Weleda Herb & Honey Cough Elixir
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Weleda Herb & Honey Cough Elixir
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml of oral solution contains 4g of liquid extract from:
Aniseed (Pimpinella anisum L.) (equivalent to 81 mg Aniseed fruit);
Elderflower (Sambucus nigra L.) (equivalent to 81 mg Elderflower);
Iceland Moss thallus (Cetraria islandica L.) (equivalent to 81 mg Iceland Moss thallus);
Marshmallow root (Althaea officinalis L.) (equivalent to 81 mg Marshmallow root);
Thyme herb (Thymus vulgaris L & Thymus zygis L) (equivalent to 81 mg Thyme herb);
White Horehound herb (Marrubium vulgare L) (equivalent 81mg to White Horehound herb).
Extraction solvent: Water.
Each 5ml of oral solution also contains 1.25 g sucrose and 1.88g honey.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear to slightly turbid amber-brown syrupy liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of dry and irritating coughs, based on traditional use only.
4.2 Posology and method of administration
For oral use.
Adults, the elderly and children over 12 years of age: Two 5ml spoonfuls (10ml) every 3-4 hours, undiluted or in a little water. Up to four doses can be taken daily.
Duration of use: 7 days
This use is not recommended for use in children under 12 years of age ( see Section 4.4, ‘Special warnings and precaution for use’).
If the symptoms worsen or persist after 1 week, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to any of the active ingredients or to Apiaceae (Umbelliferae) (caraway, celery, coriander, dill and fennel) or to anethole or to members of the Lamiaceae family or to any of the excipients.
Obstruction of the bile duct, cholangitis, liver disease, ileus.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If the symptoms worsen or persist after 1 week, a doctor or qualified healthcare practitioner should be consulted.
If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified healthcare practitioner should be consulted.
The use of this product in children under 12 years of age is not recommended because there is no experience available.
Patients with active peptic ulcer, gallstones and any other biliary disorders should consult a doctor before using White horehound herb preparations.
Contains sucrose and honey. Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data the use during pregnancy and lactation is not recommended.
Studies on the effects on fertility have not been performed
4.7 Effects on ability to drive and use machines
No studies on the effect of the product on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Allergic reactions to aniseed affecting the skin or the respiratory system may occur. The frequency is not known.
Hypersensitivity reactions (including one case of anaphylactic shock and one case of Quincke edema) and stomach disorders have been observed with Thyme herb. The frequency is not known.
If other adverse reactions do occur a doctor or qualified healthcare practitioner should be consulted.
4.9 Overdose
No case of overdose has been reported.
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 on carcinogenicity have not been performed.
An aniseed extract prepared with water was tested in an Ames test on Salmonella typhimurium strains TA98, TA100, TA102 and turned out as negative.
Results from non-clinical studies showed a weak mutagenic potential of anethole. The genotoxic risk5 related to estragole is not considered to be relevant in the specified conditions of use due to the small amount present.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water
Honey
Sucrose
Glycerol
Citric Acid, Monohydrate
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf life unopened:
3 years
Shelf life after first opening:
1 month
6.4 Special precautions for storage
Do not store above 25°C . Store in original package.
6.5 Nature and contents of container
Amber glass bottle with white screw cap closure. 100ml
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Weleda (UK) Ltd Heanor Road Ilkeston
Derbyshire DE7 8DR, UK
8 MARKETING AUTHORISATION NUMBER(S)
THR 00298/0291
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/04/2013
10 DATE OF REVISION OF THE TEXT
29/04/2013