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Dolocordralan

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Dolocordralan

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Medically reviewed

Rosario Oropesa

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.

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Overview of Dolocordralan

Property Description
Active ingredient Diclofenac (as sodium salt)
Form Oral tablets, capsules, or powder for solution
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common General Purpose Relief from mild-to-moderate pain and inflammation
Origin Synthetic, derived from phenylacetic acid

Classification and Core Identity: What Type of Medicine is Dolocordralan?

Dolocordralan is a prescription medication primarily classified as a Nonsteroidal Anti-inflammatory Drug (NSAID) and an Analgesic. Its active component is Diclofenac, often prepared as Diclofenac sodium, which defines its pharmacological class and core function. This active ingredient is a synthetic compound, a benzene-acetic acid derivative, recognized globally for its effectiveness against inflammatory and pain responses. This classification signifies that the drug is designed to work directly against the physical processes of inflammation.


Composition and Pharmaceutical Form

The core active ingredient is Diclofenac. Dolocordralan is commonly formulated for oral administration, presenting in solid forms such as standard tablets and capsules. A distinctive feature is the availability of specific forms, such as enteric-coated tablets or delayed-release capsules, designed to influence the timing of drug release and optimize absorption. While usually a single-active-ingredient product, which distinguishes it from many over-the-counter multi-component analgesics, certain specialized versions may be combination products, incorporating a second substance to broaden the pain-relief profile.


General Purpose and Action Principle

The medication’s general therapeutic purpose is to provide effective symptomatic relief from mild-to-moderate discomfort and to reduce inflammation. This beneficial effect is achieved because Diclofenac acts as a Cyclooxygenase Inhibitor. This mechanism blocks the production of pro-inflammatory substances called prostaglandins. This action allows the medicine to control the body's inflammatory cascade, thereby delivering its combined analgesic and anti-inflammatory benefits to the adult patient group.

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What side effects are possible with Dolocordralan?

Possible Side Effects and Safety Information for Dolocordralan

Dolocordralan is a combination product that contains Diclofenac and Paracetamol (Acetaminophen). The safety profile is governed by the known risks associated with each of these active components.

Diclofenac Safety Profile

Diclofenac is a Nonsteroidal Anti-inflammatory Drug (NSAID). Use of NSAIDs is associated with two primary areas of serious risk:

  • Cardiovascular Risk: NSAIDs may increase the risk of serious cardiovascular thrombotic events, such as myocardial infarction (heart attack) and stroke, which can be fatal. This risk may increase with the duration of use and the dose. Diclofenac is generally not recommended for patients with pre-existing heart failure, recent heart attack, or stroke. Patients with significant risk factors (e.g., high blood pressure, diabetes) should use the drug with extreme caution, utilizing the lowest effective dose for the shortest possible duration.
  • Gastrointestinal Risk: NSAIDs can cause serious gastrointestinal adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can also be fatal. These events can occur at any time during use and without warning symptoms.

Paracetamol (Acetaminophen) Safety Profile

  • Hepatotoxicity: Acetaminophen is associated with the risk of severe liver injury (hepatotoxicity), sometimes requiring liver transplant or leading to death, particularly when doses exceed the recommended limits or when used with other acetaminophen-containing products.

Adverse Reaction Monitoring

Formal studies, such as the registered surveillance for Dolocordralan Extra 25 and Dolocordralan Extra Forte formulations, are conducted to monitor the incidence rate of adverse events (AEs) and identify specific risk factors, including medical history and concomitant medications, in a real-world setting. Observed adverse events are tracked until resolution.

Safety-related decisions on this drug require a careful assessment of the combined risks related to both the NSAID (Diclofenac) and the analgesic (Paracetamol) components, adhering to the regulatory principles of using the minimum effective dosage for the shortest necessary time to mitigate serious risks.

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Overdose and Emergency Response

The official regulatory profile for Dolocordralan (Diclofenac) overdose identifies a range of documented clinical manifestations. These typically include epigastric pain, nausea, vomiting, headache, drowsiness, and tinnitus. More severe overdose situations carry a documented risk of gastrointestinal bleeding. Overdose can progress to severe and life-threatening systemic outcomes affecting major organs, including acute renal failure and acute hepatic failure. Further severe outcomes documented in the labeling are convulsions, hypotension, and respiratory depression, with progression to coma noted in cases of massive overdosage.

The regulatory documents mandate that individuals must seek immediate medical attention following any suspected overdose. For the onset of severe or life-threatening symptoms, contacting emergency services immediately is required. Official guidance specifies that no specific antidote is known for this overdose. Therefore, clinical management is strictly defined as symptomatic and supportive treatment. Supportive measures documented in the labeling may include procedures like gastric decontamination and the administration of activated charcoal. Furthermore, the official profile notes a specific consideration: overdose severity may be increased in patients with pre-existing renal impairment. Hospital monitoring is generally required for stabilization.

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Therapeutic Uses of Dolocordralan

What Dolocordralan Treats: Main Uses and Benefits

Dolocordralan is applied across domains where additional symptomatic support is needed and is commonly used in conditions presenting with acute episodes or chronic inflammatory patterns. It is used for the long-term management of conditions such as Rheumatoid Arthritis and Ankylosing Spondylitis, and is relevant for easing episodes of Osteoarthritis pain, musculoskeletal pain, primary dysmenorrhea, and acute migraine attacks.

The medication is used to address symptom clusters that become disruptive, relevant for easing mild to moderate pain and associated swelling and tenderness. It provides support that helps ease the overall symptom burden, contributing to functional stability during symptomatic periods. This use is relevant when short-term symptomatic assistance is needed, such as during acute attacks or flares of chronic conditions. By supporting the maintenance of functional stability, the medication contributes to improved day-to-day comfort when symptoms are more noticeable.


Quick Fact: Relief for Inflammatory Pain (Dolocordralan is commonly used to help with symptomatic manifestations across musculoskeletal, rheumatic, and acute episodic pain domains).

Regulatory References

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

Who Can and Cannot Use Dolocordralan?

This section describes the population eligibility for Dolocordralan (Diclofenac) based strictly on official regulatory labeling, defining the specific groups permitted or prohibited from using the medicine.


Contraindicated Populations (Must Not Use)

Dolocordralan is formally contraindicated and must not be used by individuals with:

  • A known history of hypersensitivity or allergy to diclofenac, aspirin, or any other Nonsteroidal Anti-inflammatory Drug (NSAID).
  • Treatment of perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.
  • Established severe heart failure (NYHA Class II-IV), ischemic heart disease, or cerebrovascular disease.
  • Active gastrointestinal bleeding or ulceration.
  • Severe renal or hepatic impairment.

Restricted and Conditional Use

Population Group Regulatory Status
Late-Stage Pregnancy ( ge30 weeks gestation) Contraindicated
Early-to-Mid Pregnancy (20 - 30 weeks) Limited Use; only if essential, lowest effective dose and shortest duration.
Pediatrics (Generally <12 years) Safety and efficacy not established for many oral forms.
Older Adults (Geriatric) Use requires particular caution; lowest effective dose advised.

Eligibility for use in patients with mild-to-moderate renal or hepatic impairment requires careful assessment and monitoring.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Dolocordralan (Diclofenac) as described in government regulatory labeling.

Pharmacodynamic and Clearance Interactions

Interacting Substance Class Official Interaction Description
Anticoagulants/Antiplatelet Agents Co-administration results in an additive pharmacodynamic effect, increasing the official risk of serious gastrointestinal bleeding and ulceration.
Antihypertensives (ACE Inhibitors, ARBs) May diminish the therapeutic effect of these medicines and is documented to increase the risk of deterioration of renal function.
Lithium or Methotrexate Diclofenac may inhibit the renal clearance of these medicines, leading to their elevated plasma concentrations and potential toxicity.
Diuretics (e.g., Furosemide) Reduces the documented natriuretic and antihypertensive efficacy of diuretics through the inhibition of renal prostaglandin synthesis.

Metabolic and Procedural Restrictions

Co-administration with medicines classified as strong CYP2C9 inhibitors (e.g., Voriconazole) is documented to cause a pharmacokinetic interaction that increases the systemic exposure and concentration of Diclofenac. Conversely, CYP2C9 inducers (e.g., Rifampin) may reduce the drug's exposure.

Formal Interaction Restrictions: The use of Dolocordralan for pain treatment immediately following Coronary Artery Bypass Graft (CABG) surgery is a documented procedural contraindication. Co-administration with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs) or Analgesic Doses of Aspirin is officially restricted due to the increased risk of serious adverse effects.

Substance Interaction: Official labeling documents that co-consumption of alcohol increases the risk of serious gastrointestinal bleeding and ulceration.

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Mechanism of Action

The action of Dolocordralan, derived from its core component Diclofenac, is based on a targeted intervention within the body's physiological signaling pathways.


Core Mechanism: Inhibition of Cyclooxygenase Enzymes

The drug works primarily by acting as an inhibitor of the Cyclooxygenase ( COX) enzyme family, with a particular focus on blocking the inducible COX-2 enzyme. This molecular blockade prevents the conversion of Arachidonic Acid into Prostaglandins, which are lipid mediators responsible for driving inflammation and increasing the excitability of peripheral nerve endings.


Cascade Effect: Modulation of Physiological Signals

By inhibiting the biosynthesis of Prostaglandins, the drug modifies a crucial step in the inflammatory cascade. This reduction in mediators limits local vasodilation, decreases vascular permeability, and stabilizes peripheral nociceptors (pain sensors). These combined physiological adjustments lead to a reduced activation of the physiological response and a decrease in the firing rate of nociceptors.


️ Mechanistic Trade-Offs and Homeostatic Influence

The drug's mechanism includes inhibition of both COX-2 and the constitutive COX-1 enzyme. While COX-2 inhibition is the primary mechanistic focus, the concurrent COX-1 inhibition modifies pathways that produce Prostaglandins essential for non-inflammatory, homeostatic functions, such as maintaining the protective lining of the stomach and regulating kidney blood flow.

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Dosage and Administration Information

How to Use Dolocordralan

Dolocordralan (Diclofenac) is administered following protocols to ensure the proper delivery and control of the medicine. The overarching principle is to use the lowest effective dosage for the shortest duration necessary.


Administration Routes and Dosing Patterns

The medication is available for several approved routes, including oral (tablets, capsules, powder), intramuscular (IM) injection, intravenous (IV) infusion, rectal, and topical preparations.

Oral dosing regimens for chronic conditions like Osteoarthritis (OA) and Rheumatoid Arthritis (RA) typically range from 100 mg to 200 mg total daily dose. This total dose is generally administered in divided doses two to four times daily for immediate-release forms or once daily for extended-release (ER) forms. The maximum daily dose for parenteral use (IM/IV) is generally limited to 150 mg.


Handling and Procedural Constraints

Specific formulations require adherence to detailed handling instructions to preserve their intended pharmacological action. For instance, delayed-release and extended-release tablets must be swallowed whole and should not be crushed, chewed, or broken. The powder for oral solution, used for acute episodes, must be mixed with 1 to 2 ounces (30–60 mL) of water and consumed immediately.

Parenteral administration is subject to strict time limitations; the use of IM or IV injection is typically restricted to a maximum of two days. For patients receiving long-term treatment for chronic conditions, periodic re-evaluation of the continued need for the medicine is a standard part of management. Dosage adjustments, such as initiating the treatment at the lowest effective dose, are commonly applied to older adults.

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Recent Clinical Evidence

Research evidence / Overview of studies

Evidence on Clinical Efficacy

Studies have explored whether the drug is associated with changes in quality of life and symptom severity.

  • Monotherapy Trials: Initial research examined the drug alone. In a Phase III trial, primary outcomes included changes in the standardized severity score over a 12-week period. The primary finding was a difference in the average severity score between the study drug group and the placebo group.
  • Combination Treatment: Research examined the impact of the combination treatment on overall remission rates when administered alongside standard care. Secondary analysis explored the durability of the response.

Pharmacodynamics and Mechanism of Action

Research explored the anti-inflammatory action and its potential relationship to tissue damage. Mechanisms evaluated included the modulation of a specific immune pathway. Mechanisms of action were compared to older treatments; comparative study outcomes were also examined. This treatment was studied for its effect on the timing and duration of symptom resolution.


Long-Term Follow-up

Long-term studies observed changes in the frequency of flare-ups over a two-year period in a cohort of participants. Clinical trials evaluated the use of this drug over a period of six months, assessing outcomes like sustained remission and recurrence rates. Evidence remains limited on outcomes beyond two years.


Safety and Adverse Events

Safety data were evaluated in this population. Trial data showed that injection-site reactions and mild headaches were the most frequently reported adverse events.

  • Specific Populations: Studies have investigated how severe liver issues may affect use of this medication, noting that potential systemic exposure could be altered. Research also examined the drug's profile in individuals over 65 years of age.
  • Adherence and Discontinuation: Reasons for discontinuing the study drug were tracked, including participant feedback on treatment response and occurrence of side effects.

Key Studies & References

  1. Dolocordralan Phase 3 Trial: Efficacy and Safety of Monotherapy in Disease X
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Frequently Asked Questions (FAQ)

Common questions about Dolocordralan (FAQ)


Q: How soon after taking Dolocordralan might I feel its effects?

Official information describing the drug's journey in the body indicates that for standard oral forms, the maximum concentration in the bloodstream is generally reached within 1.5 to 2 hours. Specialized formulations, such as those taken as a powder or by injection, are documented to reach this peak concentration faster. Individual response times may vary.


Q: How long does a dose of Dolocordralan stay active in the body?

Studies indicate the half-life of the active ingredient is approximately 1.5 to 2 hours, which is the time required for half the dose to be eliminated. The duration of pain relief from a single dose is typically described in official studies as being in the range of 4 to 6 hours. This duration is a factor in determining the dosing frequency described in prescribing information.


Q: Is Dolocordralan meant to be taken for a short time or long term?

Regulatory guidance consistently advises using the lowest effective dose for the shortest possible duration to mitigate potential risks. Although the medicine is approved for the management of chronic conditions, official documents emphasize that continued long-term use requires a periodic re-evaluation by a healthcare professional.


Q: What does the research say about how well Dolocordralan works?

Clinical studies have examined the drug’s effectiveness in treating conditions like osteoarthritis and rheumatoid arthritis. Researchers compared changes in standardized symptom severity scores between a group taking the drug and a group taking a placebo. The primary outcomes frequently report a statistical difference in the average symptom severity score change between the two groups.


Q: Where can I find the official regulatory information about Dolocordralan?

Authoritative information about the medicine is made available by government bodies. You can typically find detailed data in official documents such as the FDA's DailyMed, the European Medicines Agency (EMA) Summary of Product Characteristics (SmPC), or the patient leaflets published by regulatory bodies like the UK's MHRA.


Q: What is the mechanism of action of Dolocordralan in simple terms?

The drug is described in official documents as working mainly by blocking specific natural enzymes known as Cyclooxygenase (or COX) enzymes. By preventing these enzymes from working, the body produces fewer prostaglandins, which are the chemical substances responsible for initiating and driving pain and inflammation.


Q: What happens if I take too much Dolocordralan?

Taking more than the recommended amount is described in official documents as potentially causing symptoms that can include nausea, vomiting, stomach pain, drowsiness, and dizziness. A large overdose is officially noted as possibly leading to severe side effects such as seizures, confusion, or serious organ damage, including liver or kidney issues.


Q: What are the signs of a serious side effect from Dolocordralan?

Official patient guidance emphasizes that signs of serious side effects requiring urgent attention include chest pain, sudden weakness on one side of the body, or slurred speech (which may indicate a heart attack or stroke). Other signs include black or tarry stool (suggesting gastrointestinal bleeding) or yellowing of the skin or eyes (suggesting liver problems).


Q: Can Dolocordralan affect my sleep?

Official adverse event listings describe the potential for central nervous system effects, which can include symptoms such as drowsiness, fatigue, or difficulty sleeping (insomnia). Official guidance notes that if a person experiences side effects like dizziness or tiredness, performing tasks that require alertness, such as driving, may be impacted.


Q: Are there any long-term effects of taking Dolocordralan?

Regulatory documents state that the risk of serious side effects, such as cardiovascular thrombotic events (like heart attack or stroke) and severe gastrointestinal events, may increase with the duration of use and the dose. This is why the use of the drug should be limited to the shortest duration possible, as advised by regulatory agencies.


Q: Is it common to feel tired when starting Dolocordralan?

Regulatory data mentions both drowsiness and fatigue as potential side effects associated with the drug's use. These are listed as potential effects in the nervous system, but they are not listed as the most common side effects reported in all patient groups.


Q: Can I take Dolocordralan with common cold and flu medications?

Official warnings state that co-administration with other nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesic doses of aspirin is restricted due to an increased risk of serious adverse effects. Because many common cold and flu medications contain these ingredients, the official guidance states that product labels should be reviewed, as taking multiple nonsteroidal anti-inflammatory drugs (NSAIDs) concurrently is restricted.


Q: If I miss a dose of Dolocordralan, what is the general guidance?

General guidance provided in official documents often states that if a dose is missed, it should be taken 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. The guidance specified in official labeling is that the subsequent dose is generally not doubled.


Q: Why do some people say Dolocordralan didn't work for them?

Research suggests that the way individuals process and eliminate the active component, Diclofenac, can vary widely. This variation is often attributed to genetic differences in certain liver enzymes. This variability may be why the drug works well for some people, while others may not experience the expected therapeutic effect.


Q: Is there an age limit for starting Dolocordralan?

Official labeling generally specifies that the safety and effectiveness of many oral forms of the drug have not been established for children under 12 years of age. For older children, the use is typically restricted and depends on the specific formulation and the condition being managed.


Q: Are there ongoing clinical trials for new uses of Dolocordralan?

Government registries, such as ClinicalTrials.gov, list many active and ongoing studies examining the drug's use. This research includes looking into new formulations, different patient populations, or comparative studies against other treatments to expand the evidence base.


Q: Was Dolocordralan approved for its current use recently?

The primary active ingredient, Diclofenac, has been available and approved for use for many years. However, specific new formulations, unique delivery systems, or certain combination products may have received recent regulatory approval or an updated market status.


Q: Is Dolocordralan a controlled substance?

Regulatory scheduling documents, such as those from the US DEA, do not classify the active ingredient, Diclofenac, as a federally controlled substance. It is not listed in the Schedules I through V, meaning it is not designated as a drug with potential for physical dependence or misuse.


Q: Does Dolocordralan have the potential for dependence or misuse?

As the drug is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID) and is not designated as a controlled substance, official documents do not describe it as having the potential for physical dependence or misuse typically associated with scheduled medications.


Q: How is the effect of Dolocordralan measured in studies?

Clinical studies generally measure the drug’s effect using standardized clinical rating scales, such as validated pain intensity scales or functional status questionnaires. Primary outcomes often focus on the change in these numerical scores over a specified period when compared to a placebo or another active treatment.


Q: Does Dolocordralan require a prescription?

The prescription status varies by formulation and by country. Most oral forms (tablets, capsules) of the drug require a prescription. However, certain topical gels based on Diclofenac have been approved for non-prescription (over-the-counter or OTC) use in some countries for the temporary relief of arthritis pain.


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

Official labeling is clear that a known history of hypersensitivity or allergy to the active ingredient, Diclofenac, or any other nonsteroidal anti-inflammatory drug (NSAID) is a formal contraindication (a condition that prohibits use) for the medicine.


Q: Can Dolocordralan affect laboratory test results?

Regulatory documents indicate that due to the drug's actions on the body, it can influence laboratory test results related to kidney and liver function. Official practice often advises monitoring parameters like serum creatinine and liver enzymes with blood tests during treatment.


Q: Can Dolocordralan be taken on an empty stomach?

Regulatory information for immediate-release forms often notes that taking the drug with food may reduce the peak concentration reached in the blood and delay its effect. However, some regulatory bodies also advise taking it with food or milk to minimize potential gastrointestinal upset.


Q: Is there a generic version of Dolocordralan available?

Yes, the core active component is Diclofenac sodium, which is the generic name. After the patent protections for the branded product expire, many generic equivalents become available globally, manufactured by different pharmaceutical companies.


Q: Does Dolocordralan affect fertility?

Official information from regulatory bodies indicates that taking anti-inflammatory medicines, including this drug, for a long time or in high doses may affect ovulation in women. This effect is described as reversible upon stopping the medication.


Q: Does Dolocordralan cause headaches?

Official adverse event data collected during clinical trials shows that headache is listed as one of the most frequently reported adverse effects associated with the use of the drug. Severe or persistent headaches are often noted in official warnings, and specialized medical guidance is recommended in such instances.


Q: Is it normal to have mild stomach upset when starting this medication?

The drug is associated with potential gastrointestinal adverse effects because of how it works. Official documents list symptoms like nausea, vomiting, and diarrhea as common or occasional side effects that may occur when starting treatment.


Q: Are there specific patient groups where Dolocordralan is studied more?

Specific studies have been conducted to evaluate the drug's safety and effectiveness in particular patient groups. These commonly include older adults (the geriatric population) and individuals with impaired liver or kidney function, due to the need to assess differences in drug exposure and risk in these populations.


Q: When is Dolocordralan typically not prescribed?

Regulatory documents define conditions where the medicine is contraindicated (must not be prescribed). These include patients with severe heart failure, active gastrointestinal bleeding or ulceration, a history of allergy to NSAIDs, or for pain relief immediately following Coronary Artery Bypass Graft (CABG) surgery.


Q: Can I use natural supplements while taking Dolocordralan?

Official regulatory guidance describes that seeking specialized medical advice is necessary before combining the drug with any herbal remedies or supplements. This recommendation is due to the limited official data on how these products may interact with the medicine's active components.


Q: Are there restrictions on driving or operating machinery while on Dolocordralan?

Regulatory documents caution that if a person experiences side effects such as dizziness, vertigo, or drowsiness, they should not drive or operate machinery. The official product information specifies that these effects can impair the ability to perform skilled tasks.

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How should Dolocordralan be stored and disposed of?

Official Storage and Handling

Regulatory requirements mandate that Dolocordralan (Diclofenac sodium) be stored under controlled conditions to maintain product integrity and safety. The medicine must be kept at controlled room temperature, generally defined as below 25 C.

Key storage restrictions include the prohibition of freezing and avoidance of excessive heat, moisture, and direct light. The product must remain in its original container and be tightly closed when not in use. For safety, the medicine must be stored strictly out of the sight and reach of children.

Disposal of Unused Medicine

Expired or unused Dolocordralan must not be kept. Regulatory labeling instructs patients to consult a healthcare professional or pharmacist for guidance on proper disposal. The disposal of waste material must be conducted in accordance with local regulations.

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

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