PROSPAN COUGH SYRUP SACHETS

Active substance: GROUND IVY DRY EXTRACT 5-7.5:1 ETHANOLIC 30% W/W

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Prospan Cough Syrup Sachets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet (5 ml) contains 35 mg of extract (as dry extract) from ivy leaf (Hedera
helix L.) (5-7.5:1).

Extraction solvent: ethanol 30% w/w.
For a full list of excipients, see section 6.1.
Each sachet (5 ml) contains 1926 mg sorbitol.

3

PHARMACEUTICAL FORM
Syrup
Light brown, slightly cloudy syrup.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Traditional herbal medicinal product used to relieve chesty coughs associated with
the common cold based on traditional use only.

4.2

Posology and method of administration
For oral use only.
Massage the sachet gently before using in order to mix the contents.
Adults, the elderly, children aged 12 years and over: take one sachet (5 ml) 3
times daily.

Empty the contents of the sachet directly into the mouth.

The sachet should be taken in the morning, at middayand in the evening.

Duration of use
If symptoms worsen or persist after 7 days, a doctor or qualified healthcare pratitioner
should be consulted.

The product should not be used for more than 2 weeks.
The use in children under 12 years of age is not recommended (see Section 4.4
Special warnings and precautions for use)

4.3

Contraindications
Hypersensitivity to the active ingredient, ivy leaf or to any of the excipients.

4.4

Special warnings and precautions for use
Do not exceed the stated dose.
The use of this product in children under 12 years of age is not recommended
because data are not sufficient and medical advice should be sought.
Concomitant use with antitussives such as codeine or dextromethorphan is not
recommended without medical advice.
Caution is recommended in patients with gastritis or gastric ulcer.
If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified
healthcare practitioner should be consulted.
If symptoms worsen or persist for more than 7 days, a doctor or a qualified
healthcare practitioner should be consulted.
Contains sorbitol. Patients with rare hereditary problems of fructose intolerance
should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.

4.6

Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been
established, therefore the use of this product during pregnancy and lactation is
not recommended.

4.7

Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been
performed.

4.8

Undesirable effects
Allergic reactions (urticaria, skin rash, dyspnoea) and gastrointestinal reactions
(nausea, vomiting, diarrhoea) have been reported.
The frequency is not known.

If other adverse side effects not mentioned above occur, a doctor or a qualified
healthcare practitioner should be consulted.

4.9

Overdose
Ingestion of significantly higher amounts (more than three times the daily
dose) may lead to nausea, vomiting,diarrhoea and excitation.
Symptomatic and supportive measures should be taken as appropriate.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2

Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3

Preclinical safety data
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been
performed.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Potassium sorbate
Anhydrous citric acid
Xanthan gum
Cherry flavour
Sorbitol liquid 70% (crystallising)
Purified water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Unopened:
3 years
Opened:
To be used immediately.

6.4

Special precautions for storage
No special precautions for storage.

6.5

Nature and contents of container
Packs with 21 sachets of 5 ml.

6.6

Special precautions for disposal
Any unused product or waste material should be disposed of in accordance with local
requirements.

7

MARKETING AUTHORISATION HOLDER

Engelhard Arzneimittel GmbH & co kg
Herzbergstrasse 3
Niederdorfelden
D-61138
Germany

8

MARKETING AUTHORISATION NUMBER(S)
THR 35693/0002

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/02/2011

10

DATE OF REVISION OF THE TEXT
29/11/2012

11

DOSIMETRY (IF APPLICABLE)

12

INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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