Clindamycin - 1 A Pharma

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Clindamycin - 1 A Pharma

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Overview of Clindamycin - 1 A Pharma

Property Description
Active Ingredient Clindamycin Phosphate (Prodrug)
Form Capsules, Solution for Injection, Topical Solution/Gel
Pharmacological Class Lincosamide Antibiotic
General Purpose To halt the growth of susceptible bacteria
Origin Synthetic Derivative (of Lincomycin)

What Type of Medicine is Clindamycin - 1 A Pharma?

Clindamycin - 1 A Pharma is a prescription-only medicine (POM) that is classified as an antibiotic, belonging specifically to the lincosamide antibiotic class. The core active substance is Clindamycin, a synthetic derivative chemically modified from the naturally occurring compound lincomycin, positioning it as an effective anti-infective drug. The lincosamides are clinically recognized for their unique efficacy against many organisms, particularly against certain anaerobic bacteria and Gram-positive aerobic bacteria, differentiating their therapeutic utility from other antibiotic groups.


Composition and Forms: The Role of Clindamycin Phosphate

The key therapeutic agent in the formulation is often presented as Clindamycin Phosphate, which is a chemically stable prodrug precursor of the active Clindamycin molecule. This formulation is frequently employed to ensure efficient delivery, as the Clindamycin Phosphate is readily converted by the body’s metabolism into active Clindamycin at the sites of infection. Clindamycin works by inhibiting protein synthesis in susceptible bacterial strains. This means the drug's fundamental function is to stop bacteria from replicating, providing essential support in managing bacterial infections. As a single-ingredient product, it is manufactured in several dosage forms, including capsules for oral use, solution for injection for parenteral administration, and various topical preparations such as solutions or gels for direct skin application.


General Purpose: How Clindamycin - 1 A Pharma Works

The overall purpose of this medicine is to help control and resolve infectious processes by disrupting the growth and multiplication of susceptible bacterial pathogens. Its primary function is a bacteriostatic action, achieved because the active compound works as a protein synthesis inhibitor: it selectively binds to the 50S ribosomal subunit inside the bacterial cell, thereby halting the creation of new proteins essential for the microbe's survival. This targeted disruption reduces the overall bacterial load, providing a critical benefit in managing established bacterial infections.

Regulatory References

  1. Clindamycin: MedlinePlus Drug Information
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What side effects are possible with Clindamycin - 1 A Pharma?

Possible side effects and safety information

Clindamycin's official safety profile is organized by regulatory authorities to clarify documented adverse events and safety constraints associated with its use. The most critical safety characteristic highlighted in regulatory documents is the risk of Clostridioides difficile-associated diarrhea (CDAD) and pseudomembranous colitis, which can range in severity and may begin during treatment or up to several weeks after the medicine has been stopped.

Adverse Reaction Classification

Side effects are classified by frequency based on clinical and post-marketing data:

  • Common Reactions (affecting up to 1 in 10 people): Abdominal pain, Diarrhea, and elevated liver function tests (transaminases) are frequently cited gastrointestinal and systemic effects. Maculopapular rash may also occur.
  • Uncommon Reactions: These include Nausea, Vomiting, Urticaria, and taste disturbances (dysgeusia).

Systemic and Serious Adverse Reactions

Official labeling documents the potential for serious adverse reactions involving various organ systems, including the skin and the immune system. Severe, potentially life-threatening hypersensitivity events such as Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), and DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) have been reported, classified as frequency not known. Blood and lymphatic system disorders, such as agranulocytosis and thrombocytopenia, have also been documented. Cases of Acute Kidney Injury (AKI) have been reported in post-marketing surveillance.

Safety Considerations and Restrictions

Regulatory documents include high-level safety constraints. For instance, periodic monitoring of liver and kidney function tests is specified for patients receiving Clindamycin for prolonged periods. Furthermore, rapid intravenous administration of the injection form is associated with a risk of hypotension and cardiopulmonary events. The medicine is formally contraindicated in individuals with a history of hypersensitivity to either clindamycin or lincomycin.

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Overdose and Emergency Response

Overdose Scope

The official regulatory information for Clindamycin overdose primarily focuses on mandated emergency actions rather than describing a unique set of symptoms. No specific or unique acute overdose symptom profile is documented in the official labeling. Critical outcomes affecting breathing, consciousness, and the nervous system (e.g., seizure or collapse) are cited as the primary triggers for emergency intervention. No specific toxic dose level is defined, and no population-specific overdose notes for pediatric, geriatric, or organ-impaired patients are detailed in the regulatory overdose sections.


When Immediate Medical Help is Required

Immediate medical attention must be sought in the event of a suspected overdose. Contact a Poison Control center immediately. Emergency services (e.g., 911) must be contacted if the affected person exhibits severe, life-threatening signs, including seizure, collapse, trouble breathing, or inability to be awakened.


Overdose Management

The regulatory documentation confirms that no specific antidote is known for Clindamycin overdose. Therefore, management is officially restricted to symptomatic and supportive treatment. Furthermore, a critical procedural constraint is explicitly stated: the drug is not effectively removed from the circulation using standard elimination methods such as haemodialysis or peritoneal dialysis.

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Therapeutic Uses of Clindamycin - 1 A Pharma

What Clindamycin - 1 A Pharma Treats: Main Uses and Benefits

The fundamental role of Clindamycin - 1 A Pharma is to help manage established bacterial infections and address the associated symptoms. This medication is applied across domains where additional symptomatic support is needed against specific pathogens, especially anaerobes and certain resistant Gram-positive bacteria. It is commonly used to help manage symptoms associated with infections in various areas of the body.

It is relevant in clinical settings marked by increased discomfort or tension from serious bacterial involvement, including deep infections such as lung abscesses, osteomyelitis, severe intra-abdominal infections, and complex skin and soft tissue infections. It is considered a relevant therapeutic option for patients with penicillin allergies who require treatment for conditions like severe dental infections, as well as in managing localized issues like bacterial vaginosis and inflammatory acne vulgaris. By addressing the bacterial cause of the symptoms, it may support improved comfort and assist with maintaining functional stability during periods of acute illness.

Quick Fact: Relevant for Localized Pain

“The medication helps address symptom clusters that may become intense or disruptive, including persistent fever, swelling, and localized pain caused by the infection.”

Regulatory References

  1. NIH MedlinePlus overview of Clindamycin
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Eligibility and Restrictions for Use

Clindamycin eligibility is defined by regulatory documents based on pre-existing conditions, age, and physiological status.

Contraindications and Restrictions

Population Status Official Regulatory Rule
Absolute Contraindication Individuals with a history of hypersensitivity to clindamycin or lincomycin must not use this medicine.
Use is prohibited for meningitis because the drug does not adequately penetrate the cerebrospinal fluid.
Conditional Use (Caution) Patients with a history of colitis or other gastrointestinal disease require caution due to the risk of C. difficile diarrhea.
Atopic individuals and those with disturbances in neuromuscular transmission (e.g., Myasthenia Gravis) require caution.

Specific Population Rules

  • Age Groups: The medicine is generally approved for adults and adolescents. Its safety and dosage are not established for infants under one month of age. No specific dosage adjustment is required for older adults based on age alone.
  • Organ Impairment: Patients with impaired hepatic function or markedly reduced renal function should be carefully monitored, although dose adjustments are not typically required for mild-to-moderate impairment.
  • Pregnancy and Lactation: Use during pregnancy is advised only if clearly needed. Clindamycin is excreted in human milk; use during lactation requires consideration of potential risks to the breastfed infant, such as effects on gastrointestinal flora.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes officially documented interaction patterns for Clindamycin, focusing strictly on pharmacokinetic and pharmacodynamic effects as defined in government regulatory labeling.

Pharmacokinetic and Exposure Interactions

Clindamycin is primarily metabolized by the CYP3A4 enzyme and is a substrate for CYP3A5. This pharmacokinetic structure means its systemic exposure is sensitive to other medicines that affect these enzymes.

  • CYP3A4 Inhibitors: Co-administration with strong inhibitors, such as ketoconazole, causes a regulatory-documented pharmacokinetic interaction that increases Clindamycin systemic exposure (AUC and Cmax).
  • CYP3A4 Inducers: Co-administration with strong inducers, such as rifampin, causes a regulatory-documented pharmacokinetic interaction that decreases Clindamycin systemic exposure (AUC and Cmax).
  • Population Note: Reduced clearance is noted in patients with severe hepatic impairment, which is relevant to managing these pharmacokinetic interactions.

Pharmacodynamic and Other Interactions

A significant pharmacodynamic interaction is documented with Neuromuscular Blocking Agents (NMBAs). Clindamycin possesses properties that may enhance the action of NMBAs (e.g., tubocurarine). Due to this potential potentiation, regulatory labeling requires consideration when co-administering these agents. Additionally, antagonism between Clindamycin and Erythromycin has been demonstrated in vitro. The absorption of the oral form of Clindamycin is not significantly altered by food.

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Mechanism of Action

Targeted Inhibition of Bacterial Protein Synthesis

Clindamycin acts by physically binding to the 50S ribosomal subunit within susceptible bacteria, specifically targeting the 23S ribosomal RNA. This interaction reversibly inhibits peptidyl transferase and translocation, thereby immediately halting the elongation of peptide chains and preventing the creation of new proteins required for bacterial function and growth.


Suppression of Virulence Factors and Growth Arrest

The primary consequence of this selective protein synthesis inhibition is a significant bacteriostatic effect, which arrests bacterial multiplication. The mechanism also modulates the creation of bacterial exotoxins (virulence factors), resulting in a reduced concentration of these toxins in the tissue. This reduction in bacterial growth permits host immune mechanisms to regulate the proliferation of the infectious agent.


Limitations by Physiological Barriers and Resistance

The molecule's physiological effects are geographically constrained; its mechanism is limited in the Central Nervous System (CNS) due to poor penetration of the blood-brain barrier. Furthermore, the effectiveness of the ribosomal binding mechanism can be entirely overridden by bacterial defense strategies, such as modification of the 23S rRNA binding site (e.g., MLSB resistance).

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Dosage and Administration Information

How to Use Clindamycin – Administration Guidelines

The following information details the administration and dosing of clindamycin formulations.

Approved Administration Routes and Forms:

Route Common Dosage Forms
Oral Capsules, Oral Solution
Parenteral Intravenous (IV) Infusion, Intramuscular (IM) Injection
Local Topical (Gel, Solution), Intravaginal (Cream, Ovules)

Standard Dosing and Frequency

Patient Group Recommended Dosage Range Frequency
Adults (Oral) 150 mg to 450 mg Every 6 hours (Q6H)
Adults (IV/IM) 600 mg to 2,700 mg per day Divided into 2 to 4 doses
Pediatrics (Oral) 8 to 25 mg/kg per day Divided into 3 or 4 doses

For specific infections, such as those caused by Group A beta-hemolytic streptococci, therapy must be continued for a minimum of 10 consecutive days.


Preparation and Administration Conditions

  1. Oral Use: Capsules must be taken with a full glass of water (8 ounces) to prevent the risk of esophageal irritation. Food intake does not significantly affect absorption.
  2. Intravenous (IV) Infusion: The sterile solution must be diluted before infusion. The infusion rate must be carefully controlled and must not exceed 30 mg per minute. Rapid injection can lead to hypotension and cardiac arrest.
  3. Intramuscular (IM) Injection: A single IM injection should not exceed 600 mg, and injection sites must be rotated to minimize adverse effects.
  4. Population-Specific Dosing: Dosing for children and neonates (under one month old) is determined strictly by body weight (mg/kg). No routine dose adjustment is specified for the elderly based on age alone.

Missed Dose Instructions

If a dose is missed, take it as soon as it is remembered. However, if it is nearly time for the next scheduled dose, the missed dose should be skipped, and the regular schedule resumed. Do not take two doses at once to compensate for a missed dose.

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Recent Clinical Evidence

Research evidence / Overview of studies for Clindamycin - 1 A Pharma


Evidence for Use in Serious Systemic Infections

Research related to clindamycin's use in serious, deep-seated infections—such as those affecting the bones, joints, or internal organs—was evaluated in early clinical and regulatory settings. The evidence often takes the form of historical data and post-marketing surveillance analyses. These analyses research examined the clinical outcomes observed during treatment for acute, life-threatening conditions, monitoring whether a target clinical cure status was studied and whether microbiological clearance was observed.

However, long-term effects are not fully established beyond the immediate recovery period. Given the nature of serious systemic infections, the medicine’s use in this context relies heavily on how its activity against key target bacteria was explored. Comparative evidence is lacking regarding contemporary, large-scale randomized trials against many newer antibiotic treatments.


Evidence for Use in Skin and Soft Tissue Infections (SSTIs)

For uncomplicated skin and soft tissue infections (SSTIs), the available evidence includes Randomized Controlled Trials (RCTs) and studies that compared clindamycin against other common oral antibiotics. These trials studies explored individuals with conditions like cellulitis or localized abscesses.

Studies monitored outcomes related to physical discomfort and acute changes, such as assessing patterns of change in infection signs and whether a target clinical cure status was reached by the end of the treatment period. The findings describe patterns observed in the studies, often reporting that the patterns of resolution were observed in some studies to be similar to those seen with the comparator antibiotic group.

Follow-up durations were limited in many of these trials. While short-term outcomes are documented, long-term effects are not fully established, and data for certain groups remain insufficient.


Evidence Gaps and Areas of Research Uncertainty

Across all indications, long-term effects are not fully established as follow-up durations were limited in many key trials. This research limitation means that the findings describe group patterns, not personal outcomes, and evidence highlights what is known — and what is still uncertain.

Key Studies & References

  1. Clindamycin Vaginal: MedlinePlus Drug Information (Bacterial Vaginosis, side effects, and storage)
  2. Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris (NCT03522441) - ClinicalTrials.gov (Primary outcome measures for acne: lesion count change)
  3. Bacterial vaginosis: a review of approaches to treatment and prevention - Frontiers (Recurrence rates and long-term efficacy gaps)
  4. Rethink clindamycin for dental patient safety - Therapeutics Letter - NCBI (Evidence evaluation for dental prophylaxis and C. difficile risk)
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Frequently Asked Questions (FAQ)

Common questions about Clindamycin - 1 A Pharma (FAQ)

Q: Is Clindamycin - 1 A Pharma considered a penicillin-type antibiotic?

A: Clindamycin - 1 A Pharma is classified as a lincosamide antibiotic. This means it is structurally different from the penicillin-type antibiotics, which belong to the beta-lactam class. Official documents describe the drug class based on its unique chemical structure and mechanism of action.

Q: What kind of germs or bacteria does Clindamycin - 1 A Pharma target?

A: According to the official prescribing information, this medicine is indicated for serious infections caused by specific, susceptible strains of bacteria. These include certain anaerobic bacteria (germs that thrive without oxygen), as well as susceptible strains of streptococci, pneumococci, and staphylococci (Gram-positive bacteria).

Q: Does Clindamycin - 1 A Pharma interact with common pain relievers like ibuprofen?

A: Official regulatory documents, such as the prescribing information, do not specify a known interaction between clindamycin and nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen. The documented interactions primarily focus on agents affecting liver enzymes (CYP3A4) and neuromuscular blocking agents.

Q: Does this antibiotic affect birth control pills?

A: Official drug information indicates that clindamycin has the potential to reduce the effectiveness of oral contraceptives that contain ethinyl estradiol. Regulatory labeling indicates that using this antibiotic while taking certain birth control pills may reduce the effectiveness of the contraceptive. Individuals should consult the detailed product information for guidance regarding concomitant use.

Q: Can Clindamycin - 1 A Pharma be taken with milk or dairy products?

A: The official administration instructions confirm that the absorption of the oral form of clindamycin is not significantly changed by taking it with food. There are no specific restrictions listed in the official instructions regarding the intake of dairy products or milk.

Q: Can patients with impaired hepatic function use this medicine?

A: Official warnings state that patients with impaired hepatic function (reduced liver function) should be carefully monitored during treatment. Official prescribing information notes that reduced clearance of clindamycin has been observed in patients with markedly reduced liver function.

Q: What if a person experiences swelling or severe rash while using this drug?

A: Official product labeling documents the potential for serious, potentially life-threatening allergic reactions, such as Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome. These documented severe reactions, which may involve severe rash, blistering, and swelling, are characterized by regulatory bodies as medical emergencies.

Q: Why is Clindamycin - 1 A Pharma sometimes used for dental procedures?

A: Clindamycin is indicated for the treatment of certain infections caused by susceptible bacteria. Official resources recognize that this may include infections affecting the mouth and jaw structures in specific clinical situations, particularly when a patient cannot take penicillin.

Q: What kind of infections are not treated by Clindamycin - 1 A Pharma?

A: Clindamycin is effective only against specific bacterial infections and does not treat viral infections, such as the common cold or flu. Furthermore, the drug is prohibited for treating meningitis because official data shows it does not adequately pass into the cerebrospinal fluid to reach the infection site.

Q: Why is Clindamycin - 1 A Pharma prescribed instead of other antibiotics?

A: Regulatory documents indicate that clindamycin should generally be reserved for serious infections caused by susceptible bacteria. This is often when less toxic antimicrobial agents are not considered appropriate, such as in patients who have an allergy to penicillin or when treating specific types of anaerobic bacteria.

Q: How quickly should I expect Clindamycin - 1 A Pharma to start working?

A: Pharmacokinetic studies indicate that the drug is rapidly absorbed after being taken orally, with peak concentration in the blood reached in less than one hour for most adults. This information describes the drug's presence in the body, not the patient's individual clinical onset of action.

Q: Is it common to feel stomach upset when taking this medicine?

A: According to official safety data, gastrointestinal disturbances, which include abdominal pain and diarrhea, are classified as common reactions. This means they are observed to affect up to 1 in 10 people who use the medicine.

Q: Are there any known food restrictions while on Clindamycin - 1 A Pharma?

A: Official administration instructions specify certain conditions for taking the oral capsules to prevent irritation, such as taking them with a full glass of water. No major food restrictions are outlined in the official regulatory documents.

Q: Is Clindamycin - 1 A Pharma known to cause sensitivity to sunlight?

A: Official regulatory documents do not list photosensitivity (increased skin sensitivity to sun exposure) as a commonly reported side effect for the oral form. However, other non-specific skin reactions, such as maculopapular rash, have been documented.

Q: Does Clindamycin - 1 A Pharma have a high risk of drug resistance development?

A: The regulatory labeling includes a caution emphasizing the need to use the drug only for susceptible bacteria, which is part of the overall strategy to address concerns about the development of drug-resistant bacteria.

Q: Is it normal to have a metallic taste while taking this medicine?

A: Official product information, based on post-marketing surveillance, notes that an unpleasant or metallic taste in the mouth (dysgeusia) has been reported in connection with the use of clindamycin.

Q: Can Clindamycin - 1 A Pharma cause headache or dizziness?

A: Headache and dizziness are not listed among the most frequently reported side effects. However, dizziness is a documented symptom that can be associated with certain serious adverse reactions like systemic hypersensitivity.

Q: Does Clindamycin - 1 A Pharma cause fatigue?

A: Fatigue is not listed as a common or frequent adverse reaction in the official regulatory documents. Information on adverse effects focuses on specific events documented in clinical trials and post-marketing surveillance.

Q: Is Clindamycin - 1 A Pharma often used in combination with other drugs?

A: Regulatory-cited resources confirm that for certain serious conditions, such as some severe or deep-seated infections, clindamycin is often used in combination with one or more other antimicrobial agents. This approach may be part of an official treatment protocol in specific patient groups.

Q: Are there official documents that describe Clindamycin - 1 A Pharma's safety profile?

A: Yes. The complete safety profile, including known adverse reactions, contraindications, and warnings, is officially documented. This information is available in regulatory resources such as the FDA Prescribing Information (Label) and the European Summary of Product Characteristics (SmPC).

Q: Do studies exist regarding Clindamycin - 1 A Pharma use in specific patient groups?

A: Yes. Studies cited in official documents have investigated the way the drug is absorbed, distributed, and eliminated (pharmacokinetics) in specific groups. These groups include elderly volunteers, pediatric patients of various ages, and individuals with impaired liver or kidney function.

Q: Is it true that Clindamycin - 1 A Pharma can affect liver function?

A: Yes. The official safety data confirms that elevated liver function tests (transaminases) have been observed as a common reaction. Furthermore, rare cases of jaundice (yellowing of the skin or eyes) have been documented during treatment.

Q: Can a person be allergic to Clindamycin - 1 A Pharma?

A: Yes. The official medicine label specifies that the drug is contraindicated (must not be used) for individuals with a known history of allergy or hypersensitivity to either clindamycin or lincomycin. Documented allergic reactions range in severity, including serious, life-threatening events.

Q: Can Clindamycin - 1 A Pharma be used for a recurring infection?

A: Regulatory documents indicate the medicine is indicated for treating existing infections. The appropriateness of using it for a recurring infection depends on the bacteria's susceptibility and is outside the scope of general safety information.

Q: Is the medication intended for short-term use only?

A: Clindamycin is typically prescribed for defined, short courses of treatment to resolve an acute infection. Official guidelines state that if the drug is administered for a prolonged period, periodic monitoring of liver and kidney function tests is recommended.

Q: What is the general long-term outlook for people who use Clindamycin - 1 A Pharma?

A: The official research overview acknowledges that while short-term clinical outcomes for acute infections are established, the long-term effects are not fully established beyond the immediate recovery period. The evidence describes group patterns observed in studies, not a personal prognosis.

Q: How is the benefit of Clindamycin - 1 A Pharma generally evaluated in clinical settings?

A: Clinical evaluation studies typically focus on whether a target clinical cure status is achieved and whether the microbiological clearance of the target bacteria is successfully observed. The drug’s effectiveness is linked to its ability to inhibit bacterial protein synthesis.

Q: Do researchers know why some people react poorly to Clindamycin - 1 A Pharma?

A: Official documents categorize adverse reactions based on severity and frequency, and specify that severe reactions are documented as types of hypersensitivity responses. Individual mechanisms for adverse reactions are generally not detailed in the prescribing information.

Q: How does Clindamycin - 1 A Pharma compare generally to erythromycin?

A: Official information notes that antagonism (a counteracting effect) between clindamycin and erythromycin has been demonstrated in vitro (in a lab setting). Furthermore, clindamycin should be reserved for serious infections when less toxic antimicrobial alternatives, such as erythromycin, are determined to be unsuitable.

Q: Is Clindamycin - 1 A Pharma intended for use in the entire body (systemic)?

A: Yes, the medicine is available in various forms for both systemic use and local use. Systemic forms, such as oral capsules and injections, are intended to treat infections throughout the body, while topical preparations are used for site-specific infections.

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How should Clindamycin - 1 A Pharma be stored and disposed of?

Storage and Disposal of Clindamycin - 1 A Pharma

Official regulatory guidelines define specific conditions for storing and disposing of Clindamycin to maintain product quality and ensure safety.


Required Storage Conditions

Item Requirement
Temperature Store not above 25°C (for most forms).
Prohibitions Do not refrigerate or freeze the product.
Protection Keep in the original container (outer carton) to protect from light and moisture.
Child Safety Keep out of the sight and reach of children.

Stability and Disposal

The injectable solution is for single use only and must be used immediately after opening; any unused portion must be discarded. Disposal of expired or unused medicine must be conducted in accordance with local requirements. The product must not be thrown away via wastewater or household waste.

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

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