care is required.
Children and adolescents
Xabanel is not recommended for patients under 18 years of age. There is insufficient information regarding its use in children and adolescents.

Other medicines and Xabanel
You must tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including non-prescription medicines.

If you are taking
certain medicines for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are for topical use only;
ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol);
certain medicines for bacterial infections (e.g., clarithromycin, erythromycin);
certain antiviral medicines for HIV/AIDS (e.g., ritonavir);
other medicines to reduce blood clotting (e.g., enoxaparin, clopidogrel)
...or vitamin K antagonists, such as warfarin and acenocoumarol);
anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid);
dronedarone, a medicine for treating irregular heart rhythm;
certain medicines for treating depression (selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)).
If any of these apply to you, inform your doctor before taking Xabanel, as the effect of Xabanel may be increased. Your doctor will decide whether to treat you with this medicine and whether you need to be monitored more closely. If your doctor considers that you are at increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

If you are taking
certain medicines for treating epilepsy (phenytoin, carbamazepine, phenobarbital);
St. John’s wort (Hypericum perforatum), a herbal product used for depression;
rifampicin (an antibiotic).
If any of these apply to you, inform your doctor before taking Xabanel, as the effect of Xabanel may be reduced. Your doctor will decide whether to treat you with Xabanel and whether you need to be monitored more closely. Pregnancy, breastfeeding, and fertility
Do not take Xabanel if you are pregnant or breastfeeding. If there is a possibility that you could become pregnant, use a reliable contraceptive method while taking Xabanel. If you become pregnant while taking this medicine, inform your doctor immediately; they will decide how you should be treated.

Driving and using machines
Xabanel may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4 "Possible side effects"). Do not drive or use any machines if you experience these symptoms.

Xabanel contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, consult them before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Xabanel
Always take this medicine exactly as your doctor has told you. If you are unsure about anything, ask your doctor or pharmacist.

You must take Xabanel with food.
Swallow the tablet(s), preferably with water.

If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take Xabanel. The tablet may be crushed and mixed with water or applesauce immediately before taking it. You should eat food right after taking this mixture. If necessary, your doctor may also administer the crushed Xabanel tablet via a gastric tube.

Dose to be taken
To prevent clots in the brain (stroke) and other blood vessels in your body, the recommended dose is one 20 mg Xabanel tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Xabanel tablet once daily.
If you require a procedure to treat blocked blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting a dose reduction to one 15 mg Xabanel tablet once daily (or one 10 mg Xabanel tablet once daily if your kidneys are not functioning properly) in addition to an antiplatelet medicine such as clopidogrel.

To treat clots in the veins of your legs and clots in the blood vessels of your lungs, and to prevent clot recurrence, the recommended dose is one 15 mg Xabanel tablet twice daily for the first 3 weeks. For treatment after the third week, the recommended dose is one 20 mg Xabanel 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 Xabanel tablet once daily, your doctor may decide to reduce the dose for treatment after the third week to one 15 mg Xabanel tablet once daily, if the risk of bleeding is higher than the risk of recurrent blood clot formation.
When to take Xabanel
Take the tablet(s) every day until your doctor tells you to stop. Try to take the tablet(s) at the same time each day – this will help you remember.
Your doctor will decide how long you need to continue treatment.
To prevent blood clots in the brain (stroke) and other blood vessels in your body:
If your heart rhythm needs to be restored to normal via a procedure called cardioversion, take Xabanel at the time your doctor tells you to.
If you have taken more Xabanel than you should
Contact your doctor immediately if you have taken...
...more Xabanel tablets than necessary. Taking more Xabanel tablets than necessary increases the risk of bleeding.

If you miss a dose of Xabanel
If you take one 20 mg or 15 mg tablet once a day and miss a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a missed dose. Take the next tablet the following day and then continue taking one tablet once daily.
If you take one 15 mg tablet twice a day and miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you miss a dose, you may take two 15 mg tablets at the same time to make a total daily dose of two tablets (30 mg). On the following day, you should continue taking one 15 mg tablet twice daily.

If you stop taking Xabanel
Do not stop taking Xabanel without consulting your doctor, as Xabanel 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, Xabanel can cause side effects, although not everybody gets them. Like other similar medicines (antithrombotic agents), Xabanel may cause bleeding that is potentially life-threatening. Excessive bleeding can also lead to a sudden drop in blood pressure (shock). In some cases, the bleeding may not be visible.

Possible side effects that could be signs of bleeding: Inform your doctor immediately if you experience any of the following side effects:
prolonged or excessive bleeding;
unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina, which may be signs of bleeding. Your doctor may decide to monitor you more closely or change your treatment.
Possible side effects that could be signs of a severe skin reaction: Notify your doctor immediately if you experience skin reactions such as:
a spreading, intense skin rash, blisters, or sores on mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis). The frequency of this side effect is very rare (up to 1 in 10,000).
a drug reaction causing rash, fever, inflammation of internal organs, blood abnormalities, and systemic illness (DRESS syndrome). The frequency of this adverse reaction is very rare (up to 1 in 10,000).
Possible adverse reactions that may be signs of severe allergic reactions
Tell your doctor immediately if you experience any of the following adverse reactions:
swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing, hives, and difficulty breathing; sudden drop in blood pressure. The frequency of these adverse reactions is very rare (anaphylactic reactions, including anaphylactic shock, may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic swelling may affect up to 1 in 100 people).
Summary list of possible adverse reactions
Common (may affect up to 1 in 10 people):
decrease in the number of red blood cells, which can cause the skin to become pale and lead to weakness or shortness of breath;
bleeding in the stomach or intestines, bleeding from the genitourinary tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums;
bleeding in the eye (including bleeding in the white of the eye);
bleeding into tissue or a body cavity (bruising, hematomas);
coughing up blood;
bleeding from the skin or under the skin; bleeding after surgery; oozing of blood or fluid from a surgical wound;
swelling of the limbs; pain in the limbs;
impaired kidney function (may be seen in tests performed by your doctor);
high temperature;
stomach pain, indigestion, nausea or vomiting, constipation, diarrhoea;
low blood pressure (with symptoms such as feeling dizzy or faint upon standing up);
reduced overall strength and energy (weakness, fatigue), headache, dizziness;
rash, itching of the skin;
blood tests may show an increase in certain liver enzymes.
Uncommon (may affect up to 1 in 100 people):
bleeding in the brain or inside the skull; bleeding into a joint, causing pain and swelling;
thrombocytopenia (low platelet count; these are cells that help blood to clot);
allergic reactions, including allergic skin reactions;
impaired liver function (may be detected if your doctor orders tests);
blood tests may show an increase in bilirubin, certain pancreatic or liver enzymes, or platelet count;
feeling faint;
general malaise;
rapid heart rate;
dry mouth;
hives (urticaria). Rare (may affect up to 1 in 1,000 people):
bleeding into a muscle;
cholestasis (reduced
bile-related issues), hepatitis including hepatocellular injury (inflamed liver, including liver damage);
yellowing of the skin and eyes (jaundice);
localized swelling;
accumulation of blood (hematoma) in the groin following a complication from a heart procedure involving the insertion of a catheter into an artery in your leg (pseudoaneurysm).
Not known (frequency cannot be estimated from the available data):
kidney failure following severe bleeding;
increased pressure in the muscles of the legs or arms following bleeding, leading to pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding).
5. How to store Xabanel
Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP" and on each blister after "EXP". The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Xabanel contains
Active substance: rivaroxaban.
Each tablet contains 15 mg or 20 mg of rivaroxaban.

Other ingredients:
Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 "Xabanel contains lactose and sodium".
Film-coating: macrogol 3350, hypromellose 2910, titanium dioxide (E 171), iron oxide red (E 172). What Xabanel looks like and contents of the pack
Xabanel 15 mg film-coated tablets
Red, round, biconvex film-coated tablets, debossed with "15" on one side and plain on the other, with a diameter of approximately 6.1 mm. 14, 28, or 42 film-coated tablets packed in PVC/aluminium foil blisters. Packs containing 1, 2, or 3 blisters in a cardboard box together with a package leaflet.

Xabanel 20 mg film-coated tablets
Brown-red, round, biconvex film-coated tablets, debossed with "20" on one side and plain on the other, with a diameter of approximately 6.1 mm. 28 or 100 film-coated tablets packed in PVC/aluminium foil blisters. Packs containing 2 or 10 blisters in a cardboard box together with a package leaflet.

Not all pack sizes may be marketed.

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