Asmetic

Package leaflet: information for the patient

Asmetic, 50 micrograms/inhalation dose, inhalation powder,
divided
Salmeterol
Please read this leaflet carefully 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents

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

1. What Asmetic is and what it is used for

Asmetic contains the active substance: salmeterol.

• 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 usually begins within 10 to 20 minutes and lasts for 12 hours or longer.
• Your doctor has prescribed this medicine to prevent breathing difficulties, which may be caused by asthma. Regular use of Asmetic helps prevent asthma attacks, including those triggered by exercise or nocturnal asthma symptoms.
• Regular use of Asmetic also helps prevent breathing difficulties caused by other chest conditions, such as chronic obstructive pulmonary disease (COPD).
• Asmetic helps relieve an attack of breathlessness or wheezing in the airways. However, it does not work immediately during an acute attack of breathlessness or wheezing. If this occurs, use a fast-acting bronchodilator, such as salbutamol.
• Asmetic is delivered as a powder in an inhalation device. The medicine is inhaled directly into the lungs.

In patients with asthma, Asmetic must always be used in combination with an inhaled steroid.

2. Important information before using 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 Asmetic, discuss this with your doctor, pharmacist or nurse.

• If asthma or breathing difficulties worsen, contact your doctor immediately. This may be indicated by increased wheezing, chest tightness or increased use of fast-acting bronchodilators. If such symptoms occur, do not increase the number of Asmetic inhalations. Your chest condition may be seriously worsening. Contact your doctor, as your asthma treatment may need to be changed.
• If your doctor has prescribed Asmetic for asthma, continue taking other asthma medications you have been using, such as inhaled steroids or oral steroids. Continue treatment with your usual dose, even if you feel better, unless your doctor advises otherwise. Do not stop using inhaled steroids (or oral steroids) after starting Asmetic.
• Your doctor will regularly monitor your health if you have hyperthyroidism, 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 currently taking or have recently taken, as well as any medicines you plan to take.

• Inform your doctor about all medicines you have recently taken, including those used for asthma and any over-the-counter medicines. It may not be appropriate to use Asmetic together with certain other medicines.
• Inform your doctor if you are currently being treated with antifungal medicines containing ketoconazole or itraconazole for fungal infections, or if you are being treated with ritonavir for HIV infection. These medicines may increase the risk of adverse effects associated with Asmetic, including irregular heartbeat, or may worsen existing side effects.
• While using Asmetic, avoid taking beta-blockers unless your doctor specifically advises their use. Beta-blockers such as atenolol, propranolol and sotalol are mainly used to treat high blood pressure or other heart conditions. Inform your doctor if you are currently or recently taking beta-blockers, as these medicines may reduce or block the effect of salmeterol.
• Asmetic may reduce potassium levels in the blood. If this occurs, you may notice an irregular heartbeat, muscle weakness or muscle cramps. This is more likely if you are taking Asmetic together with certain medicines used to treat high blood pressure (diuretics), or other medicines used for breathing difficulties, such as theophylline or steroids. Your doctor may advise you to have blood tests to check potassium levels. If in doubt, contact your doctor.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a child, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
It is unlikely that side effects associated with Asmetic will affect your ability to drive or operate machinery.

Asmetic contains monohydrate lactose
Each dose of Asmetic contains approximately 12.5 mg of monohydrate lactose.
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Asmetic

Always use this medicine exactly as your doctor or pharmacist has instructed. If in doubt, consult your doctor or pharmacist.

• In patients with asthma, Asmetic must always be used in combination with an inhaled steroid.
• Use Asmetic every day, unless your doctor advises stopping treatment.
• You may notice the medicine works within the first day of use.
• Asmetic is for inhalation use only through the mouth.
• Do not exceed the recommended dose.

Adults with asthma

• The usual dose is one inhalation twice daily.
• In patients with severe asthma, your doctor may increase the dose to two inhalations twice daily.

Children with asthma

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

Adults with chronic obstructive pulmonary disease (COPD)

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

Instructions for using the inhalation device

• Your doctor, nurse or pharmacist should instruct you on how to properly use the inhalation device. They should periodically check that you are using the inhaler correctly. Incorrect use of Asmetic or failure to follow your doctor's instructions may result in the medicine not providing the expected improvement in asthma or COPD treatment.
• The inhalation device, when first removed from the Asmetic packaging, is in the closed position.

• The inhalation device contains Asmetic as individual doses of inhalation powder.
• The inhalation device is equipped with a dose counter indicating how many doses remain in the device. The counter displays the number of doses down to 0. Numbers from 5 to 0 appear with a dot to warn that only a few doses remain in the inhaler. When the counter shows 0, the inhalation device is empty. The inhalation device contains 60 doses of Asmetic.

Using the inhalation device
To use the inhalation device, follow the steps below:
1. Opening:

• To open the inhalation device, hold the cover with one hand and place the thumb of the other hand in the indentation on the body.

• Slide the thumb in the indentation away from you until you hear a click.

2. Dose preparation:

• Hold the inhalation device with the mouthpiece facing towards you. You may hold it in either hand.
• Push the slider fully away from you until you hear a distinct sound.
• After moving the slider, a small opening appears in the mouthpiece.
• The inhalation device is now ready for use.
• Each time the slider is moved, the next dose of medicine is prepared for inhalation.

Do not move the slider unnecessarily,
as the next dose will be released and doses will be lost.

3. Performing inhalation:
Before inhaling the medicine,
please read the instructions below carefully.

• Hold the inhalation device at a distance from your mouth. Remember not to turn the inhaler with the mouthpiece facing downwards, as this may cause the prepared powder dose to spill out.
• Breathe out calmly and deeply. Do not breathe out into the inhalation device.
• Place the mouthpiece in your mouth; inhale deeply through your mouth from the inhaler, not through your nose.
• Hold your breath, remove the inhaler from your mouth. Hold your breath for several seconds, or as long as possible, then breathe out calmly.
• Rinsing your mouth with water and spitting it out after inhalation helps prevent hoarseness and oral thrush.

4. Closing:

• To close the inhalation device, place your thumb in the indentation and slide it towards you.
• Closing the inhaler is accompanied by a click sound. After closing, the dose-setting slider automatically returns to its original position, and the outer cover protects the device when not in use.
• The inhalation device is now ready for reuse.

Cleaning
To clean the mouthpiece of the inhalation device, wipe it with a dry, soft cloth.

If you use more Asmetic than you should
It is important to use the inhaler as instructed. If you accidentally use more than the recommended dose, inform your doctor or pharmacist. Symptoms may include faster than normal heartbeat, tremors and/or dizziness. You may also experience increased systolic blood pressure, headache, muscle weakness and joint pain.

If you forget to use Asmetic
If you miss a dose, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
To reduce the risk of adverse effects, your doctor will prescribe the lowest dose of Asmetic that provides control of asthma or COPD.
The adverse effects observed in patients taking Asmetic are listed below:

Allergic reactions: The patient may experience sudden breathing difficulties after using Asmetic.
Worsening of wheezing, cough, and itching and swelling (usually of the face, lips, tongue or throat) – anaphylactic reactions – may occur.
If such symptoms occur, or if they occur suddenly after using Asmetic, you should contact a doctor immediately.
Allergic reactions after using Asmetic are very rare (may occur in less than 1 in 10,000 patients).

Other adverse effects are listed below:

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

• muscle cramps;
• tremor; rapid or irregular heartbeat (palpitations), headache, tremors (e.g. hand tremor). The occurrence of tremors is more likely if the patient takes more than one inhalation twice daily. These adverse effects do not last long and usually decrease over time with continued treatment with Asmetic.

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

• rash (itching and redness);
• very rapid heartbeat (tachycardia). This may occur more frequently if the patient takes more than two inhalations twice daily;
• nervousness.

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

• dizziness;
• insomnia or difficulty falling asleep;
• decreased potassium levels in the blood (may result in irregular heartbeat, muscle weakness, cramps).

Very rare adverse effects (may occur in less than 1 in 10,000 patients):

• worsening breathing difficulties or wheezing immediately after taking Asmetic (paradoxical bronchospasm). If such symptoms occur, Asmetic must be discontinued. A fast-acting inhaled medicine to ease breathing should be used and you should contact a doctor immediately;
• irregular heartbeat (cardiac arrhythmias, such as extrasystoles, atrial fibrillation or supraventricular tachycardia). In such cases, do not discontinue Asmetic, but inform your doctor;
• pain in the mouth and throat;
• increased blood sugar (glucose) levels;
• nausea;
• joint pain, swelling or chest pain.

If any of the adverse effects worsen, or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 authorization holder or its representative.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Asmetic
Keep the medicine out of sight and reach of children.
Store 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 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Asmetic contains

• Each metered dose (inhalation) contains 50 micrograms of the active substance – salmeterol (as salmeterol xinafoate).
• Other ingredient: lactose monohydrate.

What Asmetic looks like and contents of the pack
Asmetic is a powder for inhalation, divided in an OPA/Aluminium/PVC/Paper/PET/Aluminium foil blister, packed in a plastic inhaler (PP, POM, PC, ABS). The inhalation device contains 60 doses of powder, equipped with a mouthpiece and a dose counter, packed in a cardboard box.
Each package contains one, two or three inhalation devices.

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]

For further information, please contact the local representative of the Marketing Authorisation Holder.