Mucophylline
Syrup
Mucolytic, Bronchodilator
1- Disclaimer
This information is provided for general pharmaceutical and educational purposes only and is not a substitute for the official package leaflet, professional medical advice, diagnosis, or treatment. Do not use this information to start, stop, or change treatment without consulting a qualified healthcare professional.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
Medication information may vary between countries, formulations, manufacturers, and product updates. The current package leaflet and instructions supplied with the product should take precedence whenever they differ from general reference information.
2- Summary
Mucophylline is an oral syrup manufactured by Misr Company for Pharmaceuticals and currently listed in the Egyptian market as a 125 mL syrup. Each 5 mL contains Bromhexine hydrochloride 4 mg and Acefylline piperazine 100 mg. The combination provides a mucus-mobilizing/mucolytic effect together with a bronchodilator effect associated with the xanthine derivative acefylline piperazine.
The product is intended for respiratory conditions in which thick bronchial secretions and bronchospasm are present. It is not an antibiotic and does not have antibacterial or antiviral activity.
3- Brand Name
Mucophylline Syrup 125 mL
4- Category
Mucolytic / Bronchodilator
ATC classification of acefylline piperazine: R03DA09 (xanthine derivative bronchodilator). Bromhexine is classified as a mucolytic/mucoactive agent.
5- Active Ingredient
Each 5 mL contains:
- Bromhexine hydrochloride 4 mg
- Acefylline piperazine 100 mg
These concentrations are consistent with the manufacturer's published composition of 0.08 g bromhexine hydrochloride and 2 g acefylline piperazine per 100 mL.
6- Pharmaceutical Form & Strength
Pharmaceutical form: Oral syrup
Pack size: 125 mL bottle
Strength per 5 mL:
- Bromhexine hydrochloride 4 mg
- Acefylline piperazine 100 mg
The product is currently listed in Egyptian pharmacy sources in the 125 mL presentation.
7- Manufacturer & Marketing Authorization Holder
Manufacturer: Misr Company for Pharmaceuticals (Misr Pharma). The manufacturer's official product page identifies Mucophylline Syrup as a Misr product.
Marketing Authorization Holder (MAH): A separate MAH distinct from the manufacturer could not be independently verified from the publicly accessible sources reviewed. Therefore, it is preferable not to assign a separate MAH without an official Egyptian registration record.
8- Mechanism of Action
Bromhexine hydrochloride:
Bromhexine is a secretolytic/mucolytic agent that reduces mucus viscosity and promotes mucociliary clearance. It enhances lysosomal activity and hydrolysis of mucus components, increases thinner bronchial secretions, and facilitates the movement and expectoration of respiratory secretions. Bromhexine is also metabolized to ambroxol, an active metabolite.
Acefylline piperazine:
Acefylline piperazine is a xanthine derivative with bronchodilator activity. Its pharmacological mechanism is not completely established. Proposed mechanisms include phosphodiesterase inhibition and adenosine-receptor antagonism, ultimately contributing to relaxation of bronchial smooth muscle.
9- Spectrum of Activity
Not applicable as an antimicrobial spectrum.
Mucophylline is not an antibiotic, antibacterial, antifungal, or antiviral medicine. Its pharmacological effects are directed toward bronchial secretions and bronchial smooth muscle rather than microorganisms.
10- Pharmacokinetics
Bromhexine:
After oral administration, bromhexine is rapidly absorbed but undergoes extensive first-pass metabolism, resulting in relatively low systemic bioavailability. It is extensively metabolized in the liver, including conversion to ambroxol and other metabolites. Reported terminal elimination half-life values vary considerably, approximately 6.6–31.4 hours depending on the study and dosing conditions. Most administered drug is recovered as metabolites rather than unchanged bromhexine.
Acefylline piperazine:
Specific, contemporary human pharmacokinetic data for acefylline piperazine are limited in readily accessible authoritative sources. Therefore, precise absorption, half-life, metabolism, and elimination figures should not be stated without a product-specific pharmacokinetic reference.
11- Indications
Mucophylline may be used for respiratory conditions characterized by productive cough with thick bronchial secretions, particularly when bronchospasm is also present.
Product information and Egyptian market listings describe use in conditions such as:
- Cough associated with bronchospasm
- Asthma
- Emphysema
- Acute and chronic bronchitis
- Other respiratory conditions associated with excessive or viscous bronchial secretions and bronchospasm
The combination is intended to facilitate clearance of bronchial secretions while providing bronchodilator activity.
12- Administration
Route: Oral.
Current Egyptian product listings reproduce the following administration directions:
Adults:
2 teaspoonfuls (10 mL) three times daily.
Children:
- Over 10 years: 2 teaspoonfuls (10 mL) three times daily.
- 5–10 years: 1 teaspoonful (5 mL) three times daily.
- 1–5 years: ½ teaspoonful (2.5 mL) three times daily.
The listed product directions state administration after meals.
Because these directions are product-specific and acefylline piperazine is a xanthine derivative, the dosage should not be generalized to other bromhexine or xanthine products, and the current package leaflet should be checked before use.
13- Method of Preparation
Mucophylline is supplied as a ready-to-use oral syrup; no reconstitution is required.
Use the supplied or an appropriately graduated oral measuring device to measure the dose accurately. Do not dilute, mix with other medicines, or alter the preparation unless specifically instructed by a healthcare professional or by the current product leaflet.
14- Contraindications
- Known hypersensitivity to bromhexine, acefylline piperazine, other xanthine derivatives, or any component of the formulation.
- Conditions in which xanthine-induced cardiac or central nervous system stimulation would pose an unacceptable risk should be medically assessed before use.
- Significant cardiac arrhythmias or acute coronary disease require particular caution because xanthine derivatives may increase cardiac stimulation.
- Active peptic ulcer disease requires medical assessment before use.
- Severe hepatic impairment may increase the risk of xanthine toxicity and requires particular caution.
- Patients with seizure disorders require caution because xanthine derivatives can lower the seizure threshold.
15- Warnings & Precautions
- Avoid overdose, particularly in children, because excessive xanthine exposure can cause gastrointestinal, neurological, and cardiovascular toxicity.
- Use cautiously in patients with cardiac disease, arrhythmias, hypertension, hyperthyroidism, hepatic impairment, peptic ulcer disease, or seizure disorders.
- Smoking can increase the clearance of theophylline-like xanthines and may reduce their effects; changes in smoking status can therefore alter xanthine exposure.
- Bromhexine should be used cautiously in patients with a history of peptic ulceration.
- Rare but serious allergic and severe skin reactions have been reported with bromhexine. If a progressive skin rash, blistering, mucosal lesions, facial swelling, or other signs of a severe allergic reaction develop, discontinue the medicine and seek urgent medical attention.
- Pregnancy and breastfeeding should be discussed with a healthcare professional before use because adequate product-specific safety data are limited.
16- Drug Interactions
Because acefylline piperazine is a xanthine derivative, clinically relevant interactions may overlap with those known for theophylline, although the exact magnitude for acefylline piperazine is not as well characterized.
Important potential interactions include:
- Erythromycin and clarithromycin: may increase exposure to theophylline-like xanthines and increase the risk of adverse effects.
- Allopurinol and cimetidine: may reduce xanthine clearance and increase exposure.
- Carbamazepine, phenytoin, rifampicin and other enzyme inducers: may increase xanthine clearance and reduce exposure.
- Beta-blockers: may oppose bronchodilator effects and require clinical consideration.
- Sympathomimetics such as ephedrine and other stimulants: may increase cardiovascular or CNS stimulation.
- Smoking: can lower the exposure to theophylline-like xanthines.
- Caffeine-containing products: may add to CNS and gastrointestinal stimulant effects.
Patients should inform the physician or pharmacist about all medicines, supplements, and smoking habits before using the product.
17- Side Effects
Potential adverse effects related particularly to the xanthine component include:
- Nausea, vomiting, abdominal or epigastric discomfort
- Diarrhea
- Headache
- Nervousness, irritability, tremor or insomnia
- Palpitations and tachycardia
- Other cardiac rhythm disturbances at excessive exposure
- Increased urinary frequency may occur
Bromhexine may additionally cause gastrointestinal intolerance and, rarely, hypersensitivity reactions or serious skin reactions.
18- Use in Special Populations
Children:
The product is marketed with pediatric doses in Egypt; however, children are more susceptible to dosing errors and xanthine-related toxicity. Use only according to the current product instructions and professional advice.
Elderly patients:
Use with caution because the risk of adverse effects from xanthine derivatives and coexisting cardiovascular or hepatic disease may be greater.
Pregnancy:
Product-specific safety data are limited. Use should be based on medical assessment of expected benefit and potential risk.
Breastfeeding:
Consult a healthcare professional before use because adequate product-specific information on exposure through breast milk is limited.
Hepatic impairment:
Particular caution is required because hepatic dysfunction can reduce the clearance of xanthine derivatives and increase toxicity risk.
Renal impairment:
The need for caution depends on severity and the patient's overall clinical condition. A blanket statement that every degree of renal impairment is an absolute contraindication would not be scientifically justified without product-specific evidence.
19- Storage Conditions
Current Egyptian pharmacy information lists storage at a temperature not exceeding 25°C, protected from moisture, excessive heat, and direct sunlight. The package label should be followed if it specifies different storage conditions.
Keep out of the reach of children.
20- Additional Sections
Current Egyptian Market Status
Mucophylline Syrup 125 mL continues to appear in Egyptian pharmacy and medicine listings in August 2026, with Misr identified as the manufacturer/brand and with the same active ingredients and strengths described above.
Egyptian Drug Authority Safety Notice
The Egyptian Drug Authority issued a September 2025 recall notice for Mucophylline Oral Syrup, batch 422015, manufactured by Misr Company for Pharmaceuticals, because the specified batch was found not to comply with testing requirements.
Importantly, the EDA notice states that the warning applies only to the batch identified in the notice and does not apply to distribution of the product in general. Therefore, the notice should not be interpreted as a general withdrawal of all Mucophylline Syrup.
Regulatory Context of Acefylline Piperazine in Egypt
An Egyptian Drug Authority technical committee decision issued in 2023 addressed acefylline piperazine-containing products and acefylline piperazine/phenobarbital combinations, concerning new registrations and products under registration. This regulatory decision should not be interpreted automatically as a statement that every currently marketed product containing acefylline piperazine has been withdrawn; the regulatory status of an individual product depends on its specific registration and applicable regulatory procedures.
21- Frequently Asked Questions (FAQ)
What is Mucophylline used for?
It is an oral syrup combining bromhexine, which helps mobilize thick respiratory mucus, with acefylline piperazine, a xanthine derivative with bronchodilator activity. It is intended for respiratory conditions involving productive cough and, where applicable, bronchospasm.
Is Mucophylline an antibiotic?
No. It has no antibacterial activity and should not be used as a substitute for an antibiotic when an actual bacterial infection requires antimicrobial treatment.
Does Mucophylline contain theophylline?
It does not contain plain theophylline as its listed active ingredient. It contains acefylline piperazine, a xanthine derivative related pharmacologically to theophylline.
Can Mucophylline be used in children?
The Egyptian product is marketed with pediatric dosing instructions, but children require particular care because dosing errors and excessive exposure to xanthine derivatives may produce significant adverse effects. The current product leaflet and professional advice should be followed.
What should I do if I develop a severe rash or swelling while taking it?
Stop taking the medicine and seek medical attention promptly, particularly if the rash is progressive or accompanied by blistering, mucosal lesions, facial swelling, or breathing difficulty, because rare serious allergic and severe skin reactions have been reported with bromhexine.
22- References
- Misr Company for Pharmaceuticals — Mucophylline Syrup product information. Official manufacturer information confirming composition and main indication.
- Egyptian Drug Authority — Mucophylline Oral Syrup recall notice, September 2025. Confirms recall of batch 422015 and that the notice applies only to the specified batch.
- Egyptian Drug Authority — Technical Committee decisions, 2023. Regulatory information concerning acefylline piperazine-containing products.
- Australian Commission on Safety and Quality in Health Care — Bromhexine product information. Pharmacodynamic and pharmacokinetic information for bromhexine.
- European Medicines Agency — Ambroxol/Bromhexine safety review. Important updated information concerning rare severe allergic and cutaneous reactions.
- NHS Specialist Pharmacy Service — Theophylline monitoring and interactions. Information relevant to clinically important xanthine interactions and smoking-related changes in exposure.
- NCBI / PubChem — Bromhexine and Acefylline piperazine records. Pharmacological and chemical information.