Airflusal forspiro
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
AirFluSal Forspiro (Airflusan Forspiro)
(50 micrograms + 250 micrograms)/dose, inhalation powder, divided
Salmeterol + Fluticasone propionate
AirFluSal Forspiro and Airflusan Forspiro are different brand names for the same medicine.
Please read the entire leaflet before using the medicine, as it contains important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of Contents:
- 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.
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 excipient of the medicine (listed in section 6).
Warnings and precautions
Before using AirFluSal Forspiro, discuss with a doctor or pharmacist if the patient has:
- heart disease, including irregular or rapid heartbeat
- hyperthyroidism
- high blood pressure
- diabetes (AirFluSal Forspiro may increase blood sugar levels)
- low potassium levels in the blood
- tuberculosis (current or past) or other lung infections
If the patient experiences blurred vision or other visual disturbances, this should be reported to the doctor.
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AirFluSal Forspiro prevents breathlessness and wheezing. It should be remembered 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) that quickly dilates the airways must be used.
If asthma symptoms or breathing difficulties worsen, the doctor should be informed immediately. This may include:
- wheezing
- more frequent feeling of chest tightness
- increased need for a fast-acting bronchodilator compared to 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 severe illness. Contact the doctor, as additional treatment may be necessary.
Children and adolescents
AirFluSal Forspiro should not be used in children and adolescents under 18 years of age.
AirFluSal Forspiro and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines planned for use, including those available without a prescription.
AirFluSal Forspiro and the following medicines may interact with each other:
- medicines used to treat high blood pressure, heart diseases or other conditions containing an active substance with a name ending in "olol" (beta-blockers), such as atenolol, propranolol, and sotalol
- antiviral medicines, including certain medicines used to treat HIV infection, such as ritonavir or cobicistat. The doctor may wish to closely monitor the patient taking such 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 (often 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 use of AirFluSal Forspiro during pregnancy is advisable.
Driving and operating machinery
It is unlikely that AirFluSal Forspiro affects the ability to drive or operate machinery.
AirFluSal Forspiro contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, contact the doctor before using this medicine.
The amount of monohydrate lactose contained in the medicine usually does not cause problems in individuals with lactose intolerance.
3. How to use AirFluSal Forspiro
This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
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Asthma
The recommended dose for adults is:
one inhalation twice daily.
Your doctor will regularly monitor your asthma symptoms.
If your asthma 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 just before a meal,
in the morning and (or) evening.
After inhalation, rinse the mouth with water.
Improper or inconsistent use of AirFluSal Forspiro may worsen respiratory symptoms. To achieve
optimal effectiveness, the medicine should 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 regularly check
that it is being used correctly.
The inhaler contains 60 doses of inhalation powder 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 showing
the last 10 doses are displayed on a red background.
The inhaler is not refillable – when empty, it must be replaced with a new device.
Before using the inhaler
- Open the transparent side chamber cover.
- Carefully tear off the entire length of the strip using the serrated edge (as shown in the illustration). Do not pull or jerk the strip.
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- 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
markings do not contain medicine. At the end, numbered segments of the strip will appear. Do
not allow more than 2 strips to accumulate in the side chamber, as this may block the inhaler.
Gently tear off the foil strip (as shown above) and dispose of 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: The white lever should only be used when the patient is ready to take the dose. Unnecessary use may result in loss of doses.
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- Opening: Pull the white lever fully forward (audible click), which will load the dose and display its number in the dose counter.
- Closing: Fully close the white lever until an audible click is heard. The inhaler is now ready for immediate use.
3. Inhaling the dose
- Exhale as deeply as possible away from the mouthpiece. Never exhale directly into the inhaler, as this may alter the dose of medicine.
- Hold the inhaler with the protective cap pointing downward.
- Close lips tightly around the mouthpiece.
- Breathe in slowly and deeply through the mouth (not through the nose).
- Remove the inhaler from the mouth and hold your breath for 5–10 seconds, or as long as possible without discomfort.
- Then breathe out slowly, not towards the inhaler.
- Close the protective cap over the mouthpiece.
- Rinse the mouth with water (spit out the water) 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 for any other purpose!
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- Do not clean any parts of the inhaler with water or wet wipes, as moisture may alter the dose of medicine!
- Never insert a needle or any sharp objects into the mouthpiece or any other part of the inhaler, as this may damage the device.
Using more than the recommended dose of AirFluSal Forspiro
Contact your doctor or pharmacist.
Symptoms of overdose include:
- dizziness
- headache
- rapid heartbeat
- muscle weakness
- joint pain
- trembling sensation
If higher doses are used for a prolonged period, consult your doctor or pharmacist, as increased
doses of AirFluSal Forspiro may reduce steroid hormone production by the adrenal glands.
It is important to use the medicine exactly as directed by your doctor. Do not increase or decrease
the dose without your doctor’s approval.
Missing a dose of AirFluSal Forspiro
Do not use a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping AirFluSal Forspiro treatment
Do not stop or suddenly reduce the dose of AirFluSal Forspiro without your doctor’s consent, 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 occur very rarely during infection or in situations of severe stress
(e.g. due to fever, injury, serious accident, or surgical procedure). 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 side effects
Like all medicines, this medicine can cause side effects, although not everyone will get them.
Allergic reactions: the patient may experience sudden breathing difficulties immediately after
using 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), along with a sensation of very rapid heartbeat or fainting and dizziness (which may lead to falls or loss of consciousness). If any of these symptoms occur, or if they occur suddenly after using AirFluSal Forspiro, contact a doctor immediately. Allergic reactions to AirFluSal Forspiro are uncommon (may occur in fewer than 1 in 100 people).
Other possible side effects:
Very common (may affect more than 1 in 10 people)
- Headache (usually resolves during treatment)
- Increased incidence of colds in patients with chronic obstructive pulmonary disease (COPD)
Common (may affect up to 1 in 10 people)
- Oral and throat candidiasis (painful, creamy-yellow lesions), as well as tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out immediately and/or brushing teeth right after each inhalation may help. Your 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 side effects have been reported:
- Lung infection (pneumonia). Inform your doctor if any of the following symptoms occur while using AirFluSal Forspiro; these may be signs of lung infection:
- Increased mucus production
- Change in mucus color
- Fever
- Chills
- Worsening cough
- Increased breathing difficulties
- Bruising and traumatic fractures
- Sinusitis
- Low blood potassium levels (which may cause irregular heartbeat, weakness, and/or muscle cramps)
Uncommon (may affect up to 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 in children)
- Increased blood glucose levels. In patients with diabetes, more frequent monitoring of blood glucose levels may be necessary, and the dose of antidiabetic medicine may need adjustment.
- Sleep disturbances
- Chest pain
- Clouding of the lens (cataract)
- Allergic rash
Rare (may affect up to 1 in 1,000 people)
- Breathing difficulties or wheezing that worsens immediately after using AirFluSal Forspiro. Stop using AirFluSal Forspiro and contact your doctor immediately. To help breathing, use a fast-acting inhaled bronchodilator.
- Impaired production of certain hormones, especially if the medicine is used at high doses for a long time. Symptoms include:
- Slowed growth in children and adolescents
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- Osteoporosis (thinning of the bone)
- Increased eye pressure (glaucoma)
- Weight gain
- Rounded ("moon-shaped") face (Cushing's syndrome). The doctor will regularly check whether any of these side effects occur and ensure that the patient is taking the lowest possible dose.
- Behavioral changes such as unusual excitability and irritability. These symptoms mainly occur in children.
- Irregular heartbeat or extra heartbeats. Inform your 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 side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting side effects helps provide more information on the safety of this medicine.
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5. How to store AirFluSal Forspiro
Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use AirFluSal Forspiro after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. 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 250 micrograms of fluticasone propionate. This corresponds to the delivered dose containing 45 micrograms of salmeterol (as salmeterol xinafoate) and 233 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 blister strip containing 60 doses of inhalation powder.
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Pack sizes: 1 or 2 inhalation devices containing 60 doses each.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in the Czech Republic, the country of export:
Sandoz s.r.o., Na Pankráci 1724/129, 140 00 Prague 4 - Nusle
Czech Republic
Manufacturer:
Aeropharm GmbH, Francois-Mitterand-Allee 1, Wohngebiet Rudolspark
07407 Rudolstadt, Thuringia, Germany
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in the Czech Republic, the country of export: 14/411/14-C
Parallel Import Licence Number: 310/20
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