Salmeterol/fluticasone Cipla 25 micrograms/125 micrograms/inhalation suspension for inhalation in pressurised container

Patient Information Leaflet

Introduction

Patient Information Leaflet

Salmeterol/Fluticasone Cipla 25 micrograms/125 micrograms/inhalation, pressurized inhalation suspension

salmeterol/fluticasone propionate

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, ask your doctor 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

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

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

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

Your doctor has prescribed this medicine to help prevent breathing problems such as asthma.

You must use Salmeterol/Fluticasona Cipla every day as directed by your doctor. This will ensure the medicine works properly to control your asthma.

Salmeterol/Fluticasona Cipla helps prevent breathlessness and wheezing. However, Salmeterol/Fluticasona Cipla must not be used to relieve a sudden attack of breathlessness or wheezing. In such cases, you must use your "rescue" medicine with fast action, such as salbutamol. You must always carry your fast-acting rescue medicine with you.

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

Do not use Salmeterol/Fluticasona Cipla

If you are allergic (hypersensitive) to salmeterol, fluticasone propionate, or 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:

• Heart problems, including rapid or irregular heartbeat
• Overactive thyroid
• High blood pressure
• Diabetes mellitus (Salmeterol/Fluticasona Cipla may increase blood sugar levels)
• Low levels of potassium in the blood
• Tuberculosis (TB), either currently 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 medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. This is because, in some cases, Salmeterol/Fluticasona Cipla should not be used together with certain medicines.

Inform your doctor if you are taking any of the following medicines before starting Salmeterol/Fluticasona Cipla:

• β-blockers (such as atenolol, propranolol, and sotalol). β-blockers are mostly used to treat high blood pressure or other heart conditions.

• Medicines to treat infections (such as ritonavir, ketoconazole, itraconazol, and erythromycin).

• Some of these medicines 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 side effects.

• Corticosteroids (oral or injectable). If you have recently taken these medicines, this may increase the risk of this medicine affecting your adrenal gland.

• Diuretics, also known as "water pills," used to treat high blood pressure.

• Other bronchodilators (such as salbutamol).

• Medicines containing xanthines. These are often used to treat asthma.

• Some medicines may increase the effects of Salmeterol/Fluticasona Cipla, so your doctor will monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

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

Driving and using machines

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

3. How to use Salmeterol/Fluticasone Cipla

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

• Use Salmeterol/Fluticasone Cipla every day, until your doctor tells you to stop. Do not take more than the recommended dose. If in doubt, consult your doctor or pharmacist.

  • Do not stop taking Salmeterol/Fluticasone Cipla or reduce your dose without first speaking to your doctor.
  • Salmeterol/Fluticasone Cipla must be inhaled through the mouth into the lungs.

• Adults and adolescents aged 12 years and older

  • Salmeterol/Fluticasone Cipla 25/125 micrograms: 2 actuations twice daily
  • Salmeterol/Fluticasone Cipla 25/250 micrograms: 2 actuations twice daily

• Children under 12 years of age

  • Salmeterol/Fluticasone Cipla is not recommended for use in children under 12 years of age.

Your symptoms may become well controlled with Salmeterol/Fluticasone Cipla used twice daily. If so, your doctor may decide to reduce your dose to once daily. The dose may change to:

• once at night if you have nocturnal symptoms,
• once in the morning if you have diurnal symptoms.

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

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

If your asthma worsens or you have increasing difficulty breathing, see your doctor immediately. You may notice more wheezing or breathlessness more often, or find that you need to use your fast-acting rescue medication more frequently. If any of these occur, you should continue using Salmeterol/Fluticasone Cipla, but do not increase the number of actuations. Your respiratory condition may worsen and you could become seriously ill. See your doctor, as you may need additional treatment.

Instructions for use

• Your doctor, nurse, or pharmacist should show you how to use your inhaler. They should periodically check that you are using it correctly. Incorrect or improper use of the Salmeterol/Fluticasone Cipla inhaler may result in your asthma not improving as expected.

• The medicine is contained in a pressurized cartridge inside a plastic casing with a mouthpiece.

• The inhaler has a counter on the back indicating how many actuations remain.

Each time you actuate the inhaler, one dose is released and the counter decreases by one unit.

• Be careful not to drop the inhaler, as this may cause the counter to decrease by one unit.

Checking the inhaler

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

2. To ensure it works, shake the inhaler well, point the mouthpiece away from you, and press down on the cartridge to release one actuation into the air. Repeat these steps, shaking the inhaler before releasing each actuation, until the dose counter reads 120. If your inhaler has not been used for one week or longer, release two actuations of the medicine into the air.

Using the inhaler

It is important to begin inhaling as slowly as possible just before using your inhaler.

1. It is advisable to stand or sit upright while using the inhaler.
2. Remove the mouthpiece cover (as shown in figure). Check inside and outside the mouthpiece to ensure it is clean and free from foreign particles (Figure A).

1. Shake the inhaler 4 or 5 times to ensure any foreign particles are removed and the contents of the inhaler are properly mixed (Figure B).

1. Hold the inhaler vertically with your thumb at the base of the inhaler, below the mouthpiece. Breathe out as much air as possible (Figure C).

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

1. Breathe in slowly and deeply through your mouth. Immediately after starting to inhale, press firmly on the top of the inhaler to release the medicine. Do this while continuing to inhale deeply and steadily (Figure D).

2. Hold your breath, remove the inhaler from your mouth, and remove your finger from the top of the inhaler. Continue holding your breath for a few seconds, as long as possible (Figure D).

1. Wait approximately half a minute between each actuation of the medicine, then repeat steps 3 to 7.

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

3. After use, always replace the mouthpiece cover immediately to protect it from dust. When the mouthpiece cover is correctly placed, it will make a "click" sound. If it does not click, rotate the mouthpiece cover, turn it around, and try again. Do not use excessive force.

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

If you or your child finds 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 a spacer device with your inhaler, it is important that you do not stop using it without first consulting your doctor or nurse. It is also important 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 adjust the dose of medicine required to control your asthma. Always consult your doctor before making any changes to your asthma treatment.

Some people with weak 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 at the base, below the mouthpiece.

Obtain a replacement inhaler when the counter turns from green to red at 40. Stop using the inhaler when the counter reads 0, as the remaining actuations in the cartridge may not be sufficient to deliver a complete dose. Never attempt to alter the counter numbering or remove the counter from the metal cartridge.

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 the plastic casing with a dry cloth.

• Replace the mouthpiece cover. It will make a "click" when properly in place. If it does not click, rotate the mouthpiece cover, turn it around, and try again. Do not use excessive force.

Do not immerse the metal cartridge in water.

If you use more Salmeterol/Fluticasone Cipla than you should

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

If you have used large doses over long periods, you should seek advice from your doctor or pharmacist. This is because high concentrations of Salmeterol/Fluticasone Cipla may reduce the amount of steroid hormones produced by the adrenal gland.

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use Salmeterol/Fluticasone Cipla

Do not take a double dose to make up for a missed dose. Take the next dose at your usual time.

If you stop treatment with Salmeterol/Fluticasone Cipla

It is very important that you use Salmeterol/Fluticasone Cipla every day as directed. Continue taking it until your doctor tells you to stop. Do not stop your treatment with Salmeterol/Fluticasone Cipla abruptly. This could cause your breathing to worsen.

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

These adverse effects may include any of the following:

• Stomach pain
• Tiredness and loss of appetite, feeling unwell
• Malaise and diarrhea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Hypotension and seizures (fits).

When your body is under stress, such as fever, trauma (e.g., traffic accident), infection, or surgery, adrenal insufficiency may worsen, and you could 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 corticosteroid tablets during that time (such as prednisolone).

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. To reduce the occurrence of adverse 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, coughing, or shortness of breath. You may also notice itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). You may suddenly feel your heart beating very fast, feel faint, dizzy (which may 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 contact your doctor immediately. Allergic reactions to Salmeterol/Fluticasona Cipla are uncommon (affecting fewer than 1 in 100 people).

Other adverse effects listed below:

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

• Headache, which usually improves with continued treatment.
• An increased incidence of colds has been reported in patients with COPD.

Common (may affect fewer than 1 in 10 people)

• Oral thrush (itching, appearance of creamy-yellow ulcers) in the mouth and throat. Also, pain in the tongue, hoarseness, and throat irritation. Rinsing your mouth with water and spitting it out and/or brushing your teeth immediately after each dose of medication may help. Your doctor may prescribe antifungal medication to treat thrush.
• Pain, swelling in the joints, and muscle pain.
• Muscle cramps.

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

• Pneumonia and bronchitis (lung infection). Inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum color, fever, chills, increased coughing, or increased difficulty breathing.
• Bruising and fractures.
• Sinus inflammation (feeling of pressure or congestion in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased blood potassium levels (you may feel irregular heartbeats, muscle weakness, or cramps).

Uncommon (may affect fewer than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). If you have diabetes, your blood sugar levels will need to be monitored more frequently, and your usual diabetes treatment may need to be adjusted if necessary.
• Cataracts (clouding of the eye's lens).
• Very fast heart rate (tachycardia).
• Tremors and a fast or irregular heartbeat (palpitations). These adverse effects are usually harmless and decrease with continued treatment.
• Chest pain.
• Feeling anxious (occurs mainly in children).
• Sleep disorders.
• Skin rash.
• Allergic skin rash.

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

• Breathing difficulties or wheezing that worsen immediately after using Salmeterol/Fluticasona Cipla. If this happens, stop using Salmeterol/Fluticasona Cipla. Use your fast-acting "rescue" inhaler to improve your breathing and contact your doctor immediately.
• Salmeterol/Fluticasona Cipla may increase the normal production of steroid hormones, particularly if you have been taking high doses for long periods. Effects include:
• Delayed growth in children and adolescents.
• Decreased bone mineral density.
• Glaucoma.
• Weight gain.
• Rounded face (moon-shaped face) (Cushing's syndrome).
• Your doctor will regularly monitor for any of these adverse effects and ensure you are taking the lowest effective 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 may cause difficulty swallowing.

Frequency not known, but may also occur:

• Depression or aggression. These effects are more likely to occur in children.
• Blurred vision.

Reporting of adverse effects

If you experience any adverse effect, consult 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Salmeterol/Fluticasone Cipla

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

Do not use Salmeterol/Fluticasone Cipla Inhaler after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

As with most inhaled medicines delivered via pressurised canisters, the therapeutic effect may decrease if the canister becomes cold.

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

6. Contents of the pack and other information

Composition of Salmeterol/FluticasonaCipla

Each metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 125 micrograms of fluticasone propionate.

This medicinal product contains fluorinated greenhouse gases.

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

Nature of the product and contents of the pack

• A fluorocarbon polymer (FCP) canister equipped with a suitable metering valve and a polypropylene actuator, fitted with a protective cap and a dose indicator.
• Each canister contains 120 doses.

Marketing Authorization Holder and Manufacturer

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp

Belgium

Local representative

Cipla Europe NV, Spanish branch,

Guzmán el Bueno Street, 133, Edif. Britannia - 28003 - Madrid, Spain

Date of the most recent revision of the leaflet: January 2025

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