Urinalgin^® F (Tablets) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

OHFK, JSC (Russia)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

G04BX06 (Phenazopyridine)

Active Substance

Phenazopyridine (Rec.INN)

Dosage Form

Urinalgin® F

Film-coated tablets, 100 mg: 12 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets brown in color, round, biconvex; on the cross-section, the core is brown with white specks, turns red upon exposure to air.

Excipients: sodium carboxymethyl starch, microcrystalline cellulose, colloidal silicon dioxide, talc, magnesium stearate.

Shell composition Vivacoat^® PA-6P-268 [hypromellose 6, talc, polydextrose (E1200), titanium dioxide, macrogol 3350, iron oxide black color, iron oxide yellow color, iron oxide red color].

6 pcs. – contour cell packaging (1) – cardboard packs.
6 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (3) – cardboard packs.
6 pcs. – contour cell packaging (4) – cardboard packs.
6 pcs. – contour cell packaging (5) – cardboard packs.
7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.

Clinical-Pharmacological Group

A drug with local analgesic action for use in urology

Pharmacotherapeutic Group

Drugs used in urology; other drugs used in urology

Pharmacological Action

Phenazopyridine, excreted in the urine, acts on the mucous membrane of the lower urinary tract, where it exerts a local analgesic effect. This action helps reduce dysuric symptoms, including pain, burning, and frequent urination. The exact mechanism of action is unknown.

Pharmacokinetics

The pharmacokinetic properties of phenazopyridine have not been fully studied.

Metabolism and excretion

Phenazopyridine and its metabolites are rapidly excreted from the body by the kidneys: 90% within 24 hours when taking phenazopyridine 600 mg/day, with 41% as unchanged drug and 49% as a metabolite.

Indications

• Symptomatic therapy of dysuria (including pain, burning, frequent urination) caused by irritation of the mucous membrane of the lower urinary tract due to infections, trauma, surgical interventions, endoscopic procedures, use of a probe or catheter.

ICD codes

Dosage Regimen

Take orally, during or after meals, with a full glass of water. The tablets should be taken whole, without chewing.

2 tablets (200 mg) 3 times/day. The duration of treatment should not exceed 2 days (including in combination with antibacterial drugs).

In case of a missed dose, the tablets should be taken as soon as the patient remembers. If the patient remembers the missed dose directly before taking the next dose, a double dose of the drug should not be taken.

Special patient groups

Patients with impaired renal function

The use of Urinalgin^® F in patients with renal failure is contraindicated.

Patients with impaired hepatic function

The use of Urinalgin^® F in patients with hepatic failure is contraindicated.

Children

The use of Urinalgin^® F in children and adolescents under 18 years of age is contraindicated.

Adverse Reactions

In accordance with the WHO classification, adverse reactions are presented according to their frequency of occurrence: very common (≥1/10), common (≥1/100 but <1/10), uncommon (≥1/1000 but <1/100), rare (≥1/10000 but <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data).

Blood and lymphatic system disorders frequency unknown – methemoglobinemia, hemolytic anemia (in glucose-6-phosphate dehydrogenase deficiency), sulfhemoglobinemia, neutropenia, leukopenia, pancytopenia.

Immune system disorders rare – skin rash, itching, fever and other hypersensitivity reactions; very rare – bronchospasm; frequency unknown – anaphylactoid reaction.

Nervous system disorders rare – headache, dizziness, aseptic meningitis.

Eye disorders frequency unknown – visual impairment, eye irritation, reversible loss of color vision.

Ear and labyrinth disorders frequency unknown – ear pain.

Gastrointestinal disorders uncommon – nausea, vomiting, diarrhea, orange-red discoloration of feces.

Hepatobiliary disorders very rare – acute hepatotoxicity (associated with drug overdose), jaundice; frequency unknown – allergic hepatitis.

Skin and subcutaneous tissue disorders very rare (with prolonged use) – change in skin and sclera pigmentation with yellowish discoloration; frequency unknown – yellowing of nails.

Renal and urinary disorders uncommon – dark orange or reddish discoloration of urine; frequency unknown – uronephrolithiasis, acute nephrotoxicity (associated with drug overdose).

General disorders and administration site conditions very rare (with prolonged use) – edema of the face, upper and lower extremities.

Contraindications

• Hypersensitivity to phenazopyridine or to any of the excipients included in the drug;
• Impaired liver function (hepatic failure);
• Renal failure;
• Anemia and methemoglobinemia;
• Breastfeeding period (safety not established);
• Pregnancy;
• Age under 18 years.

With caution

• Glucose-6-phosphate dehydrogenase deficiency;
• Heart failure;
• Neuromuscular diseases;
• Age over 65 years (lack of experience in use).

Use in Pregnancy and Lactation

Pregnancy

In preclinical animal studies, no data on the teratogenic effect of phenazopyridine were obtained (when administered with sulfacitin to rats at a dose of up to 110 mg/kg/day and to rabbits at a dose of up to 39 mg/kg/day). Nevertheless, due to the lack of clinical studies on the safety of phenazopyridine use in pregnant women and its ability to cross the placental barrier during pregnancy, the use of phenazopyridine during pregnancy is contraindicated.

Breastfeeding period

There are no data on the penetration of phenazopyridine into human breast milk. The use of phenazopyridine during breastfeeding is contraindicated.

Use in Hepatic Impairment

The use of Urinalgin^® F in patients with hepatic failure is contraindicated.

Use in Renal Impairment

The use of Urinalgin^® F in patients with renal failure is contraindicated.

Pediatric Use

The use of Urinalgin^® F in children and adolescents under 18 years of age is contraindicated.

Geriatric Use

In elderly patients (over 65 years of age), use with caution (lack of experience in use).

Special Precautions

The use of phenazopyridine to relieve dysuria symptoms due to infection should not delay diagnosis and initiation of pathogenetic therapy. The drug should be used for symptomatic pain relief, not as a replacement for specific antibacterial therapy.

In patients with glucose-6-phosphate dehydrogenase deficiency, taking phenazopyridine can lead to hemolysis of red blood cells and the development of methemoglobinemia.

When using phenazopyridine, urine (with an alkaline reaction) may turn dark orange or reddish and feces may turn orange-red. A yellowish color of the skin or sclera may indicate accumulation of phenazopyridine due to impaired renal function or overdose or taking the drug for more than 2 days, which requires discontinuation of the drug.

Wearing contact lenses should be avoided, as Phenazopyridine may cause staining of contact lenses.

Treatment with phenazopyridine should not exceed 2 days. 2,3,6-triaminopyridine (one of the metabolites of phenazopyridine) in toxicological studies demonstrated the ability to damage striated muscle cells and cardiomyocytes. Caution is recommended when using phenazopyridine in patients with heart disease and neuromuscular diseases.

Phenazopyridine is contraindicated in patients with any liver disease. Phenazopyridine is contraindicated in patients with renal failure. The possibility of age-related decline in renal function should be considered. Data on the use of phenazopyridine in patients over 65 years of age, including those with impaired renal function, are lacking.

Phenazopyridine may cause changes in urine test results performed by colorimetric, photometric, and fluorimetric methods (determination of ketone bodies, porphyrins, urobilinogen).

Effect on ability to drive vehicles and operate machinery

The potential for the development of such an adverse reaction as dizziness should be taken into account. If dizziness occurs, refrain from driving vehicles and operating machinery.

Overdose

Exceeding the recommended dose of phenazopyridine (especially in patients with reduced renal function, as well as in elderly patients) can lead to an increase in its serum concentration and the development of toxic reactions.

Symptoms methemoglobinemia (especially in patients with glucose-6-phosphate dehydrogenase deficiency), nephro- and hepatotoxic manifestations, as well as increased severity of other adverse drug reactions.

In case of an overdose of Urinalgin^® F, a doctor should be consulted immediately.

Treatment discontinue the drug, induce vomiting and perform other measures aimed at removing phenazopyridine from the body, as well as symptomatic therapy. To eliminate methemoglobinemia and associated symptoms, intravenous administration of a 1% solution of methylene blue (1-2 mg/kg) is advisable.

Drug Interactions

When taken concomitantly, Phenazopyridine may increase the bioavailability of ciprofloxacin.

Information on interactions with other drugs is not available.

If necessary, Phenazopyridine can be prescribed in combination with antibacterial drugs.

Storage Conditions

The drug should be stored in a light-protected place, at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 5 years.

Dispensing Status

Available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.