Kaloba - common cold treatment 21 sachets

Product Description

Preparation for cough and cold-related illnesses.

Indications

Kaloba is a traditional herbal medicine indicated for the symptomatic treatment of the common cold in adults and children over 6 years of age.

The use of this traditional herbal medicine, for the indicated therapeutic indications, is based exclusively on many years of experience.

Composition

Active ingredients

One 800 mg sachet of granules contains; active ingredient: 20 mg of extract (as dried liquid extract) of Pelargonium sidoides D C, radix (Pelargonium root) (1:8 - 10) (EPs 7630).
Extraction solvent: ethanol 12% (v/v).

Excipients

Maltodextrin, xylitol, colloidal anhydrous silica.

Directions for use and Dosage

Adults and adolescents over 12 years of age: the recommended dose is 1 sachet, as a single dose, repeated 3 times a day.
Children aged between 6 and 12 years: the recommended dose is 1 sachet, as a single dose, repeated 2 times a day.
Duration of treatment: the maximum duration of treatment is 7 days. days.
If symptoms persist, consult a doctor.
Special populations: No information is available on patients with hepatic and renal impairment.
Paediatric population: The safety and efficacy of KALOBA in children under 6 years of age have not yet been established.
Method of administration: Hold the sachet on the side with the indicated line and shake briefly to release the contents.
Tear the sachet along the indicated line.
The granules can be poured directly into the mouth.
The granules dissolve in saliva and can be swallowed. be swallowed directly: this allows it to be used without water.
Liquids can be drunk at the same time.

Warnings

Cases of hepatotoxicity and hepatitis have been reported in association with the administration of the medicinal product.
In the presence of signs of hepatotoxicity, administration of the medicinal product must be stopped immediately and a re-evaluation of the case is necessary.
Treatment must also be stopped in case of tachypnoea or haemoptysis.

Contraindications

Hypersensitivity to the active substance or to any of the excipients; tendency to bleeding; taking drugs that inhibit coagulation; severe renal insufficiency; severe hepatic insufficiency.

Undesirable effects

The evaluation of adverse reactions is based on the following information regarding frequency: very common (> 1/10); common (>=1/100, < 1/10); uncommon (>1/1,000, <1/100); rare (>=1/10,000, <1/1,000); very rare (<1/10,000); not known: frequency cannot be estimated from the available data.
Gastrointestinal disorders.
Uncommon: stomach pain, heartburn, nausea, vomiting, dysphagia and diarrhoea; rare: mild gingival bleeding.
Respiratory, thoracic and mediastinal disorders.
Rare: mild nasal bleeding.
Immune system disorders.
Rare: hypersensitivity reactions (exanthema-type reactions, urticaria, pruritus of the skin and mucous membranes; type II reactions with antibody formation); very rare: severe hypersensitivity reactions with facial swelling, dyspnoea and drop in blood pressure.
Hepatobiliary disorders.
Frequency not known: hepatotoxicity.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.

Interactions

No interaction studies have been performed.
Due to the possible influence on coagulation parameters, it is not possible to It can be excluded that KALOBA increases the effects of concomitantly taken anticoagulant drugs such as phenprocoumon and warfarin.

Pregnancy and breastfeeding

Safety during pregnancy and breastfeeding has not been established.
The administration of KALOBA during pregnancy and breastfeeding is not recommended and should be considered only if the expected benefit to the mother outweighs the risk to the fetus or child.

Format

21 sachets