Asmetic

Leaflet accompanying the packaging: patient information

Asmetic, 50 micrograms/dose inhalation, inhalation powder,

divided
Salmeterol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 only. 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, please tell your doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Asmetic and what is it used for
• 2. Important information before taking Asmetic
• 3. How to take Asmetic
• 4. Possible side effects
• 5. How to store Asmetic
• 6. Contents of the pack and other information

1. What is Asmetic and what is it used for

Asmetic contains the active substance: salmeterol.

• -Salmeterol is a long-acting bronchodilator. Bronchodilators help to keep the airways open. This makes it easier for air to get in and out of the lungs. The effect usually starts within 10 to 20 minutes and lasts for 12 hours or longer.
• -Your doctor has prescribed this medicine to prevent breathing difficulties. These may be caused by asthma. Regular use of Asmetic helps to prevent asthma attacks. This includes asthma caused by exercise or symptoms that occur only at night.
• -Regular use of Asmetic also helps to prevent breathing difficulties caused by other chest conditions, such as chronic obstructive pulmonary disease (COPD).
• -Asmetic helps to relieve bronchospasm or wheezing in the airways. However, it does not work immediately in case of an asthma attack or wheezing in the airways. If this happens, a fast-acting bronchodilator, such as salbutamol, should be used.
• -Asmetic is supplied in a powder form in an inhaler device. The medicine is inhaled directly into the lungs.

In patients with asthma, Asmetic should always be used with an inhaled steroid.

2. Important information before taking Asmetic

When not to use Asmetic

• -if you are allergic to salmeterol xinafoate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Asmetic, discuss it with your doctor or pharmacist or nurse.

• -If your asthma or breathing difficulties worsen, you should contact your doctor immediately.This may be indicated by an increase in wheezing, a feeling of tightness in the chest, or an increased use of fast-acting bronchodilators. In such cases, do not increase the number of Asmetic inhalations. The chest condition may worsen. You should contact your doctor, as a change in asthma treatment may be necessary.
• -If your doctor has prescribed Asmetic for asthma, you should continue to take other asthma medicines as before. These may include inhaled steroids or steroid tablets. You should continue to take the same dose, even if you feel better, unless your doctor advises you to change the dose. Do not stop taking inhaled steroids (or steroid tablets) after starting Asmetic.

Asmetic.

• -Your doctor will regularly check your health if you have an overactive thyroid gland, diabetes (Asmetic may increase blood sugar levels), or heart disease, including irregular or rapid heartbeat.

Asmetic and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, and about any medicines you plan to take.

• -Tell your doctor about all the medicines you have taken recently. This includes asthma medicines and other medicines that are available without a prescription. It may not be suitable to use Asmetic with other medicines.
• -Tell your doctor if you are currently being treated with antifungal medicines containing ketokonazole or itraconazole for any fungal infections, or if you are being treated with ritonavir for HIV infection. These medicines may increase the risk of side effects associated with Asmetic, including irregular heartbeat, or may worsen existing side effects.
• -When using Asmetic, you should avoid taking beta-blocker medicines, unless your doctor advises you to take them. Beta-blocker medicines, such as atenolol, propranolol, and sotalol, are mainly used to treat high blood pressure or other heart conditions. You should tell your doctor about any beta-blocker medicines you are taking now or have taken recently, as these medicines may reduce or block the effect of salmeterol.
• -Asmetic may decrease the level of potassium in your blood. If this happens, you may experience irregular heartbeat, muscle weakness, or muscle cramps. This is more likely to happen if you are taking Asmetic with certain medicines used to treat high blood pressure (diuretics) and other medicines used to treat breathing difficulties, such as theophylline or steroids. Your doctor may advise you to have blood tests to check the level of potassium in your blood. If you have any doubts

you should contact your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is unlikely that side effects associated with Asmetic will affect your ability to drive or use machines.

Asmetic contains lactose monohydrate

Each dose of Asmetic contains about 12.5 mg of lactose monohydrate.
If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Asmetic

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.

• -In patients with asthma, Asmetic should always be used with an inhaled steroid.
• -Asmetic should be used every day, unless your doctor advises you to stop treatment.
• -You may feel that the medicine is working within the first day of treatment.
• -Asmetic is for inhalation use only.
• -Do not exceed the recommended dose.

Adults with asthma

• -The usual dose is one inhalation twice a day.
• -In patients with severe asthma, your doctor may increase the dose to 2 inhalations twice a day.

Children with asthma

• -In children aged 4 to 12 years, the usual dose is one inhalation twice a day.
• -Asmetic is not recommended for use in children under 4 years of age.

Adults with chronic obstructive pulmonary disease (COPD)

• -The usual dose is one inhalation twice a day. This does not apply to children and adolescents.

Instructions for using the inhaler

• –Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler properly. They should check your technique periodically. Using Asmetic not as advised by your doctor or improper use of the inhaler may result in the medicine not working as well as expected in treating your asthma or COPD.
• –The inhaler is in the closed position when first removed from the packaging.

• The inhaler contains Asmetic in the form of consecutive doses of inhalation powder.
• The inhaler has a dose counter, which shows how many doses of medicine are left in the inhaler. The counter shows the dose number down to 0. The numbers from 5 to 0 appear with a dot to warn that there are only a few doses of medicine left in the inhaler. If the counter shows 0, it means that the inhaler is empty. The inhaler contains 60 doses of Asmetic.

Using the inhaler

To use the inhaler, follow the steps below:

1. Opening:

• To open the inhaler, hold the cover with one hand and place your thumb in the indentation on the back.
• Slide your thumb away from youuntil you hear a click.

until you hear a click.

2. Setting the dose:

• Hold the inhaler with the mouthpiece facing you. You can hold it with either your right or left hand.
• Slide the slider away from youuntil you hear a distinctive sound.
• After sliding the slider, a small hole appears in the mouthpiece.
• The inhaler is now ready for use.
• Each time you slide the slider, the next dose is prepared for inhalation.

Do not slide the slider unnecessarily, as the next dose will be opened and the number of inhalation doses will decrease.

3. Taking an inhalation:

Before taking an inhalation of the medicine,
read the following instructions carefully.

• Hold the inhaler at a comfortable distance from your mouth. Remember not to turn the inhaler upside down, as this may cause the prepared dose of powder to spill out.
• Take a slow, deep exhalation. Do not breathe out into the inhaler.
• Put the mouthpiece in your mouth; take a deep inhalationfrom the inhaler through your mouth, not through your nose.
• Hold your breath, remove the inhaler from your mouth. Hold your breath for a few seconds, or as long as possible, then breathe out slowly.
• Rinsing your mouth with water and spitting it out after taking the medicine helps prevent hoarseness and thrush.

4. Closing:

• To close the inhaler, slide your thumb towards youin the indentation on the back.
• Closing the inhaler is accompanied by a clicking sound. After closing the inhaler, the dose-setting slider automatically returns to its original position, and the outer cover protects the inhaler when not in use.
• The inhaler is now ready for reuse. Cleaning To clean the mouthpiece of the inhaler, wipe it with a dry, soft cloth.

Taking a higher dose of Asmetic than recommended

It is important to use the inhaler as instructed. If you accidentally take a higher dose than recommended,
tell your doctor or pharmacist.
You may experience: faster than normal heartbeat, tremors, and (or) dizziness. You may also experience an increase in blood pressure, headache, muscle weakness, and joint pain.

Missing a dose of Asmetic

If you miss a dose, take the next dose at the scheduled time. Do not take a double dose of the medicine to make up for the missed dose.
If you have any doubts about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Asmetic can cause side effects, although not everybody gets them.
To minimize the risk of side effects, your doctor will prescribe the lowest dose of Asmetic that controls your asthma or COPD. The following side effects have been observed in patients taking Asmetic.

Allergic reactions: You may experience sudden breathing difficulties after taking

Asmetic.You may experience an increase in wheezing, coughing, as well as itching and swelling (usually of the face, lips, tongue, or throat) - anaphylactic reactions.
If you experience any of these symptoms or if they occur suddenly after taking Asmetic, you should contact your doctor immediately.Allergic reactions to Asmetic are very rare (they may occur in less than 1 in 10,000 patients).
Other side effects are listed below:
Common side effects(may affect up to 1 in 10 people):

• muscle cramps;
• feeling of trembling; fast or irregular heartbeat (palpitations), headache, tremors (e.g., trembling hands). Tremors are more likely to occur if you take more than one inhalation twice a day. These side effects do not last long and usually decrease over time while continuing treatment with Asmetic.

Uncommon side effects(may affect up to 1 in 100 people):

• rash (itching and redness);
• very fast heartbeat (tachycardia). This may occur more frequently if you take more than two inhalations twice a day;
• nervousness.

Rare side effects(may affect up to 1 in 1,000 people):

• dizziness;
• insomnia or difficulty sleeping;
• decrease in blood potassium levels (may cause irregular heartbeat, muscle weakness, or muscle cramps).

Very rare side effects(may affect less than 1 in 10,000 people):

• breathing difficulties or wheezing worsening immediately after taking Asmetic(paradoxical bronchospasm). If you experience any of these symptoms, you should stop taking Asmetic.You should use a fast-acting inhaled medicine to help you breathe and contact your doctor immediately;
• irregular heartbeat (arrhythmias, such as extrasystoles, atrial fibrillation, or supraventricular tachycardia). In this case, do not stop taking Asmetic, but inform your doctor;
• pain in the mouth and throat;
• increased blood sugar levels;
• nausea;
• pains, swelling of the joints, or chest pain.

If any of the side effects get worse, or if you experience any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Asmetic

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the label or carton after:
EXP. The expiry date refers to the last day of the month.
Medicines should 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 Asmetic contains

• Each inhalation dose contains 50 micrograms of the active substance - salmeterol (as salmeterol xinafoate).
• The other ingredient of the medicine is: lactose monohydrate.

What Asmetic looks like and contents of the pack

Asmetic is a powder for inhalation, divided, in a blister pack
OPA/Aluminum/PVC/Paper/PET/Aluminum in an inhaler made of plastic (PP, POM, PC, ABS). The inhaler, containing 60 doses of powder, has a mouthpiece and a dose counter, packaged in a cardboard box.
Each pack contains one, two, or three inhalers.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Polska (Poland)
Tel.: + 48 24 357 44 44
Fax: + 48 24 357 45 45
e-mail: polfarmex@polfarmex.pl
To obtain more detailed information, contact your local representative of the marketing authorization holder.

Date of last revision of the leaflet: