Herbion ivy lozenges lozenges

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

ivy leaf dry extract

Commercializzato da:

KRKA d.d.

Codice ATC:

R05CA12

INN (Nome Internazionale):

ivy leaf dry extract

Dosaggio:

35mg

Forma farmaceutica:

lozenges

Confezione:

(16/2x8/) in blister, (32/4x8/) in blister

Tipo di ricetta:

OTC

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2023-05-24

Scheda tecnica

PI_Text042743_1
– Updated:
Page 1 of 4
1.
NAME OF THE MEDICINAL PRODUCT
Herbion ivy lozenges
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 35 mg of extract (as dry extract) from _Hedera
helix _L., folium (ivy leaf) (5–
7.5:1).
Extraction solvent: Ethanol 30% (m/m).
Excipients with known effect
Each lozenge contains 2447.50 mg isomalt (E953) and 0.0006 mg
butylhydroxyanisole (E320).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lozenge
The lozenges are round with bevelled edges and a rough surface from
light brown to brown colour.
Allowed is presence of yellow to brown particles, lighter patches, air
bubbles and small, jagged edges.
_ _
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Herbion ivy is a herbal medicinal product used as an expectorant in
complex treatment of acute
respiratory diseases accompanied by productive cough.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS, ELDERLY AND ADOLESCENTS 12 YEARS OF AGE AND OLDER: 1 lozenge
three times daily
(corresponding to 105 mg of ivy leaf dry extract daily).
_Paediatric population _
CHILDREN 6 TO 11 YEARS OF AGE: 1 lozenge twice daily (corresponding to
70 mg of ivy leaf dry extract
daily).
For children 2 TO 5 YEARS OF AGE no adjusted dosage is possible with
the lozenge formulation. The use
of a syrup formulation is recommended in this age group.
The use in CHILDREN UNDER 2 YEARS OF AGE is contraindicated (see
section 4.3).
If the symptoms persist longer than one week during the use of the
medicinal product, a doctor or a
pharmacist should be consulted. Further duration of treatment is
determined by the doctor, taking into
account the characteristics of the disease, the achieved effect and
the tolerability of the medicinal
product.
Renal and/or hepatic impairment
PI_Text042743_1
– Updated:
Page 2 of 4
Patients with renal and/or hepatic impairment should seek medical
advice before starting treatment.
Method of administration
Oromucosal use.
Dissolve the lozenge in the mouth.
Drinking plenty of