Prospan Herbal Drops, solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HEDERA HELIX, EXTRACT

Available from:

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

ATC code:

R05CA

INN (International Name):

HEDERA HELIX EXTRACT 20 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

HEDERA HELIX EXTRACT 20 mg/ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-03-02

Patient Information leaflet

PROSPAN TROPFEN | 148X297MM | 5/5-FARBIG: PANTONE REFLEX BLUE C -
PANTONE 185 C - PANTONE 3292 C - PANTONE 347 C - PANTONE 381 C |
LAETUS CODE 1041 | WEISS HOLZFREI | 16.10.2019 MIBU
Active ingredient:
DRIED IVY LEAF EXTRACT
PATIENT INFORMATION LEAFLET. PLEASE READ CAREFULLY!
mucolytic – spasmolytic – cough-relieving
COMPOSITION:
_Active ingredients: _100 ml solution contains 2 g of dried
ivy leaf extract (5–7.5:1); [extractive agent: ethanol 30 %
(w/w)]. _Inactive ingredients:_ saccharin sodium, anise oil,
fennel oil, peppermint oil.
NOTE:
Prospan
®
Herbal Drops contain 47 % vol. alcohol!
INDICATIONS:
Acute
catarrh
(inflammation)
of
the
respiratory
tract
accompanied by coughing; symptomatic treatment of
chronic inflammatory bronchial diseases.
CONTRA-INDICATIONS:
Prospan
®
Herbal Drops are contraindicated in patients
with known hypersensitivity to the active substance or
any of the excipients contained in this medicine.
Persons whose doctors have strictly banned the taking of
even minimal quantities of alcohol (e.g. after withdrawl
treatment) should not take Prospan
®
Herbal Drops.
_Pregnancy and lactation:_ Medicines should generally be
taken during pregnancy and breast-feeding only after
previously consulting a doctor.
SIDE EFFECTS:
Very rarely, after taking medicines containing extract of
ivy leaves, allergic reactions may occur such as dyspnoea,
Quincke edema, exanthema, urticaria.
Gastrointestinal symptoms such as nausea, vomiting and
diarrhea may occur in uncommon cases.
OVERDOSAGE:
Do not exceed the recommended daily dose. Ingestion of
significantly higher amounts (more than three times the
daily dose) may lead to nausea, vomiting and diarrhea.
INTERACTION WITH OTHER MEDICAMENTS:
Adverse effects have not become known with the simul-
taneous ingestion of Prospan
®
Herbal Drops and other
medicines. This preparation can therefore be combined
safely with other drugs, such as antibiotics for example.
DOSAGE AND METHOD OF ADMINISTRATION:
Unless otherwise prescribed, infants (1- 4 years) take
10 -15 dr

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Prospan Herbal Drops, solution
_Drug substance: Dried ivy leaf extract_
_ _
_ _
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION (ACTIVE INGREDIENTS)
100 ml solution contain 2.0 g of dried ivy leaf extract [5-7.5 : 1].
[Extractive agent: ethanol 30% V/V]
Excipients see under point 6.1.
3.
PHARMACEUTICAL FORM
Solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
To
improve
symptoms
of
chronic-inflammatory
bronchial
diseases;
acute
inflammations of the respiratory tract accompanied by coughing.
The following information is given in the patient leaflet:
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
Adults and schoolchildren (> 10 years) take 20 drops, small children
(4-10 years) 15
drops and infants (1-4 years) take 10 - 15 drops 3 – 5 times daily.
The drops should be taken before meals. For young chldren and infants
it is
recommended that the drops should be administered together with some
fruit juice.
Duration of treatment depends on the type and severity of the
symptoms, but it should
last for at least one week, even in the case of minor inflammations of
the respiratory
tract.
To ensure success of therapy, treatment should be continued for 2-3
days after
symptoms have subsided.
_Inhalation therapy with ProspanHerbal Drops:_
_ _
A particularly good healing effect can be achieved by inhaling the
drops using an
aerosol, whereby practically all commercial appliances for cold
nebulization are
suitable. To avoid occasionally occuring irritation due to the alcohol
content in
Prospan
®
Herbal Drops, the drops can be diluted with drinking water at a ratio
of 1:2
when being used for inhalation purposes.
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_Dosage for inhalation:_
_ _
Unless otherwise prescribed, inhale 20 - 25 drops, several times
daily.
4.3
CONTRAINDICATIONS
Prospan
®
Herbal Drops are