4.5 micrograms/dose and 9 micrograms/dose, inhalation powder
formoterol fumarate dihydrate
What Oxis Turbohaler is and what it is used for
Oxis Turbohaler is an inhaler . It contains a medicine called formoterol. Formoterol belongs to a group of medicines called “long-acting beta-agonists” or “tracheal dilators”.
It works by getting the muscles in your airways to relax, which helps you breathe easier. The effect sets in within 1-3 minutes and lasts up to 12 hours.
Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).
Asthma
Oxis Turbohaler is used to treat asthma in adults, adolescents, and children aged 6 years and older.
In asthma, your doctor will prescribe two asthma inhalers: Oxis Turbohaler and a separate “cortisone inhaler”. These should be used together.
- Oxis Turbohaler is used to prevent the onset of asthma symptoms.
- Some people also use Oxis Turbohaler when they need an extra dose to treat asthma symptoms and make it easier to breathe again.
- Oxis Turbohaler can also be used before exertion to prevent exertional asthma symptoms.
Chronic obstructive pulmonary disease (COPD)
Oxis Turbohaler can also be used to treat the symptoms of COPD in adults. COPD is a long-term disease of the respiratory tract that has often been caused by cigarette smoking.
What you need to know before using Oxis Turbohaler
Do not use Oxis Turbohaler:
- If you are allergic (hypersensitive) to formoterol or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Oxis Turbohaler if :
- You have diabetes. You may need to check your blood sugar more often while using Oxis Turbohaler.
- You have high blood pressure or if you have ever had heart problems.
- You have thyroid problems.
- You have low levels of potassium in your blood. Your doctor may take blood samples to check your blood potassium level.
- You have severe liver problems such as liver cirrhosis.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Oxis Turbohaler.
Other medicines and Oxis Turbohaler
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal remedies. This is important because some medicines may affect or be affected by treatment with Oxis Turbohaler.
In particular, you should tell 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 ).
- Drugs such as digoxin, are often used for heart failure.
- Diuretics , also known as diuretics (such as furosemide ). These are used for high blood pressure.
- Steroids are taken by mouth (such as prednisolone ).
- Xanthines (such as theophylline or aminophylline). These are often used to treat asthma.
- Erythromycin (used to treat infections ).
- Antihistamines are (such as terfenadine).
- Other substances that dilate the trachea (bronchodilators, such as salbutamol ).
- Ephedrine (used to treat asthma or as a decongestant of mucous membranes).
- Tricyclic antidepressant drugs (such as amitriptyline).
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before using Oxis Turbohaler.
If you will need anesthesia in connection with an operation or a dental procedure, you should also tell your doctor or pharmacist.
If you are also being treated with anticholinergics (eg tiotropium or ipratropium bromide) in addition to Oxis Turbohaler, it may help to open the airways even more.
Pregnancy, breastfeeding, and fertility
- If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine – do not use Oxis Turbohaler unless your doctor advises you to do so.
- If you become pregnant while using Oxis Turbohaler, do not stop using Oxis Turbohaler but contact your doctor immediately.
Driving and using machines
Oxis Turbohaler does not affect the ability to drive or use tools or machines.
Oxis Turbohaler contains lactose
Oxis Turbohaler contains lactose which is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.
The excipient lactose contains small amounts of milk protein which can cause allergic reactions.
How to use Oxis Turbohaler
- Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Do not increase the prescribed dose of Oxis Turbohaler without first talking to your doctor.
- If you use Oxis Turbohaler regularly for asthma or COPD, continue to do so even if you have no symptoms.
Important information about your asthma or COPD symptoms
If you feel short of breath or wheezing while using Oxis Turbohaler, you should continue to use Oxis Turbohaler but consult a doctor as soon as possible as you may need further treatment.
Contact a doctor immediately if:
- Your breathing deteriorates or you often wake up at night with asthma.
- You begin to feel pressure over your chest.
- You do not feel better with your usual dose.
- You need to take more medicines than your usual dose for more than 2 days a week
- You need to use Oxis Turbohaler more than usual before exertion.
These signs may indicate that your asthma or COPD is not being adequately controlled and you may need other or immediate treatment immediately.
Dosage 4.5 micrograms / dose:
Asthma
Oxis Turbohaler should not be used by children under 6 years of age.
Adults (18 years and older)
- The recommended dose is 1 or 2 inhalations once or twice daily.
- Your doctor may increase the dose from one to 4 inhalations once or twice daily.
- Some people even use Oxis Turbohaler as an attack cop. If you get asthma symptoms, the usual dose is 1 or 2 inhalations when they occur.
- A total daily dose of more than 8 inhalations is not normally required. These include the inhalations you take every day, for asthma symptoms and before exertion. However, your doctor may allow up to 12 inhalations per day. Do not use more than a total of 12 inhalations over 24 hours.
- Do not take more than 6 inhalations at one time.
Children and adolescents (6 to 17 years)
- The recommended dose is 2 inhalations once or twice daily.
- Some children also use Oxis Turbohaler as a seizure suppressor. If your child develops asthma symptoms, the usual dose is 1 or 2 inhalations when they occur.
- A total daily dose of more than 4 inhalations is not normally required. These include the inhalation your child takes every day, for asthma symptoms and before exertion. However, your doctor may allow your child to take up to 8 inhalations per day. Your child should not use more than a total of 8 inhalations over 24 hours.
- Your child should not take more than 2 inhalations at the same time.
Your doctor (or asthma nurse) will help you manage your asthma. Once your asthma is under control, your doctor may decide to gradually reduce the dose of one of Oxis Turbohaler.
Exercise-induced asthma
If you or your child have exercise-induced asthma symptoms, your doctor may advise you or your child to also use Oxis Turbohaler before exertion. Oxis Turbohaler should not be used by children under 6 years of age.
Adults (18 years and older)
- The recommended dose is 2 inhalations before exertion.
- A total daily dose of more than 8 inhalations is not normally required. These include the inhalations you take every day, for asthma symptoms and before exertion. However, your doctor may allow up to 12 inhalations per day. Do not use more than a total of 12 inhalations over 24 hours.
- Do not take more than 6 inhalations at one time.
Children and adolescents (6 to 17 years)
- The recommended dose is 1-2 inhalations before exertion.
- A total daily dose of more than 4 inhalations is not normally required. These include the inhalation your child takes every day, for asthma symptoms and before exertion. However, your doctor may allow your child to take up to 8 inhalations per day. Your child should not use more than a total of 8 inhalations over 24 hours.
- Your child should not take more than 2 inhalations at the same time.
Chronic obstructive pulmonary disease (COPD)
- Only for adults (18 years and older).
- The recommended dose is 2 inhalations once or twice daily.
- Your doctor may prescribe an extra dose for you to treat your COPD symptoms.
- You should not take more than 8 inhalations per day.
- Do not take more than 4 inhalations at one time.
Dosage 9 micrograms / dose:
Asthma
Oxis Turbohaler should not be used by children under 6 years of age.
Adults (18 years and older)
- The recommended dose is 1 inhalation once or twice daily.
- Your doctor may increase the dose one to 2 inhalations once or twice daily.
- Some people even use Oxis Turbohaler as an attack cop. If you get asthma symptoms, the usual dose is 1 inhalation when they occur.
- A total daily dose of more than 4 inhalations is not normally required. These include the inhalation you take every day, for asthma symptoms and before exertion. However, your doctor may allow up to 6 inhalations per day. Do not use more than a total of 6 inhalations over 24 hours.
- Do not take more than 3 inhalations at one time.
Children and adolescents (6 to 17 years)
- The recommended dose is 1 inhalation once or twice daily.
- Some children also use Oxis Turbohaler as a seizure suppressor. If your child develops asthma symptoms, the usual dose is 1 inhalation when they occur.
- A total daily dose of more than 2 inhalations is not normally required. These include the inhalation your child takes every day, for asthma symptoms and before exertion. However, your doctor may allow your child to take up to 4 inhalations per day. Your child should not use more than a total of 4 inhalations over 24 hours.
- Your child should not take more than 1 inhalation at the same time.
Your doctor (or asthma nurse) will help you manage your asthma. Once your asthma is under control, your doctor may decide to gradually reduce the dose of one of Oxis Turbohaler.
Exercise-induced asthma
If you or your child have exercise-induced asthma symptoms, your doctor may advise you or your child to also use Oxis Turbohaler before exertion. Oxis Turbohaler should not be used by children under 6 years of age.
Adults (18 years and older)
- The recommended dose is 1 inhalation before exertion.
- A total daily dose of more than 4 inhalations is not normally required. These include the inhalation you take every day, for asthma symptoms and before exertion. However, your doctor may allow up to 6 inhalations per day. Do not use more than a total of 6 inhalations over 24 hours.
- Do not take more than 3 inhalations at one time.
Children and adolescents (6 to 17 years)
- The recommended dose is 1 inhalation before exertion.
- A total daily dose of more than 2 inhalations is not normally required. These include the inhalation your child takes every day, for asthma symptoms and before exertion. However, your doctor may allow your child to take up to 4 inhalations per day. Your child should not use more than a total of 4 inhalations over 24 hours.
- Your child should not take more than 1 inhalation at the same time.
Chronic obstructive pulmonary disease (COPD)
- Only for adults (18 years and older).
- The recommended dose is 1 inhalation once or twice daily.
- Your doctor may prescribe an extra dose for you to treat your COPD symptoms.
- You should not take more than 4 inhalations per day.
- Do not take more than 2 inhalations at the same time.
How to prepare your new Oxis Turbohaler inhaler
Before using your new Oxis Turbohaler inhaler for the first time, you must prepare it for use as follows:
- Unscrew the protective sleeve and lift it off. You can hear a rattling sound.
- Hold your Oxis Turbohaler inhaler upright with the turquoise knob facing down.
- Turn the turquoise knob as far as it will go in one direction. Then turn it as far as it will go in the other direction (it does not matter which direction you turn first).
- You should hear a clicking sound.
- Repeat this by turning the turquoise knob in both directions.
- Your Oxis Turbohaler inhaler is now ready for use.
How to inhale
Each time you need to inhale, follow the instructions below.
1. Unscrew the white protective sleeve and lift it off. You may hear a rattling sound.
2. Hold your Turbohaler upright with the turquoise knob facing down.
3. Do not hold the nozzle when charging your Turbohaler. To feed a dose, turn the turquoise knob in one direction as far as it will go. Then turn it the other way as far as it will go (it does not matter which direction you turn first). You should hear a clicking sound. Your Turbohaler is now charged and ready to use. Only charge your Turbohaler when you need to use it.
4. Keep your Turbohaler away from your mouth. Exhale calmly (as much as feels comfortable). Do not exhale through your Turbohaler.
5. Carefully place the nozzle between the teeth. Close your lips. Inhale through your mouth as deeply and strongly as you can. Do not chew or bite on the nozzle.
6. Remove your Turbohaler from your mouth. Then exhale gently. The amount of drugs inhaled is very small. This means that you may not feel any taste of it after inhaling it. If you have followed the instructions, you can be sure that you have inhaled dose one and that the medicine is now in your lungs.
7. If you are going to take another dose, repeat steps 2 to 6.
8. Replace the protective sleeve properly after use.
Do not attempt to remove the nozzle as it is attached to your Turbohaler and must not be removed. The nozzle can be turned but do not turn it unnecessarily. Do not use your Turbohaler if it has been damaged or if the nozzle has come loose from your Turbohaler.
As with all inhalers, caregivers should ensure that children prescribed Oxis Turbohaler use the correct inhalation technique, as described above.
Cleaning your Turbohaler
Wipe the outside of the nozzle with a dry cloth once a week. Do not use water or other liquids.
When is it time to start using a new Turbohaler?
- The dose indicator tells you how many doses you have left in the Turbohaler and starts with 60 doses when it is full.
- The dose indicator is marked in intervals of 10 doses. Therefore, it does not show every dose. When you first see a red mark at the edge of the indicator window, there are approximately 20 doses left. At the last 10 doses, the background of the dose indicator is red. When “0” on the red background has reached the center of the window, you must start using a new Turbohaler.
Note:
- The knob will still “click” when you turn it even when your Turbohaler is out.
- The sound you hear when you shake your Turbohaler comes from a desiccant and not from the medicine. Therefore, the sound can not tell you how much medicine is left in your Turbohaler.
- If you accidentally charge your Oxis Turbohaler more than once before taking your dose, you will still only get one dose. However, the indicator will record all charged doses.
If you use more Oxis Turbohaler then you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
The most common symptoms that can occur if you use too much Oxis Turbohaler are tremors, headaches, or a fast heartbeat.
If you forget to use Oxis Turbohaler
If you forget to take a dose, take it as soon as you remember. However, if it is soon 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 Turbohaler
Do not stop using Oxis Turbohaler without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
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 Turbohaler and contact your doctor immediately:
- Tracheal cramps (contraction of the muscles in the airways, causing sudden, wheezing) after inhalation of the drug. This is very rare – it can affect up to 1 in 10,000 people.
Other possible side effects:
Common (may affect up to 1 in 10 people):
- Tremors or tremors. If these side effects occur, they are usually mild and disappear as you continue to use Oxis Turbohaler.
- Headache.
- Dizziness.
- Nausea.
- Muscle cramps.
Uncommon (may affect up to 1 in 100 people):
- Heart palpitations (you know your heartbeat). If this side effect occurs, it is usually mild and usually disappears when you continue to use Oxis Turbohaler.
- Disturbed sleep.
- Fast heartbeat.
- Allergic reactions such as rash, itching, and bronchospasm ( bronchospasm ).
- Low levels of potassium in the blood.
- An increase in the amount of sugar ( glucose ) in the blood.
- Taste changes, such as an unpleasant taste in the mouth.
- Changes in blood pressure.
- Uneven heart rhythm.
- Chest pain or pressure over the chest (angina).
Rare (may affect up to 1 in 1,000 people):
- Feeling of restlessness or upset.
How to store Oxis Turbohaler
- Keep this medicine out of the sight and reach of children.
- No special storage instructions.
- Oxis Turbohaler must be stored with the protective sleeve on when not in use.
- Do not use this medicine after the expiry date which is stated on the carton or label on your Turbohaler. The expiration date is the last day of the specified month.
- Make sure you always dispose of your used Turbohaler responsibly, as some of the medicine will remain inside the inhaler. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is formoterol fumarate dihydrate. In a 4.5 microgram / Turbuhaler each dose contains 6 micrograms of formoterol fumarate dihydrate, of which you can inhale 4.5 micrograms.
In a 9 microgram/dose Turbuhaler, each dose contains 12 micrograms of formoterol fumarate dihydrate, of which you can inhale 9 micrograms.
The other ingredient is lactose monohydrate (which contains milk proteins). See section 2, Oxis Turbohaler contains lactose.
What the medicine looks like and the contents of the pack
Oxis Turbohaler is an inhaler that contains medicines. The color of the inhalation powder is white. Each Turbohaler contains 60 doses and is white with a turquoise knob.
Oxis Turbohaler 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 Authorization Holder and Manufacturer
This medicinal product is authorized under the European Economic Area under the names:
| Country | 4.5 micrograms / dose | 9 micrograms / dose |
| Belgium | Oxis Turbohaler 4.5 μg / dose | Oxis Turbohaler 9 μg / dose |
| Denmark | Oxis Turbohaler | Oxis Turbohaler |
| Finland | Oxis Turbohaler | Oxis Turbohaler |
| Greece | Oxez Turbohaler | Oxez Turbohaler |
| Ireland | Oxis Turbohaler 6, inhalation powder | Oxis Turbohaler 12, inhalation powder |
| Italy | Oxis Turbohaler 4.5 | Oxis Turbohaler 9 |
| Luxembourg | Oxis Turbohaler 4.5 μg / dose | Oxis Turbohaler 9 μg / dose |
| Netherlands | Oxis 6 Turbuhaler | Oxis 12 Turbuhaler |
| Portugal | Oxis Turbohaler | Oxis Turbohaler |
| Spanien | Oxis Turbuhaler 4,5 microgramos polvo para inhalación | Oxis Turbuhaler 9 microgramos polvo para inhalación |
| Storbritannien | Oxis Turbohaler 6, inhalation powder | Oxis Turbohaler 12, inhalation powder |
| Sverige | Oxis Turbuhaler | Oxis Turbuhaler |
| Tyskland | Oxis Turbohaler 6 Mikrogramm Pulver zur Inhalation | Oxis Turbohaler 12 Mikrogramm Pulver zur Inhalation |
| Österrike | Oxis Turbohaler 6 μg – Dosier – Pulverinhalator | Oxis Turbohaler 12 μg – Dosage |