Septolete total Lemon/Honey 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:

R02AA20

INN (mednarodno ime):

BENZYDAMINE HYDROCHLORIDE 3 mg CETYLPYRIDINIUM CHLORIDE 3 mg

Farmacevtska oblika:

LOZENGE

Sestava:

BENZYDAMINE HYDROCHLORIDE 3 mg CETYLPYRIDINIUM CHLORIDE 3 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

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
SEPTOLETE TOTAL LEMON/HONEY 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 Lemon/Honey is and what it is used for
2.
What you need to know before you take Septolete total Lemon/Honey
3.
How to take Septolete total Lemon/Honey
4.
Possible side effects
5.
How to store Septolete total Lemon/Honey
6.
Contents of the pack and other information
1.
WHAT SEPTOLETE TOTAL LEMON/HONEY IS AND WHAT IT IS USED FOR
Septolete total Lemon/Honey contains the active substances benzydamine
hydrochloride and
cetylpyridinium chloride.
Septolete total Lemon/Honey lozenge is anti-inflammatory, analgesic
and antiseptic medicine for local
oral use. Septolete total Lemon/Honey disinfects the mouth and throat
and reduces signs of
inflammation of throat such as pain, redness, swelling, heat and
impaired function.
Septolete total Lemon/Honey is used for the treatment of symptoms of
sore throat associated with mild
infections in the mouth and throat (including 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 LEMON/HONEY
DO NOT TAKE SEPTOLETE TOTAL LEMON/HONEY:
-
if you are allergic to benzydamine hydrochloride, cetylpyridinium
chloride or any of the other
ingredients of this medicine (listed in se

Lastnosti izdelka

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Septolete total Lemon/Honey 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 (E 953): 2452.8 mg/lozenge
-
sodium benzoate (E 211): up to 0.0009 mg/lozenge
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lozenge
Round lozenges with bevelled edges and rough surface from light yellow
to yellow colour. White
patches, uneven colouring, presence of air bubbles in the “hard
candy” mass and small jagged edges
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 Lemon/Honey 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 Lemon/Honey is contraindicated in children less
than 6 years of age.
It is not recommended to use the product immediately before or after
cleaning teeth.
The stated dose should not be exceeded.
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Septolete total Lemon/Honey can be used for up to 7 days.
Method of administration
The lozenge should be slowly dissolved in the mouth every 3 to 6
hours.
_ _
4.