PATIENT INFORMATION LEAFLET

Patient Information Leaflet: Information for the Patient

Lasea®

80 mg/ Soft Capsules

For Adults

Lavender Oil (Lavandula angustifolia Mill., Essential Oil)

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

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

1.What is Lasea and what it is used for

2.What you need to know before starting to take Lasea

3.How to take Lasea

4.Possible side effects

1. Storage of Lasea

6.Contents of the pack and additional information

Laseais a plant-based medication.

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

Additional information for use:

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

Laseais indicated for adults.

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 liver function impairment.

Warnings and precautions

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

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

Lasea is not recommended for use in patients with severe renal function impairment requiring dialysis due to a lack of clinical data.

There is limited data available on the use of Lasea in patients over 65 years of age.

Children and adolescents

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

Other medications and Lasea

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

No interactions with other medications have been reported. According to available data, no interactions with other medications are expected.

Available experimental data provide no evidence of interactions with other active principles affecting the CNS. As a precaution, Lasea should not be taken with other anxiolytic, sedative, or alcohol medications due to a lack of clinical data on possible interactions.

Pregnancy and breastfeeding

Pregnancy

Experimental research provides no indication of a harmful effect of Lasea on pregnant women. As there is no clinical data available on the use of Lasea during pregnancy, this medication is not recommended during pregnancy.

Breastfeeding

The components of the active principle or its metabolites are unknown to be excreted in breast milk. Consequently, breastfeeding mothers should not take Lasea.

Driving and operating machinery

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 operate machinery is negligible or insignificant. However, patients who feel affected, for example by fatigue, should not drive or operate machinery. There is no data available for patients over 58 years of age.

Lasea contains sorbitol

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults:

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

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

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

Lasea should not be taken in a lying position.

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 compensate for the missed doses; continue treatment as instructed by your doctor or as described in this leaflet.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Of unknown frequency (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 people treated):

- belching.

Of unknown frequency (cannot be estimated from available data):

- other gastrointestinal discomforts;

- skin allergic reactions

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the packaging (blister).

Do not store at a temperature above 30 °C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at your local pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Lasea

Each soft capsule contains:

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

The other components are:

Soft capsule content:Refined canola oil.

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

Appearance of the product and contents of the packaging

Oval, transparent soft capsules.

Laseais available in packaging with 14, 28, 42, 56, and 84 soft capsules.

Holder of the marketing authorization and responsible 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. Building 2, staircase 1, 2nd floor.

28108 Alcobendas, Madrid.

Last review date of this leaflet: June 2024

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