SOLTEL 25 micrograms/inhalation suspension for inhalation in pressurized container

Introduction

Leaflet: information for the patient

Soltel 25micrograms/inhalation inhalation suspension in a pressurized container

salmeterol (as xinafoate)

The name of this medicine is Soltel 25 micrograms/inhalation inhalation suspension in a pressurized container, which in this leaflet will be referred to as Soltel.

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, nurse specializing in asthma or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, nurse specializing in asthma or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Soltel and what is it used for
2. What you need to know before you start using Soltel
3. How to use Soltel
4. Possible side effects
5. Storing Soltel

6 Contents of the pack and further information.

1. What is Soltel and what is it used for

Soltel contains the active substance salmeterol. Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open. This makes it easier to breathe in and out. The effects are usually felt within 10 to 20 minutes and last for at least 12 hours.

• Your doctor has prescribed Soltel to help prevent breathing problems in adult and adolescent patients. These problems may be due to asthma. You should use Soltel every day as directed by your doctor. This will ensure that the medicine works correctly and controls your asthma, and will help prevent asthma attacks, including nighttime asthma or exercise-induced asthma.
• Taking Soltel regularly will also help prevent breathing problems associated with other lung diseases, such as chronic obstructive pulmonary disease (COPD) in adult patients.
• Soltel helps prevent shortness of breath and wheezing. It does not work if you have already become breathless or are wheezing, and it should not be used to relieve a sudden attack of shortness of breath or wheezing. In such cases, you should use a rapid-acting "rescue" inhaler, such as salbutamol. You should always carry your rapid-acting "rescue" inhaler with you.
• The medicine will be supplied to you in an inhaler. Breathe in the medicine through your mouth so that it goes directly to your lungs.

If you are being treated for asthma, you should always receive Soltel and a corticosteroid inhaler (or rarely corticosteroid tablets) to use together.Both inhalers should be used regularly.

2. What you need to know before you start using Soltel

Do not use Soltel

• If you are allergic (hypersensitive) to salmeterol xinafoate or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to peanuts or soya, as Soltel contains soya lecithin.

Warnings and precautions

Talk to your doctor, pharmacist or nurse specializing in asthma before you start using Soltel.

• If your asthma or breathing gets worse, tell your doctor immediately.You may have more wheezing, feel chest tightness more often, or need to use more "rescue" medicine. In such cases, you should continue to take Soltel, but do not increase the number of inhalations. Your chest condition may get worse, and you may become seriously ill. Visit your doctor or nurse specializing in asthma, as you may need to have your asthma treatment changed.
• If you have been prescribed Soltel for asthma, continue to use your other asthma medicines, including your corticosteroid inhaler or corticosteroid tablets. Continue to take the same doses as before, unless your doctor tells you otherwise. Do this even if you feel much better. Do not stop treatment with your corticosteroid inhaler (or corticosteroid tablets) when you start using Soltel.
• Your doctor may want to check your health more closely if you have:

• an overactive thyroid gland;
• high blood pressure;
• low levels of potassium in your blood;
• heart problems, including an irregular or fast heartbeat;
• diabetes mellitus (salmeterol may increase your blood sugar levels). If you have diabetes, your doctor may want to check your blood sugar levels more closely, and you may need to adjust your diabetes treatment.

If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before you start using this medicine.

Other medicines and Soltel

Tell your doctor, pharmacist or nurse specializing in asthma if you are taking, have recently taken or might take any other medicines, including those for asthma and inhalers or those bought without a prescription. It may not be suitable to take Soltel with other medicines.

• Tell your doctor or nurse specializing in asthma before you use Soltel if you are being treated for a fungal infection with medicines that contain ketoconazole or itraconazole, or for HIV with ritonavir. These medicines may increase the risk of side effects with salmeterol, such as irregular heartbeats, or may make side effects worse.
• The use of Soltel with beta-blockers should be avoided, unless your doctor tells you to take them. Beta-blockers, such as atenolol, propranolol and sotalol, are mainly used to treat high blood pressure or other heart conditions. Tell your doctor or nurse specializing in asthma if you are taking beta-blockers or if you have recently been prescribed beta-blockers, as they may reduce or cancel the effects of salmeterol.
• Salmeterol may reduce the amount of potassium in your blood. If this happens, you may feel an irregular heartbeat, muscle weakness or cramps. This is more likely to happen if you are taking salmeterol with other treatments used to treat high blood pressure (diuretics) or other bronchodilators, such as salbutamol, or other medicines for respiratory problems, such as theophylline or corticosteroids. Your doctor may ask you to have blood tests to check the amount of potassium in your blood from time to time. If you have any doubts, talk to your doctor or nurse specializing in asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse specializing in asthma for advice before using this medicine. They will decide whether you can use Soltel during this time.

Driving and using machines

It is unlikely that the possible side effects associated with the Soltel inhaler will affect your ability to drive or use machines.

Soltel contains ethanol and soya

This medicine contains 1.6 mg of alcohol (ethanol) in each dose. The amount in each dose of this medicine is equivalent to less than 0.04 ml of beer or 0.016 ml of wine. The small amount of alcohol in this medicine does not have any noticeable effect.

Soltel contains soya lecithin. If you are allergic to soya, do not use this medicine (see section 2 ‘Do not take Soltel’).

3. How to use Soltel

Follow the instructions for using this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• If you are being treated for asthma, you should always receive Soltel and a corticosteroid inhaler to use together.
• Use Soltel every day until your doctor advises you to stop. Do not take more than the recommended dose. If you are not sure, ask your doctor, nurse specializing in asthma or pharmacist.
• You will start to feel that the medicine is working from the first day of treatment.
• Do not stop treatment with Soltel or reduce your dose without talking to your doctor first.

Soltel should be inhaled through the mouth to reach the lungs.

Children 12 years and younger

Soltel has not been established to be safe and effective in children.No data are available.Therefore, Soltel should not be used in children 12 years and younger.

Recommended doses are

Adults and adolescents 13 to 17 years with asthma

• The recommended initial dose is 2 inhalations twice a day.
• If you have more severe asthma, your doctor may increase your dose to 4 inhalations twice a day.

Adults 18 years and older with chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema

• The recommended initial dose is 2 inhalations twice a day.
• It should not be used in children or adolescents under 18 years.

Instructions for use

Your doctor, nurse specializing in asthma or pharmacist will show you how to use your inhaler. They will check how you use it from time to time. Incorrect use of the inhaler, or not using it as prescribed or as described in the leaflet, may mean that the medicine does not work as it should, and may not help your asthma or COPD.

This medicine is provided in a pressurized cartridge inside a plastic casing with a mouthpiece.

Checking the inhaler

1. If you are using the inhaler for the first time, check that it is working correctly. Remove the mouthpiece cover by squeezing gently with your thumb and index finger and pulling it apart.
2. To make sure that it is working correctly, shake it well, hold the mouthpiece away from you and press the cartridge to release two inhalations into the air. If you have not used your inhaler for a week or more, or if you have cleaned it, release one inhalation into the air.

Using the inhaler

It is important to start breathing in slowly through your mouth just before and during the use of the inhaler. This inhaler is designed to be used in an upright position, and patients should be standing or sitting while using it. Patients should follow the instructions and not rush while using the inhaler.

1. Remove the mouthpiece cover. Check that the mouthpiece is clean and free from any foreign objects (figure 1).
2. Shake the inhaler well before use (figure 2) to ensure that any foreign objects are removed and the contents of the inhaler are mixed evenly.
3. Hold the inhaler in an upright position with your thumb on the base of the inhaler, below the mouthpiece.
4. Breathe out as slowly and as fully as you can (figure 3).
5. Put the mouthpiece in your mouth, between your teeth. Close your lips around the mouthpiece. Do not bite it (figure 4).
6. Breathe in slowly and deeply through your mouth (figure 4). Just after you start breathing in, press the top of the cartridge firmly to release one inhalation of the medicine. Do this while you continue to breathe in slowly and deeply (figure 4).
7. Hold your breath, take the inhaler out of your mouth by removing your finger from the top of the cartridge. Continue to hold your breath for a few seconds or as long as you can (figure 5).
8. Wait for about half a minute between each use of the medicine and then repeat steps 3 to 8.
9. After use, replace the mouthpiece cover immediately to prevent dust and fluff from entering. The mouthpiece cover is replaced by pushing firmly and snapping it into place.

Practice in front of a mirror the first few times. If you see a "mist" coming out of the top of the inhaler or from the corner of your mouth, you should repeat the procedure.

Older children or people with weak hands may find it easier to hold the inhaler with both hands. Place your two index fingers on the top of the inhaler and your two thumbs on the base, below the mouthpiece. Your doctor, nurse or pharmacist can give you advice.

If you find it difficult to use the inhaler, you may use a Volumatic inhaler chamber to help. Contact your doctor, nurse specializing in asthma or pharmacist. If you need to use the Volumatic inhaler chamber, read the instructions provided with the chamber, which contain all the information about the care and correct use of the chamber.

If the inhaler is very cold, take the metal cartridge out of the plastic casing and warm it in your hands for a few minutes. Never use anything else to warm it up.

After warming the inhaler, release one inhalation into the air before using it.

Cleaning the inhaler

To prevent your inhaler from becoming blocked, it is important to clean it at least once a week.

To clean your inhaler:

• Remove the mouthpiece cover.
• Do not remove the metal cartridge from the plastic casing at any time.
• Wipe the inside and outside of the mouthpiece and plastic casing with a dry cloth or tissue.
• Release one inhalation into the air before the next use to check that it is working.
• Replace the mouthpiece cover.

Do notput the metal cartridge in water.

If you take more Soltel than you should

It is important to use the inhaler as directed. If you accidentally take a higher dose than recommended, you should talk to your doctor, nurse specializing in asthma or pharmacist. You may notice that your heart is beating faster than normal, and you may feel shaky and/or dizzy. You may also have a headache, muscle weakness and joint pain.

If you have taken more Soltel than you should, talk to your doctor, pharmacist or contact the poison control center, phone 915620420, stating the medicine and the amount taken.

If you forget to use Soltel

If you forget to use your inhaler, you should take your next dose when it is due.

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Soltel

It is very important that you use Soltel every day as directed by your doctor. Continue to take Soltel until your doctor tells you to stop. Do not stop or suddenly reduce your dose, as your breathing may get worse.

If you have any further questions about the use of this medicine, ask your doctor, nurse specializing in asthma or pharmacist.

4. Possible Adverse Effects

Like all medicines, Soltel can cause adverse effects, although not all people suffer from them. To reduce the likelihood of adverse effects, your doctor will prescribe the lowest dose to control your asthma or COPD. Patients have reported the following adverse effects with salmeterol.

Allergic Reactions: you may notice that your breathing has suddenly worsened after usingSoltel.You may experience:

• Difficulty breathing.
• Sneezing or coughing.
• Skin rash, itching, swelling (usually on the face, lips, tongue, or throat).
• A sudden feeling that your heart is beating very fast and/or you feel dizzy or faint. This can cause fainting or loss of consciousness.

If you experience any of these effects or if they appear immediately after using Soltel, discontinue treatment with Soltel and inform your doctor immediately.Allergic reactions to salmeterol are rare (may affect up to 1 in 100 people).

Other Adverse Effects:

Frequent (may affect up to 1 in 10people)

• Muscle cramps.
• Feeling shaky, rapid or irregular heartbeats (palpitations), headache, and shaky hands (tremor). Tremors and rapid heartbeats are more likely to occur if you are taking more than two inhalations twice a day. These adverse effects do not last long and decrease if treatment with salmeterol continues.

Uncommon (may affect up to 1 in 100people)

• Skin rash.
• Very rapid heartbeat (tachycardia). This is more likely to occur if you are taking more than two inhalations twice a day.
• Nervousness.

Rare (may affect up to 1 in 1000people)

• Dizziness.
• Difficulty sleeping (insomnia).
• A decrease in blood potassium levels (you may notice an irregular heartbeat, muscle weakness, and/or muscle cramps). Your doctor may ask you to have blood tests to check your potassium levels occasionally. If you have any doubts, consult your doctor or asthma nurse.

Very Rare (may affect up to 1 in 10000people)

• Breathing difficulties and wheezing may worsen immediately after using Soltel.If this happens, discontinue treatment withSoltel.Use your rapid-acting "rescue" inhaler to help you breathe and inform your doctor immediately.
• Irregular heartbeats or your heart having more beats than usual (arrhythmia). If this happens, do not discontinue treatment with Soltel, but inform your doctor or asthma nurse.
• Increased blood sugar (glucose) levels (hyperglycemia). If you are diabetic, your doctor may want to check your blood sugar levels more often and adjust your usual diabetes treatment.
• Mouth ulcers or sore throat.
• Feeling unwell (nausea).
• Pain and swelling of the joints.
• Chest pain.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Soltel

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 carton after EXP. The expiry date is the last day of the month indicated.

Store below 25°C.

Do not freeze.

This cartridge contains a pressurized liquid. Do not expose to temperatures above 50°C.

Do not pierce, break, or burn the cartridge, even if it appears to be empty.

As with most pressurized inhalation medicines, the therapeutic effect of Soltel may decrease when the cartridge is cold.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Soltel Composition

• The active ingredient is salmeterol (as xinafoate).

Each measured dose (dose that comes out of the valve) contains 25 micrograms of salmeterol (as xinafoate). This is equivalent to a delivered dose (dose that comes out of the mouthpiece) of 21 micrograms of salmeterol (as xinafoate).

• This medicine contains fluorinated greenhouse gases.

Each inhaler contains 12.5 g of HFC-134a (norflurane) which corresponds to 0.018 tons of CO2 equivalent (global warming potential GWP = 1430).

• The other ingredients are anhydrous ethanol and soy lecithin (E322).

Product Appearance and Package Contents

Soltel is a homogeneous white suspension presented in an aluminum cartridge with a metering valve and a green plastic applicator with a green light plastic dust cap.

Each cartridge contains 120 measured inhalations.

Marketing Authorization Holder and Manufacturer:

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp,

Belgium

Local Representative

Cipla Europe NV, Spanish branch,

C/Guzmán el bueno, 133 Edif Britannia-28003- Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:Soltel 25 Mikrogramm/Sprühstoß Druckgasinhalation, Suspension

Spain:Soltel 25 micrograms/inhalation suspension for inhalation in a pressurized container

Date of the last revision of this leaflet: January 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)