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Sana^[1] University Hospital, Cardiology

Specific adverse reactions to Xarelto?

Xarelto (rivaroxaban) is a direct inhibitor of factor Xa.^[1] The safety profile is determined by bleeding events; the rows below are verbatim from the SmPC, Table 3.^[2]

Adverse reactions: Xarelto 20 mg

SmPC section 4.8, Table 3

⌄

Common≥ 1/100 to < 1/10

Anaemia (incl. respective laboratory parameters); Dizziness, headache; Epistaxis, haemoptysis; Gingival bleeding, gastrointestinal tract haemorrhage (incl. rectal haemorrhage); Hypotension, haematoma

Uncommon≥ 1/1,000 to < 1/100

Thrombocytosis (incl. platelet count increased)^A, thrombocytopenia; Allergic reaction, dermatitis allergic; angioedema and allergic oedema; Cerebral and intracranial haemorrhage, syncope

Rare≥ 1/10,000 to < 1/1,000

Jaundice, cholestasis

^A observed in prevention of VTE in adult patients undergoing elective hip or knee replacement surgery (Table 3, note A)

Xarelto 20 mg, SmPC section 4.8, Table 3. Source: EMA / BDA

Sources2

[1]Xarelto SmPC section 5.1 Pharmacodynamic properties (EMA / BDA)

[2]Xarelto SmPC section 4.8, Table 3 (EMA / BDA)

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Xarelto 20 mg

Rivaroxaban, film-coated tablets

ATCB01AF01antithrombotic agents MAHBayer AGGermany

SmPC (PDF)Package leaflet (PDF)

UseSafetyInteractionsPharmacologyReimbursementRegistersSmPC

Therapeutic indicationsSmPC §4.1

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Route of administration

Oral, film-coated tablets

Posology and method of administrationSmPC §4.2

Renal impairmentDosing by GFR

SmPC section 4.2 contains a separate dosing schedule in renal impairment; the source states creatinine clearance as the determining parameter.

ContraindicationsSmPC §4.3

Active clinically significant bleeding. Pregnancy and breast-feeding (see section 4.6).

Special warnings and precautions for useSmPC §4.4

In adult patients with severe renal impairment (creatinine clearance < 30 ml/min) rivaroxaban plasma levels may be significantly increased (1.6 fold on average).

Fertility, pregnancy and lactationSmPC §4.6

Pregnancy and lactationContraindicated

Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that rivaroxaban passes the placenta, Xarelto is contraindicated during pregnancy.

Effects on ability to drive and use machinesSmPC §4.7

Undesirable effectsSmPC §4.8

OverdoseSmPC §4.9

Interactions

Active substance or medicinal product

Rivaroxaban1 Amiodarone1

2 of 20 substancesClear all

ListMatrix 1 interaction

Food and alcohol1

Moderate clinical significance1

Rivaroxaban×Amiodarone Increased plasma exposure to rivaroxaban

EffectANSM

Increased plasma exposure to rivaroxaban; the clinical significance increases in renal impairment.

MechanismCerner Multum

Amiodarone inhibits CYP3A4 and P-glycoprotein, the two main elimination pathways of rivaroxaban.

Severity per: ANSM, Cerner Multum

eGFR (CKD-EPI 2021)

CKD-EPI 2021 Creatinine Equation

Save

Serum creatinine

118µmol/L ⌄

Age

Sex

MaleFemale

eGFR

42mL/min/1.73 m²

CKD stage G3bModerately to severely decreased

CKD stages

G1 ≥ 90G2 60–89G3a 45–59G3b 30–44G4 15–29G5 < 15

Source: KDIGO 2021 Clinical Practice Guideline

Related to the case

Xarelto SmPC section 4.2 states creatinine clearance (mL/min), not eGFR, as the parameter on which the dosing schedule is built. At 68 kg and this value the creatinine clearance is about 40 mL/min. The source contains a separate regimen for clearance 15–49 mL/min.

Xarelto SmPC section 4.2. Source: EMA / BDA

Sana^[1]

Specific adverse reactions to Xarelto?

Xarelto (rivaroxaban) is a direct factor Xa inhibitor.^[1] The safety profile is determined by bleeding events.^[2]

Adverse reactions: Xarelto 20 mg SmPC section 4.8, Table 3

Sources [1]Xarelto SmPC section 5.1 (EMA / BDA) [2]Xarelto SmPC section 4.8, Table 3 (EMA / BDA)

Xarelto 20 mg

Rivaroxaban, film-coated tablets

ATCB01AF01 MAHBayer AG

UseSafetyInteractions

Fertility, pregnancy and lactationSmPC sections 4.3, 4.6

Pregnancy and lactationContraindicated

Rivaroxaban Amiodarone

2 of 20 substances

Moderate clinical significance

Rivaroxaban × Amiodarone

Amiodarone inhibits CYP3A4 and P-glycoprotein, the two main elimination pathways of rivaroxaban.

Severity per: ANSM, Cerner Multum

eGFR (CKD-EPI 2021)

Serum creatinine118 µmol/L Age74 SexFemale

eGFR 42mL/min/1.73 m² CKD stage G3bModerately to severely decreased

Source: KDIGO 2021 Clinical Practice Guideline

Answers from verified sources

NCPRMP
NHIF
SESPA
MH
TGA
Cerner Multum
EAN
EHA
ERS
KDIGO
Bulgarian professional societies

NCPRMP
NHIF
SESPA
MH
TGA
Cerner Multum
EAN
EHA
ERS
KDIGO
Bulgarian professional societies

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Every source is official; nothing is entered by hand.

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Summary of Product Characteristics harmonised document, EMA / BDA
new version

section 4.1
Indications

section 4.2
Posology and method of administration
updated

section 4.3
Contraindications

section 4.8
Undesirable effects
updated

The old version is replaced by the current one.
03
Current data from the NHIF and the clinical guidelines.

The Positive Drug List is kept current, and reimbursement levels come from the database on every lookup. The newest edition of each clinical guideline is used.

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Clinical guidelinesnew edition

Atrial fibrillationEuropean Society of Cardiology

previous edition ESC 2024

Enters the corpus and is cited with the new edition, including the CHA₂DS₂-VA score.
04
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The institution’s internal protocols follow the same path and remain visible only to its members. The assistant cites them on a par with national standards, on the most recent update of the sources.

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Internal protocol Anticoagulation

National standard ESC 2023

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At the counter

metformin 850

Metformin 850 mg film-coated tablets

Posology SmPC, §4.2

Interactions Alert: SmPC, §4.5

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Answer

Concomitant use is stated to be contraindicated [1]

Sources

[1] ESC 2023: Acute coronary syndromesGuideline

[2] Simvastatin SmPC§4.5 Interactions

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Regulatory status

Marketing authorisation Active

Positive Drug List Included

Checked: 15 August 2026

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Active

New

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In practice

Is it contraindicated in severe renal failure?

The SmPC states severe renal failure as a contraindication. [1]

[1]SmPC, §4.3 Contraindications

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A clinical question in plain Bulgarian. The answer is synthesised only from the approved literature, and every statement carries a direct citation to the corresponding paragraph.

Simvastatin and clarithromycin together: what do the sources state?

The SmPC states concomitant use of simvastatin and clarithromycin to be contraindicated [1,2,3].

Mechanism, as described in the source. Clarithromycin is a potent inhibitor of the CYP3A4 enzyme [4]. Simvastatin is metabolised by the same enzyme, which leads to a many-fold increase in its plasma concentrations [5].

What the sources state

Simvastatin SmPC section 4.3 lists concomitant use with clarithromycin among the contraindications [3,4].
SmPC section 4.5 mentions statins that are not metabolised via CYP3A4, for example fluvastatin [5].
SmPC section 4.4 describes muscle symptoms and increased creatine phosphokinase among the special warnings [2,6].

Interaction: Clarithromycin + Simvastatin

Major clinical significance, 1 entry

⌄

Sources 6

[1]simvastatin + clarithromycinInteraction: major clinical significance (ANSM and Cerner Multum)

[2]SmPC: Simvastatin AL2 sections

[3]SmPC: Simvastatinsection 4.3 Contraindications

[4]Simvastatin SmPCsection 4.5 Interactions

[5]SmPC Lekoklarsection 4.5 Interaction with other medicinal products

[6]SmPC Lekoklarsection 4.4 Special warnings

Simvastatin and clarithromycin together: what do the sources state?

The SmPC states concomitant use of simvastatin and clarithromycin to be contraindicated [1]

[1]SmPC: Simvastatinsection 4.3 Contraindications

Single medicines register: all authorised products with SmPC, prices and reimbursement down to package level.

Xarelto 20 mg Rxrenal adjustment

Rivaroxaban, film-coated tablet

ATC B01AF01Form film-coated tabletMAH Bayer AG

UseSafetyInteractionsPharmacologyReimbursementRegistersSmPC

Therapeutic indicationsSmPC section 4.1

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.

Expand the full section

Posology and method of administrationSmPC section 4.2

Renal impairmentSmPC section 4.2

Route of administration: oral, film-coated tablet.

The source contains the dosing regimen by indication, the method of administration and the duration of treatment. The section is accessible directly, with the exact text of the source.

Expand the full section

Adjustment in renal impairmentSmPC section 4.2

CrCl 15–49 mL/min SmPC section 4.2 contains a separate regimen for CrCl 15–49 mL/min.

Where this screen comes from

Block	Source	Status
Therapeutic indications	SmPC section 4.1	digitised
Posology and method of administration	SmPC section 4.2	digitised
Renal adjustment	SmPC section 4.2	separate regimen

Xarelto 20 mg

Rivaroxaban, film-coated tablet

Rxrenal adjustment

Therapeutic indicationsSmPC section 4.1

Prevention of stroke and systemic embolism in non-valvular atrial fibrillation.

CrCl 15–49 mL/minSmPC section 4.2 contains a separate schedule.

Interaction analysis: up to 20 substances at once, with three severity levels and a separate section for the unclassified.

Interactions

Active substance or medicinal product

Simvastatin 1 Clarithromycin 2 Rivaroxaban 2 Amiodarone 1 Paracetamol 0

5 of 20 substances Clear all

ListMatrix3 interactions

Major clinical significance 1⌄

Simvastatin × Clarithromycin Concomitant use is contraindicated: increased risk of rhabdomyolysis-type adverse reactions due to reduced metabolism.

Moderate clinical significance 2⌄

Rivaroxaban × Amiodarone Increased rivaroxaban exposure due to inhibition of its metabolism and transport.

Rivaroxaban × Clarithromycin Increased plasma concentrations of rivaroxaban due to inhibition of its metabolism and transport.

Unclassified 0 a mechanism is described, but no curated source has assigned a severity

Interactions

Simvastatin 1Clarithromycin 2

Major clinical significance 1

Simvastatin × Clarithromycin

Concomitant use is contraindicated: increased risk of rhabdomyolysis-type adverse reactions.

Moderate clinical significance 2

89 clinical calculators and clinical scores in 14 specialities, each with its formula and the cited primary source.

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Saved 6 Nephrology 8All 89 Emergency medicine 20Cardiology 11

Calculated in the browser. It does not read medicines data and does not store patient data.

eGFR (CKD-EPI 2021)

Serum creatinine118 µmol/L

Age74

SexFemale

42mL/min/1.73 m² CKD G3bModerately to severely decreased

Source: KDIGO 2021 Clinical Practice Guideline

Therapeutic guidelines and ordinances: integrated national and international standards, including ESC, ADA, WHO, IDSA, BAM, BDD.

Guidelines

Guidelines and consensus documents

ESCESC 2023: Acute coronary syndromes Cardiology2023

ADAADA 2025: Standards of Care in Diabetes Endocrinology2025

WHOWHO AWaRe 2022: Classification of antibiotics Infectious diseases2022

BAMBAM: Empirical antibiotic therapy in outpatient care Infectious diseases2022

IDSAIDSA 2019: Asymptomatic bacteriuria Infectious diseases2019

BDDTreatment of psoriasis with biological medicines Dermatology2013

European and Bulgarian professional society guidelines, with a reader and access to the original PDF.

Guidelines

ESCESC 2023: Acute coronary syndromes

ADAADA 2025: Standards of Care in Diabetes

WHOWHO AWaRe 2022: Classification of antibiotics

European and Bulgarian professional society guidelines, with access to the original PDF.

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“Sveta Marina” University Hospital

Hospital, 48 of 60 seats

Invite staff

Paste emails separated by a new line, comma or space…

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Members (3)

Dr E. PetrovaAdmin

Dr N. Stoyanov

Pharm. R. Iliev

Invitations (1)

Dr A. TodorovaInvitation, pending confirmation

Organisation documents

▤ Anticoagulation protocol.md

▤ Internal antibiotic rules.pdf

Only members see them; “Ask” cites them on a par with the other sources.

“Sveta Marina” University Hospital

Hospital, 48 of 60 seats

Members (3)

Dr E. PetrovaAdmin

Dr N. Stoyanov

Pharm. R. Iliev

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Patient on metformin, eGFR 42, due for an investigation with a contrast agent: what do the sources state?

Manual ~6:00

SmPC of metformin
SmPC of the contrast agent
Reimbursement ordinance
PDL table
National therapeutic guideline
Internal hospital protocol

6 sources, opened by hand

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Answer with citation
The source states a separate regimen in reduced renal function.^[1]
Reimbursement status
The reimbursement status comes from the database, with the date of the lookup.^[2]
Interaction with the contrast agent
The source states monitoring of renal function.^[3]
Tools
eGFR 42 mL/min, calculated with the calculator in a separate step.

One session in the platform

The intelligent clinical assistant.

Answers from verified sources

All medical facts in one place.

Every source is official; nothing is entered by hand.

A new SmPC version replaces the previous one by section.

Current data from the NHIF and the clinical guidelines.

Your protocols, in the same flow. Ready before the first ward round.

Traceability behind every answer.

Declines rather than assumes

Numbers do not pass through the model

Closed check on safety

Solutions for institutions

Standardisation and internal protocols.

Medicines information one search from the counter.

Access for an entire cohort and traceable sources.

A single reference environment for medical departments.

A single channel to the organisation’s guidelines.

The full reference in everyday practice.

A single environment for clinical reference

From the clinical question to the calculation of the exact dose. All the tools you need for a safe therapeutic decision.

A clinical question in plain Bulgarian. The answer is synthesised only from the approved literature, and every statement carries a direct citation to the corresponding paragraph.

Skip the search. Not the check.

The intelligent
clinical assistant.