Kaloba SPC
1 Name of the medicinal product
- Kaloba Pelargonium Cough and Cold Relief oral drops
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.
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
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
Kaloba is not to be used in the following cases:
- hypersensitivity to the active substance or to the excipient,
- increased tendency to bleeding and application of coagulation-inhibiting drugs,
- severe hepatic and renal diseases, as no adequate data are available in these areas,
- pregnancy and lactation
- children < 6 years.
4.4 Special warnings and precautions for use
In the package leaflet, the patient is advised to consult a doctor immediately if his or her condition does not improve within one week, in case of fever lasting for several days or in case of shortness of breath or bloody sputum.
Kaloba oral solution contains 12 vol % ethanol (alcohol).
This corresponds to:
180 mg alcohol equivalent to 3.6 ml beer or 1.5 ml wine per adults´single dose (30 drops)
120 mg alcohol equivalent to 2.4 ml beer or 1.0 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
Drug interactions have not been reported to date.
However, due to the potential influence of Kaloba on coagulation parameters, the possibility that this product enhances the effect of coagulation-inhibiting drugs such as warfarin in cases of simultaneous intake cannot be excluded (see section 4.3).
4.6 Pregnancy and lactation
This product should not be used in women who are pregnant or breast-feeding, as there are no data available for these patient groups.
4.7 Effects on ability to drive and use machines
Kaloba has no or negligible influence on the ability to drive and use machines.
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 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. Such reactions may already occur at the first intake of the pharmaceutical product.
In very rare cases (≤ 1/10,000), serious hypersensitivity reactions with swelling of the face, dyspnea and drop of blood pressure may occur.
In single cases, signs indicating disturbances of liver function have been reported after intake of Kaloba; the causal relationship between this effect and the application of the product has not been demonstrated.
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.
5 Pharmacological properties
5.1 Pharmacodynamic properties
Not required.
5.2 Pharmacokinetic properties
Not required.
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 Pharmaceutical particulars
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
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, 50 ml oral solution.
6.6 Special precautions for disposal and other handling
No special requirements.
7 Marketing authorisation holder
Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Str. 4
D-76227 Karlsruhe
Germany
Distributed in the UK by:
Schwabe Pharma (UK) Limited
Alexander House
Mere Park
Dedmere Road
Marlow
Buckinghamshire
SL7 1PD
8 Marketing authorisation number(s)
THR 05332/0003
9 Date of first authorisation/renewal of the authorisation
26th March 2008
10 Date of revision of the text
3rd September 2013