Tercodin (Tablets) Instructions for Use

Marketing Authorization Holder

Interkhim, PJSC (Ukraine)

ATC Code

R05FA02 (Opium derivatives in combination with expectorants)

Active Substances

Sodium bicarbonate (BP British Pharmacopoeia)

Terpin hydrate (BAN British Approved Name)

Codeine (Ph.Eur. European Pharmacopoeia)

Dosage Form

Tercodin

Tablets 8 mg+250 mg+250 mg: 6 or 10 pcs.

Dosage Form, Packaging, and Composition

6 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with antitussive and expectorant action

Pharmacotherapeutic Group

Combined antitussive agent (antitussive+expectorant agent)

Pharmacological Action

Combined medicinal product.

Codeine is a centrally acting antitussive agent; a phenanthrene alkaloid. An opioid receptor agonist, it reduces the excitability of the cough center. Activation of opioid receptors in the intestine causes relaxation of smooth muscles, decreased peristalsis, and spasm of all sphincters. It has an analgesic effect, depresses respiration less than morphine, and less frequently causes miosis, nausea, vomiting, and constipation. In small doses, it does not depress the respiratory center, does not impair the function of the ciliated epithelium, and does not reduce bronchial secretion; it enhances the effect of analgesics, hypnotics, and sedative drugs.

Terpin hydrate enhances the secretion of bronchial glands and has an expectorant effect.

Sodium bicarbonate shifts the pH of bronchial mucus to the alkaline side, reduces the viscosity of sputum, and to some extent also stimulates the motor function of the ciliated epithelium and bronchioles.

It promotes the removal of mucus from the respiratory tract during coughing and weakens the cough reflex. The maximum effect occurs 30-60 minutes after oral administration and lasts for 2-6 hours.

Indications

Dry cough of various etiologies in diseases of the lungs and respiratory tract (including bronchopneumonia, bronchitis, pulmonary emphysema) in adults and children over 2 years of age (symptomatic treatment).

ICD codes

Dosage Regimen

Administer orally. Swallow the tablet whole with a sufficient amount of water.

Adhere strictly to the prescribed dosage and duration of treatment. Do not exceed the recommended dose.

For adults, the typical dose is one tablet taken two to three times per day.

The maximum single dose for adults is one tablet. The maximum daily dose for adults is three tablets.

For children over 2 years of age, dosing is based on body weight. The dose is 2.5-5 mg of codeine per 1 kg of body weight per day, divided into several doses.

For children aged 2 to 5 years, the typical dose is one-quarter to one-half of a tablet taken two to three times per day.

For children aged 5 to 10 years, the typical dose is one-half of a tablet taken two to three times per day.

For children aged 10 to 12 years, the typical dose is one-half to one whole tablet taken two to three times per day.

For children over 12 years of age, use the adult dosage.

The duration of treatment is determined by the physician based on the clinical situation. Do not use for more than 5 days as an analgesic or for more than 3 days as an antitussive without medical supervision.

In patients with renal impairment, lengthen the intervals between doses due to slowed codeine elimination.

Discontinue use if cough persists or is accompanied by fever, rash, or persistent headache.

Adverse Reactions

Allergic reactions (skin itching, urticaria).

From the digestive system nausea, vomiting, constipation.

From the nervous system headache, drowsiness.

Other development of drug dependence on codeine, allergic reactions (skin itching, urticaria).

Contraindications

Hypersensitivity to the components of the drug; respiratory failure; bronchial asthma; simultaneous use of ethanol or narcotic analgesics; children’s age (under 2 years); pregnancy; lactation period (breastfeeding).

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Use in Renal Impairment

In patients with impaired renal function, the elimination of codeine is slowed, so it is recommended to lengthen the intervals between doses of the drug.

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

In patients with impaired renal function, the elimination of codeine is slowed, so it is recommended to lengthen the intervals between doses of the drug.

Do not consume ethanol while taking the drug.

Athletes should be aware that the drug contains Codeine and is a doping agent.

Effect on ability to drive vehicles and operate machinery

Due to the possibility of sedative effects during treatment, it is not recommended to engage in activities requiring increased attention, speed of mental and motor reactions.

Drug Interactions

Chloramphenicol inhibits the metabolism of codeine in the liver and thereby enhances its effect.

With simultaneous use of drugs that depress the CNS (including hypnotics, antihistamines, antipsychotics, narcotic analgesics), enhancement of the sedative effect and depressant effect on the respiratory center is possible.

When using codeine in large doses, the effect of cardiac glycosides (e.g., digoxin) may be enhanced, because due to weakened peristalsis, their absorption increases.

Adsorbents, astringents, and coating agents may reduce the absorption of codeine.

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.