Salmeterol/fluticasone Cipla 50 micrograms/250 micrograms/inhalation, powder for inhalation (single dose)

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Salmeterol/Fluticasone Cipla 50 micrograms/250 micrograms/inhalation, inhalation powder for inhalation (single dose)

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible 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

This medicine 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 for air to flow 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 medicine to help prevent breathing problems such as:

• Asthma.

You should use this medicine every day as recommended by your doctor. This will ensure the medicine works properly to control your asthma.

Salmeterol/Fluticasona Cipla helps prevent shortness of breath and wheezing. However, this medicine must not be used to relieve a sudden attack of breathlessness or wheezing. In such a case, you must use your fast-acting "rescue" medicine, such as salbutamol. You should 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 to salmeterol, fluticasone propionate, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Salmeterol/Fluticasona Cipla if you have:

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

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

Children and adolescents

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

Use of Salmeterol/Fluticasona Cipla with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines for asthma or any other over-the-counter medicines. The reason is that in some cases, salmeterol/fluticasone should not be administered together with other medicines.

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

• medicines to treat high blood pressure, heart conditions, or other diseases containing active substances ending in “olol” (beta-blockers), such as atenolol, propranolol, and sotalol,
• medicines to treat viral infections, including some HIV medicines such as ritonavir or medicines containing cobicistat. These medicines may increase the effects of salmeterol/fluticasone, including irregular heartbeats, or may worsen side effects. Your doctor may wish to monitor you closely if you are taking these medicines,
• medicines to treat infections such as ketoconazole, itraconazole, and erythromycin,
• corticosteroids taken orally or by injection: if you have recently taken these medicines, there may be an increased risk that this medicine could affect your adrenal gland,
• diuretics, also known as water tablets, used to treat high blood pressure,
• other bronchodilators (such as salbutamol),
• medicines containing xanthines. These are often used to treat asthma.

Pregnancy, breast-feeding and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will advise you whether you can use this medicine during these times.

Driving and using machines

It is unlikely that salmeterol/fluticasone will affect your ability to drive or operate machinery.

Salmeterol/Fluticasona Cipla contains lactose

This medicine contains lactose. It may cause allergic reactions in patients allergic to cow's milk protein.

If your doctor has informed you of an intolerance to certain sugars, consult him before using this medicine.

3. How to use Salmeterol/Fluticasona Cipla

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

• Use this medicine 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 medicine or reduce your dose without first speaking to your doctor.

• This medicine must be inhaled through the mouth into the lungs.

• You may not taste or feel the powder on your tongue, even if you have used this medicine correctly.

• Asthma

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

One inhalation twice daily.

If your symptoms become well controlled using salmeterol/fluticasona twice daily, your doctor may decide to reduce your dose to once daily:

• 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 puffs and how often you should take your medication.

If you are using this medicine 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 must continue using this medicine, but do not increase the number of puffs. Your breathing condition may worsen and you may become seriously ill. See your doctor, as you may need additional treatment.

If you do not use Salmeterol/Fluticasona Cipla correctly or as prescribed, your breathing problems may worsen. For optimal treatment, you must use Salmeterol/Fluticasona Cipla daily, even if you have no symptoms.

Instructions for use

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

The inhaler contains 60 doses of powdered medicine in an aluminum strip wound inside. It has a dose counter that shows how many doses remain, counting down from 60 to 0. When the last 10 doses remain, the numbers appear on a red background.

The inhaler is not refillable; you must replace it when empty with a new one.

Before using the inhaler:

• Open the transparent side chamber of the inhaler.
• Cut the protruding aluminum strip by carefully pulling it against the "teeth" of the side chamber as shown below. Do not pull or tear forcefully.

• Close the side chamber and discard the used strip.

Important: As the inhaler is used, the side chamber gradually fills with used aluminum strip. Aluminum strips with black lines do not contain medicine. Eventually, numbered sections of the strip will appear in the side chamber. There should never be more than 3 sections of aluminum strip in the side chamber, as this may cause the inhaler to jam. Excess strip should be carefully cut and stored safely.

Using the inhaler:

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

1. Opening

• Open the protective cap downwards so that the mouthpiece appears.
• Check the dose counter to see how many doses remain.

1. Preparing the dose

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

Remember: The white lever should only be operated when you are ready to inhale your dose. Playing with the white lever will waste doses.

• Opening: The white lever must be fully raised until it reaches its limit and makes a "click". This action advances a new dose into position, with its corresponding number appearing on the counter.

• Closing: Then close the white lever until it clicks again into its original position. The inhaler is now ready for immediate use.

1. Inhaling the dose

• With the inhaler mouthpiece away from your mouth, breathe out as much as you can or until you feel comfortable. Never breathe out directly into the inhaler, as this may affect the dose.
• Hold the inhaler with the protective cap facing downwards.
• Close your lips firmly around the mouthpiece.
• Breathe in deeply and steadily through the inhaler—do not breathe through your nose.

• Remove the inhaler from your mouth and hold your breath for 5 to 10 seconds, or as long as is comfortable without causing discomfort.
• Then begin breathing slowly, but not through the inhaler.
• Close the protective cap over the mouthpiece.
• Rinse your mouth with water and spit it out. This may help prevent fungal infections in the mouth and reduce hoarseness.

Cleaning

• If necessary, the outer part of the mouthpiece can be cleaned with a dry tissue.
• Never disassemble the inhaler for cleaning or for any other purpose!
• The parts of the inhaler must not be cleaned 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 exactly as directed. If you have accidentally taken a higher dose than recommended, consult your doctor or pharmacist.

Symptoms of overdose include:

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

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

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

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

If you forget to use Salmeterol/Fluticasona 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 using Salmeterol/Fluticasona Cipla

Do not suddenly stop or reduce your dose of Salmeterol/Fluticasona Cipla without your doctor's consent, as this may cause your breathing problems to worsen.

Additionally, if you suddenly stop taking this medicine or reduce your dose, you may (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,
• low blood pressure and seizures (fits).

Very rarely, if you have an infection or 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 from occurring, your doctor may prescribe additional corticosteroids (such as prednisolone).

If you have any further questions about the use of this medicine, ask your doctor 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 this medicine 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), or swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel that your heart is beating very fast, feel dizzy, or feel like you are losing consciousness (which may lead to collapse or loss of awareness). If you experience any of these effects, or if they occur suddenly after using salmeterol/fluticasona, stop using this medicine immediately and inform your doctor

promptly. Allergic reactions to salmeterol/fluticasona are uncommon (may 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 (common adverse effect)

Inform your doctor if you experience any of the following symptoms while inhaling this medicine, as they could be signs of a lung infection:

? Fever or chills
? Increased mucus production or change in mucus color
? Increased coughing or worsening breathing difficulties

The following adverse effects are listed below:

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

• Headache. This usually improves with continued treatment.
• Increased incidence of colds in patients with COPD.

Common (may affect up to 1 in 10 people)

• Oral thrush (itching, yellowish creamy ulcers) in the mouth and throat. Also, tongue pain, hoarseness, 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 treatment of oral thrush, your doctor may prescribe antifungal medication.
• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

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

• Bruising and fractures throughout the body.
• Sinus inflammation (feeling of pressure or congestion in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Low blood potassium levels (you may experience irregular heartbeat, muscle weakness, or cramps).

Uncommon (may affect up to 1 in 100 people)

• Very fast heart rate (tachycardia).
• Tremors and a fast or irregular heartbeat (palpitations).
  These adverse effects are usually harmless and decrease with continued treatment.
• Feeling anxious. This effect is more likely to occur in children.
• Increased blood sugar levels.
  If you have diabetes, your blood sugar levels should be monitored more frequently, and your usual diabetic treatment may need to be adjusted if necessary.
• Sleep disturbances.
• Chest pain.
• Clouding of the eye lens (cataracts).
• Allergic-type skin rash.

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

• Worsening breathing difficulty or wheezing immediately after using Salmeterol/Fluticasona Cipla. If this occurs, stop using salmeterol/fluticasona and use your fast-acting "rescue" inhaler to help you breathe. Contact your doctor immediately.
• Abnormal production of steroid hormones, particularly when this medicine is used at high doses over a long period of time.

Symptoms include:

• Growth delay in children and adolescents.
• Decreased bone mineral density.
• Increased intraocular pressure (glaucoma).
• Weight gain.
• Rounded, moon-shaped face (Cushing's syndrome).

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

• Behavioral changes such as hyperactivity and irritability.
  These adverse effects occur mainly in children.
• Irregular heartbeat or extra heartbeats.
  Consult your doctor, but do not stop taking salmeterol/fluticasona unless your doctor tells you to.
• Fungal infections of the esophagus (throat), which may cause difficulty swallowing.

Frequency not known, but which 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://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.

Store below 25°C.

Do not use this medicine after the expiry date stated on the label and on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Salmeterol/Fluticasone Cipla

For the dose of 50 micrograms/250 micrograms/inhalation, powder for inhalation (single dose):

• The active substances are salmeterol and fluticasone. Each metered dose of Salmeterol/Fluticasone Cipla provides 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate. This corresponds to a delivered dose of: 45 micrograms of salmeterol (as salmeterol xinafoate) and 233 micrograms of fluticasone propionate.
• The other component is lactose monohydrate.

Appearance of Salmeterol/Fluticasone Cipla and contents of the pack

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

This medicine is available in packs containing 1, 2, 3, 4, 5, 6 or 10 inhalers with 60 doses.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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, Spanish branch,

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

Date of the most recent revision of this leaflet: July 2023

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

You can access detailed and up-to-date information on how to administer this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging and labelling.

You can also access this information at the following web address: https://cima.aemps.es/info/81790