LAILA * 14CPS SOFT
Therapeutic indications
Laila 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. Laila is indicated in adults and adolescents from 12 years.
Dosage and method of use
Posology 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 should not be used in children below 12 years (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, a doctor or a qualified health care practitioner should be consulted.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Side effects
Gastrointestinal disorders Mild gastrointestinal discomfort (eg 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 medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-unasospetta-reazione-avversa.
Special 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. Laila 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.
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.
Expiration and retention
Do not store above 30 ° C.
Interactions with other drugs
Published data demonstrate that lavender essential oil (160 mg / day) has no clinically relevant inhibition or induction effects of CYP enzymes 1A2, 2C9, 2C19, 2D6 and 3A4 in humans. Furthermore, there was no clinically relevant impact of lavender essential oil on the contraceptive efficacy of COCs.
Overdose
No cases of overdose have been reported.
Active principles
1 soft capsule contains: 80 mg of Lavandula angustifolia Miller, aetheroleum (lavender essential oil). Excipient with known effect : Sorbitol, ca. 12 mg / soft capsule. For the full list of excipients, see section 6.1.
Excipients
Capsule contents : Refined rapeseed oil. Capsule shell: Succinylated gelatin, Glycerol 85%, Uncrystallized sorbitol 70%, Titanium dioxide, Coloring agents: Carminic acid aluminum lake (E 120); Patented blue aluminum lacquer V (E 131).
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