ROGARON LEMON SUGAR FREE

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

BENZYDAMINE HYDROCHLORIDE

Tilgængelig fra:

ABIC MARKETING LTD, ISRAEL

ATC-kode:

A01AD02

Lægemiddelform:

LOZENGES

Sammensætning:

BENZYDAMINE HYDROCHLORIDE 3 MG

Indgivelsesvej:

PER OS

Recept type:

Not required

Fremstillet af:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Terapeutisk område:

BENZYDAMINE

Terapeutiske indikationer:

Rogaron is used for symptomatic local treatment of acute sore throat in adults and children over 6 years of age.

Autorisation dato:

2020-04-02

Indlægsseddel

DOR-Rog-Lem-Orng-PIL-0520-07
DOR-Rog-Lem-Orng-PIL-0520-07
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Produktets egenskaber

Rogaron lozenges, HS/SZ 04/2020 Approved
SUMMARY OF PRODUCT CHARACTERISTICS
ROGARON
® ORANGE-HONEY FLAVOR
ROGARON ® LEMON FLAVOR
1
NAME OF THE MEDICINAL PRODUCT
Rogaron
®
Orange-Honey Flavor
Rogaron
®
Lemon Flavor
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 3 mg of benzydamine hydrochloride (equivalent to
2.68 mg of
benzydamine).
Excipients with known effects:

ROGARON ORANGE-HONEY:
each lozenge contains 2464.420 mg of Isomalt (E-953) and
3.409 mg of Aspartame (E-951) and 0.013 mg of Cochenille red colorant
(E-124).

ROGARON LEMON:
each lozenge contains 2457.316 mg of Isomalt (E-953) and 3.409 mg of
Aspartame (E-951) (lemon flavor).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Lozenge.
Rogaron Orange-Honey: Round orange lozenges, 19 mm diameter, with
orange and honey
flavor.
Rogaron Lemon: Round yellow lozenges, 19 mm diameter, with lemon
flavor.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rogaron is indicated for symptomatic local treatment of acute sore
throat in adults and
children over 6 years of age.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 6 years of age: one lozenge 3 times a day.
The treatment must not exceed 7 days.
Pediatric population
Children 6-11 years of age:
The medicinal product should be administered under adult supervision.
Children below 6 years of age:
Due to the type of the pharmaceutical form, the administration should
be restricted to
children of more than 6 years of age.
Method of administration
For oropharyngeal use.
Lozenge should be dissolved slowly in the mouth
patients should not swallow or chew the lozenges.
4.2
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Rogaron lozenges, HS/SZ 04/2020 Approved
4.3
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Benzydamine use is not advisable in patient with hypersensitivity to
salicylic acid or
other NSAIDs.
Bronchospasm may be precipitated in patients suffering from or with a
previous history o