Patient Information Leaflet

LASEA, soft capsules

Lavender essential oil
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after two weeks.

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 traditional herbal medicinal product indicated for the relief of mild anxiety symptoms and to help sleep.
The use of this traditional herbal medicinal product for the therapeutic indications listed is based exclusively on long-standing use.

2. What you need to know before taking LASEA

Do not take LASEA

if you are allergic to lavender essential oil or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
If your symptoms worsen during use of the product, you should consult a doctor or qualified healthcare professional.
Use in patients with impaired liver function is not recommended, as the components of lavender essential oil are largely eliminated through hepatic metabolism.

Children and adolescents
LASEA must not be used in children under 12 years of age, as adequate data on the use of this medicine in this age group are not available.

Other medicines and LASEA
No cases of interaction between LASEA and other medicines have been reported.
If you contact a doctor or another healthcare professional, remember to inform them if you are taking or have recently taken this medicine without a prescription.

Pregnancy, breastfeeding and fertility
Due to insufficient data, the use of LASEA is not recommended during pregnancy and breastfeeding.
There are no data available regarding fertility.

Driving and using machines
LASEA has no effect or has a negligible effect on the ability to drive vehicles and operate machinery.

LASEA contains sorbitol.
This medicine contains approximately 12 mg of sorbitol per soft capsule.

3. How to take LASEA

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years of age:
One soft capsule once daily.
The soft capsules must be swallowed whole with sufficient liquid (preferably a glass of water).
Duration of treatment:
If symptoms persist after two weeks of using the medicine, consult a doctor or qualified healthcare professional.
Use in children and adolescents
LASEA must not be used in children under 12 years of age.
If you take more LASEA than you should
Cases of overdose have not been reported.
If you forget to take LASEA
Do not take a double dose to make up for the missed dose; continue taking the medicine as instructed by your doctor or pharmacist or as stated in this leaflet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known (cannot be estimated from the available data):

Mild gastrointestinal disturbances (e.g. burping);
Hypersensitivity reactions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 container (blister) after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LASEA contains

The active substance is lavender essential oil (Lavandula angustifolia Miller, aetheroleum). Each soft capsule contains 80 mg of lavender essential oil (Lavandula angustifolia Miller, aetheroleum).
The other components are: succinylated gelatin; glycerol 85%; refined rapeseed seed oil; non-crystallizing sorbitol 70%; carmine aluminum lake (E 120); patent blue V aluminum lake (E 131); titanium dioxide.

Description of the appearance of LASEA and the contents of the pack
LASEA is an oval-shaped, soft, opaque purple capsule. Capsule dimensions: length approx. 11 mm, width approx. 7 mm.
The soft capsules are packaged in blisters. LASEA is available in packs containing 14, 28 and 56 soft capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Straße 4
76227 Karlsruhe
Germany