Cortema Neomycine

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Cortema Neomycine

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Overview of Cortema Neomycine

Quick Facts

Property Description
Active Ingredients Fluocinonide, Neomycin
Form Cream or Ointment
Pharmacological Class Topical Steroid with Anti-infective
Common Use Infected inflammatory skin conditions
Origin Synthetic/Semisynthetic

What is Cortema Neomycine and its Classification?

Cortema Neomycine is a combination pharmaceutical preparation intended exclusively for topical administration to the skin. It is classified pharmacologically as a topical steroid with anti-infectives, combining a potent anti-inflammatory agent with an anti-bacterial component in a single formula. The product is presented as a dermatological preparation, typically a cream or ointment, suitable for localized application to the cutaneous surface. This dual composition defines its unique role in medicine, offering a fixed-dose solution for complex skin issues. This structure is clinically recognized for providing a comprehensive approach to dermatoses where both inflammation and bacterial contamination are present, positioning it as a specialized, prescription-only medication.


The Active Ingredients: Fluocinonide and Neomycin

The two primary active ingredients are Fluocinonide, a high-potency corticosteroid, and Neomycin, an aminoglycoside antibiotic. Both components are synthetic or semisynthetic in origin and fulfill specific therapeutic roles. Fluocinonide belongs to the glucocorticoid class, providing powerful localized anti-inflammatory and anti-pruritic action. Concurrently, Neomycin is included to exert a bactericidal effect against susceptible bacteria. Neomycin acts by disrupting bacterial protein synthesis, thereby controlling infection. This combination formulation is a differentiating feature, offering a treatment option that addresses simultaneous causes, unlike single-agent steroid preparations.


General Purpose of This Dual-Action Topical Medicine

The general purpose of Cortema Neomycine is to provide comprehensive relief for inflammatory skin conditions complicated by a bacterial presence. This combination is specifically beneficial for corticosteroid-responsive dermatoses where the integrity of the skin barrier has been compromised, leading to secondary infection. A typical use scenario involves managing acute cases of eczema or psoriasis where the site has become secondarily infected. The drug works to quickly suppress severe skin inflammation and relieve the associated intense pruritic manifestations (itching), while the antibiotic component actively controls the bacterial load, thus facilitating recovery from complex, infected skin conditions.

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What side effects are possible with Cortema Neomycine?

The safety profile of Cortema Neomycine, an aminoglycoside-containing product, is characterized by the potential for serious systemic toxicities and common local reactions.

Adverse Reaction Scope

Key Adverse Reaction Categories System-Organ Classes Involved
Systemic Toxicities: Nephrotoxicity, Ototoxicity (hearing and balance), and Neurotoxicity (Neuromuscular Blockade). Ear and Labyrinth Disorders, Renal and Urinary Disorders, Nervous System Disorders.
Hypersensitivity Reactions: Allergic sensitization and skin reactions. Skin and Subcutaneous Tissue Disorders, Immune System Disorders.
Gastrointestinal: Nausea, vomiting, diarrhea, and malabsorption syndrome (with oral use). Gastrointestinal Disorders.

Serious Adverse Reactions: Regulatory warnings, including a Boxed Warning for some formulations, highlight the risk of permanent bilateral sensorineural hearing loss (ototoxicity) and kidney damage (nephrotoxicity). Neuromuscular blockade, which can lead to respiratory paralysis, has also been reported. Ototoxicity can be delayed, sometimes manifesting after treatment is complete. Allergic contact dermatitis (cutaneous sensitization) is a common local reaction, particularly with topical use, and may present as redness, swelling, or itching.

Safety Considerations and Restrictions

Population-Specific: Patients with impaired renal function or advanced age are at a significantly increased risk of developing systemic toxicities, including ototoxicity and nephrotoxicity, due to potential drug accumulation. Caution is required in patients with muscle disorders like myasthenia gravis, as the drug may worsen muscle weakness. Use during pregnancy carries a risk of fetal harm.

Dose- or Exposure-Related Patterns: The risk of ototoxicity and nephrotoxicity increases with prolonged use or higher-than-recommended doses, even in individuals with normal kidney function. Systemic absorption of topical products is increased if applied over large surface areas or under occlusive dressings.

Safety-Related Restrictions: Cortema Neomycine is generally contraindicated in individuals with a known hypersensitivity to neomycin or other aminoglycosides. It should be used with caution alongside other potentially nephrotoxic or ototoxic medications (e.g., potent diuretics) due to additive toxicity risk.

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Overdose and Emergency Response

Overdose and When to Seek Help

The official overdose profile for Cortema Neomycine is primarily based on the risk of systemic absorption of its active ingredients, Fluocinonide and Neomycin, following excessive or prolonged topical use, or accidental ingestion.

Overdose manifestations are categorized by the systemic effects documented in regulatory prescribing information:


Documented Overdose Manifestations

Component Risk/Manifestation (Official) Action Mandated (Official)
Fluocinonide (Steroid) HPA axis suppression, features of Cushing's syndrome, hyperglycemia, and subsequent steroid withdrawal symptoms [FDA Prescribing Information]. Management requires withdrawal of the drug and periodic monitoring via tests like the ACTH stimulation test [FDA Prescribing Information].
Neomycin (Antibiotic) Potential for Ototoxicity (ear damage) and Nephrotoxicity (kidney damage) following significant systemic exposure [DailyMed]. Treatment is generally supportive to manage symptoms and complications.

Urgent Help-Seeking Requirements

Immediate medical attention is required for any known or suspected accidental ingestion of the product. In the event that a person has collapsed or is not breathing, emergency services (911) must be contacted immediately. Children are documented as being more susceptible to systemic toxicity and may show specific signs like linear growth retardation or Intracranial Hypertension.

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Therapeutic Uses of Cortema Neomycine

Cortema Neomycine is commonly used to provide dual-action symptomatic support in addressing conditions involving inflammatory or irritative processes that are further complicated by bacterial contamination. The use of this combination is relevant across therapeutic areas where both inflammation and bacterial contamination occur.

The combination is relevant in situations involving corticosteroid-responsive dermatoses—such as acute episodes of eczema or psoriasis—where the lesions have developed a secondary bacterial infection. It may assist with addressing symptom clusters that become more disruptive during flare-ups, and is applied in clinical settings marked by increased discomfort or tension.

The medicine helps ease pronounced symptoms like intense itching (pruritus), redness, and swelling. This contributes to improved day-to-day comfort during symptomatic periods, assisting with maintaining functional stability by easing the overall symptom load associated with the complex, infected episode.


Symptom Summary: Relief for Dual Manifestations

Symptom Domain General Benefit
Inflammatory Manifestations Helps ease swelling and redness.
Severe Pruritus Helps ease symptoms related to intense itching.
Secondary Bacterial Contamination Supports the easing of the overall symptom load.

Regulatory References

  1. DailyMed overview for similar combination products
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Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Cortema Neomycine — official regulatory information

Category Eligibility Rule / Official Wording
Allowed Populations Generally, adults and adolescents 12 years of age and older, provided no contraindications are present.
Contraindications Hypersensitivity to Fluocinonide, Neomycin, or any related Aminoglycoside antibiotics.
Restrictions Not recommended for use in children under 12 years of age for some high-potency formulations.
Pregnancy Use is restricted; only if the potential benefit justifies the potential risk to the fetus.

Populations for whom use is contraindicated:

  • Patients with a history of hypersensitivity to any component of the preparation, including Neomycin or other Aminoglycoside antibiotics.
  • Use to treat viral lesions (e.g., Herpes Simplex, Varicella), fungal, or tuberculous lesions of the skin.
  • Application in the external ear canal if the eardrum is perforated (due to the Neomycin component).

Age-related eligibility rules:

  • Children (Under 12 years): Safety and efficacy are not established for some formulations; chronic use carries an increased risk of systemic effects like HPA axis suppression.
  • Adults/Adolescents (12+): Generally eligible, with use limited by the size of the application area and duration.

Condition-specific eligibility rules:

  • The product must not be used for conditions such as rosacea or perioral dermatitis.
  • Use is restricted if conditions like Cushing's syndrome or Hyperglycemia are present, as systemic absorption may worsen them.

Pregnancy and lactation eligibility status:

  • Pregnancy: Use is conditional; extensive use, large amounts, or prolonged periods are explicitly warned against.
  • Lactation: Caution is advised; the medicine should not be applied to the breasts prior to breastfeeding.

Connection to the overall eligibility profile: Regulatory documents establish absolute prohibitions based on component allergy and infection type, while placing strong restrictions on use in pediatric populations and during pregnancy or lactation due to the risk of systemic absorption. Eligibility is also constrained by specific local skin conditions and warnings against use on large or broken skin areas, strictly determining the authorized patient groups.

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What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The officially documented interaction profile for Cortema Neomycine, a combination product containing Fluocinonide and Neomycin, is defined by the potential for systemic absorption of its active components. This leads to specific pharmacodynamic and exposure-modifying interaction risks detailed in regulatory documents.

Interaction Domain Official Regulatory Statement
Additive Systemic Toxicity Co-administration with other potentially neurotoxic or nephrotoxic medicines should be avoided. This includes other aminoglycosides or specific drugs such as cisplatin, vancomycin, colistin, and certain potent diuretics (e.g., furosemide or ethacrynic acid). The restriction is based on the documented risk of additive ototoxicity and nephrotoxicity.
Additive Glucocorticoid Exposure Co-use with other corticosteroid-containing products is restricted. This interaction is officially described as increasing the total systemic glucocorticoid exposure due to additive absorption from the skin.

Interaction Context and Restrictions

The risk of these systemic interactions is primarily relevant when the active ingredients are absorbed into the body. Regulatory documents specify that this risk is heightened in pediatric patients due to their increased susceptibility to systemic absorption, making any systemic interaction more clinically significant. Co-administration is thus restricted for drugs that contribute to toxicity or total glucocorticoid load. No mandatory timing or separation rules are documented, and no explicit interactions with food, alcohol, or specific herbal products are listed in the official prescribing information for this topical formulation.

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Mechanism of Action

Ribosomal Binding and Protein Synthesis Inhibition

Cortema Neomycine, an aminoglycoside, primarily exerts its action by binding with high affinity to the bacterial 30S ribosomal subunit. This interaction disrupts the ribosomal machinery responsible for protein synthesis (translation). The molecular cascade involves causing misreading of messenger RNA (mRNA) templates and inhibiting the translocation of the peptidyl-tRNA, thus halting polypeptide chain elongation. The mechanistic consequence is the production of structurally altered, non-functional proteins, contributing to the impaired cellular viability and ultimate demise of susceptible microorganisms.


Modulation of Enteric Microbial Processes

In addition to its direct antimicrobial mechanism, Cortema Neomycine modulates biological processes within the gastrointestinal tract by reducing the population of specific enteric bacteria. This action influences systems where microbial processes, such as the enzymatic production of ammonia from protein catabolism, are operative. The resulting physiological effect is a reduction in local microbial ammonia generation, which facilitates the adjustment of nitrogen balance and diminishes systemic ammonia flux.

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Dosage and Administration Information

How to Use Cortema Neomycine

The usage of Cortema Neomycine is defined by guidelines that outline a standardized, short-term topical regimen. This medicine is intended only for external use on the skin, as directed in the prescribing information.

Administration and Dosage Principles

Entity Official Instruction
Route of Administration Topical application only.
Dosing Schedule Apply a thin film to the affected area, typically two to four times daily.
Frequency Constraint The application schedule must be followed precisely until the condition is controlled or the maximum duration is reached.
Preparation Wash hands thoroughly both before and immediately after applying the preparation.
Special Conditions Avoid contact with the eyes. Do not apply over a large surface area of the skin.

Duration and Procedural Rules

The use of this combination product is intended to be short-term. Treatment should generally not exceed two consecutive weeks for the high-potency steroid component, and total application should not exceed 60 grams per week. Products containing Neomycin are often limited to a seven-day course.

Procedurally, the treated skin area must not be bandaged or otherwise covered with an occlusive dressing (such as plastic pants for infants) unless this action is specifically directed by a prescribing physician. For pediatric use, tight-fitting diapers should be avoided in the treatment area. Furthermore, the use of the high-potency steroid component is generally not recommended in children younger than 12 years of age.

These instructions define the standardized, non-occlusive, short-term application protocol used to manage the localized use of this combined medicine.

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Recent Clinical Evidence

Cortema Neomycine: Recent Clinical Evidence

The research available for Cortema Neomycine focuses on the study of its combination of a corticosteroid and an antibiotic in certain inflammatory skin conditions. This overview describes what the research has explored and the known limits of the available data, without providing medical advice or recommendations.


Evidence for Use in Infected Inflammatory Skin Conditions

The primary research for this combination product was studied for conditions characterized by fluctuating or episodic manifestations where secondary bacterial contamination is present. This includes cases of corticosteroid-responsive dermatoses, such as eczema or psoriasis, associated with acute or disruptive episodes where symptoms become more noticeable. Short-term Randomized Controlled Trials (RCTs) examined outcomes related to physical discomfort, like pruritus (itching), and utilized standardized disease severity scores. Findings describe patterns observed in the studies related to the status of symptoms during short follow-up periods.

Study Metrics and Findings Reported in Clinical Trials

Studies monitored outcomes reflecting daily functioning or activity level and outcomes linked to inflammatory or irritative states. Investigator's Global Assessment (IGA) was used in research exploring how symptoms change over time. Findings were mixed across some studies, particularly concerning the extent to which the antibiotic component contributes to the overall measured change when compared to the steroid used alone. Regulatory settings highlight that, in some instances, no clear pattern of superiority in outcome measurements was observed when comparing the combination product to the steroid alone after approximately seven days.

Long-Term Evidence and Follow-up Duration

The available research is primarily derived from studies focusing on episodes where symptoms become more noticeable. The follow-up durations were limited, often restricting observation periods to between seven days and four weeks to assess immediate response. Because the observation periods were typically short, long-term effects are not fully established. There is limited information for long-term outcomes, and research has not fully characterized the durability of any measured effect.

Evidence in Different Patient Groups

Research explored the use of the combination therapy in cohorts, primarily Adult patients, with moderate-to-severe expressions of the skin conditions. For some groups, such as Pediatric patients, the available data are limited and often derived from broader systematic reviews that cover various topical steroid/antibiotic combinations. Therefore, data for certain groups remain insufficient, and the results apply only to the populations studied in the original research.

What Research Gaps and Uncertainties Exist

The research landscape includes documented uncertainties that remain active areas of scientific discussion. A key limitation concerns the clinical contribution of the Neomycin component to the regimen. Comparative evidence is lacking to definitively show that the combination is associated with superior outcome measurements than the corticosteroid component used alone. Evidence quality was observed in some studies to vary across systematic reviews, and some trials included in those reviews were assessed as having a high risk of bias.

Key Studies & References

  1. Fluocinolone Acetonide and Neomycin Sulfate Cream, USP (DailyMed/NIH Monograph)
  2. Atopic Dermatitis: Overview and Treatment Options (National Institute of Arthritis and Musculoskeletal and Skin Diseases - NIH)
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Frequently Asked Questions (FAQ)

Common questions about Cortema Neomycine (FAQ)


Q: I heard Cortema Neomycine can cause sensitivity, is that true?

Official documents describe cutaneous sensitization as a possible local reaction, which is particularly associated with the Neomycin component. This sensitivity may appear as symptoms like redness, persistent itching, or swelling in the area of application. If a reaction is suspected, contacting a healthcare professional for guidance is important.


Q: Are there any widely reported serious side effects for Cortema Neomycine?

Regulatory warnings highlight the potential for serious, permanent systemic effects, even with topical use, if the ingredients are absorbed into the body. These potential effects include hearing loss (ototoxicity) and kidney damage (nephrotoxicity), especially with prolonged use or excessive absorption. The product literature also notes the rare risk of neuromuscular blockade.


Q: Can Cortema Neomycine interact with common over-the-counter pain relievers?

According to the official prescribing information, interactions with common over-the-counter pain relievers are not listed as a specific restriction for this topical formulation. Known restrictions primarily involve other medicines that may also affect the kidneys or nervous system, increasing the risk of toxicity.


Q: Does taking Cortema Neomycine affect birth control pills?

Official documents describing the Neomycin component have indicated that certain antibiotics may potentially reduce the effectiveness of some oral contraceptives. Official literature notes this as a point to consider, given that systemic absorption of Neomycin is possible, although it is typically low with topical administration.


Q: Are there specific foods or drinks to avoid while using Cortema Neomycine?

The official prescribing information for this topical formulation does not explicitly list any foods or drinks that must be avoided. This medicine is applied externally, reducing the likelihood of food-related interactions.


Q: Is Cortema Neomycine considered safe to use during pregnancy according to official sources?

Official guidance restricts use during pregnancy, indicating that the medicine is typically considered only if a healthcare provider determines the potential benefit justifies the potential risk to the fetus. Warnings are specifically issued against extensive, large-area, or prolonged use while pregnant.


Q: What is the maximum duration for which Cortema Neomycine is typically described as appropriate to use?

The official limits mandate short-term use for this combination product. Treatment should generally not exceed two consecutive weeks for the steroid component, and Neomycin-containing products are often limited to a seven-day course to minimize the risk of systemic toxicity.


Q: How does the official literature describe the interaction between Cortema Neomycine and blood thinners?

The official prescribing information does not list blood thinners (anticoagulants) among the medicines with which an interaction is required to be restricted or avoided. Known restrictions focus on other drug classes that carry risks of additive toxicity.


Q: Are there official warnings about combining Cortema Neomycine with alcohol?

The official prescribing information for this topical product does not explicitly list any official warnings regarding combining the medicine with alcohol.


Q: Does Cortema Neomycine work for fungal or yeast infections?

Official guidance states that this medicine must not be used to treat conditions such as fungal or yeast infections of the skin. Its action is directed specifically against susceptible bacterial contamination.


Q: Does Cortema Neomycine cause drowsiness or dizziness?

The potential for dizziness or unsteadiness is officially reported as part of the rare systemic toxicities (ototoxicity) linked to the Neomycin component. While these are not common local effects, they may be a consideration if systemic absorption were to occur.


Q: Is it normal to feel [vague sensation like mild irritation] after using Cortema Neomycine?

Local reactions, such as irritation, itching, or redness, are listed in official documents as common side effects that can occur with the topical use of the medicine.


Q: Can older adults generally use Cortema Neomycine?

Official warnings state that older adults are at an increased risk of systemic side effects, such as ototoxicity (hearing loss) and nephrotoxicity (kidney damage). This is due to their potential increased susceptibility to drug accumulation, and official information notes this as a safety consideration.


Q: Is Cortema Neomycine available without a prescription in any countries?

The official regulatory classification designates Cortema Neomycine as a prescription-only medicine.


Q: What happens if Cortema Neomycine gets on healthy skin?

Regulatory documents note that the medicine is intended only for the affected area and advise against applying it over a large surface area of the skin to limit the potential for systemic absorption. This applies to use on both affected and healthy skin.


Q: Why do some people use Cortema Neomycine when they have [general condition mentioned in core uses]?

The combination is used because it includes both an anti-inflammatory agent (steroid) and an anti-bacterial component (antibiotic) for conditions where both inflammation and bacterial contamination are present. The medicine is intended for corticosteroid-responsive skin conditions with secondary bacterial presence.


Q: Is Cortema Neomycine used for [common cold/flu/viral infection]?

Official guidance states that the product must not be used to treat viral lesions of the skin, such as Herpes Simplex or Varicella. It is also not indicated for systemic viral illnesses like the common cold or flu.


Q: Are there known issues with driving or operating machinery while on Cortema Neomycine?

Official side effect information includes the potential for rare nervous system effects, such as dizziness or unsteadiness, which may occur with systemic absorption. Official information suggests that this possibility is noted as a factor to consider when engaging in activities such as driving or operating machinery.


Q: Does Cortema Neomycine affect the results of any laboratory tests?

Systemic absorption of the Neomycin component may occur, and oral forms of Neomycin are known to affect the results of certain renal function and other laboratory tests. This is generally due to the Neomycin causing malabsorption syndrome in the gut.


Q: Are there different strengths or formulations of Cortema Neomycine?

Cortema Neomycine is officially described as being available in both cream and ointment formulations.


Q: Can Cortema Neomycine be used on sensitive areas of the body?

Official guidance advises against applying the medicine over large surface areas of the skin, which can include many sensitive areas. This restriction is primarily in place due to the increased risk of systemic absorption of the active ingredients.


Q: Is Cortema Neomycine known to cause long-term dependency or withdrawal effects?

The official product information states that prolonged use of the corticosteroid component carries the risk of HPA axis suppression. This is a key reason for the short-term use restrictions and relates to the body’s natural cortisol regulation.


Q: Why is it described that some people with specific allergies cannot use Cortema Neomycine?

The medicine is contraindicated for individuals with a known hypersensitivity (severe allergic reaction) to either of the active ingredients, Fluocinonide or Neomycin. This contraindication also extends to any related Aminoglycoside antibiotic.


Q: I'm taking herbal supplements; is there a known interaction with Cortema Neomycine?

The official documentation does not list specific interactions with herbal supplements. However, patients are typically advised to inform their healthcare provider of all products they are currently using.


Q: Is Cortema Neomycine used in veterinary medicine?

The active ingredient, Neomycin, is officially used as a component in certain medicines specifically labeled for veterinary use. However, this specific combination product (Cortema Neomycine) is formulated and labeled for human use.


Q: What are the official sources' perspectives on using Cortema Neomycine in children?

Official sources generally restrict use in children under 12 years of age. This restriction is based on the fact that safety and efficacy are often not established, and children face an increased risk of systemic effects, such as HPA axis suppression, due to their higher potential for absorption.


Q: Why is Cortema Neomycine sometimes prescribed for ear infections?

Official guidance includes a specific warning against using the product in the external ear canal if the eardrum is perforated. This suggests that the medicine may be considered for ear use under specific, non-contraindicated conditions, but its use requires professional guidance due to the specific warnings related to ear perforation.


Q: Is Cortema Neomycine meant to be used short-term or long-term?

Official guidance mandates that the use of this medicine is intended to be strictly short-term. This rule is in place due to specific maximum duration limits designed to minimize the risk of serious systemic toxicities, such as ototoxicity.


Q: Can Cortema Neomycine be stored in the refrigerator?

Official storage requirements specify controlled room temperature (15 C to 25 C) and explicitly state to avoid freezing. Therefore, storage in a refrigerator (typically below this range) is generally not advised.


Q: Is the name Cortema Neomycine used internationally?

While the active ingredients, Fluocinonide and Neomycin, are widely used in combination products worldwide, the specific brand name 'Cortema Neomycine' may not be an internationally recognized designation.


Q: What is the regulatory status of Cortema Neomycine (e.g., approved, restricted, etc.)?

Cortema Neomycine is classified and regulated as a prescription-only medicine intended exclusively for topical administration. Its use is restricted to conditions and populations outlined in its official prescribing information.


Q: Does Cortema Neomycine interact with common vitamins like Vitamin D or C?

The official prescribing information does not list common vitamins, such as Vitamin D or C, among the medicines with which an interaction is required to be restricted or avoided. Known restrictions focus on drug classes that carry specific toxicity risks.

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How should Cortema Neomycine be stored and disposed of?

Official Storage and Disposal Requirements

Cortema Neomycine (Fluocinonide/Neomycin topical) must be stored strictly according to regulatory specifications to maintain its effectiveness and stability.

Storage/Disposal Aspect Official Requirement
Temperature Store at controlled room temperature, typically 15 C to 25 C (59 F to 77 F).
Prohibitions Do not freeze and avoid storage locations with excessive heat or excess moisture.
Protection Keep the medicine in its original container, tightly closed, and protect from direct light.
Child Safety Store the product out of the sight and reach of children.
Disposal Ask a healthcare professional or pharmacist how to dispose of any unused or expired medicine properly. Do not keep outdated product.

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

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