KALOBA OS GTT 20ML

KALOBA COMPRESSE RIVESTITE WITH FILM.

active ingredients

Tablets. A movie-coated tablet contains: Active ingredient: 20 mg of extract (as dried liquid extract) of Pelargonium sidoides DC, radix (Pelargonio Root) (1:8 - 10) (EPs 7630). Extraction solvent: ethanol 12% (v/v). Excipient with known effects: lactose monohydrate. Drops. 10g (= 9,75ml) of solution contain: Active ingredient: 8.0g of extract (as liquid extract) of Pelargonium sidoides DC, radix (Pelargonio Root) (1: 8 - 10) (EPs 7630). Extraction solvent: ethanol 12% (v/v). For the full list of excipients see paragraph 6.1.

Excellent

Tablets. Maltodextrin; microcrystalline cellulose; lactose monohydrate; sodium croscarmellosa; silice precipitated; magnesium stearate; ipromellose 5 mPas; macrogol 1500; iron oxide yellow E 172; iron oxide red E 172; titanium dioxide E 171; talc; symeticons; methylcellulose; sorbial acid. Drops. 85%.

Therapeutic indications

Traditional vegetable medicine indicated for the symptomatic treatment of common cold in adults and adolescents over the age of 12. The use of this traditional medicinal product of vegetable origin, for the therapeutic indications indicated, is based exclusively on the experience of multiannual use.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. - Bloody tendency. - Assumption of drugs that inhibit clotting. - Severe kidney failure. - Severe liver failure.

Population

Population Tablets. Adults and teenagers over 12 years: the recommended dose is 1 tablet 3 times a day. Drops. Adults and adolescents over 12 years: the recommended dose is 30 drops (corresponding to about 20 mg of dried pelargonal liquid extract) 3 times a day. 30 drops of solution correspond to about 1.5 ml of solution. Duration of treatment The maximum duration of treatment is 7 days. Special popularity Information about patients with liver and kidney impairment is not available. Pediatric population The safety and effectiveness of KALOBA in children under the age of 12 have not yet been established. Method of administration Tablets. KALOBA must be taken with a little liquid, without being chewed. Drops. KALOBA can be taken directly with a spoon or diluted in some liquid.

Conservation

Tablets. This medicine does not require any special condition of conservation. Drops. Do not store at temperature above 30°C. Note: Extracts based on plants in liquid form can inflate with time; this does not affect the effectiveness of the product. Since KALOBA is a natural product, slight variations in color and taste may occur.

Warnings

Hepatotoxicity and hepatitis were reported in conjunction with the administration of the medicinal product. In the presence of signs of hepatotoxicity the administration of the medicinal product must be interrupted immediately and a revaluation of the case is necessary. Treatment should also be interrupted in case of tachypnea or hemottisis. Important information about some excipients Tablets. KALOBA contains lactose. Patients suffering from rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose mal absorption should not take this medicine. Drops. KALOBA contains ethanol (alcohol) to 12% (v/v) 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 per dose. It can be harmful to alcoholics. To be taken into account in pregnant or nursing women, children and high-risk groups such as people with liver or epilepsy disorders. Avoid the concomitant use of other products containing alcohol.

Interactions

Interaction studies have not been carried out. Due to the possible influence on the parameters of the coagulation, it cannot be excluded that KALOBA increases the effects of anticoagulant drugs assumed in conjunction with fenprocumone and warfarin.

Effects

The evaluation of adverse reactions is based on the following frequency information:

Very common: (>1/10)	City: (≥1/100,
Not common:,	Rare: (≥1/10000,
Very rare:
Notable: frequency cannot be defined on the basis of available data

Gastrointestinal diseases: Not common: stomachache, heartburn, nausea, vomiting, disfaction and diarrhea. Rare: mild gum bleeding. Respiratory, chest and mediastinic pathologies: Rare: slight nasal bleeding. Immune system disorders: Rare: reactions of hypersensitivity (reactions-type-I with exantema, hive, itching of the skin and mucous membranes; reactions-type-II with antibodies formation). Very rare: severe hypersensitivity reactions with swelling of the face, dispnea and decrease of blood pressure. Hepatobiliary diseases: Frequency not known: hepatotoxicity. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/ reports-reactions-adverse.

Overdosing

There is no information about overdose cases, however overdose could increase the frequency of appearance and/or severity of unwanted effects. The treatment of overdose must be symptomatic.

Safety during pregnancy and nursing with breast milk has not been established. The administration of KALOBA during pregnancy and nursing with breast milk is not recommended and should be taken into account only if the expected benefit for the mother exceeds the risk for the fetus or child.

Source: Farmadati