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Majamil Prolongatum

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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 Majamil Prolongatum

Property Description
Active ingredient Diclofenac sodium
Form Prolonged-release tablet
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Sustained symptomatic relief of pain and inflammation
Origin Synthetic (Phenylacetic acid derivative)

What Type of Medicine is Majamil Prolongatum?

Majamil Prolongatum is a prescription-only medicinal product classified pharmacologically as a Non-Steroidal Anti-Inflammatory Drug (NSAID), whose active substance is Diclofenac sodium. This synthetic compound belongs to the phenylacetic acid chemical derivative family, a structural group distinct from other NSAIDs. It is designed for systemic use, meaning it acts internally throughout the body's systems rather than at a single local site. Diclofenac's mechanism as a potent Cyclooxygenase (COX) inhibitor is clinically recognized for reducing discomfort.

Majamil Prolongatum is specifically manufactured by Zakłady Farmaceutyczne POLPHARMA S.A., defining its authorized origin. As an NSAID, it functions as a combined analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) agent, primarily targeting symptoms that arise from inflammatory conditions.


What Does the “Prolongatum” Form Mean?

The designation "Prolongatum" means the medicine is manufactured as a specialized extended-release tablet—a film-coated, solid-dose pharmaceutical form intended for oral consumption. This engineering is a key differentiator from standard or immediate-release tablet forms.

The extended-release mechanism ensures the Diclofenac is released steadily and gradually into the bloodstream over an extended period. The goal of this sustained-release characteristic is to maintain a more consistent therapeutic level of the active substance in the body. This sustained action is the key benefit of the Prolongatum formulation, making it suitable for managing persistent inflammatory pain.


What is the General Purpose of This Diclofenac Tablet?

The general purpose of this specific Diclofenac tablet is to provide sustained symptomatic relief by reducing pain and controlling swelling associated with various inflammatory states, such as those affecting the musculoskeletal system. This benefit is achieved because the medicine’s active substance acts by inhibiting the production of prostaglandins, which are key chemical mediators responsible for signaling pain and initiating the inflammatory process. By interrupting this chemical cascade, the Diclofenac in Majamil Prolongatum offers a dual benefit: it helps block the perception of pain while simultaneously calming the underlying biological response of inflammation.

Regulatory References

  1. Diclofenac: MedlinePlus Drug Information
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What side effects are possible with Majamil Prolongatum?

Possible Side Effects and Safety Information

The safety profile of Majamil Prolongatum (Diclofenac prolonged-release) is documented based on authoritative regulatory data, classifying adverse reactions by frequency and the body system affected (System-Organ Class or SOC).

Frequency-Classified Adverse Reactions

Adverse reactions are grouped by how often they may occur:

  • Common (may affect up to 1 in 10 people): Gastrointestinal disturbances such as nausea, abdominal pain, and dyspepsia; headache; dizziness; and rash.
  • Uncommon (may affect up to 1 in 100 people): Cardiac events such as myocardial infarction, cardiac failure, and palpitations.
  • Rare (may affect up to 1 in 1,000 people): Gastrointestinal ulceration, bleeding, or perforation; hepatitis; and hypersensitivity reactions.
  • Very Rare (may affect up to 1 in 10,000 people): Severe reactions including Stevens-Johnson Syndrome (SJS), acute renal failure, and blood disorders like thrombocytopenia.

Serious Adverse Reactions and Safety Constraints

Serious Adverse Reactions highlighted in regulatory labeling include major cardiovascular thrombotic events (myocardial infarction, stroke) and serious gastrointestinal events (bleeding, ulceration, perforation), which can be fatal.

Population-Specific Safety Constraints exist:

  • Pregnancy: The medicine is contraindicated during the third trimester due to risks to the fetus.
  • Cardiovascular Disease: It is contraindicated in patients with established congestive heart failure (NYHA Class II–IV), ischaemic heart disease, or cerebrovascular disease.

Dose and Duration Patterns are critical: The risk of serious cardiovascular and gastrointestinal events increases with higher doses and longer duration of treatment. The lowest effective dose should be used for the shortest possible duration to minimize these documented risks.

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Overdose and Emergency Response

Majamil Prolongatum (Diclofenac sodium prolonged-release) overdose is characterized in official regulatory documents by specific clinical manifestations and severe systemic risks. Documented symptoms often affect the Central Nervous System, including headache, dizziness, drowsiness (somnolence), and tinnitus. Gastrointestinal distress is also commonly reported, presenting as abdominal pain, vomiting, diarrhea, and potential gastrointestinal bleeding.

Overdose can escalate to severe, life-threatening outcomes, such as seizures, coma, acute renal failure, and severe hypotension. Due to these risks, regulatory authorities explicitly mandate that immediate medical attention must be sought for any suspected overdose. Urgent medical help is required immediately if severe symptoms like loss of consciousness or signs of serious cardiovascular events are experienced.

Management is restricted to symptomatic and supportive treatment, as the official labeling states that no specific antidote is known or available for Diclofenac overdose. Due to the prolonged-release nature of the tablet, extended clinical monitoring may be required. Regulatory documents further note that individuals with pre-existing renal or hepatic impairment, as well as elderly patients, may be at an increased risk for more severe effects in an overdose situation.

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Therapeutic Uses of Majamil Prolongatum

Majamil Prolongatum (Diclofenac prolonged-release) is formulated to provide sustained symptomatic relief across therapeutic areas where symptoms related to physical discomfort and inflammation significantly interfere with daily functioning. The medication is considered relevant for managing a wide range of conditions marked by heightened symptoms.

The medicine is commonly used in conditions presenting with systemic or localized discomfort, including chronic inflammatory diseases like Rheumatoid Arthritis and Osteoarthritis, as well as acute episodes such as Acute Gouty Arthritis and pain following trauma or minor surgery. It helps address symptom clusters that may become intense or disruptive, such as joint pain, swelling, and stiffness.

It is applied in scenarios where additional management of discomfort is required, contributing to improved comfort during periods of heightened symptoms.

“This formulation assists with maintaining functional stability during episodes of heightened discomfort by providing supportive relief when symptoms interfere with routine activities across a range of musculoskeletal conditions.”

Quick Fact: Relief for Inflammatory Pain Majamil Prolongatum is often used when symptoms intensify and supportive relief is needed to manage persistent discomfort associated with chronic inflammatory processes.

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Eligibility and Restrictions for Use

Majamil Prolongatum (Diclofenac prolonged-release) is governed by official regulatory criteria that strictly define who is eligible to use the medicine and who is prohibited from use. These criteria are based on population-specific restrictions documented in government-approved labeling.

Eligibility Scope Regulatory Status
Contraindicated Populations Absolute Prohibition
Established heart failure (NYHA Class II–IV), ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease; Active gastrointestinal ulceration, bleeding, or perforation; Severe renal or hepatic failure; Known hypersensitivity to Diclofenac or other NSAIDs (e.g., aspirin); Third trimester of pregnancy; Perioperative pain for CABG surgery.
Age-Related Eligibility Restriction/Caution
The prolonged-release formulation is not suitable for children and adolescents under 14 years of age. Older adults (65 years and above) must use the medicine with particular caution due to increased susceptibility to adverse events.
Conditional Use Populations Caution Advised
Patients with mild to moderate renal or hepatic impairment require caution. Use is not recommended in the first and second trimesters of pregnancy. Those with cardiovascular risk factors (e.g., hypertension, diabetes) should only be treated after careful regulatory consideration.

Official regulatory documents strictly define eligibility by establishing formal contraindications for populations with severe pre-existing conditions, such as established heart disease and active gastrointestinal disease. Eligibility is also limited by age constraints, which deem the prolonged-release tablet unsuitable for those under 14, and by specific physiological states like the third trimester of pregnancy, where use is prohibited.

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What should I know about interactions with other medicines?

Majamil Prolongatum's active substance, Diclofenac sodium, has officially documented interaction patterns primarily involving pharmacodynamic effects and altered drug exposure. The regulatory profile notes several interactions that result from the medicine's effect on blood pressure, fluid balance, and hemostasis. Co-administration with anticoagulants, antiplatelets, SSRIs, or SNRIs carries an additive pharmacodynamic risk that increases the potential for bleeding, as stated in prescribing information. Furthermore, Diclofenac may diminish the antihypertensive or diuretic effects of medicines like ACE inhibitors, ARBs, and Furosemide.

The official documentation identifies Diclofenac as a substrate metabolized via the CYP2C9 enzyme pathway. This pharmacokinetic context means strong enzyme inhibitors, such as Voriconazole, can increase the systemic exposure of Diclofenac. Conversely, the medicine can reduce the renal clearance and increase the plasma concentrations of substances like Lithium and Methotrexate.

A crucial restriction is the contraindication for use in the treatment of perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery. Co-use with other systemic NSAIDs is not recommended due to increased gastrointestinal risk. Alcohol consumption is a documented factor that also increases the risk of serious gastrointestinal bleeding. Finally, the label notes that combining the medicine with food delays absorption and reduces the peak plasma concentration. Specific cautions apply to elderly patients, who face a greater risk of adverse events, and to patients with renal impairment taking ACE inhibitors or ARBs.

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Mechanism of Action

Majamil Prolongatum contains diclofenac, a non-steroidal anti-inflammatory drug (NSAID), which exerts its effects through several key mechanistic domains to modulate the physiological responses of eicosanoid pathways.


Inhibition of Prostaglandin Synthesis

Majamil Prolongatum acts primarily by inhibiting the enzyme cyclooxygenase (COX), which is essential for the biosynthesis of prostaglandins and other eicosanoid mediators. Prostaglandins are signaling molecules that play a central role in mediating physiological responses. By suppressing COX activity, the drug modifies these early molecular steps, leading to reduced production of key mediators that typically accelerate biochemical cascades.


Modulation of Inflammatory Cascades

The reduction in prostaglandin levels modifies the local and systemic signaling sequences. This action limits the impact of excessive mediator activity. This results in altered local signaling within the targeted pathways, contributing to the physiological effect of reduced local fluid accumulation and vasodilation.


Modulation of Nociceptive Signaling

By inhibiting the generation of pro-nociceptive mediators, the drug contributes to the modulation of nociceptive mediator activity. This influences the local biochemical state toward a lower response threshold in relevant afferent nerve pathways. The engagement of this mechanism leads to the physiological adjustment of modifying afferent nerve sensitization.

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Dosage and Administration Information

How to Use Majamil Prolongatum: Standard Administration Guidelines

Majamil Prolongatum is an oral medication defined by a structured, once-daily regimen. The instructions focus on the proper physical administration and the fixed dosing schedule.


Administration Scope

Instruction Detail
Route of administration For oral administration only.
Dosing schedule The standard adult dose is 100 mg once daily. The overall maximum total daily dose of Diclofenac from all formulations should not exceed 150 mg.
Timing in relation to meals To be taken preferably with or after food to mitigate potential gastrointestinal effects.
Preparation requirements The prolonged-release tablet must be swallowed whole with liquid.
Age-group rules The 100 mg prolonged-release tablet is not suitable for children (pediatric use). Use the lowest effective dosage in frail older adults.

Procedural and Duration Constraints

The usage protocol is guided by the design of the prolonged-release tablet and standard principles for this class of medication. The standard approach for Diclofenac is to use the lowest effective dose for the shortest duration consistent with symptomatic management.

Crucially, the prolonged-release tablet must not be crushed, split, chewed, or broken under any circumstances, as this action would destroy the extended-release formulation and compromise the scheduled delivery of the active substance. The standard frequency pattern is once daily, reflecting the sustained action of the “Prolongatum” form.

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Recent Clinical Evidence

Research evidence / Overview of studies for Majamil Prolongatum

The research base for Majamil Prolongatum (prolonged-release diclofenac) is built upon studies, including Randomized Controlled Trials (RCTs) and supporting Meta-analyses, that have explored symptom patterns in conditions linked to inflammatory states. This overview focuses strictly on the evidence structure and what research has been conducted, without providing any clinical recommendations or making claims of efficacy. The prolonged-release formulation has been studied in research scenarios observing outcomes related to physical discomfort over extended periods.


Evidence for Use in Osteoarthritis (OA)

The research exploring systemic diclofenac in conditions like osteoarthritis was observed in numerous controlled clinical trials. These studies, which include adults and older adults with OA, were used in research exploring how symptoms change over time. Outcomes related to physical discomfort that were monitored include pain intensity scores and measures of physical function.

Evidence for Use in Rheumatoid Arthritis (RA)

Research for conditions characterized by fluctuating manifestations, such as rheumatoid arthritis, has focused on systemic diclofenac in RCTs and Systematic Reviews. Studies monitored outcomes related to systemic or functional imbalance by tracking objective measures of disease activity, alongside patient-reported outcomes describing perceived discomfort. The evidence contributes to the broader evidence landscape.

Research on Acute Pain and Inflammation

The research exploring short-term symptom changes, such as those following trauma or minor surgical procedures, was studied in short-term RCTs. Researchers monitored measures such as the speed of pain relief and the need for additional pain management over very short follow-up durations. Research describes that the prolonged-release form was observed in some studies to have a slower rate of initial relief when compared to immediate-release formulations.

What Research Gaps and Uncertainty Remain

While research describes systemic diclofenac was studied for conditions linked to inflammatory states, specific research gaps exist for the prolonged-release formulation. Follow-up durations were limited in many of the head-to-head trials. There is limited information for long-term outcomes and functional improvement that is unique to this prolonged-release form. Evidence quality varies across studies, and comparative evidence against other available therapeutic options is often lacking, as much research relies on older trials and subsequent meta-analyses.

Key Studies & References

  1. Valdecoxib is as effective as diclofenac in the management of rheumatoid arthritis with a lower incidence of gastroduodenal ulcers: results of a 26-week trial
  2. Sustained-release diclofenac conjugated to hyaluronate (diclofenac etalhyaluronate) for knee osteoarthritis: a randomized phase 2 study
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Frequently Asked Questions (FAQ)

Common questions about Majamil Prolongatum (FAQ)

Q: What is the main difference between Majamil Prolongatum and regular Majamil?

Official product information states that Majamil Prolongatum is a prolonged-release tablet. This means the active substance, Diclofenac, is released steadily and gradually into the bloodstream over time. This sustained action differs from regular, immediate-release Diclofenac, which releases the full amount of the medicine right away.

Q: How quickly do people typically start to notice any effect from Majamil Prolongatum?

Due to its prolonged-release design, research indicates that the rate of initial relief may be slower compared to immediate-release formulations. Official documents note that the benefit of this form is maintaining a consistent therapeutic level over an extended period.

Q: Are there any long-term research studies available for Majamil Prolongatum?

Research supports the use of the active substance, Diclofenac, for chronic conditions like arthritis. Regulatory summaries note that while the active substance has been studied for chronic conditions, data regarding long-term outcomes and comparative evidence specific to the prolonged-release formulation may be limited.

Q: Is it true that Majamil Prolongatum should be avoided if someone has a history of stomach problems?

Regulatory documents state that use is prohibited (contraindicated) for individuals with active gastrointestinal ulceration, bleeding, or perforation. Caution is necessary if an individual has a prior history of these problems, as the official product information indicates an increased risk of serious adverse events.

Q: Is Majamil Prolongatum safe to use if someone has high blood pressure?

Official warnings indicate that the medicine has been associated with causing or worsening pre-existing high blood pressure, and it may affect the performance of certain antihypertensive medicines. For individuals with cardiovascular risk factors, caution is applied, and close monitoring of blood pressure is a common recommendation for healthcare providers.

Q: What is the purpose of the coating on the Majamil Prolongatum tablet?

The tablet is film-coated and must be swallowed whole to protect the extended-release formulation. The coating is a key part of the manufacturing design that ensures the scheduled and gradual delivery of the medicine into the body.

Q: Does Majamil Prolongatum interfere with laboratory tests other than liver function?

Official adverse reaction lists note changes to blood components, such as thrombocytopenia (low platelet counts) and leukopenia (low white blood cell counts), which are measurable through laboratory tests. Additionally, the medicine can affect the plasma concentrations of other substances, requiring laboratory monitoring.

Q: Is it normal to feel a bit tired when starting Majamil Prolongatum?

Official product information lists neurological side effects such as dizziness, somnolence (drowsiness), and fatigue in some patients. Official information advises that if somnolence or dizziness occurs, patients should use caution when performing activities that require concentration.

Q: What are the most common reasons someone might stop taking Majamil Prolongatum?

Official data indicates that common reasons for discontinuing this type of medicine in clinical studies are often related to gastrointestinal side effects, such as abdominal pain or nausea. Official warnings indicate that patients should seek immediate medical assistance and stop the drug if they experience signs of serious reactions like a severe skin rash or liver problem.

Q: Can Majamil Prolongatum cause changes in sleep patterns?

Regulatory adverse reaction lists include neurological disturbances that can affect sleep. These reported effects include insomnia (difficulty sleeping), nightmares, and somnolence (drowsiness).

Q: Is Majamil Prolongatum considered a controlled substance?

Majamil Prolongatum, which contains Diclofenac, is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). According to governmental scheduling acts, this medicine is not classified as a controlled substance.

Q: Are there specific food types that are known to interact with Majamil Prolongatum?

The official product label describes the use of the medicine as preferably taken with or after food. While no specific food types are strictly prohibited, official documents note that taking it with food will delay its absorption and reduce the peak concentration of the drug in the blood.

Q: Does Majamil Prolongatum interact with common over-the-counter cold medicines?

Official warnings note that Majamil Prolongatum is not recommended for concomitant use with other systemic NSAIDs. This is important because many common over-the-counter cold and flu products contain other NSAIDs, and using both increases the risk of serious gastrointestinal side effects.

Q: If a dose is missed, what is the general guidance in official prescribing information?

General guidance, consistent with patient information leaflets, suggests that if a dose is missed, it should be taken when remembered. If it is almost time for the next scheduled dose, the common guidance is that the missed dose should be omitted. Official patient information emphasizes that a double dose should not be taken to make up for a missed dose.

Q: What information is available regarding Majamil Prolongatum use and driving ability?

Official patient safety information indicates that if a person experiences side effects such as dizziness, drowsiness, or visual disturbances, the ability to operate machinery or drive a vehicle may be affected.

Q: Does official information list Majamil Prolongatum as potentially interacting with supplements like St. John's Wort?

While St. John's Wort may not be explicitly listed on all product information, Diclofenac is processed by a specific liver enzyme (CYP2C9) that can be affected by certain herbal remedies. Official information advises that all prescription and non-prescription supplements being taken should be communicated to a healthcare provider, as comprehensive testing for every combination is often unavailable.

Q: What is the risk of dependence or addiction associated with Majamil Prolongatum, according to official sources?

Official regulatory information classifies Majamil Prolongatum as a Non-Steroidal Anti-Inflammatory Drug (NSAID). As such, it is not associated with a risk of dependence or addiction.

Q: How long does Majamil Prolongatum stay in the system after the last dose?

Diclofenac has a short elimination half-life, meaning it is quickly processed by the body. The prolonged-release formulation, however, is designed to sustain therapeutic activity over a longer period. The drug’s effects are extended by the specific tablet design and the way the body processes the substance.

Q: Can Majamil Prolongatum cause skin sensitivity to sunlight?

Official adverse reaction lists report that side effects such as photosensitivity (increased sensitivity to sunlight) have been noted in post-marketing experience. When using this medicine, official information notes that protective measures against sun exposure may be appropriate due to the potential for photosensitivity.

Q: Is Majamil Prolongatum known to affect mood or anxiety levels?

Official documentation lists neurological side effects that include changes in mood and mental state. These reported adverse reactions include anxiety, irritability, and depression.

Q: What should be done if someone experiences a severe headache while taking Majamil Prolongatum?

While mild headache is a common side effect of this medicine, if a headache becomes severe or persistent, official guidance indicates that seeking medical assistance is important. A severe headache, especially if accompanied by other symptoms like stiff neck or fever, may be a sign of a rare but serious reaction.

Q: Are there any known interactions between Majamil Prolongatum and common vitamins (like Vitamin D or C)?

There is no specific regulatory guidance that lists interactions between Majamil Prolongatum and common vitamins, such as Vitamin C or D. Official information advises that all prescription medicines, over-the-counter products, and supplements being used should be communicated to a healthcare provider.

Q: Does Majamil Prolongatum have a boxed warning in official FDA/EMA materials?

Yes, regulatory information from the FDA assigns Diclofenac a Boxed Warning. This is the most serious type of warning and alerts users to the risk of major cardiovascular thrombotic events (like heart attack and stroke) and serious gastrointestinal adverse events (like bleeding or ulcers).

Q: Can Majamil Prolongatum be taken during a cold or flu?

As an NSAID, Majamil Prolongatum can provide relief for fever and pain associated with a cold or flu. However, it is essential to ensure that no other systemic NSAIDs are taken at the same time, as these are frequently ingredients in multi-symptom cold and flu preparations.

Q: Are there specific patient monitoring recommendations for people taking Majamil Prolongatum long-term?

For patients undergoing long-term treatment, or those with existing risk factors, official regulatory documents generally recommend periodic monitoring. This typically includes checking parameters such as blood pressure and the function of the kidneys and liver.

Q: Does Majamil Prolongatum have any known effects on fertility?

Official safety documents address the potential impact on female fertility. NSAIDs, including this medicine, are associated with a potential for reversible infertility because they may delay or prevent ovulation. Official information notes that patients planning a pregnancy are advised to discuss this potential effect with their healthcare provider.

Q: What happens if someone accidentally takes two tablets instead of one?

Accidentally taking more than the prescribed amount constitutes an overdose, as it exceeds the recommended total daily limit. Overdose symptoms can range from mild effects like vomiting to severe issues such as gastrointestinal bleeding or kidney problems. Official guidance indicates that in the event of a suspected overdose, immediate medical assistance is necessary.

Q: Is there a generic version of Majamil Prolongatum available?

The active ingredient, Diclofenac sodium, is a substance widely available in generic form. Generic versions of the prolonged-release formulation are available in many markets and can often be dispensed in place of the brand name product.

Q: Are weight changes listed as a possible side effect of Majamil Prolongatum?

The official product information mentions that Diclofenac is associated with fluid retention and oedema (swelling). This fluid retention may be reflected as a change on the scale. Weight loss has been reported rarely in some post-marketing data.

Q: What information is provided about Majamil Prolongatum and breastfeeding?

Official regulatory data indicates that Diclofenac passes into breast milk in small amounts. Official information indicates that its use during breastfeeding requires careful consideration by a healthcare professional, particularly when treating a newborn or premature infant.

Q: Can Majamil Prolongatum cause temporary vision changes?

Official adverse reaction reports include visual disturbances, such as blurred vision or double vision (diplopia). These visual changes are generally reversible once the medicine is discontinued.

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How should Majamil Prolongatum be stored and disposed of?

How to Store and Dispose of Majamil Prolongatum?

The storage and disposal of Majamil Prolongatum (Diclofenac prolonged-release tablets) must follow official regulatory guidelines to maintain product integrity.

Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, typically not above 25°C (77°F).
Protection Keep in the original container to protect from light and moisture.
Safety Store the medicine out of the sight and reach of children.

Disposal Instructions

To prevent environmental contamination, unused or expired tablets must not be disposed of via wastewater or household garbage. Official procedures require returning the product to a pharmacist for safe disposal in accordance with local pharmaceutical waste regulations.

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

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