SALMETEROL/FLUTICASONE CIPLA 50 micrograms/500 micrograms inhalation powder (single dose)

Introduction

Patient Information Leaflet

Salmeterol/Fluticasone Cipla 50 micrograms/500 micrograms/inhalation, powder for inhalation (single-dose)

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Salmeterol/Fluticasone Cipla is and what it is 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. Package contents and further information

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

This medication 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 for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces irritation and inflammation in the lungs.

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

? Asthma.

? Chronic Obstructive Pulmonary Disease (COPD). This medication at a dose of 50/500 micrograms reduces the number of symptom exacerbations of COPD.

You should use this medication every day as your doctor has recommended. This will ensure that the medication works correctly to control your asthma or COPD.

Salmeterol/Fluticasone Cipla helps prevent shortness of breath and wheezing. However, this medication should not be used to relieve a sudden attack of shortness of breath or wheezing. In such cases, you should use your fast-acting "rescue" medication, such as salbutamol. You should always carry your fast-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 allergicto salmeterol, fluticasone propionate or to any other component of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Salmeterol/Fluticasone Cipla if you have:

• heart problems including fast or irregular heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes mellitus (salmeterol/fluticasone may increase blood sugar levels),
• low potassium levels in the blood,
• tuberculosis (TB) now or in the past or other lung infections.

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

Children and adolescents

Salmeterol/fluticasone should not be used in children under 12 years of age.

COPD

Salmeterol/fluticasone should not be used in children and adolescents.

Using Salmeterol/Fluticasone Cipla with other medications

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medications, including medications for asthma or any other medication without a prescription. The reason is that, in some cases, salmeterol/fluticasone should not be administered with other medications.

Tell your doctor if you are taking any of the following medications before starting to use this medication:

• medications to treat high blood pressure, heart disease or other conditions, with active ingredients that end in "olol" (beta-blockers), such as atenolol, propranolol and sotalol,
• medications to treat viruses including some medications for HIV, such as ritonavir or medications containing cobicistat. These medications may increase the effects of salmeterol/fluticasone, including irregular heartbeats, or may worsen side effects. Your doctor may want to monitor you closely if you are taking these medications,
• medications to treat infections such as ketoconazole, itraconazole and erythromycin,
• corticosteroids that are taken orally or injected: if you have taken these medications recently, you may be at increased risk of this medication affecting your adrenal gland.
• diuretics, also known as water pills, used to treat high blood pressure,
• other bronchodilators (such as salbutamol),
• medications that contain xanthine. They are often used to treat asthma.

Pregnancy, breastfeeding and fertility

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 taking this medication. Your doctor will tell you if you can use this medication during this time.

Driving and using machines

It is unlikely that salmeterol/fluticasone will affect your ability to drive or use machines.

Salmeterol/Fluticasone Cipla contains lactose

This medication contains lactose. It may cause allergic reactions in patients with cow's milk protein allergy.

If your doctor has told you that you have an intolerance to some sugars, consult with them before using this medication.

3. How to use Salmeterol/Fluticasone Cipla

Always use this medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

• Use this medication 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 this medication or reduce the dose without talking to your doctor first.
• This medication should be inhaled through the mouth into the lungs.
• You may not be able to taste or feel the powder on your tongue, even if you have used the medication correctly.

• Asthma

The recommended dose for adults and children over 12 years of ageis:

One inhalation twice a day.

• Chronic Obstructive Pulmonary Disease

The recommended dose for adultsis:

One inhalation twice a day.

If your symptoms are well controlled using Salmeterol/Fluticasone Cipla twice a day, your doctor may decide to reduce your dose to once a day:

• once at night if you have nighttime symptoms,
• once in the morning if you have daytime symptoms.

It is very important that you follow your doctor's instructions about how many applications and how often you should take your medication.

If you are using this medication 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 that you need to use your fast-acting rescue medication more frequently. If any of these things happen, you should continue to use this medication, but do not increase the number of applications. Your respiratory disease may get worse and you may become seriously ill. See your doctor, as you may need additional treatment.

If you do not use Salmeterol/Fluticasone Cipla correctly or as prescribed, your breathing difficulties may get worse. For optimal treatment, you should use Salmeterol/Fluticasone Cipla daily, even if you do not have symptoms.

Instructions for use

Your doctor, nurse or pharmacist should teach you how to use your inhaler and periodically check how you use it.

The inhaler contains 60 doses of medication in powder form in a rolled-up aluminum strip. It has a dose counter that shows how many doses are left in descending order from 60 to 0. When the last 10 doses are reached, the numbers appear on a red background.

The inhaler is not rechargeable, it must be replaced when empty and replaced with a new one.

Before using the inhaler:

• Open the transparent lateral chamber of the inhaler.
• Cut the aluminum strip that protrudes from the lateral chamber by carefully pulling the strip against the "teeth" of the lateral chamber as shown below. Do not pull or tear it with force.

• Close the lateral chamber and discard the used strip.

Important: As the inhaler is used, the lateral chamber will gradually fill with the used aluminum strip. The aluminum strips with black lines do not contain medication. Eventually, the numbered sections of the strip will appear in the lateral chamber. There should never be more than 3 sections of the aluminum stripin the lateral chamber, as this can cause the inhaler to jam. The excess strip should be carefully cut and left in a safe place.

Using the inhaler:

Hold the inhaler with your hands, as shown in the images.

1. Opening

• Openthe protective cap downwardsso that the mouthpiece appears.
• Check the dose counter to see how many doses are left.

1. Dose preparation

• Lift the white lever up. Make sure the lateral chamber is closed.

Remember: You should only manipulate the white lever when you are ready to inhale your dose of medication. If you play with the white lever, you will waste doses.

• Opening: The white lever should be lifted completelyuntil it reaches its stop and until it clicks. This action moves a new dose to its position with its corresponding number at the top of the counter.

• Closing: Then, close the white leveruntil it clicks again in its original position. This way, the inhaler is ready for immediate use.

1. Inhaling the dose

• With the inhaler mouthpiece away from your mouth, exhale as much as you can or until you feel comfortable. Never exhale directly over the inhaleras this can affect the dose.
• Hold the inhaler with the protective cap facing downwards.
• Close your lips firmly around the mouthpiece.
• Inhale deeply and continuously through the inhaler, not through your nose.

• Remove the inhaler from your mouth and hold your breath for 5 to 10 secondsor as long as you can without discomfort.
• Then, start breathing slowly, but outside the inhaler.
• Close the protective cap of the mouthpiece.
• Rinse your mouth with water and spit it out. This can help prevent fungal infections in the mouth and hoarseness.

Cleaning

• If necessary, the outside of the mouthpiece can be cleaned with a dry cloth.
• Never separate the parts of the inhaler to clean them or for any other purpose!
• The parts of the inhaler cannot be cleaned with water or wet cloths as moisture can affect the dose!
• Never insert pins or any other sharp object into the mouthpiece or any other part, as this can damage your inhaler!

If you use more Salmeterol/Fluticasone Cipla than you should

It is very important to use the inhaler as directed. If you have accidentally taken a higher dose than recommended, consult your doctor or pharmacist.

The symptoms of overdose are:

• dizziness,
• headache,
• rapid heartbeat,
• muscle weakness,
• joint pain,
• feeling of tremors.

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

It is important that you take your dose as directed by your pharmacist or as prescribed by your doctor. Do not increase or decrease your dose without your doctor's consent.

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/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

Do not stop using Salmeterol/Fluticasone Cipla suddenly or reduce your dose without your doctor's consent, as this may cause your respiratory problems to get worse.

Additionally, if you stop taking this medication suddenly or reduce your dose, you may (very rarely) experience problems with your adrenal gland (adrenal insufficiency), which can sometimes cause side effects.

These side effects may include any of the following:

• stomach pain,
• fatigue and loss of appetite, feeling sick,
• discomfort and diarrhea,
• weight loss,
• headache or drowsiness,
• low blood sugar levels,
• low blood pressure and seizures (fits).

Very rarely, if you have an infection or experience extreme stress (such as fever, trauma and infection, after a serious accident or if you have undergone surgery), you may experience similar side effects. To prevent these symptoms from occurring, your doctor may prescribe you additional corticosteroids (such as prednisolone).

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can 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 this medicine that controls your asthma or COPD.

Allergic Reactions: you may notice that your breathing suddenly worsens immediately after using Salmeterol/Fluticasona Cipla.You may have wheezing and coughing or shortness of breath. You may also notice itching, rash (hives) 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 going to lose consciousness, and feel dizzy (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, stop using this medicine and inform your doctor immediately.Allergic reactions to salmeterol/fluticasona are rare (they can affect up to 1 in 100 people).

Other adverse effects that may occur with the following frequencies are:

Pneumonia (lung infection) in patients with COPD (frequent adverse effect)

Inform your doctorif you have any of the following symptoms while inhaling this medicine, they could be symptoms of a lung infection:

? Fever or chills

? Increased production of mucus, change in the color of the mucus

? Increased coughing or increased difficulty breathing

The following adverse effects are listed:

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

• headache. It usually improves with continued treatment,
• increase in the number of colds in patients with COPD.

Common(may affect up to 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.

For the treatment of thrush, your doctor may prescribe antifungal medication,

• 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):

• bruises and fractures all over the body,
• inflammation of the nasal sinuses (feeling of tension or congestion in the nose, cheeks, and behind the eyes, sometimes with a pulsating pain),
• low potassium levels in the blood (you may feel irregular heartbeats, muscle weakness, or cramps).

Uncommon(may affect up to 1 in 100 people)

• very fast heart rate (tachycardia),
• feeling of trembling and a fast or irregular heart rate (palpitations).

These adverse effects are usually harmless and decrease when treatment is continued,

• feeling of anxiety. It is more likely that this effect appears in children,
• increase in blood sugar levels.

If you have diabetes, it will be necessary to monitor your blood sugar levels more frequently and adjust your usual diabetic treatment if necessary,

• sleep disorders,
• chest pain,
• opacity in the lens of the eye (cataracts),
• allergic-type skin rash

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

• difficulty breathing or wheezing that worsensright after using Salmeterol/Fluticasona Cipla. If this happens to you, stop using salmeterol/fluticasonaand use your rapid-acting "rescue" inhaler to help you breathe. Go to your doctor immediately,
• abnormal production of steroid hormones, particularly when this medicine is used at high doses for a long period.

The symptoms are:

• delayed growth in children and adolescents,
• decrease in bone mineral density,
• increased eye pressure (glaucoma),
• weight gain,
• round face (Cushing's syndrome).

Your doctor will regularly monitor any of these adverse effects and ensure that you are taking the lowest possible dose.

• Changes in behavior, such as hyperactivity and irritability.

These adverse effects occur mainly in children.

• irregular heartbeats or extra heartbeats.

Consult your doctor, but do not stop taking salmeterol/fluticasona unless your doctor tells you to,

• fungal infections in the esophagus (throat), which can cause difficulty swallowing.

Frequency not known, but which may also appear:

• depression or aggression.

It is more likely that these effects appear 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Salmeterol/Fluticasona Cipla

Keep this medicine out of sight and reach of children.

Store below 25°C.

Do not use this medicine after the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofSalmeterol/Fluticasona Cipla

For the 50 micrograms/500 micrograms/inhalation dose, powder for inhalation (single dose):

• The active ingredients are salmeterol and fluticasona. Each measured dose of Salmeterol/Fluticasona Ciplaprovides 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasona propionate. This corresponds to a released dose of: 45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasona propionate.
• The other component is lactose monohydrate.

Appearance of Salmeterol/Fluticasona Cipla and Package Contents

• The dry powder inhaler is a purple plastic device that contains 60 doses of powder in an aluminum blister.
• Each dose is a single dose.

This medicine is available in packaging that contains 1, 2, 3, 4, 5, 6, or 10 inhalers with 60 doses.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp

Belgium

Manufacturer

Aeropharm

François-Mitterrand-Allee 1

07407 Rudolstadt

Germany

Local Representative

Cipla Europe NV branch in Spain,

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

Date of the Last Revision of this Prospectus:July 2023

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

You can access detailed and updated information on how to administer this medicine by scanning the QR code included in the packaging and labeling with your mobile phone (smartphone).

You can also access this information at the following internet address: https://cima.aemps.es/info/81791