SALMETEROL/FLUTICASONE CIPLA 25 micrograms/250 micrograms INHALATION SUSPENSION in pressurized container

Introduction

Package Leaflet: Information for the User

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

salmeterol/fluticasone propionate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

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

• Salmeterol is a long-acting bronchodilator. Bronchodilators help to keep the airways in the lungs open, making it easier to breathe in and out. 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 medicine to help prevent breathing problems such as asthma.

You should use Salmeterol/Fluticasone Cipla every day, as your doctor has recommended. This will ensure that the medicine works correctly to control your asthma.

Salmeterol/Fluticasone Cipla helps to prevent shortness of breath and wheezing. However, Salmeterol/Fluticasone Cipla should not be used to relieve a sudden attack of shortness of breath or wheezing. In such cases, you should use your "rescue" medication, such as salbutamol. You should always carry your quick-acting rescue medication with you.

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

Do not use Salmeterol/Fluticasone Cipla

If you are allergic (hypersensitive) to salmeterol, fluticasone propionate, or any of the other ingredients of this medicine.

Warnings and precautions

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

• Heart problems, including fast or irregular heartbeat

• Overactive thyroid gland

• High blood pressure

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

• Low levels of potassium in the blood

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

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

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

Using Salmeterol/Fluticasone Cipla with other medicines

Tell 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/Fluticasone Cipla should not be used with other medicines.

Tell your doctor if you are taking any of the following medicines before starting to use Salmeterol/Fluticasone Cipla:

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

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

• Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This may increase your risk of side effects with Salmeterol/Fluticasone Cipla, including irregular heartbeats, or may worsen side effects.

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

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

• Other bronchodilators (such as salbutamol).

• Medicines that contain xanthines. These are often used to treat asthma.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Salmeterol/Fluticasone Cipla is unlikely to affect your ability to drive or use machines.

3. How to use Salmeterol/Fluticasone Cipla

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 again.

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

• Do not stop taking Salmeterol/Fluticasone Cipla or reduce your dose without talking to your doctor first.

• Salmeterol/Fluticasone Cipla should be inhaled through the mouth into the lungs.

Adults and adolescents 12 years and older

• Salmeterol/Fluticasone Cipla 25/125 micrograms 2 inhalations twice daily

• Salmeterol/Fluticasone Cipla 25/250 micrograms 2 inhalations 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 be well-controlled using Salmeterol/Fluticasone Cipla twice daily. If this is the case, your doctor may decide to reduce your dose to once daily. The dose may be changed to:

• once at night if you have night-timesymptoms,

• once in the morning if you have day-timesymptoms

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

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

If your asthma gets worse or you have more difficulty breathing, see your doctor immediately. You may notice more wheezing or shortness of breath more often, or you may need to use your quick-acting rescue medication more frequently. If any of these things happen, you should continue to use Salmeterol/Fluticasone Cipla, but do not increase the number of inhalations. Your lung disease may be getting worse, and you may 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 check how you use it from time to time. Not using Salmeterol/Fluticasone Cipla inhaler correctly or as prescribed may mean that your asthma does not improve as it should.

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

• The inhaler has a counter on the back that shows how many inhalations are left.

Each time you activate the inhaler, one inhalation is released, and the counter decreases by one.

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

Checking the inhaler

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

1. To make sure it works, shake the inhaler well, point the mouthpiece away from you, and press the canister down to release one inhalation into the air. Repeat these steps, shaking the inhaler before releasing each inhalation, until the counter shows 120. If you have not used your inhaler for a week or more, release two inhalations into the air.

Using the inhaler

It is important to start breathing in as slowly as possible just before using your inhaler.

1. It is recommended that you stand or sit upright while using the inhaler.
2. Remove the mouthpiece cover (as shown in the figure). Check inside and outside that the mouthpiece is clean and free from any foreign objects (Figure A).

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

1. Hold the inhaler in an upright position with your thumb on the base of the inhaler, below the mouthpiece. Breathe out as much as you can (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 breathe in, press the top of the inhaler firmly to release the medicine. Continue to breathe in slowly and deeply (Figure D).

1. Hold your breath, remove the inhaler from your mouth by taking your finger off the top of the inhaler. Continue to hold your breath for a few seconds, as long as you can (Figure D).

1. Wait for about half a minute between each inhalation of the medicine, and then repeat steps 3 to 7.

1. After use, rinse your mouth with water and spit it out and/or brush your teeth. This will help prevent the appearance of mouth ulcers and hoarseness.

1. After use, always replace the mouthpiece cover immediately, to protect it from dust. When the mouthpiece cover is replaced correctly, it will click. If it does not click, turn the mouthpiece cover, put it back on, and try again. Do not use excessive force.

Do not put the metal canister in water.

If you use more Salmeterol/Fluticasone Cipla than you should

It is very important to use the inhaler as directed. If you accidentally take a higher dose than recommended, talk to your doctor or pharmacist. You may notice that your heart beats faster than normal, and you may feel shaky. You may also get a headache, feel dizzy, weak, or have muscle pain.

If you have used high doses for long periods, you should ask your doctor or pharmacist for advice. This is because high levels of Salmeterol/Fluticasone 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, stating the medicine and the amount taken.

If you forget to use Salmeterol/Fluticasone Cipla

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

If you stop using Salmeterol/Fluticasone Cipla

It is very important that you use Salmeterol/Fluticasone Cipla every day, as directed. Continue to use it until your doctor tells you to stop. Do not stop using Salmeterol/Fluticasone Cipla suddenly.This could make your breathing worse.

Also, if you stop taking Salmeterol/Fluticasone Cipla suddenly or reduce your dose, you may (very rarely) get problems with your adrenal gland (adrenal insufficiency), which can sometimes cause side effects.

These side effects may include:

• Stomach pain

• Tiredness and loss of appetite, feeling unwell
• Discomfort and diarrhea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Low blood pressure and seizures (fits).

When your body is under stress, such as during fever, injury (e.g., car accident), infection, or surgery, adrenal insufficiency may worsen, and you may get any of the above side effects.

If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe a higher dose of corticosteroids in tablets during this time (such as prednisolone).

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

4. Possible Adverse Effects

Like all medicines, this medicine may cause adverse effects, although not all people suffer from them. To reduce the appearance 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 suffer from wheezing and coughing or shortness of breath. You may also notice itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel 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 adverse effects:

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

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

Common (may affect less than 1 in 10 people)

• Thrush (itching, appearance of yellowish-white ulcers) in the mouth and throat. Also, pain in the tongue, hoarse voice, and throat irritation. Rinsing your mouth with water and spitting it out and/or brushing your teeth immediately after each dose of medicine may help. Your doctor may prescribe antifungal medication for the treatment of thrush.
• Pain, inflammation 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 production of sputum, change in the color of sputum, fever, chills, increased coughing, increased difficulty breathing.
• Bruises and fractures.
• Sinusitis (feeling of tension or congestion in the nose, cheeks, and behind the eyes, sometimes with a pulsating pain).
• Decreased potassium levels in the blood (you may feel irregular heartbeats, muscle weakness, cramps).

Uncommon (may affect less than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). If you have diabetes, you will need to monitor your blood sugar levels more frequently and adjust your usual diabetic treatment if necessary.
• Cataracts (opacity of the eye lens).
• Very fast heart rate (tachycardia).
• Feeling tremors and a fast or irregular heartbeat (palpitations). These adverse effects are usually harmless and decrease when treatment is continued.
• Chest pain.
• Feeling of anxiety (occurs mainly in children).
• Sleep disorders.
• Skin rash.
• Allergic skin rash.

Rare (may affect less 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 rapid-acting "rescue" inhaler to improve your breathing and inform 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. The effects include:
• • Delayed growth in children and adolescents.
  • Decreased bone mineral density.
  • Glaucoma.
  • Weight gain.
  • Rounded face (moon face) (Cushing's syndrome).
• Your doctor will regularly monitor any of these adverse 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 do so.
• Fungal infection in the esophagus (throat), which can 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 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: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Salmeterol/Fluticasona Cipla

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

Do not use Salmeterol/Fluticasona Cipla Inhaler after the expiration date stated on the label and carton after CAD. The expiration date is the last day of the month indicated.

Do not store 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 pressurized inhalation medicines, the therapeutic effect may decrease if the cartridge is cooled.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Salmeterol/Fluticasona Cipla

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

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).

Appearance of the Product and Package Contents

• Fluorocarbon polymer (FCP) cartridge with a metered valve and polypropylene applicator, with a protective cap and 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, Spanish branch,

C/ Guzmán el Bueno, 133 Edif Britannia-28003- Madrid

Date of Last Revision of this Leaflet:January 2025

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