Prospan F Cough Syrup

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Hedera helix

Available from:

DELFI MARKETING SDN.BHD.

INN (International Name):

Hedera helix

Units in package:

5 ml; 100 ml

Manufactured by:

ENGELHARD ARZNEIMITTEL GMBH & CO. KG

Patient Information leaflet

INFORMATION FOR THE USER
PROSPAN
®
COUGH LIQUID
LIQUID FOR ORAL USE
Active ingredient:
Ivy leaves dry extract
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
THIS MEDICINE IS ALSO AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU
STILL NEED TO USE PROSPAN
®
COUGH LIQUID AS DIRECTED TO GET THE BEST
RESULTS FROM IT.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or
advice.
•
You must contact a doctor if your symptoms worsen
or do not improve after 7 days.
•
If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT PROSPAN
®
COUGH LIQUID IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE PROSPAN
®
COUGH LIQUID
3.
HOW TO TAKE PROSPAN
®
COUGH LIQUID
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PROSPAN
®
COUGH LIQUID
6.
FURTHER INFORMATION
1.
WHAT PROSPAN
®
COUGH LIQUID IS AND WHAT IT IS USED FOR
PROSPAN
®
COUGH
LIQUID
IS
A
HERBAL
MEDICINE
USED
TO
TREAT
CATARRHAL DISEASES OF THE RESPIRATORY TRACT.
PROSPAN
®
COUGH LIQUID IS USED
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.
2.
BEFORE YOU TAKE PROSPAN
®
COUGH LIQUID
DO NOT TAKE PROSPAN
®
COUGH LIQUID
if you are hypersensitive (allergic) to the active substance or any of
the
other ingredients of Prospan
®
Cough Liquid (see section 6).
Contains sorbitol
When used as directed, each dose contains 1.9 g of sorbitol. This
poses a health risk to patients with a hereditary intolerance to
fructose. Such patients may only take this medicine after talking to
their doctor first.
TAKE SPECIAL CARE WITH PROSPAN
®
COUGH LIQUID
Children
Prospan
®
Cough Liquid may not be used in children under the age of 6.
Taking Pr

Summary of Product characteristics

PB1700601
5.
HOW TO STORE PROSPAN
®
F COUGH SYRUP
VERY COMMON:
more than one in 10 patients treated
COMMON:
one to 10 in 100 patients treated
UNCOMMON:
one to 10 in 1,000 patients treated
RARE:
one to 10 in 10,000 patients treated
VERY RARE:
less than one in 10,000 patients treated
UNKNOWN:
frequency on the basis of available data not assessable
VERY RARE
UNCOMMON
WHAT PROSPAN
®
F COUGH SYRUP CONTAINS
THE ACTIVE INGREDIENT IS:
THE OTHER INGREDIENTS ARE:
MANUFACTURER
Engelhard Arzneimittel GmbH & Co. KG
Herzbergstraße 3
61138 Niederdorfelden
Germany
PRODUCT REGISTRATION HOLDER
Delfi Marketing Sdn. Bhd.
Level 6, Block A, Sky Park One City, Jalan USJ 25/1,
47650 Subang Jaya, Selangor, Malaysia.
DATE OF REVISION: June 2020
Note:
PROSPAN
®
- A SOLUTION FOR YOUR COUGH
WE WISH YOU A SPEEDY RECOVERY.
IF YOU FORGET TO TAKE PROSPAN
®
F COUGH SYRUP
4. POSSIBLE SIDE EFFECTS
recommended that you should keep taking Prospan
®
for
another 2-3 days after your symptoms have disappeared.
If you have the impression that the effect of Prospan
®
F
Cough Syrup is too strong or too weak, talk to your doctor
or pharmacist.
Hedera Helix Extract (Dried Ivy Leaf Extract)
5 ml of liquid contains 35 mg of hedera helix extract from
folium (5-7.5:1), 6.7 mg of potassium sorbate (Ph.Eur.)
(preservative).
Citric acid, anhydrous (Ph.Eur.); xanthan gum; sorbitol
solution 70% (crystallising) (Ph.Eur.); aromas; menthol;
purified water.
5ml of liquid contains 1.925 g of sorbitol (Ph.Eur.) (sweet-
ener) = 0.16 BU
Prospan
®
F Cough Syrup is available in (i) boxes of 3, 9
and 21 stick packs, each stick pack containing 5 ml of oral
liquid, and (ii) bottles of 100 ml oral liquid.
An important term for describing the quality of extracts is
the so-called “Drug to Extract Ratio” (DER).
A DER of 5-7.5:1 means that 5 to 7.5 parts of the drug
were needed to produce one part of extract.
Prospan
®
causes
thick
mucus
to
become
liquefied,
thereby making it easier to cough up. At the same time,
the urge to cough is reduced.
PROSPAN
®
F COUGH SYRUP conta