Soltel 25 micrograms/inhalation suspension for inhalation in pressurized container

Patient Information Leaflet

Introduction

Patient Information Leaflet

Soltel 25 micrograms/inhalation suspension for inhalation under pressure

salmeterol (as xinafoate)

The name of this medicine is Soltel 25 micrograms/inhalation suspension for inhalation under pressure, which will be referred to as Soltel in this leaflet.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, asthma nurse specialist, or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, asthma nurse specialist, or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Soltel is and what it is used for

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

• Your doctor prescribes Soltel to help prevent breathing problems in adults and adolescents. These problems may be due to asthma. You should use Soltel every day as directed by your doctor. This will ensure the medicine works properly to control your asthma and help prevent asthma attacks, including nocturnal asthma or exercise-induced asthma.
• Taking Soltel regularly may also help prevent breathing difficulties associated with other lung diseases, such as chronic obstructive pulmonary disease (COPD) in adults.
• Soltel helps prevent the occurrence of shortness of breath and wheezing. It is not effective if you already have shortness of breath or wheezing, and it should not be used to relieve a sudden asthma attack. In such cases, you must use a fast-acting "rescue" inhaler, such as salbutamol. You should always carry your fast-acting "rescue" inhaler with you.
• The medicine is delivered via an inhaler. You should inhale the medicine through your mouth so that it goes directly into your lungs.

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

2. What you need to know before using Soltel

Do not use Soltel

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

Warnings and precautions

Talk to your doctor, pharmacist, or asthma nurse before starting to use Soltel.

• If your asthma or breathing worsens, inform your doctor immediately. You may experience more wheezing, feel chest tightness more often, or need to use your rapid-acting "rescue" medicine more frequently. In such cases, you should continue taking Soltel but must not increase the number of inhalations. Your chest condition may worsen and you could become seriously ill. See your doctor or asthma nurse, as your asthma treatment may need to be changed.

• If Soltel has been prescribed to treat your asthma, continue using your current asthma medicines, including your corticosteroid inhaler or corticosteroid tablets. Continue taking 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 monitor your health more frequently if you have:

• an overactive thyroid gland;

• high blood pressure;

• low levels of potassium in your blood;

• heart conditions, including irregular or rapid heartbeat;

• diabetes mellitus (salmeterol may increase blood sugar levels). If you have diabetes, your doctor may want to check your blood sugar levels more often than usual and you may need adjustments to your diabetes treatment.

If you are unsure whether any of the above apply to you, consult your doctor, nurse, or pharmacist before starting to use this medicine.

Other medicines and Soltel

Tell your doctor, pharmacist, or asthma nurse if you are taking, have recently taken, or might need to take any other medicines, including asthma medicines, inhalers, or medicines purchased without a prescription. It may not be suitable to take Soltel with certain other medicines.

• Tell your doctor or asthma nurse before using Soltel if you are being treated for a fungal infection with medicines containing 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 worsen side effects.
• The use of Soltel should be avoided with beta-blockers unless your doctor specifically instructs you to take them. Beta-blockers such as atenolol, propranolol, and sotalol are mainly used to treat high blood pressure or other heart conditions. Inform your doctor or asthma nurse if you are taking beta-blockers or have recently been prescribed beta-blockers, as they may reduce or block the effects of salmeterol.
• Salmeterol may reduce the amount of potassium in your blood. If this occurs, you may notice an irregular heartbeat, muscle weakness, or cramps. This is more likely if you are taking salmeterol together with other treatments for high blood pressure (diuretics), or other bronchodilators such as salbutamol, or other medicines used to treat breathing problems such as theophylline or corticosteroids. Your doctor may ask you to have blood tests to check your potassium levels from time to time. If you have any doubts, speak with your doctor or asthma nurse.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or asthma nurse before using this medicine. They will assess whether you can use Soltel during this period.

Driving and using machines

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

Soltel contains ethanol and soya

This medicine contains 1.6 mg of alcohol (ethanol) per 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 contained in this medicine does not produce any noticeable effect.

Soltel contains lecithin derived from soya. If you are allergic to soya, do not use this medicine (see section 2 'Do not use Soltel').

3. How to use Soltel

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

Soltel should be inhaled through the mouth so that it reaches the lungs.

Children aged 12 years and younger

The safety and efficacy of Soltel have not been established in children. No data are available. Therefore, Soltel is not recommended and must not be used in children aged 12 years and younger.

Recommended doses are

Adults and adolescents aged 13 to 17 years with asthma

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

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

• The recommended starting dose is 2 inhalations twice daily.
• Must not be used in children or adolescents under 18 years of age.

Instructions for use

Your doctor, asthma nurse specialist, or pharmacist will show you how to use your inhaler. They should periodically check how you are using it. Incorrect use of the inhaler, or not using it as prescribed or as indicated in the leaflet, may result in the medicine not working properly and, consequently, not helping you manage your asthma or COPD.

This medicine comes 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 gently pressing the sides with your thumb and index finger and pulling it off.
2. To ensure it is working correctly, shake it well, point the mouthpiece away from you, and press the cartridge to release two puffs into the air. If you have not used your inhaler for one week or more, or if you have cleaned it, release one puff into the air.

Using the inhaler

It is important to start breathing out slowly through your mouth just before and during 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 must follow the instructions below and should not rush through the steps when using the inhaler.

1. Remove the mouthpiece cover. Check inside and outside that the mouthpiece is clean and free from any foreign particles (Figure 1).
2. Shake the inhaler well before use (Figure 2) to ensure any foreign particles are removed and the contents of the inhaler are homogeneously mixed.
3. Hold the inhaler in an upright position, with your thumb on the base of the inhaler, below the mouthpiece.
4. Breathe out as much air as possible (Figure 3).
5. Place 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 starting to breathe in, press firmly on the top of the cartridge to release one puff of medicine. Perform this step while continuing to breathe in deeply and steadily (Figure 4).
7. Hold your breath, remove the inhaler from your mouth, and take your finger off the top of the cartridge. Continue holding your breath for a few seconds or as long as possible (Figure 5).
8. Wait approximately half a minute between each dose, then repeat steps 3 to 8.
9. After use, immediately replace the mouthpiece cover to prevent dust and lint from entering. Replace the mouthpiece cover by firmly pushing and snapping it closed until it is securely in place.

Practice in front of a mirror the first few times. If you see a kind of "mist" escaping from the top of the inhaler or from the corners of your lips, you should repeat the procedure.

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

If you find it difficult to use the inhaler, you may use a Volumatic® spacer device to help. Contact your doctor, asthma nurse specialist, or pharmacist. If you need to use the Volumatic® spacer device, refer to the instructions for use provided with the spacer, which contain all information regarding proper care and use of the spacer.

If the inhaler is very cold, remove the metal cartridge from the plastic casing and warm it with your hands for a few minutes. Never use anything else to warm it.

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

Cleaning the inhaler

To prevent blockage of your inhaler, 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.
• Clean the inside and outside of the mouthpiece and plastic casing with a dry cloth or paper tissue.
• Release one puff into the air before the next use to check that it is working.
• Replace the mouthpiece cover.

Do not immerse the metal cartridge in water.

If you use more Soltel than you should

It is important to use the inhaler as directed. If you accidentally take more than the recommended dose, contact your doctor, asthma nurse specialist, or pharmacist. You may notice your heart beating faster than normal and feel tremors and/or dizziness. You may also experience headache, muscle weakness, and joint pain.

If you have taken more Soltel than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915620420, stating the medicine and the amount taken.

If you forget to use Soltel

If you forget to use your inhaler, take your next dose at the usual time.

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

If you stop using Soltel

It is very important that you use Soltel every day as directed by your doctor. Continue taking Soltel until your doctor tells you to stop treatment. Do not stop or suddenly reduce your dose, as this could worsen your breathing.

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

4. Possible adverse effects

Like all medicines, Soltel may cause adverse effects, although not everyone experiences them. To reduce the likelihood of adverse effects, your doctor will prescribe the lowest dose needed to control your asthma or COPD. The following adverse effects have been reported by patients using salmeterol.

Allergic reactions: you may notice that your breathing suddenly worsens after using Soltel. You may experience:

• Difficulty breathing.
• Sneezing or coughing.
• Skin rash, itching, swelling (usually of the face, lips, tongue, or throat).
• A sudden sensation that your heart is beating very fast and/or feeling dizzy or lightheaded. This may lead to fainting or loss of consciousness.

If you experience any of these effects, or if they occur shortly after using Soltel, stop treatment with Soltel and contact your doctor immediately. Allergic reactions to salmeterol are uncommon (may affect up to 1 in 100 people).

Other adverse effects:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

• 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 occasionally to check your potassium levels. If you have any concerns, consult your doctor or asthma specialist nurse.

Very rare (may affect up to 1 in 10,000 people)

• Breathing difficulties and wheezing may worsen immediately after using Soltel. If this occurs, stop treatment with Soltel. Use your fast-acting "rescue" inhaler to help you breathe and contact your doctor immediately.
• Irregular heartbeat or increased number of heartbeats (arrhythmia). If this occurs, do not stop treatment with Soltel, but inform your doctor or asthma specialist nurse.
• Increased blood sugar (glucose) levels (hyperglycaemia). If you are diabetic, your doctor may wish to monitor your blood sugar levels more frequently and adjust your usual diabetes treatment.
• Mouth ulcer or sore throat.
• Feeling unwell (nausea).
• Joint pain and swelling.
• Chest pain.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 on the carton after EXP. The expiry date refers to the last day of the month indicated.

Store below 25 °C.

Do not freeze.

This cartridge contains 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 inhaled medicines delivered in pressurized cartridges, the therapeutic effect of Soltel may be reduced when the cartridge is cold.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Soltel

• The active substance is salmeterol (as xinafoate).

Each metered dose (dose emitted from the valve) contains 25 micrograms of salmeterol (as xinafoate). This corresponds to a delivered dose (dose emitted from the mouthpiece) of 21 micrograms of salmeterol (as xinafoate).

• This medicinal product contains fluorinated greenhouse gases.

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

• The other components are anhydrous ethanol and soya lecithin (E322).

Nature and contents of the container

Soltel is a white, homogeneous suspension contained in an aluminium cartridge fitted with a metering valve and a green plastic actuator with a light green plastic dust cap.

Each cartridge contains 120 metered inhalations.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area (EEA) member states under the following names:

Germany: Soltel 25 Mikrogramm/Sprühstoß Druckgasinhalation, Suspension
Spain: Soltel 25 microgramos/inhalación suspensión para inhalación en envase a presión

Date of the most recent review of this leaflet: January 2025

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