OROFLAM LOZENGES

Maa: Etelä-Afrikka

Kieli: englanti

Lähde: South African Health Products Regulatory Authority (SAHPRA)

Saatavilla:

iNova Pharmaceuticals (Pty) Ltd

Annos:

See ingredients

Lääkemuoto:

LOZENGES

Koostumus:

EACH LOZENGE CONTAINS BENZYDAMINE HYDROCHLORIDE 3,0 mg CETYLPYRIDINIUM CHLORIDE 1,33 mg

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2001-08-10

Pakkausseloste

Page 1 of 7
DATE: 2021/01/05
1.5.5 PROPOSED ANNOTATED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S0
OROFLAM LOZENGES lozenge.
Benzydamine hydrochloride 3,00 mg and cetylpyridinium chloride 1,33 mg
per lozenges.
Contains sugar: isomalt 2,57 g.
Contains sweetener: sucralose 6,00 mg
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Oroflam Lozenges is available without a doctor’s prescription, for
you to treat a mild illness.
Nevertheless, you still need to use Oroflam Lozenges carefully to get
the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share Oroflam Lozenges with any other person.
•
Ask your 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 Oroflam Lozenges is and what it is used for
2.
What you need to know before you take Oroflam Lozenges
3.
How to take Oroflam Lozenges
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DATE: 2021/01/05
4.
Possible side effects
5.
How to store Oroflam Lozenges
6.
Contents of the pack and other information
1.
WHAT OROFLAM LOZENGES IS AND WHAT IT IS USED FOR
Oroflam Lozenges is used for the symptomatic relief of minor
infections and painful conditions of
the mouth and throat.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OROFLAM LOZENGES
Do not take Oroflam Lozenges:
•
if you are hypersensitive (allergic) to benzydamine hydrochloride,
cetylpyridinium
chloride or any of the ingredients of Oroflam Lozenges (listed in
section 6);
•
if you are pregnant or breastfeeding.
Do not give to children under 6 years old.
WARNINGS AND PRECAUTIONS
Take special care with Oroflam Lozenges:
•
if your sore throat is caused or complicated by a bacterial infection,
appropriate
antibacterial therapy should be considered
•
if you are allergic to salicylic acid or to other anti-inflammatory
painkillers.
•
if you have a history of asthma because it can bring on nan attack.
OTHER MEDICINES AND OROFLAM LOZENGES
Page 3 of 7
DATE: 2021/01/05

Valmisteyhteenveto

Page 1 of 6
2021/01/05
1.5.5 CLEAN PROPOSED PROFESSIONAL INFORMATION
SCHEDULING STATUS S0
1 NAME OF THE MEDICINE
OROFLAM LOZENGES benzydamine hydrochloride 3,00 mg and cetylpyridinium
chloride
1,33mg per lozenge.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains: Benzydamine HCI 3,00 mg
Cetylpyridinium chloride 1,33 mg
Contains sugar: isomalt 2,5846 g/lozenge
Contains sweetener: saccharin sodium 0,65 mg/lozenge
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Round, red, sweet raspberry custard flavoured lozenges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Symptomatic relief of minor infections and painful conditions of the
mouth and throat.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
OROFLAM LOZENGES should not be chewed. They 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.
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2021/01/05
4.3 CONTRAINDICATIONS
Patients with known hypersensitivity to benzydamine, cetylpyridinium
chloride. The safety of
benzydamine hydrochloride has not been established in pregnancy and
lactation.
OROFLAM LOZENGES are not recommended in children under 6 years of age.
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.
Excess consumption of products containing isomalt may have a laxative
effect.
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. Caution should be exercised in these patients.
4.5 INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION
No interaction studies have been performed.
4.6 FERTILITY, PREGNANCY AND LACTATION
The safety of benzydamine hydrochloride has not been established in
pregnancy and
lactation.
4.7 EFFECTS ON ABILITY TO DR