Salmeterol and fluticasone Sandoz GmbH

Package leaflet: Information for the user

SALMETEROL AND FLUTICASONE SANDOZ GMBH 25 micrograms/125 micrograms per dose

pressurised suspension for inhalation
SALMETEROL AND FLUTICASONE SANDOZ GMBH 25 micrograms/250 micrograms per dose
pressurised suspension for inhalation
Salmeterol/fluticasone propionate
Generic medicine
Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What SALMETEROL AND FLUTICASONE SANDOZ GMBH is and what it is used for
2. What you need to know before using SALMETEROL AND FLUTICASONE SANDOZ GMBH
3. How to use SALMETEROL AND FLUTICASONE SANDOZ GMBH
4. Possible side effects
5. How to store SALMETEROL AND FLUTICASONE SANDOZ GMBH
6. Contents of the pack and other information

1. What SALMETEROLO E FLUTICASONE SANDOZ GMBH is and what it is used for

SALMETEROLO E FLUTICASONE SANDOZ GMBH contains two medicines, 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 swelling and irritation in the lungs.

SALMETEROLO E FLUTICASONE SANDOZ GMBH is not indicated for use in children.
Your doctor has prescribed this medicine to help prevent breathing problems such as asthma.
You must use SALMETEROLO E FLUTICASONE SANDOZ GMBH every day as prescribed by your doctor. This ensures that the medicine works properly to control asthma.
SALMETEROLO E FLUTICASONE SANDOZ GMBH helps prevent the occurrence of breathlessness and wheezing. However, SALMETEROLO E FLUTICASONE SANDOZ GMBH must not be used to treat a sudden attack of breathlessness or wheezing. If this occurs, you must use a fast-acting "reliever" inhaler medicine, such as salbutamol. You must always have your fast-acting "reliever" inhaler with you.

2. What you should know before using SALMETEROLO E FLUTICASONE SANDOZ GMBH

Do not use SALMETEROLO E FLUTICASONE SANDOZ GMBH:
if you are allergic to salmeterol, fluticasone propionate, or any of the other ingredients of this
medicinal product (listed in section 6).

Warnings and precautions
Talk to your doctor before using SALMETEROLO E FLUTICASONE SANDOZ GMBH if you have:

• Heart disease, including irregular or rapid heartbeat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (SALMETEROLO E FLUTICASONE SANDOZ GMBH may increase blood sugar levels)
• Low levels of potassium in the blood
• Tuberculosis (TB) currently or in the past, or other lung infections

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

Other medicines and SALMETEROLO E FLUTICASONE SANDOZ GMBH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines. This includes medicines for asthma or any medicine obtained without
a prescription. This is because using SALMETEROLO E FLUTICASONE SANDOZ GMBH together with
certain other medicines may not be appropriate.

Inform your doctor if you are taking any of the following medicines before starting to use SALMETEROLO E
FLUTICASONE SANDOZ GMBH:

• β-blockers (such as atenolol, propranolol, and sotalol). β-blockers are mainly used to treat high blood pressure or other heart conditions.
• Medicines for the treatment of infections, including some medicines used to treat HIV infection (such as ritonavir, cobicistat, ketoconazole, itraconazole, and erythromycin). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in the body. This may increase the risk of experiencing adverse effects with SALMETEROLO E FLUTICASONE SANDOZ GMBH, including irregular heartbeats or worsening of side effects. Your doctor may decide to monitor you regularly if you are taking these medicines.
• Corticosteroids (taken orally or by injection). If you have recently taken one of these medicines, this may increase the risk that this medicinal product interferes with adrenal gland function.
• Diuretics, also known as "water tablets", used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine-based medicines. These are often used to treat asthma.

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

Driving and using machines
It is unlikely that SALMETEROLO E FLUTICASONE SANDOZ GMBH will affect your ability to drive or
use machinery.

For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use SALMETEROL AND FLUTICASONE SANDOZ GMBH

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Use SALMETEROL AND FLUTICASONE SANDOZ GMBH every day, until your doctor tells you to stop treatment. Do not exceed the recommended dose. If you have any doubts, consult your doctor or pharmacist.
• Do not stop using SALMETEROL AND FLUTICASONE SANDOZ GMBH or reduce the dose of SALMETEROL AND FLUTICASONE SANDOZ GMBH without first consulting your doctor.
• SALMETEROL AND FLUTICASONE SANDOZ GMBH must be inhaled into the lungs through the mouth.

Recommended dose:
Adults

• SALMETEROL AND FLUTICASONE SANDOZ GMBH 25/125 – 2 inhalations twice daily
• SALMETEROL AND FLUTICASONE SANDOZ GMBH 25/250 – 2 inhalations twice daily

Symptoms may be well controlled by using SALMETEROL AND FLUTICASONE SANDOZ GMBH twice daily. In such cases, your doctor may decide to reduce the dose to once daily. The dose may be adjusted as follows:

• once in the evening – if you suffer from nocturnal symptoms
• once in the morning – if you suffer from diurnal symptoms.

It is very important to follow your doctor's instructions regarding the number of sprays to take and how often to take the medicine.
If you are using SALMETEROL AND FLUTICASONE SANDOZ GMBH for asthma, your doctor will regularly monitor your symptoms.
If your asthma or breathing worsens, inform your doctor immediately. You may notice that your breathing becomes more laboured, that you feel chest tightness more frequently, or that you need to use your fast-acting relief medicine more often. If any of these conditions occur, continue using SALMETEROL AND FLUTICASONE SANDOZ GMBH but do not increase the number of sprays you take. Your breathing condition could worsen and become particularly severe. Consult your doctor, as additional therapy may be required.

Use in children
The use of SALMETEROL AND FLUTICASONE SANDOZ GMBH is not indicated in children.

Instructions for use

• Your doctor or pharmacist will show you how to use the inhaler. They should periodically check your inhaler technique. SALMETEROL AND FLUTICASONE SANDOZ GMBH will not help control your asthma properly if not used correctly or as prescribed.
• The medicine is contained in a pressurised canister inside a plastic holder with a mouthpiece.
• There is a dose indicator on the front of the inhaler showing how many doses remain. When you use the inhaler, the dose counter usually rotates down by one number every five to seven sprays. The dose indicator shows the approximate number of sprays remaining in the inhaler.
• Be careful not to drop the inhaler, as this may reduce the number of doses shown on the indicator.

Checking that the inhaler works

1. When using the inhaler for the first time, check that it works. Remove the mouthpiece cap by gently pressing the sides of the cap 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 the canister to release 4 sprays into the air, shaking the inhaler before each spray. The dose counter will show 120, the total number of sprays contained in the inhaler. If you have not used your inhaler for one week or more, release two sprays of medicine into the air.

Using the inhaler
It is important to begin inhaling as slowly as possible immediately before using the inhaler.

1. Stand or sit upright while using the inhaler.
2. Remove the mouthpiece cap (as described in step 1 of the section "Checking that the inhaler works"). Check inside and outside to ensure the mouthpiece is clean and free from loose parts (Figure A).

Figure A

3. Shake the inhaler 4 or 5 times to ensure any loose parts are removed and the contents are evenly mixed (Figure B).

Figure B

4. Hold the inhaler upright with your thumb on the base, below the mouthpiece. Breathe out as much as possible (Figure C).

Figure C

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

Figure D

6. Breathe in slowly and deeply through your mouth. Immediately after starting to inhale, press firmly on the top of the canister to release one spray of medicine. Continue inhaling steadily and deeply throughout this process (Figure D).
7. 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, or as long as you comfortably can (Figure E).

Figure E

8. Wait about half a minute between each spray of medicine, then repeat steps 3 to 7.
9. Afterwards, rinse your mouth with water and spit it out, and/or brush your teeth. This may help prevent the occurrence of candidiasis (thrush) and hoarseness.
10. After use, always immediately replace the mouthpiece cap to prevent dust from entering. When the protective mouthpiece cap is correctly in place, you will hear it "click" into position. If it does not "click", turn the mouthpiece cap the other way and try again. Do not force it.

Do not rush steps 4, 5, 6 and 7. It is important that you inhale as slowly as possible just before using the inhaler. The first few times, use the inhaler while standing 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 find it difficult to use the inhaler, your doctor or another healthcare professional may advise you to use a spacer device such as Volumatic or Aerochamber Plus (according to national recommendations) together with the inhaler. Your doctor, pharmacist, or another healthcare professional will show you how to use the spacer with the inhaler, how to care for the spacer, and will answer any questions you may have. If you use a spacer with the inhaler, it is important not to stop using it without first discussing it with your doctor. It is also important not to change the type of spacer you use without first talking to your doctor. If you stop using a spacer or change the type of spacer you use, your doctor may need to adjust the dose of medicine required to control your asthma.

Always talk to your doctor before making any changes to your asthma treatment.

People who have weak hands may find it easier to hold the inhaler with both hands. Place both index fingers on top of the inhaler and both thumbs on the bottom, below the mouthpiece.

Get a new medicine pack when the dose counter shows 40 and the colour of the dose indicator changes from green to red. Stop using the inhaler when the counter shows 0, as the remaining sprays in the canister may not deliver a full dose.

Never attempt to alter the number of doses shown on the counter or to disconnect the counter from the canister. The indicator cannot be reset and is permanently attached to the inhaler.

Cleaning the inhaler
To prevent blockage of the inhaler, it is important to clean it at least once a week.

To clean the inhaler:

• Remove the protective mouthpiece cap.
• Never remove the metal canister from the plastic holder.
• Clean the inside and outside of the mouthpiece and the plastic holder of the inhaler with a dry cloth or tissue.
• Replace the protective mouthpiece cap. You will hear a "click" when the cap is correctly positioned. If you do not hear the "click", turn the mouthpiece cap the other way and try again. Do not force it.

Do not put the metal canister in water.

If you use more SALMETEROL AND FLUTICASONE SANDOZ GMBH than you should
It is important to use the inhaler as instructed. If you have accidentally taken a higher dose than recommended, inform your doctor or pharmacist. You may experience an increased heart rate and a trembling sensation. You may also have dizziness, headache, muscle weakness, and joint pain.

If you have used higher doses for a prolonged period, consult your doctor or pharmacist. This is because higher doses of SALMETEROL AND FLUTICASONE SANDOZ GMBH may reduce the amount of steroid hormones produced by the adrenal glands.

If you forget to use SALMETEROL AND FLUTICASONE SANDOZ GMBH
Do not take a double dose to make up for a forgotten dose. Take the next dose at your usual time.

If you stop using SALMETEROL AND FLUTICASONE SANDOZ GMBH
It is very important to take SALMETEROL AND FLUTICASONE SANDOZ GMBH every day as prescribed by your doctor. Continue taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of SALMETEROL AND FLUTICASONE SANDOZ GMBH. This could cause your breathing to worsen.

Additionally, stopping SALMETEROL AND FLUTICASONE SANDOZ GMBH suddenly or reducing the dose of SALMETEROL AND FLUTICASONE SANDOZ GMBH may (very rarely) cause problems with the adrenal glands (adrenal insufficiency), which may sometimes lead to side effects.

These side effects may include any of the following:

• Stomach pain
• Tiredness and loss of appetite, feeling unwell
• Nausea and diarrhoea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Low blood pressure and epileptic seizures (convulsions)

When the body is under stress due to fever, trauma (e.g. after a car accident), infection, or surgery, adrenal insufficiency may worsen and one of the side effects listed above may occur. If you experience any side effect, contact your doctor or pharmacist. To prevent these symptoms from occurring, your doctor may prescribe additional doses of corticosteroids in tablet form (such as prednisolone).

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To reduce the possibility of side effects occurring, your doctor will prescribe the lowest dose of
SALMETEROL AND FLUTICASONE SANDOZ GMBH necessary to control your asthma.

Allergic reactions: you may notice that your breathing suddenly worsens immediately after taking
SALMETEROL AND FLUTICASONE SANDOZ GMBH. You may experience severe shortness of
breath, coughing, or difficulty breathing. You may also notice itching, skin rash (urticaria), or
swelling (usually of the face, lips, tongue, or throat). Alternatively, you may suddenly feel your heart
beating very fast, or feel weak and dizzy (which could cause you to collapse or lose consciousness).
If you experience any of these effects, or if they occur suddenly after using SALMETEROL AND
FLUTICASONE SANDOZ GMBH, stop using SALMETEROL AND FLUTICASONE SANDOZ GMBH
immediately and contact your doctor without delay. Allergic reactions to SALMETEROL AND
FLUTICASONE SANDOZ GMBH are uncommon (affecting fewer than 1 in 100 people).

Other side effects are listed below:

Very common (affects more than 1 in 10 people)

• Headache, which usually improves with continued treatment.
• In patients with Chronic Obstructive Pulmonary Disease (COPD), an increased number of colds has been reported.

Common (affects less than 1 in 10 people)

• Oral thrush (raised, painful, yellow-cream coloured patches) in the mouth and throat. In addition, soreness of the tongue, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out immediately and/or brushing the teeth after each dose of medicine may help. Your doctor may prescribe an antifungal medicine to treat thrush.
• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

In patients with Chronic Obstructive Pulmonary Disease (COPD), the following side effects have also been reported:

• Pneumonia and bronchitis (lung infection). Inform your doctor if you notice any of the following symptoms: increased sputum production, change in the colour of sputum, fever, chills, increased coughing, or worsening breathing problems.
• Bruising and fractures.
• Inflammation of the sinuses (a feeling of pressure or fullness in the nose, cheeks, and behind the eyes, sometimes accompanied by throbbing pain).
• Decreased potassium levels in the blood (may cause irregular heartbeat, muscle weakness, cramps).

Uncommon (affects less than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, more frequent blood glucose monitoring and possibly adjustment of your antidiabetic therapy may be required.
• Cataract (clouding of the eye's lens).
• Very fast heartbeat (tachycardia).
• Shaking sensation (tremor) and fast or irregular heartbeat (palpitations) – these side effects are usually harmless and decrease with continued treatment.
• Chest pain.
• Feeling anxious (these effects occur particularly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare (affects less than 1 in 1,000 people)

• Breathing difficulties or wheezing that worsens immediately after taking SALMETEROL AND
  FLUTICASONE SANDOZ GMBH. If this occurs, stop using SALMETEROL AND FLUTICASONE
  SANDOZ GMBH immediately. Use your fast-acting "rescue" inhaled medicine to help your
  breathing and contact your doctor immediately.

• SALMETEROL AND FLUTICASONE SANDOZ GMBH may affect the normal production of steroid
  hormones in the body, particularly if high doses have been taken for a prolonged period. Effects may include:
  o Slowed growth in children and adolescents
  o Thinning of the bones
  o Glaucoma
  o Weight gain
  o Rounded (moon-shaped) face (Cushing's syndrome).
  Your doctor will monitor you regularly for any of these side effects and will ensure you are taking the lowest effective dose of SALMETEROL AND FLUTICASONE SANDOZ GMBH to control your asthma.

• Behavioural changes such as unusual hyperactivity and irritability (these effects occur mainly in children).

• Irregular heartbeat or extra heartbeats (arrhythmia). Inform your doctor, but do not stop taking SALMETEROL AND FLUTICASONE SANDOZ GMBH unless instructed by your doctor.

• A fungal infection in the oesophagus (gullet), which may cause difficulty swallowing.

Frequency not known (frequency cannot be estimated from the available data), but which may occur:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store SALMETEROL AND FLUTICASONE SANDOZ GMBH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or carton after "Exp". The expiry date refers to the last day of that month.
Usable duration after first opening of the package containing the inhaler: use within 3 months.
Store below 25°C.
Keep the canister in the outer packaging to protect the medicine from light.
The canister contains a pressurized liquid.
Do not expose to temperatures above 50°C.
Do not pierce the canister.
Do not puncture, break, or burn the canister, even when empty.
Do not refrigerate or freeze.
As with most pressurized inhalation medicines, the therapeutic effect of this medicine may decrease when the container is cold.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What SALMETEROLO E FLUTICASONE SANDOZ GMBH contains
SALMETEROLO E FLUTICASONE SANDOZ GMBH 25 micrograms/125 micrograms/dose
pressurized suspension for inhalation
The active substances are salmeterol (as salmeterol xinafoate) and fluticasone propionate. Each delivered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 125 micrograms of fluticasone propionate.
The other component is the propellant norflurane (HFA 134a).

SALMETEROLO E FLUTICASONE SANDOZ GMBH 25 micrograms/250 micrograms/dose
pressurized suspension for inhalation
The active substances are salmeterol (as salmeterol xinafoate) and fluticasone propionate. Each delivered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate.
The other component is the propellant norflurane (HFA 134a).

Description of the appearance of SALMETEROLO E FLUTICASONE SANDOZ GMBH and contents of the pack
The inhaler consists of an aluminium container with a metering valve and a dosing device made of polypropylene, with a dose indicator and a dust-proof cap made of polypropylene (PP). The inhaler is sealed in a pouch containing a silica gel desiccant packet and packaged in a cardboard box.
The container holds a homogeneous white suspension.
Each container is filled with sufficient quantity to deliver 120 actuations.

Pack sizes:
1; 2; 2 (multipack 2x1); 3; 3 (multipack 3x1); 4; 5; 6; 10; 10 (multipack 10x1) inhalers x 120 actuations.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria

Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben, Germany

This medicinal product is authorized in the European Economic Area Member States under the following name: