Alora film-coated tablets 100 mg No. 20

Instructions for Alora film-coated tablets 100 mg No. 20

Composition

active ingredient: passiflora incarnata;

1 tablet contains 100 mg of dry passionflower extract;

excipients: povidone K-30, crospovidone, croscarmellose sodium, colloidal anhydrous silicon dioxide, microcrystalline cellulose, magnesium stearate, Sepifilm LP 007 coating, “Red wine” dye;

composition of the Sepifilm LP 007 coating: hypromellose, microcrystalline cellulose, stearic acid;

composition of the dye "Red Wine": potassium aluminum silicate, red iron oxide (E 172).

Dosage form

Film-coated tablets.

Main physicochemical properties: round, biconvex, shiny tablets, coated, from dark pink to burgundy in color.

Pharmacotherapeutic group

Sleeping pills and sedatives. ATX code N05C M.

Pharmacological properties

Pharmacodynamics.

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

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

The drug improves mood in depressive states, reduces anxiety and mental tension, has a mild hypnotic effect without symptoms of depression upon awakening. Has anticonvulsant properties

Indication

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

Contraindication

Hypersensitivity to any of the components of the drug.

Pregnancy and breastfeeding.

Interaction with other medicinal products and other types of interactions

When used simultaneously with drugs that depress the central nervous system, such as barbiturates and tranquilizers, the sedative and hypnotic effect of the drug is enhanced.

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

During treatment with Alora ®, you should not drink alcoholic beverages.

Application features

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

Elderly patients should start treatment with the minimum dose.

Use during pregnancy or breastfeeding

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

The ability to influence the reaction speed when driving or working with other mechanisms

During treatment with the drug, you should refrain from driving and working with potentially dangerous mechanisms.

Method of administration and doses

For adults and children over 12 years of age: to achieve a sedative effect, take 1-2 tablets 3 times a day before meals. For sleep disorders, take 2-3 tablets 1 time 1 hour before bedtime.

The duration of treatment is determined by the doctor individually depending on the indications and clinical efficacy of the drug. The recommended dose should not be exceeded.

Children.

The drug in this dosage form should not be used in children under 12 years of age.

Overdose

There is no data on overdose of the drug. It is possible to increase the manifestations of adverse reactions.

Treatment: gastric lavage. Symptomatic therapy.

Side effects

When used in recommended therapeutic doses, side effects are unlikely.

Cases of adverse reactions to passionflower incarnate have been described with an unknown frequency.

From the digestive tract: nausea, vomiting.

Cardiovascular system: tachycardia, bradycardia, ventricular tachycardia.

From the nervous system: dizziness, drowsiness.

On the part of the immune system: allergic reactions, including vasculitis, are possible.

Expiration date

3 years.

Storage conditions

Store in a place protected from light at a temperature not exceeding 25 ºС.

Keep out of reach of children.

Packaging

10 tablets in a blister, 2 or 5 blisters in a cardboard box.

Vacation category

Without a prescription.

Producer

NOBEL ILACH SANAI VE TJARET A.Sh.

Address.

Sankaklar Quarter, Eski Akcakoca Ave., No. 299, 81100 Duzce, Turkey.