Active substanceCodeine + TerpinhydrateCodeine + Terpinhydrate
Dosage form: & nbsppills
Composition:

Composition per 1 tablet:

Active substances: codeine monohydrate 8 mg, terpinhydrate 250 mg. Excipients: cellulose microcrystalline type 101 (microcrystalline cellulose) 122 mg, lactose monohydrate 110 mg, potato starch 60 mg, sodium carboxymethyl starch (sodium starch glycolate, primogel) 18 mg, giprolose (hydroxypropyl cellulose, klocel) 11 mg, talc 15 mg, stearic acid 6 mg .
Description:

Tablets are white with a yellowish tint of color, with a specific odor, flat-cylindrical, with a facet and a risk. Marble is allowed.

Pharmacotherapeutic group:antitussive drug combined (antitussive opioid + expectorant).
ATX: & nbsp

R.05.F.A.02   Opium derivatives in combination with expectorants

Pharmacodynamics:

Combined drug. Codeine reduces the excitability of the cough center and interrupts the cough reflex. In recommended therapeutic doses does not cause depression of the respiratory center, does not disrupt the function of ciliary epithelium of the respiratory tract and does not reduce bronchial secretion.

Terpinhydrate enhances the secretion of bronchial glands, has an expectorant effect.

Terpinkod® H weakens the cough reflex and helps to excrete sputum from the respiratory tract during coughing.

The maximum action of the drug occurs 30-60 minutes after ingestion and lasts for 2-6 hours.

Pharmacokinetics:

not described

Indications:

Dry cough of different etiology in diseases of the lungs and respiratory tract (including bronchopneumonia, bronchitis, emphysema) in adults and children over 12 years.

Contraindications:

Hypersensitivity to the components of the drug, acute attack of bronchial asthma, respiratory failure; acute respiratory depression; children's age (up to 12 years); deficiency of lactase, lactose intolerance, glucose-galactose malabsorption; toxic dyspepsia; diarrhea against pseudomembranous colitis caused by cephalosporins, lincosamides, penicillins; gastritis, peptic ulcer and 12 duodenal ulcer.

Carefully:

Acute abdominal pain of unclear etiology, chronic obstructive pulmonary disease, arrhythmias, convulsions, drug dependence (incl.in anamnesis), alcoholism, suicidal tendencies, emotional lability, cholelithiasis, surgical interventions on the gastrointestinal tract, urinary system, brain trauma, intracranial hypertension, hepatic or renal insufficiency, hypothyroidism, severe inflammatory bowel disease, prostatic hyperplasia, stricture urethra, seriously ill, weakened patients, cachexia, concomitant treatment with MAO inhibitors, elderly age, children's age over 12 years.

Pregnancy and lactation:Pregnancy (especially I and III trimester), lactation period (risk of respiratory depression in the child due to the fact that codeine well penetrates through placental and blood-brain barrier)
Dosing and Administration:

Inside, 1 tablet 2-3 times a day. The maximum duration of treatment without a doctor's consultation is 5 days.

Side effects:

From the digestive system: more often - constipation; less often - dryness of the oral mucosa, anorexia, nausea, vomiting; rarely - gastralgia, spasms in the gastrointestinal tract, biliary tract spasm,paralytic intestinal obstruction, toxic megacolon (constipation, flatulence, nausea, spasms in the stomach, vomiting); frequency unknown - hepatotoxicity (dark urine, pale stool, icteric sclera and skin).

From the nervous system and sense organs: more often - drowsiness; less often - dizziness, headache, fatigue, nervousness, confusion (hallucinations, depersonalization), blurred vision (including diplopia), in children - paradoxical agitation, anxiety; rare - restless sleep, nightmares, convulsions, depression, at high doses - stiffness of muscles (especially respiratory), tremor, involuntary muscle twitching, frequency unknown - ringing in the ears, impaired coordination of eyeball movements with visual impairment, increased smooth muscle tone at doses above 60 mg).

From the side of the cardiovascular system, less often - arrhythmias (tachy- or bradycardia), lowering blood pressure; frequency unknown - increased blood pressure.

On the part of the respiratory system, less often - atelectasis, oppression of the respiratory center.

From the side of the urinary system, less often - a decrease in diuresis, spasms of ureters (difficulty and pain when urinating, frequent urge to urinate); frequency is unknown - atony of the bladder.

Allergic reactions: less often - skin rash, hives, itching, face swelling, bronchospasm, laryngeal edema, laryngospasm.

Other: less often - sweating, imaginary feeling of well-being, a feeling of discomfort; frequency unknown - weight gain; with prolonged use - drug dependence, withdrawal syndrome.

Overdose:

Symptoms: vomiting, drowsiness, atony of the bladder, impaired coordination of eyeball movements with visual impairment, respiratory center depression, arrhythmias, bradycardia.

Treatment: gastric lavage with activated charcoal and potassium permanganate, the introduction of respiratory analeptics, atropine and a competitive codeine-naloxone antagonist.

Interaction:

With the simultaneous use of drugs that depress the central nervous system, it is possible to increase the sedative effect and inhibitory effect on the respiratory center. Codeine enhances the effect of ethanol on psychomotor functions.

With simultaneous administration with other opioid analgesics codeine increases the risk of depression of the central nervous system, breathing, lowering blood pressure.

When using codeine in large doses, the action of cardiac glycosides (digoxin etc.) can be amplified, tk. in connection with the weakening of peristalsis, their absorption increases. Adsorbents, astringents and enveloping agents can 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 codeine antagonists. Naltrexone accelerates the appearance of symptoms of "withdrawal syndrome" against the background of narcotic dependence on codeine (symptoms may appear as early as 5 minutes after drug administration, continue for 48 hours, are characterized by persistence and difficulty of their elimination); reduces the effect of opioid analgesics (analgesic, antidiarrheal, antitussive); does not affect the symptoms caused by the histamine reaction.

Medicines with anticholinergic activity, antidiarrhoeal drugs (incl. loperamide) increase the risk of constipation up to intestinal obstruction, urinary retention and central nervous system depression.

Special instructions:

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

Athletes should remember that the drug contains codeine and is doping.

Opioid analgesics reduce salivation, which can contribute to the development of caries, periodontal diseases, and candidaemia of the oral mucosa.

Effect on the ability to drive transp. cf. and fur:During the treatment it is necessary to refrain from taking ethanol and take care when driving vehicles, as well as when engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
Form release / dosage:

Tablets 8 mg + 250 mg.

Packaging:

10 tablets per contour cell pack.

1 contour pack with instructions for use is placed in a pack of cardboard.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:

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

Terms of leave from pharmacies:Without recipe
Registration number:LP-000154
Date of registration:13.01.2011
The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia
Manufacturer: & nbsp
Information update date: & nbsp13.01.2011
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