Xiltess 20 mg. 28 tablets

1. What Xyltes is and what it is used for

Xyltes film-coated tablets contain the active substance rivaroxaban.

Xyltes 15 mg and 20 mg film-coated tablets are used in adults for:

preventing clots from forming in the brain (stroke) and in other blood vessels in your body if you have a type of heart arrhythmia called non-valvular atrial fibrillation. treating 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 forming again in the blood vessels of your legs and/or lungs.

Xyltes 15 mg and 20 mg film-coated tablets are used in children and adolescents under 18 years of age and with a body weight of 30 kg or more:

treating blood clots and preventing blood clots from forming again in the veins or blood vessels of the lungs after an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Xyltes belongs to a group of medicines called antithrombotic agents. Through its action, it blocks a blood clotting factor (factor Xa) and thus reduces the blood's tendency to form clots.

2. What you need to know before you take Xyltes

Do not take Xyltes

if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6);

if you have heavy bleeding;

if you have a disease or organ condition that increases the risk of serious bleeding (eg stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery);

if you are taking medicines to prevent blood clots (eg warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while receiving heparin through a venous or arterial catheter to keep it open;

if you suffer from liver disease which leads to an increased risk of bleeding;

if you are pregnant or breastfeeding.

Do not take Xilgges and tell your doctor if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Xyltes.

Take special care when using Xyltes

if you have an increased risk of bleeding, which may be the case, for example, with:

severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, because your kidney function may affect how much of the medicine works in your body;

if you are taking other medicines to prevent blood clots (eg warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or while receiving heparin through a venous or arterial catheter to keep it open (see section 'Other medicines and Xyltes' ");

disorders related to bleeding;

very high blood pressure not controlled by medication;

diseases of the stomach or intestines or inflammation of the esophagus due to e.g. inflammation of the intestine or stomach or inflammation of the esophagus due to e.g. of gastroesophageal reflux disease (a disease in which stomach acid goes up into the esophagus), or tumors located in the stomach or intestines, or the genital tract, or the urinary tract;

a problem with the blood vessels at the bottom of the eye (retinopathy);

lung disease where your bronchi are enlarged and filled with pus (bronchiectasis) or bleeding from the lung in the past.

if you have a prosthetic heart valve;

if you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor, who will decide whether you need to change your treatment;

if your doctor finds that your blood pressure is unstable, or another treatment or surgical procedure is planned to remove a clot from your lungs.

If any of these conditions apply to you, talk to your doctor before taking

Xyltes. Your doctor will decide whether to treat you with this medicine and whether you should be monitored more closely.

If you are about to have surgery

It is very important that you take Xyltes before and after surgery exactly at the time specified by your doctor.

If the surgery involves inserting a catheter or injection into the spine (eg for epidural or spinal anesthesia or to reduce pain):

 It is very important to take Xyltes before and after the injection or removal of the catheter, exactly when your doctor tells you;

 Tell your doctor straight away if you experience numbness or weakness in your legs, or bowel or bladder problems, after the anesthetic wears off, as urgent care is needed.

Children and adolescents

Xyltes film-coated tablets are not recommended for children weighing less than 30 kg. There is insufficient information on the use of Xyltes in children and adolescents in the indications for adults.

Other medicines and Xyltes

You should tell your doctor or pharmacist,

If you are taking:

certain medicines for fungal infections (eg, fluconazole, itraconazole, voriconazole, posaconazole), unless they are for use on the skin only;

ketoconazole tablets (used to treat Cushing's syndrome - when the body produces excess corgisol);

certain medicines for bacterial infections (eg, clarithromycin, erythromycin);

certain antiviral medicines to treat HIV/AIDS (eg ritonavir);

other medicines to reduce blood clotting (eg enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol);

anti-inflammatory and pain-relieving drugs (eg, naproxen or acetylsalicylic acid);

dronedarone, a medicine to treat an irregular heart rhythm;

certain medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)).

If any of these circumstances apply to you, inform your doctor before taking Xyltes, as the effect of Xyltes may be increased. Your doctor will decide whether to treat you with this medicine and you should be monitored more closely.

If your doctor thinks you are at increased risk of developing stomach or intestinal ulcers, he/she may prescribe ulcer prophylaxis.

If you are taking:

certain medicines to treat epilepsy (phenytoin, carbamazepine, phenobarbital);

St. John's wort (Hypericum perforatum), a herbal product used for depression;

rifampicin, an antibiotic.

If any of these circumstances apply to you, inform your doctor before taking Xyltes, as the effect of Xyltes may be reduced. Your doctor will decide whether to treat you with Xyltes and whether you should be monitored further.

carefully.

Pregnancy and breastfeeding

Do not take Xyltes if you are pregnant or breast-feeding. If you are likely to become pregnant, use reliable contraception while taking Xyltes. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines

Xyltes may cause dizziness (a common side effect) or seizures (an uncommon side effect) (see section 4, 'Possible side effects'). Do not drive, ride a bicycle, or use any tools or machines if you have these symptoms.

Xyltes contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. essentially sodium free.

3. How to take Xyltes

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

You should take Xyltes 15 mg and 20 mg film-coated tablets with food.

Swallow the tablet(s) preferably with water.

If you find it difficult to swallow the tablet whole, ask your doctor about other ways to take Xyltes. The tablet can be crushed and mixed with water or applesauce immediately before taking it. You should take food immediately after this mixture.

If necessary, your doctor may give you a crushed film-coated tablet of Xyltes also through a stomach tube.

What dose to take Adults

To protect against blood clots in the brain (stroke) and other blood vessels in your body.

The recommended dose is one Xyltes 20 mg film-coated tablet once daily.

If you suffer from kidney problems, the dose can be reduced to one Xyltes 15 mg film-coated tablet once a day.

If you need a procedure to treat blocked blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to reduce the dose to one Xyltes 15 mg tablet once a day (or to one 10 mg tablet once daily if your kidneys are not working properly) in addition to an antithrombotic medicine such as clopidogrel.

To treat clots in the veins in your legs and clots in the blood vessels in your lungs and to prevent clots from forming again.

The recommended dose is one Xyltes film-coated tablet of 15 mg twice a day for the first 3 weeks. For treatment after the third week, the recommended dose is one Xyltes 20 mg film-coated tablet once daily.

After at least 6 months of treatment for clots, your doctor may decide to continue treatment with either one 10 mg tablet once a day or one 20 mg tablet once a day.

If you suffer from kidney problems and take one film-coated tablet of Xyltes 20 mg once a day, your doctor may decide to reduce the dose for treatment under the third week to one film-coated tablet of Xyltes 15 mg once a day if the risk of bleeding is greater. - high risk of re-clotting

Children and adolescents

The dose of Xyltes depends on body weight and will be calculated by the doctor:

The recommended dose in children and adolescents weighing between 30 kg and less than 50 kg is one Xyltes film-coated tablet

If you spit out the dose or vomit

less than 30 minutes after taking Xyltes, take another dose.

more than 30 minutes after taking Xyltes, do not take another dose. In this case, take the next dose of Xyltes at the usual time.

Contact the doctor if you frequently spit up the dose or vomit after taking Xyltes.

When to take Xyltes

Take the tablet(s) every day when your doctor tells you to stop. Try to take the tablet(s) at the same time each day to help you remember.

Your doctor will decide how long the treatment should last.

To prevent blood clots from forming in the brain (stroke) and other blood vessels in your body:

If your heart needs to be restored to normal by a procedure called cardioversion, take Xyltes film-coated tablet at the time your doctor tells you.

If you have taken more than the required dose of Ksnltes

Contact your doctor immediately if you have taken more Xyltes film-coated tablets. Taking more Xyltes tablets than necessary increases the risk of bleeding.

If you forget to take Xnltes

Adults, children and adolescents:

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 one day to make up for a missed dose. Take the next tablet on the following day, then continue taking one tablet once a day.

Adults:

If you are taking 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 one day. If you miss a dose, you can take two 15 mg tablets at the same time to make the total dose two tablets (30 mg) in one day. The next day you should continue to take one 15 mg tablet twice a day.

If you have taken more than the required dose of Xyltes

Do not stop taking Xyltes without consulting your doctor, because Xyltes treats and protects against some serious diseases.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Like other similar blood thinners, Xyltes can cause bleeding that is potentially life-threatening. Very heavy bleeding can also cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be visible.

Tell your doctor immediately if you or your child develop any of the following side effects:

Signs of bleeding

bleeding in the brain or skull (symptoms may include headache, one-sided weakness, vomiting, convulsions, decreased level of consciousness and neck stiffness.

Serious medical emergency. Seek medical attention immediately!);

prolonged or very heavy bleeding;

unusual weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris.

Your doctor may decide to monitor you more closely or change your treatment.

Signs of severe skin reactions

spreading intense skin rash, blisters or mucosal ulcers, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis);

a drug reaction that causes rash, fever, inflammation of internal organs, abnormal blood counts and systemic illness (DRESS syndrome).

The frequency of these side effects is "very rare" (up to 1 in 10,000 people).

Signs of severe 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 affect up to 1 in 10,000 people) and uncommon (angioedema and allergic oedema, may affect up to 1 in 100 people).

Summary list of possible side effects found in adults, children and adolescents:

Common (may affect up to 1 in 10 people):

a decrease in the number of red blood cells, which can cause the skin to become pale and cause weakness or shortness of breath

bleeding in the stomach or intestines, bleeding from the genitourinary organs (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums bleeding in the eye (including bleeding from the whites of the eyes) bleeding in a tissue or body cavity (blood clots , bruises) bloody sputum

bleeding from the skin or bleeding under the skin after surgery

bleeding of blood or fluids from a surgical wound swelling of the limbs pain in the limbs

impaired kidney function (can be seen in tests done by your doctor)

fever

stomach pains, disturbed heart

Uncommon (may affect up to 1 in 100 people):

bleeding in the brain or skull (see above, signs of bleeding) bleeding in a joint causing pain and swelling

thrombocytopenia (low number of platelets, these are cells that help blood clot)

allergic reactions, including skin allergic reactions

impaired liver function (can be detected if your doctor orders tests)

blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or platelet count

diminution

general malaise

rapid heart rate

dry mouth

hives

Rare (may affect up to 1 in 1,000 people):

bleeding into a muscle

cholestasis (reduced bile secretion), hepatitis including hepatocellular injury (inflamed liver, including liver injury) yellowing of the skin and eyes (jaundice) localized edema

a collection of blood (hematoma) in the groin after a complication of a heart procedure where a catheter is placed in an artery in your leg (pseudoaneurysm)

Very rare (may affect up to 1 in 10,000 people)

build-up of eosinophils, a type of white granulocyte blood cell that causes inflammation in the lungs (eosinophilic pneumonia)

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, resulting in the kidneys not being able to work properly (anticoagulant nephropathy) increased tension in the muscles of the legs or arms after bleeding, resulting in pain, swelling, altered sensitivity, numbness or paralysis (compartment syndrome after bleeding)

Adverse reactions in children and adolescents:

In general, side effects seen in children and adolescents treated with Xyltes were similar in type to those seen in adults and were mostly mild to moderate in severity.

Adverse reactions that have been observed more often in children and adolescents:

Very common (may affect more than 1 in 10 people):

headache

elevated temperature

nosebleeds

vomiting

Common (may affect up to 1 in 10 people):

rapid heartbeat

blood tests may show an increase in bilirubin (bile pigment) thrombocytopenia (low number of platelets, which are cells that help the blood to clot)

heavy menstrual bleeding

Uncommon (may affect up to 1 in 100 people):

blood tests may show an increase in one subtype of bilirubin (direct bilirubin, bile pigment)

5. How to store Xyltes

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date corresponds to the last day of the specified month. Store in original packaging to protect from moisture.

This medicine does not require special temperature storage conditions.

Crushed tablets

Crushed tablets are stable in water and applesauce for up to 4 hours.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Xyltes contains

The active substance is rivaroxaban. Each film-coated tablet contains 15 mg or 20 mg of rivaroxaban.

The other ingredients are:

Tablet core: microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, silicon dioxide, colloidal anhydrous.

Film coating of the tablet: hypromellose 3 cPs (E464), macrogol 3350 (E1521), talc (E553b), titanium dioxide (E 171), red iron oxide (E172).

What Xyltes looks like and contents of the pack

Xyltes 15 mg Film-coated tablets: round, biconvex, red-brown film-coated tablets, marked "E843" on one side and plain on the other side, approximately 8.1 mm in diameter.

Xyltes 20 film-coated tablets: round, biconvex, brown film-coated tablets, marked "E844" on one side and plain on the other side, with a diameter of approximately 9.1 mm.

Xyltes 15 mg film-coated tablets

28, 42, 98 or 100 film-coated tablets in OPA/A1/PVC//AI blisters packed in a cardboard box.

Xyltes 20 mg film-coated tablets

28, 98 or 100 film-coated tablets in OP A/A1/PVC//A1 blisters, packed in a cardboard box.

One blister contains 10 or 14 film-coated tablets, depending on the type of packaging.

Not all types of packaging can be marketed.