Phytocon Pelargonium Oral Drops
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PhytoCon Pelargonium oral drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
10 g (= 9.7 ml) of oral solution contains 8.0 g extract from the roots of Pelargonium sidoides DC (1:8-10)
Extraction solvent: Ethanol 15% (V/V)
1 ml (approximately 26 drops) of the product contains 0.12 ml ethanol (alcohol) equivalent to 2.4 ml beer or 1.0 ml of wine.
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Oral drops, solution.
Clear, reddish brown to brown solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Traditional herbal medicinal product used to relieve the symptoms of upper respiratory tract infections including common cold, such as sore throat, cough and blocked or runny nose, based on traditional use only.
4.2 Posology and method of administration
For oral use.
Adults, Elderly and children over 12 years: 30 drops three times per day Children from 6 to 12 years: 20 drops three times per day
The use in children under 6 years of age is not recommended (see section 4.4 “Special warnings and precautions for use”).
The drops should be taken undiluted or with a small quantity of water, followed by a sufficient amount of liquid (preferably a glass of drinking water).
20 drops is equivalent to approximately 0.74 ml.
30 drops is equivalent to approximately 1.11 ml.
Duration of application
After relief of symptoms, continuation of treatment for a further 2-3 days is recommended in order to prevent a relapse, however treatment duration should not exceed 2 weeks.
If the symptoms persist during the use of the product, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients. Patients with increased tendency to bleeding.
Patients using coagulation-inhibiting drugs.
Patients with severe hepatic and renal diseases.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Medical advice should be sought if the symptoms persist for more than one week, or in cases of fever lasting for several days or in case of shortness of breath or bloody sputum.
The product contains 12 vol % ethanol (alcohol).
This corresponds to:
0.133 ml alcohol equivalent to 2.7 ml beer or 1.1 ml wine per adults’ single dose (30 drops).
0.089 ml alcohol equivalent to 1.8 ml beer or 0.7 ml wine per children’s single dose (20 drops).
Harmful for those suffering from alcoholism. To be taken into account in children and high-risk groups such as patients with liver disease, or epilepsy.
The use in children under 6 years of age is not recommended due to lack of adequate data.
4.5 Interaction with other medicinal products and other forms of interaction
Drug interactions have not been reported.
However, due to the potential effect of the product on coagulation parameters, this product may enhance the effect of coagulation-inhibiting drugs such as warfarin and should not be taken concomitantly with these drugs (see section 4.3).
Contains alcohol, and should therefore be avoided in patients taking other medications known to interact with alcohol (e.g. metronidazole).
4.6 Fertility, pregnancy and lactation
Safety 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 on the ability to drive and use machines have been performed.
This product contains alcohol (see Section 2).
4.8 Undesirable effects
The following adverse reactions have been reported. The frequency is not known.
Gastrointestinal complaints, such as stomach pain, heartburn, nausea or diarrhoea. Increased risk of bleeding.
Hypersensitivity (e.g. oedemas, rash or pruritus on the skin or mucosa).
Serious hypersensitivity reactions with swelling of the face, dyspnea and fall in blood pressure.
Disturbances of liver function have been reported after intake of Pelargonium; the causal relationship between this effect and the application of the product has not been demonstrated.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
4.9
Overdose
No cases of overdose have been reported.
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (2.4 ml in 20 ml; equivalent to 1/10 glass of wine (of 200 ml) respectively) may result in intoxication and should be treated accordingly.
PHARMACOLOGICAL PROPERTIES
5
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
Glycerol
Ethanol (from tincture)
6.2 Incompatibilities
Not known.
6.3 Shelf life
Unopened: 2 years
In-use: stability after first opening of the container: 3 months.
6.4 Special precautions for storage
Do not store above 30 °C.
6.5 Nature and contents of container
A printed carton containing a hydrolytic class III brown glass bottle, incorporating a dropper insert (PE) and a white screw cap (PP).
Pack sizes: 20 ml
6.6 Special precautions for disposal
No special storage precautions.
7 MARKETING AUTHORISATION HOLDER
PhytoCon GmbH & Co KG Koblenzer Str. 48-56 56626 Andernach Germany
8 MARKETING AUTHORISATION NUMBER(S)
THR 34863/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27/10/2011
10 DATE OF REVISION OF THE TEXT
27/10/2011