Tedein (Tablets) Instructions for Use

Marketing Authorization Holder

Mekophar Chemical-Pharmaceutical, Joint Stock Company (Vietnam)

ATC Code

R05FA02 (Opium derivatives in combination with expectorants)

Active Substances

Terpin hydrate (BAN)

Codeine (Ph.Eur.)

Dosage Form

Tedein

Tablets 8 mg+100 mg: 10 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blisters.

Clinical-Pharmacological Group

Drug with antitussive and expectorant action

Pharmacotherapeutic Group

Combined antitussive agent (antitussive+expectorant agent)

Pharmacological Action

Combined drug with antitussive and expectorant action.

Codeine has a central antitussive effect, reducing the excitability of the cough center.

Terpin hydrate enhances the secretion of the bronchial glands, promotes the evacuation of mucus from the respiratory tract, and weakens the cough reflex.

Indications

Symptomatic treatment of bronchopulmonary diseases accompanied by a dry cough.

ICD codes

Dosage Regimen

Administer orally with water.

For adults and children over 12 years: take one tablet two to three times daily.

For children aged 5 to 12 years: take one tablet twice daily.

Do not exceed the maximum daily dose of three tablets for adults or two tablets for children.

The duration of treatment should be as short as necessary to suppress the dry cough.

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

Discontinue use if cough persists beyond 5-7 days or is accompanied by fever, rash, or persistent headache.

Avoid concomitant use with alcohol, sedatives, or other central nervous system depressants.

This product contains codeine and can cause addiction; use strictly according to the prescribed dosage regimen.

Adverse Reactions

Allergic reactions: skin itching, urticaria.

From the nervous system: headache, drowsiness.

From the digestive system: nausea, vomiting, constipation.

Other: drug dependence (with long-term use).

Contraindications

Hypersensitivity; bronchial asthma; respiratory failure; simultaneous use of centrally acting analgesics (buprenorphine, nalbuphine, pentazocine), mucolytic and expectorant drugs, ethanol; pregnancy; lactation period; children’s age (under 5 years).

With caution

Intracranial hypertension, hepatic or renal failure.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

With caution in hepatic failure.

Use in Renal Impairment

With caution in renal failure.

Pediatric Use

Use is contraindicated in children under 5 years of age.

Special Precautions

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

It should be remembered that Codeine may affect the results of a doping test.

Effect on the ability to drive vehicles and mechanisms

During treatment, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Drugs that depress the CNS (hypnotics, sedatives, antihistamines, centrally acting analgesics, anxiolytics, antipsychotic drugs) – risk of increased sedative effect and depressant effect on the respiratory center.

Chloramphenicol inhibits the metabolism of codeine, enhancing its effect.

Use of codeine in large doses enhances the effect of cardiac glycosides (e.g., digoxin) by weakening gastrointestinal motility and increasing their absorption.

Adsorbents, astringents, and coating drugs reduce the absorption of codeine in the gastrointestinal tract.

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.