Kaloba: 30 Tablets

Product Information

film-coated tablet contains 20 mg of extract (as dry extract) from the roots of Pelargonium sidoides DC (1 : 8 - 10) (EPs® 7630) Extraction solvent 11% ethanol (w/w). Adults and children 12+ should take one tablet three times a day (morning, midday, evening). Tablets should be swallowed whole with a little water. The tablets should not be chewed. If you suffer from an increased tendency to bleeding and/or take anti-coagulating drugs such as warfarin, there is a theoretical risk that taking this product may increase the risk of bleeding. Round, reddish-brown, smooth surface film coating without ruptures. 4 Clinical particulars 4.1 Therapeutic indications

In the UK, the National Institute for Health and Care Excellence (NICE) suggests that some people may wish to try Pelargonium as a “self-care treatment”, which has “limited evidence of some benefit for the relief of cough symptoms” [ 32]. There is currently sufficient evidence to recommend the use of Pelargonium sidoides root extract to warrant undertaking a high quality independent clinical trial. Feasibility outcomes were: recruitment rate, withdrawal rate from the study, return rate of patient diaries, percentage of completion of patient diaries, compliance with medication according to diary data and returned medication, type of antibiotic prescription given (i.e. immediate/delayed/not given), percentage of patients who took antibiotics, time to antibiotic usage, mean symptom severity (at days 2–4), percentage of patients resolved, time to resolution of symptoms and duration of treatment with herbal medication. The minimum key outcome dataset from the diaries was considered to be [ 1] antibiotic use in the 28 days post randomisation, [ 2] no longer experiencing moderate symptoms for two consecutive days and [ 3] study medication use. A health economic study was a part of the feasibility study which aimed to develop the methods of data collection both for quality of life and for usage of key resources for the design of the future phase III trial. Film-coating: Hypromellose 5 mPas, Macrogol 1500, iron oxide yellow E 172, iron oxide red E 172, titanium dioxide E 171, talc, simeticone, methylcellulose, sorbic acid. Several clinical trials and a Cochrane review have concluded that Pelargonium sidoides root extract may be effective at relieving symptoms of acute bronchitis in both adults and children, but the overall quality of the evidence was considered low [ 30]. Three small randomised controlled trials in acute bronchitis in adults were included and showed inconsistent but overall positive results for resolution of symptoms (all symptoms, cough and sputum production). Three additional studies in acute bronchitis in children were included showing similar inconsistent but positive findings. In adults, symptoms were consistently improved after seven days with an effect observed in individual scale items after 4 days. In a review of the bronchitis severity score (BSS), which included 17 studies of Pelargonium sidoides (11 adult and 8 children) a difference in BSS was seen by day 3–5 [ 31]. The Cochrane review suggested that the liquid formulation may be more effective than the tablets although the number of trials was insufficient to prove this. All the studies included in the review of the BSS showed symptomatic improvement following treatment with Pelargonium sidoides regardless of dosage form [ 31]. Pelargonium sidoides tablets are available in the UK and are likely to be more readily available internationally than liquid preparations but it is not clear whether liquid preparations are potentially more efficacious. There is no direct comparative data on tablet and liquid formulations and hence some there is uncertainty over their relative acceptability for consumption. In very rare cases (≤ 1/10,000), serious hypersensitivity reactions with swelling of the face, dyspnoea and drop in blood pressure may occur.This is the first feasibility trial to be conducted on the use of a herbal medicine for acute bronchitis in UK primary care. A strength of this trial is the use of both quantitative and qualitative methods to explore several feasibility aspects. The trial was not powered to detect effectiveness, so we are unable to comment on the effectiveness of the herbal medicine. However, there was no evidence of any serious side-effects due to the intervention and the patient withdrawal rate was low. Although the study was only open for 9 months as opposed to the 12 months initially planned, we recruited at a faster rate than anticipated. film-coated tablet contains 20 mg of extract (as dry extract) from the roots of Pelargonium sidoides DC (1 : 8 – 10) (EPs® 7630) Extraction solvent 11% ethanol (w/w). In rare cases (≥1/10,000 to ≤ 1/1,000), mild bleeding from the gums 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 occur after the first intake of the product. Kayser O, Kolodziej H. Antibacterial activity of extracts and constituents of Pelargonium sidoides and Pelargonium reniforme. Planta Med. 1997;63(6):508–10. Willcox M, Donovan E, Hu X-Y, Elboray S, Jerrard N, Roberts N, et al. Views regarding use of complementary therapies for acute respiratory infections: systematic review of qualitative studies. Complementary Therapies in Medicine. 2020;50:102382.

In addition to the trial treatment, GPs were allowed to select the clinically appropriate prescribing strategy as per practice policy, no antibiotics or to prescribe antibiotics, either to be taken immediately, or as a “delayed” prescription. OutcomesSerious hypersensitivity reactions with swelling of the face, breathlessness and decrease in blood pressure. Bao Y, Gao Y, Koch E, Pan X, Jin Y, Cui X. Evaluation of pharmacodynamic activities of EPs(R) 7630, a special extract from roots of Pelargonium sidoides, in animals models of cough, secretolytic activity and acute bronchitis. Phytomedicine. 2015;22(4):504–9. This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. 4.7 Effects on ability to drive and use machine This formulation is not suitable for children under 12 years of age. 4.5 Interaction with other medicinal products and other forms of interaction