Clenil Compositum

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Clenil Compositum

Method of action: Bronchodilator

Treatment option:

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 Clenil Compositum

Clenil Compositum is a prescription-only medicine defined as a fixed-dose combination (FDC) product, designed for use in respiratory management.

Property Description
Active ingredients Beclometasone dipropionate, Salbutamol
Form Aqueous solution for nebulisation
Pharmacological class Fixed-dose combination (Inhaled Corticosteroid + Selective Beta-2 Agonist)
Common use Improving airflow and controlling chronic inflammation
Origin Synthetic compound

Identity and Pharmacological Class

Clenil Compositum is a synthetic pharmaceutical combining two distinct agents: an Inhaled Corticosteroid (ICS) and a Selective Beta-2 Adrenergic Receptor Agonist. This combination, containing Beclometasone dipropionate and Salbutamol, is clinically recognized and supported by pharmacological studies as a strategic choice for managing obstructive airway conditions where both immediate relief and long-term inflammatory control are necessary. The formulation is specifically designed as an FDC to ensure the consistent simultaneous delivery of both anti-inflammatory and bronchodilating components.


Composition, Form, and General Purpose

The medication is composed of the active ingredients Beclometasone dipropionate (the anti-inflammatory component) and Salbutamol (the rapid-onset bronchodilator). It is supplied as an aqueous solution for nebulisation, suitable for administration into the lungs via the inhalation route. The overall purpose of the formulation is to optimize breathing by both immediately widening constricted bronchial tubes and reducing the underlying swelling and irritation associated with chronic airway disease.


Synergistic Action: Why Combine Beclometasone and Salbutamol?

Using Beclometasone and Salbutamol together creates a synergistic effect that provides both rapid symptomatic relief and foundational disease control. The initial relaxation of the bronchial muscles provided by Salbutamol facilitates the subsequent, more effective deep-airway penetration of the Beclometasone anti-inflammatory agent. This integrated delivery approach is a fundamental characteristic of the product, ensuring that the patient receives a comprehensive treatment that addresses both the physical narrowing and the underlying inflammatory process concurrently.

Regulatory References

  1. Beclometasone Oral Inhalation: MedlinePlus Drug Information

What side effects are possible with Clenil Compositum?

Possible Side Effects and Safety Information

The safety profile of Clenil Compositum, a fixed-dose combination, reflects the known adverse reactions of its two active components, Beclometasone dipropionate (Inhaled Corticosteroid) and Salbutamol (Selective Beta-2 Agonist), as classified by regulatory authorities (e.g., EMA/FDA).

Adverse reactions are officially organized by System-Organ Classes (SOC) and assigned a frequency tier:

  • Very Common: Oral candidiasis (thrush of the mouth and throat) is a very common local effect of the corticosteroid component.
  • Common: Adverse effects such as tremor and headache (linked to Salbutamol) and hoarseness or throat irritation (linked to Beclometasone) are commonly documented.
  • Uncommon/Rare: Less frequent effects include palpitations, tachycardia, or hypersensitivity reactions (e.g., rash, urticaria).

Serious Adverse Reactions and Safety Constraints

Official regulatory documents highlight the potential for serious adverse reactions, including an immediate, severe worsening of breathing called paradoxical bronchospasm. The risk of systemic corticosteroid effects, such as adrenal suppression and decreased bone density, is associated with prolonged exposure. Less frequent but documented events also include cardiac arrhythmias and rare eye conditions like glaucoma or cataracts.

Specific population safety considerations are mandated by the label. For pediatric patients, regular monitoring of height is required due to the risk of growth retardation associated with long-term inhaled corticosteroid use. Caution is advised for individuals with pre-existing conditions, such as severe heart disease or active tuberculosis, as specified in the official safety information.

Overdose and Emergency Response

Overdose and When to Seek Help

The information below summarizes the officially documented descriptions of overdose for Clenil Compositum (Beclometasone Dipropionate / Salbutamol) and the circumstances under which regulatory authorities mandate seeking emergency medical attention.


Documented Overdose Manifestations

Overdose primarily reflects the acute effects of the Salbutamol component, which may include tachycardia, tremor, palpitations, and headache. Potential metabolic derangements documented in regulatory sources include hypokalaemia (low serum potassium) and hyperglycaemia (high blood glucose).

Severe outcomes that may occur include potentially life-threatening conditions such as cardiac arrhythmias and lactic acidosis. The risk of adrenal suppression (HPA axis suppression) is documented with chronic, excessive exposure to the corticosteroid component.


Required Emergency Actions

Regulatory documents state that urgent medical advice must be sought if there is a sudden or progressive deterioration in symptoms or if the previously effective dose fails to provide relief for the prescribed duration. Immediate discontinuation of the product and urgent medical assessment are required if paradoxical bronchospasm occurs.

Management of overdose requires symptomatic and supportive treatment. Due to associated metabolic risks, specific monitoring of serum potassium and serum lactate levels is mandated in the official prescribing information. Consideration for population-specific risks includes monitoring children for potential signs of systemic corticosteroid exposure, such as linear growth retardation, following chronic high-dose overdose.

Therapeutic Uses of Clenil Compositum

The therapeutic role of Clenil Compositum may assist in providing simultaneous anti-inflammatory support and supportive relief for the airways in conditions marked by chronic and acute breathing difficulty. This use is generally applied across domains where additional symptomatic support is needed, such as in clinical settings evaluating the management of asthma symptoms in young children.


Therapeutic Scope and Symptom Relief

The medication is commonly used for the long-term management of Bronchial Asthma, certain Chronic Obstructive Bronchopathy conditions, and recurrent wheezing in pre-school children. It helps address symptom clusters that may become intense or disruptive, such as persistent wheezing, chronic coughing, pronounced shortness of breath, and intense chest tightness. This provides support that helps ease the overall symptom burden and is relevant for easing sudden symptoms of airway narrowing.

Quick Fact: Relevant for Acute Bronchospasm and Symptoms of Irritative States


Clinical Contexts and Patient Benefit

The medication is applied in clinical settings that involve acute or unstable symptom patterns, and is often used when symptoms intensify and supportive relief is needed. This targeted application helps maintain a sense of stability when symptoms are more noticeable and may assist with preserving comfort during episodes, which may contribute to improved management of symptoms for patients, including young children, requiring nebulised therapy.

Regulatory References

  1. NIH-supported clinical trial on nebulised BDP/Salbutamol

Eligibility and Restrictions for Use

Who can and cannot use Clenil Compositum?

This section describes official eligibility and non-eligibility based strictly on regulatory prescribing information.

Eligibility Status Population Rule
Permitted Adults and children for asthma maintenance when other inhalers are unsatisfactory; children under 5 years for recurrent wheezing
Conditional/Restricted Patients with diabetes, hypertension, glaucoma, coronary artery disease, or hyperthyroidism (use restricted to 'absolute necessity')
Contraindicated Individuals with hypersensitivity to Beclometasone dipropionate or Salbutamol; patients with active or quiescent viral or tubercular local infections

Age-Related Eligibility Rules

The medicine is approved for adults and children, with no specific lower age limit defined in the regulatory harmonization for the nebulized component. However, the official label imposes a limitation for the pediatric population: treatment for recurrent wheezing in children under 5 years must be discontinued if no benefit is observed within 2–3 months.

Pregnancy and Lactation

Clenil Compositum is generally contraindicated during pregnancy and lactation (breastfeeding), as stated in the official prescribing information.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation identifies specific drug-drug and drug-substance interaction patterns for Clenil Compositum (Beclometasone dipropionate and Salbutamol) that dictate caution or avoidance.

Official Interaction Statements

Classification Interacting Entity Interaction Outcome
Contraindicated Combination Non-selective beta-blockers (e.g., Propranolol) Co-administration is not recommended; may cause severe bronchospasm by blocking the bronchodilator effect of the Salbutamol component [3.3].
Pharmacokinetic / Exposure Risk Potent CYP 3A4 Inhibitors (e.g., Ritonavir, Cobicistat) May increase systemic exposure to the corticosteroid component, creating the potential for systemic effects [4.3].
Pharmacodynamic Risk Diuretics or Xanthine Derivatives (e.g., Theophylline) May potentiate hypokalemia (low serum potassium), which is a known effect of the Salbutamol component [3.1].
Vascular / Cardiovascular Risk MAOIs or Tricyclic Antidepressants (TCAs) May potentiate the action on the vascular system of Salbutamol, increasing the risk of cardiovascular effects [3.1].
Drug Level Alteration Digoxin Salbutamol co-administration may officially decrease serum Digoxin levels [3.3].

Population-Specific and Substance Notes

For diabetic patients, the regulatory label officially recommends additional blood glucose measurements upon initiation of treatment, due to the combination's known exaggerated hyperglycaemic effect [3.2]. A theoretical interaction risk exists with Disulfiram or Metronidazole because some Beclometasone formulations contain trace amounts of ethanol [2.5]. Co-administration with other Corticosteroids is noted to increase the overall chance of systemic corticosteroid side effects [4.2].

Connection to the Overall Interaction Profile

The official interaction profile is structured around defining dual-component risks: pharmacodynamic antagonism for the beta2-agonist (Salbutamol) and pharmacokinetic exposure increase for the corticosteroid (Beclometasone). This profile defines combinations that are not recommended ( beta-blockers) and mandates specific procedural constraints, such as required blood glucose monitoring in the presence of additive metabolic effects.

Mechanism of Action

How Clenil Compositum Works — Mechanism of Action

This medication utilizes a dual mechanism focused on two primary receptor systems. Formoterol Fumarate acts as an agonist on the beta2-Adrenergic Receptors (beta2-AR) of airway smooth muscle cells. This binding initiates the Gs-protein cascade, increasing intracellular cyclic AMP (cAMP), which results in the relaxation of the smooth muscle and the physiological outcome of bronchodilation.

Concurrently, the active metabolite of Beclomethasone Dipropionate acts as an agonist for the Glucocorticoid Receptor (GR).

The activated GR complex translocates into the nucleus, modulating gene expression via transrepression of pro-inflammatory factors (like NF-kappaB) and transactivation of anti-inflammatory proteins. This sequence results in diminished fluid accumulation and reduced sensitivity to stimuli within the air passages.

Furthermore, the steroid component enhances the responsiveness of the beta2-ARs, thereby strengthening Formoterol's bronchodilatory action, influencing the physiological adjustments within the regulated pathways.

Dosage and Administration Information

How to Use Clenil Compositum

This section describes the administration and dosing guidelines for Clenil Compositum, a fixed-dose combination product containing Beclometasone dipropionate and Salbutamol.


Administration Scope

Feature Guideline/Rule
Route of administration Inhalation route; delivered as an aerosol mist via a nebuliser device.
Dosing schedule Unit Dose: One monodose vial per administration. The total daily dose is determined by clinical titration to the lowest effective level for maintaining long-term control.
Preparation requirements The monodose vial containing the suspension should be shaken well to ensure complete re-dispersion and homogeneity of the active ingredients before being placed into the nebuliser chamber.
Age-group administration Use in pediatric patients follows the principle of dose titration to the minimum necessary amount, and is generally considered when other inhaler forms are unsuitable.
Special procedural conditions The user must rinse the mouth or gargle with water immediately after each dose to reduce the risk of local effects associated with inhaled corticosteroids.

Instruction Classifications

Classification Parameter
Administration method type Inhaled (nebulisation of an aqueous suspension).
Frequency pattern Divided daily use, with administrations spread throughout the day, according to clinical need.
Use-context constraints The solution is designed for aerosol delivery. Any residual contents from an opened vial must be refrigerated (2°C to 8°C) and administered within 12 hours of the initial opening.

Connection to the Overall Use Protocol

A structured protocol is used for delivering the fixed-dose combination, prioritizing the inhalation route via a nebuliser to ensure the correct unit strength is consistently administered. This protocol is defined by procedural requirements for shaking the suspension before use, mandatory post-administration rinsing, and strict rules governing the short-term handling of opened vials, all intended to standardize the administration technique.

Recent Clinical Evidence

The research evidence for Clenil Compositum, a fixed-dose combination, explores its investigation across two main clinical contexts.

For the long-term management of chronic asthma, studies were conducted to explore the medicine's use primarily through Randomized Controlled Trials (RCTs) involving adult populations. Researchers focused on tracking objective measurements of lung function (such as FEV1 and PEFR values) and patient-reported symptom variability scores. Trials described patterns observed in recorded symptom scores and daily reliever use over defined, often intermediate-term, study periods.

For investigation in the context of recurrent wheezing and acute airway events, evidence was explored in trials assessing short-term or episodic symptom patterns, primarily focusing on pre-school children and infants. These studies monitored outcomes related to physical discomfort, tracking changes in daily symptom scores and healthcare utilization rates. Findings were mixed regarding optimal administration strategies, and some studies showed inconsistent findings when compared to the active bronchodilator component alone.

Overall, the research indicates that long-term data are not fully established for the specific nebulised fixed-dose combination, and limited information is available to describe sustained outcomes over many years. Data for certain subgroups, such as older adults with complex conditions, remain insufficient, and comparative evidence against other fixed combinations is lacking.

Frequently Asked Questions (FAQ)

Common questions about Clenil Compositum (FAQ)


Q: Is Clenil Compositum used for asthma or just COPD?

Official regulatory documents state that this medicine is indicated for the treatment of both bronchial asthma and chronic obstructive bronchopathy. This includes conditions often referred to as COPD (Chronic Obstructive Pulmonary Disease), particularly when they involve an asthmatic component.


Q: Does Clenil Compositum come in different forms, like a nasal spray?

Clenil Compositum itself is defined as an aqueous solution for nebulisation. However, one of its active ingredients, Beclometasone dipropionate, is widely available in other delivery forms, such as nasal sprays, which are typically used to treat different conditions like allergic rhinitis.


Q: Is this medicine the same as the single-ingredient Clenil product?

No, Clenil Compositum is defined as a Fixed-Dose Combination (FDC) product because it contains two active ingredients: Beclometasone and Salbutamol. The single-ingredient Clenil product typically contains only Beclometasone dipropionate.


Q: How quickly is Clenil Compositum expected to start working?

Because the medicine contains Salbutamol, which is a rapid-onset bronchodilator, the bronchodilating effect is generally expected to begin quickly. Official documents typically describe the onset of action as within 5 minutes for the acute airway relief component.


Q: Does Clenil Compositum help with sudden breathlessness?

The Salbutamol component is included specifically for providing rapid symptomatic relief by quickly opening the airways. While the medicine is primarily used for chronic management, this component is included for addressing rapid symptomatic relief of acute breathing issues.


Q: What happens if I stop using Clenil Compositum suddenly?

Official guidance indicates that abruptly stopping the medication, especially when used long-term or at higher doses, may lead to symptoms of adrenal insufficiency. This condition is linked to low levels of natural steroids in the body, and discontinuation should be managed.


Q: Can Clenil Compositum be used long-term?

The medicine is generally prescribed for long-term maintenance therapy, utilizing the lowest effective dose. However, prolonged exposure to any inhaled corticosteroid is officially associated with risks such as a decrease in bone density.


Q: Is it normal to feel a dry throat after using Clenil Compositum?

Regulatory safety information commonly lists throat irritation as a known local side effect of the inhaled corticosteroid component. While 'dry throat' specifically is not always listed, this sensation is often related to the common documentation of irritation and hoarseness.


Q: Is there a link between Clenil Compositum and weight gain?

Weight gain, particularly in the upper back or abdomen, is officially listed as a potential systemic side effect associated with corticosteroids. This is generally only a concern when the inhaled steroid is used at higher doses for prolonged periods, which could lead to increased systemic exposure.


Q: Does Clenil Compositum affect sleep?

Sleep disturbance, including insomnia, is an officially noted side effect for medications containing beta2-agonists like Salbutamol. This effect is often linked to other common side effects such as feelings of nervousness and an increased heart rate.


Q: Are there any major food interactions with Clenil Compositum?

Official regulatory prescribing information for this nebuliser solution typically does not list any specific food interactions. It is important to focus on the documented drug-drug interactions, and some formulations may contain warnings regarding alcohol due to trace excipients.


Q: Can Clenil Compositum be used with common painkillers like ibuprofen?

General regulatory documents for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like ibuprofen and inhaled corticosteroids do not typically list a direct interaction. However, patients with certain pre-existing conditions (like cardiovascular risk) may need to review cautions for all co-administered medicines.


Q: Does Clenil Compositum interact with blood pressure medication?

Yes, caution is noted in official sources. Non-selective beta-blockers are officially contraindicated as they can severely block the bronchodilating effect of Salbutamol. Furthermore, official restrictions advise caution for patients with pre-existing conditions like hypertension due to the potential for cardiovascular effects from Salbutamol.


Q: What are the official cautions for using Clenil Compositum with antifungal medicines?

Regulatory cautions exist because many antifungal medicines, such as ketoconazole or itraconazole, are classified as CYP 3A4 inhibitors. These inhibitors may interfere with the metabolism of the corticosteroid component, potentially leading to an increase in systemic exposure and risk of side effects.


Q: Are there special considerations for using Clenil Compositum in older adults?

Official guidance notes that older adults are sometimes underrepresented in key clinical trials and may be more sensitive to the physiological effects of the medication. A physician may need to consider adjustments based on the specific product label, particularly if the patient has other complex health conditions.


Q: Is Clenil Compositum considered a maintenance or rescue medicine?

It contains components for both actions: the corticosteroid is for long-term maintenance and the Salbutamol is a rapid-onset agent for rescue-like symptomatic relief. However, the product is primarily used as a combination treatment for the maintenance control of chronic airway disease.


Q: What is the difference between Clenil Compositum and other combined inhalers?

Clenil Compositum combines Beclometasone and Salbutamol in an aqueous solution for nebulisation. Official research documents, however, note that comparative evidence against other fixed-dose combinations is often lacking or insufficient to describe direct differences in long-term outcomes.


Q: Is it true that Clenil Compositum is not a substitute for a fast-acting inhaler?

The product itself contains Salbutamol, which is a fast-acting bronchodilator for rapid relief. Its overall purpose, however, is to provide combined maintenance control (anti-inflammatory action) and symptomatic relief, rather than functioning exclusively as a short-acting, standalone rescue medication.


Q: What is the official patient information about the risk of pneumonia with this drug?

The use of inhaled corticosteroids (ICS) is officially associated with an increased risk of developing pneumonia, particularly in patients with COPD. While this risk is noted, it is generally not listed as a common side effect in the general asthma population.


Q: What official information is available on Clenil Compositum and driving ability?

Official labels generally state that the medicine is unlikely to affect your ability to drive or operate machinery. However, due to documented side effects like tremor or dizziness, official caution is advised if you experience any such effects.


Q: Are there different strengths of Clenil Compositum?

Yes, the product is available in specific, defined strengths for the nebuliser solution. For example, it is marketed in a unit dose vial containing a combination of 0.8 mg of Beclometasone and 1.6 mg of Salbutamol. The strength is fixed per vial.


Q: What is the expected duration of effect after a single use?

The bronchodilating effect of the Salbutamol component is generally described in regulatory documents as short-acting, typically lasting approximately 4 to 6 hours. This necessitates a divided daily use schedule for consistent control.


Q: What official warnings exist about using Clenil Compositum near an open flame?

Specific warnings about using a product near an open flame primarily relate to pressurized metered-dose inhalers (MDI) because their canisters present an explosion risk if punctured or exposed to fire. While the nebuliser solution is not pressurized, the general cautionary principle remains important during storage and disposal.


Q: Is Clenil Compositum used to treat allergic rhinitis?

No, the official indication for this medicine is strictly the treatment of bronchial asthma and chronic obstructive bronchopathy. It is not indicated or used to treat allergic rhinitis, which is typically managed with nasal formulations of corticosteroids.


Q: Can I use Clenil Compositum when I have a common cold or flu?

Official prescribing information includes a contraindication for patients with active or quiescent viral infections. Since the common cold and flu are viral infections, this means that the medicine may be restricted or contraindicated during these periods.


Q: What is the meaning of the word 'Compositum' in the drug name?

The term 'Compositum' is used in pharmaceutical naming, derived from Latin, to indicate that the product is a composition or combination. This aligns with its classification as a Fixed-Dose Combination (FDC), meaning it contains two different active ingredients in one product.


Q: What is the maximum length of treatment described in official documents?

Official documents do not set a general maximum length of treatment, as therapy is individualized based on patient need. However, they mandate that for certain groups, such as children under 5 with recurrent wheezing, treatment must be stopped if no benefit is observed within two to three months.


Q: Why does the packaging say to avoid getting the product in the eyes?

The warning to avoid contact with the eyes is generally a safeguard related to the nebulisation process. The solution may contain common excipients, such as Benzalkonium chloride, which are known to be eye irritants or can affect the eye's tear film.

How should Clenil Compositum be stored and disposed of?

Storage and Disposal Requirements for Clenil Compositum

Clenil Compositum must be stored according to official regulatory specifications to maintain its stability and effectiveness.


Storage Conditions

  • Temperature and Protection: The product must be stored at a temperature not exceeding 30 C and protected from frost, direct sunlight, heat, and moisture.
  • Container Rules: The medicine must be kept in its original container, tightly closed, and always out of the sight and reach of children.
  • Stability: Unused monodose nebuliser vials removed from the protective bag can be stored for up to 3 months, protected from light. Residual solution from a partially used vial must be refrigerated (2 C to 8 C) and used within 12 hours.

Disposal Instructions

The medicine must not be disposed of via wastewater or ordinary household waste. Patients should ask the pharmacist for guidance on proper disposal methods for expired or unused product. Pressurized canisters, such as those in the MDI form, must not be punctured or discarded in fire due to explosion risk.

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

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