Xarelto 15 mg and 20 mg film-coated tablets (rivaroxaban) – atrial fibrillation, thrombosis and pulmonary embolism

Xarelto® film-coated tablets contain rivaroxaban, an oral anticoagulant that directly blocks blood clotting factor Xa and thus reduces the tendency of the blood to form clots. This page describes the 15 mg and 20 mg strengths (pack of 28 tablets).

In adults, Xarelto 15 mg and 20 mg is used to prevent stroke and clots in non-valvular atrial fibrillation and to treat deep vein thrombosis and pulmonary embolism and prevent them from recurring. The 2.5 mg and 10 mg strengths are also registered in Serbia; they have other indications and dosing – a separate leaflet applies to them.

What is Xarelto 15 mg and 20 mg (rivaroxaban) used for and how is it taken correctly?

Key facts about the medicine

What is Xarelto 15 mg and 20 mg used for?

According to the patient leaflet, Xarelto 15 mg and 20 mg is used in adults to:

• prevent stroke and clots in other blood vessels in an irregular heart rhythm called non-valvular atrial fibrillation;
• treat clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent them from recurring.

In children and adolescents under 18 years weighing 30 kg or more it is used to treat clots in the veins or lung vessels and prevent recurrence, after initial treatment with injectable anticoagulants for at least 5 days.

How is it used and dosed?

Xarelto is taken with a meal, swallowing the tablet, preferably with water. If you cannot swallow the whole tablet, it can be crushed and mixed with water or apple puree immediately before taking, after which food should be eaten straight away.

• For percutaneous coronary intervention (PCI) with a stent there is limited evidence for reducing the dose to 15 mg daily (10 mg if kidney function is poor) with antiplatelet therapy – the doctor’s decision.
• Take the tablet every day at about the same time; the duration of treatment is decided by the doctor.
• If you spit out the dose or vomit within 30 minutes, take a new dose; after 30 minutes do not take a new one.
• In children the tablet is not split; for smaller doses another form – granules for oral suspension – exists. Never adjust the dose yourself.

Special patient groups

• Kidney impairment: according to the SmPC, a lower dose may be needed at creatinine clearance 15–49 ml/min; use is not recommended at clearance < 15 ml/min.
• Liver disease: must not be taken with liver disease that increases the risk of bleeding (per the SmPC including Child-Pugh B and C cirrhosis).
• Children: tablets are not recommended in children weighing less than 30 kg; the dose depends on body weight and is checked regularly.
• Elderly and patients on several medicines: special caution because of bleeding risk.

Contraindications – when the medicine must not be used

Do not take Xarelto:

• if you are allergic to rivaroxaban or the excipients;
• if you are bleeding heavily;
• if you have a disease or condition of an organ that increases the risk of serious bleeding (stomach ulcer, brain injury or bleeding, recent brain or eye surgery);
• if you use other anticoagulants (warfarin, dabigatran, apixaban, heparin), except when changing treatment or heparin to keep a catheter open;
• if you have liver disease that increases the risk of bleeding;
• if you are pregnant or breastfeeding.

Precautions and warnings

• severe kidney disease (in children – moderate or severe);
• bleeding disorders; very high blood pressure not controlled by medicines;
• diseases of the stomach, intestine or oesophagus that may bleed (inflammation, reflux, tumours);
• retinopathy; bronchiectasis or previous bleeding from the lungs;
• artificial heart valve; antiphospholipid syndrome;
• unstable blood pressure or planned surgical removal of a lung clot.

Operations and spinal/epidural anaesthesia: the medicine is taken exactly at the time set by the doctor before and after the procedure; if after anaesthesia you feel numbness or weakness in the legs or bowel/bladder problems, contact a doctor immediately. The medicine contains lactose.

Interactions with other medicines, alcohol and food

The effect of Xarelto (and the risk of bleeding) may be increased by: some antifungals (fluconazole, itraconazole, voriconazole, posaconazole – except on the skin), ketoconazole tablets, erythromycin, clarithromycin, ritonavir, other medicines that reduce clotting (enoxaparin, clopidogrel, warfarin, acenocoumarol), pain and anti-inflammatory medicines (naproxen, acetylsalicylic acid), dronedarone and SSRI and SNRI antidepressants.

The effect may be reduced by: phenytoin, carbamazepine, phenobarbital, St John’s wort and rifampicin. The doctor decides on treatment and any special monitoring; if there is an increased ulcer risk, stomach protection may be prescribed.

Pregnancy and breastfeeding

Do not take Xarelto if you are pregnant or breastfeeding. If you could become pregnant, use reliable contraception; if you become pregnant during treatment, tell your doctor immediately.

Driving and using machines

Xarelto may cause dizziness (common) or fainting (uncommon). If these symptoms occur, do not drive, ride a bicycle, use tools or operate machines.

Possible side effects

Contact a doctor immediately in case of signs of bleeding – bleeding in the brain (headache, weakness of one side of the body, vomiting, seizures, reduced consciousness, stiff neck – urgent!), prolonged or heavy bleeding, unusual weakness, pallor, dizziness, unexplained swelling, breathlessness, chest pain – and in case of severe skin (Stevens-Johnson, DRESS) or allergic reactions (swelling of the face, tongue, throat, hives, difficulty breathing).

In children, headache, fever, nosebleeds, vomiting, fast heartbeat and heavy menstrual bleeding were more common.

Overdose, missed dose and stopping treatment

• Too many tablets: contact a doctor immediately – taking too much increases the risk of bleeding.
• Missed dose (once daily 15 or 20 mg): take it as soon as you remember, but not more than one tablet in one day; continue as scheduled the next day.
• Missed dose (15 mg twice daily): take it as soon as you remember; no more than two 15 mg tablets in one day – if needed, two tablets may be taken at once to reach a total of 30 mg that day.
• Stopping: do not stop without agreement with your doctor – the medicine prevents a serious condition from developing.

Related information

• How to measure your pulse and why it matters in rhythm disorders – read the article: How to measure the pulse and why it is important to monitor heart beats.

For additional care and support with high blood pressure and heart conditions (regular blood pressure checks), see also the Blood pressure monitors category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Active substance: rivaroxaban – 15 mg or 20 mg per film-coated tablet.
• Core: microcrystalline cellulose; croscarmellose sodium; lactose monohydrate; hypromellose (2910); sodium laurilsulfate; magnesium stearate.
• Film coat: macrogol 3350; hypromellose (2910); titanium dioxide (E171); red iron oxide (E172).
• Appearance: 15 mg – red round tablets marked “BAYER” and a triangle with “15”; 20 mg – brownish-red round tablets marked “BAYER” and a triangle with “20”.
• Pack: PP/Al blisters, 2 × 14 film-coated tablets (28 tablets).
• Marketing authorisation holder: Bayer d.o.o. Belgrade, Omladinskih brigada 88b. Authorisations: 15 mg – 000456986 2023; 20 mg – 000456988 2023, both of 17 January 2024.

Storage

• Keep out of the sight and reach of children.
• No special storage conditions.
• Crushed tablets are stable in water or apple puree for up to 4 hours.
• Do not use after the expiry date; return unused medicine to a pharmacy.

Frequently asked questions

Is Xarelto taken with food?

Yes. According to the leaflet, Xarelto 15 mg and 20 mg must be taken with a meal. If the tablet is crushed and mixed with water or apple puree, food should be eaten immediately afterwards.

Why is 15 mg taken twice daily in the first 3 weeks?

In the treatment of deep vein thrombosis and pulmonary embolism the leaflet provides for a stronger initial phase: 15 mg twice daily for 3 weeks, then 20 mg once daily.

What if I forget a dose of Xarelto?

On a once-daily regimen take the missed tablet as soon as you remember, but not more than one tablet that day. On the 15 mg twice-daily regimen do not take more than two tablets (30 mg) in one day.

Can I take ibuprofen or aspirin with Xarelto?

Not without medical advice. Pain and anti-inflammatory medicines such as naproxen and acetylsalicylic acid increase the risk of bleeding with rivaroxaban.

Sources

• ALIMS – Patient Information Leaflet Xarelto 15 mg and 20 mg film-coated tablets (January 2024, in Serbian)
• ALIMS – Summary of Product Characteristics Xarelto 20 mg (in Serbian)
• ALIMS – Summary of Product Characteristics Xarelto 15 mg (in Serbian)

Sources checked on: 23 October 2026.