Piroxicam

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PIROXICAM (PIROXICAM)

Composition:

Active substance: piroxicam;

1 tablet contains: piroxicam 0.01 g;

Excipients: lactose monohydrate, microcrystalline cellulose, potato starch, colloidal anhydrous silicon dioxide, calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: white or almost white tablets with a yellowish tint, flat surface, beveled edges, and a score line.

Pharmacotherapeutic group.

Non-steroidal anti-inflammatory and anti-rheumatic drugs. Piroxicam.

ATC code M01A C01.

Pharmacological properties.

Pharmacodynamics.

Piroxicam belongs to the group of nonsteroidal anti-inflammatory drugs. It has anti-inflammatory, analgesic, and antipyretic activity. Its mechanism of action is due to potent and prolonged, but reversible, inhibition of prostaglandin synthesis through suppression of cyclooxygenase. It also exerts an inhibitory effect on platelet aggregation.

Pharmacokinetics.

After oral administration, piroxicam is rapidly and completely absorbed from the gastrointestinal tract. Maximum plasma concentration is reached within 3–5 hours. Steady-state blood concentration is achieved within 7–12 days. It is distributed in all tissues and organs. Plasma protein binding ranges from 90% to 98%. When administered concomitantly with other drugs, it may displace them from protein binding sites, thereby potentially enhancing their therapeutic effects. It penetrates through the placental and blood-brain barriers. It does not accumulate in the body. It is metabolized in the liver via oxidation and conjugation. Its main metabolites—5-hydroxypiroxicam, N-methylbenzene-sulfonamide, and others—are pharmacologically inactive.

The elimination half-life of piroxicam varies and is approximately 50 hours. It is prolonged in patients with hepatic impairment. Piroxicam is excreted mainly via the kidneys and through the gastrointestinal tract (approximately twice as much is found in urine as in feces), primarily in the form of glucuronides (5% is excreted unchanged). It penetrates into breast milk.

Clinical characteristics.

Indications.

Symptomatic treatment of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis.

Due to its safety profile, piroxicam is not a first-line agent when other nonsteroidal anti-inflammatory or antirheumatic drugs are indicated. The decision to prescribe piroxicam should be based on an assessment of the individual patient's overall risk.

Contraindications.

Use is contraindicated:

• in patients with a history of peptic ulcer, gastrointestinal bleeding, or perforation;
• in patients with a history of gastrointestinal disorders leading to bleeding, such as ulcerative colitis, Crohn’s disease, gastrointestinal malignancy, or diverticulitis;
• in active peptic ulcer, inflammatory gastrointestinal disorders, or gastrointestinal bleeding;
• when used concomitantly with other nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid in analgesic doses;
• when used concomitantly with anticoagulants;
• in patients with a history of serious allergic reactions of any type, particularly skin reactions such as erythema multiforme, Stevens–Johnson syndrome, or toxic epidermal necrolysis;
• in patients with hypersensitivity to the active substance or to any of the excipients, or with transient skin reactions (regardless of severity) in response to piroxicam, other NSAIDs, antirheumatic agents, or other medicinal products;
• in severe heart failure;
• in severe renal or hepatic impairment;
• in patients in whom acetylsalicylic acid or other NSAIDs have previously triggered symptoms of bronchial asthma, urticaria, rhinitis, nasal polyps, or Quincke’s edema;
• in hemorrhagic diathesis or blood dyscrasias of unknown origin (including in history).

Interaction with other medicinal products and other forms of interaction.

Caution is advised in patients taking any of the following medicinal products.

As with other NSAIDs, concomitant use of piroxicam with acetylsalicylic acid or with other NSAIDs, including other formulations of piroxicam, should be avoided, as there is insufficient evidence that such combination provides greater efficacy than piroxicam monotherapy. At the same time, the potential for adverse effects increases. Studies in volunteers show that concomitant administration of piroxicam and acetylsalicylic acid results in an 80% reduction in plasma concentrations of piroxicam compared to normal levels.

Aspirin and other NSAIDs: like other NSAIDs, piroxicam reduces platelet aggregation and prolongs bleeding time. This effect should be considered when assessing bleeding time.

Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.

Anticoagulants: NSAIDs, including piroxicam, may enhance the effect of anticoagulants such as warfarin. Therefore, concomitant use of piroxicam with anticoagulants such as warfarin should be avoided.

Methotrexate: piroxicam reduces methotrexate excretion, which may lead to acute toxicity.

Tacrolimus: increased risk of nephrotoxicity.

Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.

Lithium: piroxicam may increase plasma lithium levels and prolong or intensify its effects.

Diuretics: NSAIDs, including piroxicam, may reduce the therapeutic efficacy of diuretics when used concomitantly. Diuretics may increase the nephrotoxic potential of NSAIDs.

Concomitant use of piroxicam with potassium-sparing diuretics or other medicinal products containing potassium may pose a risk of hyperkalemia.

Antihypertensive agents: piroxicam may reduce the antihypertensive effect of angiotensin-converting enzyme (ACE) inhibitors and beta-blockers when used concomitantly.

Cardiac glycosides: NSAIDs may precipitate worsening heart failure, reduce glomerular filtration rate, and increase plasma levels of cardiac glycosides.

Digoxin, digitoxin: concomitant use with digoxin or digitoxin does not affect plasma levels of these drugs.

Quinolones: concomitant use of quinolones and piroxicam increases the risk of seizures in patients with epilepsy or a history of seizures.

Aminoglycosides: concomitant use with aminoglycosides in patients with impaired renal function leads to reduced excretion and increased plasma concentrations of the latter.

Probenecid: reduces metabolism and elimination of NSAIDs and their metabolites when used concomitantly.

Oral antidiabetic agents: NSAIDs inhibit metabolism of sulfonylurea drugs and increase the risk of hypoglycemia.

Antacids: concomitant use of antacids does not affect plasma levels of piroxicam.

Cimetidine: study results indicate increased absorption of piroxicam after cimetidine administration; however, there are no significant changes in elimination constant or half-life. The increased absorption is not considered clinically significant.

Mifepristone: NSAIDs may interfere with mifepristone-mediated termination of pregnancy.

Phenytoin: possible increase in phenytoin blood levels; appropriate monitoring and dose adjustment are recommended when initiating piroxicam therapy; therapy should be discontinued if necessary.

Cyclophosphamide, vinca alkaloids: administration of piroxicam before or after treatment with these agents may potentiate their adverse reactions (combinations should be avoided).

Cyclosporine: increased risk of gastrointestinal, renal, and/or hepatic injury (avoid concomitant use of low-dose piroxicam; monitoring of renal and hepatic function is recommended).

Alcohol: worsens tolerability of the drug (should be avoided).

Medicinal products highly bound to plasma proteins: piroxicam is highly protein-bound and may displace other highly protein-bound drugs. When piroxicam is administered to patients taking other highly protein-bound medicinal products, physicians should closely monitor patients and adjust dosage as necessary.

Special precautions for use.

Due to its safety profile, piroxicam is not a first-line treatment option when other nonsteroidal anti-inflammatory and anti-rheumatic medicinal products are indicated.

The decision to prescribe piroxicam should be based on an assessment of the individual patient's overall risk. Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

The clinical benefit and tolerability should be reviewed periodically, and treatment should be discontinued immediately at the first sign of skin reactions or clinically significant gastrointestinal reactions.

In elderly patients, the frequency of adverse reactions with NSAIDs increases, particularly gastrointestinal bleeding and perforation, which may be fatal.

Gastrointestinal effects, risk of gastrointestinal ulceration, bleeding, and perforation.

NSAIDs, including piroxicam, can cause serious gastrointestinal adverse events such as bleeding, ulceration, and perforation of the stomach, small intestine, and large intestine, which may be fatal. These serious adverse effects may occur at any time, with or without warning symptoms, in patients receiving nonsteroidal anti-inflammatory and anti-rheumatic medicinal products.

Both short- and long-term use of NSAIDs increases the risk of serious gastrointestinal toxicity. Based on observational study data, the use of piroxicam, similar to other NSAIDs, is associated with a high risk of serious gastrointestinal toxicity.

Piroxicam should be prescribed to patients with significant risk factors for serious gastrointestinal reactions only after careful evaluation of risks and benefits.

Consideration should be given to the need for concomitant therapy with gastroprotective agents (e.g., misoprostol or proton pump inhibitors) (see "Dosage and administration").

Patients at risk of serious gastrointestinal complications.

The risk of developing serious gastrointestinal complications increases with age. Patients over 70 years of age are at higher risk of complications, and gastrointestinal bleeding or perforation in this age group may be fatal. The use of the drug should be avoided in patients aged 80 years and older.

Patients taking concomitant oral corticosteroids, selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents such as low-dose acetylsalicylic acid have an increased risk of serious gastrointestinal complications (see below and section "Interaction with other medicinal products and other forms of interaction").

As with other NSAIDs, for these patients, piroxicam may be used in combination with gastroprotective agents (e.g., misoprostol or proton pump inhibitors).

During piroxicam treatment, patients and physicians should closely monitor for symptoms of gastrointestinal ulceration and/or bleeding. Patients should be instructed to report any new or unusual abdominal symptoms during treatment. If gastrointestinal complications are suspected during therapy, piroxicam should be discontinued immediately, and appropriate clinical evaluation and treatment initiated.

Cardiovascular and cerebrovascular effects.

Appropriate monitoring and patient counseling are required for patients with a history of hypertension and/or mild to moderate congestive heart failure, as there have been reports of edema and fluid retention associated with NSAID therapy.

Clinical trials and epidemiological data indicate that the use of NSAIDs (particularly at high doses and for prolonged periods) may be associated with a certain increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). There are insufficient data to exclude such a risk with piroxicam use.

The drug should be administered with caution to patients with a history of coagulation disorders, especially those with intracranial hemorrhage or hemorrhagic diathesis, as piroxicam inhibits prostaglandin biosynthesis and affects platelet function.

Piroxicam should be prescribed to patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease only after careful evaluation of risks and benefits. Such evaluation is required before initiating long-term treatment in patients with risk factors for cardiovascular complications (e.g., hypertension, hyperlipidemia, diabetes, smoking).

Arterial hypertension.

Like all NSAIDs, piroxicam may lead to the development of arterial hypertension or exacerbation of existing hypertension and, thus, increase the frequency of cardiovascular events. NSAIDs, including piroxicam, should be used with caution in patients with arterial hypertension. Blood pressure should be monitored regularly, both at the beginning of therapy and throughout the duration of piroxicam treatment.

Skin reactions.

Cases of localized drug rash have been reported with piroxicam use. Piroxicam should not be re-administered to patients with a history of localized drug rash after taking the drug. Cross-reactivity with other oxicams is possible.

Very rarely, serious skin reactions, some of which are fatal, have been reported, including cases of exfoliative dermatitis (see "Adverse reactions"). Observational study data suggest that piroxicam use may be associated with a higher risk of serious skin reactions compared to other non-oxicam NSAIDs. Cases of life-threatening skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with this medicinal product. Patients should be warned about the symptoms, and close monitoring for such skin reactions is necessary. The risk of Stevens-Johnson syndrome and toxic epidermal necrolysis is highest during the first weeks of treatment. If signs of toxic epidermal necrolysis or Stevens-Johnson syndrome (e.g., progressive skin rash, possibly with blisters and mucosal involvement) appear, piroxicam treatment should be discontinued. Optimal outcomes in managing these reactions are achieved with early diagnosis and immediate discontinuation of any suspected medicinal product. If a patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis while taking piroxicam, this drug should not be prescribed again to that patient.

Piroxicam should be used with caution in patients with renal impairment due to the potential for kidney damage. In rare cases, the drug may cause interstitial nephritis, glomerulonephritis, renal papillary necrosis, or nephrotic syndrome. Like other NSAIDs, piroxicam inhibits renal prostaglandin synthesis, which supports renal perfusion in patients with reduced renal blood flow and overall blood volume. In such patients, NSAID use may lead to marked renal decompensation, requiring discontinuation of treatment. The highest risk of such complications exists in patients with congestive heart failure, liver cirrhosis, nephrotic syndrome, and kidney disease; therefore, they should be closely monitored during NSAID therapy.

Long-term treatment with piroxicam, as with other NSAIDs, may cause changes in liver function, necessitating periodic monitoring of liver enzymes.

Due to its anti-inflammatory effect, the medicinal product may mask symptoms of acute inflammation; therefore, the presence of bacterial infection should be ruled out before prescribing.

There is a risk of hyperkalemia with NSAID use, particularly in patients aged 65 years and older, those with renal impairment, and those treated with beta-blockers, ACE inhibitors, and potassium-sparing diuretics. Serum potassium levels should be monitored in these patients.

Since the medicinal product contains lactose, it should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

The drug is not indicated for the treatment of postoperative pain following coronary artery bypass grafting.

Eyes.

Adverse reactions affecting the eyes may occur during NSAID therapy. Therefore, patients with a history of eye disorders should be monitored by an ophthalmologist during piroxicam treatment.

Laboratory tests.

Piroxicam administration should be monitored in cases of impaired renal function. Piroxicam administration should also be monitored in cases of impaired liver function. During long-term use of piroxicam, continuous monitoring of blood laboratory parameters (hemoglobin, hematocrit), coagulation, liver, and kidney function is required. Piroxicam, like other nonsteroidal anti-rheumatic drugs, inhibits platelet aggregation and thus prolongs bleeding time; this should be considered when determining bleeding time.

Adaptive porphyria.

Piroxicam may be used in patients with adaptive porphyria only after careful evaluation of risks and benefits, as disease exacerbation is possible. Careful consideration of the appropriateness of treatment is required before prescribing the drug to patients with bronchial asthma, allergic rhinitis, nasal mucosal polyps, or chronic obstructive pulmonary diseases.

Alcohol consumption should be avoided during treatment.

Prolonged use of analgesics may lead to medication-overuse headache, which does not respond to increased drug dosage. Patients should be informed about this.

Abrupt discontinuation of analgesics after prolonged use at high doses may cause symptoms (headache, fatigue, nervousness), which usually resolve within a few days. Resumption of analgesic use should only be initiated with a physician's approval and in the absence of symptoms.

Use during pregnancy or breastfeeding.

Pregnancy. The drug should not be used during pregnancy due to insufficient safety data. In animal studies, no teratogenic effects were observed. Piroxicam reduces the synthesis and release of prostaglandins through reversible inhibition of the enzyme cyclooxygenase. This effect, as with other NSAIDs, is associated with increased incidence of difficult and prolonged labor in experimental animals when drug administration continues in late pregnancy. NSAIDs are known to have the potential to induce premature closure of the ductus arteriosus in newborns.

Starting from the 20th week of pregnancy, piroxicam use may cause oligohydramnios due to fetal renal dysfunction. This may occur soon after initiation of treatment and is usually reversible upon discontinuation of therapy. Additionally, there have been reports of ductus arteriosus constriction after second-trimester treatment, most of which resolved after discontinuation of therapy.

Fetal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after piroxicam exposure for several days, starting from the 20th gestational week. Piroxicam treatment should be discontinued if oligohydramnios or ductus arteriosus constriction is detected.

Breastfeeding. Experimental studies show that the amount of piroxicam passing into breast milk is approximately 1% to 3% of its plasma concentration in the mother. No accumulation in breast milk has been observed.

The use of piroxicam during breastfeeding is contraindicated due to insufficient safety data or requires discontinuation of breastfeeding during treatment.

Reversible inhibition of fertility in women of reproductive age should be considered when attempting pregnancy.

Ability to affect reaction speed when driving vehicles or operating machinery.

Piroxicam may cause adverse reactions such as tinnitus, dizziness, somnolence, and auditory and visual disturbances, which may impair alertness and reflexes. Drivers and machine operators should be aware of these adverse effects, especially at the beginning of piroxicam treatment. Therefore, during treatment with this drug, it is advisable to refrain from driving vehicles and operating machinery.

Dosage and Administration.

Initial prescription of piroxicam should be made by a physician experienced in the diagnostic evaluation and treatment of patients with inflammatory or degenerative rheumatic diseases. The maximum recommended daily dose is 20 mg.

Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

The benefit of treatment and drug tolerability should be reviewed every 14 days. If long-term treatment is considered necessary, this reassessment should be performed more frequently. Given the established fact that piroxicam use increases the risk of gastrointestinal complications, concomitant use of gastroprotective agents (e.g., misoprostol or proton pump inhibitors) should be considered, especially in elderly patients.

Adults.

Take orally 2 tablets (total dose 20 mg) once daily, preferably during or immediately after a meal, with water.

The duration of treatment depends on the course of the disease and is determined individually by the physician. When combining different dosage forms of the drug (capsules, tablets, solutions, suspensions, suppositories), the total daily dose must not exceed 20 mg.

Elderly patients (over 65 years of age).

Special caution is required when treating patients over 65 years of age with piroxicam, particularly in those with impaired renal, hepatic, or cardiac function.

Children.

There is insufficient clinical experience with the use of piroxicam in children.

Overdose.

Symptoms of overdose.

Gastrointestinal disturbances such as nausea, vomiting, abdominal pain, possible gastrointestinal bleeding, as well as dizziness, headache, confusion, tinnitus, and hyperventilation leading to respiratory alkalosis, arterial hypertension. In later stages, central nervous system depression, hyperthermia, respiratory and metabolic acidosis, toxic circulatory failure, renal dysfunction (hematuria, proteinuria, acute renal failure), and hepatic dysfunction (hypoprothrombinemia), cerebral and pulmonary edema may develop; increased risk of seizures and coma.

Treatment of overdose.

There is no specific antidote. The prolonged half-life of piroxicam should be taken into account. Based on animal studies, elimination of piroxicam may be accelerated by administration of antacids and activated charcoal.

• Initial elimination (careful gastric lavage);
• monitoring of acid-base balance;
• correction of electrolyte and glucose levels;
• intensive supportive care;
• enhanced elimination (alkalinized, forced diuresis);
• administration of diazepam in case of seizures.

Administration of activated charcoal (only in conscious patients!) affects the resorption and absorption of piroxicam, thereby reducing the total amount of active substance in blood plasma.

Studies on the use of hemodialysis to accelerate elimination have not been conducted; however, hemodialysis may be ineffective due to the high protein binding of piroxicam.

Adverse Reactions

Below is a list of adverse reactions, categorized by organ systems according to frequency: very common (> 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated from available data).

Gastrointestinal system.

Very common: heartburn, epigastric pain, nausea, vomiting, flatulence, diarrhea, constipation, minor gastrointestinal blood loss, which in exceptional cases may lead to anemia.

Common: anorexia or increased appetite, belching, dyspepsia, digestive disturbances, gastrointestinal ulcers (in some cases with hemorrhage), and perforation, ulcerative stomatitis, gastritis, exacerbation of colitis or Crohn’s disease.

Uncommon: melena (black stools), vomiting blood or coffee-ground-like vomitus, ulcers with severe bleeding up to perforation.

Very rare: pancreatitis, esophagitis, abdominal pain, non-specific bleeding, and in some cases even ulcerative colitis.

Frequency not known: glossitis, hematemesis, rectal bleeding.

Nervous system and psychiatric disorders.

Uncommon: headache, dizziness and fatigue, somnolence, obtundation, fever, paresthesia, insomnia, pathological dreams, depression, irritability, nervousness, confusion, mood changes, hallucinations, agitation.

Rare: seizures.

Frequency not known: vertigo, disorientation, anxiety, weakness, difficulty concentrating, psychotic reactions, sensory disturbances including paresthesia, memory disorders.

Cardiovascular system.

Uncommon: hypertension, palpitations, tachycardia.

Rare: shock, acute heart failure.

Very rare: myocardial infarction.

Frequency not known: palpitations, angina pectoris, arrhythmia, stroke.

Blood and lymphatic system.

Uncommon: decreased hemoglobin and hematocrit levels without visible gastrointestinal bleeding, anemia (including aplastic and hemolytic anemia), leukopenia, agranulocytosis, eosinophilia, thrombocytopenia, pancytopenia, panmyelopathy.

Very rare: prolonged duration and increased severity of bleeding.

Skin and subcutaneous tissue.

Common: eczema, skin itching, hyperhidrosis.

Uncommon: photosensitivity of the skin accompanied by itching, redness, allergic edema.

Rare: alopecia, onycholysis, nail growth disturbances.

Very rare: bullous skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell’s syndrome), skin peeling, erythema multiforme.

Frequency not known: exfoliative dermatitis, allergic-type purpura, localized drug rash.

Renal and urinary system.

Common: fluid retention, increased blood urea concentration.

Uncommon: edema, particularly in patients with arterial hypertension or renal insufficiency, increased creatinine levels, renal failure, nephrotic syndrome, interstitial nephritis, azotemia, dysuria, pollakiuria, polyuria, hematuria.

Rare: acute renal failure.

Frequency not known: proteinuria, papillary necrosis.

Eye organs.

Frequency not known: diplopia, eye swelling, blurred vision, eye irritation.

Ear and labyrinth disorders.

Common: tinnitus.

Uncommon: hearing disturbances, deafness.

Hepatobiliary system.

Common: increased serum transaminases (alanine aminotransferase, aspartate aminotransferase) and alkaline phosphatase, cholestatic syndrome, hepatitis.

Uncommon: jaundice.

Very rare: liver failure.

Frequency not known: transient increase in bilirubin.

General disorders.

Uncommon: weight changes, malaise, influenza-like symptoms (chills, muscle pain).

Frequency not known: taste disturbances.

Immune system.

Uncommon: allergic reactions (bronchospasm, anaphylactic or anaphylactoid reactions, urticaria, angioedema).

Rare: dyspnea, appearance of antinuclear antibodies in blood, exacerbation of collagenoses, serum sickness.

Very rare: severe hypersensitivity reactions.

Frequency not known: erythema multiforme, fever.

Respiratory system.

Frequency not known: respiratory depression, pneumonia.

Metabolism and nutrition.

Uncommon: changes in blood glucose concentration.

Frequency not known: hypoglycemia, hyperglycemia, increased sweating, onycholysis, nail growth disturbances, alopecia, weight gain or weight loss.

Infections and infestations.

Very rare: exacerbation of infection due to inflammation (development of necrotizing fasciitis) associated with temporary systemic use of nonsteroidal anti-inflammatory agents.

Vascular system.

Rare: vasculitis.

Very rare: skin hemorrhages (Henoch-Schönlein purpura), bleeding from the oral cavity and oral mucosa.

Patients should be informed that if signs of serious adverse effects occur, they must immediately discontinue the medication and seek medical advice.

This includes the following symptoms:

• abdominal discomfort, heartburn, or abdominal pain;
• vomiting blood or coffee-ground-like vomitus;
• black-colored stools or blood in urine;
• skin reactions such as rash or itching, skin peeling;
• difficulty breathing, respiratory distress, or dyspnea, swelling of the head area;
• yellowing of the skin and whites of the eyes;
• severe feeling of stomach fullness with loss of appetite;
• persistent sore throat, mouth ulcers, weakness, or fever;
• nosebleeds, skin hemorrhages;
• facial, foot, or leg edema;
• reduced urine output with edema formation, fatigue;
• severe headaches or nuchal rigidity;
• chest pain;
• confusion.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 tablets per blister pack.

10 tablets in a blister; 1 or 2 blisters per cardboard box.

Prescription category.

Prescription only.

Manufacturer.

JSC "Chemical and Pharmaceutical Plant "Chervona Zirka".

Manufacturer's address and place of business.

1 Gordienkovskaya St., Kharkiv, 61010, Ukraine.