Leaflet: information for the user

Oxis Turbuhaler 9 micrograms/inhalation powder for inhalation

Formoterol fumarate dihydrate

1.What Oxis Turbuhaler is and what it is used for

2.What you need to know before using Oxis Turbuhaler

3.How to use Oxis Turbuhaler

4.Possible side effects

5.Storage of Oxis Turbuhaler

6. Contents of the pack and additional information

Oxis Turbuhaler is an inhaler and contains the medication called formoterol, which belongs to a group of medications called long-acting beta-agonists or bronchodilators.

Formoterol acts by relaxing the muscles of the airways, making it easier to breathe. The effect begins within 1 to 3 minutes and lasts up to 12 hours after.

Your doctor has prescribed this medication to treat asthma or chronic obstructive pulmonary disease (COPD).

Asthma:

Oxis Turbuhaler is used to treat asthma in adults, adolescents, and children over 6 years of age.

For asthma, your doctor will prescribe two inhalers: Oxis Turbuhaler and a separate corticosteroid inhaler. Both must be used together.

• Oxis Turbuhaler is used to help prevent the onset of asthma symptoms.
• Some patients also use Oxis Turbuhaler when additional doses are needed to relieve asthma symptoms and facilitate breathing recovery.
• Oxis Turbuhaler can also be used before physical exercise to prevent exercise-induced asthma symptoms.

Chronic Obstructive Pulmonary Disease (COPD):

Oxis Turbuhaler can also be used to treat COPD symptoms in adults. COPD is a chronic disease of the pulmonary airways, which often occurs due to tobacco consumption.

Do not use Oxis Turbuhaler:

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Oxis Turbuhaler if:

- You are diabetic; you may need additional blood glucose tests while using this medication.

- You have high blood pressure or have ever had any heart problems.

- You have thyroid gland problems.

- You have low levels of potassium in your blood; your doctor may ask for blood tests to check potassium levels.

- You have severe liver problems, such as cirrhosis.

If you are unsure if any of these situations affect you, ask your doctor or pharmacist before using Oxis Turbuhaler.

Using Oxis Turbuhaler with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes over-the-counter medications and herbal remedies, as Oxis Turbuhaler may affect the way some medications work, and some medications may affect Oxis Turbuhaler.

Specifically, inform your doctor or pharmacist if you are using any of the following medications:

• Beta-blockers (such as atenolol or propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medications for rapid or irregular heart rhythm (such as quinidine).
• Medications like digoxin, used to treat heart failure.
• Diuretics (such as furosemide), used to treat high blood pressure.
• Oral corticosteroids (such as prednisolone).
• Xanthine medications (such as theophylline or aminophylline), 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 any of these situations affect you, or you are unsure, ask your doctor or pharmacist before using Oxis Turbuhaler.

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

Also inform your doctor or pharmacist if you are to undergo general anesthesia for surgery or dental treatment.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication; do not use it unless your doctor tells you to.

• If you become pregnant while using Oxis Turbuhaler, do not stop using it, but talk to your doctor immediately.

Driving and operating machinery

Oxis Turbuhaler is unlikely to affect your ability to drive and use tools or machinery.

Oxis Turbuhaler contains lactose

Oxis Turbuhaler contains lactose, a type of sugar. If your doctor has told you that you have a lactose intolerance, contact them before using this medication. The amount of lactose in this medication usually does not cause problems in people with lactose intolerance.

The lactose excipient contains small amounts of milk proteins, which may cause allergic reactions.

• Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
• Do not use more doses than prescribed by your doctor without having spoken to him first.
• If you are using Oxis Turbuhaler regularly for asthma or EPOC, you should continue using it even if you do not have symptoms.

Important information about asthma or EPOC symptoms

If while using Oxis Turbuhaler you feel difficulty breathing or have "wheezing" with breathing, you should continue using it and see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

• Your breathing worsens, or if you wake up frequently at night with asthma symptoms.

• You notice that you start to feel chest tightness.
• You do not get relief with your usual dose.
• You need to use more doses than usual, for more than 2 days a week.
• You need to use the Turbuhaler more frequently than usual before exercising.

These signs may indicate that your asthma or EPOC is not being adequately controlled and that you need a different or additional treatment immediately.

Asthma

Oxis Turbuhaler should not be used in children under 6 years old.

Adults (18 years and older)

• The recommended dose is 1 inhalation, one or two times a day.
• Your doctor may increase it to 2 inhalations, one or two times a day.
• Some patients also use Oxis Turbuhaler for symptom relief. If you have asthma symptoms, the usual dose is 1 inhalation when symptoms appear.

• Normally, no more than a total of 4 inhalations per day are needed. This includes daily inhalations, when you have asthma symptoms, and before exercise. However, your doctor may allow up to 6 inhalations per day, but no more than 6 inhalations in total in 24 hours.
• Do not take more than 3 inhalations at a time.

Children and adolescents (6 to 17 years)

• The recommended dose is 1 inhalation, one or two times a day.

• Some children also use Oxis Turbuhaler for symptom relief. If you have asthma symptoms, the usual dose is 1 inhalation when symptoms appear.

• Normally, no more than a total of 2 inhalations per day are needed. This includes daily inhalations, when you have asthma symptoms, and before exercise. However, your doctor may allow up to 4 inhalations per day, but no more than 4 inhalations in total in 24 hours.
• Do not take more than 1 inhalation at a time.

Your doctor (or nurse) will help you manage your asthma. Once you have achieved good control of your asthma, your doctor may consider reducing the dose of Oxis Turbuhaler gradually.

Exercise-induced asthma

Both in children and adults, if you have asthma symptoms caused by physical exercise, your doctor may instruct you to also use Oxis Turbuhaler before exercise. Oxis Turbuhaler should not be used in children under 6 years old.

Adults (18 years and older)

• The recommended dose is 1 inhalation before exercise.

• Normally, no more than a total of 4 inhalations per day are needed. This includes daily inhalations, when you have asthma symptoms, and before exercise. However, your doctor may allow up to 6 inhalations per day, but no more than 6 inhalations in total in 24 hours.
• Do not take more than 3 inhalations at a time.

Children and adolescents (6 to 17 years)

• The recommended dose is 1 inhalation before exercise.

• Normally, no more than a total of 2 inhalations per day are needed. This includes daily inhalations, when you have asthma symptoms, and before exercise. However, your doctor may allow up to 4 inhalations per day, but no more than 4 inhalations in total in 24 hours.
• Do not take more than 1 inhalation at a time.

Chronic Obstructive Pulmonary Disease (COPD)

• It should only be used in adults (18 years and older).
• The recommended dose is 1 inhalation, one or two times a day.
• Your doctor may instruct you to use additional doses for symptom relief of COPD.
• Do not use more than 4 inhalations per day.
• Do not take more than 2 inhalations at a time.

Preparing your new Oxis Turbuhaler inhaler

Before using your new Oxis Turbuhaler inhaler for the first time, you must prepare the inhaler for use as indicated below:

• Remove and lift the cap. You may hear a rattling sound.
• Hold the inhaler in a vertical position with the turquoise ring at the bottom.
• Turn the turquoise ring to the top in one direction, then back to the top in the other direction (it does not matter which direction you turn it first).
• You should hear a click.
• Repeat this procedure again, turning the turquoise ring in both directions.
• Your Oxis Turbuhaler inhaler is now ready for use.

How to take an inhalation

Each time you need to take an inhalation, follow the instructions below:

1.-Remove and lift the white cap. You may hear a rattling sound.

2.-Holdthe inhaler in a vertical positionwith the turquoise ring at the bottom.

3.-Do not hold the mouthpiece while loading the Turbuhaler. To load the Turbuhaler with a dose, turn the turquoise ring to the top in one direction and then back to the top in the other direction (it does not matter which direction you turn it first).You should hear a characteristic "click". At this point, the Turbuhaler is loaded and ready for use. Load the Turbuhaler only when you need to use it.

4.-Hold the inhaler without bringing it to your mouth. Exhale gently (as much as you can but without discomfort). Do not exhalethrough the Turbuhaler.

5.-Placethe mouthpiecegentlybetween your teeth,close yourlips andinhale through your mouth asenergetically and deeply as possible. Do not bite or pressthe mouthpiece with your teeth.

6.-Remove the inhaler from your mouth and then exhale gently.The amount of medication released is very small, which means you may not notice its taste after inhalation. However, if you have followed the use instructions, you can be sure that you have inhaled the dose, and that the medication has reached 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 try to separate the mouthpiece as it is fixed to the Turbuhaler and should not be separated. The mouthpiece can rotate, but do not turn it unnecessarily. Do not use the Turbuhaler if it is damaged or if the mouthpiece has come loose from the Turbuhaler.

As with other inhalers, caregivers should ensure that children prescribed Oxis Turbuhaler perform the inhalation technique correctly, as described above.

Cleaning the Turbuhaler

Clean the outside of the mouthpiece once a week with a dry cloth; do not use water or liquids.

When to start a new Turbuhaler

• The dose indicator shows how many doses are left in the Turbuhaler, starting at 60 doses when it is full.

• The dose indicator is marked in intervals of 10 doses, so not all doses are shown. When you see a red mark on the end of the dose indicator window for the first time, there are approximately 20 doses left. During the last 10 doses, the bottom of the dose indicator is red. When the "0" at the bottom of the red dose indicator window reaches the center of this, you should start a new Turbuhaler.

Nota:

• The ring can continue to turn and make "click" sounds even when the Turbuhaler is empty.
• The sound you hear when shaking the inhaler is produced by a drying agent and not by the medication. Therefore, the sound does not indicate the amount of medication left in the Turbuhaler.
• If you load your Oxis Turbuhaler inhaler more than once by mistake before taking your dose, you will only inhale one dose. However, the dose indicator will record all the doses loaded.

If you use more Oxis Turbuhaler than you should

If you use more Oxis Turbuhaler than you should, consult your doctor or pharmacist immediately. You may experience the following effects: tremors, headache, or rapid heart rate.

If you forget to use Oxis Turbuhaler

• If you forget to take 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 nottake a double dose to make up for the missed doses.

If you have stopped using Oxis Turbuhaler

Do not stop using Oxis Turbuhaler without consulting your doctor.

If you have any additional questions about how to use your Turbuhaler, consult your doctor, nurse, or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

If the following occurs, stop using Oxis Turbuhaler and contact your doctor immediately:

• Bronchospasm (sudden constriction of the airway muscles causing wheezing with breathing) after inhaling. This occurs very rarely, affecting up to 1 in 10,000 people.

Other possible adverse effects

Frequent (may affect up to 1 in 10 people)

- Tremor. If these effects appear, they are usually mild and disappear while continuing treatment with Oxis Turbuhaler.

- Headache.

- Dizziness.

- Nausea (feeling of discomfort).

- Muscle cramps.

Less frequent(may affect up to 1 in 100 people)

- Palpitations (noting heartbeats). If this effect appears, it is usually mild and disappears while continuing treatment with Oxis Turbuhaler.

- Difficulty sleeping.

- Rapid heartbeats.

- Allergic reactions such as rash, itching, or bronchospasm.

- Low levels of potassium in the blood.

- Elevated levels of sugar (glucose) in the blood.

- Alterations in taste, such as an unpleasant mouth taste.

- Alterations in blood pressure.

- Irregular heartbeats.

- Chest pain or pressure (angina pectoris).

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

- Feeling of agitation and restlessness.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• This medication does not require special conditions for conservation.
• When not in use, Oxis Turbuhaler must be kept with the cap firmly closed.
• Do not use this medication after the expiration date that appears on the packaging or on one side of the Turbuhaler label. The expiration date refers to the last day of that month.
• You must always ensure that you dispose of your used Turbuhaler responsibly, as part of the medication will remain inside. Medications should not be thrown down the drain or in the trash. Deposit the containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Oxis Turbuhaler

The active ingredient is formoterol fumarate dihydrate. Each dose contains 12 micrograms of formoterol fumarate dihydrate of which 9 micrograms can be inhaled.

The excipient is lactose monohydrate (which contains milk proteins). See section 2, Oxis Turbuhaler contains lactose.

Appearance of the product and contents of the pack

Oxis Turbuhaler is an inhaler that contains your medication. The powder for inhalation is white in color.Each Turbuhaler contains 60 doses, the body of the inhaler is white with a turquoise ring.

Oxis Turbuhaler is available in the following pack sizes: 60 doses (1 inhaler), 3x60 doses (3 inhalers), 10x60 doses (10 inhalers), 18x60 doses (18 inhalers) or 20 x60 doses (20 inhalers). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio Beta, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

Manufacturer:

AstraZeneca AB

Forskargatan 18

SE-151 36Södertälje

Sweden

This medicinal product is authorized in the member states of the European Economic Area with the following names:

GermanyOxis Turbohaler 12 Mikrogramm Pulver zur Inhalation

AustriaOxis Turbohaler 12μg – Dosier - Pulverinhalator

BelgiumOxis Turbohaler 9μg/dose

DenmarkOxis Turbuhaler

SpainOxis Turbuhaler 9 microgramos/inhalación polvo para inhalación

FinlandOxis Turbuhaler

GreeceOxez Turbuhaler

NetherlandsOxis 12 Turbuhaler

IrelandOxis Turbohaler 12 inhalation powder

ItalyOxis Turbohaler 9

LuxembourgOxis Turbohaler 9μg/dose

PortugalOxis Turbohaler

SwedenOxis Turbuhaler

UKOxis Turbohaler 12 inhalation powder

Last review date of this leaflet:March 2020

Thefull and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/