Fespalen (Tablets, Syrup) Instructions for Use
ATC Code
R03DX03 (Fenspiride)
Active Substance
Fenspiride (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Agent with anti-inflammatory and anti-bronchoconstrictor activity
Pharmacotherapeutic Group
Anti-inflammatory anti-bronchoconstrictor agent
Pharmacological Action
A bronchodilator and anti-inflammatory agent. It 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.
It 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
It is well absorbed from the gastrointestinal tract.
Cmax is reached 6 hours after administration and decreases 3-fold after 12 hours.
It is excreted mainly by the kidneys (90%), and through the intestines – 10%.
T1/2 is 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
| ICD-10 code | Indication |
| A37 | Whooping cough |
| B05 | Measles |
| H66 | Suppurative and unspecified otitis media |
| J00 | Acute nasopharyngitis (common cold) |
| J01 | Acute sinusitis |
| J02 | Acute pharyngitis |
| J04 | Acute laryngitis and tracheitis |
| J06.9 | Acute upper respiratory infection, unspecified |
| J10 | Influenza due to identified seasonal influenza virus |
| J20 | Acute bronchitis |
| J31.0 | Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis) |
| J31.2 | Chronic pharyngitis |
| J32 | Chronic sinusitis |
| J37 | Chronic laryngitis and laryngotracheitis |
| J42 | Unspecified chronic bronchitis |
| J45 | Asthma |
| R05 | Cough |
| ICD-11 code | Indication |
| 1C12.Z | Whooping cough, unspecified |
| 1E30 | Influenza due to identified seasonal influenza virus |
| 1F03 | Measles |
| AA9Z | Unspecified suppurative otitis media |
| CA00 | Acute nasopharyngitis |
| CA01 | Acute rhinosinusitis |
| CA02.Z | Acute pharyngitis, unspecified |
| CA05 | Acute laryngitis or tracheitis |
| CA07.0 | Acute upper respiratory tract infection of unspecified site |
| CA09.0 | Chronic rhinitis |
| CA09.2 | Chronic pharyngitis |
| CA0A.Z | Chronic rhinosinusitis, unspecified |
| CA0G | Chronic laryngitis or laryngotracheitis |
| CA20.1Z | Chronic bronchitis, unspecified |
| CA23 | Asthma |
| CA42.Z | Acute bronchitis, unspecified |
| MD12 | Cough |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Take Fespalen orally before meals to ensure optimal absorption.
For adult patients, the standard dosage is 80 mg administered two to three times per day.
For pediatric patients over 2 years of age, calculate the daily dose based on 4 mg per kilogram of body weight per day.
Divide the total daily pediatric dose into two or three separate administrations throughout the day.
Use only the age-appropriate dosage form (tablets or syrup) as specified for the child’s age group.
The maximum daily dose for adults should generally not exceed 240 mg.
Adhere strictly to the prescribed dosing schedule and do not exceed the recommended duration of therapy.
For patients with renal impairment, consider potential adjustment of the dosing regimen based on clinical assessment.
If a dose is missed, take it as soon as remembered unless it is almost time for the next scheduled dose; in that case, continue with the regular schedule and do not double the dose.
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); childhood – 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
It can be used in children according to indications, in age-appropriate 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 should not be a reason to delay the adequate prescription of antibacterial drugs.
Fenspiride should be used with caution simultaneously with sedative drugs.
Effect on the ability to drive vehicles and machinery
During the use of fenspiride, patients should exercise caution when driving vehicles and machinery, 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 enhancement of 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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Film-coated tablets, 80 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 180, 200, or 300 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
 |
Fespalen | Film-coated tablets, 80 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 180, 200, or 300 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; on the cross-section – a white or almost white core and a film coating.
| 1 tab. | |
| Fenspiride hydrochloride | 80 mg |
Excipients : calcium hydrogen phosphate dihydrate – 118 mg, hypromellose – 106 mg, povidone K25 – 13 mg, colloidal silicon dioxide – 1 mg, magnesium stearate – 2 mg.
Coating composition hypromellose – 4.7 mg, macrogol 4000 – 0.9 mg, titanium dioxide – 1.15 mg, magnesium stearate – 0.25 mg.
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.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
20 pcs. – contour cell packaging (6) – cardboard packs.
20 pcs. – contour cell packaging (10) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
Syrup 2 mg/ml: 150 ml or 250 ml bottle with measuring spoon
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Fespalen | Syrup 2 mg/ml: 150 ml or 250 ml bottle with measuring spoon |
Dosage Form, Packaging, and Composition
Syrup orange in color, transparent, with a characteristic odor; sediment may form, which disappears upon shaking.
| 1 ml | |
| Fenspiride hydrochloride | 2 mg |
Excipients : methylparahydroxybenzoate – 0.9 mg, propylparahydroxybenzoate – 0.35 mg, potassium sorbate – 1.9 mg, sorbitol – 852 mg, glycerol – 225 mg, sodium citrate – 6 mg, citric acid monohydrate – 1.5 mg, sodium saccharin – 0.45 mg, honey flavor – 1 mg, fruit flavor – 0.1 mg, sunset yellow dye – 0.1 mg, purified water – up to 1 ml.
100 ml – dark glass bottles (1) with a measuring spoon – cardboard packs.
100 ml – polyethylene terephthalate bottles (1) with a measuring spoon – cardboard packs.
150 ml – dark glass bottles (1) with a measuring spoon – cardboard packs.
150 ml – polyethylene terephthalate bottles (1) with a measuring spoon – cardboard packs.
100 ml – dark glass bottles (1) with a measuring spoon – cardboard packs (2) – cardboard boxes (for hospitals).
100 ml – polyethylene terephthalate bottles (1) with a measuring spoon – cardboard packs (2) – cardboard boxes (for hospitals).
100 ml – dark glass bottles (1) with a measuring spoon – cardboard packs (3) – cardboard boxes (for hospitals).
100 ml – polyethylene terephthalate bottles (1) with a measuring spoon – cardboard packs (3) – cardboard boxes (for hospitals).
150 ml – dark glass bottles (1) with a measuring spoon – cardboard packs (2) – cardboard boxes (for hospitals).
150 ml – polyethylene terephthalate bottles (1) with a measuring spoon – cardboard packs (2) – cardboard boxes (for hospitals).
150 ml – dark glass bottles (1) with a measuring spoon – cardboard packs (3) – cardboard boxes (for hospitals).
150 ml – polyethylene terephthalate bottles (1) with a measuring spoon – cardboard packs (3) – cardboard boxes (for hospitals).
Dispersible tablets 20 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 50, 56, 60, 70, 75, 80, 84, 90, 100, 120, 125, 140, 150, 180, 200, 250 or 300 pcs.
Dispersible tablets 40 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 50, 56, 60, 70, 75, 80, 84, 90, 100, 120, 125, 140, 150, 180, 200, 250 or 300 pcs.
Dispersible tablets 80 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 50, 56, 60, 70, 75, 80, 84, 90, 100, 120, 125, 140, 150, 180, 200, 250, or 300 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Forms
|
Fespalen Solution Tablets | Dispersible tablets 20 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 50, 56, 60, 70, 75, 80, 84, 90, 100, 120, 125, 140, 150, 180, 200, 250 or 300 pcs. |
| Dispersible tablets 40 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 50, 56, 60, 70, 75, 80, 84, 90, 100, 120, 125, 140, 150, 180, 200, 250 or 300 pcs. | ||
| Dispersible tablets 80 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 50, 56, 60, 70, 75, 80, 84, 90, 100, 120, 125, 140, 150, 180, 200, 250, or 300 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or white with a yellowish tint, round, flat-cylindrical, with a score on one side, with a faint characteristic odor; slight marbling and surface roughness are allowed.
| 1 tab. | |
| Fenspiride hydrochloride | 20 mg |
Excipients : calcium hydrogen phosphate dihydrate – 133.5 mg, microcrystalline cellulose – 38.5 mg, crospovidone type A – 13.5 mg, aspartame – 7 mg, sodium saccharin – 1.25 mg, citric acid monohydrate – 4.5 mg, sodium stearyl fumarate – 2.25 mg, colloidal silicon dioxide – 2.25 mg, raspberry flavor – 2.25 mg.
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.
7 pcs. – contour cell packaging (6) – cardboard packs.
7 pcs. – contour cell packaging (10) – 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.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
20 pcs. – contour cell packaging (6) – cardboard packs.
20 pcs. – contour cell packaging (10) – cardboard packs.
25 pcs. – contour cell packaging (1) – cardboard packs.
25 pcs. – contour cell packaging (2) – cardboard packs.
25 pcs. – contour cell packaging (3) – cardboard packs.
25 pcs. – contour cell packaging (4) – cardboard packs.
25 pcs. – contour cell packaging (5) – cardboard packs.
25 pcs. – contour cell packaging (6) – cardboard packs.
25 pcs. – contour cell packaging (10) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
Film-coated tablets white or white with a yellowish tint, round, flat-cylindrical, with a score on one side, with a faint characteristic odor; slight marbling and surface roughness are allowed.
| 1 tab. | |
| Fenspiride hydrochloride | 40 mg |
Excipients : calcium hydrogen phosphate dihydrate – 113.5 mg, microcrystalline cellulose – 38.5 mg, crospovidone type A – 13.5 mg, aspartame – 7 mg, sodium saccharin – 1.25 mg, citric acid monohydrate – 4.5 mg, sodium stearyl fumarate – 2.25 mg, colloidal silicon dioxide – 2.25 mg, raspberry flavor – 2.25 mg.
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.
7 pcs. – contour cell packaging (6) – cardboard packs.
7 pcs. – contour cell packaging (10) – 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.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
20 pcs. – contour cell packaging (6) – cardboard packs.
20 pcs. – contour cell packaging (10) – cardboard packs.
25 pcs. – contour cell packaging (1) – cardboard packs.
25 pcs. – contour cell packaging (2) – cardboard packs.
25 pcs. – contour cell packaging (3) – cardboard packs.
25 pcs. – contour cell packaging (4) – cardboard packs.
25 pcs. – contour cell packaging (5) – cardboard packs.
25 pcs. – contour cell packaging (6) – cardboard packs.
25 pcs. – contour cell packaging (10) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
Film-coated tablets white or white with a yellowish tint, round, flat-cylindrical, with a score on one side, with a faint characteristic odor; slight marbling and surface roughness are allowed.
| 1 tab. | |
| Fenspiride hydrochloride | 80 mg |
Excipients: calcium hydrogen phosphate dihydrate – 227 mg, microcrystalline cellulose – 77 mg, crospovidone type A – 27 mg, aspartame – 14 mg, sodium saccharin – 2.5 mg, citric acid monohydrate – 9 mg, sodium stearyl fumarate – 4.5 mg, colloidal silicon dioxide – 4.5 mg, raspberry flavor – 4.5 mg.
7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (6) – cardboard packs.
7 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (2) – cardboard packs.
25 pcs. – contour cell packs (3) – cardboard packs.
25 pcs. – contour cell packs (4) – cardboard packs.
25 pcs. – contour cell packs (5) – cardboard packs.
25 pcs. – contour cell packs (6) – cardboard packs.
25 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
![Fespalen [Tablets, Syrup] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Fespalen [Tablets, Syrup] 2")