Oslif Breezhaler 150 microgram inhalation powder, hard capsules

 

What is it and how is it used?

What Oslif Breezhaler is
Oslif Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators. When you inhale it, it relaxes the muscles in the walls of the small air passages in the lungs. This helps open up the airways, making it easier to get air in and out.

What Oslif Breezhaler is used for
Oslif Breezhaler is used in adults who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD). It helps you breathe more easily and minimise the effects of COPD.

What do you have to consider before using it?

Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet.

Do not use Oslif Breezhaler

  • if you are allergic (hypersensitive) to indacaterol, to lactose or to gelatin. If this applies to you, tell your doctor without taking Oslif Breezhaler. If you think you may be allergic, ask your doctor for advice.

Take special care with Oslif Breezhaler if you have asthma in this case you should not use Oslif Breezhaler. if you have heart problems. if you have epilepsy. if you have thyroid gland problems thyrotoxicosis. if you have diabetes. If any of the above applies to you or you are not sure, tell your doctor before using Oslif Breezhaler.

Oslif Breezhaler should not be given to children or adolescents below the age of 18 years.

During treatment with Oslif Breezhaler,
- Stop using the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called bronchospasm.
- Tell your doctor immediately if your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, please tell your doctor if you are using:
- medicines for breathing problems that are similar to Oslif Breezhaler. You may be more likely to get side effects.
- medicines called beta blockers that are used for high blood pressure or other heart problems (such as propranolol), or for the eye problem called glaucoma (such as timolol). - medicines that lower the amount of potassium in your blood. These include:

  • steroids (e.g. prednisolone),
  • diuretics (water tablets) used for high blood pressure such as hydrochlorothiazide,
  • medicines for breathing problems such as theophylline.

Using Oslif Breezhaler with food and drink
You can inhale Oslif Breezhaler anytime before or after food or drink.

Pregnancy and breast-feeding
If you are pregnant or think that you may be pregnant, or if you are breast-feeding, tell your doctor before using Oslif Breezhaler. You should not use Oslif Breezhaler unless your doctor tells you so.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is unlikely that Oslif Breezhaler will affect your ability to drive and use machines.

How is it used?

Always use Oslif Breezhaler exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much Oslif Breezhaler to use
- The usual dose is to inhale the content of one capsule each day. Your doctor may tell you to use the 150 microgram capsule or the 300 microgram capsule depending on your condition and on how you respond to the treatment. Do not use more than your doctor tells you to use. - Use your inhaler at the same time each day, the effects last for 24 hours. This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night. It will also help you to remember to use it.

How to use Oslif Breezhaler
- In this pack, you will find an inhaler and capsules (in blister strips) that contain the medicine as inhalation powder. The Oslif Breezhaler inhaler enables you to inhale the medicine contained in a capsule.
- Only use the capsules with the inhaler provided in this pack (Oslif Breezhaler inhaler). The capsules should remain in the blister strip until you need to use them.
- When you start a new pack, use the new Oslif Breezhaler inhaler that is supplied in the pack. - Dispose of each inhaler after 30 days of use.

Do not swallow the capsules. Please read the instructions at the end of this leaflet for more information about how to use the inhaler.

If you use more Oslif Breezhaler than you should
If you have inhaled too much Oslif Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit. Show the pack of Oslif Breezhaler. Medical attention may be needed.

If you forget to use Oslif Breezhaler
If you forget to inhale a dose, inhale just one dose at the usual time the next day. Do not inhale a double dose to make up for a forgotten dose.

How long to continue your treatment with Oslif Breezhaler
- Keep using your treatment with Oslif Breezhaler for as long as your doctor tells you. - COPD is a long-term disease and you should use Oslif Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
If you have questions about how long to continue your treatment with Oslif Breezhaler, talk to your doctor or pharmacist.

What are possible side effects?

Like all medicines, Oslif Breezhalercan cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows very common affects more than 1 patient in 10 common affects 1 to 10 patients in 100 uncommon affects 1 to 10 patients in 1,000 rare affects 1 to 10 patients in 10,000 very rare affects less than 1 patient in 10,000 not known frequency cannot be estimated from the available data.

Some side effects may be serious. Tell your doctor immediately
- if you get crushing chest pain, or irregular heart beat.
- if you get high levels of sugar in your blood (diabetes). You will feel tired, very thirsty and hungry (without gaining weight) and will pass more urine than usual.

Other side effects may include:

Common side effects feeling of pressure or pain in the cheeks and forehead inflammation of the sinuses runny nose cough sore throat headache cold-like symptoms. You may get all or most of the following sore throat, runny nose, blocked nose, sneezing, coughing and a headache. muscle spasm difficulty to breathe as with bronchitis swollen hands, ankles and feet oedema

Uncommon side effects
- tingling or numbness
- chest pain

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Some people occasionally cough soon after inhaling the medicine. Cough is a common symptom in COPD. If you experience coughing briefly after inhaling the medicine, do not worry. Check your inhaler to see if the capsule is empty and that you have received the full dose. If the capsule is empty, there is no need for concern. If the capsule is not empty then inhale again as directed.

How should it be stored?

Keep out of the reach and sight of children.
Do not use after the expiry date shown on the box and blister strip. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture and do not remove until immediately before use.
Do not use Oslif Breezhaler if you notice that the pack is damaged or show signs of tampering. 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.

What is it?

Oslif Breezhaler is a medicine that contains the active substance indacaterol. It is available as capsules containing a powder for inhalation (150 and 300 micrograms).

What is it used for?

Oslif Breezhaler is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.
The medicine can only be obtained with a prescription.

How is it used?

Oslif Breezhaler capsules are only used with an Oslif Breezhaler inhaler and must not be swallowed. To take a dose, the patient places a capsule into the inhaler and breathes the powder in through the mouth.
The recommended dose is one 150-microgram capsule, once a day at the same time each day. A dose of one 300-microgram capsule may be used in cases of severe COPD, but this must only be done on the doctor’s instructions.

How does it work?

The active substance in Oslif Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist. It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax. When Oslif Breezhaler is inhaled, indacaterol reaches the receptors in the airways and activates them. This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.

How has it been studied?

The effects of Oslif Breezhaler were first tested in experimental models before being studied in humans.
In three main studies involving over 4,000 patients with COPD, Oslif Breezhaler at different doses has been compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD). The main measure of effectiveness was how Oslif Breezhaler compared with placebo in improving patients’ forced expiratory volumes (FEV1) after 12 weeks. FEV1 is the most air a person can breathe out in one second.

What benefits has it shown during the studies?

Oslif Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD. On average, the improvement in FEV1 in patients who received Oslif Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml. Overall, the effects of the 150- and 300-microgram doses of Oslif Breezhaler were similar, but the results showed that the 300-microgram dose may provide better relief in patients with more severe disease.

What is the risk associated?

The most common side effects with Oslif Breezhaler (seen in between 1 and 10 patients in 100) are nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (colds), sinusitis (inflammation of the sinuses), diabetes mellitus and hyperglycaemia (high blood sugar levels), headache, ischaemic heart disease (disease of the heart caused by failure in the blood supply), cough, pharyngolaryngeal (throat) pain, rhinorrhoea (runny nose), respiratory tract congestion (blocked airways), muscle spasm (cramps) and peripheral oedema (swelling, especially of the ankles and feet). For the full list of all side effects reported with Oslif Breezhaler, see the Package Leaflet. Oslif Breezhaler should not be used in people who may be hypersensitive (allergic) to indacaterol, lactose or any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Oslif Breezhaler’s benefits are greater than its risks and recommended that Oslif Breezhaler be given marketing authorisation.

How has it been studied?

The company that makes Oslif Breezhaler will ensure that doctors who are expected to prescribe the medicine and pharmacists in all Member States are provided with a card containing information on how medicine is used.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Oslif Breezhaler to Novartis Europharm Limited on 30 November 2009. The marketing authorisation is valid for five years, after which it can be renewed.