Dolonil SR

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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

Overview of Dolonil SR

Property Description
Active Ingredient Diclofenac (typically Diclofenac Sodium)
Form Sustained-Release (SR) Oral Tablet
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common Use Reduction of pain and inflammation
Origin Synthetic Phenylacetic Acid derivative

Defining Dolonil SR: Class, Composition, and Origin

Dolonil SR is a specific prescription-only brand name for a medication classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID). Its sole active substance is Diclofenac, which is a synthetic Phenylacetic Acid derivative. This chemical structure is noted for its analgesic and anti-inflammatory properties, a fundamental characteristic of the drug. Dolonil SR’s composition, as a single-ingredient NSAID, is designed to provide relief by targeting both the sensation of pain and the underlying biological process of inflammation.

The Unique Identity of Sustained-Release (SR) Tablets

The designation “SR” in Dolonil SR denotes a Sustained-Release (Extended-Release) formulation, which is a key differentiating feature from standard, immediate-release Diclofenac oral tablets. This particular oral tablet design uses specialized pharmaceutical technology to ensure the Diclofenac active ingredient is released slowly and consistently over a prolonged duration after the tablet is taken orally. This long-acting preparation is intended to maintain stable drug concentrations for conditions requiring consistent symptom management. The formulation aims to simplify the regimen compared to forms with shorter durations of action.

General Purpose: Anti-Inflammatory and Analgesic Action

The primary purpose of Dolonil SR is to offer relief from both discomfort and associated inflammation. Diclofenac accomplishes this by acting as a Cyclooxygenase Inhibitor, which means it blocks the internal production of chemical mediators, chiefly Prostaglandins. Since Prostaglandins are mediators of the inflammatory and pain response, reducing their synthesis leads to the lessening of swelling, tenderness, and discomfort. The drug's dual anti-inflammatory and analgesic effects make it an option for managing symptoms where both components are present.

Regulatory References

  1. MedlinePlus

What side effects are possible with Dolonil SR?

Possible Side Effects and Safety Information

Dolonil SR, an extended-release opioid analgesic, carries serious and life-threatening risks as highlighted in official regulatory warnings. These risks primarily involve addiction, abuse, and misuse, which can lead to overdose and death. Furthermore, the potential for serious, life-threatening, or fatal respiratory depression requires close monitoring, especially when initiating treatment or increasing the dose.

Common and Serious Adverse Reactions

The most commonly reported adverse reactions from clinical trials (incidence ge 10%) are generally gastrointestinal and central nervous system (CNS) related. These include nausea, constipation, dizziness/vertigo, headache, and somnolence. Other reported effects include vomiting, pruritus, dry mouth, and sweating.

Serious Adverse Reactions documented in official labeling include:

  • Serotonin Syndrome: A potentially life-threatening condition that may occur when Dolonil SR is used alone or concomitantly with other serotonergic drugs.
  • Seizures: Can occur even within the recommended dosage range, with risk increasing at higher doses or with certain drug combinations.
  • Severe Hypotension and Anaphylaxis and other serious hypersensitivity reactions.
  • Adrenal Insufficiency.

Safety Restrictions and Special Populations

Dolonil SR is contraindicated in several situations, including patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting, acute intoxication with alcohol or other CNS depressants, and use with Monoamine Oxidase Inhibitors (MAOIs).

Population-Specific Warnings:

  • Pediatric Use: The drug is contraindicated in children younger than 12 years of age and in children younger than 18 years following tonsillectomy and/or adenoidectomy due to the risk of life-threatening respiratory depression.
  • Pregnancy: Prolonged use during pregnancy can result in Neonatal Opioid Withdrawal Syndrome (NOWS) in the newborn.
  • Elderly or Debilitated Patients: Require close monitoring due to an increased risk of respiratory depression.

Accidental ingestion, especially by children, can result in a fatal overdose, necessitating secure storage and disposal of the medication.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

A suspected overdose of Dolonil SR (Diclofenac) requires immediate medical attention. Overdose manifestations are officially documented by regulatory authorities, affecting multiple physiological systems. Documented clinical signs often include gastrointestinal disturbances such as nausea, vomiting, abdominal pain, and potential gastrointestinal bleeding. Central nervous system (CNS) effects may present as drowsiness, dizziness, headache, or confusion. Overdose is classified as potentially severe or life-threatening due to the documented risk of major systemic complications.

Regulatory labeling explicitly lists severe outcomes such as seizures/convulsions, coma, and acute renal failure, which necessitate urgent medical intervention. Elderly patients are noted in official prescribing information as being at greater risk for serious gastrointestinal events following an overdose.

Required Emergency Actions

Immediate medical help must be sought for any suspected overdose. Emergency services should be contacted for life-threatening symptoms, particularly if signs of severe internal bleeding, seizures, or loss of consciousness occur. Management is strictly symptomatic and supportive, as official labeling states that no specific antidote is known for Diclofenac. Procedures described in official guidance include administering activated charcoal to reduce absorption and continuous hospital monitoring of vital signs and renal function.

Therapeutic Uses of Dolonil SR

What Dolonil SR Treats: Main Uses and Benefits

Dolonil SR is used across therapeutic domains involving chronic pain and inflammation. It is considered relevant for easing symptoms associated with conditions like Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis, which are characterized by persistent discomfort and stiffness. The sustained-release design may support a sustained effort in easing symptomatic discomfort throughout the day, which contributes to improved comfort during periods of heightened symptoms.

The medication is also used to help control symptoms during acute, short-term episodes like soft-tissue injuries (e.g., sprains, strains), pain following minor surgical procedures, and instances of pronounced, episodic symptoms such as primary dysmenorrhea (menstrual pain). In these scenarios, it is applied to offer supportive relief for symptom clusters that may become intense or disruptive. It is relevant for managing symptoms that interfere with daily comfort and may assist patients with coping more steadily with symptom fluctuations.

“The medication is relevant in contexts involving heightened systemic burden and helps manage symptoms that interfere with daily comfort.”


Quick Fact: Relief for Joint Pain The extended-release formulation is considered relevant in managing chronic conditions where supportive management of inflammatory or irritative states and symptoms that interfere with daily functioning is appropriate.

Eligibility and Restrictions for Use

Who Can and Cannot Use Dolonil SR?

The eligibility for using Dolonil SR (Diclofenac Sustained-Release tablets) is strictly defined by official regulatory labeling to ensure patient safety. This is a prescription-only medication primarily approved for use in Adults (18 and older).


Populations That Must Not Use Dolonil SR (Contraindications)

Dolonil SR is absolutely contraindicated in patients with:

  • A documented history of asthma, urticaria, or allergic reactions caused by aspirin or any other NSAID.
  • An active gastric or intestinal ulcer, bleeding, or perforation.
  • Severe heart failure (NYHA Class II-IV), established ischaemic heart disease, or cerebrovascular disease.
  • Severe hepatic (liver) or renal (kidney) failure.
  • The third trimester of pregnancy.
  • The setting of peri-operative pain for Coronary Artery Bypass Graft (CABG) surgery.

Eligibility Restrictions and Limitations

  • Pediatric Use: The sustained-release formulation is not recommended for children and adolescents under 18 years of age as safety and efficacy have not been established.
  • Conditional Use: Patients with a history of GI disease, mild to moderate organ impairment, or cardiovascular risk factors (e.g., hypertension) require close medical surveillance and careful assessment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Dolonil SR (tramadol) has documented interactions that primarily relate to central nervous system effects and drug metabolism.

Contraindicated and High-Risk Combinations

Official regulatory information strictly forbids the co-administration of Dolonil SR with Monoamine Oxidase Inhibitors (MAOIs), or within 14 days of stopping them, due to the risk of severe Serotonin Syndrome. Use with any other tramadol-containing products is also contraindicated.

Pharmacodynamic Interactions

Concomitant use with other CNS Depressants, including alcohol, sedatives, hypnotics, and tranquilizers, significantly increases the risk of profound sedation, respiratory depression, coma, and death, as listed in the drug labeling. Combining Dolonil SR with Serotonergic Drugs (e.g., SSRIs, SNRIs, triptans) increases the potential for Serotonin Syndrome.

Pharmacokinetic and Exposure Interactions

Dolonil SR is metabolized by CYP450 enzymes, primarily CYP2D6 and CYP3A4. Inhibitors of these enzymes, such as ketoconazole or fluoxetine, can increase tramadol plasma concentrations and the risk of adverse reactions. Conversely, inducers like Carbamazepine or Rifampin can decrease tramadol concentrations, potentially reducing its effectiveness. Ondansetron has also been documented to reduce the analgesic effect.

Mechanism of Action

Dual Mechanism: Opioid Receptor Activation and Neurotransmitter Reuptake Inhibition

The drug acts through a synchronized, two-part mechanism within the central nervous system. The compound, via its primary active metabolite O-desmethyltramadol (M1), functions as an agonist at the mu-Opioid Receptors (mu-OR). This activation directly reduces the electrical signaling capacity of nerve cells by modulating ion channel conductance. Simultaneously, the parent compound inhibits the reabsorption of the neurotransmitters Norepinephrine (NE) and Serotonin (5-HT) by blocking their respective transport proteins (NET and SERT). This increases their available concentration, resulting in heightened activity within the descending inhibitory pathways. The full effect is contingent upon the drug's conversion by the CYP2D6 enzyme into the high-affinity M1 metabolite. The integrated physiological consequence is a reduction in signal transmission, achieved by both direct receptor activation and modulation of internal inhibitory pathways, leading to an alteration of nociceptive signal processing in the central nervous system.

Dosage and Administration Information

How to Use Dolonil SR

This section outlines the administration and dosing guidelines for Diclofenac Sustained-Release (SR) tablets.


Administration Protocol

Instruction Guideline
Route of Administration The sustained-release tablet is for oral use only.
Dosing Schedule The standard regimen is typically 100 mg taken once daily. The maximum daily dosage of Diclofenac from all sources should not exceed 150 mg.
Timing and Preparation Tablets should be swallowed whole with liquid, and it is advised to take them with or immediately after food to aid tolerability.
Special Handling The prolonged-release tablet must not be crushed, broken, or chewed.

Usage Duration and Population Considerations

General prescribing principles suggest that Diclofenac therapy be maintained at the lowest effective dose for the shortest duration necessary to address symptoms. Therapy effectiveness should be periodically re-evaluated. For older adults, the use of the lowest possible dose is recommended. Diclofenac prolonged-release tablets are not generally recommended for use in children, as dosage guidelines for this population have not been established. If a dose is missed, it should be taken when remembered unless it is nearly time for the subsequent dose, in which case the missed dose is skipped; a double dose must never be taken.

Recent Clinical Evidence

The research base for sustained-release systemic diclofenac has primarily focused on chronic conditions marked by functional limitations, such as Osteoarthritis (OA) and Rheumatoid Arthritis (RA). Core evidence relies on randomized controlled trials (RCTs) and systematic reviews, which typically monitor patient-reported outcomes related to physical discomfort, stiffness, and daily functioning over intermediate periods, usually several weeks to six months. Findings describe patterns observed in these studies, often in comparison to a neutral substance or another intervention. It is not yet clear whether the specific sustained-release formula provides findings distinct from other diclofenac forms across all research.

Research has also explored short-term symptom changes relevant in trials assessing episodic symptom patterns, such as pain following minor surgical procedures or primary dysmenorrhoea. These single-dose RCTs focus on measuring the magnitude of change in pain measurements over hours and the need for rescue medication. However, the evidence for the sustained-release (SR) formulation in acute, episodic pain is limited relative to short-term studies, and comparative evidence is lacking.

For long-term use, researchers rely on data from patient registries and observational studies that extend beyond the typical six-month randomized trial window. While these settings allow researchers to describe patterns related to how symptoms evolved over time, certainty remains low regarding long-term effects of the SR formulation. Research suggests that data for certain groups, such as the pediatric population, remain insufficient, though studies evaluated older adults with existing comorbidities. Overall, comparative evidence is lacking between the sustained-release formula and other NSAID treatments, and follow-up durations were limited relative to the chronic nature of the treated conditions.

Frequently Asked Questions (FAQ)

Common questions about Dolonil SR (FAQ)


Q: How long does the effect of one dose of Dolonil SR typically last?

The 'SR' (Sustained-Release) formulation is designed to provide consistent delivery of the active ingredient over a prolonged period. According to the official product information, this is intended to support the specified once-daily dosing regimen for managing symptoms.


Q: Is it common to take Dolonil SR for many months?

Regulatory documents advise using the lowest effective dose for the shortest duration necessary to control symptoms. Official warnings note that taking the medication for longer periods is associated with an increased risk of serious adverse events, particularly cardiovascular and gastrointestinal issues.


Q: Is Dolonil SR primarily used for temporary or long-term issues?

The drug is studied for use in chronic conditions, such as osteoarthritis and rheumatoid arthritis. However, official safety guidance mandates that the medication be used for the shortest duration possible, due to potential risks associated with prolonged use.


Q: Are there any known long-term side effects associated with Dolonil SR use?

Official product warnings indicate that the risk of serious side effects, such as cardiovascular thrombotic events, gastrointestinal bleeding, and kidney injury, increases with the duration of use. Healthcare providers must periodically reassess the need for continued use.


Q: What signs of a serious reaction should a person be aware of while taking Dolonil SR?

Serious adverse reactions can be indicated by signs such as black or tarry stools (suggesting GI bleeding), chest pain or shortness of breath (suggesting cardiovascular issues), or swelling of the face, lips, or throat (suggesting a severe allergic reaction). The presence of any of these signs warrants immediate contact with medical professionals.


Q: Does Dolonil SR typically affect sleep patterns?

Somnolence, or drowsiness, is listed in official documents as a commonly reported adverse reaction. Other central nervous system effects, such as insomnia or abnormal dreams, have also been reported in clinical experience.


Q: Why do official documents include a warning about liver function for Dolonil SR?

Regulatory agencies include warnings because the drug carries a documented risk of hepatotoxicity, which is severe liver injury. Due to this potential risk, the medication is strictly contraindicated for patients who already have severe hepatic failure.


Q: Can you take Dolonil SR with common pain relief medications?

Official documents advise against the co-administration of this medication with other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). Taking Dolonil SR alongside another NSAID significantly increases the potential for adverse effects.


Q: Is Dolonil SR a controlled substance?

Official product warnings highlight the serious risks associated with addiction, abuse, and misuse. These risks can potentially lead to overdose and death, and official documents advise careful handling and monitoring.


Q: What should be done if an overdose of Dolonil SR is suspected?

Regulatory information emphasizes that suspected overdose situations require immediate contact with emergency medical services or a poison control center.


Q: Why might a doctor switch a patient from a different drug to Dolonil SR?

The Sustained-Release (SR) formulation is specifically designed to release the active ingredient slowly and consistently over a prolonged duration. This long-acting preparation is intended to support consistent symptom management and simplify the dosing regimen.


Q: Does Dolonil SR cause weight gain or loss?

Official regulatory documents list 'weight changes' as a documented adverse reaction in the metabolic category. This is generally reported as a less common effect observed during clinical experience.


Q: Are there known effects of stopping Dolonil SR suddenly?

Official drug labels warn that abruptly stopping the medication may result in signs and symptoms of withdrawal. Any decision regarding discontinuation or changes to the dosing schedule is based on professional medical guidance.


Q: Does Dolonil SR interact with any common herbal supplements?

While specific herbal supplements are not always detailed in official labeling, interactions are possible. It is important that medical professionals be informed about all complementary products and supplements being taken.


Q: What happens if Dolonil SR is taken alongside blood thinners?

Official product information states that co-administering this drug with anticoagulants, commonly known as blood thinners, significantly increases the risk of serious bleeding. This risk is particularly high in the gastrointestinal tract.


Q: Does Dolonil SR interact with oral contraceptives?

Studies and regulatory reports generally indicate that the active ingredient in Dolonil SR is not known to reduce the effectiveness of oral contraceptive medications.


Q: How successful were the initial studies for Dolonil SR described?

Clinical trials reported statistically significant improvements in patient-reported outcomes, such as measurements of pain relief and improvement in physical function. These findings were generally observed when comparing the drug to a neutral substance (placebo).


Q: What ingredients are in Dolonil SR besides the main drug component?

Besides the active ingredient, the tablet contains various inactive ingredients, often referred to as excipients. These include substances like carnauba wax, magnesium stearate, and colorants, which are all listed in the full product label for review.


Q: Does Dolonil SR contain gluten or common allergens?

The full product label lists all inactive ingredients used in the formulation. The label is the resource used to identify all inactive ingredients, which is important for individuals with known sensitivities to common allergens, such as lactose.


Q: Is Dolonil SR known by any other brand names internationally?

The active ingredient in this medication, Diclofenac Sodium, is marketed globally under many different brand names. It is also available as a generic product, which typically uses the same active substance.


Q: Can Dolonil SR be taken while breastfeeding?

Official information indicates that the active substance passes into breast milk in small amounts. Based on this limited data, the drug is generally considered acceptable for use while breastfeeding by many medical experts.


Q: Does Dolonil SR affect fertility?

Regulatory documents mention that, similar to other drugs in the NSAID class, this medication may temporarily impair female fertility. The drug label describes that discontinuation may be taken into consideration for women who are actively attempting to conceive.


Q: Is there a generic version of Dolonil SR available?

Yes, the active ingredient in Dolonil SR, Diclofenac Sodium extended-release tablets, is available as an authorized generic product.

How should Dolonil SR be stored and disposed of?

Official Storage and Disposal Requirements

Regulatory agencies define specific storage and disposal protocols for Dolonil SR (Diclofenac Sustained-Release) to ensure stability and environmental safety. These requirements are mandatory and based strictly on official labeling information.

Storage Component Official Requirement
Temperature Store at a temperature not exceeding 25 C; Do not freeze.
Protection Keep protected from light and preserve in the original, well-closed container.
Safety Must be stored securely, out of the sight and reach of children.

For disposal, unused or expired medication must be handled according to local regulations. The official labeling explicitly states that the product must not be thrown into wastewater or household waste to prevent environmental contamination.

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

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