Lasea 80 Mg 28 Soft Capsules

Lasea (80 Mg 28 Softgels)

ACTION AND MECHANISM

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

INDICATIONS

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

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: 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.

DOSAGE IN LIVER INSUFFICIENCY

Contraindicated.

RULES FOR CORRECT ADMINISTRATION

Swallow the capsules without chewing, with a sufficient amount of liquid, preferably with a glass of water. It should not be taken in a lying position.

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

CONTRAINDICATIONS

- Hypersensitivity to lavender or any component of the drug.

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

PRECAUTIONS

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

PRECAUTIONS RELATING TO EXCIPIENTS

- This medicine contains sorbitol. Patients with hereditary [FRUCTOSE INTOLERANCE] should not take this medicine.

ADVICE TO THE PATIENT

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

INTERACTIONS

They have not been described. However, the association with other anxiolytic drugs, sedatives or alcohol is not recommended due to the lack of clinical data on potential interactions.

PREGNANCY

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

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 performed in humans. Animal studies have not shown harmful effects on fertility.

LACTATION

Animal safety: no data available.

Safety in humans: it is not known if it is excreted with milk, and the consequences it could have for the infant. Its administration is not recommended during lactation.

KIDS

Safety and efficacy have not been evaluated in children and adolescents <18 years of age, so it is recommended to avoid its use.

SENIORS

Limited data are available on safety and efficacy in patients older than 65 years. However, no specific dosage recommendations have been established.

EFFECTS ON DRIVING

It does not present significant effects. However, those patients who complain of fatigue should not drive or use machines. No data are available for patients over 58 years of age.

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).

- Gastrointestinal disorders: common [AEROFAGIA]; frequency unknown other gastrointestinal complaints.

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

OVERDOSE

Symptoms: no cases have been described.

Measures to take:

- Antidote: there is no specific antidote.

- General disposal measures: have not been established.

- Monitoring: patient monitoring does not seem necessary.

- Treatment: symptomatic.

Leaflet Lasea 80 Mg 28 Softgels