Kaloba 20 mg 21 film-coated tablets

Kaloba (20 Mg 21 Coated Tablets)

Composition per 400 mg tablet:

20 mg of dried extract (liquid) of the root of Pelargoniuminados DC (1: 8-10) (EPs® 7630)

Extraction agent ethanol 11% (m / m).

Excipients:

Lactose monohydrate (20 mg) and others.

INDICATIONS

- Symptomatic treatment of [COMMON COLD] in adults, adolescents and children> 6 years.

Its use is based exclusively on traditional use.

POSOLOGY

"TABLETS"

- Adults: 1 tablet 3 times (morning, afternoon and evening).

- Children and adolescents <18 years:

* Adolescents> 12 years: the same as adults.

* Children 6-12 years: 1 tablet 2 times a day (morning and night).

* Children <6 years: not recommended.

- Elderly: no specific dosage recommendations have been made.

Duration of treatment: continue treatment for 7 days, being able to extend 2-3 additional days to avoid relapses. In case the symptoms continue or worsen after 7 days, consult with the doctor. The maximum duration is 14 days.

Missed dose: administer the next dose at the usual time. Do not double the next dose.

DOSAGE IN KIDNEY INSUFFICIENCY

No specific dosage recommendations have been made. Its use is contraindicated in severe kidney disease.

DOSAGE IN LIVER INSUFFICIENCY

No specific dosage recommendations have been made. Its use is contraindicated in severe kidney disease.

RULES FOR CORRECT ADMINISTRATION

- Tablets: swallow the tablets whole, without chewing, together with a glass of water.

Administration with food: can be taken with or without food.

CONTRAINDICATIONS

- Hypersensitivity to pelargonium or any other component of the drug.

- Patients with severe bleeding or high bleeding tendencies (see Precautions; Coagulation disorders).

- Concomitant treatment with anticoagulants (see Interactions; anticoagulants).

- Serious liver or kidney disease.

PRECAUTIONS

- [HEPATOTOXICITY]. Cases of hepatitis have been described after the use of Pelargonium. In case of suspected hepatotoxicity, discontinue treatment and monitor liver function.

- [DISORDERS OF COAGULATION]. Pelargonium may promote bleeding, so it should be used with caution in patients with a tendency to [BLEED].

PRECAUTIONS RELATING TO EXCIPIENTS

- This medicine contains lactose. Patients with hereditary [LACTOSE INTOLERANCE] or galactose, Lapp lactase deficiency, or glucose or galactose malabsorption should not take this medicine.

ADVICE TO THE PATIENT

- Consult your doctor if symptoms continue after 7 days of treatment, or if new symptoms appear such as high or persistent fever, difficulty breathing or bloody mucus.

- Tell your doctor and / or pharmacist if you experience any of these symptoms:

* Sharp and severe pain in the upper right part of the abdomen, nausea and vomiting, loss of appetite, unexplained tiredness, darkening of the urine or the appearance of a yellowish tinge to the skin or the whites of the eyes.

SPECIAL WARNINGS

- Monitoring:

* Liver function in patients with symptoms of liver damage.

INTERACTIONS

- Oral anticoagulants. Pelargonium could alter blood clotting, favoring the appearance of hemorrhages. Contraindicated use.

PREGNANCY

Animal safety: no data available.

Safety in humans: There are no adequate and well-controlled studies in humans. Its use is not recommended during pregnancy.

Effects on Fertility: No specific studies have been performed in humans.

LACTATION

Animal safety: no data available.

Safety in humans: it is not known whether its components are excreted with milk, and the consequences they could have for the infant. Its use is not recommended during lactation.

KIDS

Authorized in children and adolescents from 6 years of age, with the corresponding dosage adjustments (see Dosage).

Safety and efficacy have not been evaluated in children <6 years of age, so it is recommended to avoid its use.

SENIORS

No specific problems have been described in the elderly that require a dosage adjustment.

EFFECTS ON DRIVING

No studies have been performed, although it is unlikely that it may affect driving.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency range, being considered very common (> 10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%) , very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Digestive: infrequent [ABDOMINAL PAIN], [GASTRIC HYPERACIDITY], [NAUSEA], [DIARRHEA].

- Hepatic: frequency unknown [HEPATOTOXICITY], [HEPATITIS].

- Allergic: rare [HYPERSENSITIVITY REACTIONS], with [EXANTEMATIC ERUPTIONS], [URTICARIA], [PRURITO]; very rare facial edema, [DYSNEA] or [HYPOTENSION].

- Hematological: rare [GINGIVAL HEMORRHAGE], [EPISTAXIS].

OVERDOSE

Symptoms: no cases have been described.

Measures to take:

- Antidote: there is no specific antidote.

- General disposal measures: have not been established.

- Monitoring: clinical status of the patient and liver function.

- Treatment: symptomatic.

Kaloba 20 mg 21 coated tablets