Larfix rapid

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LARFIX® RAPID

Composition:

Active substance: lornoxicam;

1 tablet contains 8 mg of lornoxicam;

Excipients: calcium hydrogen phosphate anhydrous, calcium stearate, hydroxypropylcellulose, sodium hydrogen carbonate, low-substituted hydroxypropylcellulose, microcrystalline cellulose, Opadry Yellow 03B52941 (hypromellose/HPMC, titanium dioxide (E 171), polyethylene glycol/PEG, quinoline yellow aluminium lake).

Pharmaceutical form. Film-coated tablets.

Main physico-chemical properties: round, biconvex film-coated tablets of light yellow to yellow color, smooth on both sides.

Pharmacotherapeutic group. Non-steroidal anti-inflammatory and anti-rheumatic drugs.

ATC code M01A C05.

Pharmacological Properties

Pharmacodynamics.

Lornoxicam is a non-steroidal anti-inflammatory drug with analgesic properties and belongs to the oxicam class. The mechanism of action of lornoxicam is primarily based on inhibition of prostaglandin synthesis (cyclooxygenase inhibition), leading to desensitization of peripheral pain receptors and inhibition of inflammation. A central effect on nociceptors, unrelated to its anti-inflammatory action, is also presumed.

Lornoxicam does not affect vital parameters (e.g., body temperature, respiratory rate, heart rate, blood pressure, ECG, spirometry).

The analgesic properties of lornoxicam have been successfully demonstrated in several clinical studies.

Due to local irritation of the gastrointestinal tract (GIT) and systemic ulcerogenic effects associated with inhibition of prostaglandin synthesis, administration of lornoxicam, like other non-steroidal anti-inflammatory drugs (NSAIDs), frequently leads to the development of gastrointestinal complications.

Pharmacokinetics.

Absorption. Lornoxicam is rapidly and almost completely absorbed from the gastrointestinal tract. Maximum plasma concentration (Cmax) is reached within 30 minutes after administration. The Cmax of Lornoxicam Rapid, film-coated tablets, is higher than that of lornoxicam film-coated tablets and equivalent to the Cmax achieved with parenteral formulations of lornoxicam.

The absolute bioavailability of Lornoxicam Rapid, film-coated tablets, is 90–100% and equivalent to the bioavailability of lornoxicam film-coated tablets. No first-pass effect has been observed.

There are no data on concomitant administration of the medicinal product Larfix Rapid with food. However, considering the properties of lornoxicam, a decrease in Cmax, an increase in Tmax, and reduced absorption (AUC) may be expected.

Distribution. In plasma, lornoxicam is present in unchanged form and as the inactive form of its hydroxylated metabolite. Protein binding of lornoxicam to plasma proteins is 99% and independent of its concentration. It is also detected in synovial fluid after repeated administration.

Biotransformation. Lornoxicam is actively metabolized in the liver via hydroxylation, initially forming the inactive metabolite 5-hydroxy-lornoxicam. Lornoxicam undergoes metabolism involving cytochrome CYP2C9. Due to genetic polymorphism, individuals may exhibit either slow or extensive metabolism, which may result in significantly increased plasma levels of lornoxicam in individuals with slow metabolism. The hydroxylated metabolite has no pharmacological activity. Lornoxicam is completely metabolized. Approximately ⅔ is excreted via the liver and ⅓ via the kidneys as inactive compounds.

In animal model studies, lornoxicam did not induce hepatic enzymes. Clinical studies provided no evidence of lornoxicam accumulation after repeated administration of recommended doses. The absence of accumulation was confirmed by safety and efficacy monitoring data from 1-year-long studies.

Elimination. The elimination half-life of the drug is 3 to 4 hours. After oral administration, approximately 50% of the drug is excreted in feces and 42% via the kidneys, predominantly as 5-hydroxy-lornoxicam. The elimination half-life of 5-hydroxy-lornoxicam after once- or twice-daily parenteral administration is approximately 9 hours. There is no evidence that elimination rate changes upon repeated dosing.

In elderly patients (aged 65 years and older), clearance is reduced by 30–40%. Apart from reduced clearance, there are no significant changes in the kinetic profile of lornoxicam in elderly patients.

In patients with renal or hepatic impairment, there is no significant change in the kinetic profile of lornoxicam after 7 days of therapy with daily doses of 12 mg and 16 mg, except for accumulation observed in patients with chronic liver disease.

Clinical characteristics.

Indications. Short-term symptomatic treatment of mild to moderate acute pain in adults.

Contraindications.

• Hypersensitivity to lornoxicam or to any of the excipients;
• thrombocytopenia;
• hypersensitivity (symptoms similar to those observed in bronchial asthma, rhinitis, angioedema, or urticaria) to other nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid;
• severe heart failure;
• gastrointestinal bleeding, cerebrovascular bleeding, or other hematological disorders;
• history of gastrointestinal bleeding or perforation related to previous use of nonsteroidal anti-inflammatory drugs;
• active peptic ulcer or recurrent peptic ulcer/bleeding in history (two or more episodes of confirmed ulceration or bleeding);
• severe hepatic impairment;
• severe renal impairment (serum creatinine level > 700 µmol/L);
• third trimester of pregnancy (see section "Use in pregnancy or lactation").

Interaction with other medicinal products and other forms of interaction.

The following interactions may occur when Larfiks Rapid is used concomitantly with other drugs:

• Cimetidine: increases plasma concentration of lornoxicam, which may increase the risk of lornoxicam adverse effects (no interactions were observed between lornoxicam and ranitidine or between lornoxicam and antacids).
• Anticoagulants: NSAIDs may enhance the effect of anticoagulants (e.g., warfarin) (see section "Special precautions"). Careful monitoring of INR (International Normalized Ratio) is required.
• Phenprocoumon: reduced efficacy of phenprocoumon treatment.
• Heparin: NSAIDs increase the risk of bleeding and the occurrence of spinal/epidural hematomas when used concomitantly with heparin during spinal or epidural anesthesia (see section "Special precautions").
• ACE inhibitors (angiotensin-converting enzyme inhibitors): the antihypertensive effect of ACE inhibitors may be reduced.
• Diuretics: reduced diuretic and antihypertensive effect of loop, thiazide, and potassium-sparing diuretics (increased risk of hyperkalemia and nephrotoxicity).
• Beta-blockers: reduced antihypertensive effect.
• Angiotensin II receptor blockers: reduced antihypertensive effect.
• Digoxin: decreased renal clearance of digoxin, increasing the risk of digoxin toxicity.
• Corticosteroids: increased risk of gastrointestinal ulcers and bleeding (see section "Special precautions").
• Quinolone antibiotics (e.g., levofloxacin, ofloxacin): increased risk of seizures.
• Antiplatelet agents (e.g., clopidogrel): increased risk of bleeding (see section "Special precautions").
• Other NSAIDs: increased risk of gastrointestinal bleeding or ulcers.
• Methotrexate: increased serum methotrexate concentration, leading to increased toxicity. Close monitoring of the patient is required when used concomitantly.
• Selective serotonin reuptake inhibitors (SSRIs): increased risk of bleeding (see section "Special precautions").
• Lithium preparations: NSAIDs reduce renal clearance of lithium, thus serum lithium concentration may exceed the toxic threshold. Serum lithium levels should be monitored, especially at the beginning of treatment, during dose adjustments, and upon discontinuation of therapy.
• Cyclosporine: increased serum cyclosporine concentration, potentially increasing cyclosporine nephrotoxicity due to effects mediated by renal prostaglandins. Renal function should be monitored during combination therapy.
• Sulfonylurea derivatives (e.g., glibenclamide): hypoglycemic effect may be enhanced.
• Inducers and inhibitors of CYP2C9 isoenzymes: lornoxicam (like other NSAIDs metabolized via cytochrome CYP2C9) interacts with inducers and inhibitors of CYP2C9 isoenzymes.
• Tacrolimus: combined treatment with NSAIDs and tacrolimus increases the risk of nephrotoxicity due to reduced synthesis of prostacyclin in the kidneys. Renal function should be closely monitored during such combination therapy (see section "Special precautions").
• Pemetrexed: NSAIDs may reduce renal clearance of pemetrexed, thereby increasing renal and gastrointestinal toxicity and myelosuppression.

Since food intake slows the absorption of lornoxicam, Larfiks Rapid film-coated tablets should not be taken with food if rapid onset of action (pain relief) is required.

Food intake reduces absorption by approximately 20% and increases Tmax (see section "Pharmacological properties. Pharmacokinetics").

Special precautions for use.

Lornoxicam reduces platelet aggregation and prolongs bleeding time. Therefore, caution is required when prescribing to patients with an increased tendency to bleeding.

Lornoxicam should be prescribed only after careful assessment of the expected therapeutic benefit and potential risk:

• in patients with impaired renal function: lornoxicam should be used with caution in patients with mild (serum creatinine level 150–300 µmol/L) and moderate (serum creatinine level 300–700 µmol/L) renal insufficiency due to the important role of prostaglandins in maintaining renal blood flow (see section "Dosage and administration"). If renal function worsens during treatment, lornoxicam therapy should be discontinued;
• in patients after major surgical procedures, patients with heart failure, and patients taking diuretics or agents that may cause renal damage: renal function should be closely monitored (see section "Interaction with other medicinal products and other forms of interaction");
• in patients with coagulation disorders: careful clinical evaluation and laboratory monitoring (e.g., activated partial thromboplastin time) are recommended;
• in patients with hepatic insufficiency (e.g., liver cirrhosis): after administration of 12–16 mg/day, clinical monitoring and laboratory tests are recommended due to the possibility of lornoxicam accumulation (increased AUC) (see section "Pharmacological properties. Pharmacokinetics"). However, liver dysfunction does not affect the pharmacokinetic parameters of lornoxicam compared to healthy volunteers;
• in elderly patients (aged 65 years and older): monitoring of renal and hepatic function is recommended. Use with caution after surgical procedures.

Concomitant use of NSAIDs.

Avoid concomitant use of lornoxicam with other NSAIDs, including selective cyclooxygenase-2 inhibitors (see section "Interaction with other medicinal products and other forms of interaction").

Minimization of adverse reactions.

Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control disease symptoms (see section "Dosage and administration" and information on gastrointestinal and cardiovascular risks below).

Gastrointestinal bleeding, ulcers, and perforations. Gastrointestinal bleeding, ulcers, and perforations may occur at any time during treatment with NSAIDs, regardless of the presence of warning symptoms or history of serious gastrointestinal disorders, and may be fatal.

The risk of gastrointestinal bleeding, ulcers, or perforation increases with higher NSAID doses, in patients with a history of peptic ulcers, especially those complicated by bleeding or perforation (see section "Contraindications"), and in elderly patients. These patient groups should start treatment with the lowest therapeutic doses (see section "Dosage and administration").

For patients requiring concomitant therapy and for those concurrently taking low-dose acetylsalicylic acid or other drugs increasing the risk of gastrointestinal complications, treatment may be administered with concomitant use of protective agents (e.g., misoprostol or proton pump inhibitors) (see section "Interaction with other medicinal products and other forms of interaction"). Regular clinical monitoring is recommended.

Patients with a history of gastrointestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding) at the beginning of treatment.

The drug should be prescribed with caution to patients who are concurrently using medications that increase the risk of ulceration or bleeding, such as: oral corticosteroids, anticoagulants (warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (acetylsalicylic acid) (see section "Interaction with other medicinal products and other forms of interaction").

If gastrointestinal bleeding or ulcers occur in patients taking lornoxicam, treatment should be discontinued.

NSAIDs should be used with caution in patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease), as their condition may worsen (see section "Adverse reactions").

Elderly patients.

The frequency of adverse reactions during NSAID use, particularly gastrointestinal bleeding and perforation, is increased in elderly patients and may lead to fatal outcomes (see section "Contraindications").

Cardiovascular and cerebrovascular effects.

Patients with a history of mild to moderate arterial hypertension and/or congestive heart failure should be closely monitored, as NSAID therapy may be associated with fluid retention and edema.

Clinical trial data and epidemiological evidence suggest that the use of certain NSAIDs, particularly over prolonged periods and/or at high doses, increases the risk of arterial thrombotic events (e.g., myocardial infarction or stroke). There is insufficient data to exclude such a risk with lornoxicam.

Lornoxicam should be prescribed only after careful evaluation of indications in patients with uncontrolled arterial hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disorders. Evaluation is also required before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g., hypertension, hyperlipidemia, diabetes, smoking).

Concomitant therapy with NSAIDs and heparin increases the risk of spinal/epidural hematoma during spinal or epidural anesthesia (see section "Interaction with other medicinal products and other forms of interaction").

Skin disorders.

Very rarely, severe skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis may occur during NSAID use, sometimes resulting in death (see section "Adverse reactions"). The risk of such reactions is highest at the beginning of treatment, with most cases occurring within the first month of drug use. Lornoxicam should be discontinued at the first signs of skin rash, mucosal lesions, or other signs of hypersensitivity.

Respiratory disorders.

Use with caution in patients with bronchial asthma or a history of asthma, as NSAIDs may provoke bronchospasm in these patients.

Systemic lupus erythematosus and mixed connective tissue disease.

Use with caution in patients with systemic lupus erythematosus and mixed connective tissue diseases, as the risk of aseptic meningitis may be increased.

Nephrotoxicity.

Concomitant therapy with NSAIDs and tacrolimus increases the risk of nephrotoxicity due to reduced renal prostacyclin synthesis. Renal function should be closely monitored during such combination therapy (see section "Interaction with other medicinal products and other forms of interaction").

Laboratory abnormalities.

Like other NSAIDs, lornoxicam may cause transient elevations in serum transaminases and bilirubin, increased blood urea and creatinine concentrations, and other laboratory parameter deviations. If laboratory abnormalities are significant and persistent, treatment should be discontinued and appropriate investigations performed.

Fertility.

Lornoxicam, like other drugs that inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended for women attempting to conceive. Women experiencing difficulties in conceiving or undergoing infertility evaluation should discontinue lornoxicam (see section "Use during pregnancy or breastfeeding").

Chickenpox.

In cases of chickenpox, severe skin and soft tissue infections may develop in exceptional cases. A negative influence of NSAIDs on the course of these infectious diseases cannot be excluded. The use of lornoxicam is not recommended during chickenpox.

Excipients.

This medicinal product contains less than 1 mmol (23 mg) of sodium per dose (1 tablet), i.e., it is practically sodium-free.

Use during pregnancy or breastfeeding.

Pregnancy. Lornoxicam is contraindicated during the third trimester of pregnancy (see section "Contraindications"). There are no clinical data on the use of lornoxicam during the first and second trimesters of pregnancy and during labor; therefore, the drug is not recommended during these periods.

There are insufficient data on the use of lornoxicam in pregnant women. Animal studies have shown reproductive toxicity.

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Epidemiological data indicate an increased risk of miscarriage and congenital heart defects associated with the use of prostaglandin synthesis inhibitors in early pregnancy. The risk increases with higher doses and longer duration of therapy. In animals, prostaglandin synthesis inhibitors have been shown to increase the frequency of pre- and post-implantation fetal loss and embryofetal mortality.

From the 20th week of pregnancy, the use of lornoxicam may cause oligohydramnios due to fetal renal dysfunction. This disorder may occur soon after the start of treatment and is usually reversible upon discontinuation. Additionally, there have been reports of arterial duct constriction after treatment in the second trimester, which in most cases resolved after stopping treatment. Therefore, lornoxicam should not be prescribed during the first and second trimesters of pregnancy, except in cases of extreme necessity. If lornoxicam is used by a woman attempting to conceive or during the first and second trimesters of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible. Prenatal monitoring for oligohydramnios and arterial duct constriction may be advisable after exposure to lornoxicam for several days starting from the 20th gestational week. Treatment with Larfiks Rapid should be discontinued if oligohydramnios or arterial duct constriction is detected.

During the third trimester of pregnancy, the use of any prostaglandin synthesis inhibitors may lead to fetal:

• cardiopulmonary toxicity (premature constriction/closure of the arterial duct and pulmonary hypertension);
• renal dysfunction (see above).

Risks for the mother at the end of pregnancy and for the newborn:

• prolonged bleeding time, anti-aggregatory effect, which may occur even at very low doses;
• inhibition of uterine contractility, which may lead to delayed or prolonged labor.

Thus, the use of lornoxicam is contraindicated during the third trimester of pregnancy (see section "Contraindications").

Breastfeeding period. There are no data on the excretion of lornoxicam into human breast milk. Relatively high concentrations of lornoxicam are excreted in milk in rats. Lornoxicam should not be used during breastfeeding.

Fertility. The use of lornoxicam, like any drug that inhibits cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended for women attempting to conceive. For women experiencing difficulties with conception or undergoing infertility evaluation, discontinuation of lornoxicam should be considered.

Ability to affect reaction speed when driving or operating machinery.

If dizziness and/or drowsiness occur after taking the medicinal product, driving or operating machinery should be avoided.

Method of Administration and Dosage

The appropriate dosing regimen for all patients should be based on individual response to treatment. Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section "Special Warnings and Precautions for Use"). Larfix Rapid, film-coated tablets, should be administered orally with sufficient fluid.

Acute pain. The recommended dose is 8–16 mg (1–2 tablets) per day. On the first day of treatment, the initial dose is 16 mg, followed by an additional 8 mg after 12 hours. After the first day of treatment, the daily dose should not exceed 16 mg (2 tablets).

Elderly patients (aged 65 years and older) do not require dose adjustment, except for patients with impaired liver or kidney function. However, lornoxicam should be used with caution in this patient group due to increased susceptibility to gastrointestinal adverse reactions (see section "Special Warnings and Precautions for Use").

Patients with renal impairment. In patients with mild to moderate renal impairment, the frequency of administration of Larfix Rapid should be reduced to once daily (see section "Special Warnings and Precautions for Use"). Lornoxicam is contraindicated in patients with severe renal dysfunction (see section "Contraindications").

Patients with hepatic impairment. For patients with moderate hepatic impairment, the frequency of administration should be reduced to once daily (see section "Special Warnings and Precautions for Use"). Lornoxicam is contraindicated in patients with severe hepatic dysfunction (see section "Contraindications").

Children.

The medicinal product is not recommended for use in children (under 18 years of age) due to insufficient clinical data on efficacy and safety.

Overdose.

Currently, there are no reported cases of overdose that allow definitive conclusions regarding its consequences or recommendations for specific treatment. However, symptoms of lornoxicam overdose may include nausea, vomiting, and central nervous system symptoms (dizziness, visual disturbances). In severe cases, ataxia (progressing to coma and seizures), hepatic and renal damage, and coagulation disorders may occur.

In cases of actual or suspected overdose, administration of the drug should be discontinued. Due to the short elimination half-life, lornoxicam is rapidly eliminated from the body. It is not dialyzable. There is no specific antidote available. Standard emergency measures should be initiated. Administration of activated charcoal immediately after overdose may reduce drug absorption. For the treatment of gastrointestinal disturbances, a prostaglandin analogue or ranitidine may be used.

Adverse Reactions.

The most common adverse reactions associated with NSAIDs are gastrointestinal in nature. Peptic ulcers, perforation, or gastrointestinal bleeding may occur during NSAID therapy, sometimes resulting in fatal outcomes, particularly in elderly patients (see section "Special Warnings and Precautions for Use"). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, and exacerbations of colitis and Crohn’s disease have been reported during NSAID treatment (see section "Special Warnings and Precautions for Use"). Gastritis has been observed less frequently.

It is estimated that adverse events may occur in approximately 20% of patients treated with lornoxicam. The most commonly reported adverse reactions associated with lornoxicam are nausea, dyspepsia, digestive disturbances, abdominal pain, vomiting, and diarrhea. These symptoms were generally observed in less than 10% of patients participating in clinical trials.

Edema, arterial hypertension, and heart failure have been reported with the use of NSAIDs.

Clinical trials and epidemiological data suggest that the use of certain NSAIDs, particularly at high doses and during prolonged treatment, is associated with an increased risk of arterial thrombotic events, such as myocardial infarction or stroke (see section "Special Warnings and Precautions for Use").

Very rarely, serious skin and soft tissue infections have been reported in cases of varicella (chickenpox).

The following undesirable effects may occur during treatment with Larfiks Rapid. The frequency categories are defined as follows: very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (frequency cannot be estimated from available data).

Infections and infestations.

Rare: pharyngitis.

Blood and lymphatic system disorders.

Rare: anemia, thrombocytopenia, eosinophilia, leukopenia, coagulation disorders, prolonged bleeding time, pancytopenia.

Very rare: ecchymosis. NSAIDs can cause potentially serious hematological disorders characteristic of this class, such as neutropenia, agranulocytosis, aplastic anemia, and hemolytic anemia.

Immune system disorders.

Rare: hypersensitivity reactions, including fever, chills, anaphylactoid reactions, and anaphylaxis.

Metabolism and nutrition disorders.

Uncommon: loss of appetite, changes in body weight.

Electrolyte and fluid balance disorders.

Rare: hyponatremia.

Psychiatric disorders.

Uncommon: insomnia, depression.

Rare: confusion, restlessness, increased excitability, difficulty concentrating, attention disturbances, cognitive disorders.

Nervous system disorders.

Common: mild, transient headache, dizziness.

Rare: somnolence, paresthesia, dysgeusia, tremor, migraine, hyperkinesia, hypoesthesia.

Very rare: aseptic meningitis in patients with systemic lupus erythematosus and mixed connective tissue diseases (see section "Special Warnings and Precautions for Use").

Eye disorders.

Common: conjunctivitis.

Rare: visual disturbances, including blurred vision, color vision defects, visual field defects, amblyopia, diplopia; scotoma, iridocyclitis.

Ear and labyrinth disorders.

Uncommon: vertigo, tinnitus.

Cardiovascular disorders.

Uncommon: palpitations, tachycardia, edema, fluid retention, heart failure, facial flushing (see section "Special Warnings and Precautions for Use").

Rare: arterial hypertension, hot flushes, hemorrhage, vasculitis, hematoma.

Respiratory, thoracic and mediastinal disorders.

Uncommon: rhinitis.

Rare: dyspnea, cough, bronchospasm.

Gastrointestinal disorders.

Common: nausea, abdominal pain, dyspepsia, diarrhea, vomiting.

Uncommon: constipation, flatulence, belching, dry mouth, gastritis, gastric and duodenal ulcers, upper abdominal pain, gum bleeding, ulcerative stomatitis.

Rare: melena, hematemesis, stomatitis, esophagitis, gastroesophageal reflux disease (GERD), dysphagia, aphthous stomatitis, glossitis, peptic ulcer perforation, hemorrhoids, gastrointestinal hemorrhage.

Hepatobiliary disorders.

Uncommon: increased levels of liver enzymes (alanine aminotransferase, aspartate aminotransferase).

Very rare: hepatotoxic effects, potentially leading to liver failure, hepatitis, jaundice, and cholestasis.

Skin and subcutaneous tissue disorders.

Uncommon: rash, pruritus, increased sweating, erythematous rash, urticaria, angioedema, alopecia.

Rare: dermatitis, eczema, maculopapular rash, purpura.

Very rare: swelling and bullous reactions, nail changes, psoriasis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders.

Uncommon: arthralgia.

Rare: bone and back pain, muscle spasms, muscle weakness, myalgia, synovitis.

Renal and urinary disorders.

Rare: nocturia, urinary disorders, increased blood urea nitrogen and creatinine levels.

Very rare: lornoxicam may cause acute renal failure in patients with pre-existing kidney conditions dependent on renal prostaglandins, which play a crucial role in maintaining renal blood flow (see section "Special Warnings and Precautions for Use"). Various forms of nephrotoxicity, including nephritis and nephrotic syndrome, are characteristic effects of NSAIDs. Cases of papillary necrosis associated with NSAID use have been reported.

General disorders.

Uncommon: malaise, facial edema.

Rare: asthenia.

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after a medicinal product is authorized is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients are encouraged to report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

Store at temperatures not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Packaging.

10 tablets in a blister pack, 1 blister in a cardboard box.

10 tablets in a blister pack, 10 blisters in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Kusum Healthcare Pvt Ltd.

Manufacturer's address and place of business.

Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Distt. Dhar, Madhya Pradesh, Pin 454774, India.