Zenhale (Formoterol fumarate dihydrate, Mometasone furoate)

Serious Warnings for Asthma Patients

Formoterol, one of the medicines in ZENHALE, may increase the risk of asthma-related death. It may increase the risk of asthma-related hospitalization in pediatrics and adolescent patients. Therefore:

• Your doctor will assess your asthma control at regular intervals. ZENHALE should only be used when your doctor decides that other asthma medications (e.g. inhaled glucocorticosteroids along with an as needed relief medication) are not helping you enough, or that you need two maintenance medications to control your asthma.
• ZENHALE should not be the first medication you use, unless advised by your doctor.

Once asthma control has been achieved and maintained, your doctor will assess you at regular intervals. ZENHALE should only be used when an inhaled corticosteroid does not adequately control your asthma symptoms.

BEFORE you use ZENHALE talk to your doctor or pharmacist if you:

• you are diabetic
• have high blood pressure
• have ever had a heart problem, such as rapid or irregular heart beat or abnormal electrical signal called “prolongation of the QT interval”
• have liver disease or cirrhosis
• have problems with your thyroid or adrenal glands
• have low levels of potassium in your blood
• have or have ever had tuberculosis
• have a fungal infection (thrush) in your mouth or throat
• have eye disorders such as glaucoma or cataracts
• have hypoprothrombinemia (a blood clotting problem) and are taking acetylsalicylic acid (aspirin)
• have an aneurysm (area where an artery is swollen like a sack because the wall of the artery is weak)
• have pheochromocytoma (a tumor of the adrenal gland that can affect blood pressure)
• are pregnant, planning to get pregnant or are breastfeeding.

Important things to remember when using ZENHALE:

• If symptoms get worse (increased use of a 'reliever' medication, peak flow measurement falls, your symptoms are waking you up at night) or do not get better after using ZENHALE, you should contact your doctor as soon as possible.
• ZENHALE should not be used to treat sudden asthma symptoms.
• Do not stop taking ZENHALE on your own, even if you feel better. Your doctor can direct you on how to discontinue ZENHALE slowly to avoid asthma flare-ups.
• If you are transferring to ZENHALE from steroid tablets or syrup and your doctor is slowly decreasing the dose, you may notice that you develop symptoms of allergies such as itchy, watery eyes or rash, which had been controlled by your steroid. Your doctor will tell you how to control these symptoms. During this time, if you begin to notice joint or muscle pain, feelings of depression, tiredness or lethargy, you should tell your doctor.
• You may need to also take steroid tablets or syrup during a severe asthma attack, during other illnesses or during times of stress. Your doctor may give you some steroid tablets or a syrup to carry with you as well as a steroid warning card, which will give you advice on when and how to use them.
• Adolescents 12 years and older treated with ZENHALE may grow more slowly than others.
• You should avoid coming into contact with anyone who has measles or chicken pox. If you or your child are exposed, tell your doctor right away.
• While using inhaled corticosteroids, patients should be monitored for signs of cataracts, glaucoma (see your eye doctor regularly) or of osteoporosis (decreased bone density).
• When using drugs like ZENHALE for long term treatment, you may be at risk of:
  • Breaking a bone (bone fractures);
  • Osteoporosis (increased risk of bone fractures);
  • Take extra care to avoid any injury, especially falls.
• Drugs like ZENHALE can cause eye disorders:
  • Cataracts: clouding of the lens in the eye, blurry vision, eye pain;
  • Glaucoma: An increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.
  • You should therefore have regular eye exams.
• If you notice the following symptoms: a flu-like illness, rash, pins and needles or numbness of arms or legs, severe sinusitis and worsening lung or breathing problems, this can be a sign of Churg-Strauss syndrome. This can happen in people with asthma who are using inhaled corticosteroids. Tell your healthcare provider right away if these symptoms occur.

Like all medicines, ZENHALE can cause side effects, although not everybody gets them. Side effects may include:

• nausea
• headache
• hoarseness
• tremor
• shakiness
• nervousness
• dizziness
• disturbed sleep
• muscle cramps
• sore throat
• rounded face
• loss of bone density
• fainting
• dry mouth.

Tell your doctor or pharmacist if you are taking or have recently taken any other medications.

Drugs that may interact with ZENHALE include:

• Beta-blocker medicines ( such as atenolol or propranolol used for high blood pressure) including eye drops (such as timolol eyedrops for glaucoma)
• Ketoconazole, itraconazole (an antifungal medicine)
• Corticosteroids (by mouth or by injection)
• Diuretics (water pills)
• Xanthine medicines (such as theophylline and aminophylline) used to treat asthma
• Medicines for a fast or uneven heartbeat (such as quinidine)
• Tricyclic anti-depressants
• Monoamine oxidase inhibitors (MAOIs)
• Terfenadine or astemizole (an antihistamine used to treat allergies)
• Other medicines containing a long-acting beta2-agonist (i.e. formoterol, salmeterol)
• Disopyramide, procainamide or phenothiazines
• Ritonavir, atazanavir, indinavir, nelfinavir, saquinavir (an anti-HIV medicine)
• Macrolide antibiotics (e.g. erythromycin, azithromycin, clarithromycin)
• Inhaled anaesthetics such as halogenated hydrocarbons (e.g. halothane), used during surgery. Inform your doctor that you use ZENHALE if you are to have surgery under anaesthesia
• Acetylsalicylic acid (aspirin) if you have hypoprothrombinemia

Make sure that your doctor or pharmacist knows what other medications you are taking, including those you can buy without a prescription and as natural health products.

Always take ZENHALE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

When to replace your ZENHALE inhaler:

When the counter reads 20, you should refill your prescription or ask your doctor if you need a new prescription for ZENHALE.

Discard ZENHALE after the counter reaches 0, indicating that you have used the number of actuations on the product label and box. Your inhaler may not feel empty and it may continue to operate, but you will not get the right amount of medicine if you keep using it.

Never try to change the numbers on the counter or remove the counter from the actuator.

Warning:

Do not use the inhaler after the expiration date. The expiry date refers to the last day of that month.

How to clean your ZENHALE inhaler:

The mouthpiece should be cleaned using a dry wipe after every 7 days of use.

Routine cleaning instructions:

• Remove the cap off the mouthpiece. Wipe the inside and outside surfaces of the actuator mouthpiece with a clean, dry lint-free tissue or cloth. Do not wash or put any parts of your inhaler in water. Put the cap back on the mouthpiece after cleaning.
• Do not remove the canister from the actuator.
• Do not attempt to unblock the actuator with a sharp object, such as a pin.

Use with a spacer:

If necessary, your doctor will prescribe the use of a spacer to help you properly take this medication. Instructions provided with the spacer device should be consulted prior to use.

Overdose:

If you use more ZENHALE than you should, contact your doctor or pharmacist.

The most common symptoms that may occur if you use more ZENHALE than you should are nausea, vomiting, headache, trembling, drowsiness, low potassium levels, high sugar levels, high blood pressure or a rapid or irregular heart beat.

If you have used larger doses for a long period of time, you should talk to your doctor or pharmacist for advice. This is because larger doses of ZENHALE may reduce the amount of steroid hormones produced by the adrenal gland.

In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional poison control centre, even if there are no symptoms.

Missed dose:

If you miss a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten dose.

Do not suddenly stop using this medicine even if your asthma seems to be better. Speak with your doctor first.

Your symptoms may come back if you stop using this medicine before your doctor has told you to do so. If you think that your asthma is not getting any better or seems to be getting worse, after you have started using ZENHALE go back and see your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.