Aeromex

Package leaflet: Information for the patient

AEROMEX

50 micrograms/500 micrograms per dose inhalation powder in single-dose container
Read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 using 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 AEROMEX is and what it is used for

AEROMEX contains two medicines: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help open the airways in the lungs and make 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 such as:

• Asthma
• Chronic obstructive pulmonary disease (COPD). AEROMEX reduces the frequency of exacerbations of COPD symptoms.

AEROMEX must be used every day as directed by your doctor. This way, asthma or COPD can be effectively controlled.
AEROMEX helps control the occurrence of breathlessness and wheezing. AEROMEX must not be used to relieve a sudden attack of breathlessness or wheezing. If such an attack occurs, you must use a fast-acting inhaler, such as salbutamol. It is important to always have a fast-acting inhaler with you.
Use AEROMEX only for the treatment of asthma in adults and adolescents aged 12 years and older, and for the treatment of 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 of the other ingredients, including lactose monohydrate.

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

• heart disease, such as irregular or rapid heartbeat
• overactive thyroid gland
• high blood pressure
• diabetes mellitus (AEROMEX may increase blood glucose levels)
• low potassium levels in the blood
• newly developed or pre-existing tuberculosis (TB), or other lung infections

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

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

Other medicines and AEROMEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines for asthma or other medications obtained without prescription. AEROMEX may not be suitable to take together with certain other medicines.

Before taking AEROMEX, inform your doctor or pharmacist if you are taking any of the following medicines:

• Beta-blockers (such as atenolol, propranolol, and sotalol). Beta-blockers are generally used to treat high blood pressure or heart conditions.
• Medicines to treat infections (such as ketoconazole, itraconazole, and erythromycin), including some medicines used to treat HIV (such as ritonavir, products containing cobicistat). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in your body, making it more likely that you will experience side effects from AEROMEX, such as irregular heartbeat, or may worsen existing side effects. Your doctor may wish to monitor you closely if you are taking these medicines.
• Corticosteroids (taken orally or by injection). If you have recently taken these medicines, this may increase the risk that this medicine could impair your 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, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

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

AEROMEX contains lactose
Each dose of AEROMEX 50 micrograms/500 micrograms per dose contains approximately 12.9 mg of lactose monohydrate.
The amount of lactose contained in this medicine generally does not cause problems in individuals with lactose intolerance.

3. How to use AEROMEX

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use AEROMEX every day until your doctor tells you to stop. Do not take a higher
dose than recommended. If you have any doubts, consult your doctor or pharmacist.
Do not stop treatment with AEROMEX or reduce the dose without first consulting 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 aged 12 years and older

• AEROMEX 50 micrograms/500 micrograms/dose – One inhalation twice daily

For chronic obstructive pulmonary disease (COPD) in adults

• AEROMEX 50 micrograms/500 micrograms/dose – One inhalation twice daily

Using AEROMEX twice daily may well control your symptoms. Therefore, your doctor may decide to reduce the dose to once daily. The dosage may be adjusted as follows:

• 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 this medicine.
If you are using AEROMEX for asthma, your doctor will want to monitor your symptoms regularly.
Your doctor will help you manage your asthma and will adjust the dose of this medicine to the lowest dose that keeps your asthma under control. If your doctor considers that you need a lower dose than that available with AEROMEX, they may prescribe you another inhaler containing the same active substances as AEROMEX but with a lower dose of corticosteroid. In any case, do not change the number of inhalations prescribed by your doctor without first consulting them.
If your asthma or breathing worsens, inform your doctor immediately. If you experience increasing wheezing, more frequent chest tightness, or if you need to use your fast-acting inhaler more often. In such circumstances, continue taking AEROMEX, but do not increase the number of inhalations. Your condition may be worsening and you could become seriously ill. Contact your doctor immediately, as you may require additional treatment.

Instructions for use

• Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler. Periodically, they should also check how you are using the device. If you do not use AEROMEX correctly or as prescribed, your asthma or COPD may not improve as expected.
• The AEROMEX device contains a blister with salmeterol and fluticasone propionate in powder form.
• A dose counter is located at the top of the inhaler and shows how many doses are left, down to 0.
• When 5 doses remain, each number will be marked with a black dot, indicating that only a few doses are left. Once 0 is reached, the inhaler will be empty.

How to use the inhaler

1. To open the AEROMEX inhaler, hold the inhaler in one hand and place the thumb of the other hand on the thumb grip. Push the thumb outward 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 facing towards you. You may hold it with either your right or left hand. Slide the lever as far as possible until you hear a click. This releases a dose of medicine into the mouthpiece. See Figure 2.

Each time you pull the lever, the internal blister is pierced and the powder is prepared for inhalation. 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 breathe out as fully as possible. Do not exhale into the AEROMEX inhaler.
4. Breathe in steadily and deeply through the AEROMEX inhaler, 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. Then breathe out slowly.

5. Afterwards, rinse your mouth with water and spit it out and/or brush your teeth. This may help prevent the development of oral candidiasis (thrush) and hoarseness.
6. To close the AEROMEX inhaler, slide the thumb grip back towards yourself as far as possible until you hear a click. The lever will return to its original position, 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. You may experience a faster than normal heartbeat and feel shaky. Dizziness, headache, muscle weakness, and joint pain may also occur.
If you have used too many doses of AEROMEX for a prolonged period, consult your doctor or pharmacist. This is because excessive use of AEROMEX may 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 forgotten dose. Take the next dose at your usual time.

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

• Stomach pain
• Tiredness and loss of appetite, nausea
• Vomiting and diarrhoea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Low blood pressure and seizures (epileptic fits)

If your body is under stress, such as during fever, trauma (e.g. an accident), infection, or surgery, adrenal insufficiency may worsen and any of the unwanted effects listed above may occur.
If you experience any unwanted effects, contact your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroid tablets (such as prednisolone).
For further information on the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
To reduce the likelihood of side effects occurring, your doctor will prescribe the lowest dose of AEROMEX needed to control your asthma or COPD.
Allergic reactions: breathing may worsen immediately after using AEROMEX.
You may experience pronounced wheezing, coughing, or shortness of breath. You may also develop itching, skin rash (urticaria), or swelling (usually of the face, lips, tongue, or throat). Alternatively, your heartbeat may suddenly increase, and you may feel faint or dizzy (which could lead to collapse or loss of consciousness). If you experience any of these effects, or if they occur suddenly after using AEROMEX, stop using it immediately and contact your doctor without delay. 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).
Inform your doctor if you experience any of the following symptoms while using AEROMEX, as they may indicate an infection:

• Fever or chills
• Increased mucus production or change in mucus colour
• Worsening cough or increased difficulty breathing

Other side effects are listed below:
Very common (may affect more than 1 in 10 people)

• Headache – usually improves with continued treatment.
• An increased incidence of colds has been observed in patients with COPD.

Common (may affect up to 1 in 10 people)

• Oral and throat candidiasis (raised yellow-cream coloured patches). Also irritation of the tongue, hoarseness, and throat irritation. It may help 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 the candidiasis.
• Joint pain and swelling, and muscle pain.
• Muscle cramps.

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

• Bruising and fractures.
• Sinusitis (a feeling of pressure or swelling in the nose, cheeks, and behind the eyes, sometimes with throbbing pain).
• Decreased potassium levels in the blood (may cause irregular heartbeat, muscle weakness, cramps).

Uncommon (may affect up to 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring may be required and possibly an adjustment of your current antidiabetic treatment.
• Cataract (clouding of the eye's lens).
• Very rapid heartbeat (tachycardia).
• Shaking (tremor) and rapid or irregular heartbeat (palpitations) – these effects are usually harmless and tend to decrease with continued treatment.
• Chest pain.
• Anxiety (although this effect occurs mainly in adolescents).
• Sleep disturbances.
• Allergic skin rash.

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

• Difficulty breathing or worsening of wheezing immediately after using AEROMEX. In such cases, stop using the AEROMEX inhaler, use your fast-acting inhaler to help you breathe better, and contact your doctor immediately.
• AEROMEX may impair the body’s normal production of steroid hormones, particularly if high doses have been taken for prolonged periods. Effects include:
• Slowed growth in adolescents
• Thinning of the bones
• Glaucoma
• Weight gain
• Rounded face (moon face) (Cushing's syndrome). Your doctor will regularly monitor for any of these side effects and ensure you are taking the lowest effective dose of AEROMEX to control your asthma.
• Behavioural changes, such as unusual hyperactivity and irritability (although these effects occur mainly in adolescents).
• Irregular heartbeat or extra beats (arrhythmias). Inform your doctor, but do not stop taking AEROMEX unless instructed by your doctor.
• Fungal infection of the oesophagus, which may 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the label and on the inhaler box after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C; keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

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

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

Description of the appearance of AEROMEX and contents of the pack

• Each AEROMEX inhaler contains an aluminium strip that protects the inhaled powder from atmospheric effects.
• Each dose is pre-dispensed.

The device(s) 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 s.r.o.
Hvězdova 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 European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
United Kingdom (Northern Ireland): Stalpex 50 microgram / 500 microgram / dose inhalation powder, pre-dispensed
Romania: Salmeterol/Fluticazonă APC Instytut 50 micrograme/500 micrograme/doză pulbere de inhalat unidoză
Italy: AEROMEX
Netherlands: Salflutin 50 microgram/500 microgram/dosis inhalatiepoeder, voorverdeeld
Ireland: Stalpex 50 microgram / 500 microgram / dose inhalation powder, pre-dispensed
Malta: Salmex 50 microgram / 500 microgram / dose inhalation powder, pre-dispensed
Luxembourg: Salmex 50 microgrammes / 500 microgrammes / dose, poudre pour inhalation en récipient unidose