Terpincod^® (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

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

Terpincod®

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

Dosage Form, Packaging, and Composition

Tablets white in color, flat-cylindrical, with a bevel and a score; slight marbling is allowed.

Excipients: potato starch – 71.1 mg, stearic acid – 5.9 mg, talc – 15 mg.

10 pcs. – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with antitussive and expectorant action

Pharmacotherapeutic Group

Drugs used for cough and colds; antitussives and expectorants, combinations; opium derivatives in combination with expectorants

Pharmacological Action

Combined drug.

Codeine is a centrally acting antitussive agent; a phenanthrene alkaloid. An agonist of opioid receptors, 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 cause depression of 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 the 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 a certain 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 with a sufficient amount of water.

For adults, take one tablet two to three times per day.

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

For children aged 2 to 5 years, prescribe a quarter of a tablet two to three times per day.

For children aged 5 to 10 years, prescribe half a tablet two to three times per day.

For children aged 10 to 12 years, prescribe half a tablet three times per day.

For children aged 12 to 18 years, prescribe one tablet two to three times per day.

The duration of treatment is determined by the physician based on clinical response and should not exceed five days.

Do not exceed the recommended dosage due to the risk of codeine dependence and adverse effects.

In patients with impaired renal function, increase the interval between doses.

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 (up to 2 years); pregnancy; lactation period (breastfeeding).

Use in Pregnancy and Lactation

Contraindicated during pregnancy and during the lactation period (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.

During the use of the drug, ethanol should not be consumed.

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

Effect on the ability to drive vehicles and 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), an 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 the weakening of 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.