ANDOLEX LOZENGES ORANGE

Страна: ЮАР

Язык: английский

Источник: South African Health Products Regulatory Authority (SAHPRA)

Доступна с:

iNova Pharmaceuticals (Pty) Ltd

дозировка:

Not Indicated

Фармацевтическая форма:

Lozenge

состав:

Each lozenge contains AMYLMETACRESOL 0,6 mg 2,4-and DICHLOROBENZYL ALCOHOL 1,2 mg

Статус Авторизация:

Registered

Дата Авторизация:

2024-06-08

тонкая брошюра

iNova Pharmaceuticals (Pty) Ltd
1.3.2
Andolex Lozenges
Bezydamine hydrochloride 3,00 mg/lozenge
_________________________________________________________________________________
Page 1 of 6
2020/12/10
1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S0
ANDOLEX LOZENGES, BENZYDAMINE HYDROCHLORIDE 3,00 MG PER LOZENGE.
CONTAINS SUGAR: ISOMALT 2,59 G PER LOZENGE.
CONTAINS SWEETENER: SACCHARIN SODIUM 0,65 MG PER LOZENGE.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Andolex Lozenges is available without a doctor’s prescription, for
you to treat a mild illness.
Nevertheless, you still need to use Andolex Lozenges carefully to get
the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share Andolex Lozenges with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve
after 7 days.
WHAT IS IN THIS LEAFLET
1.
What Andolex Lozenges is and what it is used for
2.
What you need to know before you take Andolex Lozenges
3.
How to take Andolex Lozenges
4.
Possible side effects
5.
How to store Andolex Lozenges
6.
Contents of the pack and other information
1.
WHAT ANDOLEX-C LOZENGES IS AND WHAT IT IS USED FOR
iNova Pharmaceuticals (Pty) Ltd
1.3.2
Andolex Lozenges
Bezydamine hydrochloride 3,00 mg/lozenge
_________________________________________________________________________________
Page 2 of 6
2020/12/10
Andolex Lozenges is used for the symptomatic relief of painful
conditions of the mouth and
throat.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANDOLEX-C LOZENGES
Do not take Andolex Lozenges:
•
if you are hypersensitive (allergic) to benzydamine hydrochloride or
any of the
ingredients of Andolex Lozenges (listed in section 6).
WARNINGS AND PRECAUTIONS
Take special care with Andolex Lozenges:
•
if your sore throat is caused or complicated by a bacterial infection,
appropriate
antibacterial therapy should be considered;
•
if you are

Характеристики продукта

iNova Pharmaceuticals (Pty) Ltd
1.3.1.1
Andolex Lozenges
Bezydamine hydrochloride 3,00 mg/lozenge
_________________________________________________________________________________
Page 1 of 5
2020/12/10
1.3.1.1 PROFESSIONAL INFORMATION
SCHEDULING STATUS
1 NAME OF THE MEDICINE
ANDOLEX LOZENGES, benzydamine hydrochloride 3,00 mg per lozenge.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains: Benzydamine HCl 3,00 mg.
Contains sugar: isomalt 2,59 g per lozenge.
Contains sweetener: saccharin sodium 0,65 mg per lozenge.
3 PHARMACEUTICAL FORM
Round green anise-mint flavoured lozenge. With prolonged storage the
lozenge may
become slightly cloudy and rough.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Symptomatic relief of painful conditions of the mouth and throat.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Andolex Lozenges should be slowly dissolved in the mouth. One lozenge
should be sucked
slowly every one to two hours as required up to a maximum of 12
lozenges per day.
Uninterrupted treatment should not exceed seven days except under
medical supervision.
4.3 CONTRAINDICATIONS
Patients with known hypersensitivity to benzydamine hydrochloride or
any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If a sore throat is caused or complicated by a bacterial infection,
appropriate antibacterial
therapy should be considered.
S0
iNova Pharmaceuticals (Pty) Ltd
1.3.1.1
Andolex Lozenges
Bezydamine hydrochloride 3,00 mg/lozenge
_________________________________________________________________________________
Page 2 of 5
2020/12/10
Excess consumption of products containing isomalt may have a laxative
effect.
Andolex Lozenges are not recommended in children under 6 years of age.
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 of
bronchial asthma.
4.5 INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION
None known.
4.6 FERTILITY, PREGNANCY AND LACTAT