Glenspiride (Tablets) Instructions for Use

Marketing Authorization Holder

Glenmark Pharmaceuticals, Ltd. (India)

ATC Code

R03DX03 (Fenspiride)

Active Substance

Fenspiride (Rec.INN registered by WHO)

Dosage Form

Glenspiride

Extended-release film-coated tablets, 80 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Extended-release film-coated tablets from white to almost white, round, biconvex, smooth on both sides; the core on the cross-section is from white to almost white.

Excipients: anhydrous calcium hydrogen phosphate (A-TAB) – 104.5 mg, hypromellose 2208, 17700 mPa·s (Methocel K-15MCR) – 100 mg, povidone K-30 (Kollidon 30) – 12.8 mg, colloidal anhydrous silicon dioxide (Aerosil 200 Pharma) – 0.5 mg, magnesium stearate (PARTEC LUB MST) – 2.2 mg.

Shell composition Opadry white II 02G280001 – 6 mg (hypromellose HPMC 2910 – 4.3704 mg, titanium dioxide – 0.8412 mg, magnesium stearate – 0.2628 mg, macrogol (PEG) – 0.2628 mg, glycerol (glycerin) – 0.2628 mg).

15 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Agent with anti-inflammatory and anti-bronchoconstrictor activity

Pharmacotherapeutic Group

Anti-inflammatory anti-bronchoconstrictor agent

Pharmacological Action

A drug with bronchodilator and anti-inflammatory action. Reduces the manifestations of bronchospasm and inflammation in the airways. The mechanism of action is associated with antagonistic activity against histamine H₁ receptors and with myotropic antispasmodic activity.

Reduces the production of a number of biologically active substances involved in the development of inflammation and contributing to increased bronchial tone (including cytokines, TNFα, arachidonic acid derivatives, free radicals).

Pharmacokinetics

Well absorbed from the gastrointestinal tract. C_max is reached 6 hours after administration and decreases 3-fold after 12 hours.

Excreted mainly by the kidneys (90%), through the intestines – 10%. T_1/2 – 12 hours.

Indications

Rhinopharyngitis, laryngitis, otitis, sinusitis, rhinotracheobronchitis, bronchitis, maintenance therapy for isolated and complicated bronchial asthma, respiratory symptoms in measles, whooping cough, influenza; infectious diseases of the respiratory tract accompanied by cough, when standard antibiotic therapy is indicated.

ICD codes

Dosage Regimen

Take orally before meals. Swallow the tablet whole with water. Do not crush, split, or chew the extended-release tablet.

For adults, the standard dosage is 80 mg two to three times daily. The maximum daily dose is 240 mg.

For children over 2 years of age, the dosage is 4 mg per kg of body weight per day. Divide the total daily dose into multiple administrations. Use only the pediatric dosage form for this calculation; this 80 mg extended-release tablet is not suitable for pediatric dosing based on this regimen.

The duration of treatment is determined by the physician based on the indication and clinical response. Do not exceed the prescribed dose.

For bronchial asthma, use as a maintenance therapy alongside other prescribed treatments.

If a dose is missed, take it as soon as remembered unless it is almost time for the next dose. Do not double the dose to catch up.

Adverse Reactions

From the cardiovascular system rarely – tachycardia, the severity of which decreases with dose reduction; frequency unknown – palpitations, decreased blood pressure, possibly associated with tachycardia.

From the digestive system often – dyspeptic symptoms, nausea, pain in the epigastric region; frequency unknown – diarrhea, vomiting.

From the nervous system rarely – drowsiness; frequency unknown – dizziness.

From the skin and subcutaneous tissues: rarely – erythema, rash, urticaria, angioedema, fixed pigmentary erythema; frequency unknown – skin itching, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Other: frequency unknown: asthenia – increased fatigue.

Contraindications

Hypersensitivity to fenspiride; pregnancy, lactation (breastfeeding); children’s age – depending on the dosage form.

With caution

Concomitant use of sedative drugs.

Use in Pregnancy and Lactation

Fenspiride is contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Can be used in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the fenspiride drug leaflets regarding contraindications for the use of specific fenspiride dosage forms in children of different ages.

Special Precautions

Treatment with fenspiride does not replace antibacterial therapy and cannot be a reason for delaying the adequate prescription of antibacterial drugs.

Fenspiride should be used with caution simultaneously with sedative drugs.

Effect on the ability to drive vehicles and mechanisms

During the use of fenspiride, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

When using fenspiride in combination with drugs that have a sedative effect, or together with alcohol, an increase in the sedative effect is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.