LAILA ESSENTIAL OIL OF LAVENDER 80MG 28 SOFT CAPSULES

NAME:
LAILA, SOFT CAPSULES

ACTIVE PRINCIPLES:
1 soft capsule contains: 80 mg of Lavandula angustifolia Miller, aeth eroleum (lavender essential oil).

EXCIPIENTS:
Capsule content: refined rapeseed oil.
Capsule shell: succinylated gelatin, glycerol 85%, unsorbitol 70%, titanium dioxide.
Coloring agents: carminic acid aluminum lake (E 120); patented blue aluminum lacquer V (E 131).

INDICATIONS:
The drug is a traditional herbal medicine indicated for the relief of mild anxiety symptoms and to promote sleep.
The use of this traditional medicinal product of plant origin, for the indicated therapeutic indications, is based exclusively on the experience of many years of use.
The drug is indicated in adults and adolescents from 12 years.

CONTRAINDICATIONS / SECONDAR EFFECT:
Hypersensitivity 'to the active substance or to any of the excipients.

DOSAGE:
Dosage.
Adults and adolescents over 12 years of age take one soft capsule per day (corresponding to 80 mg of lavender essential oil per day).
Pediatric population.
The drug should not be used in children under 12 years old.
Method of administration.
Oral use.
The soft capsules should be swallowed whole with sufficient liquid (preferably a glass of water).
Duration of treatment.
If symptoms persist after two weeks of using the product, a doctor or qualified healthcare professional should be consulted.

STORAGE:
Do not store above 30 degrees C.

WARNINGS:
Use in children below 12 years has not been established due to insufficient data.
If symptoms worsen while using the product, a doctor or a qualified health care practitioner should be consulted.
The drug contains sorbitol.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Use in patients with impaired hepatic function is not recommended as the components of lavender essence are largely eliminated by the liver metabolism.

INTERACTIONS:
Published data demonstrate that Lavender essential oil (160 mg / day) has no clinically relevant inhibition or nduction effects of CYP enzymes 1A2, 2C9, 2C19, 2D6 and 3A4 in humans.
Furthermore, there is no clinically relevant impact of lavage essential oil on the contraceptive efficacy of COCs.

SIDE EFFECTS:
Gastrointestinal disorders.
Gastrointestinal discomfort of mild degree e (p.
ex.
belching).
Frequency not known.
Skin and subcutaneous tissue disorders / Immune system disorders.
Allergic skin reactions.
Frequency not known.
Reporting of suspected reactions if suspected The reporting of suspected adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalar e-unasospe tta-adverse-reaction.

PREGNANCY AND BREASTFEEDING:
Safety during pregnancy and lactation has not been established.
In the absence of sufficient data, use during pregnancy and lactation is not recommended.
No fertility data are available.