Cinfamucol Carbocysteine 50 Mg/Ml Oral Solution 1 Bottle 200Ml

Cinfamucol Carbocysteine ​​(50 Mg / Ml Oral Solution 1 Bottle 200 Ml)

ACTION AND MECHANISM

- Mucolytic. Carbocysteine ​​is an S-acetylated derivative of the natural amino acid cysteine. It increases the synthesis of sialomucins by activation of sialyl transferase, thereby restoring the normal composition of glycoproteins in the bronchial mucous secretion, and normalizes the viscoelasticity of the bronchial mucus. This results in improved expectoration and cleansing of the bronchus.

PHARMACOKINETICS

Orally:

- Absorption: rapid oral absorption, with a tmax of 1.5 h.

- Distribution: your Vd is 60 l. It tends to accumulate in the lung and bronchial mucus, where the maximum concentration is reached after 2 h.

- Metabolism: several inactive sulfur metabolites have been obtained, such as carboxymethyl-cysteine ​​oxide, carboxymethylthiol-cysteine, thiodiglycolic acid or the S-oxide of this acid.

- Excretion: mainly in urine, in unchanged form (80%) or as metabolites (15%). It appears in small amounts in feces (0.3%) and via the lung. The t1 / 2 is 90-120 min.

INDICATIONS

- [BRONCHIAL HYPERVISCOSITY].

* Symptomatic treatment of upper respiratory tract processes, such as [COMMON COLD] and [INFLUENZA], which occur with excess mucous secretion.

POSOLOGY

- Adults and adolescents> 12 years: 15 ml (750 mg) / 8 h. Once the patient improves, it can be reduced to 10 ml (500 mg) / 8 h. Maximum dose 45 ml (2.25 g) / 24 h.

Duration of treatment: consult a doctor and / or pharmacist if symptoms do not improve after 5 days.

Missed dose: skip the missed dose and administer the next dose at the usual time. Do not double the next dose.

POSOLOGY IN KIDNEY FAILURE

No specific dosage recommendations have been made. It is recommended to use with caution at the risk of accumulation of carbocysteine.

POSOLOGY IN LIVER FAILURE

No specific dosage recommendations have been made. It is recommended to use with caution at the risk of accumulation of carbocysteine.

RULES FOR THE CORRECT ADMINISTRATION

It is recommended to drink a glass of water after each dose. Drink plenty of water during treatment.

Administration with food: administer before meals.

CONTRAINDICATIONS

- Hypersensitivity to carbocysteine ​​or any other active ingredient related to cysteine, as well as allergy to any other component of the medicine.

- [ULCERA PEPTICA] active. Risk of aggravation.

- Children <2 years. Risk of bronchial obstruction.

PRECAUTIONS

- [HYPOTHYROIDISM]. Carbocysteine ​​has led to cases of transient hypothyroidism in patients with compromised thyroid function. In case of worsening of hypothyroidism, the patient should be evaluated.

- Kidney failure: There are no specific recommendations. However, up to 80% of the drug is excreted unchanged in the urine.

- Assess the clinical situation in asthmatic patients or those with other severe respiratory failure, since increased tracheobronchial mucus can increase COPD symptoms.

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains maltitol. Patients with hereditary [FRUCTOSE INTOLERANCE] should not take this medicine.

- This medicine contains yellow orange S as an excipient. It can cause allergic-type reactions including [ASTHMA], especially in patients with [SALICILATE ALLERGY].

- This medicine contains sodium salts. To know the exact content of sodium, it is recommended to check the composition. Oral and parenteral dosage forms with sodium amounts greater than 1 mmol (23 mg) / maximum daily dose should be used with caution in patients with [RENAL INSUFFICIENCY] or diets low in sodium.

ADVICE TO THE PATIENT

- Drink plenty of water during treatment.

- Do not use antitussives while using carbocysteine.

- Consult the doctor and / or pharmacist if symptoms worsen or do not improve within 5 days, or if fever, headache or sore throat appears.

SPECIAL WARNINGS

- The use of mucolytics and expectorants in children younger than 2 years is contraindicated as a consequence of the risk of bronchial obstruction.

INTERACTIONS

- Cough suppressants. Risk of bronchial obstruction, due to inhibition of the cough reflex, and increased mucus production and / or fluidization. Avoid association.

- Anticholinergics (atropine, antihistamines, tricyclic antidepressants, antiparkinsonians, neuroleptics, MAOIs). They may oppose the effect of carbocysteine.

PREGNANCY

Safety in animals : No adverse reactions to reproduction have been found in animals.

Safety in humans : Adequate and well-controlled studies in humans are not available. Its administration is only accepted if there are no safer therapeutic alternatives, and the benefits outweigh the possible risks.

Effects on fertility : No specific studies on its effects on fertility have been performed.

LACTATION

It is unknown whether it is excreted in milk, and the consequences it could have for the infant. Is recomended to suspend the lactancy or evy the administration.

CHILDREN

The use of mucolytics in children younger than 2 years has been related to the appearance of bronchial obstruction, as a consequence of increased production and fluidization of bronchial secretion and insufficient bronchial drainage. Therefore, the use of mucolytics in these children is contraindicated.

In older children, the dosage form and dosage should be adapted to the child's age ( see Dosage ).

ELDERLY

No specific problems have been described in the elderly that require a dosage adjustment.

EFFECTS ON DRIVING

Its effects do not seem to be particularly significant, although it must be taken into account that adverse reactions such as dizziness or dizziness have been described.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency interval, being considered very frequent (> 10%), frequent (1-10%), infrequent (0.1-1%), rare (0.01-0.1%) , very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Digestive: frequent [NAUSEAS] and [VOMITS], [DYSPEPSIA], [ABDOMINAL PAIN]; rare [DIGESTIVE HEMORRHAGE]; frequency unknown [GASTRITIS], [GASTRALGIA].

- Neurological / psychological: rare [HEADACHE], [VERTIGO], [MAREO].

- Respiratory: very rare [BRONCHIAL SPASM].

- Dermatological: rare [EXANTEMATIC ERUPTIONS], [PRURITO]; very rare [ERITEMA].

- Allergic: rare [HYPER-SENSITIVITY REACTIONS].

- Endocrinological: unknown frequency [HYPOTHYROIDISM].

ADVERSE REACTIONS RELATED TO EXCIPIENTS

- Because it contains propyl parahydroxybenzoate it can cause [HYPERSENSITIVITY REACTIONS] (possibly delayed).

- Because it contains methyl parahydroxybenzoate, it can cause [HYPERSENSITIVITY REACTIONS] (possibly delayed).

- This medicine contains maltitol. Daily doses greater than 10 g may produce some mild laxative effect and lead to [DIARRHEA].

- Because it contains orange yellow (E-110) it can cause [HYPER-SENSITIVITY REACTIONS].

OVERDOSE

Symptoms : potentiation of adverse reactions, especially of the digestive type.

Measures to take :

- Antidote: there is no specific antidote.

- General elimination measures: if ingestion is recent, less than 1 h, gastric lavage may be necessary.

- Treatment: symptomatic treatment. Ensure ventilation, keeping the bronchi free by bronchial aspiration of the mucus.

Leaflet Cinfamucol Carbocysteine ​​50 Mg / Ml Oral Solution 1 Bottle 200 Ml