ACTION AND MECHANISM

- Sedative. The active substances in lavender cross the blood-brain barrier and induce functional changes in the central nervous system, resulting in an anxiolytic effect. In a pharmacological study in healthy male volunteers, a significant reduction in the binding potential to the 5-HT1A serotonin receptor was observed in brain regions involved in the regulation of anxiety.

PATIENT ADVICE

- If symptoms persist unchanged after 1 month of treatment or if they worsen, a doctor should be consulted.

CONTRAINDICATIONS

- Hypersensitivity to lavender or any component of the medication.

- Impaired liver function, such as [LIVER FAILURE].

ADVANCED AGE

Limited data are available on the safety and efficacy of this medication in patients over 65 years of age. However, specific dosage recommendations have not been established.

EFFECTS ON DRIVING

It has no significant side effects. However, patients who experience fatigue should not drive or operate machinery. Data are not available for patients over 58 years of age.

PREGNANCY

Animal safety: Animal studies do not suggest direct or indirect harmful effects in terms of reproductive toxicity.

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

Effects on fertility: No specific studies have been conducted in humans. Animal studies have not shown adverse effects on fertility.

INDICATIONS

- Treatment in adults of transient symptoms of [ANXIETY].

INTERACTIONS

None have been described. However, combination with other anxiolytic drugs, sedatives, or alcohol is not recommended due to a lack of clinical data on potential interactions.

LACTATION

Animal safety: no data available.

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

CHILDREN

Safety and efficacy have not been evaluated in children and adolescents < 18 years, therefore its use is not recommended.

GUIDELINES FOR PROPER ADMINISTRATION

Swallow the capsules whole with plenty of liquid, preferably a glass of water. Do not take while lying down.

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

POSOLOGY

- Adults: one capsule once a day, at approximately the same time.

- Children and adolescents < 18 years: not recommended.

- Elderly: no specific dosage recommendations have been made.

Duration of treatment: should not exceed 3 months. If symptoms persist or worsen after 1 month of treatment, a doctor should be consulted.

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

DOSAGE IN HEPATIC INSUFFICIENCY

Contraindicated.

DOSAGE IN RENAL INSUFFICIENCY

No specific dosage recommendations have been made.

PRECAUTIONS

- [DIALYSIS]. Not recommended due to a lack of clinical data.

PRECAUTIONS RELATING TO EXCIPIENTS

This medicine contains sorbitol. Patients with hereditary fructose intolerance should not take this medicine.

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).

- Gastrointestinal disorders: frequent [AEROPHAGIA]; frequency unknown other gastrointestinal discomfort.

- Skin and subcutaneous tissue disorders: [HYPERSENSITIVITY REACTIONS] of the skin.

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: monitoring the patient does not appear to be necessary.

- Treatment: symptomatic.