Kaloba Pelargonium Cough And Cold Relief Oral Drops
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kaloba Pelargonium Cough & Cold Relief oral drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
10 g (= 9.75 ml) of oral solution contains 8.0 g extract from the roots of Pelargonium sidoides DC (1: 8 - 10) (EPs® 7630).
Extraction solvent: 11% ethanol (w/w).
1 ml (approximately 20 drops) of Kaloba Oral Drops, solution contains 120 mg 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
Light brown to reddish 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
Adults and adolescents over the age of 12:
Take 30 drops three times per day.
Children aged between 6-12 years: Take 20 drops three times per day.
Not recommended for use in children under 6 years of age.
The necessary amount of drops may be taken directly from a spoon or, if preferred, can be mixed with half a glass of water and the contents of the entire glass should be drunk straightaway.
The dose should be taken in the morning, at midday and in the evening.
20 drops is equivalent to approximately 1ml 30 drops is equivalent to approximately 1.5ml.
Duration of application
If symptoms worsen, or do not improve after one week, a doctor or a qualified healthcare practitioner should be consulted.
After relief of symptoms, continuation of treatment for further 2 - 3 days is recommended in order to prevent a relapse, however treatment duration should not exceed 2 weeks.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients Severe hepatic diseases
4.4 Special warnings and precautions for use
Do not exceed the stated dose
The use in children under 6 years of age has not been established due to lack of adequate data.
If symptoms worsen, or do not improve after one week, a doctor or a qualified healthcare practitioner should be consulted.
If fever, shortness of breath or blood in the sputum occurs, a doctor or a qualified healthcare practitioner should be consulted.
Hepatotoxicity and hepatitis cases have been reported in association with the administration of the medicinal product. The causal relationship between this finding and the use of the product has not been demonstrated. Patients should stop taking this product immediately and consult their doctor if they develop signs and symptoms that suggest liver dysfunction (fatigue, anorexia, yellowing of the skin and eyes or severe stomach pain with nausea and vomiting or dark urine.)
Kaloba oral solution contains 12 vol % ethanol (alcohol). This corresponds to:
- 125 mg alcohol equivalent to 2.5 ml beer or 1.0 ml wine per adults'single dose (30 drops)
- 84 mg alcohol equivalent to 1.7 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.
4.5 Interaction with other medicinal products and other forms of interaction
None reported.
4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data 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 effects on the ability to drive and use machines have been performed.
This product contains ethanol (alcohol) (See Section 4.4. ‘Special warnings and precautions for use’).
4.8 Undesirable effects
The evaluation of adverse reactions is based on the following information on frequency:
|
Very common: more than 1 out of 10 treated persons |
Common: more than 1 out of 100 treated persons |
|
Uncommon: more than 1 out of 1000 treated persons |
Rare: more than 1 out of 10 000 treated persons |
|
Very rare: 1 or less out of 10 000 treated persons including single cases | |
Gastro-intestinal complaints such as stomach pain, heartburn, nausea, vomiting, dysphagia or diarrhoea may occur uncommonly (> 1/1,000 to < 1/100) during treatment with Kaloba.
In rare cases (>1/10,000 to < 1/1,000), mild bleeding from the gingiva or nose may occur. Furthermore, hypersensitivity reactions (e.g. exanthema, urticaria, pruritus of skin and mucous membranes) have been described in rare cases.
In very rare cases (< 1/10,000), serious hypersensitivity reactions with swelling of the face, dyspnea and decrease in blood pressure may occur.
Hepatotoxicity (including hepatitis, liver dysfunction of different origin) has been reported. The causal relationship between this finding and the use of the product has not been demonstrated. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care 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
The effects of overdose are unknown.
Although there are no data on cases of overdose, overdose is likely to increase side effects. Thus, treatment should be symptomatic and as clinically indicated.
Overdose of this product may result in alcohol intoxication and should be treated accordingly.
The amount of alcohol in a full bottle is
1.68 g equivalent to 33 mls of beer or 13 mls of wine in a 20ml bottle.
4.20 g equivalent to 83 mls of beer or 33 mls of wine in a 50ml bottle.
8.40 g equivalent to 165 mls of beer or 66 mls of wine in a 100ml bottle.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per article 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per article 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
6.1 List of excipients
Glycerol 85%
Ethanol
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Unopened:
2 years In-use:
- for bottles with 20 ml and 50 ml: 3 months
- for bottles with 100 ml: 6 months
6.4 Special precautions for storage
Do not store above 30°C.
6.5 Nature and contents of container
Brown glass bottles, hydrolytic class III (Ph. Eur.), with dropper tip and screw cap (PP/PE), in pack sizes of 20 ml or 50 ml oral solution.
6.6 Special precautions for disposal
No special requirements.
7. MARKETING AUTHORISATION HOLDER
Dr. Willmar Schwabe GmbH & Co. KG Willmar-Schwabe-Str. 4 D-76227 Karlsruhe Germany
8 MARKETING AUTHORISATION NUMBER(S)
THR 05332/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/03/2008
10 DATE OF REVISION OF THE TEXT
18/02/2015