Prospecto:information for the patient

Soltel 25micrograms/inhalation suspension for inhalation in pressurized container

salmeterol (as xinafoate)

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

Read this prospectus carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, asthma nurse or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, asthma nurse or pharmacist, even if they are not listed in this prospectus. See section4.

6 Contents of the pack and additional information.

Soltel contains the active ingredient salmeterol. Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways of the lungs open. This facilitates the entry and exit of air. The effects usually become noticeable within 10 to 20 minutes and last for a minimum of 12 hours.

• Your doctor prescribes Soltel to help prevent respiratory problems in adult and adolescent patients. These problems may be due to asthma. You must use Soltel every day as instructed by your doctor. This will ensure the medication works correctly and controls your asthma, and will help prevent asthma attacks, including nocturnal asthma or exercise-induced asthma.
• Periodic use of Soltel will also help prevent respiratory problems associated with other lung diseases such as, for example, chronic obstructive pulmonary disease (COPD) in adult patients.
• Soltel helps prevent shortness of breath and wheezing. It does not work if you have become short of breath or wheezing and should not be used to relieve a sudden episode of shortness of breath or wheezing. In such cases, you must use a rapid-acting rescue inhaler such as salbutamol. You should carry your rapid-acting rescue inhaler with you at all times.
• The medication will be supplied in an inhaler. Inhale the medication through your mouth so that it reaches your lungs directly.

If you are receiving treatment for asthma, you must always receive Soltel and an inhaled corticosteroid (or rarely, oral corticosteroids) to use together.Both inhalers must be used regularly.

No use Soltel

• If you are allergic (hypersensitive) to salmeterol xinafoate or to any of the other components of this medication (listed in section6).
• If you are allergic to peanuts or soy, since Soltel contains lecithin.

Warnings and precautions

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

• If your asthma or breathing worsens, inform your doctor immediately.It is possible that you may experience more wheezing, feel chest tightness more often, or need to use more rescue medication with rapid action. In such cases, you should continue taking Soltel, but without increasing the number of inhalations. Your respiratory condition may worsen and you could become seriously ill. Visit your doctor or asthma specialist nurse, as you may need to have your asthma treatment changed.
• If you have been prescribed Soltel to treat your asthma, continue to use the asthma medications you are taking, including the 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 interrupt treatment with the corticosteroid inhaler (or corticosteroid tablets) when starting to use Soltel.
• Your doctor may wish to check your health more frequently if you have:

• Hyperactive thyroid gland;
• High blood pressure;
• Low levels of potassium in the blood;
• Cardiac 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 frequently than usual, and you may need to adjust your diabetes treatment.

If you are unsure whether you fall into any of the above situations, consult your doctor, nurse, or pharmacist before starting to use this medication.

Other medications and Soltel

Inform your doctor, pharmacist, or asthma specialist nurse if you are taking, have taken recently, or may need to take any other medication, including asthma medications and inhalers or those obtained without a prescription. It may not be suitable to take Soltel with other medications.

• Inform your doctor or asthma specialist nurse before using Soltel if you are receiving treatment for a fungal infection with medications containing ketoconazole or itraconazole, or for HIV with ritonavir. These medications may increase the risk of salmeterol side effects, such as irregular heartbeat, or may worsen side effects.
• 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 cardiac conditions. Inform your doctor or asthma specialist nurse 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 occurs, you may experience orn irregular heartbeat, muscle weakness, or cramps. It is more likely to occur if you are taking salmeterol with other treatments used to treat high blood pressure (diuretics) or other bronchodilators, such as salbutamol and other medications for respiratory problems, such as theophylline or corticosteroids. Your doctor may ask you to undergo blood tests to check your potassium levels occasionally. If you have any doubts, speak with your doctor or asthma specialist nurse.

Pregnancy and breastfeeding

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

Driving and operating machinery

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 soy

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

Soltel contains soy-derived lecithin. If you are allergic to soy, do not use this medication (see section2 ‘Do not use Soltel’).

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

• If you are receiving treatment for asthma, you must always receive Soltel and an inhaled corticosteroid inhaler to use them together.
• Use Soltel every day until your doctor advises you to stop treatment. Do not take more than the recommended dose. In case of doubt, ask your doctor, asthma nurse or pharmacist.
• You will start to notice that the medication works from the first day of administration.
• Do not interrupt treatment with Soltel or reduce the dose of Soltel without talking to your doctor first.

Soltel must be inhaled through the mouth until it reaches the lungs.

Children under 12 years old

The safety and efficacy of Soltel in children have not been established. There is no data available. Therefore, Soltel is not recommended or should not be used in children under 12 years old.

Recommended doses

Adults and adolescents 13 to 17 years old 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 old and over with chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema

• The recommended initial dose is 2 inhalations twice a day.
• Do not use in children or adolescents under 18 years old.

Instructions for use

Your doctor, asthma nurse or pharmacist will show you how to use your inhaler. They should check how you use it from time to time. Incorrect use of the inhaler, or not using it as prescribed or as indicated in the leaflet, may cause the medication not to work as it should and, as a result, may not help you treat your asthma or COPD.

This medication is presented 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 works correctly. Remove the mouthpiece protector by pressing it gently on both sides with your thumb and index finger and separate it.
2. To make sure it works correctly, shake it well, move the mouthpiece away from you and press the cartridge to release two puffs of air. If you have not used your inhaler for a week or more, or if you have cleaned it, release one puff of air.

Using the inhaler

It is essential to start breathing through your mouth as slowly as possible just before and during the use of the inhaler. This inhaler has been designed to be used in a vertical position and patients should stand or sit while using it. Patients should follow the instructions below and not rush through the steps while using the inhaler.

1. Remove the mouthpiece protector. Check inside and out that the mouthpiece is clean and does not contain any foreign particles (figure 1).
2. Shake the inhaler well before using it (figure 2) to ensure the elimination of any foreign particles and that the contents of the inhaler are mixed homogeneously.
3. Hold the inhaler in a vertical position with your thumb on the base of the inhaler, below the mouthpiece.
4. Exhale 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 the top of the cartridge firmly to release one puff of medication. Perform this step while continuing to breathe in deeply and constantly (figure 4).
7. Hold your breath, remove the inhaler from your mouth by releasing your thumb from the top of the inhaler. Continue holding your breath for a few seconds or as long as possible (figure 5).
8. Wait approximately half a minute between each application of the medication and then repeat steps 3 to 8.
9. After using it, replace the mouthpiece protector immediately to prevent dust and fluff from entering. The mouthpiece protector is replaced by pushing it firmly and closing it with a snap until the cap is in place.

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

Children over 12 years old or people with limited hand strength 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, asthma nurse or pharmacist can advise you.

If you find it difficult to use the inhaler, you could use a Volumatic inhalation chamber to solve this problem. Contact your doctor, asthma nurse or pharmacist. If you need to use the Volumatic inhalation chamber, consult the instructions for use provided with the chamber, which contain all the information related to the proper care and use of the chamber.

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

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

Cleaning the inhaler

To prevent blockage of your inhaler, it is essential to clean it at least once a week.

To clean your inhaler:

• Remove the mouthpiece protector.
• Do not remove themetal cartridge from the plastic casing at any time.
• Clean the inside and outside of the mouthpiece and plastic casing with a dry cloth or a paper tissue.
• Release one puff of air before the next use to check that it works.
• Replace the mouthpiece protector.

Do notimmerse the metal cartridge in water.

If you take more Soltel than you should

It is essential to use the inhaler as indicated. If you accidentally take a higher dose than recommended, you must contact your doctor, asthma nurse or pharmacist. You may notice that your heart beats faster than normal and feel tremors and/or dizziness. You may also have headaches, muscle weakness and joint pain.

If you have taken more Soltel than you should, consult your doctor, pharmacist or call the toxicology information service, phone 915620420, indicating the medication and the amount taken.

If you forget to use Soltel

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Soltel

It is very important to use Soltel every day as your doctor has indicated. Continue taking Soltel until your doctor advises you to stop treatment. Do not interrupt or suddenly reduce your dose because it may worsen your breathing.

If you have any other doubts about the use of this medication, ask your doctor, asthma nurse or pharmacist.

Like all medications, Soltel may produce side effects, although not everyone will experience them. To reduce the likelihood of side effects, your doctor will prescribe the lowest dose to control your asthma or COPD. Patients have reported the following side effects with salmeterol.

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

• Difficulty breathing.
• Runny nose or cough.
• 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 disoriented. This may cause a fainting spell or loss of consciousness.

If you experience any of these side effects or if they occur 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 100people).

Other side effects:

Frequent (may affect up to 1 in 10people)

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

Rare (may affect up to 1 in 100people)

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

Uncommon (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 undergo blood tests occasionally to check your potassium levels in the blood. If you have any doubts, consult your doctor or a specialized nurse in asthma.

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

• Difficulty breathing and wheezing may worsen immediately after using Soltel.If this occurs,discontinue treatment withSoltel.Use your rescue inhaler for quick action to help you breathe andinform your doctor immediately.
• Irregular heartbeats or an abnormally fast heart rate (arrhythmia). If this occurs, do not discontinue treatment with Soltel, but inform your doctor or a specialized nurse in asthma.
• Increased blood sugar levels (hyperglycemia). If you are diabetic, your doctor may want to monitor your blood sugar levels more frequently and adjust your usual diabetes treatment.
• Mouth ulcers or sore throat.
• Feeling unwell (nausea).
• Joint pain and swelling.
• Chest pain.

Reporting side effects

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

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the box after CAD. The expiration 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.

Like most inhaled medications in pressurized cartridges, the therapeutic effect of Soltel may decrease when the cartridge is cold.

Medications should not be disposed of through drains or in the trash. Deposit containers and medications that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Soltel

• The active ingredient is salmeterol (as xinafoate).

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

1. The other components are anhydrous ethanol, soy lecithin (E322), and the propellant, norflurano (HFA 134a).

Appearance of the product and contents of the packaging

Soltel is a homogeneous white suspension that is presented in an aluminum cartridge provided with a dosing valve and a green plastic applicator with a clear green plastic dust cover.

Each cartridge contains 120measured inhalations.

Marketing authorization holder and responsible manufacturer:

Cipla Europe NV

De Keyserlei, 60C, Bus-1301,

2018, Antwerp,

Belgium

Local representative

Cipla Europe NV subsidiary in Spain,

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

This medicine is authorized in the member states of the European Economic Area with the following names:

United Kingdom:Ospertus 25mcg per actuation pressurised inhalation, suspension

Germany:Soltel 25 Mikrogramm/Sprühstoß Druckgasinhalation, Suspension

Spain:Soltel 25 microgramos/inhalación suspension for inhalation in pressurized container

Last review date of this leaflet: August 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)