Prospecto: information for the user

Salmeterol/Fluticasona Cipla 25 micrograms/250 micrograms/inhalation, suspension for inhalation in a pressurized container

salmeterol/fluticasone propionate

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

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Salmeterol/Fluticasona Cipla and what is it used for

2.What you need to know before starting to use Salmeterol/Fluticasona Cipla

3.How to use Salmeterol/Fluticasona Cipla

4.Possible adverse effects

5.Storage of Salmeterol/Fluticasona Cipla

6.Contents of the container and additional informationl

Salmeterol/Fluticasona Cipla contains two active ingredients, salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open, making it easier for air to enter and leave. The effects last for at least 12 hours.

• Fluticasone propionate is a corticosteroid that reduces inflammation and irritation in the lungs.

Your doctor has prescribed this medication to help prevent respiratory problems such as asthma.

You must use Salmeterol/Fluticasona Cipla every day as recommended by your doctor. This will ensure the medication works correctly to control your asthma.

Salmeterol/Fluticasona Cipla helps prevent shortness of breath and wheezing. However, Salmeterol/Fluticasona Cipla should not be used to relieve a sudden attack of shortness of breath or wheezing. In such a case, you must use your quick-relief medication, such as salbutamol. You should carry your quick-relief medication with you at all times.

No use Salmeterol/Fluticasona Cipla

If you are allergic (hypersensitive) to salmeterol, fluticasone propionate or to any of the other ingredients, norflurane (HFC-134a).

Warnings and precautions

Your doctor will monitor your treatment more closely if you have any of the following conditions:

• Cardiac alterations including rapid and irregular heartbeats

• Hyperthyroidism

• High blood pressure

• Diabetes mellitus (Salmeterol/Fluticasona Cipla may increase blood sugar levels)

• Low levels of potassium in the blood

• Tuberculosis (TB) today or in the past or other lung infections.

If you have had any of these conditions, inform your doctor before using Salmeterol/Fluticasona Cipla.

• Contact your doctor if you experience blurred vision or other visual disturbances.

Use of Salmeterol/Fluticasona Cipla with other medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those acquired without a prescription. This is because, in some cases, Salmeterol/Fluticasona Cipla should not be administered with other medications.

Inform your doctor if you take the following medications, before starting to use Salmeterol/Fluticasona Cipla:

• β blockers (such as atenolol, propranolol and sotalol). β blockers are used mainly to treat hypertension or other cardiac conditions.
• Medications to treat infections (such as ritonavir, ketoconazole, itraconazole and erythromycin).
• Some of these medications may increase the amount of fluticasone propionate or salmeterol in your body. This may increase your risk of experiencing adverse effects with Salmeterol/Fluticasona Cipla, including irregular heartbeats, or may worsen the adverse effects.
• Corticosteroids (oral or injectable). If you have taken these medications recently, this may increase the risk that this medication will affect your adrenal gland.
• Diuretics, also known as medications to urinate, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medications containing xanthine. They are often used to treat asthma.
• Some medications may increase the effects of Salmeterol/Fluticasona Cipla, so your doctor will make meticulous checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Salmeterol/Fluticasona Cipla is unlikely to affect your ability to drive or operate machinery.

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

Adults and adolescents 12 years and older

Children under 12 years of age

Your symptoms may be well controlled using Salmeterol/Fluticasona Cipla twice a day. If so, your doctor may decide to reduce your dose to once a day. The dose may change to:

It is very important that you follow your doctor's instructions on how many applications and how often you should administer them.

If you are using Salmeterol/Fluticasona Cipla to treat asthma, your doctor will want to monitor your symptoms regularly.

If your asthma worsens or you have greater difficulty breathing, see your doctor immediately. You may notice more wheezing or a feeling of choking more often or that you have to use your rescue medication more frequently. If any of these things happen, you should continue using Salmeterol/Fluticasona Cipla, but do not increase the number of applications. Your respiratory disease may worsen and seriously harm you. See your doctor, as you may need additional treatment.

Instructions for use

Each time you activate the inhaler, one application will be released and the counter will decrease by one unit.

Checking the inhaler

1. If you are using the inhaler for the first time, check that it works properly. Remove the mouthpiece protector by pressing it gently on both sides with your thumb and index finger and pulling it off.

2. To make sure it works, shake the inhaler well, direct the mouthpiece away from you, and press the cartridge down to release one application into the air. Repeat these steps, shaking the inhaler before releasing each application, until the counter marks 120. If you have not used the inhaler for a week or more, release two applications of the medication into the air.

Using the inhaler

It is essential to start inhaling as slowly as possible just before using the inhaler.

1. It is recommended that you stand or sit upright while using the inhaler.

2. Remove the mouthpiece protector (as shown in the figure). Check inside and out that the mouthpiece is clean and free of any foreign particles (figure A).

3. Shake the inhaler 4 or 5 times to ensure the removal of any foreign particles and that the contents of the inhaler are well mixed (figure B).

4. Hold the inhaler in a vertical position with your thumb on the base of the inhaler, below the mouthpiece. Exhale as much air as possible (figure C).

5. Place the mouthpiece in your mouth, between your teeth. Close your lips around the mouthpiece. Do not bite it (figure D).

6. Take a deep breath in through your mouth slowly and deeply. Immediately after starting to breathe in, press firmly on the top of the inhaler to release the medication. Do this while continuing to breathe in deeply and constantly (figure D).

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, as long as possible (figure D).

8. Wait approximately half a minute between each application of the medication and then repeat steps 3-7.

9. After using it, rinse your mouth with water and spit it out and/or brush your teeth. This will help prevent mouth ulcers and hoarseness.

10. After using it, always put the mouthpiece protector back on immediately, to preserve it from dust. When the protector is put back on correctly, it will make a "click" sound. If it does not make a "click" sound, turn the protector around, put it back on, and try again. Do not use excessive force.

Take your time in steps 4, 5, 6, and 7. It is essential to breathe out as slowly as possible just before using the inhaler. The first time you use the inhaler, you should use it in front of a mirror. If you see "fog" coming out of the top of the inhaler or from the sides of your mouth, you should start again from step 3.

If you or your child find it difficult to use the inhaler, your doctor, nurse, or other healthcare professional may recommend using the inhaler with a spacer device, such as Volumatic or AeroChamber Plus. Your doctor, nurse, pharmacist, or other healthcare professional should show you how to use the spacer device with your inhaler, how to maintain your spacer device, and answer any questions you may have. If you are using the spacer device with your inhaler, it is essential that you do not stop using it without consulting your doctor or nurse first. Also, it is essential that you do not change the type of spacer device you are using without consulting your doctor. If you stop using the spacer device or change the type of spacer device, your doctor may need to change the dose of medication needed to control your asthma. Always consult your doctor before making any changes to your asthma treatment.

Some people with limited hand strength 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.

You should get a replacement inhaler when the indicator marks 40 and changes from green to red. Stop using the inhaler when the indicator marks 0, as the remaining applications in the cartridge may not be enough to complete a dose. Never try to modify the indicator or remove it from the metal cartridge.

Cleaning the inhaler

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

To clean your inhaler:

Do not immerse the metal cartridge in water.

If you use more Salmeterol/Fluticasona Cipla than you should

It is very important to use the inhaler as instructed. If you accidentally take a higher dose than recommended, consult your doctor or pharmacist. You may notice that your heart beats faster than normal and feel tremors. You may also have headaches, dizziness, muscle weakness, and joint pain.

If you have used high doses for a long time, you should ask your doctor or pharmacist for advice. This is because high concentrations of Salmeterol/Fluticasona Cipla may reduce the amount of steroid hormones produced by the adrenal gland.

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

If you forget to use Salmeterol/Fluticasona Cipla

Do not take a double dose to compensate for the missed doses. Take the next dose at the usual time.

If you interrupt treatment with Salmeterol/Fluticasona Cipla

It is very important to use Salmeterol/Fluticasona Cipla every day as instructed.Continue taking it until your doctor tells you to stop. Do not stop using Salmeterol/Fluticasona Cipla abruptly.Your breathing may worsen.

Additionally, if you stop taking Salmeterol/Fluticasona Cipla suddenly or reduce your dose, you may (rarely) cause problems with your adrenal gland (adrenal insufficiency), which sometimes causes adverse effects.

These adverse effects may include any of the following:

When your body is under stress, such as fever, trauma (e.g., car accident), infection, or surgery, adrenal insufficiency may worsen and you may experience any of the adverse effects listed above.

If you experience any adverse effects, consult your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe an additional dose of corticosteroids in tablets during that time (such as prednisolone).

If you have any other questions about using this medication, ask your doctor, nurse, or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them. To reduce the occurrence of side effects, your doctor will prescribe the lowest dose of Salmeterol/Fluticasona Cipla that controls your asthma.

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using Salmeterol/Fluticasona Cipla.You may experience wheezing and coughing or shortness of breath. You may also notice itching, hives (urticaria), and swelling (usually of the face, lips, tongue, or throat). You may also feel, suddenly, that your heart is beating very fast, feel like you are losing consciousness, and dizziness (which can lead to collapse or loss of consciousness).If you experience any of these effects or if they appear suddenly after using Salmeterol/Fluticasona Cipla, stop taking Salmeterol/Fluticasona Cipla and inform your doctor immediately.Allergic reactions to Salmeterol/Fluticasona Cipla are rare (affect less than 1 in 100 people).

The following are other side effects:

Very common (may affect more than 1 in 10 people)

• Headache, usually improves with continued treatment.
• An increase in the number of colds in patients with COPD has been reported.

Common (may affect less than 1 in 10 people)

• Stomatitis (itching, appearance of yellowish cream-colored ulcers) in the mouth and throat. Also, tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing teeth immediately after each dose of medication may help. Your doctor may prescribe antifungal medication for the treatment of stomatitis.
• Joint pain, inflammation, and muscle pain.
• Muscle cramps.

The following side effects have been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

COPD:

• Pneumonia and bronchitis (pulmonary infection). Inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum color, fever, chills, increased cough, increased difficulty breathing.
• Osteoporosis and fractures.
• Pharyngitis (inflammation of the sinuses, sensation of tension or congestion in the nose, cheeks, and behind the eyes, sometimes with a pulsating pain).
• Reduced potassium levels in the blood (may feel irregular heartbeats, muscle weakness, cramps).

Rare (may affect less than 1 in 100 people)

• Increased blood sugar levels (hyperglycemia). If you have diabetes, you will need to monitor your blood sugar levels more frequently and adjust your usual diabetes treatment as needed.
• Cataracts (opacity of the crystalline lens of the eye).
• Very fast heart rate (tachycardia).
• Feeling tremors and a very fast or irregular heart rate (palpitations). These side effects are usually harmless and decrease when treatment continues.
• Chest pain.
• Feeling anxious (mainly occurs in children).
• Sleep disturbances.
• Dermatological eruption.
• Allergic eruption on the skin.

Rare (may affect less than 1 in 1,000 people)

• Difficulty breathing or wheezing that worsens immediately after using Salmeterol/Fluticasona Cipla. If this happens, stop using Salmeterol/Fluticasona Cipla. Use your quick-relief inhaler to improve your breathing and inform your doctor immediately.
• Salmeterol/Fluticasona Cipla may increase normal cortisol production, particularly if you have been taking high doses for long periods of time. The effects include:
• • Delayed growth in children and adolescents.
  • Decreased bone mineral density.
  • Glaucoma.
  • Weight gain.
  • Rounded face (moon-shaped) (Cushing's syndrome).
• Your doctor will regularly monitor any of these side effects and ensure that you are taking the lowest dose of Salmeterol/Fluticasona Cipla to control your asthma.
• Changes in behavior, such as hyperactivity and irritability (these effects occur mainly in children).
• Irregular heartbeats or extra heartbeats (arrhythmias). Consult your doctor, but do not stop taking Salmeterol/Fluticasona Cipla unless your doctor tells you to.
• Fungal infection of the esophagus (throat), which can cause difficulty swallowing.

Unknown frequency, but may also occur:

• Depression or aggression. It is more likely that these effects will occur in children.
• Blurred vision.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 Salmeterol/Fluticasona Cipla Inhaler after the expiration date that appears on the label and on the case after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

The cartridge contains pressurized liquid. Do not expose to temperatures above 50°C, protect from direct sunlight. Do not pierce or burn the cartridge even if it is empty.

As with most medications administered via inhalation in pressurized cartridges, the therapeutic effect may decrease if the cartridge cools down.

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

Salmeterol/Fluticasona Cipla Composition

Each pressurized dose contains: 25 micrograms of salmeterol (as xinafoate of salmeterol) and 250 micrograms of propionato of fluticasona.

This medicine contains fluorinated greenhouse gases.

Each inhalator contains 12.5 g of HFC-134a (norflurano) corresponding to 0.018 tons of CO2equivalent to (global warming potential PCG= 1430).

Product appearance and packaging contents

• Fluorocarbon polymer (FCP) cartridge provided with a suitable dosing valve and a polipropylene applicator, provided with a protective cap with a dose indicator.
• Each cartridge contains 120 doses.

Marketing authorization holder and 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

Last review date of this leaflet:January 2025

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