OXIS

Package Leaflet: Information for the User

Oxis Turbohaler 4.5 micrograms/dose Inhalation Powder

formoterol fumarate dihydrate
Please read this leaflet carefully before using this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Oxis is and what it is used for
2. What you need to know before using Oxis
3. How to use Oxis
4. Possible side effects
5. How to store Oxis
6. Contents of the pack and other information

1. What Oxis is and what it is used for

Oxis is an inhaler. It contains a medicine called formoterol, which belongs to a group of medicines known as "long-acting beta-agonists" or "bronchodilators".
It works by relaxing the muscles in the airways, thus helping you to breathe more easily. It starts to work within 1-3 minutes and its effects last up to 12 hours.
Your doctor has prescribed this medicine for the treatment of asthma or chronic obstructive pulmonary disease (COPD).

Asthma
Oxis is used in the treatment of asthma in adults, adolescents, and children over 6 years of age. For the treatment of asthma, your doctor has prescribed two inhalers: Oxis and a separate corticosteroid inhaler. These must be used together.

• Oxis is used to help prevent the onset of asthma symptoms.
• Some people also use Oxis when additional doses are needed to relieve asthma symptoms and make breathing easier.
• Oxis may also be taken before exercise to prevent asthma symptoms triggered by physical activity.

Chronic obstructive pulmonary disease (COPD)
Oxis may also be used for the treatment of COPD symptoms in adults. COPD is a chronic lung disease affecting the airways, often caused by cigarette smoking.

2. What you need to know before using Oxis

Do not use Oxis:

• If you are allergic (hypersensitive) to formoterol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Oxis if:

• You have diabetes. Additional blood glucose tests may be needed if you are using Oxis.
• You have high blood pressure or have ever had heart problems.
• You have a thyroid disorder.
• You have low levels of potassium in the blood. Your doctor may require further tests to assess potassium levels in the blood.
• You have severe liver problems, such as cirrhosis. If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before using Oxis.

Other medicines and Oxis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal products. This is because Oxis may affect how some medicines work, and some medicines may affect Oxis. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Beta-blockers (such as atenolol or propranolol used to treat high blood pressure), including eye drops (such as timolol used to treat glaucoma).
• Medicines for rapid or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics (such as furosemide). These are used to treat high blood pressure.
• Corticosteroid medicines taken by mouth (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline), often used to treat asthma.
• Erythromycin (used to treat infections).
• Antihistamines (such as terfenadine).
• Other medicines that open the airways (bronchodilators, such as salbutamol).
• Ephedrine (used to treat asthma or as a decongestant).
• Tricyclic antidepressants (such as amitriptyline). If you fall into any of the above categories or have any doubts, speak to your doctor or pharmacist before using Oxis. Also inform your doctor or pharmacist if you are due to undergo general anaesthesia for a surgical or dental procedure.

The addition of anticholinergics (such as tiotropium or ipratropium bromide) to treatment with Oxis may help open your airways further.
Pregnancy, breast-feeding and fertility

• If you are pregnant, think you may be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor before taking this medicine – do not use Oxis unless your doctor tells you to.
• If you become pregnant while being treated with Oxis, do not stop using Oxis but consult your doctor immediately.

Driving and using machines
It is unlikely that Oxis will affect your ability to drive or operate machinery.
Oxis contains lactose
Oxis contains lactose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before using this medicine. The amount of lactose contained in this medicine does not normally cause problems in people who are lactose intolerant.
The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions.

3. How to use Oxis

• Always use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
• Do not increase the dose of Oxis prescribed by your doctor without first speaking to them.
• If you are using Oxis regularly for the treatment of asthma or COPD, you must continue taking the medicine even in the absence of symptoms.

Important information about asthma or COPD symptoms
If you notice the onset of breathlessness or wheezing while using Oxis, continue using Oxis but consult your doctor as soon as possible, as additional treatment may be necessary.
Contact your doctor immediately if:

• Your breathing suddenly worsens or you wake up frequently at night with asthma symptoms.
• You begin to feel chest tightness.
• The usual dose does not provide relief.
• You need to take a higher dose than usual for more than 2 days in a week.
• You need to use the Turbohaler more often than usual before physical exercise.

These signs may indicate that your asthma or COPD is not adequately controlled and that you may need immediate alternative or additional treatment.
Asthma
Oxis must not be used in children under 6 years of age.
Adults (18 years of age and over)

• The recommended dose is 1 or 2 inhalations, one or two times daily.
• Your doctor may increase the dose to 4 inhalations, one or two times daily.
• Some people also use Oxis as a "reliever inhaler". If you experience asthma symptoms, the usual dose is 1 or 2 inhalations when symptoms occur.
• A total daily dose exceeding 8 inhalations is not normally necessary. This dose includes all inhalations taken daily, those taken when asthma symptoms occur, and those taken before physical exercise. However, your doctor may allow you to take up to 12 inhalations per day. Do not use more than 12 inhalations in total within 24 hours.
• Do not take more than 6 inhalations at a time.

Children and adolescents (6 to 17 years of age)

• The recommended dose is 2 inhalations, one or two times daily.
• Some children also use Oxis as a "reliever inhaler". If your child experiences asthma symptoms, the usual dose is 1 or 2 inhalations when symptoms occur.
• A total daily dose exceeding 4 inhalations is not normally necessary. This dose includes all inhalations taken daily, those taken when asthma symptoms occur, and those taken before physical exercise. However, your doctor may allow your child to take up to 8 inhalations per day. Your child must not take more than 8 inhalations in total within 24 hours.
• Your child must not take more than 2 inhalations at a time.

Your doctor will help you manage asthma. Once asthma is well controlled, your doctor may consider gradually reducing the dose of Oxis.
Exercise-induced asthma
If you or your child experience asthma symptoms triggered by physical exercise, your doctor may advise you or your child to take Oxis before such exercise. Oxis must not be used in children under 6 years of age.
Adults (18 years of age and over)

• The recommended dose is 2 inhalations before physical exercise.
• A total daily dose exceeding 8 inhalations is not normally necessary. This dose includes all inhalations taken daily, those taken when asthma symptoms occur, and those taken before physical exercise. However, your doctor may allow you to take up to 12 inhalations per day. Do not use more than 12 inhalations in total within 24 hours.
• Do not take more than 6 inhalations at a time.

Children and adolescents (6 to 17 years of age)

• The recommended dose is 1 or 2 inhalations before physical exercise.
• A total daily dose exceeding 4 inhalations is not normally necessary. This dose includes all inhalations taken daily, those taken when asthma symptoms occur, and those taken before physical exercise. However, your doctor may allow your child to take up to 8 inhalations per day. Your child must not take more than 8 inhalations in total within 24 hours.
• Your child must not take more than 2 inhalations at a time.

Chronic obstructive pulmonary disease (COPD)

• For use only in adults (18 years and over)
• The recommended dose is 2 inhalations, one or two times daily.
• Your doctor may advise you to take additional doses for relief of COPD symptoms.
• You must not take more than 8 inhalations per day.
• You must not take more than 4 inhalations at a time.

Preparing a new Oxis Turbohaler inhaler
Before using a new Oxis Turbohaler inhaler for the first time, prepare the inhaler for use as follows:

• Unscrew and remove the cap. You may hear a rattling sound.
• Hold the Oxis Turbohaler vertically with the blue wheel facing downwards.
• Turn the blue wheel fully in one direction, then fully in the other direction (the initial direction does not matter). You should hear a click.
• Repeat the above step once more, turning the blue wheel in both directions.
• The Oxis Turbohaler is now ready for use.

How to take an inhalation
Each time you need to take a dose, follow the instructions below.

1. Unscrew and remove the white cap. You may hear a metallic sound.
2. Hold the Turbohaler vertically with the blue wheel facing downwards.
3. Do not grip the mouthpiece when loading the Turbohaler. To load a dose, turn the blue wheel fully in one direction, then fully in the other direction (the initial direction does not matter). You will hear a click. The Turbohaler is now loaded and ready for use. Only load the Turbohaler when you are ready to use it.

4. Hold the Turbohaler away from your mouth. Breathe out gently (without forcing). Do not breathe out through the Turbohaler.
5. Gently place the mouthpiece between your teeth. Close your lips around it. Breathe in as deeply as possible through your mouth. Do not chew or bite the mouthpiece.

6. Remove the Turbohaler from your mouth. Then breathe out gently. The amount of medicine inhaled is very small. This means you may not taste it after inhalation. If you have followed the instructions correctly, you can be sure that the dose has been taken and that the medicine is now in your lungs.
7. If a second inhalation is needed, repeat steps 2 to 6.
8. Replace the cap firmly after use.

Do not attempt to remove or rotate the mouthpiece. It is fixed to the Turbohaler and must not be detached. Do not use the Turbohaler if it is damaged or if the mouthpiece has come loose.
As with all inhalers, caregivers must ensure correct inhalation technique in children prescribed Oxis, as described above.
How to clean the Turbohaler inhaler
Clean the outside of the mouthpiece once a week by wiping it with a dry cloth. Do not use water or liquids.
When to start using a new Turbohaler

• The dose indicator shows how many doses remain, starting from 60 doses when full.

• The dose indicator is marked in 10-dose intervals. Therefore, it does not show every single dose. When a red mark first appears at the top of the indicator window, approximately 20 doses remain. For the last 10 doses, the background of the dose indicator turns red. When the '0' on the red background reaches the middle of the window, you should start using a new Turbohaler.

Note:

• You may still be able to turn the wheel and hear a "click" even when the Turbohaler is empty.
• The sound heard when shaking the inhaler comes from a drying agent and not from the medicine. Therefore, this sound does not indicate the amount of medicine remaining in the Turbohaler.
• If, by mistake, you load Oxis more than once before taking a dose, only one dose will be delivered. However, the dose counter will record all loading actions.

If you use more Oxis than you should
If you use more Oxis than prescribed, contact your doctor or pharmacist immediately for advice. The following effects may occur: tremor, headache, or rapid heartbeat.
If you forget to use Oxis
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop using Oxis
Do not stop treatment with Oxis without first consulting your doctor.
If you have any questions about how to use the Turbohaler, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone gets them.
If you experience any of the following, stop using Oxis and contact your doctor
immediately:

• Bronchospasm (contraction of the muscles in the airways causing sudden wheezing) after inhaling the medicine. This occurs very rarely and may affect up to 1 in 10,000 people.

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Tremor or shakiness. If these effects occur, they are usually mild and disappear with continued treatment with Oxis.
• Headache.
• Dizziness.
• Nausea (feeling unwell).
• Muscle cramps.

Uncommon (may affect up to 1 in 100 people)

• Palpitations (awareness of heartbeat). If this occurs, it is generally mild and usually disappears with continued use of Oxis Turbohaler.
• Sleep disturbances.
• Fast heartbeat.
• Allergic reactions such as skin rash, itching, and bronchospasm.
• Low level of potassium in the blood.
• Increased blood sugar (glucose) levels.
• Taste disturbances, for example, unpleasant taste in the mouth.
• Changes in blood pressure.
• Irregular heartbeat.
• Chest pain or tightness (angina pectoris).

Rare (may affect up to 1 in 1,000 people)

• Feeling restless or agitated.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oxis

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special storage conditions.
• When not in use, Oxis must be stored with the cap firmly closed.
• Do not use this medicine after the expiry date stated on the pack or on the side of the Turbohaler. The expiry date refers to the last day of the month.
• Always dispose of the used Turbohaler responsibly, as some medicine will remain inside. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Oxis Contains
The active substance is formoterol fumarate dihydrate. Each inhaled dose contains 6 micrograms of formoterol fumarate dihydrate, of which 4.5 micrograms are inhaled.
The other excipient is monohydrate lactose (which contains milk proteins). See section 2 "Oxis contains lactose".

Description of the appearance of Oxis and contents of the pack
Oxis is an inhaler containing the medicine. The inhalation powder is white in colour. Each Turbohaler contains 60 doses and has a white body with a blue wheel.
Oxis is available in the following pack sizes: 60 doses (1 inhaler), 3x60 doses (3 inhalers), 10x60 doses (10 inhalers), 18x60 doses (18 inhalers), or 20x60 doses (20 inhalers).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
AstraZeneca S.p.A.
Palazzo Ferraris
Via Ludovico il Moro 6/C
Basiglio (MI) 20080
Italy

Manufacturer:
AstraZeneca AB
SE - 151 85 Södertälje – Sweden
Or
AstraZeneca GmbH
Wedel (Germany)
Or
AstraZeneca UK Limited
Silk Road Business Park
Macclesfield, Cheshire, SK10 2NA (United Kingdom)

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Oxis Turbohaler 6 µg – Dosier – Pulverinhalator
Belgium Oxis Turbohaler 4.5 μg/dose
Denmark Oxis Turbuhaler
Finland Oxis Turbuhaler
France Oxis Turbuhaler 6 μg per dose
Germany Oxis Turbohaler 6 Mikrogramm Pulver zur Inhalation
Greece Oxez Turbuhaler
Ireland Oxis Turbohaler 6, inhalation powder
Italy Oxis 4.5 µg/dose
Luxembourg Oxis Turbohaler 4.5 µg/dose
Netherlands Oxis 6 Turbuhaler
Portugal Oxis Turbohaler
Spain Oxis Turbuhaler 4.5 microgramos polvo para inhalación
Sweden Oxis Turbuhaler
United Kingdom Oxis Turbohaler 6, inhalation powder

Blue box for local requirements
For individuals engaged in sports activities
Using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Patient Information Leaflet: Information for the User

Oxis Turbohaler 9 micrograms/dose Inhalation Powder
formoterol fumarate dihydrate
Please read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Oxis is and what it is used for
2. What you need to know before using Oxis
3. How to use Oxis
4. Possible side effects
5. How to store Oxis
6. Contents of the pack and other information

1. What Oxis is and what it is used for

Oxis is an inhaler. It contains a medicine called formoterol, which belongs to a group of medicines known as "long-acting beta-agonists" or "bronchodilators".
It works by relaxing the muscles in the airways, thus helping you to breathe more easily. It starts to work within 1-3 minutes, and its effects last up to 12 hours.
Your doctor has prescribed this medicine for the treatment of asthma or chronic obstructive pulmonary disease (COPD).

Asthma
Oxis is used for the treatment of asthma in adults, adolescents, and children aged over 6 years.
For asthma treatment, your doctor has prescribed two inhalers: Oxis and a separate corticosteroid inhaler. These must be used together.

• Oxis is used to help prevent the onset of asthma symptoms.
• Some people also use Oxis when additional doses are needed to relieve asthma symptoms and make breathing easier again.
• Oxis may also be taken before physical exercise to prevent asthma symptoms triggered by such activity.

Chronic obstructive pulmonary disease (COPD)
Oxis may also be used for the treatment of COPD symptoms in adults. COPD is a chronic lung disease affecting the airways, often caused by cigarette smoking.

2. What you need to know before using Oxis

Do not use Oxis:
If you are allergic (hypersensitive) to formoterol or to any of the other ingredients
of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Oxis if:

• You have diabetes. Additional blood glucose monitoring may be required while you are using Oxis.
• You have high blood pressure or have ever had heart problems.
• You have thyroid problems.
• You have low levels of potassium in your blood. Your doctor may require further tests to assess your blood potassium levels.
• You have severe liver problems, such as liver cirrhosis. If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before using Oxis.

Other medicines and Oxis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those obtained without a prescription and herbal
products. This is because Oxis may affect how some medicines work, and some
medicines may affect Oxis. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Beta-blockers (such as atenolol or propranolol) used to treat high blood pressure, including eye drops (such as timolol used to treat glaucoma).
• Medicines for fast or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics (such as furosemide), used to treat high blood pressure.
• Corticosteroid medicines taken by mouth (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline), often used to treat asthma.
• Erythromycin (used to treat infections).
• Antihistamines (such as terfenadine).
• Other substances that dilate the airways (bronchodilators, such as salbutamol).
• Ephedrine (used to treat asthma or as a decongestant).
• Tricyclic antidepressants (such as amitriptyline).
  If you fall into any of the above categories or have any doubts, speak with your doctor or pharmacist before using Oxis. Also inform your doctor or pharmacist if you are due to undergo general anaesthesia for a surgical or dental procedure.

The addition of anticholinergics (such as tiotropium or ipratropium bromide) to treatment with Oxis may help further open your airways.

Pregnancy, breastfeeding and fertility

• If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine. Do not use Oxis unless instructed to do so by your doctor.
• If you become pregnant while being treated with Oxis, do not stop using Oxis but consult your doctor immediately.

Driving and using machines
It is unlikely that Oxis will affect your ability to drive or operate machinery.

Oxis contains lactose
Oxis contains lactose, a type of sugar. If your doctor has informed you that you have
an intolerance to certain sugars, consult your doctor before using this medicine.
The amount of lactose contained in this medicine does not normally cause problems in people who are lactose intolerant.
The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions.

3. How to use OXIS

• Always use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
• Do not increase the dose of Oxis prescribed by your doctor without first speaking to them.
• If you are using Oxis regularly for the treatment of asthma and COPD, you must continue taking the medicine even in the absence of symptoms.

Important information about asthma and COPD symptoms
If you notice the onset of breathlessness or wheezing while using Oxis, continue using Oxis but consult your doctor as soon as possible, as additional treatment may be necessary.
Contact your doctor immediately if:

• Your breathing worsens suddenly or you wake up frequently at night with asthma symptoms.
• You begin to experience chest tightness.
• The usual dose does not provide relief.
• You need to take a higher dose than usual for more than 2 days in a week.
• You need to use the Turbohaler more often than usual before physical exercise.

These signs may indicate that your asthma or COPD is not adequately controlled and that you may need an alternative or additional treatment immediately.
Asthma
Oxis must not be used in children under 6 years of age.
Adults (18 years of age and over)

• The recommended dose is 1 inhalation, one or two times daily.
• Your doctor may increase the dose to 2 inhalations, one or two times daily.
• Some people also use Oxis as a "reliever inhaler". If you experience asthma symptoms, the usual dose is 1 inhalation when symptoms occur.
• A total daily dose exceeding 4 inhalations is not normally necessary. This dose includes the inhalations taken every day, those taken when asthma symptoms occur, and those taken before physical exercise. However, your doctor may allow you to take up to 6 inhalations per day. Do not use more than 6 inhalations in total within 24 hours.
• Do not take more than 3 inhalations at a time.

Children and adolescents (6 to 17 years of age)

• The recommended dose is 1 inhalation, one or two times daily.
• Some children also use Oxis as a "reliever inhaler". If your child experiences asthma symptoms, the usual dose is 1 inhalation when symptoms occur.
• A total daily dose exceeding 2 inhalations is not normally necessary. This dose includes the inhalations your child takes every day, those taken when asthma symptoms occur, and those taken before physical exercise. However, your doctor may allow your child to take up to 4 inhalations per day. Your child must not take more than 4 inhalations in total within 24 hours.
• Your child must not take more than 1 inhalation at a time.

Your doctor will help you manage asthma. Once asthma is well controlled, your doctor may consider it appropriate to gradually reduce the dose of Oxis.
Exercise-induced asthma
If you or your child experience asthma symptoms caused by physical exercise, your doctor may advise you or your child to take Oxis before such exercise. Oxis must not be used in children under 6 years of age.
Adults (18 years of age and over)

• The recommended dose is 1 inhalation before physical exercise.
• A total daily dose exceeding 4 inhalations is not normally necessary. This dose includes the inhalations taken every day, those taken when asthma symptoms occur, and those taken before physical exercise. However, your doctor may allow you to take up to 6 inhalations per day. Do not use more than 6 inhalations in total within 24 hours.
• Do not take more than 3 inhalations at a time.

Children and adolescents (6 to 17 years of age)

• The recommended dose is 1 inhalation before physical exercise.
• A total daily dose exceeding 2 inhalations is not normally necessary. This dose includes the inhalations the child takes every day, those taken when asthma symptoms occur, and those taken before physical exercise.

However, your doctor may allow the child to take up to 4 inhalations per day. The child must not take more than 4 inhalations in total within 24 hours.

• The child must not take more than 1 inhalation at a time.

Chronic obstructive pulmonary disease (COPD)

• For use only in adults (18 years and over)
• The recommended dose is 1 inhalation, one or two times daily.
• Your doctor may advise you to take additional doses for relief of COPD symptoms.
• You must not take more than 4 inhalations per day.
• You must not take more than 2 inhalations at a time.

Preparing a new Oxis Turbohaler inhaler
Before using a new Oxis Turbohaler inhaler for the first time, prepare the inhaler for use as follows:

• Unscrew and remove the cap. You may hear a rattling sound.
• Hold the Oxis Turbohaler inhaler vertically with the blue wheel facing downwards.
• Turn the blue wheel fully in one direction, then turn it fully in the opposite direction (the direction in which you turn the wheel first does not matter). You should hear a click.
• Repeat the above step once more, turning the blue wheel in both directions.
• The Oxis Turbohaler inhaler is now ready for use.

How to take an inhalation
Each time you need to take a dose, follow the instructions below.

1. Unscrew the white cap and remove it. You may hear a metallic sound.
2. Hold the Turbohaler vertically with the blue wheel facing downwards.
3. Do not grip the mouthpiece when loading the Turbohaler. To load a dose into the Turbohaler, turn the blue wheel fully in one direction, then turn it fully in the opposite direction (the direction in which you turn the wheel first does not matter). You will feel a click. The Turbohaler is now loaded and ready for use. Only load the Turbohaler when you are ready to use it.

4. Hold the Turbohaler away from your mouth. Breathe out gently (without forcing). Do not breathe out through the Turbohaler.
5. Gently place the mouthpiece between your teeth. Close your lips. Breathe in through your mouth as deeply as possible. Do not chew or bite the mouthpiece.

6. Remove the Turbohaler from your mouth. Then breathe out gently. The amount of medicine inhaled is very small. This means you may not taste it after inhalation. If you have followed the instructions, you can be sure that the dose has been taken and that the medicine is now in your lungs.
7. If you need to take a second inhalation, repeat steps 2 to 6.
8. Replace the cap firmly after use.

Do not attempt to remove or rotate the mouthpiece. It is fixed to the Turbohaler and must not be detached. Do not use the Turbohaler if it has been damaged or if the mouthpiece has become detached from the Turbohaler.
As with all inhalers, caregivers must ensure correct inhalation technique in children prescribed Oxis Turbohaler, as described above.
How to clean the Turbohaler inhaler
Clean the outside of the mouthpiece once a week by wiping it with a dry cloth. Do not use water or liquids.
When to start using a new Turbohaler

• The dose indicator allows you to check how many doses remain in the Turbohaler, starting from 60 doses when full.

• The dose indicator is marked in intervals of 10 doses. Therefore, it does not show every single dose. When a red mark first appears at the top of the indicator window, approximately 20 doses remain. For the last 10 doses, the background of the dose indicator turns red. When the '0' on the red background reaches the middle of the window, you should start using a new Turbohaler.

Note:

• You will still be able to turn the wheel and hear a "click" even when the Turbohaler is empty.
• The sound heard when shaking the inhaler is produced by a drying agent and not by the medicine. Therefore, this sound does not indicate the amount of medicine remaining in the Turbohaler.
• If, by mistake, you load Oxis more than once before taking the dose, you will still only inhale one dose. However, the dose indicator will record all loaded doses.

If you use more Oxis than you should
If you use more Oxis than you should, contact your doctor or pharmacist immediately for advice. The following effects may occur: tremor, headache, or rapid heartbeat.
If you forget to use Oxis
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop using Oxis
Do not stop treatment with Oxis without first consulting your doctor.
If you have any questions about how to use the Turbohaler, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following occur, stop using Oxis and contact your doctor immediately:

• Bronchospasm (contraction of the muscles in the airways causing sudden wheezing) after inhaling the medicine. This occurs very rarely and may affect up to 1 in 10,000 people.

Other possible side effects

Common (may affect up to 1 in 10 people)

• Tremor or shakiness. If these effects occur, they are usually mild and disappear with continued treatment with Oxis.
• Headache.
• Dizziness.
• Nausea (feeling unwell).
• Muscle cramps.

Uncommon (may affect up to 1 in 100 people)

• Palpitations (awareness of heartbeat). If this occurs, it is usually mild and tends to disappear with continued use of Oxis Turbohaler.
• Sleep disturbances.
• Fast heartbeat.
• Allergic reactions such as skin rash, itching, and bronchospasm.
• Low level of potassium in the blood.
• Increased blood sugar (glucose) levels.
• Taste disturbances, for example unpleasant taste in the mouth.
• Changes in blood pressure.
• Irregular heartbeat.
• Pain or tightness in the chest (angina pectoris).

Rare (may affect up to 1 in 1,000 people)

• Feeling restless or agitated.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oxis

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special storage conditions.
• When not in use, Oxis must be stored with the cap firmly closed.
• Do not use this medicine after the expiry date stated on the pack or on the side of the Turbohaler. The expiry date refers to the last day of the month.
• Always dispose of the used Turbohaler responsibly, as some medicine will remain inside. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Oxis contains
The active substance is formoterol fumarate dihydrate. Each inhaled dose contains 12 micrograms of formoterol fumarate dihydrate, of which 9 micrograms are inhaled.
The other excipient is lactose monohydrate (which contains milk proteins). See section 2: Oxis contains lactose.

Description of the appearance of Oxis and contents of the pack
Oxis is an inhaler containing the medicinal product. The inhalation powder is white in colour. Each Turbohaler contains 60 doses and has a white body with a blue wheel.
Oxis is available in the following pack sizes: 60 doses (1 inhaler), 3x60 doses (3 inhalers), 10x60 doses (10 inhalers), 18x60 doses (18 inhalers), or 20x60 doses (20 inhalers).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
AstraZeneca S.p.A.
Palazzo Ferraris
Via Ludovico il Moro 6/C
Basiglio (MI) 20080, Italy

Manufacturer
AstraZeneca AB
SE - 151 85 Södertälje, Sweden
Or
AstraZeneca GmbH
Wedel, Germany
Or
AstraZeneca UK Limited
Silk Road Business Park
Macclesfield, Cheshire, SK10 2NA, United Kingdom

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria Oxis Turbohaler 12 µg – Dosier - Pulverinhalator
Belgium Oxis Turbohaler 9 μg/dose
Denmark Oxis Turbuhaler
Finland Oxis Turbuhaler
France Oxis Turbuhaler 12 μg per dose
Germany Oxis Turbohaler 12 Mikrogramm Pulver zur Inhalation
Greece Oxez Turbuhaler
Ireland Oxis Turbohaler 12, inhalation powder
Italy Oxis 9 µg/dose
Luxembourg Oxis Turbohaler 9 µg/dose
Netherlands Oxis 12 Turbuhaler
Portugal Oxis Turbohaler
Spain Oxis Turbuhaler 9 microgramos polvo para inhalación
Sweden Oxis Turbuhaler
United Kingdom Oxis Turbohaler 12, inhalation powder

Blue box for local requirements
For individuals engaged in sports activities
The use of this medicinal product without therapeutic need constitutes doping and may lead to a positive anti-doping test.