Ambroxyl

Tablet: AMBROXYL is a pink, round, shallow and concave tablet bisected on one side and plain on the other side.
Each tablet contains: Ambroxol (as Hydrochloride), USP 30 mg.
Syrup: Clear light yellow to yellowish syrup in appearance, pineapple and strawberry flavored with sweet fruit taste.
Each 5 mL (1 teaspoonful) syrup contains: Ambroxol Hydrochloride, PP 15 mg.

Tablet: AMBROXYL contains the active ingredient Ambroxol Hydrochloride, a mucolytic agent that causes phlegm to be less thick and sticky and thus easier to cough up and expel.
Syrup: This medicine contains Ambroxol, which stimulates fluid secretion in the respiratory tract and breaks down mucus resulting in the production of less thick and less sticky mucus/phlegm. Ambroxol improves mucociliary clearance (mucus flow and transport) making phlegm easier to cough up and expel.

Tablet: Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport.
Syrup: This medicine is used for the relief of cough secondary to acute and chronic diseases of the respiratory tract accompanied by excessive lung secretions such as chronic bronchitis, asthmatic bronchitis and bronchial asthma.

Tablet: Always take AMBROXYL exactly as the healthcare provider has prescribed. The patient should check with the healthcare provider if unsure.
The usual dose is: Adults: 1 tablet 3 times daily.
The therapeutic effect may be enhanced by administering 2 tablets 2 times daily. The tablets should be taken with liquid.
General: In acute respiratory indication, medical advice should be sought if symptoms do not improve or worsen in the course of therapy.
Ambroxol hydrochloride (AMBROXYL) can be taken with or without food.
Syrup: Adult and children over 10 years: 10 mL (2 teaspoonfuls) three times a day.
Children below 10 years: 6-10 years old: 5 mL (1 teaspoonful) three times a day.
Or as directed by the physician.
Missed dose: Tablet: If the patient misses a dose, he/she should just take the next dose if still needed for the condition being treated and the subsequent doses at the recommended time or schedule. Do not double the dose to make up for a forgotten dose.
Syrup: Take the missed dose as soon as remembered if still needed for the condition being treated, and the subsequent doses at the recommended time or schedule (i.e., after 24 hours).
Do not double the dose.

Tablet: No specific overdose symptoms have been reported in man to date. Based on accidental overdose and/or medication error reports, the observed symptoms are consistent with the known side effects of Ambroxol hydrochloride (AMBROXYL) at recommended doses.
Syrup: Symptoms of Ambroxol overdose include extensions of common undesirable effects (e.g., diarrhea, dyspepsia (indigestion), pyrosis (heartburn), nausea, vomiting, and skin rashes).
When the patient has taken more than the recommended dosage: Tablet: If the patient takes AMBROXYL more than the patient should, he/she should talk to a doctor immediately. If manifestations of poisoning do occur, symptomatic treatment is recommended.
Syrup: If the patient has taken more than the daily dose, consult a physician.

Tablet: Ambroxol hydrochloride (AMBROXYL) should not be used in patients known to be hypersensitive to ambroxol hydrochloride or other components of the formulation.
In case of rare hereditary conditions that may be incompatible with an excipient of the product, the use of the product is contraindicated.
Syrup: If the patient is allergic (hypersensitive) to Ambroxol hydrochloride or to any ingredients of the syrup.

Tablet: There have been very few reports of severe skin lesions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis (TEN) in temporal association with the administration of expectorants such as ambroxol hydrochloride. Mostly these could be explained by the severity of the patient's underlying disease and/or concomitant medication. In addition during the early phase of a Stevens-Johnson Syndrome or TEN, a patient may first experience non-specific influenza-like prodromes e.g. fever, aching body, rhinitis, cough and sore throat. Misled by these non-specific influenza-like prodromes, it is possible that a symptomatic treatment is started with a cough and cold medication.
Therefore if new skin or mucosal lesions occur, medical advice should be sought immediately and treatment with ambroxol hydrochloride discontinued as a precaution.
In the presence of impaired renal function, Ambroxol hydrochloride (AMBROXYL) may be used only after consulting a physician.
Syrup: Severe skin lesion such as Stevens-Johnson syndrome and Lyell's syndrome have been reported rarely with the administration of mucolytics such as Ambroxol. These may be due to the severity of the underlying disease or concomitant medication. If new skin or mucosal lesions occur, patient should discontinue Ambroxol and consult a physician immediately.
When should a patient consult a doctor: Tablet: A doctor should be consulted if the cough persists for more than 14 days and if symptoms do not improve or if new symptoms appear.
If the patient has any further questions on the use of this product, he/she should consult a doctor.
Syrup: If symptoms do not improve or new symptoms appear.
If undesirable effect develops.

Syrup: Patient should not take this medicine if she is pregnant or breastfeeding unless advised by a doctor.

Tablet: Like all medicines, AMBROXYL can cause side effects, although not everybody gets them.
Immune system disorder, skin and subcutaneous tissue disorders: Anaphylactic reactions including anaphylactic shock, angioedema, rash, urticaria, pruritus, and other hypersensitivity.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia and abdominal pain.
If any of the side effects gets serious, or if the patient notices any side effects not listed in this monograph, he/she should tell the healthcare provider.
Syrup: Heartburn, indigestion, occasionally nausea, and vomiting may occur. Allergic reactions have occurred rarely, primarily skin rashes. Seek immediate medical attention if the patient notices any symptoms of a serious allergic reaction including itching/swelling (especially of the face/tongue/throat), severe dizziness, and trouble breathing.

Tablet: Antitussives: Concomitant administration of antitussives may impair the expectoration of liquefied bronchial mucus due to inhibition of cough reflex and cause congestion of secretions.
Antibiotics: After using ambroxol, the concentrations of the antibiotics amoxicillin, cefuroxime and erythromycin in bronchial secretions and sputum are increased.
Tell the healthcrae provider if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Syrup: There are no reports of adverse drug interactions with other medications. Administration of Ambroxol with antibiotics (e.g., Amoxicillin, Cefuroxime, Erythromycin) leads to higher antibiotic concentration in bronchopulmonary secretions and in sputum. Tell the doctor about other medicines that the patient is taking, especially other medicines for cough, cold and allergy.

Store at temperatures not exceeding 30°C.

Cough & Cold Preparations

R05CB06 - ambroxol ; Belongs to the class of mucolytics. Used in the treatment of wet cough.

Non-Rx