Lasea 80 mg soft capsules
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
PACKAGE LEAFLET
Package leaflet: Information for the patient
Lasea®
80 mg/ soft capsules
For adults
Lavender oil (Lavandula angustifolia Mill., essential oil)**
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to refer to it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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 your condition worsens.
Contents of this leaflet
- What Lasea is and what it is used for
- What you need to know before taking Lasea
- How to take Lasea
- Possible side effects
- How to store Lasea
- Contents of the pack and other information
1. What Lasea is and what it is used for
Lasea is a herbal medicinal product.
Lasea is used for the treatment of transient anxiety symptoms.
Additional information on use:
Anxiety may cause one or more temporary symptoms, such as difficulty controlling worry, restlessness, tension, or sleep disturbance.
Lasea is indicated for use in adults.
2. What you need to know before taking Lasea
Do not take Lasea
if you are allergic to lavender oil or to any of the other components of this medicine (listed in section 6), or if you have impaired liver function.
Warnings and precautions
If you experience excessive anxiety and/or uncontrollable worries and/or three or more anxiety-related symptoms (e.g., restlessness, fatigue, difficulty concentrating, irritability, muscle tension, sleep disturbances) over a prolonged period, you should consult a doctor, as you may have a mental health condition requiring medical supervision.
If you feel that your symptoms remain unchanged after one month of treatment or if they worsen, consult your doctor.
The use of Lasea is not recommended in patients with severe renal impairment requiring dialysis due to lack of clinical data.
Limited data are available on the use of Lasea in patients over 65 years of age.
Children and adolescents
The use of Lasea is not recommended in children and adolescents under 18 years of age, as there are no data available on the use of this medicine in this age group.
Other medicines and Lasea
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
No cases of interaction between Lasea and other medicines have been reported. According to available data, no interactions with other medicines are expected.
Available experimental data provide no evidence of interactions with other active substances acting on the CNS. As a precautionary measure, Lasea should not be taken together with other anxiolytic, sedative drugs or alcohol due to the lack of clinical data on potential interactions.
Pregnancy and breastfeeding
Pregnancy
Experimental studies do not provide any indication suggesting a harmful effect of Lasea in pregnant women. However, as there are no clinical data on the use of Lasea during pregnancy, this medicine is not recommended during pregnancy.
Breastfeeding
It is unknown whether the active substance components or their metabolites are excreted in breast milk. Therefore, 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 driving ability in a small number of healthy individuals, the influence of Lasea on the ability to drive and use machines is none or negligible. However, patients who feel affected, for example by fatigue, should not drive or operate machinery. Data are not available for patients over 58 years of age.
Lasea contains sorbitol
This medicine contains approximately 12 mg of sorbitol in each soft capsule.
3. How to take Lasea
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults:
Take one soft capsule daily, at approximately the same time each day.
Do not take Lasea for longer than 3 months. If symptoms persist unchanged after 1 month of treatment, or if symptoms worsen, you should consult your doctor.
The soft capsules must 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® must not be administered to individuals under 18 years of age.
If you take more Lasea than you should
There have been no reported cases of overdose.
If you forget to take Lasea
Do not take a double dose to make up for missed doses; continue treatment as directed by your doctor or as described in this leaflet.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
The following list of adverse effects includes all reactions reported during treatment with Lasea, including those occurring at higher doses or during prolonged treatment.
Frequency not known (cannot be estimated from available data):
Severe hypersensitivity reactions (allergic reactions) have been reported, with swelling, circulatory problems and/or breathing difficulties. In such cases, contact a doctor immediately.
If you experience a hypersensitivity reaction (allergic reaction), stop taking Lasea.
Frequent (1 to 10 in every 100 treated people):
- burping.
Frequency not known (cannot be estimated from available data):
- other gastrointestinal discomforts;
- skin allergic reactions.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lasea
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the packaging (blister).
Do not store above 30 °C.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your usual pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Lasea
Each soft capsule contains:
Active substance: 80 mg of essential oil of Lavandula angustifolia Miller (lavender oil).
The other components are:
Capsule contents: Refined canola oil.
Capsule shell: Succinylated gelatin; glycerol 85%; sorbitol 70%, liquid (non-crystallizing).
Appearance of the product and contents of the container
Oval, transparent soft capsules.
Lasea is available in packs containing 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. Building 2, staircase 1, 2nd floor.
28108 Alcobendas, Madrid.
Date of the most recent revision of this leaflet: June 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.