Oxis Turbuhaler 4.5 micrograms/inhalation powder for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxis Turbuhaler 4.5 micrograms/inhalation powder for inhalation

Formoterol fumarate dihydrate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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 adverse effects
5. How to store Oxis Turbuhaler
6. Contents of the pack and other information

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

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

Formoterol works by relaxing the muscles in the airways, helping you to breathe more easily. The effect starts within 1 to 3 minutes and lasts up to 12 hours after administration.

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

Asthma:

Oxis Turbuhaler is used for the treatment of 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 occurrence of asthma symptoms.
• Some patients also use Oxis Turbuhaler when they need additional doses to relieve asthma symptoms and to help restore normal breathing.
• Oxis Turbuhaler may also be used before exercise to prevent exercise-induced asthma symptoms.

Chronic Obstructive Pulmonary Disease (COPD):

Oxis Turbuhaler may also be used to treat the symptoms of COPD in adults. COPD is a chronic lung airway disease, which frequently occurs due to tobacco smoking.

2. What you need to know before using Oxis Turbuhaler

Do not use Oxis Turbuhaler:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• You have diabetes; you may require additional blood glucose monitoring while using this medicine.
• 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 request blood tests to check your potassium levels.
• You have severe liver problems, such as hepatic cirrhosis.

If you are unsure whether any of these conditions apply to you, ask your doctor or pharmacist before using Oxis Turbuhaler.

Use of Oxis Turbuhaler with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription and herbal medicines, as Oxis Turbuhaler may affect how some medicines work, and likewise, some medicines may affect Oxis Turbuhaler.

Specifically, inform your doctor or pharmacist if you are taking any of the following medicines:

• Beta-blockers (such as atenolol or propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medicines for fast or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, commonly used to treat heart failure.
• Diuretics (such as furosemide), used to treat high blood pressure.
• Medicines containing oral corticosteroids (such as prednisolone).
• Medicines containing xanthines (such as theophylline or aminophylline), commonly used for the treatment of 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 amitriptiline).

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

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

Also inform your doctor or pharmacist if you are undergoing 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 medicine; do not use it unless your doctor advises you to.
• If you become pregnant while being treated with Oxis Turbuhaler, do not stop using it, but speak to your doctor immediately.

Driving and using machines

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

Oxis Turbuhaler contains lactose

Oxis Turbuhaler contains lactose, which is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, contact him before using this medicine. The amount of lactose in this medicine usually does not cause problems in people with lactose intolerance.

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

3. How to use Oxis Turbuhaler

• Follow exactly the instructions given by your doctor or pharmacist on how to take this medicine. If in doubt, consult your doctor or pharmacist again.
• Do not use a higher dose than prescribed by your doctor without first speaking to them.
• If you are using Oxis Turbuhaler regularly for asthma or COPD, you should continue using it even if you do not have symptoms.

Important information about asthma or COPD symptoms

If, while using Oxis Turbuhaler, you experience difficulty breathing or wheezing, 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 you frequently wake up at night with asthma symptoms.
• You notice a feeling of chest tightness.
• You do not experience relief with your usual dose.
• You need to use more doses than usual for more than 2 days per week.
• You need to use the Turbuhaler more often than normal before physical exercise.

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

Asthma

Oxis Turbuhaler must not be used in children under 6 years of age.

Adults (aged 18 years and over)

• The recommended dose is 1 or 2 inhalations, one or two times daily.

• Your doctor may increase this to 4 inhalations, one or two times daily.

• Some patients also use Oxis Turbuhaler for symptom relief. If you have asthma symptoms, the usual dose is 1 or 2 inhalations when symptoms occur.

• A total daily dose of more than 8 inhalations is usually not needed. This includes inhalations taken daily, when asthma symptoms occur, and before exercise. However, your doctor may allow you up to 12 inhalations per day, although no more than 12 inhalations should be taken in total within 24 hours.

• Do not take more than 6 inhalations at one time.

Children and adolescents (aged 6 to 17 years)

• The recommended dose is 2 inhalations, one or two times daily.

• Some children also use Oxis Turbuhaler for symptom relief. If they have asthma symptoms, the usual dose is 1 or 2 inhalations when symptoms occur.

• A total daily dose of more than 4 inhalations is usually not needed. This includes inhalations taken daily, when asthma symptoms occur, and before exercise. However, the doctor may allow up to 8 inhalations per day, although no more than 8 inhalations should be taken in total within 24 hours.

• Children must not take more than 2 inhalations at one time.

Your doctor (or nurse) will help you manage your asthma. Once good asthma control has been achieved, your doctor may consider it appropriate to gradually reduce the dose of Oxis Turbuhaler.

Exercise-induced asthma

In both children and adults who experience asthma symptoms triggered by physical exercise, your doctor may instruct you to use Oxis Turbuhaler before exercise. Oxis Turbuhaler must not be used in children under 6 years of age.

Adults (aged 18 years and over)

• The recommended dose is 2 inhalations before exercise.

• A total daily dose of more than 8 inhalations is usually not needed. This includes inhalations taken daily, when asthma symptoms occur, and before exercise. However, your doctor may allow you up to 12 inhalations per day, although no more than 12 inhalations should be taken in total within 24 hours.

• Do not take more than 6 inhalations at one time.

Children and adolescents (aged 6 to 17 years)

• The recommended dose is 1 or 2 inhalations before exercise.

• A total daily dose of more than 4 inhalations is usually not needed. This includes inhalations taken daily, when asthma symptoms occur, and before exercise. However, the doctor may allow up to 8 inhalations per day, although no more than 8 inhalations should be taken in total within 24 hours.

• They must not take more than 2 inhalations at one time.

Chronic Obstructive Pulmonary Disease (COPD)

• Must only be used in adults (aged 18 years and over).
• The recommended dose is 2 inhalations, one or two times daily.
• Your doctor may instruct you to use additional doses to relieve your COPD symptoms.
• You must not use more than 8 inhalations per day.
• Do not take more than 4 inhalations at one time.

How to prepare your new Oxis Turbuhaler inhaler

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

• Unscrew and lift off the cap. You may hear a rattling sound.
• Hold the inhaler in an upright position with the turquoise screw at the bottom.
• Turn the turquoise screw fully in one direction, then turn it fully in the opposite direction (it does not matter which direction you turn first).
• You should hear one click.
• Repeat this procedure once more, turning the turquoise screw in both directions.
• Your Oxis Turbuhaler inhaler is now ready for use.

How to inhale

Each time you need to inhale, follow the instructions below:

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

2.- Hold the inhaler in an upright position with the turquoise-colored screw at the bottom.

3.- Do not hold the mouthpiece while loading the Turbuhaler. To load a dose into the Turbuhaler, turn the turquoise-colored screw fully in one direction and then fully back in the other direction (it does not matter which direction you start with). You will hear a distinct "click". At this point, the Turbuhaler is loaded and ready to use. Only load the Turbuhaler when you are ready to use it.

4.- Hold the inhaler away from your mouth. Gently breathe out as much air as you can (without discomfort). Do not breathe out through the Turbuhaler.

5.- Gently place the mouthpiece between your teeth, close your lips around it, and inhale quickly and deeply through your mouth as forcefully as possible. Do not bite or press on the mouthpiece with your teeth.

6.- Remove the inhaler from your mouth and then breathe out gently. The amount of medication released is very small, so you may not taste it after inhalation. However, if you have followed the instructions correctly, you can be sure that you have inhaled the dose and that the medication has reached your lungs.

7.- If a second inhalation is required, repeat steps 2 to 6.

8.- Replace the cap firmly after use.

Do not attempt to detach the mouthpiece, as it is fixed to the Turbuhaler and must not be removed. The mouthpiece may rotate, but avoid unnecessary turning. Do not use the Turbuhaler if it is damaged or if the mouthpiece has become detached.

As with other inhalers, caregivers should ensure that children prescribed Oxis Turbuhaler use 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 remain in the Turbuhaler, starting at 60 doses when full.

• The dose indicator is marked in 10-dose intervals, so not every dose is shown. When you first see a red mark at the end of the indicator window, approximately 20 doses remain. During the last 10 doses, the background of the dose indicator turns red. When the "0" at the bottom of the red indicator window reaches the center of the window, you should start using a new Turbuhaler.

Note:

• The screw may continue to turn and produce a "click" even when the Turbuhaler is empty.
• The sound heard when shaking the inhaler is caused by a drying agent, not the medication. Therefore, this sound does not indicate the amount of medication remaining in the Turbuhaler.
• If you accidentally load your Oxis Turbuhaler more than once before taking your dose, you will only inhale one dose. However, the dose counter will record each loading action as a used dose.

If you use more Oxis Turbuhaler than you should

If you use more Oxis Turbuhaler than prescribed, contact your doctor or pharmacist immediately. You may experience the following effects: tremor, headache, or rapid heartbeat.

If you forget to use Oxis Turbuhaler

• If you forget to inhale 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 missed dose.

If you have stopped using Oxis Turbuhaler

Do not stop using Oxis Turbuhaler without consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If any of the following occur, stop using Oxis Turbuhaler and contact your doctor immediately:

• Bronchospasm (narrowing of the muscles in the airways causing sudden wheezing when breathing) after inhaling. This is very rare and may affect up to 1 in 10,000 people.

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people)

• Tremor. If these effects occur, they are usually mild and disappear while continuing treatment with Oxis Turbuhaler.
• Headache.
• Dizziness.
• Nausea (feeling of discomfort).
• Muscle cramps.

Uncommon (may affect up to 1 in 100 people)

• Palpitations (awareness of heartbeat). If this effect occurs, it is usually mild and disappears while continuing treatment with Oxis Turbuhaler.
• Difficulty sleeping.
• Rapid heartbeat.
• Allergic reactions such as rash, itching, or bronchospasm.
• Low levels of potassium in the blood.
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as unpleasant taste in the mouth.
• Changes in blood pressure.
• Irregular heartbeats.
• Chest pain or tightness (angina).

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

• Feeling of restlessness or agitation.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxis Turbuhaler

• 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 Turbuhaler should be kept with the cap firmly closed.
• Do not use this medicine after the expiry date stated on the carton or on one side of the Turbuhaler label. The expiry date refers to the last day of that month.
• You should always ensure responsible disposal of your used Turbuhaler, as some medicine will remain inside. Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Oxis Turbuhaler

The active substance is formoterol fumarate dihydrate. Each dose contains 6 micrograms of formoterol fumarate dihydrate, of which 4.5 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 containing your medicine. The inhalation powder is white in colour. Each Turbuhaler contains 60 doses, with the body of the inhaler being white and the screw-cap turquoise.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorio Beta, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

Manufacturer:

AstraZeneca AB

Forskargatan 18

SE-151 36 Södertälje

Sweden

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany Oxis Turbohaler 6 Mikrogramm Pulver zur Inhalation

Austria Oxis Turbohaler 6 μg – Dosier - Pulverinhalator

Belgium Oxis Turbohaler 4,5 μg/dose

Denmark Oxis Turbuhaler

Spain Oxis Turbuhaler 4,5 microgramos/inhalación polvo para inhalación

Finland Oxis Turbuhaler

Greece Oxez Turbuhaler

Netherlands Oxis 6 Turbuhaler

Ireland Oxis Turbohaler 6, inhalation powder

Italy Oxis Turbohaler 4.5

Luxembourg Oxis Turbohaler 4,5 μg/dose

Portugal Oxis Turbohaler

Sweden Oxis Turbuhaler

UK Oxis Turbohaler 6, inhalation powder

Date of the most recent review of this leaflet: March 2020

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