Aerolys-200 SR

1. What Aerolys-200 SR is and what it is used for

Aerolys-200 SR contains acebrophylline 200 mg as the active substance.

Acebrophylline is an airway mucoregulator and anti-inflammatory medicine. It is a combination of ambroxol and theophylline-7-acetic acid.

Acebrophylline has bronchodilating, mucoregulating and anti-inflammatory properties. It helps relax the muscles of the airways, reduces the viscosity of mucus and helps improve the clearance of mucus from the airways.

Aerolys-200 SR is used in adults for the treatment of chronic obstructive pulmonary disease (COPD) and bronchial asthma.

It is intended for regular treatment as prescribed by your doctor.

Important: Aerolys-200 SR does not work immediately and should not be used to relieve sudden breathing problems. Keep your fast-acting rescue inhaler available if your doctor has prescribed one for sudden breathing difficulties.

2. What you need to know before you take Aerolys-200 SR

Do not take Aerolys-200 SR

if you are allergic to acebrophylline, ambroxol, theophylline or any other xanthine derivative;
if you have had an acute myocardial infarction (heart attack);
if you have low blood pressure, haemodynamic instability or certain heart rhythm disturbances (arrhythmias);
if you have kidney disease or liver disorder.

If you are not sure whether any of these conditions apply to you, talk to your doctor before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Aerolys-200 SR if you:

have congestive heart failure;
have chronic alcoholism;
have liver problems;
have a viral infection;
have heart rhythm disturbances or other cardiovascular disease;
have an overactive thyroid gland (hyperthyroidism);
have high blood pressure;
have a stomach or duodenal ulcer;
have a seizure or convulsive disorder;
have kidney or liver impairment.

Your doctor may decide that you need closer monitoring or a change in treatment.

Your doctor may perform blood tests during treatment, including monitoring of potassium levels and the level of the medicine in your blood when considered necessary.

Tell your doctor if you have a history of smoking, heart disease, kidney disease or liver disease, as your treatment may need to be adjusted.

Other medicines and Aerolys-200 SR

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may affect the way acebrophylline is cleared from your body. Your doctor may need to adjust your dose or monitor you more closely.

Medicines that may reduce the clearance of the medicine include:

allopurinol;
cimetidine;
ciprofloxacin;
corticosteroids;
diltiazem;
erythromycin;
frusemide;
isoprenaline;
oral contraceptives;
thiabendazole;
verapamil;
doxycycline;
amoxicillin.

Xanthines may increase the risk of low potassium levels when used with medicines such as beta-2 agonists, corticosteroids or diuretics, or in patients with hypoxia.

If you have severe asthma, particular caution is advised and your doctor may monitor your potassium level.

Tell your doctor or pharmacist about all medicines you take, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Aerolys-200 SR is not recommended during pregnancy or during labour.

If you are breast-feeding, ask your doctor for advice before taking this medicine.

The safety of acebrophylline during breast-feeding has not been established. Therefore, use during breast-feeding is not advisable.

Driving and using machines

Aerolys-200 SR does not usually affect your ability to drive or use machines.

However, if you experience dizziness or drowsiness, do not drive or use machines until you feel well again.

Important information about some of the ingredients

Aerolys-200 SR contains titanium dioxide as a colourant.

If your doctor has told you that you have an intolerance to any other ingredients, contact your doctor before taking this medicine.

3. How to take Aerolys-200 SR

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose

Adults

The recommended dose is:

One tablet once daily.

Take the tablet at the same time each day, preferably in the evening after food, unless your doctor has advised you otherwise.

Your doctor will determine how long you should continue treatment.

Do not change the dose or stop treatment without talking to your doctor.

How to take the tablet

Take the tablet by mouth.

Swallow the tablet with water.

Because Aerolys-200 SR is a sustained-release tablet, take it exactly as prescribed by your doctor.

Do not take more tablets than prescribed.

If you take more Aerolys-200 SR than you should

If you take more tablets than prescribed, contact your doctor or seek medical advice immediately.

Symptoms of overdose may include:

nausea;
severe vomiting;
pain in the upper part of the abdomen;
vomiting blood;
restlessness;
increased muscle tone;
exaggerated limb reflexes;
convulsions;
fast heartbeat (tachycardia).

Persistent abdominal pain may be associated with pancreatitis.

Treatment of overdose is symptomatic and should be managed by a healthcare professional.

If you forget to take Aerolys-200 SR

Do not take a double dose to make up for a forgotten dose.

Take your next dose at the usual time.

If you are unsure what to do, ask your doctor or pharmacist.

If you stop taking Aerolys-200 SR

Do not stop taking this medicine without first talking to your doctor, even if you feel better.

Your symptoms may return if treatment is stopped without medical advice.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you notice any side effects

The following side effects have been reported with acebrophylline.

Commonly reported side effects

You may experience:

nausea;
dizziness;
abdominal discomfort;
abdominal or stomach distension;
vomiting;
abdominal pain;
diarrhoea;
constipation;
heartburn;
loss of appetite;
skin rash;
hives (urticaria);
itching;
drowsiness;
difficulty in breathing;
inflammation of the nose.

Nausea and dizziness may be temporary and reversible. These symptoms generally disappear after stopping treatment.

Other reported side effects

Other side effects that have been reported include:

headache;
occasional numbness, including numbness of the arm;
difficulty sleeping (insomnia);
fast heartbeat (tachycardia);
tiredness (fatigue);
high blood pressure;
low blood pressure;
albumin in the urine (albuminuria);
glucose in the urine (glycosuria);
high blood glucose (hyperglycaemia);
increased white blood cell count (leukocytosis);
bleeding from the oesophagus.

Stop taking the medicine and contact your doctor immediately

If you develop chills or fever, stop taking Aerolys-200 SR and contact your doctor immediately.

If you develop severe or unusual symptoms, seek medical attention.

Reporting side effects

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zorvia.com

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aerolys-200 SR

Keep this medicine out of the sight and reach of children.
Store protected from light and moisture.
Store at a temperature not exceeding 30°C.
Do not use this medicine after the expiry date which is stated on the pack.
Improper storage may deteriorate the product.
Store the tablets in their original packaging until required for use.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Aerolys-200 SR contains

The active substance is acebrophylline.

Each film-coated sustained-release tablet contains:

Acebrophylline 200 mg

Other ingredients are present in quantities sufficient to manufacture the tablet.

Colour: Titanium dioxide IP.

What Aerolys-200 SR looks like and contents of the pack