Diclofenac, 25 mg/ml 3 ml 10 pcs

Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAID).

The ATC code: M01AB05

Pharmacological properties

Pharmacodynamics

Diclofenac Velfarm contains diclofenac sodium, a substance of non-steroidal structure with pronounced anti-inflammatory, analgesic and antipyretic effect.

The main mechanism of action of diclofenac, established in studies, is considered to be inhibition of prostaglandin biosynthesis. Prostaglandins play an important role in the genesis of inflammation, pain and fever.

In vitro diclofenac sodium in concentrations equivalent to those achieved with human use does not inhibit cartilage proteoglycan biosynthesis.

In rheumatic diseases, the anti-inflammatory and analgesic properties of the drug provide a clinical effect characterized by a significant reduction of manifestations such as pain at rest and on movement, morning stiffness and joint swelling, as well as improvement of functional status.

In posttraumatic and postoperative inflammatory phenomena diclofenac quickly relieves pain (both at rest and on the move), reduces inflammatory edema and swelling of the postoperative wound.

The pronounced analgesic effect of diclofenac in moderate to severe pain was noted

of non-rheumatic origin. Pain relief comes in 15-30 minutes. In addition, diclofenac relieves migraine attacks.

When used in combination with opioids in patients with postoperative pain, diclofenac significantly reduces the need for opioid analgesics.

Pharmacokinetics

Absorption

After intramuscular (I/M) administration of 75 mg diclofenac its absorption begins immediately. The maximum plasma concentration (Cmax), which averages about 2.5 µg/mL (8 µmol/L), is reached after about 20 minutes. The amount of absorbed active ingredient is linearly related to the dose amount of the drug.

The magnitude of the area under the curve “concentration-time” (AUC) after diclofenac injection is approximately twice as large as after its oral or rectal administration, because in the latter cases about half of diclofenac is metabolized during the “first passage” through the liver.

The pharmacokinetic parameters do not change with subsequent administration. No cumulation is observed if the recommended intervals between diclofenac administration are observed.

Distribution

The binding to serum proteins is 99.7%, predominantly to albumin (99.4%). Apparent volume of distribution is 0.12-0.17 l/kg.

Diclofenac penetrates into the synovial fluid, where its maximum concentration is reached 2-4 hours later than in the blood plasma. The elimination half-life from synovial fluid is 3-6 hours. In 2 hours after reaching the maximum concentration in plasma, the concentration of diclofenac in synovial fluid is higher than in blood plasma, and its values remain higher for up to 12 hours.

Diclofenac was detected in low concentrations (100 ng/ml) in the breast milk of one nursing mother. The estimated amount of diclofenac absorbed through breast milk into the baby is equivalent to 0.03 mg/kg/day.

Metabolism

. Diclofenac is metabolized partly by glucuronidation of the unchanged molecule, but predominantly by single and multiple hydroxylation and methoxylation, resulting in several phenolic metabolites (3′-hydroxy-, 4′-hydroxy-, 5′-hydroxy-, 4′,5-dihydroxy- and 3′-hydroxy-4′-metoxydiclofenac),

most of which are converted to glucuron conjugates. Two phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.

The total systemic plasma clearance of diclofenac is 263 ± 56 ml/min. Final elimination half-life is 1-2 hours. The half-life of 4 metabolites, including two pharmacologically active ones, is also short and is 1-3 hours. One of the metabolites, 3′-hydroxy-4′-methoxydiclofenac, has a longer half-life, but this metabolite is completely inactive.

About 60% of diclofenac dose is excreted by the kidneys as glucuron conjugates of the unchanged active substance, and as metabolites, most of which are also glucuron conjugates. Less than 1% of diclofenac is excreted unchanged. The remaining part of diclofenac is excreted as metabolites in the bile.

The concentration of diclofenac in plasma is linearly dependent on the dose used.

Pharmacokinetics in special groups of patients

The absorption, metabolism and excretion of diclofenac are independent of age. In children the concentrations of diclofenac in plasma when using equivalent doses of the drug (mg/kg body weight) are similar to those in adults. But in some elderly patients after 15-min intravenous infusion an increase of diclofenac plasma concentration by 50% was noted in comparison with such index in healthy volunteers of younger age.

In patients with impaired renal function, there is no cumulation of the unchanged active substance while following the recommended dosing regimen.

In patients with a creatinine clearance of less than 10 ml/min, the calculated equilibrium concentrations of diclofenac hydroxymetabolites are approximately 4 times higher than in healthy volunteers, and the metabolites are excreted exclusively in the bile.

In patients with chronic hepatitis or compensated cirrhosis the pharmacokinetics of diclofenac are similar to those of patients without liver disease.

Indications

– rheumatoid arthritis,

– ankylosing spondylitis and other spondyloarthropathies,

– osteoarthritis,

– gouty arthritis,

Active ingredient

Composition

Per 1 ml:

Active ingredient: diclofenac sodium – 25 mg.

Excipients: benzyl alcohol, propylene glycol, mannitol (mannitol), sodium disulfite (sodium metabisulfite), sodium hydroxide solution 1 M, water for injection.

How to take, the dosage

The dose of the drug is chosen individually, and in order to reduce the risk of side effects it is recommended to use the lowest effective dose, with the shortest possible treatment period, according to the purpose of treatment and the patient’s condition.

Diclofenac Welfarm in ampoules is particularly suitable for the initial treatment of inflammatory and degenerative rheumatic diseases as well as pain due to inflammation of non-rheumatic origin.

Diclofenac Welfarm is administered by deep injection into the gluteal muscle. Diclofenac Wellfarm injections should not be used for more than 2 consecutive days. If necessary, treatment can be continued with diclofenac in tablets or rectal suppositories.

Injection into the injection site to avoid damage to the nerve or other tissues at the injection site (which may lead to muscle weakness, paresis or decreased sensitivity), it is recommended that the following rules be followed. The drug should be injected deeply into the upper outer quadrant of the gluteal region by using an aseptic technique.

The dose is usually 75 mg (the contents of 1 ampoule) once daily. In severe cases (e.g. colic), 2 injections of 75 mg may be given as an exception, several hours apart (the second injection should be given in the contralateral buttock). Alternatively, one injection daily (75 mg) may be combined with other diclofenac dosage forms (tablets, rectal suppositories), with the total daily dose not exceeding 150 mg.

In case of migraine attacks the treatment is started as soon as possible after the attack with intravenous injection of Diclofenac Wellfarm in dose of 75 mg (1 ampoule). If necessary, it is possible to use diclofenac in other dosage forms, with total daily dose not exceeding 150 mg per day.

The solution of the drug should be clear. Do not use the solution with crystalline or other sediment.

An ampoule of the drug should be used only once. The solution should be administered immediately after opening the ampoule. After a single use, unused remains of Diclofenac Wellfarm solution should be disposed in accordance with local requirements.

Diclofenac Velfarm solution contained in ampoules should not be mixed with solutions of other medicinal products for injection.

Children and adolescents under 18 years of age

Diclofenac Wellfarm solution for intramuscular injection should not be used in children and adolescents under 18 years of age due to difficulty in dosing the drug; if treatment in this category of patients is necessary, diclofenac may be used in tablets or suppositories.

Elderly patients (≥65 years)

Adjustment of the initial dose in patients aged 65 years and older is generally not required. However, based on general medical considerations, caution should be exercised in frail elderly patients or patients of low body weight.

Patients with cardiovascular disease or high risk of cardiovascular disease

Patients with cardiovascular disease or high risk of cardiovascular disease should use the drug with special caution. If prolonged therapy (more than 4 weeks) in such patients is necessary, the daily dose of the drug should not exceed 100 mg.

Patients with impaired renal function

There is no data on the need to adjust the dose when using the drug in patients with impaired renal function due to the lack of safety studies of the drug in patients of this category. Caution should be exercised when using the drug in patients with impaired renal function.

The drug is contraindicated in patients with renal insufficiency (GFR less than 15 ml/min/1.73 m2 of body surface area) (see section “Contraindications”).

Patients with hepatic impairment

There is no data on the need to adjust the dose when using the drug in patients with mild to moderate hepatic impairment due to the lack of safety studies of the drug in this category of patients. The drug is contraindicated in patients with severe hepatic impairment (see section “Contraindications”).

Interaction

Identified interactions CYP2C9 isoenzyme inhibitors

Caution should be exercised when diclofenac and CYP2C9 isoenzyme inhibitors (such as voriconazole) are used simultaneously due to possible increase in serum concentration of diclofenac and its exposure.

Lithium, digoxin

Diclofenac may increase lithium and plasma concentrations of digoxin. Monitoring of lithium and digoxin serum concentrations is recommended.

Diuretics and hypotensive agents

Diclofenac may decrease their hypotensive effect when used simultaneously with diuretics and hypotensive drugs (e.g., beta-adrenoblockers, angiotensin-converting enzyme inhibitors – ACE). Therefore, in patients, especially elderly patients, when concomitant use of diclofenac and diuretics or hypotensive agents it is necessary to measure BP regularly, control renal function and degree of hydration (due to increased risk of nephrotoxicity).

Cyclosporine and tacrolimus

The effect of diclofenac on renal prostaglandin activity may increase nephrotoxicity of cyclosporine and tacrolimus. Therefore, the dose of diclofenac in patients receiving cyclosporine or tacrolimus should be lower than in patients not receiving these drugs.

Drugs that may cause hyperkalemia

Concomitant use of diclofenac with potassium-saving diuretics, cyclosporine, tacrolimus and trimethoprim may lead to an increase in plasma potassium (in case of such simultaneous use this indicator should be monitored frequently). Antibacterials – quinolone derivatives.

There have been isolated reports of seizures in patients receiving quinolone derivatives and diclofenac concomitantly.

Presumed interactions of NSAIDs and glucocorticosteroids

The concomitant systemic use of diclofenac and other systemic NSAIDs or glucocorticosteroids may increase the incidence of NTs (particularly gastrointestinal).

Anticoagulants and antiaggregants

We should use diclofenac with these groups of drugs with caution because of the risk of bleeding. In spite of the fact that in clinical trials it has not been established the effect of diclofenac on anticoagulant drugs action, there are separate reports about increasing of bleeding risk in patients taking this combination of preparations. Patients receiving concomitant treatment with these drugs should be closely monitored.

Selective serotonin reuptake inhibitors

The concomitant use of diclofenac with selective serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

Hypoglycemic agents

The concomitant use of diclofenac and hypoglycemic agents does not change their effectiveness. However, there have been some reports of hypoglycemia and hyperglycemia in these cases, and doses of hypoglycemic drugs have to be varied with diclofenac. Due to the above mentioned it is recommended to monitor blood glucose concentration during concomitant use of diclofenac and hypoglycemic drugs.

There have been some reports of metabolic acidosis when diclofenac is concomitantly used with metformin, especially in patients with impaired renal function.

Methotrexate

Cautious use of diclofenac less than 24 hours before or 24 hours after methotrexate administration is necessary, because this can increase methotrexate concentration in blood and increase its toxic effect.

Phenytoin

Phenytoin and diclofenac, when used concomitantly, should be monitored in plasma concentrations due to possible increase in its systemic effects.

CYP2C9 isoenzyme inducers

Precautions must be taken when diclofenac is coadministered with CYP2C9 isoenzyme inducers (such as rifampicin), as this can significantly decrease plasma concentration of diclofenac and decrease its exposure.

Special Instructions

Gastrointestinal tract involvement

When using diclofenac, bleeding or gastrointestinal ulcers/perforations have been reported, in some cases with fatal outcome. These phenomena can occur at any time when using the drugs in patients with or without previous symptoms and a history of serious gastrointestinal disease. In elderly patients, such complications may have serious consequences. If patients receiving Diclofenac Welfarm develop bleeding or gastrointestinal ulcers, the drug should be discontinued.

In order to reduce the risk of gastrointestinal toxicity in patients with gastrointestinal ulcers, especially those complicated by bleeding or perforation in the history, as well as in elderly patients, the drug should be used in the lowest effective dose. Patients with increased risk of gastrointestinal complications, as well as patients receiving therapy with low doses of acetylsalicylic acid should take gastroprotectors (proton pump inhibitors or misoprostol) or other drugs to reduce the risk of adverse effects on the GI tract. Patients with a history of gastrointestinal damage, especially the elderly, should report all abdominal symptoms to their physician.

Patients with bronchial asthma

Patients with bronchial asthma. Bronchial asthma exacerbations (NSAID intolerance/bronchial asthma triggered by taking NSAIDs), Quincke’s edema and urticaria are most commonly seen in patients with bronchial asthma, seasonal allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease or chronic airway infections (especially those associated with allergic rhinitis-like symptoms). In this group of patients, as well as in patients with allergies to other drugs (rash, itching or urticaria) special caution should be exercised when using Diclofenac Velfarm (readiness for resuscitation measures).

Skin reactions

Severe dermatological reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, in some cases with fatal outcome, against the background of using diclofenac have been very rare. The greatest risk and frequency of severe dermatological reactions were observed in the first month of treatment with diclofenac. If patients receiving the drug Diclofenac Wellfarm develop the first signs of skin rash, mucous membrane lesions or other symptoms of hypersensitivity the drug should be discontinued.

In rare cases, patients who are not allergic to diclofenac may develop anaphylactic/anaphylactoid reactions when using the drug Diclofenac Wellfarm.

Hypatic effects

Since during the use of the drug Diclofenac Welfarm an increase in the activity of one or more liver enzymes may be noted, during long-term therapy with the drug, as a precautionary measure, monitoring of liver function is indicated. If liver function abnormalities persist and progress or if there are signs of liver disease or other symptoms (e.g., eosinophilia, rash, etc.), the drug should be discontinued. It should be borne in mind that hepatitis during the use of the drug Diclofenac Welfarm may develop without prodromal signs.

Impact on the kidneys

. During the therapy with Diclofenac Welfarm it is recommended to monitor renal function in patients with hypertension, impaired heart or renal function, elderly patients, patients receiving diuretics or other drugs that affect renal function as well as in patients with significant reduction of circulating blood plasma volume of any etiology, for example, before and after massive surgical interventions. After discontinuation of therapy by the drug normalization of renal function parameters to initial values is usually noted.

Cardiovascular effects

Therapy with NSAIDs, including diclofenac, especially long-term and high-dose therapy, may be associated with a small increase in the risk of serious cardiovascular thrombotic complications (including myocardial infarction and stroke).

In patients with cardiovascular disease and high risk of cardiovascular disease (e.g., arterial hypertension, hyperlipidemia, diabetes, smokers) the drug should be used with extreme caution, at the lowest effective dose with the shortest possible duration of treatment because the risk of thrombotic complications increases with increasing dose and duration of treatment. In long-term therapy (more than 4 weeks) the daily dose of diclofenac in such patients should not exceed 100 mg. The effectiveness of treatment and the patient’s need for symptomatic therapy should be periodically evaluated, especially in cases where its duration is more than 4 weeks. The patient should be instructed to seek immediate medical attention if the first symptoms of thrombotic disorders (e.g., chest pain, shortness of breath, weakness, speech disorders) occur.

Effects on the hematopoietic system

Diclofenac Welfarm may temporarily inhibit platelet aggregation. Therefore, in patients with impaired hemostasis it is necessary to closely monitor the relevant laboratory parameters.

In long-term use of the drug Diclofenac Welfarm it is recommended to perform regular clinical peripheral blood tests.

Masking of signs of an infectious process

The anti-inflammatory effect of the drug Diclofenac Wellfarm may complicate the diagnosis of infectious processes.

Simultaneous use with other NSAIDs

Diclofenac Welfarm should not be used simultaneously with other NSAIDs, including COX-2 selective inhibitors due to the risk of increased adverse events.

Impact on driving, operating machinery

Patients who experience visual disturbances, dizziness, drowsiness, vertigo or other central nervous system disorders while using Diclofenac Welfarm should not drive vehicles or operate machinery.

Synopsis

Contraindications

– Exacerbation of gastric and duodenal ulcer, bleeding from the gastrointestinal tract (GIT), perforation of the GIT organs.

– Hypersensitivity to diclofenac and any other components of the drug (including sodium disulfite).

– III trimester of pregnancy.

– Like other NSAIDs, Diclofenac Wellfarm is contraindicated in patients with a complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose or sinuses and intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including a history).

– Severe hepatic impairment, renal insufficiency (GFR less than 15 ml/min/1.73 m2), chronic heart failure (functional class II-IV according to NYHA classification).

– Clinically confirmed coronary heart disease.

– Diseases of peripheral arteries and cerebral vessels.

– Uncontrolled arterial hypertension.

– Conditions accompanied by a risk of bleeding.

– Confirmed hyperkalemia.

– Aortocoronary bypass surgery (perioperative period).

– Inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in the acute phase.

– Active liver disease.

– The period of breastfeeding.

The drug Diclofenac Velpharm, solution for intramuscular injection, is not indicated for use in children and adolescents under 18 years of age.

Cautions

When using Diclofenac Welfarm and other NSAIDs, caution should be exercised and patients with symptoms/signs suggestive of GI lesions/diseases or with anamnestic data suggestive of gastric or intestinal ulceration, bleeding or perforation should be closely monitored; in patients with a history of Helicobacter pylori infection, ulcerative colitis, Crohn’s disease, a history of liver dysfunction, and in patients with complaints suggestive of GI disease. The risk of gastrointestinal bleeding increases with increasing doses of NSAIDs or with a history of ulcers, especially bleeding and ulcer perforation and in elderly patients. Special caution should be exercised when using Diclofenac Wellfarm in patients receiving drugs that increase the risk of gastrointestinal bleeding: Systemic glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiaggregants (including clopidogrel, acetylsalicylic acid) or selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).

Perhaps caution is necessary when using Diclofenac Welfarm in patients with mild to moderate hepatic impairment as well as in patients with hepatic porphyria because the drug may provoke porphyria attacks.

The drug should be used with caution in patients with bronchial asthma, seasonal allergic rhinitis, nasal mucosal edema (including nasal polyps), chronic obstructive pulmonary disease, chronic infectious respiratory diseases (especially those associated with allergic rhinitis-like symptoms).

Particular caution is required when treating patients with cardiovascular disease, impaired renal function, including chronic renal failure (FFR 15-60 ml/min/1.73 m2), dyslipidemia/hyperlipidemia, diabetes mellitus, hypertension, when treating patients who smoke or abuse alcohol, when treating elderly patients who receive diuretics or other drugs that affect renal function, and patients with a significant decrease in circulating blood volume (RBC) of any etiology, e.g. in periods before and after massive surgical procedures.

Diclofenac Welfarm should be used with caution in patients with defects of the hemostatic system. Caution should be exercised when using Diclofenac Wellfarm in patients at risk of cardiovascular thrombosis.

Caution should be exercised when using Diclofenac Wellfarm in elderly patients. This is especially true in frail or underweight elderly people. In patients in this category it is recommended to use the drug in the lowest effective dose.

Particular caution should be exercised when administering Diclofenac Welfarm intramuscularly in patients with bronchial asthma due to the risk of exacerbation of the disease since sodium disulfite contained in the drug is capable of causing severe hypersensitivity reactions.

Side effects

The following are the adverse events (AEs) that have been identified in clinical trials as well as with diclofenac in clinical practice.

The following criteria were used to evaluate the incidence of NIs: “very common” (> 1/10); “common” (> 1/100, < 1/10); “infrequent” (> 1/1000, < 1/100); “rare” (> 1/10000, < 1/1000); “very rare” (< 1/10000).

NJs are grouped according to the system-organ class of the MedDRA Medical Regulatory Dictionary; within each class, NJs are listed in decreasing order of frequency of occurrence; within each group identified by frequency of occurrence, NJs are categorized in decreasing order of importance.

Infectious and parasitic diseases: very rare, post-injection abscess. Blood and lymphatic system disorders: very rarely – thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis.

Disorders of the immune system: rarely – hypersensitivity, anaphylactic/anaphylactoid reactions, including decreased blood pressure (BP) and shock; very rarely – angioedema (including facial edema).

Mental disorders: very rare – disorientation, depression, insomnia, nightmares, irritability, mental disorders.

Nervous system disorders: frequently – headache, dizziness; rarely – somnolence; very rarely – sensory disorders, including paraesthesia, memory disorders, tremor, seizures, anxiety, acute cerebral circulation disorders, aseptic meningitis.

Visual disorders: very rare – visual disturbances (blurred vision), diplopia.

Hearing and labyrinth disorders: often – vertigo; very rare – hearing disorders, tinnitus.

Cardiac disorders: infrequent – myocardial infarction, heart failure, palpitations, chest pain.

Vascular disorders: very rarely – increase in BP, vasculitis.

Respiratory system disorders, thoracic and mediastinal organs: rarely –

bronchial asthma (including dyspnea); very rarely – pneumonitis.

Gastrointestinal disorders: frequent – abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, decreased appetite; rare – gastritis, gastrointestinal bleeding, vomiting blood, melena, diarrhea with blood admixture, gastric and intestinal ulcers (with or without bleeding, stenosis or perforation, with possible development of peritonitis); very rare – stomatitis, glossitis, esophageal damage, occurrence of diaphragm-like strictures in the intestine, colitis (nonspecific hemorrhagic colitis, ischemic colitis, exacerbation of ulcerative colitis or Crohn’s disease), constipation, pancreatitis, dysgeusia.

Liver and biliary tract disorders: often – increased plasma aminotransferase activity; rarely – hepatitis, jaundice, liver dysfunction; very rarely – hepatitis fulminant, liver necrosis, liver failure.

Skin and subcutaneous tissue disorders: common – skin rash; rare – urticaria; very rare – bullous dermatitis, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome (toxic epidermal necrolysis), exfoliative dermatitis, itching, alopecia, photosensitivity reactions, purpura, Schoenlein-Henoch purpura. Renal and urinary tract disorders: very rare – acute renal damage (acute renal failure), hematuria, proteinuria, tubulointerstitial nephritis, nephrotic syndrome, papillary necrosis.

General disorders and disorders at the injection site: often – pain, thickening at the injection site; rarely – edema, necrosis at the injection site.

Cardiovascular disorders

The risk of cardiovascular thrombotic complications (e.g., myocardial infarction) may increase slightly, especially with prolonged use of diclofenac in high doses (daily dose over 150 mg).

Visual disturbances

Visual disturbances such as visual disturbances, blurred vision or diplopia appear to be class effects of NSAIDs, and are reversible after discontinuation. A possible mechanism for the development of such disorders is inhibition of the synthesis of prostaglandins and other related substances, which alters the regulation of blood flow in the retina, which manifests as potential visual disturbances. If these symptoms develop with diclofenac therapy, ophthalmologic evaluation should be considered to exclude any other cause.

If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, seizures. In case of significant poisoning, acute renal failure and liver damage are possible.

Treatment: supportive and symptomatic treatment is indicated for complications such as decreased BP, renal failure, seizures, GI disorders and respiratory depression. Forced diuresis, hemodialysis or hemoperfusion for excretion of NSAIDs, including diclofenac, from the body are ineffective, as active substances of these drugs are largely bound to plasma proteins and undergo intensive metabolism.

Pregnancy use

There is insufficient data on the safety of diclofenac use in pregnant women, and therefore the drug Diclofenac Welfarm should only be used in I and II trimesters of pregnancy when the expected benefits to the mother exceed the potential risk to the fetus. Diclofenac, as well as other NSAIDs (inhibitors of prostaglandin synthesis) is contraindicated in the last 3 months of pregnancy (inhibition of uterine contractility, impaired renal function in the fetus with subsequent oligohydroamnios and/or premature closure of the fetal arterial duct may occur).

While diclofenac, like other NSAIDs, penetrates into the breast milk in small amounts, the drug should not be used during breastfeeding to avoid adverse effects on the child. If it is necessary to use the drug in a woman during this period, breastfeeding should be stopped.

Since diclofenac, like other NSAIDs, may have adverse effects on fertility, women planning to become pregnant are not recommended to use the drug. Patients undergoing examination and treatment for infertility should discontinue the drug.

Similarities