SPECIAL WARNINGS

- Monitoring:

* Liver function in patients with symptoms of liver damage.

SENIORS

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

PATIENT ADVICE

- 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.

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

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

CONTRAINDICATIONS

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

- Patients with severe bleeding or high tendencies to bleed (see Precautions; coagulation disorders).

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

- Severe liver or kidney disease.

EFFECTS ON DRIVING

No studies have been conducted, although it is unlikely to affect driving.

PREGNANCY

Animal safety: no data available.

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

Effects on fertility: no specific studies have been conducted in humans.

INDICATIONS

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

Its use is based exclusively on traditional use.

INTERACTIONS

- Oral anticoagulants. Pelargonium may alter blood clotting, increasing the risk of bleeding. Use is contraindicated.

LACTATION

Animal safety: no data available.

Safety in humans: It is unknown whether its components are excreted in breast milk, and the potential consequences for the infant. Its use during breastfeeding is not recommended.

CHILDREN

Authorized for 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, therefore its use is not recommended.

GUIDELINES FOR PROPER ADMINISTRATION

- Syrup: take with some liquid in the morning, at noon and at night.

POSOLOGY

Syrup:

- Adults and adolescents > 12 years: 7.5 milliliters 3 times a day (morning, afternoon and evening).

- Children 6-12 years: 5 milliliters 3 times a day (morning, afternoon and evening).

- Children < 6 years: not recommended.

- Elderly: no specific dosage recommendations have been made.

Treatment duration : Continue treatment for 7 days, which may be extended for an additional 2-3 days to prevent relapse. If symptoms persist or worsen after 7 days, consult your doctor. The maximum duration is 14 days.

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

DOSAGE IN HEPATIC INSUFFICIENCY

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

DOSAGE IN RENAL INSUFFICIENCY

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

PRECAUTIONS

- [HEPATOTOXICITY]. Cases of hepatitis have been reported following the use of Pelargonium. If hepatotoxicity is suspected, discontinue treatment and monitor liver function.

- [COAGULATION DISORDERS]. Pelargonium may promote bleeding, so it should be used with caution in patients prone to [BLEEDING].

ADVERSE REACTIONS

Adverse reactions are described according to each frequency interval, 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 [SKIN RASHES], [URTICARIA], [PRURITUS]; very rare facial edema, [DYSPNEA] or [HYPOTENSION].

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

OVERDOSE

Symptoms: no cases have been described.

Measures to be taken:

- Antidote: there is no specific antidote.

- General elimination measures: none have been established.

- Monitoring: patient's clinical status and liver function.

- Treatment: symptomatic.