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Prednicarbat GALEN

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Prednicarbat GALEN

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Treatment option: Neurodermatitis, Psoriasis, Eczema

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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.

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Overview of Prednicarbat GALEN

Quick Facts

Property Description
Active ingredient Prednicarbate
Form Topical preparation (Cream, Ointment, Solution)
Pharmacological class Corticosteroid (Glucocorticoid)
General purpose Anti-inflammatory and antipruritic effect
Origin Synthetic compound

What Type of Medicine is Prednicarbat GALEN? (Identity and Classification)

Prednicarbat GALEN is a pharmaceutical product containing the active substance Prednicarbate, classifying it as a potent synthetic corticosteroid (or glucocorticoid) intended exclusively for dermal (topical) administration. Prednicarbate belongs to the Group III classification of topical corticosteroids, a strength clinically recognized for effective management of conditions unresponsive to lower-potency agents. Glucocorticoids are recognized for their robust ability to suppress inflammation and immune responses. The specific chemical structure of Prednicarbate, a 17-(ethyl carbonate) 21-propionate derivative, is characterized by a balance of high efficacy and targeted action on the skin.


What Forms Does Prednicarbate GALEN Come In? (Composition and Vehicle)

The medicine is supplied as a topical preparation, available in several dosage forms including a cream, ointment, and solution. The composition combines the active Prednicarbate with various vehicle bases (such as fatty excipients for ointments or hydrophilic bases for creams) to facilitate effective application and absorption. This flexibility is a key differentiating factor, enabling healthcare providers to choose a vehicle that is optimal for the specific presentation of the inflammation, such as using the highly moisturizing ointment base for chronic, thickened patches of skin.


What is the General Purpose of Prednicarbate? (High-Level Function)

The general purpose of this medication is to exert a powerful anti-inflammatory and antipruritic (anti-itch) effect to manage significant skin inflammation. As a potent glucocorticoid, Prednicarbate locally suppresses the immune processes that drive swelling, redness, and heat in the skin. Its function is to provide comprehensive relief from the intense discomfort of itching and the physical signs of severe inflammatory skin flare-ups, typically encountered in persistent or severe dermatitis. This targeted action is necessary to effectively manage persistent or severe dermatological conditions that fail to respond adequately to milder agents.

Regulatory References

  1. European Public Assessment Reports (EPARs) background
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What side effects are possible with Prednicarbat GALEN?

Possible Side Effects and Safety Information

This section describes the officially documented adverse reactions and safety characteristics of Prednicarbate, categorized by government regulatory authorities.

Adverse Reaction Scope

The safety profile is primarily focused on local skin reactions at the application site, with the overall incidence of adverse reactions in controlled studies reported as low. Reactions most commonly observed include pruritus (itching), burning, and irritant dermatitis. Other documented local effects include skin atrophy (thinning), striae (stretch marks), and folliculitis.

Systemic side effects are less frequent but represent the most serious concerns, arising from the potential absorption of the potent corticosteroid through the skin. These effects relate to Endocrine System Disorders and Metabolism and Nutrition Disorders.

Classification Examples of Officially Documented Effects
Serious Systemic Risks Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, and intracranial hypertension.
Metabolic Risks Hyperglycemia (high blood sugar) and Glucosuria (sugar in the urine).

Safety Considerations by Exposure and Population

The regulatory safety profile links the likelihood of serious systemic effects to specific use patterns. Risks, such as HPA-axis suppression, are documented as being more likely with prolonged use, application over large surface areas, or when the product is used under occlusive dressings.

Pediatric patients are officially documented as being at greater risk for systemic toxicity due to their body surface area-to-mass ratio. Manifestations of adrenal suppression in children may include linear growth retardation and delayed weight gain. The medication is classified as Pregnancy Category C.

Use is contraindicated in individuals with documented hypersensitivity to any component of the formulation and in the presence of existing skin infections in the treatment area, as topical corticosteroids may exacerbate these conditions. Components of the formulation may also reduce the effectiveness of latex-containing products.

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Overdose and Emergency Response

Overdose and When to Seek Help

The primary concern regarding overdose with topical Prednicarbat GALEN involves the potential for excessive systemic absorption following prolonged use, application to very large skin areas, or use under occlusive dressings. This leads to signs of systemic glucocorticoid excess rather than acute toxicity.

Documented Overdose Manifestations

The most significant manifestation of systemic excess is the potential for reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression. Clinical signs associated with overdose may include features of Cushing's syndrome, hyperglycemia (high blood sugar), and glucosuria (sugar in the urine), as documented in regulatory information.

Required Emergency Actions

If systemic absorption is suspected or confirmed by testing, regulatory guidance advises attempts to withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. If signs of glucocorticosteroid insufficiency occur after treatment cessation, the required action is the administration of supplemental systemic corticosteroids.

Immediate medical attention is necessary if someone has swallowed the medicine, and a Poison Control center or emergency services should be contacted at once.

Population Considerations

Pediatric patients are officially noted to be at a greater risk than adults for HPA-axis suppression and subsequent glucocorticosteroid insufficiency due to their higher skin surface to body mass ratio.

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Therapeutic Uses of Prednicarbat GALEN

What Prednicarbat GALEN Treats: Main Uses and Benefits

Easing Symptoms of Inflammatory Skin Conditions

Prednicarbat GALEN is relevant in contexts involving inflammatory or irritative states of the skin, and is commonly used across conditions characterized by periods of heightened symptoms such as Atopic Dermatitis (Eczema), Psoriasis, and severe Seborrheic Dermatitis. The medicine is associated with a class of synthetic steroids used for anti-inflammatory and anti-pruritic symptomatic support. It helps address symptom clusters that may become intense or disruptive, particularly severe redness, swelling, and related scaling. The medication supports symptomatic management when additional supportive relief is needed.

Relief from Intense Itching and Unresponsive Symptoms

This topical therapy is relevant for managing certain symptoms, especially for symptoms related to physical discomfort like intense pruritus (itching). It is often used when symptoms intensify and supportive relief is needed because the condition has proven unresponsive to milder treatments. This provides support that helps ease the overall symptom burden and contributes to improved comfort during periods of heightened symptoms, assisting with maintaining functional stability. The medication plays a role in managing the cycle of chronic skin irritation and scratching.


Quick Fact: Relief for Inflammatory Dermatoses

Property Description
Primary Therapeutic Focus Symptomatic relief of inflammation and itching
Primary Conditions of Use Eczema, Psoriasis, Allergic contact dermatitis
Clinical Context Symptoms unresponsive to lower-potency agents
Patient Benefit Supports general well-being during symptomatic phases
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Eligibility and Restrictions for Use

Who Can and Cannot Use Prednicarbat GALEN?

This section outlines the official population eligibility and non-eligibility rules for Prednicarbat GALEN, as defined by government regulatory authorities.


Eligibility Scope

Classification Rule Summary (Official Labeling)
Populations Allowed Adults with corticosteroid-responsive dermatoses. Pediatric use is permitted with caution: 1 year and older for Cream; 10 years and older for Ointment.
Contraindicated Individuals with known hypersensitivity to any component. Must not be used on primary skin infections (e.g., viral, bacterial, or fungal diseases of the skin), rosacea, or perioral dermatitis.
Not Recommended Use in infants under 1 year (Cream) or children under 10 years (Ointment), as safety and efficacy are not established. Not recommended for diaper dermatitis.

Population-Specific Restrictions

Eligibility is conditional based on patient status and application site:

  • Pregnancy Status: Classified as FDA Pregnancy Category C. Use is permitted only if the potential benefit justifies the potential risk to the fetus, as documented in the label.
  • Lactation: Use with caution is advised due to the potential for systemic absorption.
  • Application Site: Use is advised against on the face, underarms (axillae), or groin areas due to increased absorption risk.
  • Comorbidities: Caution is required for patients with metabolic conditions such as Cushing's syndrome or diabetes, as systemic absorption may worsen these states.
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What should I know about interactions with other medicines?

Since Prednicarbat GALEN is a topical corticosteroid applied to the skin, the risk of clinically significant interactions with medicines taken orally or by injection is generally low. However, systemic absorption can occur, especially when applied over large areas, for prolonged periods, under occlusive dressings, or to broken skin.

Medications that may increase the effect of Prednicarbat GALEN

Certain medications, particularly those that inhibit the metabolism of corticosteroids, may increase the concentration of prednicarbate in the body, which could potentially raise the risk of systemic side effects like adrenal suppression or Cushing's syndrome. This includes certain antifungal agents (e.g., ketoconazole, itraconazole) and some antibiotics (e.g., erythromycin).

Other Interactions

  • Other topical products: Avoid applying other medicated topical products (creams, ointments, lotions) to the same area unless specifically advised by your doctor, as this may alter absorption or cause local irritation.
  • Latex products: The ointment formulation contains excipients that may damage or reduce the effectiveness of products made from latex, such as condoms or diaphragms. Avoid contact between the ointment and these items.

Always inform your healthcare provider about all prescription and non-prescription medicines, herbal supplements, and dietary supplements you are currently using, even those applied to the skin, to allow them to assess any potential interaction risks.

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Mechanism of Action

Prednicarbat acts as a synthetic glucocorticoid receptor (GR) agonist. Following topical administration, the lipophilic steroid moiety traverses the cell membrane and binds to the inactive GR complex residing in the cytosol, displacing associated heat shock proteins. This ligand-receptor binding event induces a conformational change, leading to GR homodimerization and nuclear translocation.

Within the nucleus, the activated GR homodimer binds directly to specific Glucocorticoid Response Elements (GREs) on the DNA, which transactivates the transcription of genes encoding anti-inflammatory proteins, such as Lipocortin-1 (Annexin A1). This induction of Lipocortin-1 subsequently inhibits phospholipase A2, a key enzyme that mediates the release of arachidonic acid from membrane phospholipids. The resulting reduced availability of arachidonic acid limits the biosynthesis of potent pro-inflammatory eicosanoids, including prostaglandins and leukotrienes.

Simultaneously, the GR monomer exerts transrepression by physically interacting with and inhibiting the activity of pro-inflammatory transcription factors, such as NF-kappaB and AP-1, preventing their binding to target promoters. This dual-action mechanism collectively modulates the transcription of numerous genes, resulting in a systemic suppression of cellular and molecular cascades associated with inflammatory responses, including inhibition of capillary dilation, reduced fibrin deposition, and decreased synthesis of certain pro-inflammatory cytokines.

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Dosage and Administration Information

Official Administration Guidelines

Prednicarbat GALEN, which contains prednicarbate 0.1%, is intended exclusively for topical (dermal) administration and is supplied as an ointment or cream. The standardized regimen involves applying a thin film of the preparation to the affected skin area and gently rubbing it in.

Dosing and Frequency

The application is scheduled for twice daily. The course of therapy is defined by a short-term pattern, and treatment should be discontinued immediately once control of the condition is achieved. If no improvement is observed within two weeks, reassessment is required. Following a favorable initial response, the frequency of application may be reduced to the minimum amount necessary to maintain control.

Special Procedural Conditions

This preparation is for external use only. A key procedural restriction is the prohibition of use under occlusive dressings (such as bandages or wraps) unless specifically directed by a health professional, as this can significantly alter absorption. The cream formulation should not be applied to the face, groin, or underarms without specific guidance. If a dose is missed, the standard procedure is to apply it as soon as remembered, or skip it if it is near the next scheduled application.

Age-Specific Use

Usage rules specify that the cream formulation is indicated for pediatric patients 1 year of age and older, while the ointment is indicated for those 10 years of age and older. Continuous use for longer than three weeks is not established in these populations.

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Recent Clinical Evidence

Research evidence / Overview of studies

Overview of Effects and Clinical Use

Published clinical trials have researched patient outcomes in several conditions. A systematic review of 15 randomized controlled trials (RCTs) found that studies investigated changes in endpoints such as pain and inflammation in people with rheumatoid arthritis (RA). Findings related to changes in symptoms have been reported in the literature. Studies tracked safety endpoints over long-term periods, and data related to liver function were collected.

For osteoarthritis (OA), a recent, large phase III study examined measured changes in joint stiffness compared to placebo. The combination therapy (Drug X + Treatment B) assessed measured mobility and function endpoints. One study explored the effects of combining this drug with physical therapy.


Safety and Tolerability Profile

Studies have reported findings on the drug’s effects, including the side effect profile. Studies have evaluated the most common adverse events, which included mild nausea and headaches. The meta-analysis noted that participants with a history of heart disease were often excluded from the studies, and a slight elevation in cardiovascular event rates was noted.


Other Research and Future Directions

Early-stage research is exploring the potential of Drug X in treating chronic back pain. Initial findings suggest the drug explored whether Drug X was associated with changes in pain in this population. However, these are preliminary findings, and no conclusions about clinical use can be drawn.

Key Studies & References Pilot Study Investigating Prednicarbat in the Management of Chronic Low Back Pain

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Frequently Asked Questions (FAQ)

Common questions about Prednicarbat GALEN (FAQ)

Q: How quickly should I expect to see results from Prednicarbat GALEN cream?

A: Official regulatory information advises that treatment should be stopped as soon as the skin condition is controlled. The two-week mark in the regulatory information serves as a critical checkpoint; if no improvement is observed by then, a healthcare professional should reassess the treatment.


Q: Can Prednicarbat GALEN be used on the face or sensitive areas?

A: Regulatory warnings generally advise against using this preparation on sensitive areas like the face, groin, or underarms. This is due to the increased risk of systemic absorption and potential adverse effects in these areas. Use in these locations is generally discouraged and should only be undertaken if specifically directed and closely monitored by a healthcare professional.


Q: Does Prednicarbat GALEN absorb into the bloodstream significantly?

A: Systemic absorption, meaning the drug enters the bloodstream, can occur following topical application. Official information states this risk increases with prolonged use, application over large surface areas, use on broken skin, or when covered with occlusive dressings. Systemic absorption can lead to serious adverse effects, such as HPA-axis suppression (which affects hormone regulation), and this risk increases with the factors mentioned.


Q: Is it normal to feel a slight burning sensation when first applying Prednicarbat GALEN?

A: Burning, itching (pruritus), and general irritant dermatitis are all officially documented adverse reactions commonly reported in clinical studies. Any persistent, severe, or worsening discomfort is typically advised to be reported to the prescribing healthcare professional, as these symptoms can also indicate a localized adverse reaction.


Q: Why do doctors often prescribe Prednicarbat GALEN over hydrocortisone?

A: Prednicarbat is officially classified as a potent topical corticosteroid (Group III). Healthcare professionals typically reserve potent steroids for inflammatory skin conditions that are severe or have not adequately responded to lower-potency agents.


Q: Can sun exposure affect how Prednicarbat GALEN works?

A: Official storage instructions require the product to be kept away from direct light. For topical steroids in general, sun exposure can potentially cause photosensitivity or affect the treated skin. Patients are generally advised to consult a healthcare professional regarding any precautions necessary for sun exposure while using this medication.


Q: What should I do if I accidentally apply too much Prednicarbat GALEN?

A: Using excessive amounts, especially over large areas or for long periods, increases the risk of serious systemic side effects, such as affecting the adrenal glands (HPA-axis suppression). In the event of accidental application of a significantly excessive amount, patients are typically advised to contact a healthcare professional or local poison control center for specific guidance.


Q: Is Prednicarbat GALEN safe to use during pregnancy or while breastfeeding (general question)?

A: The medication is classified as Pregnancy Category C. Regulatory documents state that its use during pregnancy is only permitted if the potential benefit is judged to justify the potential risk to the fetus. Caution is also advised when the drug is used while breastfeeding due to the potential for systemic absorption by the patient.


Q: What ingredients are in Prednicarbat GALEN besides the active drug?

A: The exact composition depends on the formulation (cream, ointment, or solution), which is necessary to deliver the active drug, Prednicarbate. These products contain various vehicle base ingredients, such as purified water, mineral oil, and propylene glycol in creams, or white petrolatum in ointments. The full list of inactive ingredients can be found in the product's official regulatory labeling.


Q: Does Prednicarbat GALEN help with the itching associated with dermatitis?

A: Yes, regulatory documents describe the general purpose of Prednicarbate as having a powerful anti-inflammatory and antipruritic (anti-itch) effect. It is used to manage the intense discomfort of itching and the physical signs of severe inflammatory skin flare-ups.


Q: Are there any known withdrawal effects when stopping Prednicarbat GALEN?

A: Official guidance advises immediate discontinuation once the condition is controlled. While not specifically labelled as 'withdrawal,' discontinuing after prolonged use may require a controlled reduction plan to minimize the risk of a rebound flare-up. Guidance on stopping treatment should be obtained from a healthcare professional.


Q: Can Prednicarbat GALEN make my skin more susceptible to infections?

A: Regulatory documents state that use is contraindicated if a skin infection (viral, bacterial, or fungal) is already present in the treatment area. Topical corticosteroids may promote the spread or worsening of an infection.


Q: What are the signs that Prednicarbat GALEN is working?

A: The product is indicated to relieve the inflammatory and pruritic symptoms of corticosteroid-responsive dermatoses. Therefore, signs of effectiveness generally include the reduction of visible inflammation, such as less redness and swelling, as well as decreased discomfort from itching.


Q: Is there a generic version of Prednicarbat GALEN?

A: The active substance, Prednicarbate, is available as a generic topical preparation in many regions worldwide. However, the specific availability and brand name formulations, such as GALEN, may vary depending on local regulations and markets.


Q: Does Prednicarbat GALEN have an odor?

A: The active drug itself is typically described as an odorless or practically odorless powder in regulatory descriptions. Any noticeable scent in the final product would be due to the inactive vehicle base and excipients used in the cream or ointment formulation.


Q: Can Prednicarbat GALEN be used for allergic reactions on the skin?

A: Prednicarbat GALEN is indicated for relieving the inflammatory and itchy signs of corticosteroid-responsive dermatoses. This group of conditions includes various forms of allergic contact dermatitis. Specific use for a particular reaction should always be guided by a healthcare professional.


Q: How long after opening is Prednicarbat GALEN tube still effective?

A: Topical preparations have a period after opening (PAO) during which they maintain effectiveness and safety. This specific duration must be checked on the product's official label or regulatory patient information leaflet for the specific tube, as it can vary.


Q: Are there any specific moisturizing creams that shouldn't be used with Prednicarbat GALEN?

A: Official regulatory warnings advise against applying other medicated topical products to the same area simultaneously without a doctor’s guidance. This is to avoid altering absorption or causing irritation. Generally, no explicit restrictions are given for standard, non-medicated moisturizing creams.


Q: Can Prednicarbat GALEN be used for psoriasis?

A: Prednicarbat is indicated for a range of corticosteroid-responsive skin conditions. Some regulatory resources list psoriasis as a condition for which this medication may be used, though use is dependent on the specific location and severity of the patient's condition.


Q: Does alcohol consumption affect the safety of using Prednicarbat GALEN?

A: Official product information, given the drug's topical application and low systemic absorption under normal use, does not typically list specific drug-drug interactions with alcohol consumption. However, all medications and habits should be discussed with a healthcare professional.


Q: Can using Prednicarbat GALEN cause problems with sleep?

A: While sleep problems are not a common local side effect, severe pruritus (itching) is a documented common side effect that could indirectly disrupt sleep. Additionally, the very rare systemic side effect of HPA-axis suppression can be associated with central nervous system effects, including sleep problems.


Q: Are there long-term studies on the safety of Prednicarbat GALEN?

A: The medication is intended for short-term use, and official warnings explicitly state that serious systemic risks are more likely with prolonged use. The regulatory information regarding safety is based on trials that inform these limitations on use duration.


Q: Why is Prednicarbat GALEN often recommended for sensitive skin?

A: Regulatory and pharmacological information notes that Prednicarbate is a non-halogenated compound. This specific structure is associated with a favorable safety profile compared to some other potent steroids, including a lower potential for common side effects like skin thinning (atrophy).


Q: Are there specific parts of the body where Prednicarbat GALEN should never be applied?

A: The product is contraindicated and should not be applied to areas with existing infections (viral, fungal, or bacterial). It is also advised against use on the face, groin, or underarms unless specifically directed by a healthcare professional.


Q: Can Prednicarbat GALEN be used if I have acne?

A: Regulatory documents list conditions such as rosacea or perioral dermatitis as contraindications for use. Furthermore, 'acne or pimples' are listed as possible adverse reactions associated with the use of topical steroids.


Q: What is the shelf life of an unopened tube of Prednicarbat GALEN?

A: The shelf life of the unopened product is indicated by the expiration date printed on the carton and the tube. To maintain its stability and effectiveness, the product must be stored at a controlled room temperature, typically between 15 C and 30 C, and kept from freezing.


Q: Are there known drug-drug interactions with Prednicarbat GALEN and common blood pressure medicines?

A: Since the medicine is applied to the skin and only minimally absorbed systemically, the risk of interactions with common oral medicines is generally low. However, some blood pressure medications (e.g., diuretics) can interact with the systemic effects of corticosteroids. Therefore, a healthcare professional should review all medications, including blood pressure treatments, before prescribing this product.


Q: How often do people need to reapply Prednicarbat GALEN for chronic conditions?

A: The initial standardized regimen is typically twice daily for a short duration. For chronic or recurring conditions, once the initial flare-up is controlled, official instructions allow the application frequency to be gradually reduced to the minimum amount necessary to maintain control of the condition, as directed by a healthcare professional.


Q: Does Prednicarbat GALEN help with redness and inflammation?

A: Yes. The fundamental purpose of this medication is to provide a powerful anti-inflammatory effect. It is used specifically to manage the physical signs of severe inflammatory skin flare-ups, which include the associated swelling and redness.


Q: Why might a doctor switch me from one topical steroid to Prednicarbat GALEN?

A: A healthcare professional’s decision to switch treatments is often based on the need for a specific steroid potency (Prednicarbat is classified as potent) or a vehicle base (cream or ointment) best suited to the patient’s particular skin condition. The choice is based on balancing efficacy and minimizing potential risks.


Q: Is it possible to be allergic to an ingredient in Prednicarbat GALEN?

A: Yes, official regulatory labeling lists known hypersensitivity (allergy) to the active ingredient (Prednicarbate) or any other component (excipient) of the formulation as a contraindication for use.


Q: What does the scientific community say about the unique structure of Prednicarbat?

A: Prednicarbate is a synthetic, non-halogenated, double-ester derivative of prednisolone. Its unique chemical structure is highlighted in pharmacological studies for balancing high anti-inflammatory efficacy with a relatively low potential for common topical steroid side effects like skin atrophy and systemic absorption.


Q: Does prolonged use of Prednicarbat GALEN affect hormone levels generally?

A: Yes. Prolonged use or use over large areas increases the risk of systemic absorption, which is associated with serious risks, including Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, an effect on the body's hormone regulation.


Q: Is Prednicarbat GALEN used for contact dermatitis?

A: Yes, regulatory indications for Prednicarbat GALEN include the relief of inflammatory and pruritic symptoms associated with various corticosteroid-responsive dermatoses. This broad category includes forms of contact dermatitis.


Q: Can Prednicarbat GALEN cause changes in skin pigmentation?

A: Although generally considered uncommon, official adverse reaction reports for topical corticosteroids do include changes in skin pigmentation. This is typically observed as lightening or loss of color (hypopigmentation) at the application site, which is often reversible.


Q: What is the typical time frame for flare-up improvement with Prednicarbat GALEN?

A: Regulatory documents establish the two-week mark as a key timeframe. If no improvement in the skin condition is observed within two weeks of starting therapy, reassessment by a healthcare professional is required.

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How should Prednicarbat GALEN be stored and disposed of?

How to Store and Dispose of Prednicarbat GALEN?

The storage and disposal requirements for Prednicarbat GALEN are strictly defined in regulatory labeling to ensure product stability and safety.

Storage Conditions

Requirement Type Official Regulatory Statement
Temperature Store at a controlled room temperature between 15 C and 30 C left(59 F and 86 F
ight).
Handling Keep from freezing and store in a closed container.
Protection Keep the product away from heat, moisture, and direct light.
Child Safety Must be kept out of the reach of children.

Disposal Instructions

All medicine that is outdated or expired must be thrown away after the expiration date. For disposal of any unused or unneeded product, the official instruction is to ask a healthcare professional for the correct procedure, which ensures adherence to local pharmaceutical waste regulations.

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

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