ALORA®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Alora® (ALORA)

Composition:

Active substance: Passiflora incarnata;

5 ml of syrup contain 694.444 mg of liquid extract of passionflower;

Excipients: sucrose, glycerol, ethanol, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: transparent dark brown liquid

Pharmacotherapeutic group.
Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

Passionflower extract is produced from the medicinal plant Passiflora incarnata, which contains 0.04% indole alkaloids (harmine, harmaline, harmol), certain flavonoids (vitexin, quercetin), as well as coumarins, quinones, etc.

The components of the extract inhibit nerve impulse conduction in the spinal cord and brain, reduce excitability of the central nervous system, and produce a sedative effect.

The drug improves mood in depressive states, reduces anxiety and mental tension, exerts a mild hypnotic effect without causing a feeling of drowsiness upon awakening, and possesses anticonvulsant properties.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

As a sedative in patients with neurasthenic and depressive conditions, stress, anxiety, nervousness, and sleep disorders, as well as during climacteric and pre-climacteric periods. The drug is effective for vegetative symptoms of nervous system disorders (neurocirculatory dystonia, hypertensive disease, cerebral vascular crises, excessive sweating, palpitations), and also in post-infectious asthenia.

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with central nervous system depressants such as barbiturates and tranquilizers, the sedative and hypnotic effects of the drug are enhanced.

Concomitant use with benzodiazepines is not recommended. Concomitant use with disulfiram should be avoided.

Alcoholic beverages should not be consumed during treatment with Alora**®** syrup.

Special precautions for use.

Use with caution in patients with severe organic diseases of the gastrointestinal tract.

Treatment in elderly patients should be initiated with the minimum dose.

The product contains sucrose and therefore should not be administered to patients with diabetes mellitus or to patients with rare hereditary forms of fructose intolerance, sucrase-isomaltase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

The efficacy and safety of use during pregnancy or breastfeeding have not been established.

Ability to influence reaction rate when driving or operating machinery.

During treatment with Alora**®** syrup, patients should refrain from driving vehicles and operating potentially hazardous machinery.

Method of Administration and Dosage.

Adults: to achieve a sedative effect, take 5–10 mL of syrup (1–2 teaspoons) three times daily before meals. For sleep disorders – take 10 mL (2 teaspoons) before bedtime.

Children (aged 3 years and older): 2.5 mL (½ teaspoon) of syrup 2–3 times daily.

The duration of treatment is determined individually by a physician depending on the indications and clinical efficacy of the drug. Do not exceed the recommended single dose.

Children.

The drug is contraindicated in children under 3 years of age. For children aged 3 to 12 years, use only as directed by a physician.

Overdose.

There are no data regarding overdose. An overdose may enhance the manifestations of adverse reactions.

In case of overdose, gastric lavage is recommended. Symptomatic treatment should be administered.

Side effects.

When used at recommended therapeutic doses, the occurrence of adverse effects is unlikely.

Adverse reactions related to Passiflora incarnata have been reported at an unknown frequency.

Gastrointestinal system: nausea, vomiting.

Cardiovascular system: tachycardia, bradycardia, ventricular tachycardia.

Nervous system: dizziness, drowsiness.

Immune system: allergic reactions (possibly delayed), including vasculitis.

Shelf life.

3 years.

After first opening, the syrup should be stored for no more than 6 months.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Packaging.

100 ml in a bottle, 1 bottle with a measuring spoon in a cardboard box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

NOBEL ILAC SANAYI VE TICARET A.S.

Manufacturer's address and place of business.
Sankaklar Quarter, Eskih Akcakoca Avenue, No. 299, 81100 Duzce, Turkey.