KALOBA SCIR FL100ML 20MG/7,5ML

CALOBA SYRUP

active ingredients

100 g (= 93,985 ml) of syrup contain: Active ingredient: 0.251 g of extract (as dried liquid extract) of Pelargonium sidoidedC, radix (Pelargonio Root) (1:8-1O) (EPs 7630). Extraction solvent: ethanol 12% (v/v). For the full list of excipients see paragraph 6.1.

Excellent

Maltodextrin, xylitol, glycerol 85%, citric acid anidro, potassium sorbate, xanthan rubber, purified water.

Therapeutic indications

Traditional vegetable medicine indicated for the symptomatic treatment of common cold in adults and children over the age of 6. 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 paragraph 6.1; - Trend in bleeding; - Assumption of drugs that inhibit coagulation; - Severe kidney failure; - Severe liver failure.

Population

Population. Adults and teenagers over the age of 12: the recommended dose is 7.5 ml syrup (corresponding to 20 mg of pelargon extract) 3 times a day. Children aged between 6 and 12 years: the recommended dose is 5 ml syrup (corresponding to about 13 mg of pelargon extract) 3 times a day. 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 6 have not yet been established. Method of administration: The dispenser glass attached to the packaging has different markings. The syrup can be drunk directly from the dispenser or transferred to a spoon.

Conservation

This medicine does not require any special condition of conservation. Note: Because KALOBA is a natural product, there may be variations in color and taste.

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.

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: (≥1/10.000,
Very rare:
Notable: frequency cannot be defined on the basis of available data

Gastrointestinal diseases. Not common: stomachache, heartburn, nausea and diarrhea; Rare: mild gum bleeding. Respiratory, thoracic and mediastinic pathologies. Rare: slight nasal bleeding. Immune system disorders. Rare: reactions of hypersensitivity (reactions-type-I with exantema, hives, 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. Very rare: alterations of liver function. 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/segnalazioni-reazioni-avverse.

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