ALORA SLEEPING Anxiety Sleeping disorders 100 mg 20 tabs FORMULA: Each Alora film tablet contains 100 mg Passiflora extract (as vitexin 3.5%) , flavonoid and iron oxide as coloring agent. PHARMACOLOGICAL PROPERTIES: Passiflora extract is a sedative medicine, which is obtained from the natural plant named Passiflora incarnata. As active ingredients; passiflora extract contains a group of alkoloids such as harmane, harmol, harmaline (hallucinagent agent), harmine, harmalol and aribine, and some flavonoids like vitexin and orientin. Extract also contains apigenin which is responsible antispasmodic activity. These substances have complex activity on the central nervous system and cause sedative, hypnotic, analgesic, anxiolytic and antispasmodic effects. Since natural passiflora extract does not cause addiction and side effects, it is safer than tranquilizers and barbiturates. INDICATIONS: Alora film tablet is indicated for the symptomatic relief of the following conditions: Anxiety, sleeping disorders, nervousness, distress, minimal depression, Nervous gastrointestinal and cardiovascular events, Hypertension due to sympathetic hyperactivity, General nervous agitation Nervousness during menstrual bleeding and menopause. WARNINGS / PRECAUTIONS: Central depressive activity of the drug should be kept in mind; especially in people driving vehicles and operating machines which necessitate proper attention. Since safety and effectiveness has not been established for pediatric patients under 3 years of age, it is not recommended for use in this ages. In older children and geriatric patients, treatment should be started with minimum dosage. Passiflora extract is generally safe and has not been found to negatively interact with other drugs. Use in pregnant women and nursing mothers: Alora film tablets should be used only if clearly needed. SIDE EFFECTS AND ADVERSE EVENTS: No health hazards or side effects are known in conjunction with the proper administration of designated therapeutic dosages. DOSAGE AND ADMINISTRATION: To cause sedaive effects during all day: Recommended adult oral dose is 100 mg three times a day before the meals. In sleeping disorders: Recommended adult oral dose is 200-300 mg once a day, one hour before the sleep. STORAGE CONDITIONS: Store in dry, protected from light plac at the temperature not more than 25C HOW SUPPLIED: Alora film 100 mg Tablet; presented in white opaque PVC/TE/PVDC/Al blister of 20 tablets.