Kaloba 21 Tablets

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Indications
- Symptomatic treatment of the COMMON COLD. Its use is based exclusively on traditional use.

Posology
- Adults, oral:
Oral drops: 30 drops, 3 times a day.

- Children, oral:

Children over 12 years old: Same as adults.

Children 6-12 years: 20 drops, 3 times a day.

Children 2-5 years: 10 drops, 3 times a day.

Children under 2 years of age: Safety and efficacy have not been evaluated.

The duration of treatment is 7 days, although it could be used for an additional 2-3 days to prevent relapses. Treatments longer than 2 weeks are not recommended.

- Oral drops: The drops can dissolve in some liquid.

Interactions
- Oral anticoagulants. Pelargonium may enhance the effects of oral anticoagulants. It is recommended to avoid the association. It has been proven that pelargonium does not interact with penicillin V.

Adverse reactions
- Digestive: [NAUSEA], [DIARRHEA], [GASTRICAL HYPERACIDITY] and [GASTRALGIA].- Hepatic: [INCREASED TRANSAMINASES], although the causal relationship has not been proven.- Allergic: [HYPERSENSITIVITY REACTIONS], with [EXANTEMATIC ERUPTIONS], [URTICARIA], [PRURITUS]. Rarely more serious cases with [CUTANEOUS EDEMA], [DYSSNEA] and [HYPOTENSION].- Hematological: [HEMORRHAGE], with [GINGIVAL HEMORRHAGE] and [EPISTAXIS].

Advice to the patient
- Do not use for more than 2 weeks in a row. - It is recommended to drink plenty of water and other liquids during treatment. - If fever or difficulty breathing appears, consult your doctor and/or pharmacist.

Overdose
Symptoms: There is no clinical experience in overdose with pelargonium. Treatment: Symptomatic treatment will be instituted. In case of overdose or accidental ingestion, go to a medical center or consult the Toxicological Information Service, indicating the product and the amount ingested.

Composition
10 g (= 9.75 ml) of solution contains 8.0 g of Pelargonium Sidoides root extract (1:8-10) with an ethanol content of 11% m/m. Per tablet: 20 mg of dried liquid extract of the root from the root of Pelargonium Sidoides (1:8-10).

Precautions regarding excipients
- This medicine contains ethanol. It is recommended to check the composition to know the exact amount of ethanol per dose. * Amounts less than 100 mg/dose are considered small and are not usually harmful, especially in children. * Amounts greater than 100 mg/dose may be harmful to people with [CHRONIC ALCOHOLISM], and should also be taken into account in pregnant and lactating women, children, and in high-risk groups, such as patients with [HEPATOPATHY] or [EPILEPSY ]. * Amounts greater than 3 g/dose may impair the ability to drive or operate machinery, and may interfere with the effects of other medications.

Doping
This medicine contains alcohol. Its intake is prohibited during competition in certain sports. Detection will be carried out by breath and/or blood analysis. The anti-doping rule violation threshold (hematological value) is 0.1 g/l in the following sports: aeronautics, motorsports, motorcycling, motorboating and archery. Alcohol is considered a specific substance and, therefore, a violation of the rule in which this substance is involved can cause a reduction in sanction as long as the athlete can demonstrate that the use of the specific substance in question was not with the intention of increase your sports performance.

Contraindications
- Hypersensitivity to pelargonium or any component of the medication. - Severe liver and kidney diseases. Safety and efficacy have not been evaluated.- [PEPTICA ULCER]. Possible worsening and increased risk of gastric bleeding.- [COAGULATION ALTERATIONS], or patients treated with oral anticoagulants. It could increase the risk of bleeding.

Precautions
- [HEPATOPATHY]. Cases of elevations in transaminases have been reported, although it has not been possible to directly relate this to pelargonium. It is recommended to use with caution in patients with liver diseases, avoiding it in severe cases (see Contraindications). It is recommended to periodically monitor transaminase levels, and in case of a significant and unjustified increase, suspend treatment.- History of peptic ulcer. Pelargonium has been linked to digestive problems such as gastric hyperacidity and stomach pain. In addition, it must be taken into account that it has a certain capacity to alter coagulation. In patients who have suffered from a peptic ulcer in the past, they could favor the appearance of a new erosion, with a greater probability of gastric bleeding. Therefore, extreme caution is advised in these patients. If symptoms of gastroduodenal erosion are observed, such as nausea, vomiting, gastric hyperacidity or pain in the epigastric area, it is recommended to suspend the administration of harpagofito.- [RESPIRATORY INFECTION]. It could mask symptoms of respiratory infections. If the patient describes fever, dyspnea or purulent sputum, it is recommended to reevaluate the diagnosis.

Pregnancy
There are no adequate and well-controlled studies in pregnant women, so the use of pelargonium during pregnancy is only accepted in the event that there are no safer therapeutic alternatives, the benefits outweigh the possible risks.

Lactation
It is unknown whether pelargonium components are excreted with breast milk, and the possible consequences this could have for the nursing infant. It is advisable to stop breastfeeding or avoid its use during breastfeeding.

Children
Safety and efficacy have not been evaluated in children under 12 years of age (tablets) or 2 years of age (oral drops), so it is recommended to avoid its use.

Seniors
No specific problems have been described in the elderly.

Period of validity
20 and 50 ml bottles: 3 months after opening the container. 100 ml bottles: 6 months after opening the container.

Special warnings
- If the patient presents fever, dyspnea or purulent sputum, the existence of a respiratory infection will be investigated.