December 18, 2014
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Drug Factsheets

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Zenhale

(formoterol - mometasone)

DIN (Drug Identification Number)

02361752 ZENHALE 100/5 INHALATION AEROSOL

What side effects are possible with Zenhale?

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 this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. 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
  • 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 check with your doctor or 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)
  • eye pain
  • fast or uneven heartbeat
  • high blood pressure
  • increased pressure in the eye (glaucoma)
  • 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)

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 this medication.





Are there any other precautions or warnings for Zenhale?

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 this medication.

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

  • diabetes
  • high blood pressure
  • heart problems
  • 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

Risks of similar medications: The results of a large clinical trial showed an increased risk of asthma-related death in 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 this medication) is also a long-acting bronchodilator. It is unknown whether this product would have similar results.

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

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

Breast-feeding: It is not known if this medication passes into breast milk. If you are a breast-feeding mother and are taking this medication, 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.

What other drugs could interact with Zenhale?

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

  • beta-blocker medications (e.g., atenolol, propranolol) including eye drops (e.g., timolol eye drops)
  • corticosteroids (by mouth or by injection)
  • diuretics (water pills)
  • disopyramide
  • ketoconazole (an antifungal medication)
  • medications for a fast or uneven heartbeat (e.g., quinidine)
  • monoamine oxidase inhibitors (MAOIs, e.g., tranylcypromine, phenelzine)
  • other medications containing a long-acting beta2-agonist (e.g., formoterol, salmeterol)
  • phenothiazines (e.g., chlorpromazine, fluphenazine)
  • procainamide
  • sympathomimetic medications (e.g., epinephrine)
  • tricyclic anti-depressants (e.g., amitriptyline, imipramine)
  • xanthine medications (e.g., theophylline, aminophylline) used to treat asthma

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 this medication. 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.

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