LASEA 80 mg SOFT CAPSULES

Introduction

PACKAGE LEAFLET

Package Leaflet: Information for the Patient

Lasea®

80 mg/ soft capsules

For adults

Lavender oil (Lavandula angustifoliaMill., essential oil)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Follow the administration instructions for this medication exactly as stated in this package leaflet or as directed by your doctor or pharmacist.
• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if you do not improve after 1 month of treatment or if you worsen.

Contents of the package leaflet

1. What is Lasea and what is it used for
2. What you need to know before taking Lasea
3. How to take Lasea
4. Possible side effects
   1. Storage of Lasea

1. Package contents and additional information

1. What is Lasea and what is it used for

Lasea is a herbal-based medication.

Lasea is used for the treatment of transient symptoms of anxiety.

Additional information for use:

Anxiety can cause one or more temporary symptoms, such as uncontrollable worry, restlessness, tension, or sleep disturbance.

Lasea is indicated for adults.

2. What you need to know before taking Lasea

Do not take Lasea

if you are allergic to lavender oil or any of the other components of this medication (listed in section 6), or if you have impaired liver function.

Warnings and precautions

If you suffer from excessive anxiety and/or uncontrollable worries and/or three or more symptoms related to anxiety (e.g., restlessness, fatigue, difficulty concentrating, irritability, muscle tension, sleep disturbances) for a prolonged period, you should consult a doctor because you may be suffering from a mental illness that requires medical supervision.

If you feel that your symptoms persist without change after a month of treatment or worsen, consult your doctor.

Lasea is not recommended for patients with severe renal impairment requiring dialysis due to the lack of clinical data.

Only limited data are available on the use of Lasea in patients over 65 years of age.

Children and adolescents

Lasea is not recommended for children and adolescents under 18 years of age, as no data are available on the use of this medication in this age group.

Other medications and Lasea

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

No cases of interaction between Lasea and other medications have been reported. According to available data, no interaction with other medications is expected.

Experimental data do not provide any evidence of interactions with other active substances with activity on the central nervous system. As a precautionary measure, Lasea should not be taken with other anxiolytic, sedative, or alcohol medications due to the lack of clinical data on potential interactions.

Pregnancy and breastfeeding

Pregnancy

Experimental research does not provide any indication that suggests a harmful effect of Lasea on pregnant women. As no clinical data are available on the use of Lasea during pregnancy, this medication is not recommended during pregnancy.

Breastfeeding

It is unknown whether the active components or their metabolites are excreted in breast milk. Consequently, breastfeeding mothers should not take Lasea.

Driving and using machines

According to the results of a clinical study designed to evaluate the influence of Lasea on the ability to drive in a small number of healthy individuals, the influence of Lasea on the ability to drive and use machines is nil or insignificant. However, patients who feel affected, for example by fatigue, should not drive or operate machines. No data are available for patients over 58 years of age.

Laseacontains sorbitol

This medication contains approximately 12 mg of sorbitol in each soft capsule.

3. How to take Lasea

Follow the administration instructions for the medication exactly as stated in this package leaflet or as directed by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults:

You should take one soft capsule per day, approximately at the same time.

Do not take Lasea for more than 3 months. If your symptoms persist without change after 1 month of treatment or worsen, you should consult your doctor.

The soft capsules should be taken without chewing, with a sufficient amount of liquid (preferably a glass of water).

Lasea should not be taken while lying down.

Children and adolescents

Lasea®should not be administered to individuals under 18 years of age.

If you take more Laseathan you should

No cases of overdose have been reported.

If you forget to take Lasea

Do not take a double dose to make up for forgotten doses; continue treatment as directed by your doctor or as described in this package leaflet.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following list of side effects includes all reactions that occurred during treatment with Lasea, including those that occurred with higher doses or during prolonged treatment.

Frequency not known (cannot be estimated from available data):

Severe hypersensitivity reactions (allergic reactions) with swelling, circulatory problems, and/or respiratory problems have been reported. In such cases, call a doctor immediately.

If you experience a hypersensitivity reaction (allergic reaction), stop taking Lasea.

Frequent (1 to 10 out of 100 treated individuals):

• belching.

Frequency not known (cannot be estimated from available data):

• other gastrointestinal disorders;
• skin allergic reactions

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lasea

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the box and blister pack.

Do not store above 30 °C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Lasea

Each soft capsule contains:

Active ingredient: 80 mg of essential oil of Lavandula angustifoliaMiller (lavender oil).

The other ingredients are:

Soft capsule contents: Refined canola oil.

Soft capsule shell: Succinylated gelatin; glycerol 85%; sorbitol 70%, liquid (non-crystallizing).

Appearance of the product and package contents

Oval, transparent soft capsules.

Lasea is available in packs of 14, 28, 42, 56, and 84 soft capsules.

Marketing authorization holder and manufacturer

Dr. Willmar Schwabe GmbH & Co. KG

Willmar-Schwabe-Str. 4

76227 Karlsruhe

Germany

Local representative:

SCHWABE FARMA IBÉRICA, S.A.U.

Avenida de la Industria, 4. Edificio 2, escalera 1, 2ª planta.

28108 Alcobendas, Madrid.

Date of the last revision of this package leaflet: June 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.