Septolete total Eucalyptus 3 mg/1 mg lozenges

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

BENZYDAMINE HYDROCHLORIDE, CETYLPYRIDINIUM CHLORIDE

Dostopno od:

KRKA DD Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Koda artikla:

R02AX03

INN (mednarodno ime):

BENZYDAMINE HYDROCHLORIDE 3 mg CETYLPYRIDINIUM CHLORIDE 1 mg

Farmacevtska oblika:

LOZENGE

Sestava:

BENZYDAMINE HYDROCHLORIDE 3 mg CETYLPYRIDINIUM CHLORIDE 1 mg

Tip zastaranja:

OTC

Terapevtsko območje:

THROAT PREPARATIONS

Povzetek izdelek:

Licence number in the source country: NOT APPLICAPABLE

Status dovoljenje:

Authorised

Datum dovoljenje:

2021-01-12

Navodilo za uporabo

Page 1 of 5
PACKAGE LEAFLET
Page 2 of 5
Package leaflet: Information for the user
Septolete total Eucalyptus 3 mg/1 mg lozenges
benzydamine hydrochloride/cetylpyridinium chloride
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
What is in this leaflet
1.
What Septolete total Eucalyptus is and what it is used for
2.
What you need to know before you take Septolete total Eucalyptus
3.
How to take Septolete total Eucalyptus
4.
Possible side effects
5.
How to store Septolete total Eucalyptus
6.
Contents of the pack and other information
1.
What Septolete total Eucalyptus is and what it is used for
Septolete total Eucalyptus lozenge is anti-inflammatory, analgesic and
antiseptic medicine for local
oral use. Septolete total Eucalyptus disinfect the mouth and throat
and reduces signs of inflammation
of throat such as pain, redness, swelling, heat and impaired function.
Septolete total Eucalyptus is used in the anti-inflammatory, analgesic
and antiseptic treatment:
-
of irritations in the throat, mouth and gums,
-
in gingivitis and pharyngitis.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2.
What you need to know before you take Septolete total Eucalyptus
Do not take Septolete total Eucalyptus
-
if you are allergic to benzydamine hydrochloride, cetylpyridinium
chloride or any of the other
ingredients of this medicine (listed in section 6).
-
this medicine should not be used in children aged under 6 years since
pharmaceutical form is
not suitable for this

Lastnosti izdelka

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
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Page 3 of 7
1.
NAME OF THE MEDICINAL PRODUCT
Septolete total Eucalyptus 3 mg/1 mg lozenges
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 3 mg benzydamine hydrochloride and 1 mg
cetylpyridinium chloride.
Excipient with known effect:
-
isomalt (E953): 2471.285 mg/lozenge
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lozenge
Round, blue-white to blue lozenges with bevelled edges. Some small
scratches could be present.
Lozenge diameter: 18.0 mm – 19.0 mm, thickness: 7.0 mm – 8.0 mm.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Septolete total Eucalyptus is indicated in adults, adolescents and
children over 6 years of age for anti-
inflammatory, analgesic and antiseptic treatment of irritations in the
throat, mouth and gums, in
gingivitis and pharyngitis.
4.2
Posology and method of administration
Posology
Adults: The recommended dosage is 34 lozenges a day. The lozenge
should be slowly dissolved in
the mouth every 3 to 6 hours.
Elderly patients: The recommended dose is the same as for adults.
Paediatric population
Adolescents over 12 years of age: The recommended dosage is 34
lozenges a day. The lozenge
should be slowly dissolved in the mouth every 3 to 6 hours.
Children aged from 6 to 12 years of age: The recommended dosage is 3
lozenges a day. The lozenge
should be slowly dissolved in the mouth every 3 to 6 hours.
Children less than 6 years of age: Septolete total Eucalyptus is
contraindicated in children less than 6
years of age.
For optimal effect, it is not recommended to use the product
immediately before or after cleaning
teeth.
The stated dose should not be exceeded.
Septolete total Eucalyptus can be used for up to 7 days.
Page 4 of 7
Method of administration
The lozenge should be slowly dissolved in the mouth every 3 to 6
hours.
4.3
Contraindications
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Children aged less than 6 years since the pharm