Frequently asked questions

Proxor^® is a pressurised inhalation solution containing two active substances which are inhaled through your mouth and delivered directly into your lungs. The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate.

Beclometasone dipropionate belongs to a group of medicines called corticosteroids which have an anti-inflammatory action reducing the swelling and irritation in your lungs. Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators which relax the muscles in your airways and helps you to breathe more easily.

Together these two active substances make breathing easier, by providing relief from symptoms such as shortness of breath, wheezing and cough in patients with asthma or COPD and also help to prevent the symptoms of asthma.

Asthma
Proxor^® is indicated in the regular treatment of asthma in adult patients in whom:

• asthma is not adequately controlled by using inhaled corticosteroids and “as needed” short-acting bronchodilators or
• asthma is responding well to treatment with both corticosteroids and long-acting bronchodilators.

COPD (Proxor^® 100/6 only)
Proxor^® 100/6 can also be used to treat the symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a long term disease of the airways in the lungs which is primarily caused by cigarette smoking.

Do not use Proxor^®:

• if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate
• if you are allergic to any of the other ingredients of this medicine. See the Proxor^® 100/6 or 200/6 Package Leaflet for more information.

Always use this medicine exactly as your doctor, nurse or pharmacist has told you. Do not take more doses per day than stated on your prescription.

Taking more formoterol than you should can have the following effects: feeling sick, being sick, heart racing, palpitations, disturbances of heart rhythm, certain changes in the electrocardiogram (heart trace), headache, trembling, feeling sleepy, too much acid in the blood, low blood potassium levels, high levels of glucose in the blood. Your doctor may wish to carry out some blood tests to check your blood potassium and blood glucose levels.

Taking too much beclometasone dipropionate can lead to short-term problems with your adrenal glands. This will get better within a few days however your doctor may need to carry out some blood tests to check your serum cortisol levels.

Tell your doctor if you have any of these symptoms.

Take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time. Do not double the dose.

Do not lower the dose or stop using the medication. Even if you are feeling better, do not stop taking Proxor^® or lower the dose. If you want to do this, talk to your doctor. It is very important for you to use Proxor^® regularly even though you may have no symptoms.

Keep this medicine out of the sight and reach of children.

Before use: store the inhaler in a refrigerator (at 2-8°C) for a maximum of 18 months.

After first use: Use the inhaler for a maximum of three months and do not store above 25 °C. Do not use the inhaler after this period and never use it after the expiry date which is stated on the carton and label after “EXP”. Expiry date refers to the last day of that month. Do not freeze.

If the inhaler has been exposed to severe cold, warm it with your hands for a few minutes before using. Never warm it by artificial means.

Warning: The canister contains a pressurised liquid. Do not expose the canister to temperatures higher than 50°C. Do not pierce the canister.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Talk to your doctor or pharmacist before using Proxor^®:

• If you have any heart problems, such as angina (heart pain, pain in the chest), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries around your heart (coronary heart disease), valvular heart disease or any other known abnormalities of your heart or if you have a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a condition where the heart muscle is abnormal).
• If you have narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure or if you know that you have an aneurysm (an abnormal bulging of the blood vessel wall).
• If you have disorders of your heart rhythm such as increased or irregular heart rate, a fast pulse rate or palpitations or if you have been told that your heart trace is abnormal.
• If you have an overactive thyroid gland.
• If you have low blood levels of potassium.
• If you have any disease of your liver or kidneys.
• If you have diabetes (if you inhale high doses of formoterol your blood glucose may increase and therefore you may need to have some additional blood tests to check your blood sugar when you start using this inhaler and from time to time during treatment).
• If you have a tumour of the adrenal gland (known as a phaeochromocytoma).
• If you are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop taking Proxor^® at least 12 hours before the anaesthesia.
• If you are being, or have ever been, treated for tuberculosis (TB) or if you have a known viral or fungal infection of your chest.
• If you must avoid alcohol for any reason.

If any of the above applies to you, always inform your doctor before you use Proxor.

If you have or had any medical problems or any allergies or if you are not sure as to whether you can use Proxor^® talk to your doctor, asthma nurse or pharmacist before using this medicine.

Treatment with a beta-2-agonist like the formoterol contained in Proxor^® can cause a sharp fall in your serum potassium level (hypokalaemia).

If you have severe asthma, you should take special care.

This is because a lack of oxygen in the blood and some other treatments you may be taking together with Proxor, such as medicines for treating heart disease or high blood pressure, known as diuretics or “water tablets” or other medicines used to treat asthma can make the fall in potassium level worse. For this reason, your doctor may wish to measure the potassium levels in your blood from time to time.

If you take higher doses of inhaled corticosteroids over long periods, you may have more of a need for corticosteroids in situations of stress. Stressful situations might include being taken to hospital after an accident, having a serious injury or before an operation. In this case, the doctor treating you will decide whether you may need to increase your dose of corticosteroids and may prescribe some steroid tablets or a steroid injection.

Should you need to go to the hospital, remember to take all of your medicines and inhalers with you, including Proxor^® and any medicines or tablets bought without a prescription, in their original packaging, if possible.

Contact your doctor if you experience blurred vision or other visual disturbances

There are no clinical data on the use of Proxor^® during pregnancy.

Proxor^® must not be used if you are pregnant, think that you might be pregnant or are planning to become pregnant, or if you are breast-feeding, unless you are advised to do so by your doctor.

Proxor^® is unlikely to affect your ability to drive and use machines. However, if you experience side effects such as dizziness and/or trembling, your ability to drive or operate machinery may be affected.

Proxor contains alcohol

This medicine contains 7 mg of alcohol (ethanol) in each actuation which is equivalent to 0.19 mg/kg per dose of two actuations. The amount in of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.