AEROMEX 50 MICROGRAMS/500 MICROGRAMS Ингаляционный порошок

Содержание инструкции

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

AEROMEX

50 micrograms/ 500 micrograms/dose of powder for inhalation, in single-dose container
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours because it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What AEROMEX is and what it is used for
• 2. What you need to know before you use AEROMEX
• 3. How to use AEROMEX
• 4. Possible side effects
• 5. How to store AEROMEX
• 6. Contents of the pack and other information

1. What is AEROMEX and what is it used for

AEROMEX contains two medicines: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help to open the airways in the lungs and make it easier for air to enter and leave the lungs. Its effectiveness lasts 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, such as:

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD). AEROMEX reduces exacerbations of COPD symptoms.

AEROMEX should be used every day as directed by your doctor. This allows you to
effectively control asthma or COPD.

AEROMEX helps to control the onset of shortness of breath and wheezing. AEROMEX
should not be used to relieve a sudden attack of shortness of breath or wheezing. If you
experience this type of attack, you should use a fast-acting inhaler, such as
salbutamol. It is important to always have a fast-acting inhaler with you.
Use AEROMEX to treat asthma only in adults and adolescents 12
years of age and older and COPD in adults.

2. What you need to know before using AEROMEX

Do not use AEROMEX:
If you are allergic to salmeterol, fluticasone propionate or any other ingredient, lactose monohydrate.

Warnings and precautions
Talk to your doctor before using AEROMEX if you suffer from:

• heart disease, such as irregular or accelerated heart rhythm
• hyperactive thyroid gland
• high blood pressure
• diabetes mellitus (AEROMEX may increase blood glucose)
• low levels of potassium in the blood
• tuberculosis (TB) of recent or long-standing onset, or other lung infections

Talk to your doctor if you experience blurred vision or other visual disturbances.

Children
The medicine is not recommended for children under 12 years of age.

Other medicines and AEROMEX
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. This includes medicines for asthma or other medicines obtained
without a prescription. AEROMEX may not be suitable to be taken at the same time
as other medicines.
Before taking AEROMEX, tell your doctor or pharmacist if you are taking any of these
medicines:

• Beta-blockers (such as atenolol, propranolol and sotalol). Beta-blockers are generally used to treat high blood pressure or heart conditions.
• Medicines for the treatment of infections (such as ketoconazole, itraconazole and erythromycin) including some medicines for the treatment of HIV (such as ritonavir, products containing cobicistat). Some of these medicines can increase the amount of fluticasone propionate or salmeterol in the body and make it more likely that you will have unwanted effects from AEROMEX, such as irregular heartbeat or the unwanted effects may worsen. Your doctor may want to monitor you carefully if you are taking these medicines.
• Corticosteroids (by mouth or injection). If you have recently taken these medicines, this could increase the risk that this medicine will impair the adrenal glands.
• Diuretics, also known as “water tablets”, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine medicines. These are often used to treat asthma.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is unlikely that AEROMEX will affect your ability to drive and use machines.

AEROMEX contains lactose
Each dose of AEROMEX 5 micrograms/ 500 micrograms/ dose contains approximately 12.9 mg of lactose
monohydrate.
The amount of lactose contained in this medicine generally does not cause problems in individuals
intolerant to lactose.

3. How to use AEROMEX

Use this medicine following the doctor's or pharmacist's instructions exactly. If you have
doubts, consult your doctor or pharmacist.
Use AEROMEX every day until your doctor tells you to stop. Do not take a dose
greater than the recommended one. If you have doubts, consult your doctor or pharmacist.
Do not stop treatment with AEROMEX and do not reduce the dose of AEROMEX without having
consulted your doctor.

• AEROMEX must be inhaled through the mouth into the lungs.
• You may not be able to taste or feel the powder on your tongue, even if you have used the inhaler correctly.

For asthma in adults and adolescents 12 years of age and over

• AEROMEX 50 micrograms/ 500 micrograms/ dose - One inhalation twice a day

For chronic obstructive pulmonary disease (COPD) in adults

• AEROMEX 50 micrograms/ 500 micrograms/ dose - One inhalation twice a day

Using AEROMEX twice a day can effectively control your symptoms. Therefore, your doctor may
decide to reduce the dose to once a day. The dosage can be changed in this way:

• one inhalation at night - if you experience symptoms during the night
• one inhalation in the morning - if you experience symptoms during the day.

It is very important to follow your doctor's instructions regarding the number and frequency of
inhalations with the medicine.
If you are using AEROMEX for asthma, your doctor will want to check your symptoms regularly.
The doctor will help you manage your asthma and set the dose of this medicine to the lowest dose that
allows you to keep asthma under control. If your doctor believes you need a dose lower than that
available with AEROMEX, they may prescribe you another inhaler containing the
same active ingredients as AEROMEX, but with a lower dose of corticosteroid. In any case, do not
change the number of inhalations prescribed by your doctor without consulting them.

If your asthma or breathing gets worse, tell your doctor immediately.If wheezing
increases, if you experience chest tightness more often, or if you need to use your quick-relief inhaler more
frequently. In these circumstances, continue to take AEROMEX,
but do not increase the number of inhalations. Your condition may be worsening and you
may become seriously ill. Consult your doctor immediately, as you may need
other therapies.

Instructions for use

• The doctor, nurse or pharmacist must instruct you on how to use the inhaler. In addition, from time to time, they must verify how you use the device. If you do not use AEROMEX correctly or as prescribed, you may not be improving your asthma or COPD as you should.
• The AEROMEX device is equipped with a blister containing salmeterol and fluticasone propionate in powder.
• A dose counter is located at the top of the inhaler and shows how many doses are available down to 0.
• When 5 doses remain, each number will appear marked with a black dot to indicate that only a few doses remain. Once 0 is reached, the inhaler will be empty.

How to use the inhaler

• 1. To open the AEROMEX inhaler, grasp the inhaler in one hand and place your thumb of the other hand on the grip. Press your thumb outwards as far as possible until you hear a click. A small hole will open in the mouthpiece. See figure 1.

• 2. Hold the AEROMEX inhaler with the mouthpiece towards yourself. You can hold it with either your right or left hand. Slide the lever as far as possible, until you hear a click. This will release a dose of medicine into the mouthpiece. See figure 2.

Each time you pull the lever, the inner blister is pierced and the powder is prepared to be
inhaled. Do not play with the lever, as this will pierce the blister and waste the medicine.

• 3. Hold the AEROMEX inhaler away from your mouth and exhale as much as possible. Do not exhale into the AEROMEX inhaler.

• 4. Inhale steadily and deeply into the AEROMEX inhaler and not through your nose. See figure 3. Remove the AEROMEX inhaler from your mouth. Hold your breath for about 10 seconds or as long as possible. Exhale slowly.

• 5. Afterwards, rinse your mouth with water and spit it out and/or brush your teeth. This can help prevent the appearance of thrush and hoarseness.
• 6. To close the AEROMEX inhaler, slide the grip towards yourself as far as possible until you hear a click. The lever will return to its starting position and ready for the next use. See figure
• 4.

The AEROMEX inhaler is now ready for the next use.

How to clean the inhaler
Clean the mouthpiece of the inhaler with a dry wipe.

If you use more AEROMEX than you should
It is important to use the inhaler as prescribed. If you accidentally take more doses than
recommended, contact your doctor or pharmacist. Your heart may beat faster than
usual and you may feel dizzy. Dizziness, headache, muscle weakness and
joint pain may also occur.
If you have used too many doses of AEROMEX for a long time, consult your doctor or pharmacist. This
is because excessive use of AEROMEX can reduce the amount of steroid hormones produced by
the adrenal glands.

If you forget to use AEROMEX
Do not take a double dose to make up for a missed dose. Take the next dose
at the usual time.

If you stop taking AEROMEX
It is very important to take AEROMEX every day as prescribed. Continue to take it until
your doctor tells you to stop. Do not stop treatment and do not suddenly
reduce the dose of AEROMEX.Otherwise, your breathing problems may worsen.
In addition, if you suddenly stop treatment with AEROMEX or reduce the dose, problems with the adrenal glands (adrenal insufficiency) may occur (very rarely), sometimes
causing side effects.
These side effects can include any of the following effects:

• Stomach ache
• Fatigue and loss of appetite, nausea
• Vomiting and diarrhea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Low blood pressure and seizures

If the body is under stress, such as in case of fever, trauma (such as an accident), infection or
surgery, adrenal insufficiency can worsen and any of the
above side effects may occur.
If you experience any side effect, contact your doctor or pharmacist. To prevent these
symptoms, your doctor may prescribe you other corticosteroids in tablets (such as prednisolone).
For further information on the use of this medicine, contact your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To reduce the likelihood of side effects occurring, your doctor will prescribe you the lowest dose of AEROMEX
to keep your asthma or COPD under control.

Allergic reactions: breathing may worsen immediately after using AEROMEX.
Wheezing, coughing or shortness of breath may occur. Itching, rash (urticaria) and swelling (usually of
the face, lips, tongue or throat) may also appear, or the heartbeat may suddenly speed up and you may
feel a sensation of fainting and dizziness (which may lead to collapse or loss of consciousness). If any
of these effects occur, or if they occur suddenly after using AEROMEX, stop using it and inform your
doctor immediately.Allergic reactions to AEROMEX are not common (may affect up to 1 in 100
people).

Pneumonia (lung infection) in patients with COPD. (Common side effect)
Tell your doctor if you experience any of the following symptoms while using AEROMEX, as they may be
symptoms of an infection:

• fever or chills
• increased mucus production, change in mucus color
• increased cough or greater difficulty breathing

Other side effects are listed below:

Very common (may affect more than 1 in 10 people)

• Headache - usually improves as treatment continues.
• An increase in cases of colds has been observed in patients with COPD.

Common (may affect up to 1 in 10 people)

• Thrush (raised, creamy-yellow patches) in the mouth and throat. Also irritation of the tongue, hoarseness
  and irritation of the throat. It may be helpful to rinse your mouth with water and spit it out immediately
  and/or brush your teeth after each dose of the medicine. Your doctor may prescribe an antifungal medicine
  to treat thrush.
• Pain and swelling in the joints, and muscle pain.
• Muscle cramps.

The following side effects have also been observed in patients with chronic obstructive pulmonary disease
(COPD):

• Bruising and fractures.
• Inflammation of the sinuses (a feeling of tension or fullness in the nose, cheeks and behind the eyes,
  sometimes with throbbing pain).
• Decreased potassium levels in the blood (irregular heartbeat, muscle weakness, cramps may occur).

Uncommon (may affect up to 1 in 100 people)

• Increased sugar (glucose) in the blood (hyperglycemia). If you have diabetes, you may need more frequent
  blood sugar checks and possibly an adjustment to your current diabetes treatment.
• Cataract (clouding of the lens in the eye).
• Very fast heartbeat (tachycardia).
• Feeling of instability (tremor) and fast or irregular heartbeat (palpitations) - these effects are usually
  harmless and decrease as treatment continues.
• Chest pain.
• Anxiety (although this effect is more common in adolescents)
• Sleep disturbances.
• Allergic skin rash.

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

• Difficulty breathing or worsening wheezing immediately after usingAEROMEX. In this case, stop
  using the AEROMEX inhalerand use your fast-acting inhaler to breathe better and tell your doctor
  immediately.
• AEROMEX can impair the normal production of steroid hormones in the body, particularly if you have taken
  high doses for long periods of time. The effects include:
• Slowed growth in adolescents
• Thinning of the bones
• Glaucoma
• Weight gain
• Rounded face (moon face) (Cushing's syndrome). Your doctor will regularly check for any of these side
  effects and ensure you are taking the lowest dose of AEROMEX to control your asthma.
• Changes in behavior, such as unusual activity and irritability (although these effects are more common in
  adolescents).
• Irregular heartbeat or extra beats (arrhythmias). Tell your doctor, but do not stop taking AEROMEX unless
  your doctor tells you to.
• Fungal infection in the esophagus, which can cause difficulty swallowing.

Frequency not known, but may also occur:

• Depression or aggression. These effects are more likely to occur in adolescents.
• Blurred vision.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store AEROMEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the box
of the inhaler after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C, in the original packaging to protect the medicine
from humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AEROMEX contains
Each pre-set dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 500
micrograms of fluticasone propionate.

• The other component is lactose monohydrate (containing milk proteins).

Description of the appearance of AEROMEX and contents of the pack

• Each AEROMEX inhaler contains an aluminum strip that protects the powder for inhalation from the effects of the atmosphere.
• Each dose is pre-set

The device/s is/are packaged in packs of:
1 x AEROMEX containing 60 doses
2 x AEROMEX containing 60 doses
3 x AEROMEX containing 60 doses
10 x AEROMEX containing 60 doses
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Glenmark Pharmaceuticals srò
Hvèzdova 1716/2b, 140 78 Prague
Czech Republic (CZ)

Manufacturer
Celon Pharma S.A.
Mokra 41A, Kiełpin
05-092 Łomianki
Poland
Celon Pharma S.A.
Marymoncka 15,
05-152 Kazuń Nowy
Poland
This medicinal product is authorised in the member states of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following denominations:
United Kingdom (Northern Ireland) Stalpex 50 micrograms / 500 micrograms / dose inhalation powder, pre-
dispensed
Romania Salmeterol/Fluticazonă APC Instytut 50 micrograms/500
micrograms/dose inhalation powder single dose
Italy AEROMEX
Netherlands Salflutin 50 micrograms/500 micrograms/dose inhalation powder,
pre-dispensed
Ireland Stalpex 50 micrograms / 500 micrograms / dose inhalation powder, pre-
dispensed
Malta Salmex 50 micrograms / 500 micrograms / dose inhalation powder, pre-
dispensed
Luxembourg Salmex 50 micrograms / 500 micrograms / dose, powder for
inhalation in single-dose container