Airflusal forspiro
Poland
Table of Contents
Package leaflet: Information for the patient
AirFluSal Forspiro
(50 micrograms + 500 micrograms)/dose, inhalation powder, divided
Salmeterolum + Fluticasoni propionas
Read the entire leaflet before using the medicine, as it contains important information for the patient.
Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others.
This medicine may harm another person, even if their symptoms are the same.
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet:
- What AirFluSal Forspiro is and what it is used for
- Important information before using AirFluSal Forspiro
- How to use AirFluSal Forspiro
- Possible side effects
- How to store AirFluSal Forspiro
- Contents of the pack and other information
1. What AirFluSal Forspiro is and what it is used for
AirFluSal Forspiro is used in the treatment of:
bronchial asthma
chronic obstructive pulmonary disease (COPD)
This disease is characterized by persistent breathing difficulties due to narrowing of the airways, often accompanied by cough and mucus retention. The medicine reduces the frequency of COPD exacerbations.
The medicine contains two active substances:
salmeterol: a long-acting bronchodilator
fluticasone: a corticosteroid that reduces swelling and inflammation in the lungs.
2. Important information before using AirFluSal Forspiro
When not to use AirFluSal Forspiro
if the patient is allergic to salmeterol, fluticasone, or to any of the excipients of the medicine
(listed in section 6).
Warnings and precautions
Before using AirFluSal Forspiro, consult a doctor or pharmacist if the patient:
- has heart disease, including irregular or rapid heartbeat
- has hyperthyroidism
- has high blood pressure
- has diabetes (AirFluSal Forspiro may increase blood sugar levels)
- has low potassium levels in the blood
- has tuberculosis (current or past) or other lung infections
If the patient develops blurred vision or other visual disturbances, inform the doctor immediately.
AirFluSal Forspiro helps prevent breathlessness and wheezing. It is important to remember that the medicine does not work when breathlessness or wheezing has already started.
In case of a breathlessness attack, a fast-acting medicine (such as salbutamol) must be used to quickly open the airways.
If asthma symptoms or breathing difficulties worsen, contact the doctor immediately. This may include:
- wheezing
- more frequent feeling of chest tightness
- needing to use a fast-acting bronchodilator more often than usual
In such cases, continue using AirFluSal Forspiro, but do not increase the number of inhalations, as the patient's condition may deteriorate, leading to a serious illness. Contact the doctor, as additional treatment may be necessary.
Children and adolescents
AirFluSal Forspiro must not be used in children and adolescents under 18 years of age.
AirFluSal Forspiro and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including those available without a prescription.
AirFluSal Forspiro may interact with the following medicines:
- medicines used to treat high blood pressure, heart disease, or other conditions containing an active substance ending in "olol" (beta-blockers), such as atenolol, propranolol, and sotalol
- antiviral medicines, including some used to treat HIV infection, such as ritonavir or cobicistat
The doctor may need to closely monitor the patient's condition when taking these medicines.
- medicines used to treat infections, such as ketoconazole, itraconazole, and erythromycin
- corticosteroids taken orally or by injection: medicines used to treat inflammation or to prevent transplant rejection
- diuretics used to treat high blood pressure
- other bronchodilators (such as salbutamol)
- medicines containing xanthine derivatives (commonly used in asthma treatment)
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will assess whether the use of AirFluSal Forspiro is appropriate during pregnancy.
Driving and operating machinery
It is unlikely that AirFluSal Forspiro will affect the ability to drive or operate machinery.
AirFluSal Forspiro contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before using this medicine.
The amount of lactose contained in the medicine usually does not cause problems in people with lactose intolerance.
3. How to use AirFluSal Forspiro
This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Asthma
The recommended dose for adults is:
one inhalation twice daily.
Your doctor will regularly monitor your asthma symptoms.
COPD
The recommended dose for adults is:
one inhalation twice daily.
If symptoms are well controlled with AirFluSal Forspiro taken twice daily, your doctor
may reduce the dose to once daily:
once in the evening, if symptoms occur at night
once in the morning, if symptoms occur during the day.
Method of administration
AirFluSal Forspiro should be used daily as directed by your doctor, preferably immediately before
a meal, in the morning and/or evening.
After inhalation, rinse the mouth with water.
Incorrect or inconsistent use of AirFluSal Forspiro may worsen respiratory symptoms. To achieve
optimal effectiveness, the medicine must be used daily, even if symptoms are not present.
Instructions for use
Your doctor, nurse, or pharmacist should demonstrate how to use the inhaler and should regularly
check that you are using it correctly.
The inhaler contains 60 doses of powder for inhalation in a coiled foil strip (blister strip). It is equipped
with a dose counter indicating the number of doses remaining (from 60 to 0). The numbers indicating
the last 10 doses are displayed on a red background.
The inhaler is not refillable – once empty, it must be replaced with a new device.
Before using the inhaler
Open the transparent side chamber cover.
Carefully peel off the entire length of the strip using the serrated edge (as shown in the
illustration). Do not pull or jerk the strip.
Close the chamber cover and dispose of the used foil strip.
Note:
As the inhaler is used, the side chamber gradually fills with the used foil strip. Foil strips with black
lines do not contain medicine. At the end, numbered segments of the strip will appear in the chamber.
Do not allow more than 2 strips to accumulate in the side chamber, as this may block the inhaler.
Gently peel off the foil strip (as shown above) and remove it safely.
Using the inhaler
Hold the inhaler in your hands as shown in the illustrations.
1. Opening
Uncover the mouthpiece by pulling down the protective cap.
Check the dose counter window to see how many doses remain.
2. Preparing the dose
Lift the edge of the white lever. Ensure the side chamber is closed.
Note: Use the white lever only when ready to take the dose.
Unnecessary use will result in loss of medicine doses.
Opening: Pull the white lever fully upwards (audible click) to load the dose and display its number in the dose counter.
Closing: Firmly close the white lever until a click is heard. The inhaler is now ready for immediate use.
3. Inhaling the dose
Breathe out as deeply as possible away from the mouthpiece. Never breathe out directly into
the inhaler, as this may alter the dose delivered.
Hold the inhaler with the protective cap pointing downwards.
Seal your lips tightly around the mouthpiece.
Breathe in slowly and deeply through your mouth (not through your nose).
Remove the inhaler from your mouth and hold your breath for 5–10 seconds, or as long as
comfortably possible without discomfort.
After this time, breathe out slowly away from the inhaler.
Close the protective cap over the mouthpiece.
Rinse the mouth with water (spit the water out), to help prevent the development of oral fungal
infection and hoarseness.
Cleaning
If necessary, wipe the outer part of the mouthpiece with a clean, dry cloth.
Do not disassemble the inhaler for cleaning or any other purpose!
Do not clean any parts of the inhaler with water or wet wipes, as moisture may alter the dose delivered!
Never insert needles or other sharp objects into the mouthpiece or any other part of the inhaler, as this may damage the device!
Use of a higher than recommended dose of AirFluSal Forspiro
Contact your doctor or pharmacist.
Symptoms of overdose may include:
dizziness
headache
increased heart rate
muscle weakness
joint pain
tremor
If higher doses have been used for a prolonged period, consult your doctor or pharmacist for advice, as long-term use of higher doses of AirFluSal Forspiro may reduce the adrenal glands' production of steroid hormones.
It is important to use this medicine exactly as prescribed by your doctor. Do not increase or decrease the dose without medical advice.
Missing a dose of AirFluSal Forspiro
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping treatment with AirFluSal Forspiro
Do not stop using or suddenly reduce the dose of AirFluSal Forspiro without consulting your
doctor, as this may worsen breathing problems and very rarely cause adverse effects such as:
abdominal pain
feeling of fatigue and loss of appetite, nausea
vomiting and diarrhoea
weight loss
headache or drowsiness
low blood sugar levels
low blood pressure and seizures.
Similar adverse effects may also very rarely occur during infection or in situations of severe stress (e.g. due to fever, injury, serious accident or surgery). To prevent these symptoms, your doctor may prescribe additional corticosteroids (e.g. prednisolone).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Allergic reactions: the patient may experience sudden breathing difficulties immediately after
administration of AirFluSal Forspiro. Wheezing, coughing, or shortness of breath may occur,
as well as itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat),
including a sensation of very rapid heartbeat or fainting and dizziness (which may lead to falling
or loss of consciousness). If any of these symptoms occur, or if they occur suddenly after
administration of AirFluSal Forspiro, contact a doctor immediately.
Allergic reactions to AirFluSal Forspiro occur uncommonly (may occur in fewer than 1 in 100 people).
Other possible adverse reactions:
Very common (may occur in more than 1 in 10 people)
headache (usually resolves during treatment)
increased number of colds in patients with chronic obstructive pulmonary disease (COPD)
Common (may occur in fewer than 1 in 10 people)
oral and pharyngeal candidiasis (painful, creamy-yellow lesions), as well as tongue pain, hoarseness,
and throat irritation.
Rinsing the mouth with water and immediately spitting it out and/or brushing teeth
immediately after each inhalation may be helpful. The doctor may prescribe an antifungal medicine
to treat candidiasis.
joint pain, joint swelling, and muscle pain
muscle cramps
In patients with chronic obstructive pulmonary disease (COPD), the following adverse reactions
have been reported:
pneumonia (lung infection)
Inform the doctor if any of the following symptoms occur during treatment with AirFluSal Forspiro;
they may be signs of lung infection:
- increased mucus production
- change in mucus color
- fever
- chills
- worsening cough
- increased difficulty breathing
- bruising and traumatic fractures
- sinusitis
- low blood potassium levels (which may cause irregular heartbeat, weakness, and/or muscle cramps)
Uncommon (may occur in fewer than 1 in 100 people)
very fast heartbeat (tachycardia)
tremor and sensation of rapid or irregular heartbeat (palpitations)
These are usually harmless symptoms that resolve during treatment.
feeling of sadness (mainly occurs in children)
increased blood sugar levels
In patients with diabetes, more frequent monitoring of blood sugar levels may be necessary,
and adjustment of the dose of antidiabetic medication may be required.
sleep disturbances
chest pain
lens opacity (cataract)
allergic rash
Rare (may occur in fewer than 1 in 1000 people)
breathing difficulties or wheezing that worsens immediately after administration
of AirFluSal Forspiro
Discontinue use of AirFluSal Forspiro and contact a doctor immediately.
To facilitate breathing, a fast-acting bronchodilator should be used via inhalation.
abnormal production of certain hormones, especially if the medicine is used in high doses
for a prolonged period
Symptoms include:
- slowed growth in children and adolescents
- bone thinning (osteoporosis)
- increased intraocular pressure (glaucoma)
- weight gain
- rounded ("moon-shaped") face (Cushing's syndrome)
The doctor will regularly check whether any of these adverse reactions occur and will ensure
that the patient is using the lowest possible dose of the medicine.
behavioral changes such as unusual excitability and irritability
These symptoms mainly occur in children.
irregular heartbeat or extra heartbeats
Inform the doctor, but do not stop using AirFluSal Forspiro without medical advice.
fungal infection of the esophagus, which may cause difficulty swallowing
Frequency not known, but may also occur:
depression or aggression
These symptoms mainly occur in children.
blurred vision
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor,
pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring
Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301 / fax: +48 22 49 21 309 / website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store AirFluSal Forspiro
Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use AirFluSal Forspiro after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What AirFluSal Forspiro contains
The active substances are salmeterol and fluticasone propionate. Each metered dose contains
50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate.
This corresponds to the delivered dose containing 45 micrograms of salmeterol (as salmeterol xinafoate)
and 465 micrograms of fluticasone propionate.
The other ingredient is lactose monohydrate.
What AirFluSal Forspiro looks like and contents of the pack
Violet plastic inhalation device with a foil blister containing 60 doses of inhalation powder.
Pack sizes: 1 or 2 inhalation devices, each containing 60 doses.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Aeropharm GmbH
Francois-Mitterrand-Allee 1
07407 Rudolstadt, Germany
For further information about the medicinal product and its names in the Member States of the
European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
tel. +48 22 209 70 00