Kaloba 20mg / 1.5ml

Drops

Composition:

Tablets. Active ingredient: one film-coated tablet contains 20 mg of dried liquid extract of the roots of Pelargonium sidoides (1: 8 -10) (EPs® 7630). The extracting agent is 12% (v / v) ethanol. Drops. Active ingredient: 10 g (= 9.75 ml) of solution contain 8.0 g of extract of the roots of Pelargonium sidoides (1: 8 - 10) (EPs® 7630). The extractive agent is ethanol a1 12% (v / v). For the full list of excipients see section 6.1.

Excipients

Tablets. Maltodextrin, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, precipitated silica, magnesium stearate, hypromellose 5 mPas, macrogol 1500, yellow iron oxide E172, red iron oxide E 172, titanium dioxide E 171, talc, simethicone, methylcellulose, sorbic acid. Drops. 85% glycerol.

Therapeutic indications

KALOBA is a medicinal product of plant origin of traditional use for the relief of the common cold, based solely on long-term use and whose therapeutic effect has not been demonstrated in controlled clinical studies.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Increased bleeding tendency. Taking drugs that inhibit clotting. Severe liver and kidney disease, as there is insufficient experience in these cases. Pregnancy or breastfeeding. Children under 12 years of age.

Dosage

Tablets. Adults and adolescents over 12 years of age take 1 tablet 3 times a day (in the morning, at noon and in the evening). KALOBA should be taken with some liquid, without chewing it. Drops. Adults and adolescents over 12 years of age take 30 drops 3 times a day. The drops can be taken directly with a spoon or diluted in a little liquid in the morning, at noon and in the evening. Duration of treatment: the maximum duration of therapy is 7 days.

Warnings and Precautions

Consult a doctor or a qualified healthcare professional if symptoms persist during use of the medicinal product or if adverse reactions not mentioned in the package leaflet occur. Consult a doctor if your condition does not improve within a week, if you have a fever that lasts for several days, or if you have tachypnea or hemoptysis (blood in the spit). Tablets. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine. Drops. This medicinal product contains 12% (v / v) ethanol (alcohol) which corresponds to 180 mg of alcohol for each single dose (30 drops) equivalent to 3.6 ml of beer or 1.5 ml of wine: it can be harmful to alcoholics; to be taken into consideration in adolescents and high-risk groups such as people with liver disease or epilepsy. Avoid concomitant use of other alcohol-containing products.

Interactions

No information is available regarding possible interactions with other medicinal products. If the patient is already being treated with drugs, it is necessary to take the product after consulting the doctor. Due to the possible influence on coagulation parameters, it cannot be excluded that the product increases the effects of anticoagulant drugs taken concomitantly such as phenprocoumon and warfarin.

Side effects

Assessment of adverse reactions is based on the following information on frequency: very common: more than 1 in 10 people treated common: less than 1 in 10 but more than 1 in 100 people treated uncommon: less than 1 in 100 but more than 1 in 1000 people treated rare: less than 1 in 1000 but more than 1 in 10,000 people treated very rare: less than 1 in 10,000 people treated, including cases with unknown frequency Gastrointestinal disorders: Uncommon: stomach pain, heartburn , nausea or diarrhea. Rare: mild gingival bleeding. Respiratory, thoracic and mediastinal disorders: Rare: slight nasal bleeding. Skin and subcutaneous tissue disorders / Immune system disorders: Rare: hypersensitivity reactions (type-I reactions with rash, urticaria, itching of the skin and mucous membranes; type-II reactions with formation of antibodies). Very rare: severe hypersensitivity reactions with swelling of the face, dyspnoea and drop in blood pressure. Hepatobiliary disorders: Very rare: impaired liver function; the causal link between this finding and the use of the product has not been demonstrated.

Pregnancy and breastfeeding

Safety during pregnancy and breastfeeding has not been established. As a precautionary measure, due to lack of data, use during pregnancy and lactation is contraindicated.