Expel: Dosages and Ingredients | Full Prescribing Info

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Contents

Ambroxol hydrochloride.

Description

Ambroxol (Expel) 6 mg/mL (Oral Drops) is a colorless to very light yellow-colored, clear to slightly hazy syrup with the odor and taste of orange.
Ambroxol (Expel) 15 mg/5 mL (Syrup) is a colorless to very light yellow-colored, clear to slightly hazy syrup with the odor and taste of orange.
Each mL syrup (oral drops) contains: Ambroxol (as hydrochloride) 6 mg.
Each 5 mL (1 teaspoonful) syrup contains: Ambroxol (as hydrochloride) 15 mg.

Action

These medicines contain 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.

Indications/Uses

These medicines are 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.

Dosage/Direction for Use

These medicines should be taken orally (by mouth). (See table.)

Click on icon to see table/diagram/image

Doses are best taken after meals.
Missed Dose: If the patient misses a dose, just take the next dose if still needed for the condition being treated, and the subsequent doses at the recommended time or schedule (i.e., every 8 or 12 hours).
Do not exceed recommended dose.

Overdosage

Signs and Symptoms of Overdosage: Symptoms of overdose are consistent with the known undesirable effects of Ambroxol at recommended doses.
If the patient has taken more than the recommended dosage, consult a doctor.

Contraindications

If the patient is allergic to any ingredient in the product.

Special Precautions

Severe skin lesions 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, discontinue Ambroxol and consult a physician immediately.
In the presence of impaired kidney function, a doctor must be consulted.
Do not take more than the recommended dose.
Consult the Doctor: Ask a doctor before use if: The patient has kidney or liver disease; The patient is pregnant or breastfeeding.
Stop use and ask a doctor if: Symptoms worsen or do not improve; New symptoms occur; Any undesirable effect occurs.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.

Use In Pregnancy & Lactation

Do not take this medicine if the patient is pregnant or breastfeeding unless advised by a doctor. The use of Ambroxol in the first trimester is not recommended.

Adverse Reactions

Immune system disorders: Anaphylactic reactions (rare, life-threatening allergic reactions) [including anaphylactic shock, angioedema (rapid swelling of the skin), pruritus (itchiness), rash, urticaria, and other hypersensitivity], severe allergic reactions, severe cutaneous allergic reactions (SCARs) [which includes erythema multiforme and Stevens-Johnson syndrome].
Gastrointestinal disorders: Abdominal pain, diarrhea, dyspepsia (indigestion, feeling of fullness), heartburn, nausea, vomiting.
Nervous system disorders: Dysgeusia (changed taste).
Respiratory, thoracic and mediastinal disorders: Dry throat, oral and pharyngeal hypoesthesia (partial loss of sensation).
Gastrointestinal disorders: Dry mouth.

View ADR Reporting Link

Drug Interactions

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 the patient is taking, including vitamins, supplements, and herbal medicines.

Storage

Store at temperatures not exceeding 30°C.

MIMS Class

Cough & Cold Preparations

ATC Classification

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

Regulatory Classification

Non-Rx

Presentation/Packing

Form

Expel oral drops 6 mg/mL

Packing/Price

15 mL x 1's (P117.25/bottle)

Form

Expel syr 15 mg/5 mL

Packing/Price

60 mL x 1's (P134.75/bottle)

Expel

ambroxol

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc