Tuspan^® (Syrup) Instructions for Use

Marketing Authorization Holder

Sopharma, JSC (Bulgaria)

ATC Code

R05CA12 (Hederae Helix folia)

Active Substance

Hederae Helix folia (Grouping Name)

Dosage Form

Tuspan®

Syrup 7 mg/ml: 120 ml bottle with measuring cup included

Dosage Form, Packaging, and Composition

Syrup is a brownish liquid with a characteristic lemon odor; opalescence is allowed.

Excipients: xanthan gum (E415) – 1 mg, liquid sorbitol (non-crystallizing) (E420) – 550 mg, citric acid monohydrate (E330) – 0.4 mg, potassium sorbate (E202) – 1.34 mg, liquid essence* – 0.2 mg, purified water – up to 1 ml.

* The liquid essence contains cis-citral, trans-citral, lemon oil, propylene glycol (E1520).

120 ml – dark glass bottles (1) with a measuring cup included – cardboard boxes.
120 ml – dark polyethylene terephthalate bottles (1) with a measuring cup included – cardboard boxes.

Clinical-Pharmacological Group

Herbal preparation with expectorant effect

Pharmacotherapeutic Group

Herbal expectorant

Pharmacological Action

Herbal remedy. It has an expectorant, mucolytic, and antispasmodic effect due to the presence of saponins.

Indications

As an expectorant in the complex therapy of infectious and inflammatory diseases of the respiratory tract, accompanied by cough with difficult sputum discharge.

ICD codes

Dosage Regimen

Administer orally. Use the provided measuring cup for accurate dosing. Shake the bottle well before each use.

For adults and adolescents over 12 years: take 5 ml of syrup ( 35 mg of dry extract) three times daily.

For school-age children 6 to 12 years: take 2.5 ml of syrup ( 17.5 mg of dry extract) three times daily.

For young children 2 to 6 years: take 2.5 ml of syrup ( 17.5 mg of dry extract) twice daily.

The duration of treatment depends on the severity of symptoms. Continue therapy for several days after symptom improvement.

Do not use in infants and children under 2 years of age due to risk of adverse effects.

If symptoms persist beyond 4-5 days of treatment, or if high fever, persistent headache, or shortness of breath occurs, discontinue use and consult a physician.

Adhere to the recommended dosage. Do not exceed the stated daily dose.

Adverse Reactions

Possible allergic reactions, nausea, vomiting, diarrhea.

Rarely pain in the epigastric region.

Contraindications

Hypersensitivity to the product; childhood – depending on the dosage form.

Use in Pregnancy and Lactation

Not recommended for use during pregnancy and lactation.

Pediatric Use

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

Special Precautions

During treatment, it is recommended to consume a sufficient amount of warm fluids (water, tea, etc.).

If there is no effect after 5-7 days of treatment with the product and/or if the condition worsens (appearance of asthma attacks, purulent sputum, fever), it is necessary to consult a doctor.

Drug Interactions

Should not be used simultaneously with antitussive medications, as this impedes the discharge of liquefied sputum.

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

Over-the-Counter

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.