Salmeterol fluticasone Sandoz

Package leaflet: Information for the user

SALMETEROLO FLUTICASONE SANDOZ 50 micrograms/500 micrograms/dose, inhalation powder in single-dose container

Salmeterol/fluticasone propionate
Generic medicine

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

SALMETEROLO FLUTICASONE SANDOZ is used to treat:

• asthma
• chronic obstructive pulmonary disease (COPD). This disease is characterised by persistent breathing difficulties caused by narrowing of the airways, often accompanied by cough and mucus production. This medicine reduces the number of exacerbations of COPD symptoms.

This medicine contains two active substances:

• Salmeterol: a long-acting substance that opens the airways
• Fluticasone: a corticosteroid that reduces swelling and inflammation in the lungs

2. What you need to know before using SALMETEROL FLUTICASONE SANDOZ

Do not use SALMETEROL FLUTICASONE SANDOZ

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

Warnings and precautions
Talk to your doctor or pharmacist before using SALMETEROL FLUTICASONE SANDOZ if you have:

• Heart disease, including irregular or rapid heartbeat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus
• Low potassium levels in the blood
• Active or past tuberculosis or other lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.
SALMETEROL FLUTICASONE SANDOZ prevents the onset of breathlessness and wheezing. It does not work when you are already experiencing breathlessness or wheezing.
If such a breathlessness attack occurs, you must use a medicine that rapidly opens the airways, such as salbutamol.
Contact your doctor immediately if your asthma or breathing worsens. You may notice:

• Increased wheezing
• More frequent chest tightness
• Needing to use your fast-acting inhaler more often to open the airways
  Continue using SALMETEROL FLUTICASONE SANDOZ if any of the above symptoms occur, but do not increase the number of inhalations. Your breathing condition could worsen and you could become seriously ill. Consult your doctor, as additional treatment may be necessary.

Children and adolescents
Asthma:
SALMETEROL FLUTICASONE SANDOZ must not be used in children under 12 years of age.
COPD:
SALMETEROL FLUTICASONE SANDOZ must not be used in children and adolescents.

Other medicines and SALMETEROL FLUTICASONE SANDOZ
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
The following medicines may affect or be affected by SALMETEROL FLUTICASONE SANDOZ:

• Medicines for treating high blood pressure, heart diseases, or other conditions containing active substances whose names end in "olol" (beta-blockers), such as atenolol, propranolol, and sotalol
• Medicines for treating viral infections, including some medicines used to treat HIV, such as ritonavir or cobicistat; your doctor may wish to monitor you closely if you are taking these medicines
• Medicines for treating infections, such as ketoconazole, itraconazole, and erythromycin
• Corticosteroids taken by mouth or by injection: medicines used to treat inflammation or prevent transplant rejection
• Diuretics, also known as "water tablets", used to treat high blood pressure
• Other bronchodilators (such as salbutamol)
• Xanthine-containing medicines. These are often used to treat asthma.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will assess whether you can take SALMETEROL FLUTICASONE SANDOZ during this time.

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

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

SALMETEROL FLUTICASONE SANDOZ contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
The amount of lactose in this medicine normally does not cause problems in people who are lactose intolerant.

3. How to use SALMETEROL FLUTICASONE SANDOZ

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure,
ask your doctor or pharmacist.

• Asthma The recommended dose for adults and children aged 12 years and older is:
  One inhalation twice daily

Your doctor will regularly monitor your asthma symptoms.

• Chronic obstructive pulmonary disease (COPD) The recommended dose for adults is:
  One inhalation twice daily
  If your symptoms are well controlled using SALMETEROL FLUTICASONE SANDOZ twice daily,
  your doctor may decide to reduce the dose to once daily:
• once in the evening if you suffer from nocturnal symptoms,
• once in the morning if you suffer from daytime symptoms.

Method of administration
Use SALMETEROL FLUTICASONE SANDOZ every day as prescribed by your doctor, preferably
in the morning and/or evening just before meals.
After use, rinse your mouth with water.
Not using SALMETEROL FLUTICASONE SANDOZ correctly or as prescribed may worsen
your breathing difficulties. For optimal therapy, it is essential to use SALMETEROL
FLUTICASONE SANDOZ daily, even when you have no symptoms.

Instructions for use
Your doctor, nurse, or pharmacist will show you how to use the inhaler and will check periodically
that you are using it correctly.
The inhaler contains 60 doses of medicine in powder form, contained in an aluminium strip wound in a spiral.
The inhaler has a dose counter that shows the number of doses remaining, counting down from 60 to 0.
When only the last 10 doses remain, the numbers will appear on a red background.
The inhaler is not reusable – discard the inhaler when empty and replace it with a new one.

Before using the inhaler

• Open the transparent door of the side compartment.
• Remove the aluminium strip from the side compartment by carefully tearing it along its entire length against the "teeth" of the side compartment, as shown in the figure below. Do not pull or tear the strip.

• Close the door of the side compartment and dispose of the used strip.

Important:
During use of the inhaler, the used strip will gradually fill the side compartment.
The aluminium strips with black bars do not contain medicine.
Eventually, the numbered sections of the strip will appear in the side compartment.
Do not allow more than 2 sections of aluminium strip to accumulate in the side compartment,
as the inhaler may jam. Carefully remove the strip as described above and dispose of it safely.

Using the inhaler
Hold the inhaler in your hands as shown in the figures.

1. Opening

• Open the protective cap by pulling downwards to expose the mouthpiece.
• Check the dose counter to see how many doses remain.

2. Dose preparation

• Lift the edge of the white lever. Make sure the side compartment is closed.

Remember: lift the white lever only when you are ready to inhale a dose of the medicine. If
you "play" with the white lever, you will waste doses of medicine.

• Opening: Pull the white lever fully until it reaches the end and until you hear a click. This action loads a new dose into position, with the number facing upwards.

• Closing: Then close the white lever completely until it returns to its original position, producing a click. The inhaler is now ready for immediate use.

3. Inhalation

• Breathe out fully, keeping away from the mouthpiece of the inhaler. Never breathe directly into the inhaler, as this may affect the dose.
• Hold the inhaler horizontally with the protective cap facing downwards.
• Close your lips firmly around the mouthpiece.
• Inhale steadily and deeply through the inhaler, not through your nose.

• Remove the inhaler from your mouth and hold your breath for 5–10 seconds, or as long as you can comfortably do so.
• Then breathe out slowly, but not into the inhaler.
• Close the protective cap over the mouthpiece.
• Rinse your mouth with water and spit it out. This may help prevent the development of fungal infections in the mouth and hoarseness.

Cleaning

• Clean the outside of the mouthpiece with a clean, dry cloth if necessary.
• Do not attempt to disassemble the inhaler for cleaning or for any other purpose!
• Do not use water or wet wipes to clean any parts of the inhaler, as moisture may affect the dose!
• Never insert pins or other sharp objects into the mouthpiece or any other part of the inhaler, as this may damage it!

If you use more SALMETEROLO FLUTICASONE SANDOZ than you should
Contact your doctor or pharmacist.
Symptoms of overdose include:

• dizziness
• headache
• rapid heartbeat
• muscle weakness
• joint pain
• trembling sensation

If you have used higher doses for a prolonged period, consult your doctor or pharmacist.
This is because higher doses of SALMETEROLO FLUTICASONE SANDOZ may reduce the amount of steroid hormones produced by the adrenal gland.
It is important that you take the dose as prescribed by your doctor. Do not increase or decrease the dose without first consulting your doctor.

If you forget to use SALMETEROLO FLUTICASONE SANDOZ
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

If you stop using SALMETEROLO FLUTICASONE SANDOZ
Do not stop or abruptly reduce your dose of SALMETEROLO FLUTICASONE SANDOZ without your doctor's permission, as this could worsen your breathing symptoms and, very rarely, may lead to adverse effects. These include:

• 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 seizures

Very rarely, if you have an infection or are experiencing any period of extreme stress (such as after a serious accident or if undergoing surgery), you may experience similar adverse effects.
To prevent such symptoms from occurring, your doctor may prescribe additional doses of corticosteroids (such as prednisolone).
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Allergic reactions: you may notice a sudden worsening of breathing after taking SALMETEROLO FLUTICASONE SANDOZ.
You may experience severe wheezing and coughing. You might also notice itching, a skin rash (urticaria), or swelling (usually of the face, lips, tongue, or throat), or you may suddenly feel your heart beating very fast or feel weak and as if you are about to faint (this could lead to collapse or loss of consciousness). If you experience any of these effects or if they occur suddenly after using SALMETEROLO FLUTICASONE SANDOZ, inform your doctor immediately.
Allergic reactions to SALMETEROLO FLUTICASONE SANDOZ are uncommon (affecting fewer than 1 in 100 users).

Other side effects may occur with the following frequencies:

Very common – may affect more than 1 in 10 users

• Headache. This usually improves with continued treatment.
• Increased number of colds in patients with COPD (chronic obstructive pulmonary disease)

Common – may affect up to 1 in 10 users

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

In patients with chronic obstructive pulmonary disease (COPD), the following side effects have also been reported:

• Pneumonia (lung infection). Inform your doctor if you experience any of the following symptoms while taking SALMETEROLO FLUTICASONE SANDOZ, as they could be signs of a lung infection:
  • inflammation of the lung and/or airways
  • increased mucus production
  • change in mucus colour
  • fever
  • chills
  • increased coughing
  • worsening breathing difficulties
• Bruising and fractures anywhere in the body
• Inflammation of the nasal sinuses
• Low levels of potassium in the blood (you may notice an irregular heartbeat, muscle weakness and/or cramps)

Uncommon – may affect up to 1 in 100 users

• Very fast heartbeat (tachycardia)
• Trembling sensation and fast or irregular heartbeat (palpitations). This side effect is usually harmless and decreases with continued treatment.
• Feeling anxious. This side effect occurs particularly in children.
• Increased blood sugar levels. If you have diabetes, you may need more frequent blood sugar monitoring and possibly adjustment of your antidiabetic therapy.
• Disturbed sleep
• Chest pain
• Clouding of the eye lens (cataract)
• Allergic skin rash

Rare – may affect up to 1 in 1,000 users

• Breathing difficulties or wheezing that worsens immediately after taking SALMETEROLO FLUTICASONE SANDOZ.
  Stop treatment with SALMETEROLO FLUTICASONE SANDOZ and use your fast-acting inhaled medicine to open the airways to help breathing. Inform your doctor immediately.
• Abnormal production of certain hormones, especially if you have used high doses of this medicine for a prolonged period. Effects include:
  • Slowed growth in children and adolescents,
  • Thinning of the bones,
  • Increased eye pressure (glaucoma),
  • Weight gain,
  • Rounded, moon-shaped face (Cushing's syndrome).

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

• Behavioural changes, such as unusual hyperactivity and irritability. These effects occur particularly in children.
• Irregular heartbeat or extra heartbeats. Inform your doctor, but do not stop taking SALMETEROLO FLUTICASONE SANDOZ unless your doctor tells you to.
• Fungal infection of the oesophagus (throat), which may cause difficulty swallowing.

Frequency not known – but may also occur:

• Depression or aggression. These effects occur particularly 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SALMETEROL FLUTICASONE SANDOZ

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the label and the box after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SALMETEROLO FLUTICASONE SANDOZ contains
SALMETEROLO FLUTICASONE SANDOZ 50 micrograms/500 micrograms per dose, inhalation powder in single-dose container

• The active substances are salmeterol and fluticasone. Each dose of SALMETEROLO FLUTICASONE SANDOZ contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate. This corresponds to an inhaled dose of:
• 45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate
• The other ingredient is lactose monohydrate.

Description of the appearance of SALMETEROLO FLUTICASONE SANDOZ and contents of the pack

• In the plastic purple dry powder inhalation device, 60 doses of a powder mixture are contained in an aluminum blister.
• Each dose is for single use.

Pack sizes:
1 device containing 60 doses.
Not all pack sizes may be marketed.

Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Aeropharm GmbH
Francois-Mitterrand-Allee 1
Thueringen 07407 Rudolstadt
Germany
Italy SALMETEROLO FLUTICASONE SANDOZ
Sweden Lastenol Forspiro