Asaris pmdi

Patient Information Leaflet

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, 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. What you need to know 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, making it easier for air to flow into and out of the lungs. Its 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 treat sudden attacks of breathlessness or wheezing. If such an attack occurs, you must use a fast-acting bronchodilator, such as salbutamol, immediately. You should always have this 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 norflurane (HFA-134a), an excipient of the medicine.

Warnings and precautions
Before starting treatment with ASARIS pMDI, discuss with the 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 the doctor.
ASARIS pMDI and other medicines
Inform the doctor about all medicines currently used or recently used, 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 belonging to the class of β-blockers (e.g. atenolol, propranolol, and sotalol). β-blockers are commonly used in the treatment of high blood pressure or other heart conditions.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, and erythromycin), including certain medicines used to treat HIV (e.g. ritonavir, drugs 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 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 (e.g. salbutamol).
• Medicines containing xanthine derivatives, commonly 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 her 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 physician. If in doubt, consult a doctor or pharmacist.

• ASARIS pMDI should be used daily until otherwise instructed by a physician.
• Do not take a higher dose than recommended. If in doubt, consult a doctor or pharmacist.
• Do not stop using ASARIS pMDI or reduce the dose without first consulting a physician.
• 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, the physician may recommend reducing the frequency of administration to once daily.
The dose may be administered:

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

It is very important that the physician instructs the patient on the number of inhalations and how often the medicine should be used.
If the patient is using ASARIS pMDI for asthma, the physician will regularly monitor symptoms.
If asthma symptoms worsen or asthma control deteriorates, contact the physician immediately.
This 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 a case, continue using ASARIS pMDI, but do not increase the number of inhalations.
Symptoms may worsen and the patient's condition may deteriorate.
Contact the physician, as the patient may require additional treatment.

Instructions for using the inhaler

• The physician, nurse, or pharmacist should instruct the patient on the correct use of the inhaler and should periodically check that the patient is using it properly. Incorrect use of ASARIS pMDI or improper use of the inhaler may result in the medicine not producing the expected improvement in asthma.
• The medicine is contained in a pressurized canister within 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 the thumb and index finger.
2. To confirm 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 slow, controlled breathing—slowest 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 evenly mix the contents (Figure B).
4. Hold the inhaler upright with fingers, placing the thumb under the base of the inhaler, below the mouthpiece. Breathe out deeply, as fully as possible (Figure C).
5. Place the mouthpiece in the mouth and close lips tightly around it. Do not bite the mouthpiece.
6. Begin a slow and deep inhalation. Immediately after starting inhalation through the mouth, press down on the inhaler to release the dose of ASARIS pMDI, then continue a calm, deep inhalation (Figure D).
7. Hold the breath, remove the inhaler from the mouth, and remove the finger from the top of the inhaler. Hold the breath for several seconds, or as long as comfortable without discomfort, then breathe out slowly.
8. If the physician has prescribed two inhalations, wait approximately 30 seconds before repeating steps 3–7.
9. Rinsing the mouth with water and spitting it out and/or brushing teeth after inhalation helps prevent hoarseness and oral thrush.
10. After inhalation, always replace the mouthpiece cap to prevent dust from entering (Figure E). Press the cap firmly into place. If a clicking sound is not heard when placing 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 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 the patient has difficulty coordinating breathing with inhalation from the inhaler, a spacer device may be recommended. The physician, nurse, or pharmacist should instruct the patient on the correct use of the inhaler with a spacer, how to maintain the spacer, and answer any related questions. If a spacer is used, it is important not to discontinue its use without consulting the physician or nurse. It is also important not to change the type of spacer without consulting the physician. If the patient stops using a spacer or changes to a different type, the physician may decide to adjust the dose of medicine needed to control asthma symptoms. Always consult the physician before making any changes to asthma treatment.
Older children or individuals with weak hands may find it easier to hold the inhaler with both hands. Grip 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 placed, a click should be heard. If no click is heard, remove the cap, turn it around, and try again. Do not use excessive force.

Do not immerse the metal canister in water.

Use of a higher than recommended dose of ASARIS pMDI
It is important to use the inhaler exactly as instructed. If a higher than recommended dose is accidentally used, inform the physician or pharmacist.
Possible symptoms include: rapid heartbeat, tremors, dizziness, headache, muscle weakness, and joint pain.
If higher doses are used for a prolonged period, contact the physician or pharmacist for advice, as high doses of ASARIS pMDI may reduce steroid hormone production by the adrenal glands.

Missing a 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 daily as directed.
Continue taking the medicine until the physician advises otherwise.
Do not suddenly stop taking ASARIS pMDI or reduce the dose, as symptoms may worsen.
Additionally, sudden discontinuation or dose reduction of ASARIS pMDI may (very rarely) lead to adrenal insufficiency, which may cause adverse effects.
These adverse effects may include any of the following:

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

If any of these adverse effects occur, inform the physician or pharmacist. To prevent these symptoms, the physician may prescribe additional corticosteroids in tablet form (e.g., prednisolone).
If there are any further questions about the use of this medicine, consult the physician, nurse, or pharmacist.

4. Possible adverse effects

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

Allergic reactions: The patient may experience sudden breathing difficulties immediately after using ASARIS pMDI. Wheezing, cough, or shortness of breath may worsen, and itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat) may occur. There may also be a sensation of very rapid heartbeat, weakness, or dizziness (which may lead to collapse or loss of consciousness). If any of these symptoms occur suddenly after using ASARIS pMDI, the use of ASARIS pMDI must be stopped immediately and medical advice must be sought without delay. Allergic reactions to ASARIS pMDI occur uncommonly (may occur in 1 to 10 out of 1,000 patients taking the medicine).

Other adverse effects:

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

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

Common adverse effects (may affect 1 to 10 out of 100 patients):

• Oral and pharyngeal candidiasis (painful, creamy-white lesions), 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 oral candidiasis.
• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

The following adverse effects 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 colour, worsening cough, or increased difficulty breathing.
• Easy bruising and traumatic fractures.
• Sinusitis (feeling of pressure and fullness in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased blood potassium levels (the patient may experience irregular heartbeat, muscle weakness, or cramps).

Uncommon adverse effects (may affect 1 to 10 out of 1,000 patients):

• Increased blood glucose levels (hyperglycaemia). In diabetic patients, more frequent monitoring of blood glucose levels and adjustment of previously prescribed antidiabetic medications 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 tend to decrease with continued treatment.
• Atrial fibrillation.
• Ischaemic heart disease, characterised by chest pain or pressure, and shortness of breath.
• Sleep disturbances.
• Anxiety.
• Allergic skin rash.

Rare adverse effects (may affect 1 to 10 out of 10,000 patients):

• Wheezing or breathing difficulties worsening immediately after taking ASARIS pMDI. If such symptoms occur, the use of ASARIS pMDI must be stopped immediately, a fast-acting inhaled medicine to relieve breathing difficulties should be used, and medical advice must be sought immediately.
• ASARIS pMDI may interfere with the body's normal production of steroid hormones, especially when high doses are used for a prolonged period. 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 monitor for these adverse effects and ensure that you are using the lowest effective dose of ASARIS pMDI to control asthma.
• Behavioural changes such as excessive excitement 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 effects with unknown frequency (frequency cannot be estimated from available data):

• Depression or aggression. These effects are more likely in children.
• Blurred vision.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse effects can be reported directly to the Department of Monitoring Adverse Effects 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 effects can also be reported to the marketing authorisation holder or its representative.

Reporting adverse effects helps to provide more information on the safety of this 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 Lot number 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 when the container 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 appears 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. This will help protect the environment.

6. Contents of the pack and other information

What ASARIS pMDI contains

• The active substances 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 constituent is: norflurane, HFA-134a.

This medicinal product 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 a pressurized suspension for inhalation via the mouth into the lungs.
• The pressurized container holds a homogeneous (uniform) suspension for inhalation.
• Pack: An aluminium 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