Алора

Quick links to important sections

Алора

Selected form

Method of action: Hypnotic, Sedative

Treatment option:

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Алора

Quick Facts

Property Description
Active ingredient Passiflorae herba extract (Passiflora Incarnata)
Form Film-coated tablets, Syrup
Pharmacological class Sedative and Anxiolytic
Common use Mild mental stress, nervous restlessness
Origin Natural/Herbal

What Type of Medicine is Алора?

Алора is a specific trade name for a recognized herbal medicinal product (phytomedicine), which is distinctly derived from a natural plant source rather than being chemically synthesized. It is classified as a Sedative and Anxiolytic agent, reflecting its intended therapeutic function. The use of Passiflora Incarnata preparations in traditional medicine has been recognized for supporting mood and sleep, which supports the product's primary positioning for relaxation and managing nervous system states.

Composition and Source: Is Алора Natural or Synthetic?

Алора is a monocomponent product of natural/herbal origin, with the sole active ingredient being the dry extract of Passiflorae herba, sourced from the aerial parts of Passiflora Incarnata L. This formula is clinically recognized for containing key phytochemicals, specifically flavonoids, like vitexin, which are the basis for the sedative properties. A distinguishing feature of Алора is its availability in multiple dosage form(s) for oral administration, specifically film-coated tablets and a liquid syrup, offering patient choice.

General Purpose and Core Therapeutic Benefit

The general purpose of Алора is achieved through its physiological action as a mild CNS depressant, which assists in stabilizing the nervous system. The active components are known to gently modulate the gamma-aminobutyric acid (GABA) system, leading to a demonstrable reduction in nervous excitability. By supporting the body's natural relaxation response, the product provides a core therapeutic benefit by helping to relieve daily tension and facilitating the ability to transition into rest.

Regulatory References

  1. European Medicines Agency (EMA)

What side effects are possible with Алора?

Possible Side Effects and Safety Information

The safety profile for preparations containing Passiflorae herba (such as Алора) is primarily based on documentation from traditional use and post-market experience, rather than extensive controlled studies. Consequently, the official European regulatory monograph classifies the incidence of undesirable effects, or side effects, as "None known." This status reflects a lack of sufficient data to establish a frequency category (e.g., common, uncommon, or rare) under normal conditions of use.

Safety Considerations and Functional Constraints

Despite the regulatory classification of "None known" side effects, specific mandatory safety constraints are documented. Due to the product's mild sedative properties, official labeling warns that it may impair the ability to drive and use machines as a result of potential effects on the nervous system, such as drowsiness or dizziness.

Serious, though isolated, safety signals have been noted in safety reviews. These high-level signals concern the cardiovascular system, including reports of QT interval prolongation, and the immune system, involving reactions like cutaneous vasculitis.

Population-Specific Restrictions

Official regulatory documents place strict constraints on the use of Алора in certain populations due to a lack of established safety data:

  • Pediatrics: Use is not recommended in children under 12 years of age.
  • Pregnancy and Lactation: Use during these periods is not recommended, as safety has not been established and data are insufficient.

Contraindication: Use is restricted in individuals with known hypersensitivity to the active substance or any of the excipients.

Overdose and Emergency Response

The official regulatory documents regarding the active ingredient in Алора (Passiflora incarnata extract) indicate that no case of overdose has been formally reported in the primary monograph. Despite the absence of documented cases, regulatory guidance exists for managing scenarios where an excessive amount of the product has been consumed, focusing on the expected pharmacological profile.

Documented Overdose Manifestations

Overdose manifestations are primarily associated with the exaggerated sedative properties of the herbal extract, leading to potential signs of central nervous system (CNS) depression. These may include marked drowsiness and sedation to a greater extent than intended. A specific risk noted for excessive use is the potential for potentiation of therapy with MAOIs (Monoamine Oxidase Inhibitors).

Emergency Actions and Required Medical Help

In the event that an excessive amount of Алора is taken, regulatory instruction mandates that the individual must contact a doctor or pharmacist straight away for assessment. Immediate medical attention should be sought for any severe, unexpected, or life-threatening symptoms that may result from the excessive use.

Supportive Management

The management of overdose is restricted to symptomatic and supportive treatment, as no specific antidote is known for Passiflora incarnata extract. No population-specific overdose considerations are explicitly detailed in the official regulatory sections.

Therapeutic Uses of Алора

What Алора Treats: Main Uses and Benefits

The primary therapeutic benefit of Алора is associated with its role as a mild sedative and anxiolytic, offering symptomatic relief in functional nervous states and mild sleep disturbances. This herbal preparation is traditionally used for the relief of mild symptoms of mental stress and to aid sleep.

The medication is commonly used to help with symptoms of nervous restlessness, heightened irritability, and functional sleep difficulties. This includes situations where feelings of inner tension or worry interfere with the ability to settle down and ease into rest.

“It is commonly used across conditions presenting with episodic or fluctuating symptom patterns, providing support that helps ease the overall symptom burden.”

Quick Fact: Relief for Nervous Tension

This domain covers the use of the medication to address symptom clusters such as feelings of inner tension and nervous excitability that may appear suddenly or fluctuate during periods of daily pressure. By supporting a gentle calming effect, the medication helps moderate these distressing manifestations and may assist in easing the overall symptom load and contributes to comfort during symptomatic periods.

Алора is applied when an individual experiences difficulty falling asleep or poor sleep quality that is primarily linked to an overly active, restless mind at bedtime. Its supportive therapeutic benefit helps facilitate the ability to settle down and ease into rest, which may help support functional stability and supports general well-being during symptomatic phases.

Regulatory References

  1. European Medicines Agency (EMA) monograph on Passiflora incarnata

Eligibility and Restrictions for Use

The eligibility profile for this medicine is defined by specific regulatory criteria that determine who is permitted to use the product and who is formally excluded. The information is based on official government documentation.

Eligibility Status Summary

Population Status Regulatory Rule
Allowed Use is established for Adults and Adolescents aged 12 years and older.
Contraindicated Use is absolutely prohibited in patients with known hypersensitivity to the active substance (Passiflorae herba extract) or any excipients.
Not Recommended Use is not recommended for children under 12 years of age.
Not Recommended Use is not recommended during pregnancy or lactation.

Eligibility Classifications

Age-Related Eligibility: Use is officially restricted to individuals 12 years of age and older. The medicine is formally classified as not recommended for children younger than 12 due to a lack of adequate data to establish safety in that age group.

Reproductive Status Limitations: Use during pregnancy and lactation is officially classified as not recommended by regulatory authorities. This classification is applied because the safety profile of the medicine has not been established for either population.

Comorbidity-Based Eligibility: Official regulatory documentation does not specify contraindications or restrictions based on common underlying conditions such as hepatic (liver) or renal (kidney) impairment.

What should I know about interactions with other medicines?

Алора Interactions with other medicines and products

The interaction profile for Алора (Passiflorae herba extract) is primarily defined by the potential for pharmacodynamic interactions with agents that also affect the central nervous system (CNS).


Pharmacodynamic Interactions

Official regulatory documentation notes the risk of additive sedative effects when this product is co-administered with other sedative medicinal products.

  • Interacting Product Category: Sedative Medicinal Products
  • Specific Example in Documentation: Benzodiazepines (cited as an example of a class that may contribute to additive sedative effects).

Substance and Other Restrictions

While no medicinal combinations are formally labeled as contraindicated, regulatory monographs contain a specific restriction regarding non-medicinal substances:

  • Alcohol: The simultaneous intake of alcohol is not recommended due to the potential for enhanced sedative effects.

Absence of Pharmacokinetic Interactions

The authoritative regulatory assessments contain no official documentation of pharmacokinetic interactions. This includes no documented involvement with CYP enzymes, drug transporters (such as P-gp), or any substances that modify the drug’s plasma levels or clearance.

Mechanism of Action

The mechanism of action for Алора, derived from Passiflora incarnata extract, centers on the modulation of the central GABAergic system. The extract contains multiple active compounds, primarily flavonoids (such as chrysin and vitexin) and minor indole alkaloids.

These flavonoids function as partial agonists at the benzodiazepine binding site of the GABA A receptor complex. This interaction promotes an allosteric change in the receptor structure, increasing the frequency of chloride ion channel opening. The resulting influx of negatively charged chloride ions causes neuronal hyperpolarization in the postsynaptic cell.

This hyperpolarization increases the threshold required for an action potential to fire, leading to a general depression of central nervous system (CNS) activity. Downstream effects may also include the inhibition of GABA reuptake by synaptosomes and potential interaction with GABA B and opioid receptor systems, further contributing to the overall modulation of neuronal excitability.

Dosage and Administration Information

How to Use Алора: Administration Guidelines

Administration of this traditional herbal medicinal product, derived from Passiflorae herba extract, follows established guidelines. These instructions govern the appropriate method, frequency, and duration of use, based on the product's traditional classification and use.

Administration Scope

Parameter Instruction
Route of Administration Oral use (ingestion only).
Dosing Schedule Dosing is standardized by the amount of powdered herbal substance (e.g., 0.5 to 2 g) or its equivalent extract per single dose.
Frequency Pattern For contexts of mild mental stress, the single dose is generally administered up to four times daily. For use as an aid to sleep, a single dose is taken shortly before bedtime.
Age-Group Rules The medicinal product is indicated for use in adolescents over 12 years of age, adults, and the elderly. Use is not recommended for children under 12 due to insufficient data.

Procedural Structure and Constraints

The usage protocol establishes that the preparation is to be taken orally, aligning the frequency of intake with the intended time of use (divided use for daytime support versus a single dose for night). For solid dosage forms and liquid extracts, ingestion is typically direct. When the comminuted herbal substance is used, it is prepared as an infusion by steeping in boiling water before ingestion. Use of the product is generally defined as short-term. If symptoms persist after two weeks of use, it is recommended to seek advice from a qualified health practitioner. Furthermore, the labeling includes the practical constraint that the product may impair the ability to operate machinery, which directly affects the context of administration.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Алора

Research Evidence for Mild Symptoms of Mental Stress and Nervous Restlessness

The active ingredient in Алора (Passiflora Incarnata extract) was studied for its use in individuals experiencing symptoms like inner tension, irritability, and general nervous restlessness. Researchers often utilized short-term, randomized controlled trials (RCTs) where participants were compared in placebo-controlled designs. These studies examined patient-reported experiences and used standardized rating scales to measure changes in stress and anxiety scores. Specific research was observed in adult populations, including those facing temporary periods of high tension or those preparing for minor procedures where preoperative nervousness was monitored.

Findings describe patterns observed in the studies where participants reported patterns in measured scores for tension and anxiety during the short treatment periods. These comparisons were often made against the placebo group. The core research typically limits follow-up durations to a few weeks (e.g., 30 days).


Research Evidence for Supporting Sleep in Mild Difficulties

The research focusing on sleep was examined for mild sleep difficulties, particularly when they are linked to an active, restless mind at bedtime. These studies primarily involved short-term, placebo-controlled RCTs. The main approach involved applied studies examining patient-reported experiences through sleep diaries, which monitored outcomes related to overall perceived sleep quality and the time it took to fall asleep (sleep onset latency).

Studies report how symptoms evolved in the observed populations of healthy adults who described having mild sleep fluctuations. The data show patterns where participants reported changes in their perception of restfulness. Evidence is limited for long-term use, meaning there is limited information for long-term outcomes regarding the sustained influence on chronic sleep disorders.


Key Uncertainties and Research Gaps

The evidence base for Алора's active ingredient, while substantial for its traditional use, contains recognized limitations. Evidence quality varies across studies, partly due to sample sizes were modest in many of the included trials. The reliance on subjective data—such as patient-reported outcomes—is a noted limitation, as objective confirmation is less common in the existing literature. The results apply only to the populations studied, meaning the research provides context but not individual predictions for those with complex or underlying health conditions.

Key Studies & References Passiflora incarnata L.: A Review of its Traditional Uses, Phytochemistry and Pharmacology (PubMed Central ID: 7700940)

Frequently Asked Questions (FAQ)

Common questions about Алора (FAQ)

Q: How quickly can one expect to notice any effect from Алора?

Official guidelines for using this medicine as an aid to sleep suggest taking a single dose shortly before the intended bedtime. The administration advice suggests that the medicine is typically taken shortly before sleep to support the transition to rest. However, regulatory documents do not specify a precise time frame for when effects are generally noticed.

Q: What should be done if a potential side effect is noticed?

Official regulatory documents advise that if any adverse reactions are noticed, a qualified healthcare practitioner should be consulted. The official documentation states that the use of the product should be stopped if signs of hypersensitivity or an allergic reaction occur.

Q: Are there any known interactions between Алора and common over-the-counter pain relievers?

Regulatory documents primarily note the risk of enhanced drowsiness or sedative effects when this medicine is combined with other products that also cause drowsiness. The official product information does not list non-sedating, over-the-counter pain relievers (such as common fever reducers or anti-inflammatories) as known interacting products.

Q: Does Алора interact with birth control pills?

Authoritative regulatory assessments, which look for drug-altering effects, do not document any pharmacokinetic interactions for this medicine. The official documentation does not state that this medicine affects the proper functioning or effectiveness of hormonal birth control pills.

Q: What is the expected duration of effect after taking one dose of Алора?

The medicine is administered as an aid to sleep, which suggests a duration of effect intended to support rest. Official guidelines do not specify a precise pharmacological half-life or duration of effect for a single dose.

Q: Why is Алора sometimes used before certain medical procedures?

The official, approved purpose of this medicine is restricted to the relief of mild mental stress and to aid sleep. However, research has examined the use of the active ingredient to help individuals experiencing nervousness before minor medical procedures.

Q: What is the difference between taking Алора as a tablet versus a liquid form?

Official regulatory documents confirm that the active ingredient is available in various forms, including tablets and liquid extracts (syrup). The intended dosing is standardized based on the amount of active herbal extract in each form, meaning the effects are primarily related to the quantity of the active substance delivered, not the form itself.

Q: What happens if a patient wants to stop taking Алора suddenly?

The official product warnings do not include risks of dependence or withdrawal symptoms. In the context of its traditional use, research has suggested that the active ingredient can be discontinued without reports of rebound effects. It is always appropriate to consult a qualified healthcare practitioner regarding decisions about starting or stopping any medicine.

Q: Does taking Алора require any specific lifestyle changes?

Official labeling specifically advises exercising caution if driving or operating machinery, due to the potential for drowsiness. Additionally, regulatory documents recommend against the simultaneous intake of alcohol due to the potential for enhanced sedative effects.

Q: Is it possible to have an overdose of Алора?

As with all medicines, taking more than the stated amount is possible. Regulatory documentation advises seeking medical help in case of suspected overdose. Management of excessive intake typically involves symptomatic and supportive therapy.

Q: Does Алора affect mood in ways other than calming?

The officially recognized purpose of the medicine, according to regulatory documents, is restricted to supporting the relief of mild mental stress and nervous restlessness. The official product information does not include other specific effects on mood.

Q: Is Алора known to interact with herbal remedies or supplements?

Official regulatory warnings caution against combining this product with other sedative medicinal products. This is a general caution that would extend to any other herbal remedies or supplements that are also known to have sedative effects.

Q: Are there special considerations for people with liver or kidney conditions taking Алора?

Official regulatory documents and contraindication sections do not specify any restrictions or cautions for individuals with hepatic (liver) or renal (kidney) impairment.

Q: Do regulatory agencies have specific statements on the quality of Алора's ingredients?

Yes. Regulatory bodies, such as the European Medicines Agency (EMA), maintain official quality standards, known as monographs, for the herbal substance (Passiflorae herba extract) used in this medicine. These standards are intended to ensure the consistent quality of the active ingredient.

Q: Can Алора be taken with multivitamins?

The official interaction profile focuses on co-administration with other sedative medicines or alcohol. There is no official warning or documentation of an interaction between this medicine and typical daily multivitamins.

Q: What should be done if Алора does not seem to be working?

Official guidelines on the duration of use stipulate that if symptoms persist or worsen after the recommended period of use (typically two weeks for traditional herbal medicines), consulting a qualified healthcare practitioner is recommended.

Q: How is the effectiveness of Алора measured in clinical studies?

In clinical studies, the effectiveness of the active ingredient is typically assessed using patient-reported outcome measures. These commonly include standardized rating scales to assess stress and anxiety levels, as well as sleep diaries to monitor perceived sleep quality.

Q: Does Алора have any known withdrawal symptoms if stopped?

Official regulatory warnings do not include dependence or withdrawal symptoms. Research has indicated that the active ingredient was easily discontinued in studies without reports of rebound or withdrawal effects.

Q: Is Алора habit-forming or addictive?

Official regulatory documents do not list dependence or addiction as a known risk associated with this medicine. Research has suggested that the active ingredient can be discontinued without evidence of psychological dependence.

Q: What evidence exists regarding Алора and generalized stress?

The official regulatory indication is specifically for the relief of mild symptoms of mental stress and nervous restlessness. Evidence focuses on these mild, temporary conditions, and the official indication is not for chronic or formally diagnosed conditions.

Q: Can Алора affect blood pressure readings?

Official safety reviews have noted isolated, high-level signals concerning the cardiovascular system, specifically reports of QT interval prolongation. However, official labeling does not generally warn about effects on routine blood pressure readings under normal conditions of use.

Q: Is Алора used for short-term or chronic conditions?

Regulatory guidelines define the use of this medicine as generally short-term. Official instructions stipulate that if symptoms persist after the recommended short duration of use, consulting a healthcare provider is appropriate.

How should Алора be stored and disposed of?

How to Store and Dispose of Алора?

Storage & Disposal Requirement Official Condition
Temperature Range Store at a temperature not exceeding 25 C
Environmental Protection Keep in a dry place and protected from light
Packaging Rule Keep the product in its original container (blister/bottle)
Post-Opening Stability Syrup must be discarded 4 weeks after first opening
Child Safety Must be kept out of the sight and reach of children

Storage of this medicinal product requires maintaining the temperature below the stated maximum limit to preserve quality. The original packaging protects the product from light and moisture. For the syrup, the limited stability after the first use requires discarding any remaining liquid after four weeks. Unused or expired Алора must not be thrown into household waste or flushed down the toilet, but should be disposed of according to local pharmaceutical waste requirements.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Алора found in:

A-Z Index: