Almiral

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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.

Overview of Almiral

Quick Facts

Property Description
Active ingredient Diclofenac Sodium
Form Gastro-resistant tablets, Injections, Gels (varied forms)
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use General relief of pain, inflammation, and fever
Origin Synthetic (Phenylacetic acid derivative)

Almiral: What Type of Medicine is Diclofenac?

Almiral is a specific trade name for the active substance Diclofenac Sodium, which is unambiguously classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). This synthetic medication belongs to the phenylacetic acid derivative family, defining its unique chemical structure among pain relievers. Almiral is often supplied in gastro-resistant tablets, a specialized formulation designed to protect the active ingredient before absorption, a characteristic recognized in pharmacological studies.

This classification confirms its role as a potent agent designed to manage symptoms arising from the body's inflammatory processes. Clinical studies have repeatedly supported the efficacy of Diclofenac as an analgesic and anti-inflammatory agent, making it a frequently selected option for managing conditions characterized by pain and swelling. This substance is globally recognized, being included on the WHO Model List of Essential Medicines.

Available Forms and General Purpose

The active ingredient Diclofenac is made available in numerous dosage forms, including oral forms like gastro-resistant tablets, as well as solutions for injection and various topical gels. This broad range of forms, often manufactured by the pharmaceutical company Almirall, enables tailored administration, whether requiring targeted relief via a topical route or a systemic effect via oral or injectable forms.

Its generalized therapeutic purpose stems directly from the NSAID class: providing relief through potent anti-inflammatory action, a distinct analgesic effect, and an antipyretic effect (fever reduction). This combination of actions establishes its core function of helping to broadly reduce inflammation and discomfort, exemplified by its use in cases of general joint or muscle pain.

Regulatory References

  1. Diclofenac Information

What side effects are possible with Almiral?

Possible Side Effects and Safety Information

The official safety information for Almiral (Diclofenac Sodium), consistent with regulatory classification for Nonsteroidal Anti-inflammatory Drugs (NSAIDs), outlines adverse reactions across multiple system-organ classes. The most common adverse effects documented in regulatory labeling are related to the Gastrointestinal Disorders (e.g., nausea, vomiting, dyspepsia, abdominal pain) and Nervous System Disorders (e.g., headache, dizziness).

Serious Adverse Reactions

Government health authorities highlight serious risks that are potentially life-threatening. These include Gastrointestinal Perforation, Bleeding, and Ulceration, which can occur at any time during use. The medicine is also associated with an increased risk of serious Cardiovascular Thrombotic Events, such as Myocardial Infarction and stroke. Other documented severe risks include Hepatotoxicity (severe liver injury) and serious Skin Reactions like Stevens-Johnson Syndrome (SJS).

Population and Contextual Safety Patterns

The official safety profile defines constraints based on patient condition and duration of exposure. Cardiovascular and gastrointestinal risks are documented to increase with higher dose and longer duration of treatment. The medication is contraindicated in patients with established congestive heart failure (NYHA Class II–IV), ischemic heart disease, and in the setting of peri-operative pain for Coronary Artery Bypass Graft (CABG) surgery. Furthermore, use is officially avoided during the late stage of pregnancy (after 30 weeks gestation).

This regulatory structure emphasizes that the risk profile is non-uniform, being formally defined by the patient's existing health status and the duration of use.

Overdose and Emergency Response

Almiral Overdose and when to seek help

Overdose manifestations of Diclofenac Sodium, the active ingredient in Almiral, are documented in regulatory sources to include a range of gastrointestinal and neurological symptoms. Common presentations involve nausea, vomiting (which may contain blood or appear like coffee grounds), epigastric pain, diarrhea, drowsiness, dizziness, and headache. Tinnitus and blurred vision are also officially noted signs.

A large overdose can be highly harmful, with specific severe outcomes reported in regulatory documents. These include severe gastrointestinal bleeding, ulceration, and perforation, as well as acute renal failure, seizures, and coma. Elderly patients are noted to be at a greater risk for serious gastrointestinal adverse events.

When to Seek Immediate Medical Help

Urgent medical attention is required immediately if signs of a severe event are experienced. These mandated emergency action triggers include chest pain, shortness of breath, weakness or slurred speech (suggesting a cardiovascular event), vomiting blood, black or bloody stools (suggesting a GI event), or signs of hepatotoxicity such as jaundice or flu-like symptoms. The medication must be discontinued immediately if any serious adverse event is suspected.

Management of Overdose

Management is primarily symptomatic and supportive, as regulatory documents state that no specific antidote is known. Procedures described in official guidance include the consideration of activated charcoal or gastric lavage following recent, large ingestion. Hospital monitoring is required in severe cases and may involve an electrocardiogram (ECG), blood/urine tests, and specialized support such as dialysis for severe kidney damage.

Therapeutic Uses of Almiral

Almiral: Main Uses and Benefits

Almiral (Diclofenac) is relevant in clinical settings where supportive symptomatic relief is needed for conditions involving symptoms that interfere with daily functioning and symptoms related to inflammatory or irritative states. This medicine is used for the relief of pain and inflammation in a wide range of conditions, and is considered relevant within therapeutic areas involving arthritic and acute musculoskeletal disorders.

The medication is applied across domains where additional symptomatic support is needed for certain distressing symptoms. It is commonly used across conditions characterized by periods of heightened symptoms such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. Almiral is also relevant for easing symptoms that become more disruptive during flare-ups of gout, migraine headaches, or primary dysmenorrhea, and for pain following sprains or trauma. This support helps ease the overall symptom burden and may help patients cope more steadily with symptom fluctuations.

Quick Fact: Relief for Pain and Inflammation
Therapeutic Relevance Symptoms related to inflammatory or irritative states
Primary Support Contributes to improved comfort and eases overall symptom load
Use Context Acute episodic flares and chronic symptomatic support

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Almiral — Official Regulatory Information

Official labeling for Almiral (Diclofenac Sodium) strictly defines the patient populations permitted to use the medicine and those who are excluded due to regulatory contraindications.


Eligibility Status Population/Condition
Absolute Contraindications History of allergic reactions (including asthma or urticaria) to any NSAID or aspirin. Treatment of pain following Coronary Artery Bypass Graft (CABG) surgery. Established severe heart failure (NYHA Class II-IV) or major vascular disease (Ischaemic Heart Disease, Cerebrovascular Disease). Active gastrointestinal ulceration, bleeding, or perforation. Severe renal or hepatic impairment.
Use Restricted/Caution Geriatric patients (use lowest effective dose). Patients with mild-to-moderate renal or hepatic impairment. Patients with cardiovascular risk factors (e.g., hypertension, hyperlipidaemia).
Age-Related Rules Standard oral tablets are typically not recommended for children under 14 years of age. Adult use is standard.
Reproductive Status Contraindicated at or after 30 weeks gestation in pregnancy; use before this time is restricted to the lowest dose for the shortest duration possible. Not recommended during breastfeeding or for women attempting to conceive.

Official regulatory documents establish Almiral's eligibility by classifying absolute contraindications based on a patient's history of NSAID allergy, current status of major organ function, and late-stage pregnancy. The use is allowed primarily for adults, while limitations are placed on pediatric age groups and those with pre-existing risk factors, necessitating cautionary use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory interaction profile for Almiral (Diclofenac Sodium) is defined by documented restrictions and the potential for clinically significant drug-drug interactions.


Formal Restrictions and Contraindications

Almiral is formally contraindicated for the treatment of perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery. It is also contraindicated in patients who have experienced allergic reactions, such as asthma or urticaria, following the use of aspirin or other Nonsteroidal Anti-inflammatory Drugs (NSAIDs).


Pharmacodynamic and Exposure Interactions

The profile is dominated by additive pharmacodynamic risks. Co-administration with anticoagulants, SSRIs, oral corticosteroids, or alcohol significantly increases the documented risk of serious gastrointestinal adverse events, including bleeding.

Furthermore, Almiral may diminish the antihypertensive and natriuretic effects of ACE Inhibitors, ARBs, and Diuretics. Regarding exposure modification, Almiral may cause an increase in the plasma concentrations of co-administered medicines such as Lithium, Methotrexate, and Digoxin, typically by reducing their renal or metabolic clearance. Conversely, strong inhibitors of the CYP2C9 enzyme are documented to increase the overall systemic exposure of Almiral itself.


Population-Specific Notes

Regulatory documentation notes that elderly patients are at a greater risk for serious gastrointestinal adverse events, an effect compounded by interacting substances. Additionally, high-risk patients, including the elderly or those with underlying renal impairment, are at increased risk of renal function deterioration when Almiral is combined with ACE Inhibitors or ARBs.

Mechanism of Action

How Almiral Works — Mechanism of Action

Diclofenac Sodium (Almiral) acts primarily by targeting and inhibiting the Cyclooxygenase (COX) enzyme system. This selective molecular interference results in changes to physiological processes across several systems.


Targeting the Prostanoid Synthesis Pathway

This mechanistic domain covers the drug's core action of inhibiting the COX-1 and COX-2 enzymes, which are critical catalysts in the lipid-signaling cascade. By preventing these enzymes from converting arachidonic acid into prostaglandins and other prostanoids, the molecule suppresses the synthesis of mediators involved in the inflammatory response.


Modulation of Inflammatory Mediators and Nociception

The reduction in prostaglandin synthesis is the key step that leads to a change in two major physiological processes. Peripherally, lower levels of PGE2 decrease the sensitization of pain receptors in damaged tissues, thereby modulating the transmission of nociceptive signals. Centrally, the suppression of PGE2 production in the hypothalamus allows for the recalibration of the body's elevated temperature set point.


️ Mechanistic Specificity and Physiological Constraints

Diclofenac exhibits a preferential inhibitory effect on COX-2, the enzyme primarily induced during inflammation, while also inhibiting COX-1, which is involved in vital maintenance functions. This reliance on enzyme inhibition inherently limits the physiological processes that depend on constitutive COX-1 activity. The effects on the central nervous system's thermoregulatory center establish a full mechanistic scope across pain signaling, inflammation, and temperature.

Dosage and Administration Information

How to Use Almiral (Diclofenac): Official Administration Guidelines

The usage of systemic Almiral (Diclofenac) is strictly guided by the principle of administering the lowest effective dose for the shortest duration necessary. The medicine is available in multiple official forms, each with specific administration requirements.

Official Routes and Dosing

Administration Route Standard Adult Dosing Principles Specific Use Constraints
Oral (Delayed-Release, Extended-Release Tablets) For chronic conditions, typical maintenance is 50 mg to 75 mg two to three times daily, or 100 mg extended-release once daily. Max dose is generally 150 mg per day. Tablets must be swallowed whole and not crushed, split, or chewed to preserve the intended release profile.
Oral (Powder for Solution) Used as a single 50 mg dose for acute situations (e.g., migraine). Must be mixed with only 30 mL to 60 mL of plain water and consumed immediately, typically on an empty stomach.
Parenteral (IM/IV Injection) 75 mg dose, which may be repeated once. Max daily dose is 150 mg. Parenteral use is generally restricted to a maximum of two days before switching to an oral form. IV infusion requires dilution with buffered saline or glucose solution and must be administered over a specific duration (e.g., 30 minutes to 2 hours).
Topical (Gel/Solution/Patch) Applied directly to the affected area, usually three to four times daily for the gel. Application is for local use; dosage adjustment is generally not required for mild-to-moderate renal or hepatic impairment when using systemic forms, but caution and the lowest dose are advised for all populations, including older adults.

General Procedural Rule

Different oral formulations (e.g., immediate-release, delayed-release, extended-release) are not bioequivalent and should not be interchanged without specific instruction. If a dose is missed, the general guidance is to take it as soon as remembered, unless it is near the time for the next dose, in which case the missed dose should be skipped; do not double the dose.

Recent Clinical Evidence

Research evidence / Overview of Studies for Almiral (Diclofenac)


Evidence for Use in Chronic Joint Conditions (Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis)

Research exploring the medicine's role in chronic joint symptoms has utilized short-term Randomized Controlled Trials (RCTs) and subsequent Systematic Reviews and Meta-Analyses in research exploring the medicine's effect on chronic symptoms of pain and inflammation. These studies were used in research exploring how symptoms change over time in adult populations with diagnosed conditions like osteoarthritis (OA) and rheumatoid arthritis (RA), and ankylosing spondylitis. The outcomes primarily monitored included outcomes related to physical discomfort, scores for physical function and daily activity level, and measurements of joint stiffness and swelling.

Findings describe patterns observed in the studies in the treatment group and the control groups, including those receiving placebo or vehicle. Research highlights changes measured during the study period for outcomes linked to inflammatory or irritative states. Research has explored both oral and topical formulations for conditions like OA.


Evidence for Use in Acute Pain and Inflammation

Research has explored conditions characterized by acute or disruptive episodes, such as acute musculoskeletal injuries, post-operative pain, and primary dysmenorrhea, primarily using short-term RCTs. Studies focused on episodes where symptoms become more noticeable, measuring outcomes related to physical discomfort and outcomes describing episodic changes, such as the use of supplemental pain medication.

Findings describe patterns observed in the studies related to pain intensity that were recorded during the short observation intervals. Research indicates that the outcomes monitored in post-operative settings monitored the amount of supplemental pain medication used and pain scores in the immediate recovery period. Because these conditions are temporary, the research typically focused on very short-term observation periods, often only a few days to a few weeks. The evidence base for this specific acute use is considered established.


What is Still Uncertain About the Research

Scientific reviews indicate that key limitations exist within the overall evidence base. Follow-up durations were limited across many trials, which creates limited information for long-term outcomes and the consistency of symptomatic patterns. Additionally, certain aspects of the evidence quality vary across studies, particularly when comparing older, historical trials with modern designs.

Data for certain groups remain insufficient; for instance, comprehensive long-term evidence in young adults or those with specific, rare comorbidities is often lacking. The research primarily describes group responses, and comparative evidence against all available treatment options is always evolving or lacking in head-to-head trials for all specific symptomatic outcomes.

Key Studies & References

  1. Efficacy and safety of over-the-counter analgesics for primary dysmenorrhea - A network meta-analysis

How should Almiral be stored and disposed of?

Storage and Protection Requirements

Almiral must be stored in specific environmental conditions to maintain its quality. Tablets and injection solutions are typically required to be stored below 30°C and must be kept in the original container to be protected from light and moisture. Furthermore, the container must remain tightly closed.

All Almiral formulations must be kept out of the sight and reach of children and stored in a secure, locked-up location. For the injectable solution, any remaining product in an opened ampoule must be discarded immediately and not reused.

Disposal Instructions

Unused or expired Almiral must not be disposed of in general household waste or wastewater, as this can contaminate the environment. Disposal must be managed safely in accordance with local requirements by returning the product to a pharmacy or an approved waste disposal collection point.

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

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