If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or healthcare practitioner. Side-effects If you take more than the recommended dose, speak to your doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you. You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.yellowcard.gov.uk. Alternatively you can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call Freephone 0808 100 3352 (available 10am–2pm Monday – Friday). How to store this product Kaloba is a herbal medicinal product made from Pelargonium root (Pelargonii radix) (Capeland Pelargonium) for the symptomatic treatment of acute bronchial infections with cough and mucus production. Kaloba is an orange to light brown, viscous syrup. 4. Clinical particulars 4.1 Therapeutic indications

Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18–21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. Conclusions

MLW: Conceptualisation, funding acquisition, investigation, methodology, formal analysis, supervision, writing – original draft, review and editing. CS: investigation, methodology, project administration, resources, supervision, validation, visualisation, writing – review and editing. SW: Formal analysis, writing – review and editing. BLS: Conceptualisation, Formal analysis, methodology, software, visualisation, writing – original draft, review and editing. DS: Investigation, project administration, formal analysis, writing – review and editing. AW: Conceptualisation, Methodology, software, Formal analysis. AM: project administration, investigation. EW: Data curation. SZ: Formal analysis (health economics), writing – original draft, review and editing. GY: Formal analysis (health economics), writing – review and editing. FW: Funding acquisition, supervision, writing – review and editing. RY: investigation, writing – review and editing. JB: PPI contributor, conceptualisation, writing – review and editing. MB: PPI contributor, conceptualisation, writing – review and editing. GG: Conceptualisation, methodology, supervision, writing – review and editing. GL: methodology, supervision, writing – review and editing. PL: Conceptualisation, methodology, writing – review and editing. CB: Conceptualisation, methodology, writing – review and editing. ADH: Conceptualisation, methodology, writing – review and editing. MM: Conceptualisation, Funding acquisition, methodology, project administration, supervision, writing – review and editing. The author(s) read and approved the final manuscript. Corresponding author 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. A. Pelargonium sidoides offer several health benefits. They possess antibacterial and antimicrobial properties and aid in treating bronchitis and stomach ailments like diarrhoea and tuberculosis. It is also used in various ethnoveterinary applications. For example, it helps cure dysentery in cattle and anthelmintic remedies in calves. Q. What is Kaloba syrup? Serious hypersensitivity reactions with swelling of the face, breathlessness and drop in blood pressure. Single cases Due to assumptions described above, an evaluation of a different approach to treat cough, instead of synthetic drugs, appears to be interesting. The safeguarding effect of a mechanical barrier in the throat may be considered a well-founded therapeutic approach that indirectly exhibits anti-inflammatory activity and is able to reduce the damage produced by irritant agents or microbes. This protective activity may be acquired from natural substances such as honey and plant extracts.

Kayser O, Kolodziej H. Antibacterial activity of extracts and constituents of Pelargonium sidoides and Pelargonium reniforme. Planta Med. 1997;63(6):508–10. Parents often believe that the administration of honey to relieve cough and improve sleep quality at night is more desirable than the administration of drugs such as diphenhydramine or dextromethorphan. Moreover, evidence from some clinical studies support the use of honey to relieve cough. Results from a study comparing a single dose of honey, dextromethorphan and no treatment indicated that parents view honey as the most favourable treatment for symptomatic relief of nocturnal cough due to upper respiratory tract infection in children aged 2–18 years [ 10]. Kaloba contains Pelargonium sidoides, a member of the geranium family. It has long stalked leaves that are mildly aromatic, heart shaped and velvety. Kaloba Pelargonium Cough & Cold Relief syrup is an orange to light brown syrup. However it is a natural product and therefore slight variations in colour and taste may occur. This product also contains the following ingredients:Children were orally treated with KalobaTUSS ® or placebo for 8 days. Children receiving KalobaTUSS ® showed an early and significant reduction in night-time and day-time cough scores measured using a specific scale and a shorter duration of cough than children treated with the placebo. Conclusions Tell your doctor or pharmacist if any of the above side-effects becomes serious or if you notice any other side-effects not listed above. a Whitehead A, Simpson C, Willcox M, Webley F, Hay AD, Butler C, et al. HATRIC: a study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for the treatment of acute cough due to lower respiratory tract infection in adults—study protocol for a double blind, placebo-controlled randomised feasibility trial. Pilot and Feasibility Studies. 2019;5(1):98. A. The leaves and other parts of the pelargonium sidoides herb have been traditionally used for medicinal purposes for a very long time. They have proven beneficial in many health conditions like tuberculosis, respiratory tract infections, diarrhoea, etc. In addition, its leaves also possess antifungal properties. Q. What is a pelargonium root? Of the 127 eligible patients not randomised, in 69 cases this was because the patient declined, and 51 of these gave a reason. Most frequent were concerns about the medication (21/51 patients: 5 didn’t want a placebo; 5 were concerned about potential side-effects; 4 didn’t want to take more medicines; 2 didn’t want a herbal medicine; 2 did not want the liquid preparation; 1 did not want the tablets; 2 wanted antibiotics). Second most frequent (12/51) were patients who were too busy to participate or had personal circumstances which would make it difficult (planned holiday, unwell family member). Nine patients felt either that they were too unwell to take part [ 6] or that they were improving and didn’t need to take anything [ 2] or that taking part would make them too anxious [ 1]. Three patients stated that they just didn’t want to be involved in research. Five patients specifically mentioned that they wouldn’t be good at completing the diary and one would have had to travel to another branch surgery of his GP practice to be recruited.

The use of this product in children or adolescents under 6 years of age is not recommended because data are not sufficient and medical advice should be sought. 4.5 Interaction with other medicinal products and other forms of interaction It is recommended to continue treatment for several days after symptoms have subsided to avoid relapse.One of the primary benefits of pelargonium sidoides is their effectiveness in treating acute bronchitis. That is because it enhances the body’s natural healing ability. According to research, almost 50% of people with acute bronchitis who supplemented it entirely recovered their symptoms within a week. Some individuals experienced benefits within two to three days. In the patient information 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 blood in the sputum. We conducted a randomized, double blind, placebo-controlled clinical trial of 106 children with acute cough to evaluate the efficacy and safety of KalobaTUSS ®, a paediatric cough syrup based on acacia honey and on Malva sylvestris extract, Inula helenium extract, Plantago major extract, and Helichrysum stoechas extract by using a validated 6 points Likert scale. Results

Moreover, the pharmacological uses of Pelargonium sidoides must take notice of the vast context involving the need for conservation-friendly approaches in its applications. In this consideration, plant biotechnology implementations can play a significant role in an integrated preservation strategy. Frequently Asked Questions (FAQs) Q. What are the common brands for Pelargonium sidoides?No studies on the effects on the ability to drive and use machines have been performed. 4.8 Undesirable effects The World Health Organization has identified honey as a possible demulcent treatment for cough [ 7, 8]. Demulcent is a substance that is usually based on polysaccharides, covers the throat and reduces pain when the mucosa is irritated by increasing saliva production to reduce the cough reflex [ 9].