Oxeze Turbuhaler

Long-term maintenance therapy:

• Adults: The usual dose of inhaled formoterol is 6 µg or 12 µg twice daily inhaled every 12 hours. Some people may need 24 µg twice daily, as directed by their doctor. The maximum recommended daily dose is 48 µg.
• Children 6 to 16 years old: The usual dose is 6 µg or 12 µg twice daily inhaled every 12 hours. The maximum recommended daily dose is 24 µg.

Prevention of asthma caused by exercise:

• Adults and children (6 years of age and older): The usual dose is 6 µg or 12 µg before exercise.

Formoterol should not be used to treat acute symptoms; it is meant for prevention purposes only.

The effectiveness of the medication depends on the proper use of the device for adequate delivery. Have your doctor or pharmacist instruct you in how to use the device correctly.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important that Oxeze Turbuhaler (Formoterol-inh) be used exactly as prescribed by your doctor. If you use Oxeze Turbuhaler (Formoterol-inh) regularly and forget a dose, administer it as soon as you remember. If it has been more than 6 hours since your last dose, skip the missed dose and go back to your regular schedule. Do not exceed the dosage recommended by your doctor.

Store Oxeze Turbuhaler (Formoterol-inh) at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause palpitations (rapid and strong heart beat); it may cause shakiness. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

6 µg/metered dose

Each inhalation contains a white-to-off-white or slightly yellow nonhygroscopic crystalline powder of formoterol fumarate dihydrate 6 µg. Nonmedicinal ingredients: lactose monohydrate 600 µg/metered dose (this amount does not normally cause problems in lactose-intolerant people). Turbuhaler of 60 doses with a light greenish-blue turning grip.

12 µg/metered dose

Each inhalation contains a white-to-off-white or slightly yellow nonhygroscopic crystalline powder of formoterol fumarate dihydrate 12 µg. Nonmedicinal ingredients: lactose monohydrate 600 µg/metered dose (this amount does not normally cause problems in lactose-intolerant people). Turbuhaler of 60 doses with a dark greenish-blue turning grip.

Do not use formoterol if you:

• are allergic to formoterol or any ingredients of Oxeze Turbuhaler (Formoterol-inh)
• are allergic to, or intolerant of, inhaled lactose
• have abnormal heart rhythms associated with fast heart rate
• are not using a corticosteroid inhaler

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

• Alfuzosin
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• antihistamines (e.g., Chlorpheniramine, Diphenhydramine, Dimenhydrinate)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Atomoxetine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• beta-blockers (e.g., Atenolol, Carvedilol, Propranolol, Timolol)
• Betahistine
• caffeine
• cannabis
• chloral hydrate
• chloroquine
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• decongestants (e.g., naphazoline, oxymetazoline, phenylephrine, Pseudoephedrine)
• Degarelix
• Digoxin
• Disopyramide
• diuretics (e.g., Furosemide, Hydrochlorothiazide, Spironolactone)
• dipivefrin
• dofetilide
• Domperidone
• Dronedarone
• efavirenz
• ephedrine
• Epinephrine
• Fingolimod
• Flecainide
• Galantamine
• lithium
• lopinavir
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• MAO inhibitors (e.g., Moclobemide, Phenelzine, Rasagiline, Tranylcypromine)
• Maprotiline
• Mefloquine
• Methadone
• Methylphenidate
• mifepristone
• Nabilone
• norepinephrine
• pentamidine
• procainamide
• Propafenone
• protein kinase inhibitors (e.g., Bosutinib, Dasatinib, Nilotinib, Sunitinib)
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rilpivirine
• ritonavir
• Romidepsin
• salbutamol
• salmeterol
• saquinavir
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• terbutaline
• Tetrabenazine
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine, Doxepin)

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 Oxeze Turbuhaler (Formoterol-inh). 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 Oxeze Turbuhaler (Formoterol-inh).

Asthma-related death: Do not stop using corticosteroid medications when you are prescribed formoterol. Formoterol is not a substitute for inhaled corticosteroids. When long-acting bronchodilators, such as formoterol, are used without inhaled (or oral) corticosteroids, there is an increased likelihood of death occurring due to severe asthma symptoms.

Asthma treatment: Do not stop or reduce your dosage of inhaled medications without consulting your doctor, even if you feel better after starting treatment with formoterol. Parents and guardians of children and adolescents who have been prescribed formoterol need to be aware of the importance of consistent and correct use of the medication, the importance of continuing to use the anti-inflammatory medications (corticosteroids) the doctor has prescribed, and the warning signs of worsening asthma such as increased use or reduced effectiveness of formoterol.

Formoterol is intended for the maintenance treatment of asthma only and should not be used in place of a short-acting reliever medication (a "rescue medication") for treatment of acute asthma symptoms. Be sure you have discussed with your doctor and clearly understand what to do in the event of asthma flare-ups. If you find you need to use your short-acting inhaler more often, your condition seems to worsen, or the relief from the formoterol doesn't last as long as it used to, call your doctor. These may be signs that your asthma is worsening, and they need to be evaluated by your doctor.

Bronchospasm: Occasionally, inhaled medications may cause the airways to spasm and close up, making breathing even more difficult (bronchospasm) and can be life-threatening. If you experience increased difficulty breathing after using a dose of formoterol, seek immediate medical attention.

Diabetes: Formoterol can cause increased blood glucose. If you have diabetes or are at risk of developing diabetes, discuss with your doctor how Oxeze Turbuhaler (Formoterol-inh) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Oxeze Turbuhaler (Formoterol-inh), and whether any special monitoring is needed.

Drowsiness/reduced alertness: Since in rare cases formoterol may cause dizziness, be cautious when operating dangerous machinery or driving cars until you have determined how formoterol affects you.

Heart rhythm: Rarely, 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. 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 Oxeze Turbuhaler (Formoterol-inh) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Oxeze Turbuhaler (Formoterol-inh), and whether any special monitoring is needed.

Monitoring asthma: Talk to your doctor about ways for you to monitor your asthma at home, such as a peak flow meter. Peak flow meters measure the amount of air you can expel in a short time and can help you identify when your asthma might be flaring up even before you begin to experience symptoms.

Thyroid: People with an overactive thyroid gland (Hyperthyroidism) are more likely to experience side effects from formoterol. If you have thyroid disease, discuss with your doctor how Oxeze Turbuhaler (Formoterol-inh) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Oxeze Turbuhaler (Formoterol-inh), and whether any special monitoring is needed.

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

Pregnancy: The safety of formoterol during pregnancy has not been established. Oxeze Turbuhaler (Formoterol-inh) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Oxeze Turbuhaler (Formoterol-inh), contact your doctor immediately.

Breast-feeding: It is not known if formoterol passes into breast milk. If you are a breast-feeding mother and are using Oxeze Turbuhaler (Formoterol-inh), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of formoterol have not been established for use by children less than 6 years of age. Children and adolescents appear to be more likely to experience asthma symptoms causing hospitalization when they use formoterol.

This product must be inhaled by mouth. Carefully follow the package's instructions. If needed, ask your pharmacist for additional information or for a demonstration. This medication is typically used twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Use it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up.