Laila 14 soft capsules

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Laila is a traditional medicine of plant origin 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 many years of experience of use. Laila It is indicated in adults and adolescents aged 12 and over.

ACTIVE INGREDIENTS

1 soft capsule contains: 80 mg of Lavandula angustifolia Miller, aetheroleum (lavender essential oil). Excipient with known effects: Sorbitol, approx. 12 mg/soft capsule. For the full list of excipients, see section 6.1.

EXCIPIENTS

Capsule contents: Refined rapeseed oil. Capsule shell: Gelatin succinylate, Glycerol 85%, Non-crystallized sorbitol 70%, Titanium dioxide, Coloring agents: Carminic acid aluminum lake (E 120); Patented blue V aluminum lacquer (E 131).

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

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 Laila must not be used in children under 12 years of age (see section 4.4 Special warnings and precautions for use). 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, you should consult a doctor or qualified healthcare practitioner.

CONSERVATION

Do not store above 30°C.

WARNINGS

Use in children under 12 years has not been established due to insufficient data. If symptoms worsen during use of the product, a doctor or qualified healthcare professional should be consulted. Laila contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Use in patients with impaired liver function is not recommended since the components of lavender essence are largely eliminated by liver metabolism.

INTERACTIONS

Published data demonstrate that in humans lavender essential oil (160 mg/day) has no clinically relevant effects of inhibition or induction of CYP 1A2, 2C9, 2C19, 2D6 and 3A4 enzymes. Furthermore, no clinically relevant impact of lavender essential oil on the contraceptive efficacy of combined oral contraceptives has emerged.

SIDE EFFECTS

Gastrointestinal disorders Mild gastrointestinal discomfort (e.g. belching). Frequency not known. Skin and subcutaneous tissue disorders / Immune system disorders Allergic skin reactions. Frequency not known. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-unasospetti-reazione-avversa.

OVERDOSE

No cases of overdose have been reported.

PREGNANCY AND BREASTFEEDING

Safety during pregnancy and breastfeeding has not been established. In the absence of sufficient data, use during pregnancy and breastfeeding is not recommended. No data on fertility are available.

EFFECTS ON DRIVING ABILITY

Laila does not or negligibly alter the ability to drive and use machinery.