Diclac Hexal

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Diclac Hexal

Diclac Hexal is a medication manufactured by Hexal AG whose fundamental identity is defined by its active ingredient, Diclofenac, and its classification within a core group of pain and inflammation relievers.

Property Description
Active ingredient Diclofenac (as sodium or potassium salt)
Form Systemic (tablets, capsules) and Topical (gel, emulsion, plaster)
Pharmacological class Non-steroidal anti-inflammatory drug (NSAID)
Common purpose Symptomatic relief of pain and inflammation
Origin Synthetic phenylacetic acid derivative

What Type of Medicine is Diclac Hexal? (Identity and Classification)

Diclac Hexal is a specific brand of medication classified as a Non-steroidal anti-inflammatory drug (NSAID), whose primary function is to relieve discomfort and swelling. Its active component, Diclofenac, is a synthetic compound derived chemically from phenylacetic acid. The preparation is a single-active-ingredient product, focusing its therapeutic action entirely on Diclofenac.


Available Forms and Core Composition (Form and Components)

Diclac Hexal is manufactured in various pharmaceutical preparations, enabling both systemic and topical routes of administration, often distinguished by their strength and intended route. These forms include film-coated tablets and prolonged-release capsules for internal use, alongside external preparations like gels and emulsions. Diclofenac penetrates the skin when applied topically to localize its action in underlying tissues, which allows for targeted symptomatic relief. The core composition utilizes the Diclofenac salt combined with necessary bases or vehicles (excipients) to ensure effective delivery for the specific dosage form.


The General Purpose of Diclac Hexal (High-Level Benefit)

The general purpose of Diclac Hexal is to provide symptomatic relief by interrupting the body's pain and inflammation pathways. It works conceptually by limiting the production of prostaglandins, which are the chemical messengers responsible for triggering pain, swelling, and fever. By targeting this foundational biological mechanism—the inhibition of prostaglandin synthesis—the preparation's core benefit is the reduction of discomfort and inflammation.

Regulatory References

  1. WHO Model List of Essential Medicines

What side effects are possible with Diclac Hexal?

Safety Profile and Potential Side Effects

Diclac Hexal, which contains the active substance diclofenac, is a Non-Steroidal Anti-Inflammatory Drug (NSAID) and is associated with known class effects, including risks of serious cardiovascular and gastrointestinal adverse events. The risk of these serious events, such as myocardial infarction (heart attack), stroke, or gastrointestinal bleeding, ulceration, and perforation, is dose- and duration-dependent. Therefore, the lowest effective dose for the shortest duration of treatment should be used.


Clinically Significant Adverse Reactions

  • Cardiovascular Thrombotic Events: Increased risk of serious, potentially fatal, cardiovascular thrombotic events, including heart attack and stroke. It is contraindicated in patients with established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, or congestive heart failure (NYHA Class II–IV), and immediately following Coronary Artery Bypass Graft (CABG) surgery.
  • Gastrointestinal Events: Serious GI adverse reactions can occur without warning symptoms. The risk of upper GI ulcers, gross bleeding, or perforation is approximately 1% in long-term users. This risk is increased by concurrent use of other NSAIDs, including aspirin, and in elderly patients.
  • Hepatotoxicity: Liver injury (hepatotoxicity) may occur in rare cases. Patients should be monitored for signs of liver dysfunction.
  • Hypersensitivity: Serious allergic reactions, including anaphylaxis and severe skin reactions, have been reported and necessitate immediate discontinuation.

Frequency Classification

Adverse reactions are classified by frequency, with Gastrointestinal disorders (such as nausea, vomiting, dyspepsia, and abdominal pain) and Nervous system disorders (such as headache and dizziness) being among the most common reported events. Serious and clinically significant reactions, such as severe heart failure or serious GI perforation, are generally classified as rare or very rare.

Population-Specific Safety Notes

The use of diclofenac is generally contraindicated during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Use is generally avoided in the first and second trimesters unless essential. Elderly patients are at an increased risk for serious adverse events, particularly GI bleeding and cardiorenal effects.

Overdose and Emergency Response

Overdose and When to Seek Help

An overdose of Diclac Hexal, which contains Diclofenac, requires immediate medical attention. The profile of an overdose is strictly defined by regulatory authorities and focuses on critical systemic manifestations and mandatory emergency response actions.

Documented Manifestations and Severe Outcomes

Officially documented signs of an overdose commonly include gastrointestinal effects such as nausea, vomiting, stomach pain, and diarrhea. Central nervous system (CNS) manifestations like dizziness, headache, agitation, confusion, and tinnitus are also noted. A large overdose carries the risk of severe, life-threatening outcomes, including gastrointestinal bleeding or perforation, acute renal toxicity leading to little or no urine output, and severe CNS depression which may escalate to seizures or coma. The regulatory information notes that elderly patients face a greater risk of serious gastrointestinal complications in overdose scenarios. Since no specific antidote is known, treatment is entirely supportive and symptomatic, with procedures like activated charcoal administration and continuous monitoring of vital signs being required.

Mandatory Emergency Action

For any suspected overdose, authorities mandate that individuals seek medical help right away. This includes contacting the local emergency services or a Poison Control Center immediately for guidance. Emergency assistance must be secured without delay if severe reactions, such as an anaphylactic reaction, are observed.

Therapeutic Uses of Diclac Hexal

What Diclac Hexal Treats: Main Uses and Benefits

Symptomatic Support for Inflammatory and Pain Conditions

The therapeutic benefit of Diclac Hexal is generally aligned with its classification as an NSAID, which is applied in clinical settings that involve acute or disruptive symptom patterns. The core application of this medication is commonly used to help with a cluster of symptoms associated with various inflammatory and pain-related conditions.

This medication is relevant for easing groups of symptoms that may intensify over time, providing support across conditions presenting with chronic, acute, or recurrent manifestations. Indications for which supportive symptom management is appropriate commonly include osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute gout flares, soft tissue injuries like sprains and strains, primary dysmenorrhoea, and the acute pain phase of a migraine attack. This pharmacological support contributes to improved comfort during periods of heightened symptoms and may assist with maintaining a sense of functional stability.

“The role of this medication is to help moderate distressing pain and stiffness, supporting the patient during difficult episodes by easing distress.”

Targeted Relief in Specific Clinical Contexts

Diclac Hexal is applied in scenarios where additional management of discomfort is required, whether to address persistent joint pain and stiffness associated with chronic disease, or to manage the localized swelling and pain that follow acute post-traumatic injury or minor surgical procedures. The preparation is relevant for easing the overall symptom burden, particularly when symptoms create noticeable physiological strain and interfere with routine activities.

Quick Fact: Relief for Pain and Stiffness
Diclac Hexal is commonly used to address symptoms related to inflammatory or irritative states, which often cluster into patterns of pain and functional limitation.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Official Eligibility and Non-Eligibility Status

Regulatory documents strictly define the populations permitted to use diclofenac, the active ingredient in Diclac Hexal, as well as those who are contraindicated.

Classification Population/Condition
Contraindicated History of asthma, urticaria, or allergic reactions to aspirin or other NSAIDs (Non-Steroidal Anti-inflammatory Drugs) [1.1, 1.3].
Contraindicated Patients with active gastrointestinal ulceration, bleeding, or perforation [1.1].
Contraindicated Established severe renal or hepatic failure [1.1].
Contraindicated Established congestive heart failure (NYHA II–IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease [1.8, 1.9].
Contraindicated Third trimester of pregnancy (starting at 30 weeks gestation) [1.1, 2.7].
Restricted Use Elderly patients (65+) and those with mild to moderate organ impairment must be treated with caution and close medical surveillance [1.1, 1.2].
Restricted Use Patients with high cardiovascular risk factors (e.g., hypertension, diabetes) should only use the medicine after careful consideration and at the lowest effective dose for the shortest possible duration [1.9].
Age Rule Systemic tablets are generally not recommended for children and adolescents below 14 years of age [1.1].
Special Status Not recommended for women who are actively trying to conceive due to the association with reversible infertility [1.6, 2.2].

These official regulatory constraints determine eligibility based on pre-existing conditions and physiological status, ensuring the medicine is used only by approved populations.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Official regulatory documents require careful consideration of co-administration with several medicinal product categories due to potential clinically significant interactions.

Documented Interacting Categories

Category Specific Agents/Classes Interaction Constraint
Other NSAIDs Other Non-Steroidal Anti-Inflammatory Drugs, including Aspirin Avoid co-administration due to increased risk of serious gastrointestinal adverse events.
Anticoagulants Warfarin, antiplatelet drugs, SSRIs, SNRIs Increased risk of bleeding or hemorrhage; requires close monitoring.
Antihypertensives ACE Inhibitors, ARBs, Beta-blockers, Diuretics May diminish the therapeutic blood pressure-lowering or diuretic effects; renal function monitoring is critical, especially in the elderly or volume-depleted patients.
Immunosuppressants Cyclosporine, Methotrexate Increased risk of specific organ toxicities (e.g., nephrotoxicity for Cyclosporine).
Metabolic Inhibitors Strong CYP2C9 Inhibitors (e.g., Voriconazole) Significantly increases the systemic exposure ( C max and AUC) of the drug; may require dosage adjustment or special monitoring.

Interaction Profile Summary

The official interaction profile is structured around two key areas: pharmacokinetic and pharmacodynamic interactions. Pharmacodynamic interactions with anticoagulants and other NSAIDs lead to the primary restrictions concerning an increased risk of bleeding and gastrointestinal toxicity. Pharmacokinetic interactions, such as those with CYP2C9 inhibitors, necessitate monitoring for increased drug exposure. Additionally, co-administration with antihypertensives is documented to risk diminishing the effects of these agents and may precipitate a decline in renal function, particularly in vulnerable populations.

Mechanism of Action

Diclac Hexal exerts its effect through the inhibition of enzyme activity, primarily targeting the arachidonic acid cascade.

Inhibition of Cyclooxygenase (COX) Activity

Diclac Hexal acts as an inhibitor of the Cyclooxygenase (COX-1 and COX-2) enzymes. These enzymes catalyze the conversion of arachidonic acid into various prostaglandins. This mechanism modifies molecular steps that shape systemic physiological outcomes, resulting in decreased concentrations of inflammatory mediators at local sites.

Modulation of Prostaglandin-Mediated Signaling Pathways

By limiting prostaglandin production, diclofenac suppresses signaling sequences associated with nociception and inflammatory vascular changes in peripheral tissues. This action decreases the intensity of local vascular permeability (vasodilation) and the sensitization of nociceptors (pain receptors).

Consequence for Thermal Regulation and Nociception

The inhibitory mechanism affects systems where prostaglandin E2 ( PGE2) dominates, including signaling in the hypothalamus (the body's thermal regulatory center). This inhibitory action prevents the prostaglandin-mediated upward shift of the thermal set point. The net physiological result is a lowering of body temperature (antipyresis) and an increase in the sensitivity threshold of nociceptive pathways (analgesia).

Dosage and Administration Information

How Diclac Hexal is Used: Official Administration Guidelines

The usage of Diclac Hexal, which contains the active ingredient Diclofenac, follows established medical standards to ensure proper administration. This medicine is available for oral (tablets/capsules), topical (gel/solution), and parenteral (Intramuscular/Intravenous) routes, with specific instructions governing each method.


Official Dosing and Frequency

Administration Route Standard Adult Dose Range Frequency Key Instructions
Oral (Immediate-Release) Typically 50 mg to 100 mg daily. Two to three times daily. Take tablets whole; may be taken before meals for best absorption.
Oral (Prolonged-Release) Up to 100 mg once daily. Once daily. Must be swallowed whole and not crushed or chewed.
Topical Gel (e.g., 1%) Measured dose (e.g., 2g to 4g per joint). Four times daily. Apply only to clean, intact skin; wash hands after application unless hands are the treatment site.
Parenteral (IM/IV) 75 mg per administration. Up to twice daily; maximum of 150 mg in 24 hours. Use is generally limited to a maximum of two days before switching to an oral form.

Use Protocol and Special Populations

A primary principle of use is to use the lowest effective dosage for the shortest possible duration necessary to manage symptoms.

For older adults, the standard practice is to initiate treatment at the lowest end of the effective dose range. Dose adjustments are not typically necessary for patients with mild-to-moderate renal or hepatic impairment, though use is generally contraindicated in severe organ failure. The injectable form is generally not recommended for use in children.

Recent Clinical Evidence

Overview of Key Studies

Clinical trials involving diclofenac, the active substance in Diclac Hexal, have consistently focused on its use for pain and inflammation. Research has primarily evaluated its role in adults diagnosed with chronic conditions like osteoarthritis (OA) and rheumatoid arthritis (RA), as well as in acute soft tissue injuries such as sprains. The trials generally use randomized, placebo-controlled designs, with outcomes typically measured using validated tools like the Visual Analogue Scale (VAS) for pain and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for function.


Specific Findings

Pain and Functional Outcomes

In placebo-controlled trials for knee and hip osteoarthritis, findings reported a lower average pain score and improved physical function in the groups receiving diclofenac compared to those receiving placebo over several weeks. For acute injuries, such as ankle sprains, research reported a reduction in pain on movement (POM) in subjects using the topical formulation.

It is important to note that many studies in chronic pain also report a significant placebo effect, meaning a number of participants experience reduced pain even without the active drug. Comparisons to other existing therapies were not the primary focus of all individual trials.

Safety and Tolerability

Studies investigating the safety profile of topical diclofenac formulations generally reported a low incidence of systemic adverse events (AEs), such as gastrointestinal discomfort, compared to oral NSAIDs. The most frequently reported adverse events across trials with topical diclofenac were mild local skin reactions, such as irritation or itching, which were typically self-resolving. Researchers evaluated the occurrence of serious AEs across all studies, and no definitive conclusions about the long-term safety profile have been established from the available evidence in all populations.


Pharmacological Studies

Research has explored the drug's hypothesized mechanism: as a non-steroidal anti-inflammatory drug (NSAID), it is thought to work by interfering with the synthesis of pro-inflammatory mediators. Pharmacokinetic studies using topical formulations have explored how the drug is absorbed through the skin, indicating that it is detectable in the underlying tissue, such as the synovial fluid and synovial tissue of affected joints, which aligns with its intended site of action.

Key Studies & References Osteoarthritis: care and management (NICE Clinical Guideline CG177)

Frequently Asked Questions (FAQ)

Common questions about Diclac Hexal (FAQ)

Q: How quickly do the effects of Diclac Hexal typically start?

Official product information on the active ingredient, diclofenac, indicates that for oral forms, peak levels in the bloodstream are often reached within one to four hours. The medicine is known to accumulate in the synovial fluid (the lubricating fluid in joints), and this accumulation may prolong the therapeutic effect in the joints.

Q: How long does one application of Diclac Hexal usually last?

Studies of diclofenac's behavior in the body show that its time in the bloodstream is generally short, typically only a couple of hours. However, the medicine is known to accumulate in tissues around the joints, such as the synovial fluid. This localized concentration is thought to allow the pain-relieving effects to be maintained beyond its rapid elimination from the blood.

Q: Do you need a prescription to get Diclac Hexal?

The need for a prescription depends on the specific formulation and the country's regulatory policies. Oral diclofenac is often restricted to prescription-only status in many regions due to cardiovascular risk factors. In contrast, certain low-strength topical (applied to the skin) forms of diclofenac are commonly approved for purchase over-the-counter (OTC).

Q: How long can Diclac Hexal be used before seeing a healthcare provider?

Official guidelines for over-the-counter (OTC) topical diclofenac typically suggest limiting continuous use for pain relief to a short period, such as up to seven days. If the condition persists or symptoms worsen after this period of self-treatment, the continuation of use beyond that period is subject to re-evaluation by a healthcare professional.

Q: Can Diclac Hexal affect my ability to drive?

Prescribing information for the systemic forms of this medicine cautions that side effects like dizziness, blurred vision, or somnolence (drowsiness) may occur. Regulatory documentation includes a warning against activities requiring alertness, such as driving or operating heavy machinery, if these effects are experienced.

Q: What should I do if I accidentally swallow Diclac Hexal gel?

Accidental ingestion of the topical gel is a circumstance where seeking immediate medical assistance is documented as necessary. Although the amount absorbed systemically from topical application is generally low, the documented standard approach for non-steroidal anti-inflammatory drug (NSAID) poisoning involves supportive and symptomatic treatment.

Q: Can I use other topical products on the same area as Diclac Hexal?

Patient information generally advises against applying other products, such as cosmetics, sunscreens, or lotions, to the same area treated with Diclac Hexal. Applying other products before the medicine has fully dried could potentially alter its absorption into the skin.

Q: Does alcohol consumption affect how Diclac Hexal works?

For the oral forms of this medicine, there is an increased risk of gastrointestinal side effects, including bleeding. Official warnings for systemic Non-Steroidal Anti-inflammatory Drugs (NSAIDs) generally caution that alcohol consumption can exacerbate or increase this risk.

Q: How long does Diclac Hexal stay in your system after stopping use?

Pharmacokinetic data shows that the active substance, diclofenac, has a short elimination half-life of approximately one to two hours from the plasma for systemic forms. The drug is largely excreted through the urine and bile. Based on this, complete systemic clearance is typically expected to occur within one or two days after stopping treatment.

Q: Are there warnings about sun exposure while using Diclac Hexal?

Official warnings exist, particularly for certain topical formulations, regarding the risk of photosensitivity, which is an increased sensitivity to light. The warning specifies avoidance of direct sunlight and sunbeds on the treated area. The documentation notes the need for protective clothing to minimize the risk of sun-related skin reactions.

Q: Are there any specific packaging or dispensing types for Diclac Hexal?

The packaging type depends on the pharmaceutical form of the medicine. For instance, topical gels are typically dispensed in tubes, while tablets are often packaged in blister packs or bottles. The specific container materials and sizes used for dispensing the product are formally detailed in the official regulatory product information.

Q: Is Diclac Hexal addictive?

The active substance in Diclac Hexal is diclofenac, which is a Non-Steroidal Anti-inflammatory Drug (NSAID) and not an opioid. Official documentation does not associate this class of medication with the known risks of physical dependence or addiction that are related to opioid pain relievers.

Q: What if Diclac Hexal doesn't seem to be working?

Regulatory guidelines stress the importance of using the lowest effective dose for the shortest period required to relieve symptoms. If the expected symptomatic relief is not achieved, official advice specifies that the patient’s response to the medicine and continuation of treatment are subject to re-evaluation by a healthcare professional.

Q: Is Diclac Hexal used globally?

Yes, the active ingredient in Diclac Hexal, diclofenac, is recognized and regulated by multiple major international health authorities, including the FDA, EMA, MHRA, and others. This widespread regulation confirms that it is a commonly used medication internationally.

How should Diclac Hexal be stored and disposed of?

How to Store and Dispose of Diclac Hexal

Official regulatory documents define strict conditions for storing Diclac Hexal (Diclofenac) to maintain its stability. The medicine must generally be stored below 25 C or 30 C and should be protected from light. To ensure safety, it must be kept out of the sight and reach of children and maintained in its original container until the expiry date.

Disposal Requirements

Unused or expired Diclac Hexal must not be thrown away via wastewater or household waste. This regulation is in place because the product poses a risk to the aquatic environment. Patients are directed to follow local requirements and consult a pharmacist regarding proper disposal methods for medicinal waste.

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

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