Pulmoterol

Leaflet accompanying the packaging: patient information

Pulmoterol

50 µg/inhalation dose, powder for inhalation in hard capsules

Salmeterol

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Pulmoterol and what is it used for

• Pulmoterol contains the active substance salmeterol. It is a long-acting bronchodilator. It allows the airways in the lungs to expand. It facilitates the flow of air into and out of the lungs. The action usually starts within 10 to 20 minutes after taking the medicine and lasts for 12 hours or longer.
• The doctor has prescribed this medicine to prevent breathing difficulties. They may be caused by asthma. Regular use of Pulmoterol helps prevent asthma attacks. This also applies to asthma caused by exercise or symptoms of asthma that occur only at night.
• Regular use of Pulmoterol also prevents breathing difficulties caused by other chest diseases, such as chronic obstructive pulmonary disease (COPD).
• Pulmoterol helps to interrupt an attack of shortness of breath or wheezing in the airways. However, it does not work immediately in the event of an attack of shortness of breath or wheezing in the airways. If this happens, a fast-acting bronchodilator, such as salbutamol, should be used.
• Pulmoterol is available in the form of a powder for inhalation in hard capsules. The medicine is inhaled directly into the lungs.
• In patients with asthma, Pulmoterol should always be used with an inhaled steroid.

2. Important information before using Pulmoterol

When not to use Pulmoterol:

• if the patient is allergic (hypersensitive) to salmeterol xinafoate or any of the other ingredients of the medicine (listed in section 6).

Warnings and precautions

Before starting to use Pulmoterol, discuss it with your doctor.

• If asthma or breathing difficulties worsen, 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 the event of such symptoms, do not increase the number of Pulmoterol inhalations. The chest disease may worsen significantly. Contact your doctor, as a change in asthma treatment may be necessary.
• If the doctor has prescribed Pulmoterol for asthma, continue to use other asthma medications that have been used so far. These may include inhaled steroids or steroids in tablets. Continue the treatment with the previously used dose, even if there is an improvement, unless the doctor recommends a different dosage. Do not stop using inhaled steroids (or steroids in tablets) after starting to use Pulmoterol.
• The doctor will regularly check the patient's health if they have hyperthyroidism, diabetes (Pulmoterol may increase blood sugar levels), or heart disease, including irregular or rapid heartbeat.
• The doctor may recommend gradually reducing the dose of Pulmoterol if asthma is well-controlled.

Pulmoterol and other medicines

• Tell your doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines you plan to use. It may not be appropriate to use Pulmoterol 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 the use of Pulmoterol, including irregular heartbeat or may worsen existing side effects.
• When using Pulmoterol, avoid taking beta-adrenergic receptor blockers, unless your doctor recommends using such medicines. Beta-adrenergic receptor blockers, such as atenolol, propranolol, and sotalol, are used mainly to treat high blood pressure or other heart diseases. Tell your doctor about any beta-adrenergic receptor blockers you are currently taking or have recently taken, as these medicines may reduce or inhibit the action of salmeterol.
• Pulmoterol may decrease blood potassium levels. If this happens, the patient may experience irregular heartbeat, muscle weakness, or muscle cramps. This is more likely to happen if the patient is taking Pulmoterol with certain medicines used to treat high blood pressure (diuretics) and other medicines used to treat breathing difficulties, such as theophylline or steroids. The doctor may recommend that the patient have blood tests to determine their blood potassium levels. In case of doubts, contact your doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. The doctor will assess whether the patient can use Pulmoterol in such cases.

Driving and using machines

It is unlikely that side effects associated with the use of Pulmoterol will affect the ability to drive or use machines.

Pulmoterol contains lactose.

Each dose of Pulmoterol contains 15 mg of lactose. In people with lactose intolerance, this amount of lactose usually does not cause any problems. However, if the patient has been diagnosed with intolerance to some sugars, such as lactose, they should consult their doctor before using Pulmoterol.

3. How to use Pulmoterol

This medicine should always be used as directed by your doctor. If you have any doubts, consult your doctor.

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

The patient may feel that the medicine is working within the first day of use. Pulmoterol should be used daily, unless the doctor recommends stopping the treatment. Pulmoterol is intended for inhalation use only with an inhaler. Do not swallow the capsules. Do not exceed the recommended dose.

Adults and adolescents over 12 years old with asthma

• The usual dose is the inhalation of the contents of 1 capsule (1 x 50 micrograms) twice a day.
• In patients with severe asthma, the doctor may increase the dose to the inhalation of the contents of 2 capsules (2 x 50 micrograms) twice a day.

Children with asthma

• In children aged 4 to 12 years, the usual dose is the inhalation of the contents of 1 capsule (1 x 50 micrograms) twice a day.
• Pulmoterol is not recommended for use in children under 4 years of age.
• The medicine should be used in children only when they are able to use the inhaler correctly. Children should use the inhaler under adult supervision.

Adults with chronic obstructive pulmonary disease (COPD)

• The usual dose is the inhalation of the contents of 1 capsule (1 x 50 micrograms) twice a day.
• This does not apply to children and adolescents.

Before starting to use the medicine, read the "Inhaler user manual".

Inhaler user manual

The powder in the capsule is intended for inhalation only. Do not swallow the capsules. The inhaler is designed to deliver the powder from the number of capsules in the packaging. Do not use the same inhaler for a different packaging of the medicine.

• 1. Remove the inhaler cap.

• 2. Hold the base of the inhaler and open it by turning the mouthpiece in the direction indicated by the arrow.

• 3. Place the powder capsule in the base chamber of the inhaler. The capsule should be removed from the foil blister pack immediately before use.

• 4. Close the inhaler by turning the mouthpiece in the opposite direction of the arrow to the initial position - closed.

• 5. Holding the inhaler in a vertical position once, press the inhaler buttons until they stop.

• 6. Release the inhaler buttons. NOTE: at this point, the capsule may break, and small pieces of gelatin may enter the mouth or throat. Since the gelatin is edible, its consumption is not harmful. The likelihood of such an event is minimal if the capsule is not punctured more than once, the storage conditions are maintained, and the capsule is removed from the foil blister pack immediately before use (see point 3).
• 7. Holding the inhaler with the outlet facing the mouth, exhale slowly and deeply.

• 8. Slightly tilt your head back, put the inhaler mouthpiece in your mouth, and seal it with your lips.

• 9. Take a quick, deep, and even breath. During inhalation, a characteristic sound should be heard. If this sound does not appear, it may mean that the capsule is stuck in the base chamber of the inhaler. Then, open the inhaler and, by lifting the capsule, remove it from the chamber. Do notlift the capsule by repeatedly pressing the buttons. Then, repeat the actions described in point 9.
• 10. After hearing the characteristic sound, hold your breath for as long as possible without discomfort, then remove the inhaler from your mouth and exhale through your nose.
• 11. Open the inhaler and check if there is still powder in the capsule. If powder remains, repeat the procedure from point 7 to point 10.
• 12. After use, open the inhaler, remove the empty capsule, close the mouthpiece, and put the cap back on.

Cleaning the inhaler:

The powder inhaler requires cleaning. To remove powder residue or a capsule, wipe the mouthpiece and chamber with a drycloth or a soft brush. Do not use water to clean the inhaler.

Using a higher dose of Pulmoterol than recommended

It is important to use Pulmoterol as directed by your doctor. If you accidentally take a higher dose of Pulmoterol than recommended, consult your doctor or pharmacist. The patient may experience rapid heartbeat or tremors. They may also experience headache, feeling of weakness, or joint pain.

Missing a dose of Pulmoterol

If a dose of Pulmoterol is missed, take the next dose at the usual time. Do not take a double dose to make up for the missed dose. If you have any doubts about using the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pulmoterol can cause side effects, although not everybody gets them. To minimize the risk of side effects, the doctor will recommend the smallest dose of Pulmoterol that controls asthma or COPD. The following are side effects observed in patients taking salmeterol.

Allergic reactions: after using Pulmoterol, sudden breathing difficulties may occur

breathing difficulties. Wheezing in the airways and coughing may worsen. Other symptoms, such as itching and swelling (usually of the face, lips, tongue, or throat), may also occur. If such symptoms are noticed or occur suddenly after using Pulmoterol, inform your doctor immediately. Allergic reactions after using Pulmoterol are very rare (they occur less often than in 1 in 10,000 people). Other side effects are listed below:

Common (occurring in less than 1 in 10 people):

• muscle cramps;
• feeling of trembling; rapid or irregular heartbeat (palpitations), headache, tremors (e.g., hand tremors). Tremors may occur more frequently if the patient uses more than one capsule for inhalation twice a day. These side effects do not last long and usually decrease during continued treatment with Pulmoterol.

Uncommon (occurring in less than 1 in 100 people):

• rash;
• very rapid heartbeat (tachycardia). This may occur more frequently if the patient takes more than two capsules for inhalation twice a day;
• nervousness.

Rare (occurring in less than 1 in 1,000 people):

• feeling of dizziness;
• insomnia or difficulty falling asleep;
• decreased blood potassium levels (may cause irregular heartbeat, muscle weakness, or muscle cramps).

Very rare (occurring in less than 1 in 10,000 people):

• breathing difficulties or wheezing in the airways worsening immediately after taking Pulmoterol. If such symptoms occur, stop using Pulmoterol. Use a fast-acting inhaled medicine to facilitate breathing, and contact your doctor immediately.
• irregular heartbeat or extra beats (heart rhythm disorders). In such a situation, do not stop using Pulmoterol, but inform your doctor.
• pain in the mouth and throat;
• nausea;
• pain, swelling of the joints, or chest pain;
• increased blood sugar (glucose) levels.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, e-mail: [email protected]. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Pulmoterol

Keep the medicine out of sight and reach of children. Store it in its original packaging, at a temperature below 25°C. Protect it from light and moisture. Do not use Pulmoterol after the expiry date stated on the blister pack or carton. The expiry date is the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pulmoterol contains

• The active substance of Pulmoterol is salmeterol. One inhalation capsule contains 50 µg (micrograms) of salmeterol in the form of salmeterol xinafoate.
• The other ingredients of the medicine are lactose monohydrate and gelatin.

What Pulmoterol looks like and what the packaging contains

Pulmoterol is a powder for inhalation in hard capsules. The transparent, colorless hard capsules contain a white or cream-colored powder. Pulmoterol is packaged in OPA/Aluminum/PVC-Aluminum blisters, which, along with the inhaler and patient leaflet, are placed in a cardboard box. Pulmoterol is available in packaging containing 30, 60, 90, or 120 capsules, as well as an inhaler.

Responsible entity and manufacturer

LEK-AM Pharmaceutical Company Ltd. ul. Ostrzykowizna 14 A, 05-170 Zakroczym, phone: +48 22 785 27 60, fax: +48 22 785 27 60 ext. 106

Date of the last update of the leaflet: