Oxeze turbuhaler

About Oxeze turbuhaler

What Oxeze turbuhaler is used for

OXEZE TURBUHALER is used to help breathing problems in patients with asthma and its related conditions. Your doctor has prescribed OXEZE TURBUHALER because you or your child’s asthma is not well controlled with current asthma medications (e.g. inhaled glucocorticosteroids along with an as needed short-acting bronchodilator medication). An inhaled glucorticosteroid must always be used if you or your child is using OXEZE TURBUHALER.

The efficacy and safety of OXEZE TURBUHALER in children younger than 6 years has not been established.

What Oxeze turbuhaler does

Twice daily maintenance treatment with OXEZE TURBUHALER gives 24 hour relief or prevention of symptoms such as shortness of breath in patients with asthma and its related conditions.

Formoterol is a fast-acting bronchodilator with a long duration of action. It widens the airways enabling you to breathe more easily. You usually notice an effect from OXEZE TURBUHALER within 1-3 minutes.

When Oxeze turbuhaler should not be used

OXEZE TURBUHALER should not be used in patients who are allergic to formoterol or inhaled lactose (which may contain milk protein residue).

What the medicinal ingredient is

Formoterol fumarate dihydrate.

What the important nonmedicinal ingredients for Oxeze turbuhaler are

Lactose monohydrate (which may contain milk protein residue).

OXEZE TURBUHALER contains an inhalation powder. The powder is a mixture of the medicine formoterol and lactose. (It is unlikely that the very small amount of lactose in the powder would cause any problems to patients who are intolerant to lactose.)

What dosage forms Oxeze turbuhaler comes in

OXEZE TURBUHALER is supplied in two strengths: 6 μg/metered dose (60 doses) and 12 μg/metered dose (60 doses). TURBUHALER is the brand name for a multiple dose, dry powder inhaler. When you breathe in through the mouthpiece, your breath provides the necessary force to deliver the drug to your lungs.

Warnings and Precautions

Serious Warnings and Precautions

A large US clinical trial showed an increased risk of asthma related death and serious respiratory-related outcomes in patients who used salmeterol (a long-acting bronchodilator) in addition to their usual asthma therapy, in comparison with those who used placebo in addition to their usual asthma therapy. The active ingredient in OXEZE is formoterol fumarate dihydrate, which is a different long-acting bronchodilator. Although similar findings have not been seen with formoterol fumarate dihydrate, the risks associated with salmeterol may also apply to other long-acting bronchodilator drugs including OXEZE.

Your doctor has prescribed OXEZE TURBUHALER because your asthma is not well controlled with your current asthma medications (i.e. inhaled glucocorticosteroids along with an as needed short-acting bronchodilator medication). An inhaled glucocorticosteroid must always be used when taking OXEZE TURBUHALER.

BEFORE you use OXEZE TURBUHALER talk to your doctor or pharmacist:

• about all health problems you have now or have had in the past, especially if you have a heart disorder, diabetes, or a disturbed thyroid function (thyrotoxicosis)

• about all medicines you take, including those you have bought without a prescription

• if you have ever had a bad, unusual or allergic reaction to formoterol or lactose or to other medicines for breathing problems

• if you are pregnant, plan to become pregnant or are breast feeding.

When to call your doctor

If you are using more of your fast-acting bronchodilator medication or if you feel that it is less effective TELL YOUR DOCTOR RIGHT AWAY. Your doctor may adjust your treatment.

If your symptoms are waking you up at night, TELL YOUR DOCTOR RIGHT AWAY. Your doctor may adjust your treatment.

If you have taken all your medication as instructed by your doctor and your symptoms are not relieved or you notice a sudden worsening of your shortness of breath, YOU MAY NEED EMERGENCY TREATMENT.

Interactions with Oxeze turbuhaler

Drugs that may interact with OXEZE TURBUHALER include: certain types of medicines—for example, beta-blockers (some heart medicines or eye drops) which may reduce or block the effect of OXEZE TURBUHALER when taken at the same time.

Proper Use of Oxeze turbuhaler

(See package insert for illustrations.)

Before using OXEZE TURBUHALER, read this leaflet carefully. It contains general points about OXEZE TURBUHALER and should add to more specific advice from your doctor or pharmacist.

This medication is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

Please keep this leaflet to refer to until you have used up all medication in OXEZE TURBUHALER.

The dosage of OXEZE TURBUHALER is individual. Follow your doctor’s instructions carefully. They may differ from the information contained in this leaflet.

TURBUHALER is a multidose inhaler from which very small amounts of powder are administered. When you breathe in through TURBUHALER the powder is delivered to the lungs. It is therefore important that you inhale forcefully and deeply through the mouthpiece.

OXEZE TURBUHALER is very easy to use.

Note: You may not taste or feel any medication when inhaling from OXEZE TURBUHALER. This is common.

If you follow the instructions below, you will receive the medication.

Using the inhaler

To administer a dose, simply follow the instructions below. Unscrew and lift off the cover.

TURN: Hold the inhaler upright with the grip downwards. To load the inhaler with a dose turn the greenish-blue grip as far as it will go in one direction and then back to the original position.

CLICK: The “click” you heard means the inhaler is ready to use. Breathe out. Do not breathe out through the mouthpiece.

INHALE: Place the mouthpiece gently between your teeth, close your lips and breathe in forcefully and deeply through your mouth. Do not chew or bite on the mouthpiece.

Note: Do not use TURBUHALER if it has been damaged or if the mouthpiece has become detached.

Remove the inhaler from your mouth, before breathing out.

If more than one dose has been prescribed, repeat the above steps. Replace the cover.

If you accidentally drop, shake or breathe out into OXEZE TURBUHALER after it is loaded, you will lose your dose. If this happens, you should load a new dose and inhale it.

Note: Never breathe out through the mouthpiece. Always replace the cover properly after use.

As the amount of powder dispensed is very small, you may not be able to taste it after inhalation. However, you can still be confident that the dose has been inhaled if you have followed the instructions.

Cleaning

Clean the outside of the mouthpiece once a week with a dry tissue. Never use water or any other fluid. If fluid enters the inhaler it may not work properly.

How do you know when OXEZE TURBUHALER is empty?

OXEZE TURBUHALER has a dose indicator. A new TURBUHALER provides 60 doses for inhalation. When a red mark first appears in the little window underneath the mouthpiece, there are approximately 20 doses left. Now is the time to obtain your next inhaler.

When the red mark reaches the bottom of the window, you should discard your inhaler. The sound you hear when you shake the inhaler is produced by a drying agent, not medication. OXEZE TURBUHALER cannot be re-filled with drug and should be discarded.

How do you identify your different asthma medications?

You may be prescribed the following AstraZeneca medications to help control your asthma. It is important that you understand how to tell them apart and when to use each medication. Before use, carefully read the label on each TURBUHALER device.

Specific information on product identification is provided on the drug product label. Ask your doctor or pharmacist for clarification if you are having difficulty understanding when or how often your medications should be taken.

Usual dose

Maintenance Treatment:

• For long-term twice daily maintenance treatment of asthma:

  Adults: The usual dose is 6 or 12 μg, twice daily, at 12 hour intervals. Some adults may need 24 μg, twice daily. In adults, the maximum recommended daily dose is 48 μg.

  Children (6-16 years): The usual dose is 6 or 12 µg, twice daily, at 12 hour intervals. In children, the maximum recommended daily dose is 24 µg.

Rescue Treatment:

• For the relief of acute bronchoconstriction (asthma attacks) in patients who are on maintenance treatment with OXEZE TURBUHALER:

  Adults and Adolescent Children (12-16 years): The usual dose is 6 or 12 μg as needed.

• For relief of acute bronchoconstriction (asthma attacks) and prevention of bronchospasm (shortness of breath or chest tightness) for patients who remain symptomatic on inhaled corticosteroids:

  Adults and Adolescent Children (12-16 years): The usual dose is 6 or 12 μg as needed. Treatment should always aim for the lowest effective dose.

• For the prevention of exercise-induced asthma:

  Adults and Children 6 years of age and older: 6 or 12 μg before exercise.

When OXEZE TURBUHALER is used on demand, the maximum dose during a 24 hour period should not normally exceed 72 μg in adults and 48 μg in adolescent children. You usually get an effect from OXEZE TURBUHALER within 1-3 minutes. The effect of OXEZE TURBUHALER lasts up to 12 hours.

OXEZE TURBUHALER is not currently recommended for on-demand use in children younger than 12 years of age. For long-term maintenance therapy and prevention of exercise-induced asthma, OXEZE TURBUHALER is not recommended for children younger than 6 years.

You should see your doctor if:

• your usual dose does not provide relief

• the effects of one dose last less than 12 hours

• you use more than 48 μg of OXEZE TURBUHALER on 3 days in a row.

These may be signs that your asthma is getting worse.

Do NOT exceed the dose prescribed by your doctor.

For maintenance treatment of asthma, OXEZE TURBUHALER should be taken together with an anti-inflammatory medication, such as a corticosteroid, to reduce inflammation of the lungs due to asthma. You must continue to regularly take the anti-inflammatory medications your doctor has prescribed. Your anti-inflammatory medications and OXEZE TURBUHALER are designed to act together to best treat your condition. Even though you feel better, DO NOT STOP or reduce your doses of anti-inflammatory medications or OXEZE TURBUHALER without first consulting your doctor.

Overdose

There is no clinical experience on the management of overdose. The most common signs and symptoms that may occur after overdosage are trembling, headache and rapid heartbeat.

Contact your doctor, the Regional Poison Control Centre, or go to the nearest hospital immediately if any of these symptoms bother you, or if you think you have taken too much OXEZE TURBUHALER.

Missed dose

If you miss a dose of your twice daily maintenance treatment of OXEZE TURBUHALER and remember within 6 hours, you should take your usual dose as soon as possible. Then go back to your regular schedule. If it is more than 6 hours when you remember, do not take the missed dose. Just take the next dose on time. Never take a double dose of OXEZE TURBUHALER to make up for missed doses. If you are still unsure, check with your doctor or pharmacist to see what you should do.

Side Effects for Oxeze turbuhaler and What to Do About Them

Usually you do not feel any side effects when you use OXEZE TURBUHALER. However, like any medication, OXEZE TURBUHALER may cause side effects in some people.

The most common side effects are trembling, rapid heartbeat, and headache. Rare or uncommon side effects are muscle cramps, skin rash, agitation, restlessness and sleep disturbances.

Side effects that do occur are usually mild and disappear by themselves within one or two weeks of treatment, however, be sure to tell your doctor if any of the side effects bother you or if they continue. Also contact your doctor if any other unusual effects bother you while you are using OXEZE TURBUHALER.

This is not a complete list of side effects. For any unexpected effects while taking OXEZE TURBUHALER, contact your doctor or pharmacist.