Package leaflet: Information for the patient

Laila, soft capsules

Lavandulae aetheroleum
Please read this leaflet carefully before taking this medicine because it contains important information for 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 adverse reaction, 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 you experience worsening of symptoms after two weeks.

Contents of this leaflet:

What Laila is and what it is used for
What you need to know before taking Laila
How to take Laila
Possible side effects
How to store Laila
Contents of the pack and other information

1. What Laila is and what it is used for

Laila is a traditional herbal medicinal product indicated for the relief of mild anxiety symptoms and for
promoting sleep.
The use of this traditional herbal medicinal product for the specified therapeutic indications is based solely on long-standing, traditional use.

2. What you need to know before taking Laila

Do not take Laila
If you are allergic to lavender essential oil or to any of the other ingredients of this medicinal product
(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 essence
are largely eliminated through hepatic metabolism.

Children and adolescents
Laila must not be used in children under 12 years of age, as there are insufficient data on the use of this
medicinal product in this age group.

Other medicines and Laila
No cases of interaction between Laila and other medicines have been reported.
If you contact a doctor or another healthcare professional, remember to tell 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 Laila is not recommended during pregnancy and breastfeeding. There
are no data available regarding fertility.

Driving and using machines
Laila does not affect or affects negligibly the ability to drive vehicles and use machinery.

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

3. How to take Laila

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 treatment with this product, consult a doctor or qualified healthcare professional.

Use in children and adolescents
Laila must not be taken by individuals under 12 years of age.

If you take more Laila than you should
Cases of overdose have not been reported.

If you forget to take Laila
Do not take a double dose to make up for the missed dose, but 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 discomfort (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 Laila

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the container (blister strips) 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. Contents of the pack and other information

What Laila contains

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

Description of the appearance of Laila and pack contents
Laila is an opaque, oval-shaped soft capsule with a bluish-violet colour.
Capsule dimensions: length approx. 11 mm, width approx. 7 mm.
The soft capsules are packaged in blister strips. Laila is available in packs containing 14, 28 and 56 soft capsules. Not all pack sizes may be marketed.

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

Sales Concessionaire
A. Menarini Industrie Farmaceutiche Riunite s.r.l.
Via Sette Santi 3
50131 Florence
Italy