Prospan Cough Syrup in stick packs

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

HEDERA HELIX

Mevcut itibaren:

Engelhard Arzneimittel GmbH & Co. KG Herzbergstrasse 3 61138 Niederdorfelden, Germany

ATC kodu:

R05CA

INN (International Adı):

HEDERA HELIX 35 mg/5ml

Farmasötik formu:

ORAL LIQUID

Kompozisyon:

HEDERA HELIX 35 mg/5ml

Reçete türü:

OTC

Terapötik alanı:

COUGH AND COLD PREPARATIONS

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2013-09-25

Bilgilendirme broşürü

Cough Syrup
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROSPAN
® COUGH SYRUP - STICK PACK
_Active substance:_ Ivy leaves dry extract
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION
FOR YOU. THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU
STILL
NEED TO USE PROSPAN
® COUGH SYRUP AS DIRECTED TO GET THE BEST RESULTS FROM IT.
1. WHAT PROSPAN
® COUGH SYRUP IS AND WHAT IT IS USED FOR
PROSPAN
® COUGH SYRUP IS A HERBAL MEDICINE USED TO TREAT CATARRHAL DISEASES
OF THE RESPIRATORY TRACT, BY ITS SECRETOLYTIC, BRONCHO-SPASMOLYTIC AND
COUGH-
RELIEVING EFFECTS.
PROSPAN
® COUGH SYRUP IS USED to improve symptoms of chronic-inflammatory bron-
chial diseases; acute inflammations of the respiratory tract
accompanied by coughing.
NOTE: In the event of persistent complaints or the appearance of
shortness of breath, fever
as well as purulent or bloody expectoration, a doctor should be
consulted immediately.
2. BEFORE YOU TAKE PROSPAN
® COUGH SYRUP
DO NOT TAKE PROSPAN
® COUGH SYRUP
if you are hypersensitive (allergic) to the active substance or any of
the other ingre-
dients of Prospan
®
Cough Syrup (see section 6).
TAKE SPECIAL CARE WITH PROSPAN
® COUGH SYRUP:
CHILDREN: Prospan
®
Cough Syrup should be used in children under the age of one
only after having consulted a doctor. Compared with older children,
this age group
should be monitored very carefully when being given Prospan
®
Cough Syrup, as
particular attention must be paid to possible diarrhoea and vomiting.
Please also
read the notes contained in the section “Side effects”.
TAKING PROSPAN
® COUGH SYRUP TOGETHER WITH OTHER MEDICINES:
Please tell your doctor or pharmacist if you are taking / using or
have recently
taken / used any other medicines, including medicines obtained without
prescription.
No interactions have become known so far. However, no studies have
been carried out.
PREGNANCY AND BREAST-FEEDING:
Medicines should generally be taken during pregnancy and
breast-feeding only
after having previously consulted a d

Ürün özellikleri

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Prospan® Cough Syrup in stick packs
Oral Liquid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION (ACTIVE INGREDIENTS)
5ml liquid (1 stick pack) contain 35 mg of ivy leaves extract [5-7.5 :
1].
100 ml solution contains 0.7g of ivy leaf dry extract [5-7.5 : 1].
[Extractive agent: ethanol 30% w/w]
Excipients see under point 6.1.
3.
PHARMACEUTICAL FORM
Oral Liquid
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
To improve complaints of chronic-inflammatory bronchial diseases;
acute inflammations of
the respiratory tract accompanied by coughing.
Note:
In the event of persistent complaints or the appearance of shortness
of breath, fever as well
as purulent or bloody expectoration, a doctor should be consulted
immediately.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Children under the age of 6 years take 2.5 ml solution 2 times daily
(corresponding to 35 mg
of ivy leaves dry extract), children aged 6 to 12 years take 5 ml
solution 2 times daily
(corresponding to 70 mg of ivy leaves dry extract), children from the
age of 12 years and
adults take 5 ml solution 3 times daily (corresponding to 105 mg of
ivy leaves dry extract).
Take the syrup with the enclosed measuring cup.
SHAKE THE BOTTLE WELL BEFORE EVERY USE !
The syrup should be taken in the morning, (at lunchtime) and in the
evening.
Cough Syrup in stick packs
Adults and adolescents from 12 years onwards take the solution of 1
stick (5ml) 3 times
daily corresponding to 105 mg of ivy leaves dry extract and children
aged 6-11 years take
the solution of 1 stick pack (5ml) 2 times daily corresponding to 70
mg of ivy leaves dry
extract.
Knead the stick pack lightly before using!
Take the liquid undiluted in the morning, (at lunchtime) and in the
evening.
Pg. 1
Page 2 of 4
Duration of treatment depends on the type and severity of the
symptoms, but it should last
forat least one week, even in the case of minor inflammations of the
respiratory tract.
To ensure success of therapy, treatment should b