Синупрет

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Синупрет

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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 Синупрет

Property Description
Active ingredients Standardized extract blend of five medicinal plants
Form Coated tablets (dragee), Oral drops (solution), Syrup
Pharmacological class Herbal medicinal product, Secretolytic agent
Common use Supporting nasal and sinus clearance
Origin Natural (Plant-derived), Manufactured in Germany

Pharmacological Class and Origin

Синупрет is an orally administered herbal medicinal product categorized as a phytopharmaceutical secretolytic agent. This classification reflects its reliance on a sophisticated, standardized extract of botanicals to achieve its therapeutic effect, differentiating it from single-synthetic-compound medications. The medication is globally recognized as a fixed combination preparation, with its development and manufacturing primarily based in Germany (Bionorica SE). It is classified as a secretolytic that supports mucosal function and secretion clearance.

Composition and Available Forms

Its core identity lies in its precise, standardized extract derived from a blend of five specific plant components: Gentian root, Primula flower with calyx, Sorrel herb, Elderflower, and Verbena herb. The specific ratio of these extracts is a distinctive feature of the preparation. This multi-component extract is formulated into several accessible dosage form(s): coated tablets (dragee), oral drops (solution), and syrup, addressing a broad target patient group, including children who may require a liquid alternative.

General Purpose: Supporting Nasal and Sinus Clearance

Синупрет's general therapeutic purpose is to improve the natural clearance mechanisms within the sinuses and upper respiratory tract. Its action supports the body by simultaneously promoting the liquefaction of thickened mucus and enhancing ciliary movement within the airways. This clinically recognized effect aids in relieving the physical sensation of pressure and fullness often associated with congestion, supporting the overall process of natural respiratory drainage.

What side effects are possible with Синупрет?

Possible Side Effects and Safety Information

The safety profile for Sinupret is primarily characterized by gastrointestinal reactions and hypersensitivity reactions, as documented in official regulatory materials.

Adverse Reactions by Frequency

Classification Frequency Specific Reactions (Examples) System Organ Class
Uncommon Up to 1 in 100 people Stomach pain, nausea, abdominal discomfort Gastrointestinal disorders
Rare Up to 1 in 1,000 people Rash, itching, erythema, angioedema (swelling of face, lips, tongue, or throat), dyspnea (shortness of breath) Immune System, Skin and Subcutaneous Tissue
Not Known Cannot be estimated from available data Dizziness Nervous System

Clinically Significant and Serious Reactions

Serious adverse events are predominantly related to severe hypersensitivity reactions. These rare events, such as facial swelling or difficulty breathing, require immediate medical attention and are grounds for discontinuing the product.

Safety Restrictions and Monitoring

Sinupret is contraindicated for use in individuals with a known hypersensitivity or allergy to any of the active components or excipients contained in the formulation.

Patients should seek prompt medical advice if any symptoms of a hypersensitivity reaction occur, or if gastrointestinal symptoms become severe. Additionally, medical consultation is required if symptoms do not improve within 7–14 days, worsen, or recur periodically, or if the patient develops fever, nosebleeds, severe pain, purulent discharge, or blurred vision. These measures ensure appropriate diagnostic follow-up and management.

Overdose and Emergency Response

Overdose and When to Seek Help

The following information on overdose for Синупрет is strictly based on official regulatory documentation.

Documented Overdose Manifestations

In cases of documented overdose with Синупрет, the official regulatory texts state that the known side effects may appear in a more intense form. The primary physiological system affected, based on reported side effects at supratherapeutic doses, is the gastrointestinal system.

Specific presentations of overdose noted in the labeling include the potential for:

  • Intensified nausea
  • Exacerbated stomach ache
  • Increased incidence of diarrhea

No reports of serious, life-threatening outcomes or specific organ system failure due to overdose have been documented in official product information.

Emergency Actions and Management

If more Синупрет than the recommended dose is taken, official guidance requires the user to seek immediate professional medical advice. Regulatory documents explicitly state the following immediate actions:

  • Seek medical attention: Contact a doctor, pharmacist, the nearest hospital, or a national poison control center immediately.

Overdose Management

Regulatory documentation confirms that the treatment for an overdose of Синупрет is to be symptomatic treatment. There is no specific pharmacological antagonist or reversal agent (antidote) designated or recommended in the official labeling. Management focuses on addressing the presented symptoms, such as the intensified gastrointestinal complaints.

Therapeutic Uses of Синупрет

What Синупрет Treats: Main Uses and Benefits

Синупрет is commonly applied for symptomatic relief in acute rhinosinusitis and is considered relevant during symptomatic periods of chronic rhinosinusitis. The therapeutic area of use involves managing symptoms of paranasal sinus inflammation.

It is generally used in situations to help manage conditions where symptoms may intensify temporarily, such as those related to the common cold and upper respiratory tract infections. The primary symptomatic areas include symptoms related to physical discomfort such as nasal congestion, excessive and thickened mucus retention, and the associated distress of sinus pressure and tension.

“This approach is applied across domains where additional symptomatic support is needed, assisting with maintaining functional stability during periods of heightened symptoms.”

A key therapeutic benefit is supporting the body's processes to promote the necessary change in mucus consistency. This supports patients during episodes of heightened discomfort by easing distress. This use offers symptomatic relief that may help patients cope more steadily with symptom fluctuations, relevant for managing symptoms that interfere with daily comfort.


Quick Fact: Relevant for Easing Congestion Symptoms

Regulatory References

  1. Swedish Medical Products Agency Public Assessment Report

Eligibility and Restrictions for Use

Who Can and Cannot Use Синупрет?

The official eligibility profile for Синупрет (Sinupret extract, high-strength formulation) strictly dictates who can use the medicine based on regulatory documentation, focusing on absolute restrictions, age limits, and conditional use.

Absolute Non-Eligibility (Contraindications)

The medicine must not be used by individuals with specific pre-existing conditions or sensitivities:

  • Hypersensitivity: Patients with a known allergy to the active plant ingredients (Gentian root, Primula flower, Sorrel herb, Elderflower, or Verbena herb) or any other excipients.
  • Gastrointestinal Ulcers: Patients with a current or history of stomach (gastric) or duodenal ulcers.

Age and Physiological Restrictions

Population Group Eligibility Status (Regulatory)
Children and Adolescents (Under 18) Not recommended due to insufficient data for this age group.
Pregnancy Use should be avoided for safety reasons.
Breastfeeding Should not be used as transfer of active substances into milk is unknown.

Limitations and Conditional Use

Use is limited or requires special consideration in specific patient groups:

  • Renal/Hepatic Impairment: There are insufficient data available for specific dosage recommendations for patients with impaired kidney or liver function.
  • Sugar Intolerance: Patients with specific sugar intolerances (e.g., sucrose, glucose) must consult a physician before using the coated tablet form.

The eligibility status is defined by regulatory classification, restricting use to adults 18 years and older without contraindications.

What should I know about interactions with other medicines?

The official regulatory profile for Синупрет regarding interactions with other medicines and products is defined by the available clinical documentation. Regulatory documents explicitly state that dedicated systematic interaction studies have not been conducted with other co-administered medicinal products. This absence of specific data necessitates the inclusion of a formal regulatory caveat within the official labeling.

Due to this lack of documented evidence, it cannot be ruled out that co-administration may result in an alteration of the effects of other medicines. This potential for effects to be either enhanced or weakened is a non-specific pharmacokinetic or pharmacodynamic consideration that applies broadly to combining Синупрет with other therapeutic agents. No specific interacting substances are listed as having known metabolic (e.g., CYP enzyme) or transporter-mediated interactions in official regulatory texts, nor are there any mandatory timing separation requirements for administration.

Interaction warnings are not issued for specific patient populations, such as those with hepatic impairment or advanced age. A separate clarification addresses the content of ethanol in the liquid formulations (oral drops and syrup). Official regulatory assessment confirms that the quantity of ethanol present in a single dose is not considered clinically relevant for interaction purposes and does not necessitate specific use restrictions. No combinations are formally classified as contraindicated based solely on interaction risk.

Mechanism of Action

How Синупрет Works

The extract acts via a pleiotropic mechanism, engaging targets across three primary physiological domains: modulating secretion and transport, influencing inflammatory pathways, and exhibiting antiviral activity. The mechanism influences molecular targets at the epithelial level to modulate processes related to sinonasal secretion and local defense.

Secretomotoric Mechanism: Activating Ion Transport

The extract acts as a secretomotoric agent by stimulating specific transepithelial chloride channels on respiratory cells. This molecular activation increases the secretion of chloride ions and subsequently water into the airway surface liquid. This cascade facilitates the hydration of viscous mucus and increases the ciliary beat frequency, promoting the overall rate of mucociliary transport.

Anti-Inflammatory Pathway Modulation

The blend also influences inflammatory processes by targeting key enzyme systems. It inhibits the activity and expression of Cyclooxygenase-2 (COX-2), which reduces the synthesis of pro-inflammatory mediators like Prostaglandin E₂. This reduction in chemical signaling subsequently modulates local vascular permeability. The resulting physiological effect includes the modulation of mucosal edema.

Synergistic and Antiviral Effects

The overall pharmacological action is dependent on the synergistic interaction of all five components, which coordinates secretion transport mechanisms with local defense modulation. Furthermore, the extract exhibits non-specific antiviral activity in vitro against common respiratory pathogens, acting by interfering with viral proliferation. This multi-target approach facilitates the modulation of both secretion viscosity and the underlying inflammatory and infective signaling pathways.

Dosage and Administration Information

Administration and Dosing Principles

Синупрет (including Forte and Extract formulations) is administered according to standard dosing protocols, primarily via the oral route. Its dosage forms include coated tablets (dragee), oral drops (solution), and syrup, which allows for age-appropriate delivery.

General Dosing Principles

Administration is generally fixed at a three-times-daily (TID) frequency, usually spaced morning, noon, and evening. Dosing volume and concentration are dependent on the patient's age and the specific product strength:

  • Adults and Adolescents (ge 12 years): Typically 1 tablet (Forte/Extract strength) or approx 7.0 ml of syrup, 3 times per day.
  • Children (6–11 years): approx 3.5 ml of syrup or 1 tablet (Original strength), 3 times per day.

Procedural Instructions and Course Duration

Coated tablets must be swallowed whole (unchewed) with a sufficient quantity of liquid. Liquid forms (drops/syrup) require accurate measurement with the provided device. While the medicine can often be taken independently of meals, it is recommended for patients with a sensitive stomach (e.g., gastritis) to take the dose after meals.

The typical course of treatment for acute conditions is 7 to 14 days. If symptoms persist after this period, worsen, or recur, a physician must be consulted. Furthermore, if a dose is missed, it is advised not to take a double dose to compensate; the next scheduled dose should be taken at the usual time.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Синупрет

Evidence for use in Acute Rhinosinusitis (ARS) and Related Symptoms

Research primarily involves short-term Randomized Controlled Trials (RCTs). These studies were used in research exploring how symptoms change over time, comparing the preparation against an inactive treatment (placebo) or sometimes against other agents. Researchers examined patient-reported outcomes describing perceived discomfort, focusing on the Major Symptom Score (MSS). This score is a composite measure of outcomes related to physical discomfort, such as difficulties with nasal breathing and feelings of facial pressure.

Findings describe patterns observed in studies conducted during periods of increased symptom activity. In trials focusing on adults with uncomplicated ARS, some research reported patterns related to differences in study-defined responder rates over the short study intervals. Studies also examined outcomes related to patterns of follow-up medication usage in the observed populations. Evidence contributes to understanding symptom patterns, but results apply only to the populations studied. Data for certain comparative scenarios are limited, and existing research provides limited insight into long-term changes or the effect on symptom recurrence after the acute episode has passed.

Evidence for use in Chronic Rhinosinusitis (CRS)

This part describes the findings from longer-term Randomized Controlled Trials that have investigated the product's role in managing persistent or recurring symptoms. These studies monitored outcomes reflecting daily functioning alongside assessments of the Major Symptom Score (MSS) in adults with chronic rhinosinusitis, typically excluding individuals with nasal polyps.

In some large trials, the primary measures of symptom change over time were not always reliably different across the entire study group. Separately, subgroup analyses described patterns related to changes in symptoms for those with more severe disease at the start of the study. Data for the general CRS population remain insufficient, and limited information exists for long-term outcomes, as follow-up durations were restricted to a few months.

Research Quality and Areas of Uncertainty

The evidence base for acute rhinosinusitis research has been evaluated in various systematic reviews and meta-analyses. Evidence quality varies across studies, particularly in older literature. Key limitations across the evidence landscape include the fact that comparative evidence is lacking against all standard-of-care treatments, and that data for certain groups (such as patients with co-morbidities or nasal polyps) remain insufficient. The research does not determine individual outcomes based on the group patterns observed in the studies.

Key Studies & References

  1. Assessment of efficacy and safety of the herbal medicinal product BNO 1016 in chronic rhinosinusitis

Frequently Asked Questions (FAQ)

Common questions about Синупрет (FAQ)


Q: What is the difference between Sinupret and Sinupret Forte?

According to regulatory documents, the primary difference between Sinupret Original and Sinupret Forte/Extract is the concentration of the active herbal extract. The Forte strength contains exactly twice the amount of the active substance extract compared to the Original strength coated tablet formulation.


Q: Can Sinupret cause heartburn?

Official product information lists general gastrointestinal discomfort, such as stomach pain and nausea, as uncommon side effects that have been reported. While heartburn is not explicitly named in the adverse reaction tables, it falls under the general classification of gastrointestinal disorders. Patients are advised in the product information to seek medical attention if severe or persistent gastrointestinal symptoms occur.


Q: Does Sinupret help with frontal sinusitis?

The medicine is officially indicated for the management of Acute Rhinosinusitis (ARS) and Chronic Rhinosinusitis (CRS). This indication addresses inflammation across the paranasal sinuses, including the frontal sinus area.


Q: Does Sinupret affect the liver or kidneys?

Official regulatory documents state that there are insufficient data available to provide specific dosage recommendations for patients who have pre-existing impaired kidney or liver function. This limitation in data is noted in the official regulatory prescribing details.


Q: What is the difference between Sinupret tablets and drops/syrup?

The difference between the coated tablets and the liquid forms (drops/syrup) primarily lies in their composition and intended delivery. The liquid forms, such as drops, contain different excipients like ethanol, while the syrup and tablets may contain various sugars. These different forms allow for administration options that may be suitable for various age groups, subject to specific regulatory guidelines for each.


Q: Does Sinupret help with headaches associated with sinusitis?

Yes, official product indications describe the medicine for use in acute rhinosinusitis with symptoms that include headache and facial pain or tension. The indication is aligned with the symptoms reported in the official product information.


Q: Is there sugar in Sinupret (important for diabetics)?

Regulatory information advises that the coated tablet form contains the sugars glucose and sucrose. For diabetic patients, the official product information indicates that one coated tablet contains on average 0.026 carbohydrate exchange units (CEU).


Q: From what age can Sinupret syrup be used?

According to the Summary of Product Characteristics, the syrup formulation is indicated for use in children from the age of 2 years and older. Specific dosing schedules are provided for the 2–5 year old age group in the product documentation.


Q: How is Sinupret different from other mucolytics?

Regulatory documents classify this medicine as a phytopharmaceutical secretolytic agent, which is a specialized category of herbal drug. It is described as having a pleiotropic mechanism that acts simultaneously on secretion modulation, inflammatory pathways, and exhibits in vitro antiviral activity, which is the basis of its described pharmacological activity.


Q: If symptoms disappear, should I continue taking Sinupret?

Official regulatory documents establish the typical course of treatment for acute conditions as lasting 7 to 14 days. The required course duration is defined in the official prescribing information.


Q: Can I take Sinupret with alcohol?

The official product literature, including the patient leaflet and Summary of Product Characteristics, does not indicate any specific known interaction between the medicine and co-ingested alcohol.


Q: Does Sinupret cause drowsiness?

The regulatory safety profile mentions that some patients may experience dizziness as an adverse reaction (frequency 'Not Known'). However, an explicit finding of drowsiness (sleepiness) is not listed among the common or uncommon adverse reaction tables.


Q: Can Sinupret help with nasal congestion without a runny nose?

Yes, the medicine is officially indicated for the treatment of acute rhinosinusitis that presents with symptoms such as a blocked nose and facial pain or tension. This is consistent with the product's reported use for the symptom of a blocked nose.


Q: Are there hormones in Sinupret?

The official regulatory listing of active components includes only the standardized blend of five plant extracts. Hormones are not listed as an active component in the preparation's composition.


Q: How can I tell what the original Sinupret packaging looks like?

The patient information leaflet generally describes the packaging size, such as the number of coated tablets per pack. It also provides a description of the physical appearance of the tablets themselves, such as their color (e.g., green), shape (round), and surface (biconvex).


Q: Is Sinupret available by prescription?

The medicine is regulated as an Over-the-Counter (OTC) Traditional Herbal Medicinal Product in many territories. This classification defines its availability for purchase.


Q: Does Sinupret affect the ability to drive?

The patient leaflet includes a warning regarding driving and operating machinery. It advises that some patients may experience dizziness, which could affect the ability to safely drive and operate machines.


Q: Can I take Sinupret if I have lactose intolerance?

According to the excipient information, the coated tablets (Original and Forte strengths) typically contain lactose. However, the liquid formulations, such as drops and syrup, as well as the eXtract tablet, are generally formulated to be lactose-free.

How should Синупрет be stored and disposed of?

Official Storage and Disposal Instructions

All forms of this medicine must be kept out of the sight and reach of children.

Formulation Maximum Storage Temperature Stability After Opening
Coated Tablets Do not store above 30 C Up to Expiry Date
Oral Drops / Syrup Do not store above 25 C 3 months (Drops), 6 months (Syrup)

The coated tablets require protection from moisture and must be kept in the original carton and blister. Liquid forms (drops and syrup) require protection from light. The medicine must not be used after the expiration date printed on the packaging.

For disposal, unused or expired product must not be thrown away via wastewater or household waste. You must consult a pharmacist for guidance on how to dispose of the medicine properly to help protect the environment.

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

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