ULTIBRO BREEZHALER. 30 capsules

NOVARTIS
ULTIBRO BREEZHALER. 30 capsules
€ 119.00
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What is Ultibro Breezhaler and what it is used
What is Ultibro Breezhaler
This medicine contains two active substances called indacaterol and glikopironium. They belong to a group of medicines called bronchodilators.

What is Ultibro Breezhaler
This drug is used to facilitate breathing in elderly patients who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD). COPD muscles around the airways tighten. This impedes breathing. This drug blocks the tightening of the muscles in the lungs and facilitates entry and exit of air from the lungs.
Using this medicine once a day will help to reduce the effects of COPD on your daily life.

2. What you should know before using Ultibro Breezhaler
Do not use Ultibro Breezhaler:
if you are allergic to indacaterol or glikopironium or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Ultibro Breezhaler, if something is written below applies to you:
if you have asthma - this drug should not be used as a treatment for asthma;
if you have heart problems;
if you have epilepsy;
if you have thyroid problems (thyrotoxicosis)
if you have diabetes;
if you use any drugs for lung containing active substances similar (the same class) of those in Ultibro Breezhaler (see section "Other medicines and Ultibro Breezhaler");
if you have kidney problems;
If you have severe liver problems;
if you have an eye problem called glaucoma;
if you have difficulty passing urine.
If any of the above, applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before using this medicine.

During treatment with Ultibro Breezhaler
Stop using this medication and tell your doctor immediately if you experience any of the following responses:
eye pain or discomfort, temporary blurring of vision, with the appearance of a halo or colored spots, accompanied by redness of the eye - this may be signs of an acute attack of angle-closure glaucoma;
difficulty breathing or swallowing, swelling of the tongue, lips or face, hives, skin rash - these may be signs of an allergic reaction;
chest tightness, coughing, wheezing or breathlessness immediately after using this medicine - it may be signs of a condition called paradoxical bronchospasm;
Tell your doctor immediately if your COPD symptoms such as breathlessness, wheezing, cough, do not improve or get worse.
Ultibro Breezhaler is used as a continuous treatment in COPD. Do not use this medicine to treat an acute attack of breathlessness or wheezing.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years.

Other medicines and Ultibro Breezhaler
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, please tell your doctor if you use:
any medicine that may be similar to Ultibro Breezhaler (containing such active substances);
medicines called beta-blockers which may be used to treat high blood pressure or other cardiac problems (such as propranolol), or for the eye problem called glaucoma (such as timolol);
drugs that lower potassium levels in the blood. Includes:
steroids (eg. prednisone);
diuretics (water pills), which are used to treat high blood pressure, such as hydrochlorothiazide;
drugs for breathing problems (such as theophylline);
drugs used to treat depression (such as tricyclic antidepressants, monoamine oxidase inhibitors.
Pregnancy and lactation
There are no data on the use of this medicine in pregnant and does not know whether the active substances in this medicine passes into breast milk.
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. You should not use Ultibro Breezhaler, unless your doctor tells you to do.

Driving and using machines
It is unlikely that this medicine affect your ability to drive and use machines. However, the drug can cause dizziness (see. Section 4 "Possible Side Effects"). If you feel dizzy while taking this medicine, do not drive or operate machinery.

Ultibro Breezhaler contains lactose
This drug contains lactose (23,5 mg per capsule). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Ask your doctor or pharmacist before taking any medicine.

3. How to use Ultibro Breezhaler
Always use this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

How Ultibro Breezhaler accept
The usual dose is to inhale the contents of one capsule daily.
We have to inhale once daily because the effect of this medicine lasts for 24 hours. Do not take more than your doctor has told you.

Elderly (75 years and older)
If you are aged 75 and over can use this medicine at the same dose as other adults.

When to inhale Ultibro Breezhaler
Use this medicine at the same time each day. This will help you never forget it.
Can inhale Ultibro Breezhaler anytime predi or after taking food or drinks.

How to inhale Ultibro Breezhaler
In this package will find an inhaler and capsules (in blister packs) containing a medicament in the form of powder for inhalation. Only use the capsules with the inhaler provided in this pack (inhaler Ultibro Breezhaler). The capsules should remain in the blister pack until it is time to use them.
Peel the blister to open it - do not remove the capsule through the foil.
When you start a new pack, use the new inhaler Ultibro Breezhaler, in the pack.
Dispose of each inhaler after 30 days of use.
Do not swallow capsules.
Please read the instructions at the end of this leaflet for further information on the use of the inhaler.

If you use more than the amount Ultibro Breezhaler
If you have inhaled too much of this medicine or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency room. Show packaging Ultibro Breezhaler. You may need medical attention.

If you forget to use Ultibro Breezhaler
If you forget to inhale a dose at the usual time, inhale January as soon as possible the same day. Then inhale the next dose at the usual time the next day. Not inhale more than one dose in a single day.

How long to continue your treatment with Ultibro Breezhaler
Continue treatment Ultibro Breezhaler for as long as you have been told by your doctor.
COPD is a chronic disease and you should use Ultibro Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
If you have any questions about the duration of treatment with this medicine, talk to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious:
Uncommon (may affect up to 1 in 100 people):
crushing chest pain with increased sweating - it can be a serious problem with your heart (coronary heart disease);
difficulty breathing or swallowing, swelling of the tongue, lips or face, hives, skin rash - these may be signs of an allergic reaction;
difficulty breathing with wheezing and coughing;
feeling tired or thirst, the presence of increased appetite without weight gain and release of a larger amount of urine is usually - this could be a sign of high blood sugar (hyperglycemia);
eye pain or discomfort, temporary blurring of vision, with the appearance of a halo or color images combined with red eyes - these may be signs of glaucoma;
irregular heartbeat.
If any of these serious side effects, tell your doctor immediately.

Other side effects may include:
Very common (may affect more than 1 in 10 people):
stuffy nose, sneezing, coughing, headache with or without fever - these may be signs of infection of the upper respiratory tract.
Common (may affect up to 1 in 10 people):
combination of sore throat and runny nose - that may be signs of nasopharyngitis;
painful and frequent urination - this may be signs of a urinary tract infection, called cystitis;
sensation of pressure or pain in the cheeks and forehead - this may be signs of inflammation of the sinuses called sinusitis;
runny or stuffy nose;
dizziness;
headache;
cough;
sore throat;
upset stomach, indigestion;
caries in teeth;
pain that affects the muscles, ligaments, tendons, joints and bones;
fever;
chest pain;
diarrhea or stomach pain.
Uncommon:
sleep disorders;
tingling or numbness;
palpitations;
palpitations - signs of irregular heartbeat;
nosebleeds;
dry mouth;
itching or rash;
muscle spasms;
muscle pain, soreness or tenderness;
pain in arms or legs;
difficult or painful passing of urine - this may be signs of obstruction of the bladder or urinary retention;
swelling of hands, ankles and feet;
fatigue.
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system. As reported adverse reactions you can do your bit to get more information on the safety of this medicine.

5. How to store Ultibro Breezhaler
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP" / "EXP". The expiry date refers to the last day of that month.
Do not store above 25 ° C.
The capsules can be stored in the original blister in order to protect from moisture and do not draw it until immediately before use.
Each inhaler should be discarded after 30 days of use.
Do not use this medicine if you notice that the pack is damaged or shows signs of opening.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Ultibro Breezhaler
The active substances are: indacaterol (as maleate) and glikopironium bromide. The delivered dose (the dose that leaves the mouthpiece of the inhaler) corresponds to 85 microgram indacaterol (which is equivalent to 110 microgram indacaterol maleate) and 43 micrograms glikopironium (equivalent to 54 micrograms glycopyrronium bromide).
The other ingredients of the powder for inhalation are lactose monohydrate and magnesium stearate.

Ultibro Breezhaler looks like and contents of the pack
In this package you will find an inhaler, together with capsules in blister packs.
The capsules have a yellow cap and transparent colorless transparent body. Contain a white to off-white powder, with product code "IGP110.50", printed in blue below two features on the body and the company logo printed in black on the cap.

The following packages:
Single pack containing 6h1, 12h1 or 30h1 hard capsules, with an inhaler.
Multipacks containing 90 (3 packs of 30x1) hard capsules and 3 inhaler.
Multipacks containing 96 (4 packs of 24x1) hard capsules and 4 inhaler.
Multipacks containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.
Not all pack sizes may be marketed.

Instructions for use of the inhaler Ultibro Breezhaler
Please read the following instructions carefully to learn how to use this medicine.
Use only the inhaler Ultibro Breezhaler in this box. Do not use Ultibro Breezhaler capsules with any other inhaler, Ultibro Breezhaler inhaler to take any other capsule;
Do not remove the capsule through the foil to take it out of the blister;
When you start a new pack, only use the inhaler Ultibro Breezhaler in new packaging;
Each inhaler should be discarded after 30 days of use. Ask your pharmacist how to dispose of medicines and inhalers no longer required;
Do not swallow capsules. The powder in the capsules is inhaled.
Your package Ultibro Breezhaler
Each pack contains Ultibro Breezhaler:
an inhaler Ultibro Breezhaler;
one or more blister packs of capsules Ultibro Breezhaler, to be used with the inhaler.
How to use the inhaler
1. Pull off the cap.
2. Open inhaler:
Hold the base of the inhaler and tilt the mouthpiece. Thus the inhaler is opened.
3. Prepare capsule:
Take one of the blister from the blister card as a tear along the perforations. Take individual blister and peel off the protective film to access the capsule.
Do not remove the capsule through the foil.
4. Take the capsule:
The capsules should always be stored in the blister, and only removed immediately before use.
With dry hands, take the capsule from the blister.
Do not swallow capsule.
5. Place the capsule:
Place the capsule in the capsule chamber of the inhaler.
Never place a capsule directly into the mouthpiece.
6. Close the inhaler:
Close the inhaler until you hear a "click".
7. Drill capsule:
Hold the inhaler upright with the mouthpiece pointing up.
Puncture the capsule by pressing the buttons located on both sides. Do this only once.
Drilling of the capsule should hear a "click".
8. Release the side buttons fully.
9. Breathe:
Before placing the mouthpiece in your mouth, breathe out fully.
Do not blow into the mouthpiece.
10. Inhale the medicine:
To breathe the medicine deep into the lungs:
Hold the inhaler as shown in the figure. The side buttons should be facing left and right. Do not press them.
Place the mouthpiece in your mouth and close your lips around it.
Breathe in rapidly but without a break as you deeper. Do not press the side buttons.
11. Note:
As you breathe in through the inhaler, the capsule spins around in the chamber and you should hear a whirring noise. Will experience a sweet flavor as the medicine goes into your lungs.
If you do not hear a whirring noise:
The capsule may be blocked in the capsule chamber. If this happens:
Open the inhaler and carefully loosen the capsule by tapping the base of the inhaler. Do not press the side buttons.
Inhale the medicine again by repeating steps 9 and 10.
12. Hold your breath:
Once you have inhaled the medicine:
Hold your breath for at least 5-10 seconds or as long as you can while taking the inhaler out of your mouth.
Then exhale.
Open the inhaler to see if any powder is left in the capsule.
If the remaining powder in the capsule:
Close the inhaler.
Repeat steps 9 to 12.
Most people are able to empty the capsule with one or two inhalations.

additional information
Sometimes it is possible some people to cough briefly after inhaling the medicine. If this happens, do not worry. Once the capsule is empty, you have received enough of your medicine.

13. Once you have finished taking
Your daily dose Ultibro Breezhaler:
Open the mouthpiece again, and remove the empty capsule by tipping it out of the capsule chamber. Discard the empty capsule into the trash.
Close the inhaler and place the cap.
Unbored store capsules in the inhaler.

additional information
Occasionally, very small pieces of the capsule can pass through the filter and fall into your mouth. If this happens, you can feel these particles tongue. Not harmful if swallowed or inhale these particles. Likelihood capsule breaking into pieces will be increased if accidentally pierced more than once (step 7).

How to clean your inhaler
Never rinse the inhaler with water. If you need to clean, wipe the nozzle inside and out with a clean, dry, lint-free cloth to remove any residual dust. Hold the inhaler dry.
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