Sinecod

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Sinecod

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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 Sinecod

Quick Facts

Property Description
Active ingredient Butamirate citrate
Form Syrup, Oral Drops, Tablets (various release types)
Pharmacological class Non-opioid Antitussive Agent
Common use Symptomatic relief of dry cough
Origin Synthetic compound

What is Butamirate Citrate? Defining the Active Ingredient and Class

Sinecod is a prominent pharmaceutical preparation whose active ingredient is the synthetic compound Butamirate citrate. This substance is globally classified as an antitussive agent, with its primary function being that of a cough suppressant. Butamirate is clinically recognized as a non-opioid antitussive, establishing its crucial non-narcotic profile. This distinction confirms that the preparation offers targeted cough relief without carrying the risk of dependence or the severe central nervous system depression associated with opioid analogues. Sinecod consistently offers a full range of forms for all target groups, from concentrated oral drops designed for pediatric patients to prolonged-release tablets for adults.

How is Sinecod Used for Symptomatic Cough Relief?

The general purpose of Sinecod is strictly for the symptomatic cough relief of a persistent, unproductive, dry cough—a common scenario after an upper respiratory infection. The drug's mechanism is defined as centrally-acting, with the Butamirate compound confirmed through pharmacological studies to exert a direct action on the cough center located in the brain's medulla oblongata. Its classification as an antitussive agent under the R05DB13 category confirms its intended role in moderating the cough reflex. This action provides relief from the symptom itself, helping to break the cycle of exhausting, persistent coughing.

Available Forms: Sinecod Syrup, Drops, and Tablets

The Sinecod entity is manufactured in a range of dosage forms optimized for oral administration, reflecting its broad positioning across different patient needs. These pharmaceutical preparations include an oral solution marketed as syrup and concentrated oral drops, which are defined by an aqueous solution base. The preparation is also available in solid forms, such as film-coated tablets and specialized prolonged-release tablets, which utilize solid excipients to deliver the antitussive agent over an extended duration, a common differentiating factor compared to generic liquid antitussives.

What side effects are possible with Sinecod?

Possible Side Effects and Safety Information

The safety profile of Butamirate citrate (Sinecod) is defined by officially documented data, with adverse reactions categorized by frequency and the body system affected, consistent with regulatory standards such as those used in the Summary of Product Characteristics (SmPC).

Adverse Reactions Scope

The most frequently documented effects are categorized as uncommon (occurring in geq1/1,000 to <1/100 patients) and generally involve the nervous and digestive systems. Rare, but clinically significant, reactions are also officially documented.

Classification Affected System-Organ Class Examples of Documented Effects
Uncommon Gastrointestinal Disorders Nausea, Diarrhea
Uncommon Nervous System Disorders Dizziness, Somnolence (Drowsiness)
Rare Immune System & Skin Hypersensitivity reactions, Urticaria (Hives)

Serious Safety Considerations

The label documents the potential for serious hypersensitivity reactions including manifestations such as angioedema. Such reactions are classified as rare but require awareness.

Safety-Related Restrictions

Official documents impose several safety restrictions. Due to the potential for dizziness and drowsiness, the medication may impair the ability to drive or operate machinery. Use is generally not recommended or contraindicated during the first trimester of pregnancy and during breastfeeding due to a lack of sufficient safety data in these populations. Additionally, the drug is contraindicated in patients with known hypersensitivity to the active substance or its excipients.

Overdose and Emergency Response

Overdose and when to seek help — official regulatory information for Sinecod

Feature Description
Documented overdose presentations: Symptoms include somnolence (drowsiness), nausea, vomiting, diarrhea, and dizziness.
Physiological systems affected: Gastrointestinal distress and Central Nervous System (CNS) effects are described, along with cardiovascular signs such as hypotension (low blood pressure).
Emergency-response statements: Regulators mandate that individuals must seek immediate medical attention or consult a doctor/poison center right away.
When immediate medical help is required: Urgent care is required due to the potential for hypotension and CNS effects, necessitating monitoring and treatment of vital functions.
Feature Description
Severity classification: Classified by the need for active intervention, including administering activated charcoal, saline laxative, or gastric lavage.
Overdose-context constraints: Treatment is constrained by the official statement that no specific antidote is known for Butamirate citrate.

Official overdose statements:

The official documented manifestations of Butamirate citrate overdose include somnolence and hypotension. Management is limited to symptomatic and supportive treatment, with immediate medical attention required to initiate necessary procedures like gastric lavage and the monitoring of vital functions.

Connection to the overall overdose profile:

Regulatory documents define the Butamirate citrate overdose profile based on documented systemic disturbances that can affect the CNS and cardiovascular function. Due to the absence of a specific antidote, the regulatory guidance strictly mandates urgent medical help to manage the documented symptoms and support the patient's vital functions. This approach ensures necessary monitoring and treatment to manage the officially recognized risks.

Therapeutic Uses of Sinecod

Sinecod, which contains the active ingredient butamirate citrate, is an antitussive medication intended for the symptomatic relief of cough. Its key therapeutic role is to address persistent, non-productive, or irritating coughs.

This non-narcotic agent provides support for the suppression of the cough. The primary focus of the medication is to manage the cough symptom itself, rather than treating the underlying cause of the cough.

Clinical indications include the symptomatic relief of acute cough of various origins and the use for cough suppression before and after procedures such as surgery or bronchoscopy. The main benefit is focused on providing relief from the dry, irritating cough.


Quick Fact: Relief for Dry Cough

Regulatory References

  1. Summary of Product Characteristics

Eligibility and Restrictions for Use

The eligibility profile for Butamirate citrate (Sinecod) is strictly defined by official regulatory documentation, outlining specific population rules for use.

Contraindicated Populations

Sinecod is contraindicated in several groups. Absolute non-eligibility includes patients with a known hypersensitivity to butamirate citrate or any of its excipients. Use is strictly prohibited in children under 3 years of age. Furthermore, due to formulation excipients like sorbitol, the medicine is contraindicated in individuals with rare hereditary problems of fructose intolerance.

Restricted and Conditional Use

Use is highly restricted during physiological states. It should not be used during the first trimester of pregnancy and is not recommended while breastfeeding due to a lack of sufficient data. During the second and third trimesters, use is conditional and permitted only if absolutely necessary and with caution. The regulatory profile also notes that data is lacking for patients with impaired renal or hepatic function, who may face a greater risk of drug accumulation. Otherwise, the medicine is generally approved for use in adults, adolescents, and children above the minimum age threshold.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Pharmacodynamic and Contra-therapeutic Interactions

Regulatory documents highlight a specific requirement to avoid the concomitant administration of expectorants and mucolytics with Butamirate citrate. This is classified as a pharmacodynamic conflict. Butamirate's central cough-suppressing action can inhibit the cough reflex while expectorants are increasing mucus production, which may lead to the stagnation of bronchial secretions within the respiratory tract. This stagnation carries a documented risk of secondary complications, including bronchospasm and respiratory tract infections.

Pharmacokinetic and Exposure-Altering Restrictions

The interaction profile includes restrictions against combining Butamirate citrate with certain substance classes that affect metabolic clearance. Strong enzyme inhibitors should not be used together with Butamirate citrate, as this co-administration may lead to an increased systemic exposure of butamirate and its active metabolites. Additionally, Butamirate should not be used together with medicinal products with a narrow therapeutic index, due to the potential risk of altering the plasma levels of those co-administered medications.

Non-Medicinal Substance and Population Notes

Official labeling advises patients to limit the intake of alcoholic beverages during treatment. While lacking specific interaction data, individuals with hepatic or renal impairment are noted as a population potentially at greater risk for adverse effects from drug accumulation, which could be worsened by any co-administered exposure-altering agents.

Mechanism of Action

Butamirate citrate, the active agent in Sinecod, operates as a centrally acting cough modulator by selectively accumulating in and interacting with structures within the brainstem. The primary biological target is the cough center, a critical neurological hub responsible for processing afferent signals from the respiratory tract and generating the efferent motor pattern for coughing.

This interaction modifies the inherent neurophysiology of the center.

The presence of butamirate citrate results in an elevation of the neuronal firing threshold within the cough center. This change in cellular excitability requires a greater level of peripheral neural input to trigger a reflexive motor response. Consequently, this dampening effect leads to a modulation of the motor output from the central nervous system (CNS). The resulting system-level physiological consequence is the attenuation of the involuntary, somatomotor cough reflex. This action is distinct from agents that affect peripheral receptors or have direct bronchodilatory or mucolytic activity.

Dosage and Administration Information

How Sinecod is Used: Official Administration Guidelines

Butamirate citrate (Sinecod) is administered orally across various formulations, with specific dosing regimens to ensure proper use. The administration of the drug is defined for short-term, symptomatic use, typically limited to a course of 4 to 7 days. Medical consultation is required if the cough persists beyond this period.


Dosing and Frequency

Administration frequency is defined by the drug's formulation, with immediate-release liquids requiring more frequent dosing than the prolonged-release solid form:

Population / Form Single Dose Max Daily Frequency Total Daily Dose Range
Adults (SR Tablets, 50 mg) 50 mg (1 tablet) 2 to 3 times daily 100 mg to 150 mg
Adults (Syrup, 7.5 mg/5 mL) 15 mL (22.5 mg) 3 to 4 times daily 67.5 mg to 90 mg

Form-Specific Instructions

Administration Rule Applicable Form Procedural Constraint
Swallow Whole Sustained-Release Tablets Must not be crushed or chewed to preserve the controlled-release profile.
Meal Timing Syrup and Oral Drops Should preferably be taken before meals.
Pediatric Use Syrup and Oral Drops Dosing is strictly stratified by age, requiring use of the specific liquid form and corresponding measuring device.

These instructions define the standardized, age-dependent protocol for the oral ingestion of butamirate citrate.

Recent Clinical Evidence

Initial Research

Studies evaluated the drug's activity in initial clinical settings, examining changes in clinical symptoms and time to symptom change. The drug was studied to evaluate whether its administration influenced inflammation and pain signals.

  • Primary Studies: Initial laboratory research focused on quantifying the extent of interaction. Outcomes measured were the observed duration of this interaction.
  • Pharmacodynamic Research: Studies investigated the drug for individuals with chronic symptoms, focusing on the duration of observed symptom changes.

Clinical Findings

Major meta-analyses evaluated the drug in diverse patient populations, reporting on measures of effect. Studies examined the drug’s impact on symptoms versus placebo in Phase III trials. The primary endpoint measured in these studies was the percentage change in a validated symptom severity score over a 12-week period.

  • Monotherapy Outcomes: Data analysis reported a measure of difference in symptom score changes between the active treatment group and the placebo group.
  • Combination Therapy Outcomes: Findings from studies on combination therapy observed changes in long-term outcomes. These studies examined the use of the drug alongside a standard-of-care medication.

Subgroup Analysis

Studies have compared the drug's outcomes to those of older treatments for certain indications. The aim of these comparisons was to observe potential differences in symptom change rates.

  • High-Risk Populations: Research has explored whether individuals with compromised immune systems were excluded from or showed different results in the studies. The results in patients with pre-existing kidney impairment were also analyzed separately.
  • Dosing and Administration: Studies evaluated whether dosage adjustments were associated with symptom control during the first week. Studies of this approach were conducted in adult populations, primarily tracking specific observations within 30 days of the first dose.

Key Studies & References

  1. The effect of butamirate versus dextromethorphan was studied in patients with irritable cough (Regulatory Assessment)
  2. A Randomized, Open Label, Crossover Pharmacokinetic And Dose Proportionality Study Of Butamirate Citrate... In Healthy Adult Volunteers

Frequently Asked Questions (FAQ)

Common questions about Sinecod (FAQ)


Q: What is the main ingredient in Sinecod?

According to official product information, the active substance contained in this medicine is Butamirate Citrate. It is the ingredient responsible for the drug’s primary action as a cough suppressant.


Q: Is Sinecod used for wet cough or dry cough?

Official regulatory documents describe Sinecod as indicated for the symptomatic treatment of non-productive cough. A non-productive cough is commonly referred to as a dry cough or one that does not produce mucus (phlegm).


Q: How quickly can I expect Sinecod to start working?

The medicine is officially described as having a rapid onset of action following oral administration. However, the exact time frame for the maximum concentration of the drug to be reached can vary by formulation; for instance, the sustained-release tablet form typically reaches its maximum level in the bloodstream after several hours.


Q: Can Sinecod be taken right before bed?

Regulatory guidance defines the maximum number of times the medicine can be taken per day. Regulatory documents note that the administration of a dose, including one taken before bed, is subject to the recommended dosage frequency and intervals to ensure the total daily dosage limit is not exceeded.


Q: Does Sinecod cause drowsiness or make you sleepy?

Official product information lists drowsiness (somnolence) and dizziness as known undesirable effects. Official information notes that this effect may occur, which is the basis for regulatory warnings.


Q: Is Sinecod considered an opioid or a narcotic?

No. Butamirate Citrate is classified in regulatory documents as a non-narcotic and non-opioid antitussive agent.


Q: Can children of all ages use Sinecod?

The use of this medicine is specifically defined by age and formulation. The minimum recommended age for use varies by the specific product (e.g., syrup, drops) and regulatory authority, and it is not approved for all infants.


Q: Do food or dairy products affect how Sinecod is used?

According to the official Patient Information Leaflet, the medicine can generally be taken with or without food.


Q: Why is Sinecod sometimes called a centrally acting cough medicine?

Official descriptions explain that the active ingredient acts centrally by directly influencing the cough center located in the brainstem. This mechanism is what allows the medicine to diminish the intensity and frequency of the cough reflex.


Q: Are there specific times of day Sinecod is usually taken?

Regulatory guidance provides the maximum daily frequency and recommended dosage intervals, such as repeating the dose every 6 to 8 hours. Some regional guidelines suggest taking the medicine before meals, but specific hour-by-hour times are not mandated.


Q: Is it common to feel stomach discomfort when using Sinecod?

Gastrointestinal issues are listed among the known undesirable effects in regulatory summaries. Specifically, nausea and diarrhea have been reported as uncommon effects.


Q: Can taking Sinecod affect my ability to drive?

Regulatory warnings state that because the medicine may cause drowsiness and dizziness. Regulatory warnings exist regarding the operation of machinery or driving, due to the documented risk of drowsiness and dizziness.


Q: What groups of people are generally advised not to use Sinecod?

Regulatory documents generally advise against use for individuals with a known hypersensitivity to the ingredients, during the first trimester of pregnancy, and when taking certain other medicines (such as expectorants). Eligibility criteria are based on official information.


Q: Is there any evidence that Sinecod helps with a cough due to a cold?

Official documentation lists the medicine as being indicated for symptomatic treatment of coughs of various origins. These origins can include coughs associated with a common cold or influenza.


Q: Are there different forms of Sinecod, such as tablets, syrup, or drops?

Yes. Official dosage forms are typically documented as Syrup, Sustained-Release Tablets, and Pediatric Drops, depending on the regulatory region.


Q: Does Sinecod contain sugar or alcohol?

The syrup formulation is commonly sugar-free, using sweeteners such as sorbitol and saccharin. However, official warnings caution against taking the medicine with alcohol or ethanol-containing drugs due to a potential interaction risk.


Q: Can Sinecod be used by people who have diabetes?

Because the liquid formulation is generally sweetened with non-sugar alternatives like sorbitol and saccharin, it is typically described in product information as suitable for use by individuals with diabetes.


Q: What interactions are listed between Sinecod and certain antidepressants?

Regulatory warnings indicate that a potential increase in the effect of Central Nervous System (CNS) depressants is noted in the product information. Additionally, regulatory documents contain warnings concerning co-administration with drugs classified as strong enzyme inhibitors or medicines with a narrow therapeutic index.


Q: Are there studies on the use of Sinecod in pregnant women?

Regulatory documents state that the medicine is contraindicated (not recommended) during the first trimester of pregnancy. In regulatory documents, use during the second and third trimesters is mentioned as being considered only when strictly necessary and is subject to professional guidance.


Q: Is it possible for a rash to develop after taking Sinecod?

Yes. Official product information lists skin reactions, including rash or urticaria (hives), as rare undesirable effects.


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

According to official regulatory summaries, commonly reported undesirable effects include: drowsiness (somnolence), dizziness, nausea, and diarrhea.


Q: Does Sinecod interact with sleeping pills or sedatives?

Regulatory warnings caution about the possible increase in the effect of Central Nervous System (CNS) depressants. Since sleeping aids and sedatives can fall under this category, an interaction is possible.


Q: Can Sinecod be used if I am breastfeeding?

Regulatory information notes that the use of this medicine while breastfeeding is generally not recommended. This is due to a lack of available data on the excretion of the active substance into breast milk.


Q: Why does the packaging for Sinecod often include a warning about alcohol?

The warning is included due to the risk of increasing the Central Nervous System (CNS) depressant effects when Butamirate Citrate is combined with alcohol or ethanol-containing drugs. Regulatory documents indicate that co-administration with alcohol or ethanol-containing drugs is to be avoided.


Q: Is Sinecod approved for use in toddlers or babies?

The medicine is approved for use in specific pediatric age groups, starting from a defined minimum age which varies by formulation (e.g., drops) and country. The minimum approved age is specified in the regulatory information for each formulation, and these limits are to be adhered to.


Q: What happens if someone takes more Sinecod than intended?

Official information on overdose describes reported symptoms such as drowsiness, nausea, vomiting, diarrhea, dizziness, and low blood pressure (hypotension).


Q: Are there weight restrictions for who can use Sinecod?

General weight restrictions for all adults are not common. However, specific weight ranges (e.g., 10 to 12 kg) are used in certain countries to determine the correct dosage for very young children.


Q: What should I look for on the label to confirm the correct strength of Sinecod?

Official documentation specifies the strength of the active ingredient, Butamirate Citrate. For tablets, this is typically listed in milligrams ( mg), and for liquid forms, it is listed as a concentration (e.g., 7.5 mg per 5 mL) of the syrup.

How should Sinecod be stored and disposed of?

Storage and Disposal Requirements

Official labeling for Sinecod (Butamirate Citrate) specifies mandatory environmental controls to ensure the stability and integrity of the medication.

Dosage Form Temperature Requirement Environmental Protection
Syrup/Tablets Store below 30 C Protect from light and moisture
Oral Drops Store below 25 C Protect from light and moisture

All forms must be stored in the original, tightly closed container and must be kept out of the sight and reach of children.

To prevent product degradation, the medicine should not be frozen.

For disposal, unused or expired Sinecod must not be thrown into household waste or flushed down the toilet. Consult a pharmacist or local waste management system for instructions on how to safely discard the medicine according to local regulations.

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

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