Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Zenhale. If you are concerned about side effects, discuss the risks and benefits of Zenhale with your doctor.

The following side effects have been reported by at least 1% of people taking Zenhale. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

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

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision
• Cataracts (clouding of the lens of the eye)
• decreased function of the adrenal glands (e.g., tiredness, weakness, nausea, vomiting, and Low Blood Pressure)
• decreased potassium in the blood (e.g., irregular heartbeat, muscle weakness, general feeling of being unwell)
• eye pain
• fainting
• fast or uneven heartbeat
• high blood pressure
• increased pressure in the eye (Glaucoma)
• Churg-Strauss Syndrome (flu-like illness, rash, pins and needles or numbness of the arms and legs, severe sinus pain, worsening lung or breathing problems)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• thrush (a fungal infection in the mouth; thrush is less likely to occur if you rinse your mouth with water and spit after using the medication)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• allergic reaction (symptoms include rash, itching, Hives, redness or swelling of the eyes, lips or throat, trouble breathing)
• chest pain
• sudden coughing, wheezing, and trouble breathing after using inhaler
• worsening asthma symptoms

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Zenhale.

50/5
Each inhalation delivers 50 µg of mometasone furoate and 5 µg of formoterol fumarate dihydrate. Nonmedicinal ingredients: ethanol anhydrous, oleic acid, and HFA-227 (propellant).

100/5
Each inhalation delivers 100 µg of mometasone furoate and 5 µg of formoterol fumarate dihydrate. Nonmedicinal ingredients: ethanol anhydrous, oleic acid, and HFA-227 (propellant).

200/5
Each inhalation delivers 200 µg of mometasone furoate and 5 µg of formoterol fumarate dihydrate. Nonmedicinal ingredients: ethanol anhydrous, oleic acid, and HFA-227 (propellant).

Do not take Zenhale if you:

• are allergic to formoterol, mometasone, or any ingredients of the medication
• are experiencing an acute asthma attack
• have a fast heart rate (tachyarrhythmia)
• have a fungal, bacterial, viral, or parasitic infection that has not been treated
• have an active Tuberculosis infection
• have herpes simplex (virus) infection of the eye

There may be an interaction between formoterol - mometasone and any of the following:

• Aldesleukin
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Atomoxetine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• beta-blocker medications (e.g., Atenolol, Propranolol) including eye drops (e.g., Timolol eye drops)
• Betahistine
• fast acting bronchodilators (e.g., salbutamol, terbutaline)
• other long acting bronchodilators (e.g., salmeterol, Indacaterol)
• caffeine
• cannabis
• Cobicistat
• conivaptan
• corticosteroids (by mouth or by injection)
• decongestant cold medications (e.g., phenylephrine, Pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• Deferasirox
• Desmopressin
• dexmethylphenidate
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Dronedarone
• Epinephrine
• Hepatitis C antivirals (e.g., dasabuvir, ombitasvir, paritaprevir)
• HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir)
• Linezolid
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methadone
• Methylphenidate
• mifepristone
• Modafinil
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• procainamide
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Ofloxacin,)
• rilpivirine
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Tetrabenazine
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• tricyclic anti-depressants (e.g., Amitriptyline, Imipramine)
• tyrosine kinase inhibitors (e.g., Ceritinib, Idelalisib, Lapatinib, Pazopanib, Sunitinib)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Zenhale. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Zenhale.

Asthma attacks: Zenhale is not a "reliever" medication. If you start developing asthma symptoms, be sure to use your reliever medication for rapid relief of your asthma symptoms. It is very important that you have your reliever medication with you at all times. If you persistently use more of your reliever medication, contact your doctor.

Diabetes: Both formoterol and mometasone may cause an increase in blood sugar levels. If you have diabetes, you may find it necessary to monitor your blood sugar more frequently while using Zenhale. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Zenhale may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zenhale, and whether any special monitoring is needed.

Eye problems: If you are at risk of developing glaucoma or cataracts, have your eyes checked by your doctor before starting long-term treatment with Zenhale. You should have your eyes monitored at regular intervals while using Zenhale.

Heart rhythm: Beta-agonists such as formoterol can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death.

Formoterol may cause a fluttering of the heartbeat (atrial fibrillation) or rapid heartbeat, increased blood pressure, chest pain, and decreased oxygen reaching the heart muscle.

If you are at risk for heart rhythm problems (e.g., people with heart failure, Angina, low potassium or magnesium levels), discuss with your doctor how Zenhale may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zenhale, and whether any special monitoring is needed.

Infections: Corticosteroids, such as mometasone, can reduce your body’s ability to fight infections and may hide signs of infection that is developing. Infections such as Chickenpox and Measles can be more serious for people taking medications such as fluticasone. If you are exposed to someone with chickenpox or measles, contact your doctor.

Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways, which make breathing difficult. If you experience this problem when using formoterol - mometasone, stop using Zenhale immediately. Speak to your doctor if you experience any problems with breathing while taking this or other inhaled medication.

Medical conditions: Discuss with your doctor how Zenhale may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zenhale, and whether any special monitoring is needed, if you have any of the following conditions:

• herpes simplex (virus) infection of the eye
• liver disease
• low levels of potassium in the blood
• problems with Thyroid or adrenal glands
• tuberculosis
• any other type of untreated infection

Oral hygiene: Adequate oral hygiene, such as rinsing your mouth with water after using Zenhale, helps reduce the chances of developing a yeast infection of the mouth or throat (thrush). If you develop symptoms of thrush, such as white patches in your mouth, contact your doctor.

Osteoporosis: Long-term use of corticosteroids, including inhaled corticosteroids such as mometasone, may increase the risk of bone loss and osteoporosis. If your doctor recommends that you use Zenhale for a lengthy period of time, talk to your doctor about supplements and strategies to slow down and reduce bone loss.

Risks of similar medications: The results of a large clinical trial showed an increased risk of asthma-related death for patients who used another long-acting bronchodilator (salmeterol) in addition to their usual asthma therapy when compared to patients who used placebo (an inactive medication) in addition to their usual asthma therapy. Formoterol fumarate dihydrate (one of the active ingredients is Zenhale) is also a long-acting bronchodilator. It is unknown whether this product would have similar results.

Steroid medication use: If you have taken oral steroid medications over the last several months or are still taking oral corticosteroids, consult with your doctor before using Zenhale. In times of stress or during a severe asthma attack, your doctor may want you to start your oral steroid medication again.

Stopping the medication: Zenhale contains an inhaled corticosteroid, mometasone furoate. Abruptly stopping inhaled corticosteroids can make asthma worse. Do not stop Zenhale suddenly. Instead, speak to your doctor about how to stop the medication safely by gradually reducing the dose.

Worsening symptoms: If you find you need to use your short-acting ("rescue") inhaler more often or if your condition seems to worsen, call your doctor. If you have not been given instructions beforehand, contact your doctor immediately about what to do if any of the following situations occur (they may be signs of seriously worsening asthma):

• decreased effectiveness of short-acting, inhaled bronchodilators such as salbutamol, terbutaline, or fenoterol (less than 4 hours of relief)
• need for more inhalations than usual of short-acting, inhaled bronchodilators
• peak flow meter showing results in the below-normal range

Pregnancy: Zenhale should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Zenhale, contact your doctor immediately.

Breast-feeding: It is not known if Zenhale passes into breast milk. If you are a breast-feeding mother and are taking Zenhale, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children less than 12 years of age.