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1. What Lasea is and what it is used for
Lasea is an herbal medicine.
Lasea is used for the treatment of transient symptoms of anxiety.
Additional information for use:
Anxiety may cause one or more temporary symptoms, such as worry that is difficult to control, restlessness, tension or disturbed sleep.
Lasea is indicated for use in adults.
2. What you need to know before you start taking Lasea
Do not take Lasea
if you are allergic to lavender oil or any of the other ingredients of this medicine (listed in section 6), or if you have impaired liver function.
Warnings and precautions
If you suffer from excessive anxiety and/or worries that are difficult to control and/or three or more anxiety-related symptoms (e.g. restlessness, fatigue, difficulty concentrating, irritability, muscle tension, sleep disturbances) for a prolonged period of time you should consult a doctor because you may be suffering from a mental illness that requires medical supervision.
If you have the impression that your symptoms remain unchanged after one month of treatment or if they worsen, consult your doctor.
Lasea is not recommended for use in patients with severely impaired renal function requiring dialysis due to 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 use in children and adolescents under 18 years of age, as there are no data available on the use of Lasea in this age group.
Other medicines and Lasea
Tell your doctor or pharmacist if you are taking, have recently taken or may need to take any other medicines.
No cases of interaction of Lasea with other medicines have been reported. Based on the available data, no interaction with other medicines is expected.
The available experimental data do not provide any evidence of interactions with other active substances with CNS activity. As a precautionary measure, Lasea should not be taken together with other anxiolytic drugs, sedatives or alcohol due to the lack of clinical data on possible interactions.
Pregnancy and lactation
Pregnancy
Experimental investigations do not provide any indication suggesting a harmful effect of Lasea in pregnant women. As no clinical data on the use of Lasea during pregnancy are available, this medicinal product is not recommended during pregnancy.
Breast-feeding
It is not known whether the active substance components or their metabolites are excreted in breast milk. Therefore, breast-feeding mothers should not take Lasea.
Driving and use of machines
According to the results of a clinical study designed to assess the influence of Lasea on the ability to drive in a somewhat small number of healthy people, the influence of Lasea on the ability to drive and use machines is nil or negligible. However, patients who are affected, e.g. by fatigue, should not drive or operate machines. No data are available for patients over 58 years of age.
Lasea contains sorbitol
This medicinal product contains approximately 12 mg of sorbitol in each soft capsule.
3. How to take Lasea
Follow the instructions for taking the medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults:
You should take one softgel a day, at approximately the same time of day.
You should not take Lasea for more than 3 months. If symptoms remain unchanged after 1 month of treatment or if symptoms worsen, you should consult your doctor.
The softgels should be taken without chewing, with a sufficient amount of liquid (preferably a glass of water).
Lasea should not be taken lying down.
Children and adolescents
Lasea® should not be taken by anyone under 18 years of age.
If you take more Lasea than 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 a forgotten dose; continue treatment as directed by your doctor or as described in this leaflet.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following list of side effects includes all reactions occurring during treatment with Lasea, including those occurring at higher doses or during prolonged treatment.
Frequent (1 to 10 out of 100 people treated):
- belching.
Of unknown frequency (cannot be estimated from available data):
- other gastrointestinal discomfort;
- allergic skin reactions
Reporting of side effects
If you experience any side effects, please tell your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects you can help to provide more information on the safety of this medicine.
5. Storage of Lasea
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister pack.
Do not store above 30 °C.
Medicines should not be flushed down the drain or thrown away. Dispose of unneeded medicines and packaging at the SIGRE Point at your regular pharmacy. Ask your pharmacist how to dispose of unneeded medicine containers and medicines. In this way, you will help to protect the environment.
6. Package contents and additional information
Composition of Lasea
Each soft capsule contains:
Active substance: 80 mg essential oil of Lavandula angustifolia Miller, (lavender oil).
The other ingredients are:
Capsule contents: Refined canola oil.
Capsule shell: Gelatin, succinylated; glycerol 85%; sorbitol 70%, liquid (non-crystallising); aluminium salt of carminic acid (E 120); aluminium salt of patent blue V (E 131); titanium dioxide (E 171).
Appearance of the product and contents of the package
Oval, opaque, violet-blue, soft capsules.
