Codelac® Broncho with thymus serpyllum (Tablets, Elixir) Instructions for Use
ATC Code
R05CA10 (Expectorants in combination)
Active Substances
Ambroxol (Rec.INN registered by WHO)
Glycyrrhizinic acid (BP British Pharmacopoeia)
Thymus serpyllum (DAB German Pharmacopoeia)
Clinical-Pharmacological Group
Drug with mucolytic, expectorant and anti-inflammatory action
Pharmacotherapeutic Group
Combined expectorant
Pharmacological Action
A combined expectorant drug. It has a mucolytic and expectorant effect, and also possesses anti-inflammatory activity. The action of Codelac® Broncho with thymus serpyllum elixir is due to the pharmacological properties of its components.
Ambroxol has secretomotor, secretolytic and expectorant action, normalizes the disturbed ratio of the serous and mucous components of sputum, and increases the secretion of surfactant in the alveoli. It reduces the viscosity of sputum and promotes its discharge.
Sodium glycyrrhizinate has anti-inflammatory and antiviral action. It exerts a cytoprotective effect due to its antioxidant and membrane-stabilizing activity. It enhances the action of endogenous glucocorticoids, exerting anti-inflammatory and anti-allergic effects. Due to its pronounced anti-inflammatory activity, it helps reduce the inflammatory process in the respiratory tract.
Thymus serpyllum herb extract contains a mixture of essential oils that have expectorant and anti-inflammatory effects. Furthermore, this extract has weak antispasmodic and reparative properties.
Pharmacokinetics
Pharmacokinetic data for Codelac® Broncho with thymus serpyllum are not provided.
Indications
Diseases of the respiratory tract with the formation of viscous sputum
- Acute and chronic bronchitis;
- Pneumonia;
- COPD;
- Bronchiectasis.
ICD codes
| ICD-10 code | Indication |
| J15 | Bacterial pneumonia, not elsewhere classified |
| J20 | Acute bronchitis |
| J42 | Unspecified chronic bronchitis |
| J44 | Other chronic obstructive pulmonary disease |
| ICD-11 code | Indication |
| CA20.1Z | Chronic bronchitis, unspecified |
| CA22.Z | Chronic obstructive pulmonary disease, unspecified |
| CA40.0Z | Bacterial pneumonia, unspecified |
| CA42.Z | Acute bronchitis, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Elixir
It is taken orally during meals with a small amount of water.
Adults and children over 12 years – 10 ml 4 times/day.
Children aged 2 to 6 years are prescribed 2.5 ml 3 times/day, aged 6 to 12 years – 5 ml 3 times/day.
The maximum duration of treatment without consulting a doctor is 5 days.
Tablets
It is taken orally. The dose depends on the patient’s age.
The maximum duration of treatment without consulting a doctor is 5 days.
Adverse Reactions
From the digestive system rarely – diarrhea, dry mouth, constipation; with long-term use in high doses – gastralgia, nausea, vomiting.
From the respiratory system dryness of the respiratory mucosa, rhinorrhea.
Other allergic reactions; rarely – weakness, headache, dysuria, exanthema.
Contraindications
- Pregnancy;
- Lactation period (breastfeeding);
- Children under 2 years of age;
- Hypersensitivity to the drug components.
The drug should be used with caution in patients with hepatic and/or renal insufficiency, gastric and duodenal ulcer, bronchial asthma.
Use in Pregnancy and Lactation
The use of the drug is contraindicated during pregnancy and lactation (breastfeeding).
Use in Hepatic Impairment
The drug should be used with caution in patients with hepatic insufficiency.
Use in Renal Impairment
The drug should be used with caution in patients with renal insufficiency.
Pediatric Use
Contraindicated for use in children under 2 years of age.
Special Precautions
Do not combine with antitussive agents.
In patients with diabetes mellitus, the drug can be used taking into account the sorbitol content of 0.18 XU in 5 ml of elixir.
Overdose
Symptoms nausea, vomiting, diarrhea, dyspepsia.
Treatment induced vomiting, gastric lavage within the first 1-2 hours after drug intake.
Drug Interactions
Concomitant use with antitussive drugs leads to difficulty in sputum discharge.
Storage Conditions
The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F).
Shelf Life
Shelf life – 1.5 years.
Dispensing Status
The drug is approved for use as an over-the-counter remedy.
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Elixir 10 mg+30 mg+500 mg/5 ml: 50 ml, 100 ml or 125 ml bottle with meas. spoon
Marketing Authorization Holder
Otisipharm, JSC (Russia)
Manufactured By
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Form
 |
Codelac® Broncho with thymus serpyllum | Elixir 10 mg+30 mg+500 mg/5 ml: 50 ml, 100 ml or 125 ml bottle with meas. spoon |
Dosage Form, Packaging, and Composition
Elixir from light brown to brown in color; sediment formation is allowed during storage.
| 5 ml | |
| Ambroxol hydrochloride | 10 mg |
| Sodium glycyrrhizinate | 30 mg |
| Liquid extract of thyme | 500 mg |
Excipients : methylparahydroxybenzoate (nipagin) – 3.75 mg, propylparahydroxybenzoate (nipasol) – 1.25 mg, sorbitol (sorbitol) – 3000 mg, purified water – up to 5 ml.
50 ml – dark glass bottles (1) with a measuring spoon – cardboard packs.
100 ml – dark glass bottles (1) with a measuring spoon – cardboard packs.
125 ml – dark glass bottles (1) with a measuring spoon – cardboard packs.
Effervescent tablets 20 mg+60 mg+1000 mg
Marketing Authorization Holder
Otisipharm, JSC (Russia)
Manufactured By
PharmVILAR NPO, LLC (Russia)
Dosage Form
|
Codelac® Broncho with thymus serpyllum | Effervescent tablets 20 mg+60 mg+1000 mg |
Dosage Form, Packaging, and Composition
Effervescent tablets
| 1 tab. | |
| Ambroxol | 20 mg |
| Sodium glycyrrhizinate | 60 mg |
| Thymus serpyllum herb extract | 1000 mg |
10 pcs. – tubes – cardboard packs (10 pcs.) – Over-the-counter
10 pcs. – tubes (2 pcs.) – cardboard packs (20 pcs.) – Over-the-counter
20 pcs. – tubes – cardboard packs (20 pcs.) – Over-the-counter
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