Prospecto: information for the patient

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

salmeterol/fluticasona propionate

Read this prospectus carefully before starting to use this medication, 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 or pharmacist.
• This medication has been prescribed only to 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. 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 package and additional information

This medication contains two active principles, salmeterol and fluticasona 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.
• Fluticasona 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 episodes of COPD symptoms.

You must use this medication every day as recommended by your doctor. This will ensure the medication acts correctly in controlling your asthma or COPD.

Salmeterol/Fluticasona 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 a case, you must use your rescue medication, such as salbutamol. You should carry your rescue medication with you at all times.

Do not use Salmeterol/Fluticasona Cipla

• if you areallergicto salmeterol, fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to useSalmeterol/Fluticasona Ciplaif you have:

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

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

Children and adolescents

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

Asthma

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

Use of Salmeterol/Fluticasona Cipla with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or might take any other medicine, including medicines for asthma or any other non-prescription medicine. The reason is that, in some cases, salmeterol/fluticasona should not be administered with other medicines.

Inform your doctor if you take any of the following medicines, before starting to use this medicine:

• medicines to treat high blood pressure, heart disease or other diseases, with active ingredients that end in “olol” (beta-blockers), such as atenolol, propranolol and sotalol,
• medicines to treat viruses, including some medicines for HIV, such as ritonavir or medicines containing cobicistat. These medicines may increase the effects of salmeterol/fluticasona, including irregular heartbeats, or may worsen side effects. Your doctor may want to closely monitor you if you are taking these medicines,
• medicines to treat infections such as ketoconazole, itraconazole and erythromycin,
• oral or injected corticosteroids: if you have taken these medicines recently, you may increase the risk of this medicine affecting your adrenal gland.
• diuretics, also known as medicines to urinate, used to treat high blood pressure,
• other bronchodilators (such as salbutamol),
• medicines 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will tell you if you can use this medicine during this time.

Driving and operating machines

It is unlikely that salmeterol/fluticasona will affect your ability to drive or operate machines.

Salmeterol/Fluticasona Cipla contains lactose

This medicine contains lactose. It may cause allergic reactions in patients with a milk protein allergy.

If your doctor has told you that you have a certain sugar intolerance, consult with him before using this medicine.

Always follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult 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 in doubt, consult your doctor or pharmacist.
• Do not stop taking this medication or reduce your dose without talking to your doctor first.
• This medication must 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 this medication correctly.

• Asthma

The recommended dose foradults and children over 12 years of ageis:

One inhalation twice a day.

• Chronic Obstructive Pulmonary Disease

The recommended dosefor adultsis:

One inhalation twice a day.

If your symptoms are well controlled usingSalmeterol/Fluticasona Ciplatwice a day, your doctor may decide to reduce your dose to once a day:

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

It is very important that you follow your doctor's instructions on 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 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 need to use your rescue medication more frequently. If any of these things happen, you should continue using this medication, but do not increase the number of applications. Your respiratory disease may worsen and seriously ill. See your doctor, as you may need additional treatment.

If you do not useSalmeterol/Fluticasona Ciplacorrectly or as prescribed by your doctor, your breathing difficulties may worsen. For optimal treatment, you must useSalmeterol/Fluticasona Cipladaily, 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 on a rolled aluminum strip. It has a dose counter that indicates how many doses are left in decreasing order from 60 to 0. When the last 10 doses are reached, the numbers appear on a red background.

The inhaler is not rechargeable, you must replace it when it is empty and change it for a new one.

Before using the inhaler:

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

• Close the side chamber and discard the used strip.

Important: As the inhaler is used, the side chamber will gradually fill with the used aluminum strip. The aluminum strips withblack lines do not contain medication. Eventually, the numbered sections of the strip will appear in the side chamber.Never have more than 3 sections of the aluminum stripin the side chamber, as this may cause the inhaler to jam. The remaining strip should be cut carefully and left in a safe place.

Using the inhaler:

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

1. Opening

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

1. Preparing the dose

• Push up the white lever. Make sure the side chamber is closed.

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

• Opening:The white lever must be lifted completelyuntil it reaches its top anduntil it makes a "click" sound. This action moves a new dose to its position with its corresponding number above on the counter.

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

1. Inhaling the dose

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

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

Cleaning

• If necessary, the exterior 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!
• Never clean the parts of the inhaler with water or damp cloths, as moisture may affect the dose!
• Never insert paper clips or any other sharp objects into the mouthpiece or any other part, as this may damage your inhaler!

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.

The symptoms of overdose are:

• dizziness,
• headache,
• rapid heartbeats,
• muscle weakness,
• joint pain,
• shaking.

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/fluticasona may reduce the amount of steroid hormones produced by the adrenal gland.

It is very important to take your dose as instructed by your pharmacist or as prescribed by your doctor. Do not increase or decrease your dose without your doctor's consent.

If you have an overdose, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

If you forgot 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

Do not stop taking this medication or reduce your dose without consulting your doctor first, as this may worsen your breathing problems.

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

These adverse 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 (convulsions).

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. To reduce the occurrence of side 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 coughing and wheezing or shortness of breath. You may also notice itching, hives (urticaria), and swelling (usually on the face, lips, tongue, or throat). You may also 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 side 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 (can affect up to 1 in 100 people).

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

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

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

?Fever or chills

?Increased mucus production, change in mucus color

?Increased coughing or difficulty breathing

The following are other side effects:

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

• Headache. Usually improves when continuing treatment,
• Increased number of colds in patients with COPD.

Common(can affect up to 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 medicine may help.

Your doctor may prescribe antifungal medication for the treatment of stomatitis,

• Pain, inflammation in the joints and muscles, and muscle pain,
• Muscle cramps.

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

• Osteoporosis and fractures throughout the body,
• Inflammation of the nasal sinuses (sensation of tension or congestion in the nose, cheeks, and behind the eyes, sometimes with a pulsating pain),
• Low potassium levels in the blood (may feel irregular heartbeats, muscle weakness, or cramps).

Uncommon(can affect up to 1 in 100 people)

• Very fast heart rate (tachycardia),
• Feel tremors and a very fast or irregular heart rate (palpitations).

These side effects are usually harmless and decrease when treatment continues,

• Feeling of concern. It is more likely to appear in children,
• Increased blood sugar levels.

If you have diabetes, you will need to monitor your blood sugar levels more frequently and adjust your usual diabetes treatment as needed,

• Sleep disorders,
• Chest pain,
• Opacity in the crystalline lens of the eye (cataracts),
• Allergic skin eruption

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

• Difficulty breathing or wheezing that worsensjust after usingSalmeterol/Fluticasona Cipla. If this happensstop using salmeterol/fluticasonaand use your rescue inhaler for quick action to help you breathe.See your doctor immediately,
• Abnormal production of steroid hormones, particularly when using this medicine at high doses for a long period of time.

The symptoms are:

• Delayed growth in children and adolescents,
• Decreased bone mineral density,
• Increased intraocular pressure (glaucoma),
• Weight gain,
• Full moon face (Cushing's syndrome).

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

• Changes in behavior, such as hyperactivity and irritability.

These side effects occur primarily 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 may also appear:

• Depression or aggression.

It is more likely that these side effects will appear in children.

• Blurred vision

Reporting of 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 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 medicine.

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

Store below 25°C.

Do not use this medication 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 disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition ofSalmeterol/Fluticasona Cipla

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

• The active principles are salmeterol and fluticasona. Each measured dose ofSalmeterol/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 contents of the packaging

• The dry powder plastic inhaler of purple color 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 sizes of packaging may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp

Belgium

Responsible manufacturer

Aeropharm

François-Mitterrand-Allee 1

07407 Rudolstadt

Germany

Local representative

Cipla Europe NV subsidiary in Spain,

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

Last review date of this leaflet:July 2023

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

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

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