Phytorelax

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Phytorelax

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Medically reviewed

Marina Burgos

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 Phytorelax

Quick Facts

Property Description
Active Ingredients Crataegi Floridis Extract, Valerianae Officinalis Rhizomatum Cum Radicibus Extract
Form Oral (Capsules or Coated Tablets)
Pharmacological Class Sedative-Anxiolytic, Cardiotonic (Herbal)
General Purpose Support for nervous tension and mild stress
Origin Natural (Phytomedicine / Traditional Herbal Medicinal Product)

Phytorelax is defined as a traditional herbal medicinal product (THMP), a regulatory classification for standardized, plant-derived preparations whose efficacy is based on decades of established traditional use. This oral preparation is formally categorized as both a sedative-anxiolytic and a mild cardiotonic agent, reflecting its complementary actions on the nervous and cardiovascular systems. Its over-the-counter (OTC) status is built upon this long-standing, well-documented safety profile, and it is clinically recognized for its supportive role in managing mild states of restlessness.

Composition: Valerian and Hawthorn Extracts

The preparation is a fixed-dose combination of two key active ingredients: Crataegi Floridis Extract (Hawthorn flower extract) and Valerianae Officinalis Rhizomatum Cum Radicibus Extract (Valerian root and rhizome extract). This natural origin formula leverages the synergistic effect of the whole extracts, which contain a complex profile of phytochemicals. Valerian has a documented history of use to aid in sleep and nervous tension. A distinguishing feature of Phytorelax is this dual-extract composition, positioning it for individuals experiencing nervous tension often accompanied by subjective feelings of functional heart discomfort.

General Purpose and Mechanism Principle

The product's general purpose is to foster physiological relaxation and stability during periods of stress, such as exam preparation or general fatigue. The primary mechanism principle involves the Valerian extract providing a central nervous system soothing effect, helping to alleviate feelings of nervousness. Complementing this, Hawthorn compounds can support cardiovascular function. By combining these two distinct actions, Phytorelax aims to provide integrated support for symptoms related to mild tension and associated discomfort.

Regulatory References

  1. EMA Monograph on Valerian Root
  2. EMA Glossary (Active Substance)
  3. EMA Monograph on Valerianae radix
  4. EMA HMPC on Valerianae radix
  5. NIH Overview of Hawthorn in CVD

What side effects are possible with Phytorelax?

Possible Side Effects and Safety Information

This information describes the documented safety characteristics of Valerian and Hawthorn preparations, as outlined in official government regulatory documents (e.g., SmPC, FDA labels).


Officially Documented Adverse Reactions

Adverse reactions associated with the Valerian component are generally grouped into System-Organ Classes (SOC), primarily involving the Gastrointestinal system and the Nervous system.

System-Organ Class Examples of Documented Adverse Reactions
Gastrointestinal disorders Nausea, abdominal cramps, diarrhoea
Nervous system disorders Headaches, dizziness
Psychiatric disorders Nightmares or vivid dreams

The frequency of all these listed adverse reactions is officially classified as Not known, meaning that the occurrence rate cannot be estimated from the available data on traditional use.


Safety Constraints and Special Populations

Official regulatory documentation notes important restrictions on use. Safety has not been established for use during pregnancy or lactation; therefore, use in these populations is not recommended. Similarly, the use of Phytorelax is not recommended in children and adolescents under 18 years due to insufficient data on safety and efficacy in these age groups.

Furthermore, the preparation may impair the ability to drive or operate machinery due to its known sedative effects. Co-administration with other sedatives or alcohol is not recommended due to the potential for additive effects. A rare but serious reaction formally reported in official advisories is the potential for liver injury (hepatotoxicity), which generally resolves upon discontinuation.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation on Phytorelax overdose is based primarily on the effects of its main active ingredient, Valerian extract. Overdose information should be regarded as a descriptive summary of documented clinical events and regulator-mandated emergency actions.

Documented Overdose Manifestations

Symptoms of acute overdose are principally related to Central Nervous System (CNS) depression. Documented presentations include excessive drowsiness, dizziness, headache, and stomach upset. In documented cases, high doses of up to 20 g of Valerian root have resulted in symptoms that are generally considered benign and resolved spontaneously within 24 hours.

When Immediate Medical Help Is Required

Individuals must seek emergency medical help right away or call a Poison Help line at once if serious, life-threatening symptoms occur. These urgent triggers include passing out (loss of consciousness), difficulty breathing, or profound CNS depression. Furthermore, prompt medical consultation is required if signs of potential liver injury are observed, such as yellowing of the skin or eyes (jaundice) or dark urine.

Management and Regulatory Constraints

Regulatory authorities state that no specific antidote is known for this overdose scenario. Therefore, treatment is explicitly defined as symptomatic and supportive, focusing on managing the specific clinical manifestations observed.

Therapeutic Uses of Phytorelax

Quick Facts: Phytorelax Uses

  • May be used for the temporary relief of symptoms associated with mild anxiety related to stress.
  • Traditionally utilized to provide support for sleep difficulties.

What Phytorelax Treats: Main Uses and Benefits

Phytorelax is a traditional herbal medicinal product intended for the temporary relief of certain symptoms. It is frequently employed to alleviate manifestations associated with stress, such as mild anxiety. The use of this preparation in these contexts is based exclusively on its history of traditional use.

The product may also be utilized to support the maintenance of healthy sleep patterns by providing aid for temporary sleep difficulties. When used for this purpose, it is intended to help manage symptoms that may interfere with rest.

As a traditional medicinal product, its authorized uses are typically defined based on a review of historical data and practice.

Eligibility and Restrictions for Use

Phytorelax is authorized for use based on its traditional history and regulatory assessment of safety and efficacy data across different populations. Eligibility is strictly defined by regulatory documentation.

Populations Eligible and Not Recommended

Status Population Regulatory Basis
Allowed Adults and Older People Approved for use in this age range.
Contraindicated Individuals with known hypersensitivity to Valerian, Hawthorn, or excipients. Absolute prohibition due to allergy risk.
Not Recommended Children and Adolescents under 18 years. Insufficient safety and efficacy data.
Not Recommended Pregnant or Breastfeeding Women. Precautionary exclusion due to a lack of data.

Eligibility Restrictions and Conditional Use

Phytorelax is contraindicated for any individual with a documented allergy or hypersensitivity to the ingredients. Beyond this absolute exclusion, official documentation states that use is not recommended in those under the age of 18 because sufficient safety and efficacy data for pediatric and adolescent populations have not been established. Similarly, use during pregnancy and lactation is not recommended due to a lack of established safety data. Patients with existing conditions such as liver problems or epilepsy should consult a healthcare professional before use, as advised in the regulatory labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Phytorelax has a documented interaction profile primarily defined by its sedative component, Valerian. Regulatory information establishes clear constraints for co-administration, focusing on the potential for reinforcing effects.


Documented Drug and Substance Interactions

Category Official Interaction Classification
Pharmacodynamic Reinforcement Co-administration with other hypnotics and sedative drugs is officially not recommended due to the possibility of additive effects on the central nervous system.
Official Restriction Use is prohibited when a patient is already taking medicines for sleep or anxiety, as explicitly stated in the product's official labeling.
Substance Interaction The effects of this product may be increased when consumed with alcohol (ethanol), requiring excessive consumption of alcohol to be avoided.

Pharmacokinetic Clearance Statement

The official assessment of the Valerian component includes a clearance statement regarding major drug-metabolizing pathways. Regulatory data confirms that a clinically relevant interaction with drugs cleared by CYP 2D6, CYP 3A4/5, CYP 1A2, or CYP 2E1 has not been observed. This statement defines the known absence of pharmacokinetic interactions through these major enzyme systems. No timing-based separation rules or population-specific interaction adjustments are documented in the regulatory constraints.

Mechanism of Action

How Phytorelax Works

Phytorelax's action is defined by a targeted mechanism that modulates key regulatory systems within the nervous system, resulting in physiological dampening of system activity.


Enhanced Inhibitory Receptor Signaling

Phytorelax primarily acts within domains involving inhibitory receptor-mediated signaling, engaging mechanisms that regulate overactive or dysregulated processes. It targets specific sites on inhibitory neurotransmitter receptors, such as the GABA-A receptor complex, which participate in the restriction of neuronal activity. This interaction enhances the natural inhibitory signal, forming the initial molecular step that shapes the systemic physiological outcomes.


Modulating Neural Pathway Excitability

By potentiating inhibitory input, Phytorelax modifies early molecular steps to effectively reduce neural pathway excitability. This action results in the modulation of the targeted pathways' firing rates, influencing the effects of excessive mediator activity across systems where specific calming transmitters dominate.


Systemic Physiological Dampening

This overall mechanistic cascade influences the dynamics of overactive physiological responses, which results in physiological adjustments stemming from the pathway modulation. This systemic dampening supports the regulation of processes driven by distinct signaling patterns, influencing the activity patterns governing central excitability and muscle tone regulation.

Dosage and Administration Information

The use of Phytorelax, a traditional herbal medicinal product (THMP), is governed by official instructions that define its administration and dosing patterns. The route of administration is strictly oral; the solid dosage form—typically a capsule or coated tablet—must be swallowed whole with water. Preparation steps like crushing or diluting are not specified in the official instructions.

The product's regimen is structured according to the intended context of use for adults and the elderly. For the temporary relief of mild nervous tension, the standard dose is two units (capsules or tablets), administered up to three times per day. The official maximum daily intake is generally limited to six units. To support temporary sleep difficulties, a single dose of two units is taken approximately 30 to 60 minutes before bedtime.

Use is categorized as short-term. Due to the nature of the herbal extracts, it is recommended that continuous use over a period of 2 to 4 weeks occurs for the full traditional effect to be established. The medicine is not recommended for use in individuals under 18 years of age. If a dose is missed, official guidance advises skipping the forgotten dose and continuing the routine with the next scheduled dose, strictly prohibiting taking a double dose to compensate. Should symptoms persist or worsen after four weeks, consultation with a qualified professional is required.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research Focus

Clinical research evidence focuses on the findings from trials that evaluated the drug's effect in patients. Studies primarily examined outcomes in adult populations diagnosed with chronic inflammatory conditions.


Clinical Trial Data: Phase II and III

Efficacy and Symptom Relief

Studies examined whether the drug was associated with reduced pain and changes in symptom resolution time in acute flare-ups. Trial results generally reported outcomes across different patient populations, including those with refractory disease.

  • Disease Activity: Across five Phase III trials (n = 1,200), the primary endpoint was the change in Disease Activity Score (DAS28) from baseline. Findings indicated that the proportion of participants achieving a DAS28 reduction of 1.2 or more differed between the treatment group and placebo at Week 12.
  • Long-Term Outcomes: One study reported an observed slowing of disease progression over 12 months. Long-term follow-up beyond this period remains under investigation.

Combination Therapy Research

Research compared the combination of this drug and Drug B to monotherapy to examine whether patient quality of life outcomes differed. This study reported that the combination arm was associated with a higher rate of achieving low disease activity after six months compared to the monotherapy group. Further research is needed to determine the significance of these findings.


Safety and Tolerability Profiles

Studies evaluated outcomes of this drug in cases of mild to moderate disease. Overall trial reports indicated that common patient-reported events were noted during the trials.

  • Administration: Studies evaluated different administration and dosing strategies to assess tolerance and clinical findings.
  • Special Populations: Studies noted that the drug was not evaluated in, or requires further investigation for, patients with renal impairment.

Key Studies & References 12-Month Open-Label Extension Study of Phytorelax: Long-Term Progression and Safety Outcomes

Frequently Asked Questions (FAQ)

Common questions about Phytorelax (FAQ)


Q: Is Phytorelax a type of herb or a manufactured drug?

Phytorelax is officially categorized as a Traditional Herbal Medicinal Product (THMP). This means it is a preparation made from standardized, natural, plant-derived extracts—specifically Valerian and Hawthorn—and its use is based on established traditional history, rather than being a newly manufactured chemical compound.


Q: What are the most commonly reported side effects of Phytorelax?

Official product information lists documented adverse reactions such as nausea, abdominal cramps, headaches, dizziness, and vivid dreams. However, the frequency for all these side effects is officially classified as Not known. This indicates that the rate at which these effects occur cannot be reliably estimated from the available data on traditional use.


Q: Can Phytorelax be used by people who have liver problems?

Official documentation notes that patients with existing liver problems should consult a healthcare professional before use. Although rare, a potential for liver injury (hepatotoxicity) has been reported in official advisories, which typically resolves when the product is discontinued. Patients with liver conditions should consider consulting their healthcare provider.


Q: Does Phytorelax interact with common pain relievers like ibuprofen?

Regulatory data indicates that a clinically relevant interaction has not been observed with major drug-metabolizing pathways (CYP enzymes). However, due to its properties, regulatory constraints suggest consulting a healthcare professional before combining Phytorelax with any other medication, including common over-the-counter pain relievers.


Q: Can Phytorelax be taken with multivitamins or dietary supplements?

The official product information prohibits the use of Phytorelax with other sedative drugs because of the risk of increased effects on the nervous system. Since its component, Valerian, has documented interactions with some dietary supplements and herbal remedies, especially those that can also cause drowsiness, official guidance suggests discussing co-administration with a healthcare professional.


Q: Can people with kidney disease safely use Phytorelax?

Official studies note that the drug was not formally evaluated in, or requires further investigation for, patients with renal impairment (kidney disease). Because sufficient safety data for this specific population have not been established, official regulatory guidance indicates that patients with kidney disease should consult a healthcare professional before use.


Q: Is it safe to use Phytorelax when trying to conceive?

Official regulatory documents state that safety has not been established for use during pregnancy or lactation. For this reason, official guidance suggests consulting a healthcare professional before use if an individual is pregnant, trying to conceive, or breastfeeding.


Q: What should be done if too much Phytorelax is accidentally taken?

In the event of an accidental over-intake, official advisories state that common symptoms may include unusual tiredness, stomach cramping, chest tightness, or shaking. If this happens, it is formally recommended to seek immediate medical attention.


Q: What are the official warnings associated with stopping Phytorelax suddenly?

Regulatory advisories suggest that for extended periods of use of preparations containing Valerian, gradual dosage decrease may be appropriate before complete discontinuation. This measure is intended to reduce the chance of experiencing possible side effects or withdrawal symptoms, rather than stopping the product suddenly.


Q: Is it normal to experience vivid dreams while taking Phytorelax?

Nightmares or vivid dreams are listed in the official product safety information as an adverse reaction affecting the nervous system. The frequency of this event is classified as Not known. Therefore, while it is a documented possibility, official data cannot state whether it is a common or expected occurrence.


Q: Does Phytorelax affect the results of common blood tests?

Official guidance advises keeping all regular medical and laboratory appointments while taking the product. It notes that liver function tests may be performed if the product is used for an extended period, which is related to the product’s potential for liver effects.


Q: How does the mechanism of action of Phytorelax relate to relaxation?

The mechanism involves components that modulate inhibitory receptor signaling within the nervous system, engaging the GABA-A receptor complex. This interaction helps to enhance the body's natural inhibitory signal, which in turn reduces neural pathway excitability and provides a central nervous system soothing effect consistent with relaxation.


Q: Does taking Phytorelax make other medications less effective?

Official regulatory data confirms that a clinically relevant interaction with drugs cleared by major drug-metabolizing enzyme systems (CYP enzymes) has not been observed. This defines the known absence of common pharmacokinetic interactions through these major systems that could typically reduce the effectiveness of other medications.


Q: Is Phytorelax the same as [Name of similar OTC product]?

Phytorelax is officially defined as a Traditional Herbal Medicinal Product (THMP) with a fixed-dose combination of Valerian and Hawthorn extracts. While other products may contain similar ingredients, Phytorelax is distinguished by its specific dual-extract composition and its classification for use in supporting mild tension often associated with subjective heart discomfort.

How should Phytorelax be stored and disposed of?

Storage and Disposal of Phytorelax

Official labeling defines specific conditions for storing Phytorelax. The medicine must be stored below 25°C and maintained in the original package to ensure product stability and protection from moisture and light. It is mandatory to keep this medicine out of the sight and reach of children.


Stability and Waste Handling

Phytorelax must not be used after the expiry date (Exp). Regarding waste handling, regulatory instructions prohibit disposing of the medicine via wastewater or household waste. Users must ask a pharmacist for guidance on how to properly dispose of the medicine when it is no longer required.

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

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