Ibuduo

Hauptinformation

  • Handelsname:
  • Ibuduo 200 mg/30 mg Filmtabletten
  • Verschreibungstyp:
  • Arzneimittel zur Abgabe ohne aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Ibuduo 200 mg/30 mg Filmtabletten
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 137621
  • Berechtigungsdatum:
  • 12-05-2017
  • Letzte Änderung:
  • 13-06-2018

Öffentlichen Beurteilungsberichts

CMDh/223/2005

February 2014

Public Assessment Report

Scientific discussion

Ibuduo 200 mg/30 mg Filmtabletten

IBUPROFEN, PSEUDOEPHEDRINE

HYDROCHLORIDE

AT/H/0614/001/DC

Date: 16.04.2018

This module reflects the scientific discussion for the approval of Ibuduo 200 mg/30 mg.

The procedure was finalised at 05.04.2017. For information on changes after this date

please refer to the module ‘Update’.

I.

INTRODUCTION

Based on the review of the quality, safety and efficacy data, the Member States have granted a

marketing authorisation for

Ibuduo 200 mg/30 mg Filmtabletten

, from Orifarm Gnerics A/S.

The product is indicated for:

Symptomatic relief of nasal/sinus congestion with headache, fever and pain associated with common

cold. Ibuduo 200 mg/30 mg Filmtabletten

is indicated in adults and adolescents from the age of 15

years.

A comprehensive description of the indications and posology is given in the SmPC.

The marketing authorisation has been granted pursuant to 10 (1) Article of Directive

2001/83/EC.

Ibuduo 200 mg/30 mg is a medicine consisting of a combination of two active substances: ibuprofen

and pseudoephedrine.

Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors.

It has alpha and beta stimulant adrenergic stimulant activity and some stimulant effect on the central

nervous system.

The sympathomimetic effect of pseudoephedrine produces vasoconstriction which relieves nasal

congestion.

Ibuprofen is an anti-inflammatory analgesic and antipyretic drug belonging to the group of non-

steroidal anti-inflammatory drugs.

In humans it has been shown to be effective in reducing the symptoms (pain, fever and swelling)

associated with inflammation and influenza.

The therapeutic effects of the drug are the result of an inhibitory activity on the prostaglandin

synthesis.

II.

QUALITY ASPECTS

II.1

Introduction

Ibuduo 200 mg/30 mg

is a film-coated tablet which is presented in a

Aluminium/PVC/PVDC

blister pack.

II.2

Drug Substance

The active substances in

Ibuduo 200 mg/30 mg

ibuprofen and pseudoephedrine hydrochloride.

The specification of the active substances meets the current scientific requirements. The

adequate quality of the active substances has been shown by submitting the appropriate

control data. The stability of the active substances has been tested under ICH conditions. The

results of the stability studies support the established retest-period.

II.3

Medicinal Product

Ibuduo 200 mg/30

mg contains the following excipients:

Tablet core

Silica, colloidal anhydrous

Crosscarmellose sodium

Calcium hydrogen phosphate, anhydrous

Magnesium stearate

Maize starch

Cellulose, microcrystalline

Film-coating

Hypromellose

Macrogol 400

Talc

Titanium dioxide E171

Iron oxide yellow E172

The development of the product has been sufficiently made and deemed appropriate. The

usage of all the excipients has been described.

The release specification includes the check of all parameters relevant to this pharmaceutical

form. Appropriate data concerning the control of the finished product support the compliance

with the release specifications.

The packaging of the medicinal product complies with the current legal requirements.

Stability studies under ICH conditions have been performed and data presented support the

shelf life claimed in the SmPC, with a shelf life of 3 years when stored below 30°C and stored

in the original package to protect from light.

The pharmaceutical quality of

Ibuduo 200 mg/30 mg

has been adequately shown.

II.4

Discussion on chemical, pharmaceutical and biological aspects

Information on development, manufacture and control of active substance and medicinal

product has been presented in a satisfactory manner. The results of tests carried out indicate

satisfactory consistency and uniformity of important product quality characteristics.

III.

NON-CLINICAL ASPECTS

III.1

Introduction

Pharmacodynamic, pharmacokinetic and toxicological properties of Ibuduo 200 mg/30 mg are

well known. The applicant has not provided additional studies and further studies are not

required. Overview based on literature review is appropriate.

III.2

Ecotoxicity/environmental risk assessment (ERA)

Since Ibuduo 200 mg/30 mg is intended for generic substitution, this will not lead to an

increased exposure to the environment. An environmental risk assessment is therefore not

deemed necessary.

III.3

Discussion on the non-clinical aspects

non-clinical

overview

pre-clinical

pharmacology,

pharmacokinetics

toxicology is adequate

IV.

CLINICAL ASPECTS

Main study: 2014-3489

Open-label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover study in

healthy male and female subjects under fasting conditions.

Concentrations of (1S, 2S)-pseudoephedrine, (R)-ibuprofen and (S)-ibuprofen were measured from the

samples collected over a 24-hour interval after dosing in each period. Plasma concentrations were

measured by LC-MS/MS and LCMS/MS respectively.

Planned for inclusion: 66, completed: 63, included in safety data analysis: 66, included in PK-analysis:

Included in the statistical data analyses: 62 subjects for (1S, 2S)-pseudoephedrine; 61 subjects for (S)-

ibuprofen and 63 subjects for (R)-ibuprofen.

Table 1.

Pharmacokinetic

parameters

(non-transformed

values;

arithmetic

mean ± SD, t

max

median, range)

Treatment

AUC

0-t

xg/ml/h

AUC

0-∞

xg/ml/h

C

max

xg/ml

t

max

h

Test

1347.76

143.47

1.50 (0.50-3.00)

Reference

1394.29

145.67

1.50 (0.75-3.00)

*Ratio (90% CI)

96.47 (93.57-99.46)

97.92 (95.36-

100.54)

AUC

0-t

Area under the plasma concentration curve from administration to last observed

concentration at time t.

0-72h

be reported instead of AUC

, in studies with sampling period of

72 h, and where the concentration

at 72 h is quantifiable. Only for immediate release products

AUC

0-∞

Area under the plasma concentration curve extrapolated to infinite time.

0-∞

does not need to be reported when

0-72h

is reported instead of

C

max

Maximum plasma concentration

t

max

Time until Cmax is reached

*ln-transformed values

Table 2.Plasma (S)-ibuprofen Levels

Pharmacokinetic parameters (non-transformed values; arithmetic mean ± SD, t

max

median, range)

Treatment

AUC

0-t

µg/ml/h

AUC

0-∞

µg/ml/h

C

max

µg/ml

t

max

h

Test

42.0738

8.7495

2.00 (0.50-6.00)

Reference

42.8172

9.9784

1.50 (0.50-6.00)

*Ratio (90% CI)

97.90 (96.09-

99.73)

87.73 (83.63-

92.04)

AUC

0-t

Area under the plasma concentration curve from administration to last observed concentration at time t.

0-72h

be reported instead of AUC

, in studies with sampling period of 72 h, and where the

concentration

at 72 h is quantifiable. Only for immediate release products

AUC

0-∞

Area under the plasma concentration curve extrapolated to infinite time.

0-∞

does not need to be reported when

0-72h

is reported instead of AUC

C

max

Maximum plasma concentration

t

max

Time until Cmax is reached

*ln-transformed values

Table 2.

Plasma (R)-ibuprofen Levels

Pharmacokinetic parameters (non-transformed values; arithmetic

mean ± SD, t

max

median, range)

Treatment

AUC

0-t

µg/ml/h

AUC

0-∞

µg/ml/h

C

max

µg/ml

t

max

h

Test

36.4400

9.3668

2.00 (0.75-6.00)

Reference

37.9080

10.9404

1.25 (0.33-4.00)

*Ratio (90% CI)

95.60 (91.93-

99.42)

85.62 (81.25-

90.22)

AUC

0-t

Area under the plasma concentration curve from administration to last observed concentration at time t.

0-72h

be reported instead of AUC

, in studies with sampling period of 72 h, and where the

concentration

at 72 h is quantifiable. Only for immediate release products

AUC

0-∞

Area under the plasma concentration curve extrapolated to infinite time.

0-∞

does not need to be reported when

0-72h

is reported instead of AUC

C

max

Maximum plasma concentration

t

max

Time until Cmax is reached

*ln-transformed values

Conclusion on bioequivalence studies:

The results show that the 90% confidence intervals of the relative mean (1S, 2S)-Pseudoephedrine and

(S)- Ibuprofen AUCt and Cmax of the test to reference products are within the 80.00-125.00% range.

Therefore, the test product Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets (Swiss

Caps AG, Switzerland) exhibits an equivalent rate and extent of absorption to the reference product

RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets (Wyeth Santé Familiale, France) in healthy

subjects after a single, oral dose, under fasting conditions.

Safety

There were 31 adverse events (AEs) involving 19 subjects in the study. All AEs were judged to be

mild in severity. There were 3 non treatment emergent adverse events (NTEAEs) involving 3 subjects

in the study. All NTEAEs were judged to be mild in severity.

No serious adverse events (SAEs) were reported during the conduct of the study.

Based

submitted

bioequivalence

study/ies

Ibuduo

mg/30

considered

bioequivalent with

RhinAdvil Rhume 200 mg/30 mg.

IV.1

Pharmacodynamics

pharmacodynamic

profiles

ibuprofen

pseudoephedrine

hydrochloride

well

established. No additional pharmacodynamic study has been submitted by the applicant and

none is required.

IV.2

Clinical efficacy/Clinical safety

Efficacy and safety of ibuprofen and pseudoephedrine hydrochloride in the proposed indications are

known and assessed as being scientifically based considering recent knowledge, guidelines, and

recommendations.

IV.3

Risk Management Plan

The MAH has submitted a risk management plan, in accordance with the requirements of

Directive

2001/83/EC

amended,

describing

pharmacovigilance

activities

interventions designed to identify, characterise, prevent or minimise risks relating to Ibuduo

200 mg/30 mg Filmtabletten.

Summary of the safety concerns

- Summary of Safety Concerns and Planned Risk Minimisation Activities as approved in

IV.4

Discussion on the clinical aspects

The dossier contains an adequate review of published clinical data and bioequivalence has

been shown.

V.

USER CONSULTATION

A user consultation with target patient groups on the package information leaflet (PIL) has

been

performed

basis

bridging

report

making

reference

Ibuprofene

psudoefedrina Wick Pharma 200 mg/30 mg Tablets,

IT/H/0331/001/DC

. The bridging report

submitted by the applicant has been found acceptable.

VI.

OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND

RECOMMENDATION

The pharmaceutical quality of Ibuduo 200 mg/30 mg has been adequately shown.

There are no non-clinical or clinical concerns.

The benefit/risk relation is considered positive.

Public Assessment Report

Update

Ibuduo 200 mg/30 mg Filmtabletten

IBUPROFEN, PSEUDOEPHEDRINE

HYDROCHLORIDE

AT/H/0614/001/DC

This module reflects the procedural steps and scientific information after the finalisation

of the initial procedure.

Procedure

number

Scope

Product Information

affected

Date of end

of procedure

Approval/

non approval

Summary/ Justification for

refuse

AT/H/0614/0

01/IA/001

Implemenation of wording agreed by the competent authority

16.03.2018

approvable

Packungsbeilage

Bundesamt für Sicherheit im Gesundheitswesen, Traisengasse 5, A-1200 Wien

www.ages.at, DVR: 2112611, Konto Nr.: 50670 871 619

BLZ: 12000, IBAN: AT971200050670871619; UID: ATU 54088605, BIC/SWIFT: BKAUATWW

1 von 1

Die gegenständliche Arzneispezialität wurde in einem europäischen Zulassungsverfahren

geprüft.

Die Vermarktung des Produktes in Österreich ist derzeit seitens des Zulassungsinhabers nicht

geplant, daher liegen zur Zeit keine deutschsprachigen Übersetzungen der Fach- und

Gebrauchsinformation vor.

Traisengasse 5, 1200 Wien