Airbufo 160 mcg.4.5 mcg. 60 doses

What ErBuFo Forspiro is and what it is used for
ErBuFo Forspiro is an inhaler that is used to treat:

asthma in adults and adolescents aged 12-17 years;
symptoms of chronic obstructive pulmonary disease (COPD) in adult patients aged 18 years and older.
It contains two different medicines: budesonide and formoterol fumarate dihydrate.

Budesonide is in a group of medicines called 'corticosteroids'. It works by reducing and preventing swelling and inflammation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called 'long-acting beta 2-adrenoceptor agonists' or 'bronchodilators'. It works by relaxing the muscles in the airways. This makes breathing easier.
Asthma
ErBuFo Forspiro can be prescribed for asthma in two different ways
a) Some people are prescribed two inhalers to treat asthma. ErBuFo Forspiro and a separate "relief" inhaler.
They use ErBuFo Forspiro every day. This helps prevent the onset of asthmatic symptoms.
They use the "relief" inhaler when asthma symptoms occur to make breathing easier.

b) Some people are prescribed ErBuFo Forspiro as the only inhaler to treat asthma.
These people use ErBuFo Forspiro every day. This helps prevent the onset of asthmatic symptoms.
They also use ErBuFo Forspiro when they need extra doses to relieve asthma symptoms to make breathing easier again. They do not need a separate inhaler for this purpose.

Chronic Obstructive Pulmonary Disease (COPD)
ErBuFo Forspiro can also be used to treat COPD symptoms in adults. COPD is a long-term disease that is characterized by persistent breathing difficulties due to narrowing of the airways, which are often accompanied by coughing and sputum production. A common cause is smoking.

2. What you need to know before you take ErBuFo Forspiro
Do not use ErBuFo Forspiro if:
you are allergic to budesonide, formoterol or to the other ingredient of this medicine - lactose (which contains small amounts of milk proteins).

Warnings and precautions
Talk to your doctor or pharmacist before taking ErBuFo Forspiro if:

you are diabetic;
you have a lung infection;
you have high blood pressure or have ever had heart problems (including irregular heartbeat, very fast pulse, narrowing of the arteries or heart failure);
you have problems with your thyroid or adrenal glands;
you have low levels of potassium in your blood;
you have severe liver problems.
Contact your doctor if you have blurred vision or other visual disturbances.

Other medicines and ErBuFo Forspiro
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are using any of the following medicines:

beta-blockers (eg, atenolol or propranolol, to treat high blood pressure), including eye drops (eg, timolol, to treat glaucoma);
medicines for a fast or irregular heartbeat (such as quinidine, disopyramide, procainamide);
medicines to treat allergies, also called antihistamines, such as terfenadine;
oxytocin, a drug to ease labor; procarbazine, a drug used to treat cancer;
medicines such as digoxin, often used to treat heart failure;
diuretics, also called "water tablets" (for example, furosemide). These are used to treat high blood pressure;
corticosteroids (eg, prednisolone). They are used to treat inflammation or prevent rejection of a transplanted organ;
xanthine drugs (eg, theophylline or aminophylline). They are often used to treat asthma;
other medicines to widen the airways, also called bronchodilators (for example, salbutamol);
medicines to treat depression, also called tricyclic antidepressants (for example, amitriptyline) and the antidepressant nefazodone;
medicines to treat mental disorders, nausea or vomiting called phenothiazine medicines (for example, chlorpromazine and prochlorperazine);
medicines to treat fungal infections (eg, ketoconazole, itraconazole, voriconazole, posaconazole) and bacterial infections (eg, clarithromycin and telithromycin, furazolidone);
medicines to treat Parkinson's disease (for example, levodopa);
medicines to treat thyroid problems (for example, levothyroxine);
ritonavir, cobicistat (medicines against HIV infections). The effect of ErBuFo Forspiro may be reduced and your doctor may want to monitor you closely.
If any of the above apply to you or if you are not sure, talk to your doctor or pharmacist before using ErBuFo Forspiro.

Also inform your doctor or pharmacist if you will undergo general anesthesia for surgery or dental treatment.
Pregnancy, lactation and fertility
If you are pregnant or planning to become pregnant, talk to your doctor before using ErBuFo Forspiro - do not use ErBuFo Forspiro unless your doctor tells you to.
If you become pregnant while using ErBuFo Forspiro, do not stop using ErBuFo Forspiro, but talk to your doctor immediately.
If you are breast-feeding, talk to your doctor before using ErBuFo Forspiro.

Driving and using machines
ErBuFo Forspiro does not affect or slightly affects the ability to drive and use machines.

ErBuFo Forspiro contains lactose
ErBuFo Forspiro contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before using this medicine. The amount of lactose in this medicine does not usually cause problems in people who are lactose intolerant.

The excipient lactose contains small amounts of milk proteins that can cause allergic reactions.

3. How to use ErBuFo Forspiro
Always use ErBuFo Forspiro exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
It is important to use ErBuFo Forspiro every day, even if you do not currently have asthma or COPD symptoms.
If you use ErBuFo Forspiro for asthma, your doctor will want to check your symptoms regularly.

If you are taking corticosteroid tablets to treat asthma or COPD, your doctor may reduce the number of tablets you take after starting ErBuFo Forspiro. If you are taking oral corticosteroid tablets for a long period of time, your doctor may consider it necessary to have periodic blood tests. When tapering off oral corticosteroid tablets, you may feel generally unwell, even though your chest symptoms are improving. You may have symptoms such as a stuffy or runny nose, joint or muscle weakness or pain, and a rash (eczema). If any of these symptoms bother you, or if symptoms such as headache, tiredness, feeling sick (feeling sick) or vomiting (nausea) occur, contact your doctor immediately. You may need to take another medicine if you develop allergy or arthritis symptoms. You should talk to your doctor if you are worried about whether you should continue using ErBuFo Forspiro.

Your doctor may add corticosteroid tablets to your usual treatment at times of stress (for example, when you have a chest infection or before surgery).

Important information about your asthma or COPD symptoms

If you feel that you are getting short of breath or wheezing while using ErBuFo Forspiro, you should continue using it, but see your doctor as soon as possible as you may need additional treatment.

Contact your doctor immediately if:

your breathing has worsened or you often wake up at night with asthma.
you feel chest tightness in the morning or the tightness lasts longer than usual.
These signs may indicate that your asthma or COPD is not properly controlled and you may need a different or additional treatment immediately.

Asthma
ErBuFo Forspiro can be prescribed for asthma in two different ways. How much ErBuFo Forspiro you should use and when to use it depends on your prescription.

a) if you have been prescribed ErBuFo Forspiro and a separate reliever inhaler, read the section entitled "a) Using ErBuFo Forspiro and a separate 'relief' inhaler."
b) if you have been prescribed ErBuFo Forspiro as a single inhaler, read the section entitled "b) Use of ErBuFo Forspiro as a single inhaler for the treatment of asthma".

a) Use of ErBuFo Forspiro and a separate 'relief* inhaler.
Use your ErBuFo Forspiro every day. This helps prevent the onset of asthmatic symptoms.

Adults (18 and over)
The usual dose is 1 or 2 inhalations, twice a day.
Your doctor may increase the inhalations to 4 inhalations, two
If your symptoms are well controlled, your doctor may tell you to take your medicine once a day.

Juniors (12 to 17 years)
The usual dose is 1 or 2 inhalations, twice a day.
If your symptoms are well controlled, your doctor may tell you to take your medicine once a day.

ErBuFo Forspiro is not recommended for children under 12 years of age.
Your doctor (or asthma nurse) will help you manage your asthma. They will adjust the dose of this medicine to the lowest dose that is needed to control your asthma. However, do not adjust the dose without first checking with your doctor (or asthma nurse).

Using your own 'relief' inhaler to relieve asthma symptoms.

Always carry your "relief" inhaler with you so you can use it when needed. Do not use ErBuFo Forspiro for relief
Use of ErBuFo Forspiro as a single inhaler for asthma.
Use ErBuFo Forspiro in this way only as directed by your doctor and if you are 12 years of age or older.

Use your ErBuFo Forspiro every day. This will help prevent asthma symptoms. You may take:

1 inhalation in the morning and 1 inhalation in the evening or
2 inhalations in the morning or
2 inhalations in the evening.
Your doctor may increase the intake to 2 inhalations twice a day.

Also use ErBuFo Forspiro as a 'relief' inhaler to treat asthma symptoms when they occur.

If you have asthma symptoms, take 1 inhalation and wait a few minutes.
If you do not feel better, take another inhalation.
Do not take more than 6 inhalations at the same time in one intake.

Always carry ErBuFo Forspiro with you so you can use it when needed.

Usually no more than 8 inhalations are needed per day. However, your doctor may allow you to take up to 12 inhalations a day for a limited period of time.

If you regularly need 8 or more inhalations a day, make an appointment with your doctor or nurse. Your treatment may need to be changed.
Do not take more than 12 inhalations in total in one day.

If you exercise and asthma symptoms occur, use ErBuFo Forspiro as described here. But do not use ErBuFo Forspiro immediately before exercise to prevent asthma symptoms.

Chronic Obstructive Pulmonary Disease (COPD)
To be used by adults (18 years and older) only.
The usual dose is 2 inhalations twice a day.

Your doctor may prescribe other medicines to widen the airways, also called bronchodilators (for example, tiotropine or ipratropine bromide), to treat your COPD.

Instructions for use
Your doctor, nurse or pharmacist should show you how to use the inhaler and should check its use regularly.

The inhaler contains 60 doses of the medicinal product in powder form, in a rolled strip of foil. There is a dose counter that shows how many doses are left, counting from 60 to 0. When the last 10 doses are reached, the numbers are on a red background.

The inhaler is not refillable - when it is empty, it must be thrown away and replaced with a new one.
Important:
As you use the inhaler, used tape gradually accumulates in the side chamber. The foil strip with black lines does not contain medicinal product. Finally, the numbered parts of the strip appear in the side camera. Do not leave more than 2 pieces of the foil strip in the side chamber, as the inhaler may become clogged. Tear off the tape carefully as shown above and dispose of it safely.
Remove the inhaler from your mouth and hold your breath for 5-10 seconds or as long as possible without making you feel unwell.
Then exhale slowly, but not into the inhaler.
Close the protective cover over the mouthpiece.
Rinse your mouth with water and then spit it out. This can help prevent fungal infections in the mouth and hoarseness.
Cleaning
If necessary, wipe the outside of the mouthpiece with a clean, dry cloth.
Do not attempt to disassemble the inhaler for cleaning or other purposes!
Do not use water or wet towels to clean the parts of the inhaler, as moisture can affect the dose!
Never insert needles or other sharp objects into the mouthpiece or other parts, as this may damage the inhaler!
If you have used more than the required dose of ErBuFo Forspiro
It is important to take your dose as directed by your pharmacist or as advised by your doctor. You should not exceed your prescribed dose without consulting a medical professional.

The most common symptoms that may occur if you have used more ErBuFo Forspiro than you should are tremors, headache or a fast or irregular heartbeat.

If you forget to use ErBuFo Forspiro
If you miss a dose, take it as soon as you remember. However, if it is time for the next dose, do not take the missed dose.
Do not take a double dose to make up for a missed dose.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

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

If any of the following happen to you, stop using ErBuFo Forspiro and talk to your doctor straight away:

Swelling of the face, especially around the mouth (tongue and/or throat, and/or difficulty swallowing), or hives with difficulty breathing (angioedema) and/or sudden weight loss. This could mean you are having an allergic reaction. This is rare (may affect up to 1 in 1,000 people);
Sudden appearance of sharp wheezing or shortness of breath immediately after u
How to store ErBuFo Forspiro
Keep out of the reach of children. To be stored below 30°C.

Do not use this medicine after the expiry date which is stated on the carton or label of your inhaler after EXP/EXP. The expiration date corresponds to the last day of the specified month.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What ErBuFo Forspiro contains
The active substances are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 160 micrograms budesonide and 4.5 micrograms formoterol fumarate dihydrate; this corresponds to a metered dose (preloaded dose contained in the blister) of 194.7 micrograms budesonide and 6.1 micrograms formoterol fumarate dihydrate.
The other ingredient is lactose monohydrate (contains milk proteins).

What ErBuFo Forspiro looks like and contents of the pack
ErBuFo Forspiro is a red and white, plastic inhaler that contains your medicine. Each inhaler contains an OPA/A1/PVC-A1 blister with 60 doses of pre-dosed inhalation powder. Inhalation powder is white to off-white or slightly yellowish in color, free of agglomerates.

ErBuFo Forspiro is available in packs of 1, 2, 3, 4 or 6 inhaler(s), each containing 60 doses. Not all types of packaging can be put on sale.

 

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