Terpincod^® N (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

ATC Code

R05FA02 (Opium derivatives in combination with expectorants)

Active Substances

Terpin hydrate (BAN)

Codeine (Ph.Eur.)

Dosage Form

Terpincod® N

Tablets 8 mg+250 mg: 10 or 5000 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blisters (1) – carton packs.

Clinical-Pharmacological Group

Drug with antitussive and expectorant action

Pharmacotherapeutic Group

Combined antitussive agent (antitussive+expectorant agent)

Pharmacological Action

A combined drug. Codeine reduces the excitability of the cough center and interrupts the cough reflex. In recommended therapeutic doses, it does not cause depression of the respiratory center, does not impair the function of the ciliated epithelium of the respiratory tract, and does not reduce bronchial secretion.

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

Terpincod^® N weakens the cough reflex and promotes the removal of sputum from the respiratory tract during coughing.

The maximum effect of the drug 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 12 years of age.

ICD codes

Dosage Regimen

Take the tablets orally with a sufficient amount of liquid.

The standard adult and adolescent (over 12 years) dose is 1 tablet 2-3 times per day.

Adhere to approximately equal intervals between doses.

Do not exceed the maximum daily dose of 3 tablets.

Limit the duration of self-treatment to a maximum of 5 days without consulting a physician.

For patients with renal impairment, extend the intervals between doses due to slowed codeine elimination.

In elderly patients and those with hepatic insufficiency, use with caution and consider a reduced frequency of administration.

Discontinue use if cough persists beyond 5 days or is accompanied by fever, rash, or persistent headache.

Adverse Reactions

From the digestive system more frequently – constipation; less frequently – dry mouth, anorexia, nausea, vomiting; rarely – gastralgia, gastrointestinal cramps, biliary tract spasm, paralytic ileus, toxic megacolon (constipation, flatulence, nausea, stomach cramps, vomiting); frequency unknown – hepatotoxicity (dark urine, pale stools, jaundice of the sclera and skin).

From the CNS more frequently – drowsiness; less frequently – dizziness, headache, fatigue, nervousness, confusion (hallucinations, depersonalization), blurred vision (including diplopia), in children – paradoxical agitation, anxiety; rarely – restless sleep, nightmares, convulsions, depression, at high doses – muscle rigidity (especially respiratory muscles), tremor, involuntary muscle twitching, frequency unknown – tinnitus, impaired coordination of eye movements with visual impairment, increased smooth muscle tone (at doses above 60 mg).

From the cardiovascular system less frequently – arrhythmias (tachy- or bradycardia), decreased blood pressure; frequency unknown – increased blood pressure.

From the respiratory system less frequently – atelectasis, respiratory depression.

From the urinary system less frequently – decreased diuresis, ureteral spasms (difficulty and pain during urination, frequent urge to urinate); frequency unknown – bladder atony.

Allergic reactions less frequently – skin rash, urticaria, skin itching, facial edema, bronchospasm, laryngeal edema, laryngospasm.

Other less frequently – sweating, false sense of well-being, feeling of discomfort; frequency unknown – weight gain; with long-term use – drug dependence, withdrawal syndrome.

Contraindications

• Acute attack of bronchial asthma;
• Respiratory failure;
• Acute depression of the respiratory center;
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• Toxic dyspepsia;
• Diarrhea due to pseudomembranous colitis caused by cephalosporins, lincosamides, penicillins;
• Gastritis;
• Peptic ulcer of the stomach and duodenum;
• Children’s age (under 12 years);
• Hypersensitivity to the components of the drug.

With caution pregnancy (especially I and III trimester), lactation period (risk of developing respiratory depression in the child due to the fact that Codeine penetrates well through the placental and blood-brain barriers), acute abdominal pain of unclear etiology, chronic obstructive pulmonary disease, arrhythmias, convulsions, drug dependence (including history), alcoholism, suicidal tendency, emotional lability, cholelithiasis, surgical interventions on the gastrointestinal tract, urinary system, brain injuries, intracranial hypertension, hepatic or renal failure, hypothyroidism, severe inflammatory bowel diseases, prostatic hyperplasia, urethral strictures, severely ill patients, debilitated patients, cachexia, simultaneous treatment with MAO inhibitors, elderly age, children over 12 years of age.

Use in Pregnancy and Lactation

With caution pregnancy (especially I and III trimester), lactation period (risk of developing respiratory depression in the child due to the fact that Codeine penetrates well through the placental and blood-brain barriers).

Use in Hepatic Impairment

With caution: hepatic insufficiency.

Use in Renal Impairment

With caution: renal insufficiency.

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 12 years of age.

Children over 12 years of age should be prescribed with caution.

Geriatric Use

Use with caution in the elderly.

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.

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

Opioid analgesics reduce salivation, which may contribute to the development of caries, periodontal disease, and candidiasis of the oral mucosa.

Effect on the ability to drive vehicles and operate machinery

During the treatment period, it is necessary to refrain from consuming ethanol and exercise caution when driving vehicles, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms vomiting, drowsiness, bladder atony, impaired coordination of eye movements with visual impairment, respiratory depression, arrhythmias, bradycardia.

Treatment gastric lavage with activated charcoal and potassium permanganate, administration of respiratory analeptics, atropine, and the competitive antagonist of codeine – naloxone.

Drug Interactions

With simultaneous use of drugs that depress the CNS, an increase in the sedative effect and depressant effect on the respiratory center is possible. Codeine enhances the effect of ethanol on psychomotor functions.

With simultaneous use with other opioid analgesics, Codeine increases the risk of CNS depression, respiratory depression, and decreased blood pressure.

When codeine is used in high doses, the effect of cardiac glycosides (digoxin and others) may be enhanced, because due to weakened peristalsis, their absorption increases.

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

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

Codeine enhances the effects of antihypertensive and antipsychotic drugs (neuroleptics), anxiolytics (tranquilizers), barbiturates, and drugs for general anesthesia, reduces the effect of metoclopramide.

Naloxone and naltrexone are specific antagonists of codeine. Naltrexone accelerates the onset of withdrawal symptoms against the background of narcotic dependence on codeine (symptoms may appear as early as 5 minutes after administration of the drug, last for 48 hours, and are characterized by persistence and difficulty in their elimination); reduces the effect of opioid analgesics (analgesic, antidiarrheal, antitussive); does not affect symptoms caused by a histamine reaction.

Drugs with anticholinergic activity, antidiarrheal drugs (including loperamide) increase the risk of constipation up to intestinal obstruction, urinary retention, and CNS depression.

Storage Conditions

Store the drug in a dry, light-protected place at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the package.

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.