Syresp (Syrup) Instructions for Use

Marketing Authorization Holder

Polpharma Pharmaceutical Works, Sa (Poland)

Manufactured By

Medana Pharma, SA (Poland)

ATC Code

R03DX03 (Fenspiride)

Active Substance

Fenspiride (Rec.INN registered by WHO)

Dosage Form

Syresp

Syrup 2 mg/1 ml: 150 ml or 250 ml bottle with dosing spoon or dosing syringe

Dosage Form, Packaging, and Composition

Syrup is a transparent orange-colored liquid; opalescence is allowed.

Excipients: methylparaben – 0.9 mg, propylparaben – 0.35 mg, potassium sorbate – 1.9 mg, glycerol – 22.5 mg, sodium saccharin – 0.45 mg, sucrose – 600 mg, vanilla flavor – 4 mg, honey flavor – 2.5 mg, sunset yellow FCF (E110) – 0.1 mg, citric acid monohydrate – 0.2 mg, purified water – up to 1 ml.

150 ml – dark plastic bottles (1) in a cardboard box with a dosing spoon.

Clinical-Pharmacological Group

Agent with anti-inflammatory and anti-bronchoconstrictor activity

Pharmacotherapeutic Group

Anti-inflammatory anti-bronchoconstrictor agent

Pharmacological Action

Fenspiride exhibits anti-inflammatory and anti-bronchoconstrictor activity by reducing the production of a number of biologically active substances (cytokines (especially TNFα), arachidonic acid derivatives, free radicals), which play an important role in the development of inflammation and bronchospasm.

Fenspiride’s inhibition of arachidonic acid metabolism is potentiated by the blockade of histamine H₁-receptors, since histamine stimulates the metabolism of arachidonic acid with the formation of prostaglandins and leukotrienes. Fenspiride blocks α-adrenergic receptors, the stimulation of which is accompanied by an increase in the secretion of bronchial glands. Thus, Fenspiride reduces the action of a number of factors that contribute to the hypersecretion of pro-inflammatory factors, the development of inflammation and bronchial obstruction.

Fenspiride also has an antispasmodic effect.

Pharmacokinetics

Absorption

After oral administration, Fenspiride is well absorbed from the gastrointestinal tract. C_max in plasma after oral administration is reached after 2.3±2.5 h (from 0.5 to 8 h).

Elimination

T_1/2 averages 12 h. It is excreted mainly by the kidneys (90% of the dose taken) and less than 10% through the intestines.

Indications

Symptomatic therapy of diseases of the upper and lower respiratory tract

• Rhinopharyngitis and laryngitis;
• Tracheobronchitis;
• Bronchitis (against the background of chronic respiratory failure or without it);
• Bronchial asthma (as part of complex therapy);
• Respiratory phenomena (cough, hoarseness, sore throat) with measles, whooping cough and influenza;
• Infectious diseases of the respiratory tract, accompanied by cough, when standard antibiotic therapy is indicated.

Otitis and sinusitis of various etiologies, including allergic (both seasonal and perennial).

ICD codes

Dosage Regimen

The drug is taken orally, before meals.

Children aged 2 years and older are prescribed the drug at a dose of 4 mg/kg/day. Children with body weight up to 10 kg – from 2 to 4 dosing spoons of syrup (10-20 ml)/day, can be added to a feeding bottle; children with body weight over 10 kg – from 6 to 12 dosing spoons of syrup (from 2 to 4 tablespoons or 30-60 ml)/day.

Adults are prescribed from 9 to 18 dosing spoons of syrup (from 3 to 6 tablespoons or 45-90 ml)/day.

1 dosing spoon (5 ml of syrup) contains 10 mg of fenspiride hydrochloride and 3 g of sucrose.

1 tablespoon (15 ml of syrup) contains 30 mg of fenspiride hydrochloride and 9 g of sucrose.

The duration of treatment is determined by the doctor.

Adverse Reactions

The adverse effects listed below are presented according to the frequency of occurrence: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10 000, <1/1000), very rare (<1/10 000). Adverse effects recorded in the post-marketing period, due to the lack of accurate data on their frequency, are marked as “frequency unknown”.

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

From the cardiovascular system rare – moderate tachycardia, the severity of which decreases when the drug dose is reduced.

From the digestive system common – gastrointestinal disorders, nausea, epigastric pain; frequency unknown – diarrhea, vomiting.

From the skin and subcutaneous tissues rare – erythema, rash, urticaria, angioedema, fixed pigmentary erythema; frequency unknown – skin itching.

Other frequency unknown – asthenia, increased fatigue.

Contraindications

• Fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency;
• Pregnancy;
• Lactation period (breastfeeding);
• Children under 2 years of age;
• Hypersensitivity to fenspiride or other components of the drug.

With caution the drug should be prescribed for diabetes mellitus (due to the presence of sucrose in the drug composition).

Use in Pregnancy and Lactation

The use of the drug during pregnancy is not recommended.

Fenspiride therapy is not a reason for termination of an established pregnancy. There are no clinical data on the fetotoxic effect of fenspiride or its ability to cause malformations in case of use during pregnancy.

Syresp should not be used during breastfeeding due to the lack of data on the ability of fenspiride to penetrate into breast milk.

Pediatric Use

The use of the drug is contraindicated in children under 2 years of age.

Special Precautions

Syresp syrup contains parabens (methylparaben and propylparaben), so the use of the drug can provoke the development of allergic reactions, including delayed ones.

When prescribing the drug to patients with diabetes mellitus, it should be taken into account that Syresp syrup contains sucrose (1 dosing spoon (5 ml of syrup) – 3 g of sucrose = 0.25 XE).

The drug contains the dye sunset yellow FCF (E110), which can cause the development of allergic reactions.

The glycerol contained in the drug may cause headache, stomach upset, diarrhea.

Effect on ability to drive vehicles and mechanisms

Caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, since drowsiness may develop during the use of the drug.

Overdose

Symptoms drowsiness or agitation, nausea, vomiting, sinus tachycardia.

Treatment gastric lavage, ECG monitoring, maintenance of vital body functions.

Drug Interactions

No specific studies on the interaction of fenspiride with other drugs have been conducted.

Due to the possible enhancement of the sedative effect when taking histamine H₁-receptor blockers, the use of Syresp in combination with drugs that have a sedative effect, or together with ethanol, is not recommended.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is dispensed by 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.