Summary of Product Characteristics (SmPC) - Prospan Cough syrup
1 NAME OF THE MEDICINAL PRODUCT
Prospan Cough Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml of oral liquid 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 5 ml of liquid 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.
Shake the bottle well before use.
Adults, the elderly, children aged 12 years and over: take 5 ml of oral liquid using the enclosed measuring cup 3 times daily.
The syrup should be taken in the morning, at midday and 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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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:
3 months.
6.4 Special precautions for storage
No special precautions for storage.
6.5 Nature and contents of container
100 ml / 200 ml in glass bottle
Not all pack sizes may be marketed.
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 35693/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/02/2011
10 DATE OF REVISION OF THE TEXT
06/07/2015
11 DOSIMETRY (IF APPLICABLE)
12 INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)