Descrizione Clinica
Other disorders Laila 14cps soft Laila
LAILA, CAPSULE MOLLI
active ingredients
1 soft capsule contains: 80 mg of Lavandula angustifolia Miller, aetheroleum (essential lavender oil). Excipient with known effects: Sorbitol, approx. 12 mg / soft capsule. For the full list of excipients, see paragraph 6.1.Excellent
Content of the capsule: Oil of refined rapeseed seeds. Capsule envelope: Gelatina succinilato, Glicerol 85%, Sorbitol not crystallized 70%, Titanium dioxide, Coloring agents: Aluminium carmine acid lacquer (E 120); Blue aluminium lacquer licensed V (E 131).Therapeutic indications
Laila is a traditional medicinal product of vegetable origin indicated for the relief of symptoms of mild anxiety and to promote sleep. The use of this traditional medicinal product of vegetable origin, for the therapeutic indications indicated, is based exclusively on the experience of multiannual use. Laila is indicated in adults and teens from 12 years.Contraindications
Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.Population
Population Adults and teenagers over the age of 12 take a soft capsule daily (corresponding to 80 mg of lavender essential oil per day). Pediatric population Laila should not be used in children under 12 years (see paragraph 4.4 Special warnings and precautions of use). Method of administration Oral use. Soft capsules must be ingested whole with sufficient liquid (preferably a glass of water). Duration of treatment If the symptoms persist after two weeks of use of the product, you should consult a qualified physician or health care professional.Conservation
Do not store at temperature above 30°C.Warnings
Use in children under 12 years has not been established due to insufficient data. If during the use of the product the symptoms worsen, consult a doctor or a qualified healthcare provider. Laila contains sorbitol. Patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. The use in patients with compromised liver function is not recommended since the components of lavender essence are largely eliminated by liver metabolism.Interactions
The published data show that in man the essential oil of lavender (160 mg/die) has no clinically relevant effects of inhibition or induction of CYP 1A2, 2C9, 2C19, 2D6 and 3A4 enzymes. Moreover, no clinically significant impact of lavender essential oil on the anti-inflammatory effects of combined oral contraceptives emerged.Effects
Gastrointestinal diseases Mild gastrointestinal malaise (e.g. eruption). Frequency not known. Skin and subcutaneous tissue pathologies / Immune system disorders Skin allergic reactions. Frequency not known. Reporting of suspicious adverse reactions The reporting of suspicious 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 medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.agenziafarmaco.gov.it/content/come-segnalare-unasospetta-reazione-avversa.Overdosing
No overdose cases have been reported.Safety during pregnancy and nursing has not been established. In the absence of sufficient data, use during pregnancy and breastfeeding is not recommended. Fertility data is not available.
Source: Farmadati
