Asaris pmdi

Package leaflet: Information for the patient

ASARIS pMDI, (50 μg + 25 μg)/inhalation dose, inhalation aerosol, suspension
ASARIS pMDI, (125 μg + 25 μg)/inhalation dose, inhalation aerosol, suspension
ASARIS pMDI, (250 μg + 25 μg)/inhalation dose, inhalation aerosol, suspension
Fluticasone propionate + Salmeterol
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific patient only. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What ASARIS pMDI is and what it is used for
2. Important information before using ASARIS pMDI
3. How to use ASARIS pMDI
4. Possible side effects
5. How to store ASARIS pMDI
6. Contents of the pack and other information

1. What ASARIS pMDI is and what it is used for

ASARIS pMDI contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways open. This makes it easier for air to flow into and out of the lungs. The effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation in the lungs.

Your doctor has prescribed this medicine to prevent breathing problems caused by asthma.
To ensure proper asthma control, ASARIS pMDI must be used every day as directed by your doctor.
ASARIS pMDI helps prevent episodes of breathlessness and wheezing. However, it should not
be used to relieve sudden asthma attacks or acute wheezing. If such an attack occurs, a
fast-acting bronchodilator, such as salbutamol, must be used immediately. You should always
have such a medicine available.

2. Important information before using ASARIS pMDI

When not to use ASARIS pMDI

• if the patient is allergic to salmeterol, fluticasone propionate, or to norflurane (HFA-134a), an excipient of the medicine.

Warnings and precautions
Before starting treatment with ASARIS pMDI, consult a doctor if the patient has:

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (ASARIS pMDI may increase blood glucose levels),
• low blood potassium levels,
• active or previously treated tuberculosis, or other lung infections.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.
ASARIS pMDI and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take, including asthma medications and over-the-counter medicines. ASARIS pMDI should not be used with certain medicines.
Before starting ASARIS pMDI, inform the doctor if the patient is taking any of the following medicines:

• Medicines from the group of β-blockers (e.g. atenolol, propranolol, and sotalol). β-blockers are commonly used in the treatment of high blood pressure or other heart diseases.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, and erythromycin), including certain medicines used in the treatment of HIV (e.g. ritonavir, medicines containing cobicistat). Some of these medicines may increase the concentration of fluticasone propionate or salmeterol in the body. This may increase the risk of adverse effects, including irregular heartbeat, or may worsen existing adverse effects. The doctor may wish to closely monitor the patient's condition when taking such medicines.
• Corticosteroids (oral or injectable). If the patient has recently taken such medicines, this may increase the risk of adrenal dysfunction.
• Diuretics used in the treatment of high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives, often used in the treatment of asthma.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
The doctor will assess whether the patient can use ASARIS pMDI during this period.
Driving and operating machinery
It is unlikely that ASARIS pMDI will affect the ability to drive or operate machinery.

3. How to use ASARIS pMDI

ASARIS pMDI must always be used exactly as directed by the doctor. If in doubt, consult your doctor or pharmacist.

• ASARIS pMDI should be used daily until your doctor advises otherwise.
• Do not take a higher dose than recommended. If in doubt, consult your doctor or pharmacist.
• Do not stop using ASARIS pMDI or reduce the dose without first consulting your doctor.
• ASARIS pMDI should be inhaled into the lungs through the mouth.

Adults and adolescents aged 12 years and older:

• ASARIS pMDI, (50 μg + 25 μg)/inhalation dose: two inhalations twice daily.
• ASARIS pMDI, (125 μg + 25 μg)/inhalation dose: two inhalations twice daily.
• ASARIS pMDI, (250 μg + 25 μg)/inhalation dose: two inhalations twice daily.

Children aged 4 to 12 years:

• ASARIS pMDI, (50 μg + 25 μg)/inhalation dose: two inhalations twice daily.
• ASARIS pMDI is not recommended for use in children under 4 years of age.

If asthma symptoms are well controlled while using ASARIS pMDI twice daily, your doctor may recommend reducing the frequency of administration to once daily.
The dose may be administered:

• once daily in the evening, if symptoms occur at night,
• once daily in the morning, if symptoms occur during the day.

It is very important that your doctor instructs you on how many inhalations to take and how often.
If you are using ASARIS pMDI for asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or asthma control deteriorates, you must
contact your doctor immediately. Symptoms may include increased wheezing, more frequent chest tightness, or the need to use a higher dose of a fast-acting, inhaled medicine to relieve breathing difficulties. In such cases, continue using ASARIS pMDI, but do not increase the number of inhalations.
Symptoms may worsen and your condition may deteriorate.
Contact your doctor, as you may require additional treatment.

Instructions for using the inhaler

• Your doctor, nurse, or pharmacist should instruct you on the correct way to use the inhaler. They should periodically check that you are using the inhaler correctly. Incorrect or off-label use of ASARIS pMDI or improper inhaler technique may result in the medicine not providing the expected improvement in asthma control.
• The medicine is contained under pressure in a plastic housing with a mouthpiece.

Checking the inhaler

1. Before first use, check that the inhaler is working. Remove the mouthpiece cap by gently pressing the sides of the cap with your thumb and index finger.
2. To ensure the inhaler is working, shake it vigorously, point the mouthpiece away from you, and release two doses into the air. If the inhaler has not been used for one week or longer, remove the mouthpiece cap, shake the inhaler vigorously, and release two doses into the air.

Using the inhaler
It is important to begin breathing slowly and as steadily as possible even before using the inhaler.

1. Use the inhaler while standing or sitting.
2. Remove the mouthpiece cap. Check the mouthpiece inside and outside to ensure it is clean and free of foreign objects (Figure A).
3. Shake the inhaler 4 or 5 times to remove any foreign particles and to ensure the contents are evenly mixed (Figure B).
4. Hold the inhaler upright with your fingers, placing your thumb on the base of the inhaler, below the mouthpiece. Breathe out fully and as deeply as possible (Figure C).
5. Place the mouthpiece in your mouth and seal your lips tightly around it. Do not bite the mouthpiece.
6. Begin a slow and deep inhalation. Immediately after starting to inhale through your mouth, press down on the inhaler to release one dose of ASARIS pMDI, then continue a steady, deep inhalation (Figure D).
7. Hold your breath, remove the inhaler from your mouth, and remove your finger from the top of the inhaler. Hold your breath for several seconds, or as long as comfortable without discomfort, then breathe out slowly.
8. If your doctor has prescribed two inhalations, wait approximately half a minute before repeating steps 3–7.
9. Rinsing your mouth with water and spitting it out and/or brushing your teeth after inhalation helps prevent hoarseness and oral thrush.
10. After inhalation, always replace the mouthpiece cap to prevent dust from entering (Figure E). Push the cap firmly into place. If you do not hear a click when attaching the cap, remove it, turn it around, and try again. Do not use excessive force.

Do not rush through steps 4, 5, 6, and 7. It is important to breathe as slowly as possible immediately before inhalation. To ensure correct inhalation technique, initially practice using the inhaler in front of a mirror. Visible "mist" escaping from the inhaler, mouth, or nose during inhalation indicates incorrect technique. Repeat the steps starting from step 3.
As with all inhalers, caregivers should ensure that children prescribed ASARIS pMDI use the inhaler correctly as described above.
If you have difficulty coordinating your breathing with inhalation from the inhaler, your doctor may recommend using a spacer device. Your doctor, nurse, or pharmacist should instruct you on the correct use of the inhaler with a spacer, how to maintain the spacer, and answer any related questions. If you use a spacer, it is important not to stop using it without consulting your doctor or nurse. It is also important not to change the type of spacer without consulting your doctor. If you stop using a spacer or change to a different type, your doctor may decide to adjust the dose of medicine needed to control your asthma symptoms. Always consult your doctor before making any changes to your asthma treatment.
Older children or individuals with weak hands may find it easier to hold the inhaler with both hands. Hold the inhaler with both index fingers on top and both thumbs underneath, below the mouthpiece.

Cleaning the inhaler
To prevent blockage, clean the inhaler at least once a week.
To clean the inhaler:

• Remove the mouthpiece cap.
• Do not remove the metal canister from the plastic housing during cleaning or at any other time.
• Wipe the mouthpiece inside and outside, and the outside of the plastic housing, with a dry cloth or tissue.
• Replace the mouthpiece cap. When properly attached, you should hear a click. If you do not hear a click, remove the cap, turn it around, and try again. Do not use excessive force.

Do not immerse the metal canister in water.

Accidental overdose of ASARIS pMDI
It is important to use the inhaler exactly as instructed. If you accidentally use more than the recommended dose, inform your doctor or pharmacist.
Symptoms may include: faster than normal heartbeat, tremors, dizziness, headache, muscle weakness, and joint pain.
If higher doses are used for a prolonged period, contact your doctor or pharmacist for advice, as high doses of ASARIS pMDI may reduce the adrenal glands' production of steroid hormones.

Missed dose of ASARIS pMDI
Do not take a double dose to make up for a missed dose.
Take the next dose at the scheduled time.

Stopping treatment with ASARIS pMDI
It is very important to take ASARIS pMDI every day as directed.
Continue taking the medicine until your doctor advises you to stop.
Do not suddenly stop taking ASARIS pMDI or reduce the dose,
as your symptoms may worsen.
Additionally, abruptly stopping or reducing the dose of ASARIS pMDI may (very rarely) lead to adrenal gland dysfunction (adrenal insufficiency), which may cause the following adverse effects:

• abdominal pain,
• fatigue and loss of appetite, nausea,
• vomiting and diarrhea,
• weight loss,
• headache and drowsiness,
• low blood sugar,
• low blood pressure and seizures.

During periods of stress such as fever, injury (e.g., car accident), infection, or surgery, adrenal insufficiency may worsen and any of the adverse effects listed above may occur.

If you experience any of these adverse effects, inform your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroids in tablet form (e.g., prednisolone).

If you have any further questions about the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them. To reduce the risk of adverse symptoms, your doctor will prescribe the lowest dose of ASARIS pMDI that provides asthma control.

Allergic reactions: The patient may experience sudden breathing difficulties immediately after using ASARIS pMDI. Worsening of wheezing, cough, or shortness of breath may occur, as well as itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). A sensation of very rapid heartbeat, weakness, or dizziness (which may lead to collapse or loss of consciousness) may also occur. If any of these symptoms occur suddenly after using ASARIS pMDI, stop using ASARIS pMDI immediately and contact your doctor without delay. Allergic reactions to ASARIS pMDI are uncommon (may occur in 1 to 10 out of 1,000 patients taking the medicine).

Other adverse reactions:

Very common adverse reactions (may affect more than 1 in 10 patients):

• Headache – this adverse reaction usually decreases over time with continued treatment.
• Increased frequency of colds has been reported in patients with COPD.

Common adverse reactions (may affect 1 to 10 in 100 patients):

• Oral and pharyngeal candidiasis (painful, creamy-white lesions in the mouth and throat), as well as tongue pain, hoarseness, loss of voice, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing teeth immediately after each inhalation may be helpful. Your doctor may prescribe an antifungal medicine to treat candidiasis.
• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

The following adverse reactions have been reported in patients with chronic obstructive pulmonary disease (COPD):

• Pneumonia (lung infection). Inform your doctor if any of the following symptoms occur during treatment with ASARIS pMDI – these may be signs of lung infection: fever or chills, increased mucus production, change in mucus color, worsening cough, or increased breathing difficulties.
• Easy bruising and traumatic fractures.
• Sinusitis (feeling of pressure and fullness in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased potassium levels in the blood (the patient may experience irregular heartbeat, muscle weakness, or cramps).

Uncommon adverse reactions (may affect 1 to 10 in 1,000 patients):

• Increased blood sugar (glucose) levels (hyperglycaemia). In diabetic patients, more frequent monitoring of blood glucose levels and adjustment of previously used antidiabetic medication doses may be necessary.
• Cataract (clouding of the eye lens).
• Very rapid heartbeat (tachycardia).
• Tremor and rapid or irregular heartbeat (palpitations) – these symptoms are usually not serious and decrease with continued treatment.
• Atrial fibrillation.
• Ischaemic heart disease, characterized by chest pain or pressure, and shortness of breath.
• Sleep disturbances.
• Restlessness.
• Allergic skin rash.

Rare adverse reactions (may affect 1 to 10 in 10,000 patients):

• Worsening of wheezing or breathing difficulties occurring immediately after using ASARIS pMDI. If such symptoms occur, stop using ASARIS pMDI immediately, use a fast-acting inhaled medicine to relieve breathing difficulties, and contact your doctor immediately.
• ASARIS pMDI may interfere with the body's normal production of steroid hormones, particularly when high doses are used for prolonged periods. These effects include:
  • slowed growth in children and adolescents,
  • reduced bone mass,
  • glaucoma,
  • increased body weight,
  • facial rounding (moon face) (Cushing's syndrome). Your doctor will regularly check for these adverse effects and ensure that you are using the lowest effective dose of ASARIS pMDI to control asthma.
• Behavioral changes such as excessive excitability and irritability (these effects occur mainly in children).
• Irregular heartbeat or extra beats (arrhythmias). Inform your doctor, but do not stop using ASARIS pMDI unless instructed by your doctor.
• Fungal infection of the oesophagus, which may cause difficulty swallowing.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Depression or aggression. These reactions are more likely to 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 authorisation holder or its representative.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store ASARIS pMDI

• Keep the medicine out of the sight and reach of children.
• Do not use ASARIS pMDI after the expiry date stated on the packaging. The expiry date (EXP) refers to the last day of the stated month. The abbreviation Lot indicates the batch number.
• Store below 25°C.
• As with most inhaled medicines in pressurised containers, the therapeutic effect of this medicine may be reduced if the canister is cold.
• The metal container holds a pressurised suspension. Do not expose to temperatures above 50°C. Protect from direct sunlight. Do not pierce or burn the container, even if it seems to be empty.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What ASARIS pMDI contains

• The active substances in this medicine are: salmeterol and fluticasone propionate. Each metered dose contains 50, 125 or 250 μg (micrograms) of fluticasone propionate and 25 μg (micrograms) of salmeterol (as salmeterol xinafoate).
• The other ingredient is: norflurane, HFA - 134a.

This medicine contains fluorinated greenhouse gases.
Each inhaler contains 11.2 g of HFA – 134a (norflurane), equivalent to 0.0160 tonnes of CO(_2)
equivalent (global warming potential GWP = 1430).
What ASARIS pMDI looks like and contents of the pack

• ASARIS pMDI is supplied in an inhaler containing the medicine as a pressurized suspension for inhalation via the mouth into the lungs.
• The pressurized container holds a homogeneous (uniform) suspension for inhalation.
• Packaging: An aluminum container with a metering valve, mouthpiece made of PP and closure made of PP, all contained in a cardboard box. One pressurized container contains 120 doses.

Marketing Authorisation Holder and Manufacturer:
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: + 48 24 357 44 44
Fax: + 48 24 357 45 45
e-mail: [email protected]
Manufacturer:
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Italy