Alflam

Quick links to important sections

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 Alflam

Property Description
Active ingredient Diclofenac (Sodium/Potassium salt)
Form Tablets, Capsules, Gels, Solutions, Suppositories
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common Action Analgesic, Anti-inflammatory, Antipyretic
Origin Synthetic (Phenylacetic acid derivative)

What Type of Medicine is Alflam? (Identity and Classification)

Alflam is a trade name for a medicinal product that features the active substance Diclofenac, which is globally classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). Diclofenac is a synthetic compound derived from phenylacetic acid, recognized in pharmacology for its combined analgesic (pain-relieving) and anti-inflammatory actions.

Alflam is typically associated with systemic (oral) dosage forms containing Diclofenac Sodium or Potassium, often distributed under a prescription-only (Rx) status due to its potent action. The inherent nature of Diclofenac as a phenylacetic acid class NSAID positions it among the anti-inflammatory agents used to manage conditions such as acute soft-tissue injuries or flares of musculoskeletal inflammation.

Composition and Physical Forms of Diclofenac

The main therapeutic agent in Alflam is Diclofenac, which is normally presented as a single active ingredient product. This medication is available in multiple high-level dosage forms tailored for different patient needs.

These forms include oral options like tablets and capsules, which can be specially coated for delayed-release properties to optimize absorption in the gastrointestinal tract, and topical forms such as gels. Diclofenac is noted for its established role in pain management and inflammation reduction.

What is the General Purpose of Alflam?

The general purpose of Alflam is to intervene in the body's response to injury or disease by acting directly on the inflammatory process. It functions primarily by inhibiting the biosynthesis of prostaglandins, which are key messengers that trigger pain and swelling.

By restricting the production of these pro-inflammatory compounds through the inhibition of Cyclooxygenase (COX) enzymes, the Diclofenac in Alflam delivers a simultaneous analgesic, anti-inflammatory, and antipyretic effect. This mechanism is utilized to provide relief in scenarios where pain is linked to an underlying inflammatory condition.

Regulatory References

  1. Diclofenac: MedlinePlus Drug Information

What side effects are possible with Alflam?

Possible Side Effects and Safety Information

Overview of Adverse Reactions

The most commonly reported adverse reactions are generally classified within the Gastrointestinal and Nervous System System-Organ Classes. These frequently include gastrointestinal discomfort, such as nausea, vomiting, diarrhea, stomach pain, and indigestion. Other common effects include headache, dizziness, and drowsiness.

Serious and Clinically Significant Adverse Reactions

The use of medications containing these components is associated with a risk of serious, clinically significant events. These risks are typically dose- and duration-related.

  • Gastrointestinal Risk: Serious events include the risk of ulceration, bleeding, and perforation of the stomach or intestines, which can be fatal.
  • Hepatic Risk: Serious liver damage, including dose-related hepatotoxicity (associated with paracetamol) and rare, severe idiosyncratic liver failure (associated with nimesulide), have been reported. Increased liver enzymes are a common finding requiring monitoring.
  • Cardiovascular Risk: The use of some NSAID components may increase the risk of serious cardiovascular thrombotic events, including myocardial infarction (heart attack) and stroke.
  • Hypersensitivity: Severe allergic reactions, including life-threatening anaphylaxis and serious skin reactions (e.g., Stevens-Johnson syndrome), are rare but documented.

Population-Specific Safety Considerations

Safety-related restrictions advise caution or contraindication for use in individuals with existing peptic ulcers, gastrointestinal bleeding, severe liver disease, severe kidney disease, or heart failure. Use in the third trimester of pregnancy is generally contraindicated due to potential harm to the fetus. The use in children under 12 is often restricted, especially for certain NSAID components.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

Overdose involving Diclofenac (Alflam) is typically classified by regulators based on documented clinical signs and the potential for severe systemic injury. Symptoms following a substantial ingestion are primarily related to gastrointestinal disturbances, including vomiting, abdominal pain, diarrhoea, and the risk of gastrointestinal bleeding. Central nervous system effects may also present as headache, drowsiness, dizziness, and tinnitus. In cases of acute, massive overdosage, severe outcomes documented in official labeling include acute renal failure, hepatic damage, hypotension, and respiratory depression. Clinical observation and laboratory monitoring are required following ingestion of a potentially toxic amount.

Emergency Actions and Management

Immediate medical attention must be sought upon suspicion of an Alflam overdose. Regulatory authorities mandate contacting emergency services or a poison control center for urgent guidance, as the management of a significant overdose requires rapid clinical assessment. Official regulatory documentation states that no specific antidote is known for Diclofenac. Treatment is defined as symptomatic and supportive care. Ingestion of a large amount within one hour may warrant consideration of procedures such as gastric lavage or administration of activated charcoal, but measures like forced diuresis are generally noted as unlikely to be beneficial. Patients with pre-existing renal or hepatic impairment are recognized to be at increased risk for severe adverse effects.

Therapeutic Uses of Alflam

What Alflam Treats: Main Uses and Benefits

The therapeutic uses of Alflam (Diclofenac) are commonly associated with the management of symptoms related to physical discomfort and inflammatory-driven conditions, including symptoms such as tenderness, stiffness, and pain.

Alflam is commonly used across conditions presenting with chronic symptoms, including rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It is also considered relevant in clinical settings that involve acute or disruptive symptom patterns, such as sudden gout flare-ups, painful post-traumatic injuries, acute migraine attacks, and severe primary dysmenorrhea (menstrual cramps).

Quick Fact: Supports Management of Pain, Swelling, and Stiffness

The medication is applied in contexts where persistent inflammation causes symptoms that create noticeable physiological strain and interferes with joint function. This supportive relief contributes to improved comfort during symptomatic periods and may assist with maintaining functional stability.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Alflam?

Eligibility for Alflam (Diclofenac) is strictly governed by regulatory classifications based on pre-existing health status, age, and physiological state.

Contraindicated Populations

Use of this medicine is absolutely prohibited for individuals with a known hypersensitivity to Diclofenac, aspirin, or any other Nonsteroidal Anti-inflammatory Drug (NSAID), including those with a history of NSAID-induced asthma or urticaria. It is also contraindicated in patients with active gastrointestinal bleeding or ulceration, severe heart failure (NYHA class II-IV), established ischaemic heart disease, or cerebrovascular disease. Alflam must not be used following coronary artery bypass graft (CABG) surgery.


Restricted Use and Age Eligibility

The medicine is contraindicated during the third trimester of pregnancy (after 30 weeks gestation). For children and adolescents, eligibility is restricted; use is generally not established or contraindicated in children under 14 years of age for many systemic formulations. Individuals with severe hepatic or renal failure are also formally contraindicated from using this medicine. Elderly patients and those with cardiovascular risk factors should only use the medicine with particular caution and under strict medical supervision.

What should I know about interactions with other medicines?

The official interaction profile for Alflam (Diclofenac) is defined by pharmacokinetic and pharmacodynamic constraints documented in regulatory sources.

Pharmacodynamic Risk Reinforcement

Co-administration with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including other salicylates or COX-2 inhibitors, is generally restricted due to the high, documented risk of serious gastrointestinal ulceration and bleeding. The risk of bleeding is also officially increased when Alflam is used concurrently with anticoagulants (such as Warfarin), antiplatelet agents, Selective Serotonin Reuptake Inhibitors (SSRIs), or corticosteroids.

Exposure Modification and Clearance

Diclofenac can alter the systemic exposure of several co-administered medicines. By reducing their renal clearance, Diclofenac may increase the plasma concentrations of medicines like Lithium, Digoxin, and Methotrexate, potentially leading to the toxicity of the co-administered drug. The blood pressure-lowering effect of certain antihypertensive agents, including ACE inhibitors and ARBs, may be officially diminished when used with Diclofenac. Use with potassium-sparing diuretics is associated with an increased risk of hyperkalemia.

Metabolic and Timing Constraints

Interactions involving the CYP2C9 enzyme are documented; strong CYP2C9 inhibitors may increase Diclofenac’s plasma exposure. For absorption management, some regulatory labels advise separating the administration of Diclofenac from bile acid sequestrants (like Cholestyramine) by four to six hours. Official warnings also note that alcohol use may increase the documented risk of stomach bleeding associated with Diclofenac. Elderly patients are noted as having a greater risk for adverse effects linked to these interactions.

Mechanism of Action

Inhibition of Prostaglandin Synthesis and Inflammatory Pathways

Diclofenac (Alflam) operates by engaging two primary mechanistic domains that collectively modulate biological processes involving eicosanoid synthesis. The core action is the competitive inhibition of Cyclooxygenase ( COX) enzymes, targeting both COX-1 and COX-2 isoforms. By blocking these enzymes, the drug suppresses the biosynthesis of prostaglandins, which are key lipid mediators in the arachidonic acid cascade . This molecular suppression limits the downstream chemical signals involved in local vascular permeability and vasodilation, which modulates signaling within the inflammatory pathways.

Modulation of Peripheral Nociceptive Signaling and Thermoregulation

The reduced availability of Prostaglandin E2 ( PGE2) directly affects nociceptive signaling by decreasing the hypersensitivity of peripheral nociceptors (sensory nerves), thereby modulating sensory signal output. Additionally, the same mechanism acts centrally within the hypothalamus to prevent PGE2 from raising the body’s thermal set-point. These combined actions lead to predictable physiological adjustments that modulate signaling related to nociception and thermoregulation.

Dosage and Administration Information

How to Use Alflam: Official Administration Guidelines

Alflam, which contains Diclofenac, is administered through multiple routes and schedules. The guiding principle across all forms is to utilize the lowest effective dose for the shortest duration necessary.

Official Routes and Dose Schedules

Diclofenac is approved for oral, topical (gels/solutions), and rectal administration, alongside intramuscular (IM) and intravenous (IV) injection for acute use in clinical settings.

Form Type Frequency Pattern Standard Adult Dose Range (Daily) Administration Context
Delayed-Release (DR) Oral Divided doses (2–4 times daily) 100 mg to 200 mg Taken with or without food
Extended-Release (ER) Oral Once daily 100 mg Swallowed whole; do not crush/chew
Oral Solution (Powder) Single dose (for acute pain) 50 mg Mixed with water only on an empty stomach

Procedural and Population Rules

Dosing for Chronic Conditions such as rheumatoid arthritis typically involves a maintenance regimen of divided doses within a maximum daily limit that is dependent on the specific formulation being used. In contrast, use for acute pain, such as migraine, relies on a single-dose administration following specific preparation requirements, which demand the powder be mixed exclusively with water and consumed immediately on an empty stomach to ensure rapid action.

For older adults, guidance emphasizes starting at the lowest end of the dosing range and limiting the duration of treatment. Furthermore, extended-release tablets must maintain their physical integrity and should not be crushed, split, or chewed, regardless of the dose or patient group, as this alters the intended drug release over time.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Alflam


Evidence for Use in Chronic Joint Conditions

Research exploring Alflam (diclofenac) in chronic conditions for which research has explored its use in conditions characterized by outcomes related to systemic or functional imbalance, such as osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS), primarily relies on short- to medium-term Randomized Controlled Trials (RCTs) and systematic reviews. Studies explored outcomes related to physical discomfort and functional ability. Trials were monitored against an inactive substance (placebo) or reference standard medications. Studies report how symptoms evolved in the observed populations during observation periods, typically lasting between 4 and 12 weeks. Research for AS was conducted during periods of increased symptom activity and was studied for its impact on functional status and spinal stiffness.

What remains uncertain is whether long-term outcomes are not well characterized regarding the progression of the underlying joint disease; the evidence contributes to understanding symptom patterns but is limited in determining whether structural disease changes are monitored or affected. In AS, continuous use was observed in some studies to assess the impact on long-term spinal changes, but the reported findings were mixed.


Evidence for Use in Acute Pain and Symptom Flares

Research on Alflam for conditions associated with acute or disruptive episodes, such as acute migraine attacks and primary dysmenorrhea (menstrual cramps), involved trials relevant in settings assessing short-term or episodic symptom patterns. These studies were designed as single-dose RCTs, meaning they monitored the effects of one or a few doses over a very short time interval (typically 2 to 24 hours).

In migraine studies, the research examined outcomes related to the measurement of a pain-free status and the need for rescue medication use. Findings describe group patterns, with some systematic reviews reporting that specific oral formulations were observed in some studies that measured changes in outcomes related to physical discomfort within two hours. The main limitation in this area is that the research is uniformly short-term, providing no characterization of outcomes for repeated use over many cycles or episodes, and comparative evidence is lacking for all the differing doses and formulations of diclofenac that are available.


What is Still Uncertain About the Evidence Base

While a significant body of research describes the acute effects of Alflam across its main uses, evidence highlights what is known — and what is still uncertain. Key limitations noted in the regulatory research include the often short follow-up durations of many trials, particularly for chronic diseases, meaning limited information is available for long-term outcomes. For the broad range of acute pain conditions, the evidence is highly specific to the type of pain studied, and results apply only to the populations studied in the trials.

Key Studies & References

  1. NIH MedlinePlus Drug Information: Diclofenac (Oral route)
  2. World Health Organization (WHO) Model List of Essential Medicines

Frequently Asked Questions (FAQ)

Common questions about Alflam (FAQ)

Q: How long does it typically take for Alflam to start working?

For chronic use, such as for arthritis, regulatory documents state that the medicine usually begins to show effects within one week, though it may take several weeks for the full effect to be observed. For acute pain, some specific formulations are administered on an empty stomach, which is described as supporting more rapid absorption.


Q: What is the expected duration of the effects of Alflam?

Official product information describes the Diclofenac in Alflam as having a terminal half-life of approximately two hours. This measurement describes the rate at which the active compound is eliminated from the body after a dose.


Q: Is Alflam a long-term treatment or a short-term one?

Alflam is approved for managing both acute (short-term) pain and the symptoms of chronic conditions like rheumatoid arthritis. However, official guidance strongly emphasizes using the lowest effective dose for the shortest duration possible to control symptoms, as the risk of serious side effects is generally documented to increase with the duration of use.


Q: Is it true that Alflam is only approved for short-term use?

No, official product information indicates that Alflam is approved for both short-term pain relief and the treatment of long-term inflammatory conditions. While it is used for chronic conditions, regulatory warnings clearly state that the risk of serious side effects increases with the length of use.


Q: What is the difference between Alflam and its generic versions?

Regulatory agencies require that generic versions of a brand-name drug, such as Alflam, must be bioequivalent and therapeutically equivalent. This means that they must contain the same active ingredient ( Diclofenac) and work in the body in the same way, and are required to meet the same strict quality and effectiveness standards.


Q: Can Alflam be used for headaches?

Diclofenac, the active ingredient in Alflam, is officially approved in specific formulations for the treatment of acute pain. This can include conditions such as migraine attacks.


Q: Why is Alflam sometimes restricted in certain populations?

Restrictions are based on documented safety data from clinical studies and post-market reports. Official warnings note that the documented risks are elevated in certain groups, which is the basis for contraindications or cautions described in official documents.


Q: What official body approved Alflam for use?

The product's active ingredient and its various formulations are subject to approval by national regulatory bodies in the region where it is sold. Examples include the U.S. Food and Drug Administration ( FDA) or the European Medicines Agency ( EMA).


Q: Is Alflam a Schedule drug in the US or other countries?

Alflam contains Diclofenac, which is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). It is not classified as a controlled substance under the U.S. Controlled Substances Act ( CSA) or similar international drug scheduling laws.


Q: What information is legally required to be on the Alflam label?

Regulatory bodies mandate that drug labels provide specific patient information to ensure proper use. This required content includes the drug's intended use, precautions and warnings, and a comprehensive list of documented side effects.


Q: Why do official sources list so many potential interactions for Alflam?

Official sources list numerous interactions because the Diclofenac in Alflam is metabolized primarily through a specific pathway involving the CYP2C9 enzyme. It can also affect the renal clearance (how the kidneys remove) of other medicines, necessitating the documentation of many potential drug interactions.


Q: What are the common signs of an allergic reaction to Alflam?

Official warnings state that signs of a serious allergic reaction may include swelling of the face, throat, or tongue, or difficulty breathing. Other reported reactions may include a rash or hives ( urticaria). An allergic reaction is generally classified as a serious, clinically significant event in the regulatory documents.


Q: Does Alflam have any potential for misuse or dependence?

As a Nonsteroidal Anti-inflammatory Drug (NSAID), Diclofenac is not classified as a controlled substance. Therefore, regulatory data does not associate the use of Alflam with a potential for misuse or dependence.


Q: What is Alflam typically used for in a hospital setting?

Regulatory documents describe the use of injectable forms ( IM or IV) in clinical settings. These formulations are typically used for managing acute pain, such as when treating certain types of post-operative pain or severe migraine attacks.


Q: Do I need to take Alflam with food?

Regulatory information for standard oral tablets indicates that taking them with food may delay the onset of absorption, but generally does not affect the total amount of the drug absorbed. However, certain specific formulations, such as the oral solution, must be taken on an empty stomach, as this supports rapid absorption, which is a key requirement for that formulation.


Q: Can I crush or split Alflam tablets?

Official guidelines state that Extended-Release ( ER) and Delayed-Release tablets must be swallowed whole and not crushed, split, or chewed. This rule exists because breaking the tablet would alter the product's intended drug release over time.


Q: Can Alflam affect my sleep patterns?

Official labels list drowsiness (sleepiness) as a common side effect of the medicine. Due to the potential for other Nervous System side effects, like changes in mood, any concerns about changes to sleep patterns are part of the information described in the regulatory documents.


Q: How does the risk of side effects change with the length of use?

Studies and official warnings document that the risk of serious cardiovascular thrombotic events and serious gastrointestinal bleeding or ulceration is increased with the duration of exposure to Diclofenac, particularly during long-term use.

How should Alflam be stored and disposed of?

The storage and disposal of Alflam (Diclofenac) must strictly follow the conditions specified in official regulatory labeling to ensure product stability and safety.

Item Official Storage Requirement
Temperature Store at controlled room temperature (20 C to 25 C / 68 F to 77 F); Do not freeze.
Protection Keep away from heat, moisture, and direct light in a closed container.
Child Safety Must be stored out of the sight and reach of children.

For disposal, unused or expired Alflam must be handled in accordance with local regulations. The preferred method is using a drug take-back program. If this is not available, the product should be mixed with an undesirable substance (e.g., used coffee grounds), placed in a sealed bag, and discarded in the household trash; do not flush down the toilet.

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

Available in countries:

Equivalent of Alflam found in:

A-Z Index: