Echinaforce throat spray

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

即購入

ダウンロード 製品の特徴 (SPC)
04-03-2020
ダウンロード 公開評価報告書 (PAR)
20-04-2020

有効成分:

Sage leaf; Echinacea root extract; Echinacea

から入手可能:

A.Vogel UK Ltd

ATCコード:

n/a

INN(国際名):

Sage leaf; Echinacea root extract; Echinacea

投薬量:

430mg/1ml ; 45.5mg/1ml ; 863.3mg/1ml

医薬品形態:

Spray

投与経路:

Oromucosal

クラス:

No Controlled Drug Status

処方タイプ:

Never Valid To Prescribe As A VMP

製品概要:

BNF: 12030300; GTIN: 7610313405039

情報リーフレット

                                Echinaforce
®
Sore Throat Spray
Echinacea & Sage extracts
i
Information
Patient Information Leaflet
_Please turn over..._
Important things you need
to know
This product is used to relieve
sore throats.
Don't take this product if
you are allergic to any of the
ingredients: see section 6.
Before you take this product:
read section 2.
Dosage instructions: see section
3.
Talk to your doctor if your
symptoms worsen or do not
improve within 7 days.
Side effects can occur when
using this product: see section 4.
Now read the rest of this leaflet
carefully. Keep this leaflet. You may
need to read it again.
2. Before you use
this product
Do not take this product
If you are under 18 years of age.
If you are allergic to
Echinacea_ _or plants of_ _
the daisy (Asteraceae/
Compositae) family.
Echinacea is a member of
the daisy family.
Sage
Peanut or soya. This
product contains soy
lecithin.
Any of the other ingredients
in this product (see section
6 Further Information)
If you have a tendency to allergies
such as hives, allergic eczema or
asthma.
If you are pregnant or breast-
feeding.
If you are taking ciclosporin
or methotrexate, or any other
immunosuppressant medicine.
If you are taking another medicine
which is affected by alcohol
3. How to use this
product
Remove the cap from the bottle and
fit the nozzle onto the cap. Replace
the cap gently but firmly onto the
bottle, taking care to point the nozzle
away from you. Before using this
product for the first time press the
pump 2-3 times to activate the spray.
To use the spray shake the bottle
well, place the nozzle just inside
your mouth and point it towards the
back of your throat. Press the pump
to spray.
After use, turn the nozzle back down.
If you suffer from
TB (the infection
tuberculosis)
Sarcoidosis (a connective
tissue disease disorder
which causes the formation
of clumps of cells mainly in
the lymph nodes, lungs and
liver)
An autoimmune disease
such as collagenoses
(inflammation of the
connective tissue) or
multiple sclerosis
HIV, AIDS or any other
condition which d
                                
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製品の特徴

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Echinaforce Sore Throat Spray
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
•
863.3 mg of tincture from fresh _Echinacea purpurea_ (L.)
Moench herb (1:12-13). Extraction solvent: Ethanol 65% V/V.
•
45.5 mg of tincture from fresh _Echinacea purpurea_ (L.)
Moench root (1:11-12). Extraction solvent: Ethanol 65% V/V.
•
430.0 mg of tincture from fresh Sage leaves (_Salvia officinalis_
L. folium) (1:17-18). Extraction solvent: Ethanol 68% V/V.
1 spray
0.22 ml
Excipients:
1 ml contains a maximum of 407 mg sorbitol, 370 mg ethanol (alcohol),
20
mg of soy lecithin and 5 mg sucrose laurate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oromucosal spray, solution.
Brown to yellow-green, clear liquid
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used to relieve sore throats
associated with
coughs, colds and flu, based on traditional use only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oromucosal administration
Adults and the elderly:
2 sprays six to ten times daily to the back of the throat.
The use in children and adolescents under 18 years of age is not
recommended
(see section 4.3 ‘Contraindications’).
Method of administration:
Remove the cap from the bottle and fit the nozzle onto the cap.
Replace the
cap gently but firmly onto the bottle.
Before using the product for the first time activate the spray by
pressing the
pump 2-3 times.
To use the spray, shake the bottle well, place the nozzle just inside
the mouth
and point it towards the back of the throat. Press the pump to spray.
Do not use the product for more than 7 days. If symptoms worsen during
the
use of the product or persist for more than 7 days, a doctor or
qualified
healthcare practitioner should be consulted (see section 4.4
‘Special warnings
and precautions for use’).
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances, plants of the Asteraceae
(Compositae)
family or to any of the excip
                                
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