Septabene lemon and elderflower 3 mg /1 mg lozenges

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

BENZYDAMINE HYDROCHLORIDE; Cetylpyridinium chloride

থেকে পাওয়া:

KRKA, d.d., Novo mesto

এটিসি কোড:

R02AA20

INN (আন্তর্জাতিক নাম):

BENZYDAMINE HYDROCHLORIDE; Cetylpyridinium chloride

ডোজ:

3 mg /1 mg mg/mg

ফার্মাসিউটিকাল ফর্ম:

Lozenge

থেরাপিউটিক এলাকা:

various

অনুমোদন অবস্থা:

Not marketed

অনুমোদন তারিখ:

2019-03-15

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEPTABENE LEMON AND ELDERFLOWER 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 Septabene lemon and elderflower is and what it is used for
2.
What you need to know before you take Septabene lemon and elderflower
3.
How to take Septabene lemon and elderflower
4.
Possible side effects
5.
How to store Septabene lemon and elderflower
6.
Contents of the pack and other information
1.
WHAT SEPTABENE LEMON AND ELDERFLOWER IS AND WHAT IT IS USED FOR
Septabene lemon and elderflower lozenge contains the active substance
benzydamine hydrochloride
and cetylpyridinium chloride.
Septabene lemon and elderflower lozenge is anti-inflammatory,
analgesic (causing pain relief) and
antiseptic (preventing the spread of pathogens) medicine for local
oral use. Septabene lemon and
elderflower disinfect the mouth and throat and reduces signs of
inflammation of throat such as pain,
redness, swelling, heat and difficulty swallowing.
Septabene lemon and elderflower is intended for the treatment of sore
throat associated with mild
infections in the mouth and throat (including inflammation of the
pharynx) in adults, adolescents and
children from 6 years of age.
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 SEPTABENE LEMON AND ELDERFLOWER
DO NOT TAKE SEPTABENE LEMON AND ELDERFLOWER:
-
if you are

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
01 December 2023
CRN00DYXQ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Septabene lemon and elderflower 3 mg /1 mg lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 3 mg benzydamine hydrochloride and 1 mg
cetylpyridinium chloride.
Excipient(s) with known effect:
- isomalt (E 953): 2448.3 mg/lozenge
- butylated hydroxyanisole (E 320): 0.0004 mg/lozenge
- sodium benzoate (E 211): up to 0.00075 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 pale green
to green 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
Septabene lemon and elderflower is intended for anti-inflammatory,
analgesic and antiseptic treatment of sore throat
associated with upper respiratory infections including pharyngitis in
adults, adolescents and children from 6 years of age.
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: Septabene lemon and elderflower is
contraindicated in children less than 6 years of age
(see section 4.3).
The stated dose should not be exceeded.
Septabene lemon and elderflower can be used for up to 7 days.
Method of administration
The lozenge should be slowly dissolved in the mouth ev