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What is AirFluZal Forspiro and what it is used for
ErFluZal Forspiro is used to treat:
chronic obstructive pulmonary disease (COPD).
This disease is characterized by constant difficulty in breathing caused by narrowing of the airways, which is often accompanied by coughing and sputum. This medicine reduces the number of attacks of COPD symptoms.
This medicine contains two active substances.
salmeterol: a long-acting substance that dilates the airways;
fluticasone: a cortisone that reduces swelling and inflammation in the lungs.
2. What you need to know before you use AirFluZal Forspiro
Do not use AirFluZal Forspiro:
if you are allergic to salmeterol, fluticasone or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using ErFluZal Forspiro if you have:
heart disease, including an irregular or fast heartbeat;
overactive thyroid gland;
high blood pressure;
low levels of potassium in the blood;
tuberculosis - now or in the past.
AirFluZal Forspiro helps prevent shortness of breath and wheezing. Please note that the medicine does not work if you are currently short of breath or wheezing.
If such an attack of shortness of breath occurs, it is necessary to use a drug that rapidly expands the airways, such as salbutamol.
If your asthma or breathing gets worse, tell your doctor straight away. You may feel that:
you get chest tightness more often;
you need to use your inhaler more often to rapidly expand the airways.
If this happens, continue using AirFluZal Forspiro, but do not increase the number of inhalations. Your lung condition may worsen and you may become seriously ill. Talk to your doctor as you may need further treatment.
Children and adolescents
ErFluZal Forspiro is not recommended for children under 12 years of age.
Other medicines and ErFluZal Forspiro
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicines may affect or be affected by ErFluZal Forspiro:
medicines to treat high blood pressure or other heart problems, with an active substance whose name ends in "olol" (beta-blockers), such as atenolol, propranolol and sotalol;
medicines to treat viral infections, such as ritonavir;
medicines to treat fungal infections, such as ketoconazole and itraconazole;
corticosteroids that are taken by mouth or injected: medicines to treat inflammation or to prevent rejection of a transplanted organ.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Your doctor will decide whether to take ErFluZal Forspiro during this time.
Driving and using machines
ErFluZal Forspiro is unlikely to affect your ability to drive or use machines.
ErFluZal Forspiro contains lactose
If your doctor has told you that you have an intolerance to some sugars, consult him before taking this product.
3. How to use AirFluZal Forspiro
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults and children over 12 years of age is:
One inhalation twice daily.
Your doctor will monitor your asthma symptoms regularly.
Chronic obstructive pulmonary disease
The recommended dose for adults is:
One inhalation twice daily.
If your symptoms are well controlled when you use ErFluZal Forspiro twice a day, your doctor may reduce your dose to once a day:
one inhalation in the evening if you have symptoms at night;
one inhalation in the morning if you have symptoms during the day.
Use ErFluZal Forspiro every day as prescribed by your doctor, preferably just before meals in the morning and/or evening.
After inhalation, rinse your mouth with water.
If you do not use ErFluZal Forspiro correctly or as prescribed by your doctor, your breathing may get worse. You must use ErFluZal Forspiro every day, even when you have no symptoms, for the treatment to be optimal.
Instructions for use
Your doctor, nurse or pharmacist should show you how to use the inhaler and regularly check that you are using it correctly.
The inhaler contains 60 doses of the powdered medicine packed in a rolled strip of foil. There is a dose counter that shows how many doses are left, counting down from 60 to 0. When 10 doses remain, the number is on a red background.
The inhaler cannot be refilled - it must be thrown away when empty and replaced with
Before using the inhaler
Open the transparent camera door.
Remove the foil strip from the side camera by carefully tearing it away from the entire strip using the "teeth" as shown below. Do not pull or pull the tape.
Close the side camera door and discard the used tape.
As you use the inhaler, the side chamber will gradually fill with used tape. Foil strips with black lines do not contain medicine. Eventually, the numbered parts of the tape will appear in the side camera. You should never leave more than 3 pieces of foil in the side chamber as they may clog the inhaler. The tape should be carefully torn off as shown above and disposed of safely.
Using the inhaler
Hold the inhaler with your hands as shown in the images.
Open the protective cap downwards to reveal the mouth applicator;
Check the dose counter to see how many doses are left.
2. Preparation of the dose
Lift the edge of the white plunger. Check if the side camera is closed.
Remember: Only move the white plunger if you are ready to inhale a dose of medicine. If you play with the white plunger, you will lose doses.
Open: Lift the white plunger up and all the way until it clicks. This action will move a new dose, with the corresponding number at the top.
Close: Then fully close the white plunger so that it clicks back into its original position. So the inhaler is ready to use immediately.
Exhale as much as you can away from the mouthpiece. Never exhale directly into the inhaler as this may affect the dose.
Hold the inhaler in a horizontal position with the protective cap pointing down.
Press your lips tightly around the lip applicator.
Inhale long and deeply through the inhaler, not through the nose.
Do not block the air openings.
Remove the inhaler from your mouth and hold your breath for 5-10 seconds or as long as you can without discomfort.
Then exhale slowly, but not into the inhaler.
Close the protective cap over the mouthpiece.
Rinse your mouth with water and spit it out. This can help protect against yeast infection and hoarseness.
If necessary, wipe the outside of the mouthpiece with a clean, dry cloth.
Do not disassemble the inhaler to clean it or for any other reason!
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 of the inhaler, as this may damage it!
If you have used more than the required dose of ErFluZal Forspiro
Contact your doctor or pharmacist.
Symptoms of overdose are:
If you have used higher doses for a long time, you should consult your doctor or pharmacist. This is necessary because high doses of ErFluZal Forspiro can lower the levels of steroid hormones that are produced by the adrenal gland.
If you forget to take ErFluZal Forspiro
Do not take a double dose to make up for a missed dose. Use the next dose when it is time.
If you have stopped taking ErFluZal Forspiro
Do not stop or reduce the dose of ErFluZal Forspiro suddenly without your doctor's permission, as this may make breathing problems worse and very rarely side effects may occur.
fatigue and lack of appetite;
nausea and diarrhea;
headache or drowsiness;
low levels of potassium in the blood;
low blood pressure and seizures.
Very rarely, if you have an infection or during times of great stress (such as after a serious accident or surgery), you may experience similar side effects. In order to prevent the occurrence of these symptoms, your doctor may prescribe additional corticosteroids (eg prednisolone).
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.
Allergic reactions: you may notice that your breathing suddenly becomes worse after using ErFluZal Forspiro. A lot of wheezing and coughing may occur. You may also notice itching and swelling (usually on the face, lips, tongue or throat). If you get any of these symptoms or if they appear suddenly after using ErFluZal Forspiro, tell your doctor immediately. Allergic reactions to ErFluZal Forspiro are uncommon (may affect up to 1 in 100 people).
Other side effects that may occur with the following frequencies:
Very common, may affect more than 1 in 10 people:
Uncommon, may affect up to 1 in 100 people:
very fast heartbeat (tachycardia);
feeling of an irregular, fast or unusual heartbeat (palpitations) - This is usually harmless and will decrease during treatment;
anxiety - This reaction is mainly observed in children;
elevated blood sugar levels - If you have diabetes, your blood sugar may need to be checked more often and the dose of your diabetes medication may need to be adjusted;
increased eye pressure (cataract).
Rare, may affect up to 1 in 1,000 people:
difficulty breathing or wheezing that gets worse immediately after using AirFluZal Forspiro - Stop using AirFluZal Forspiro and use your rapid airway dilation inhaler to help breathing. Tell your doctor right away;
abnormal production of certain hormones, especially if you use this medicine in high doses for a long time. Signs include:
growth retardation in children and adolescents;
thinning of the bones;
clouding of the lens of the eye (glaucoma);
increase in body weight;
round, moon-shaped face (Cushing's syndrome).
Your doctor will regularly check for these side effects to make sure you are on the lowest possible dose.
behavioral changes such as unusual activity and irritability - These reactions are mostly seen in children;
abnormal heartbeat or extra heartbeat - Tell the doctor, but do not stop using ErFluZal Forspiro if he does not tell you;
depression or aggression - These reactions are mostly seen in children.
5. How to store AirFluZal Forspiro
Keep out of the reach of children.
Do not store above 25 °C.
Do not use this medicine after the expiry date which is stated on the label and carton after 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 AirFluZal Forspiro contains
ErFluZal Forspiro 50/500 micrograms inhalation powder, pre-dosed:
The active substances are: salmeterol and fluticasone. Each metered dose of ErFluZal Forspiro delivers 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate. Corresponding to a delivered dose of:
45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate.
The other ingredient is: lactose monohydrate.
What AirFluZal Forspiro looks like and what the pack contains
Aluminum blister containing 60 pre-measured doses of powder mixture, placed in a purple plastic powder inhaler device.
Each dose is pre-dosed.
Pack size: 1, 2, 3, 4, 5, 6 or 10 inhaler devices containing 60 doses each.
Not all types of packaging can be put on sale.
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