Medicinal Products

DIFICLIR 200 mg

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
active ingredients: Fidaxomicin
laboratory: Astellas Pharma Europe BV

Coated tablet
Box of 2 Pre-cut plates of 10
All forms

Indication

DIFICLIR is indicated in adults for the treatment of Clostridium difficile infections (CDI), also known as C. difficile- associated diarrhea (CDAD) (see section 5.1).

Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage DIFICLIR 200 mg Film-coated tablet Box of 2 Pre-cut plates of 10

Dosage

Adults and seniors (≥ 65 years old)

The recommended dose is 200 mg (one tablet) twice daily (once every 12 hours) for 10 days.

Pediatric population

The safety and effectiveness of fidaxomicin in children under 18 years of age have not been established. No data available.

Renal failure

No dosage adjustment is deemed necessary. Due to limited clinical data in this population, DIFICLIR should be used with caution in patients with severe renal impairment (see sections Warnings and Precautions and Pharmacokinetic Properties ).

Hepatic insufficiency

No dosage adjustment is deemed necessary. Due to limited clinical data in this population, DIFICLIR should be used with caution in patients with moderate to severe hepatic impairment (see sections Warnings and Precautions and Pharmacokinetic Properties ).

Administration mode

DIFICLIR is administered orally.

DIFICLIR can be taken during or after meals.

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Side effects Dificlir

Summary of the job security profile

The safety profile of DIFICLIR is based on data from 564 patients with DCI treated with fidaxomicin in phase III studies.

The most common treatment-related adverse events were vomiting (1.2%), nausea (2.7%) and constipation (1.2%).

Summary of adverse effects

Table 1 presents the adverse effects associated with fidaxomicin given twice daily in the treatment of C. difficile infection, reported in at least 2 patients; adverse effects are presented by class of organ systems.

The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥1 / 1000, <1/100), rare (≥ 1) / 10, 000, <1/1000), very rare (<1 / 10, 000), not known (can not be estimated based on available data). Within each frequency group, adverse effects are presented in descending order of severity.

Table 1: Summary of Adverse Reactions by MedDRA System Organ Class

MedDRA Organ System Class

frequent

Uncommon

Not known frequency

MedDRA Organ System Class

frequent

Uncommon

Not known frequency

Immune system disorders

rash, pruritus

hypersensitivity reactions (angioedema, dyspnea)

Disorders of

metabolism and nutrition

decreased appetite

Nervous system disorders

dizziness, headache,

dysgeusia

Gastrointestinal disorders

vomiting,

nausea, constipation

abdominal meteorism,

flatulence, dry mouth

affections

Hepatobiliary

elevation of alanine aminotransferase

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions through the national reporting system - see Annex V

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