Alora

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

Composition:

Active substance: Passiflora incarnata;

One tablet contains 100 mg of dry extract of passionflower;

Excipients: povidone K-30, crospovidone, sodium croscarmellose, colloidal anhydrous silicon dioxide, microcrystalline cellulose, magnesium stearate, coating agent Sepifilm LP 007, colorant "Red Wine";

Composition of Sepifilm LP007 coating: hypromellose, microcrystalline cellulose, stearic acid;

Composition of the colorant "Red Wine": potassium aluminium silicate, red iron oxide (E 172).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex, glossy film-coated tablets, ranging in color from dark pink to burgundy.

Pharmacotherapeutic group.

Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

Passionflower extract is derived from the medicinal plant Passiflora incarnata, which contains 0.04% indole-type 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 depressive symptoms upon awakening, and possesses anticonvulsant properties.

Clinical characteristics.

Indications.

As a sedative in patients with neurasthenic and depressive conditions, stress, anxiety, nervousness, sleep disorders, and 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), as well as for post-infectious asthenia.

Contraindications.

Hypersensitivity to any component of the drug.

Pregnancy and breastfeeding period.

Interaction with other medicinal products and other types of interactions.

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**®**.

Special precautions for use.

Use with caution in patients with severe organic gastrointestinal disorders.

Elderly patients should start treatment with the minimum dose.

Use during pregnancy or breastfeeding.

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

Ability to influence reaction speed when driving or operating machinery.

During treatment with this medicinal product, driving and working with potentially hazardous machinery should be avoided.

Dosage and Administration.

For adults and children aged 12 years and older: to achieve a sedative effect, take 1–2 tablets 3 times daily before meals. For sleep disorders – take 2–3 tablets once, 1 hour before bedtime.

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

Children.

The drug in this pharmaceutical form is not intended for children under 12 years of age.

Overdose.

There is no data regarding overdose. Overdose may enhance the manifestations of adverse reactions.

Treatment: gastric lavage. Symptomatic therapy.

Adverse reactions.

When used at recommended therapeutic doses, adverse effects are unlikely.

Adverse reactions associated with Passiflora incarnata have been reported with unknown frequency.

Gastrointestinal system: nausea, vomiting.

Cardiovascular system: tachycardia, bradycardia, ventricular tachycardia.

Nervous system: dizziness, drowsiness.

Immune system: possible allergic reactions, including vasculitis.

Shelf life.

3 years.

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

10 tablets per blister pack, 2 or 5 blisters per cardboard box.

Prescription status.

Over-the-counter.

Manufacturer.

NOBEL ILAC SANAYI VE TICARET A.S.

Manufacturer's address.

Sankaklar Quarter, Eskikarakodja Avenue, No: 299, 81100 Duzce, Turkey.