Salmeterol and fluticasone Teva

Package leaflet: Information for the user

Salmeterolo and Fluticasone Teva 25 micrograms / 125 micrograms/dose, suspension

pressurised for inhalation
Salmeterolo and Fluticasone Teva 25 micrograms / 250 micrograms/dose, suspension
pressurised for inhalation
Generic medicine
The name of this medicine is Salmeterolo and Fluticasone Teva 25 micrograms / 125 micrograms and 25 micrograms / 250 micrograms/dose, pressurised suspension for inhalation, referred to as Salmeterolo and Fluticasone Teva in this leaflet.
Please 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 effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Salmeterol and Fluticasone Teva is and what it is used for

Salmeterol and Fluticasone Teva belongs to the class of anti-asthma medicines. Salmeterol and Fluticasone Teva contains two active substances, salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. In the lungs, bronchodilators help keep the airways open, allowing air to flow in and out more easily. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation in the lungs.

Your doctor has prescribed this medicine to help prevent breathing problems such as asthma.
You must use Salmeterol and Fluticasone Teva every day as prescribed by your doctor. This will ensure it works effectively in controlling your asthma.
Salmeterol and Fluticasone Teva helps prevent symptoms such as shortness of breath and wheezing. However, Salmeterol and Fluticasone Teva must not be used to relieve sudden attacks of shortness of breath or wheezing. If this occurs, you must use a fast-acting medicine for symptom relief (a rescue medicine), such as salbutamol. You should always carry a fast-acting "rescue" medicine with you.

2. What you need to know before taking Salmeterol and Fluticasone Teva

Do not take Salmeterol and Fluticasone Teva:
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, pharmacist, or nurse before taking Salmeterol and Fluticasone Teva.
Your doctor will monitor your treatment more closely if you have any of the following
concomitant medical conditions:

• heart disease, including irregular or rapid heartbeat
• overactive thyroid gland
• high blood pressure
• diabetes mellitus (Salmeterol and Fluticasone Teva may increase blood sugar levels)
• low potassium levels 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.
If you have ever suffered from any of these conditions, inform your doctor before using
Salmeterol and Fluticasone Teva.

Adolescents
Adolescents under 16 years of age, when treated with high doses of fluticasone propionate (typically
doses exceeding 1,000 micrograms per day), may be particularly at risk of systemic effects.
Systemic effects may occur especially at high doses when prescribed over a long period. Possible
systemic effects include: Cushing's syndrome, Cushingoid appearance, adrenal suppression,
acute adrenal crisis, and growth retardation, as well as, less commonly, a range of psychological or
behavioural effects such as psychomotor hyperactivity, sleep disturbances, anxiety, depression, or
aggression.
The height of adolescents receiving long-term treatment with an inhaled corticosteroid should be
monitored regularly.
The dose of inhaled corticosteroid should be reduced to the lowest dose at which effective asthma
control is maintained.

Other medicines and Salmeterol and Fluticasone Teva
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 other medicines obtained with or without a
prescription. This is because Salmeterol and Fluticasone Teva might not be suitable to take with other
medicines.
Before starting to use Salmeterol and Fluticasone Teva, inform your doctor if you are taking the
following medicines:

• Beta-blockers (such as atenolol, propranolol, sotalol). Beta-blockers are mainly used for high blood pressure or other heart problems.
• Medicines for the treatment of infections (such as ketoconazole, erythromycin, and itraconazole). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This may increase the risk of side effects with Salmeterol and Fluticasone Teva, including irregular heartbeat, or worsen existing side effects.
• Corticosteroids (by mouth or by injection). If you have recently taken these medicines, this may increase the risk that this medicine will affect your adrenal gland.
• Diuretics, also known as "water tablets", used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine medicines. These are often used to treat asthma.
• Some medicines may increase the effects of Salmeterol and Fluticasone Teva, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV medicines: ritonavir, cobicistat).

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

Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breast-feeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine. Your doctor will
assess whether you can take Salmeterol and Fluticasone Teva during this time.

Driving and using machines
You may experience blurred vision during treatment with this medicine. If this occurs, do not drive or
use any tools or machinery until you feel well again.

3. How to take Salmeterol and Fluticasone Teva

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.

• Use Salmeterol and Fluticasone Teva every day until your doctor tells you to stop treatment. Do not take a higher dose than recommended. If in doubt, consult your doctor or pharmacist.
• Do not stop treatment with Salmeterol and Fluticasone Teva or reduce the dose of Salmeterol and Fluticasone Teva without first consulting your doctor.
• Salmeterol and Fluticasone Teva must be inhaled through the mouth into the lungs.

Use in adults and adolescents aged over 12 years

• Salmeterol and Fluticasone Teva 25 micrograms/125 micrograms per dose – pressurised suspension for inhalation – 2 doses twice daily
• Salmeterol and Fluticasone Teva 25 micrograms/250 micrograms per dose – pressurised suspension for inhalation – 2 doses twice daily

Your symptoms may be well controlled by using Salmeterol and Fluticasone Teva twice daily.
If this is the case, your doctor may decide to reduce your dose to once daily. The dose may then be taken:

• once in the evening – if you have night-time symptoms
• once in the morning – if you have daytime symptoms.

It is very important to follow your doctor’s instructions on how many inhalations to take and how often to take the medicine.
If you are using Salmeterol and Fluticasone Teva for asthma, your doctor will regularly monitor your symptoms.
If your asthma or breathing worsens, contact your doctor immediately. This may include becoming breathless more easily, feeling chest tightness more frequently, or needing to use your 'reliever' medicine more often. If any of these occur, continue taking Salmeterol and Fluticasone Teva but do not increase the number of doses. Your breathing condition may be worsening and you could become seriously ill. Contact your doctor as you may need additional treatment.

Instructions for use

• Your doctor, nurse or pharmacist should show you how to use your inhaler. They should also check regularly how you use the inhaler. Not using Salmeterol and Fluticasone Teva correctly or as prescribed may mean it will not treat your asthma as effectively as it should.

• The medicine is contained in a pressurised canister inside a plastic casing with a mouthpiece.

• There is a dose indicator on the front of the inhaler which shows you how many doses remain. As you use the inhaler, the dose indicator will rotate every five to seven
  doses to the next lower number. The dose indicator will approximately show the number of doses remaining in the inhaler.

• Be careful not to drop the inhaler, as this could cause the number shown on the dose indicator to decrease.

Checking that the inhaler works

1. When using the inhaler for the first time, you need to check that it works. Remove the protective mouthpiece cap by gently pressing the sides 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 four sprays into the air. The dose indicator will show '120', indicating the number of doses available in the inhaler. If you have not used your inhaler for a week or more, shake it well and release two sprays into the air.

Using the inhaler
It is important to start breathing as slowly as possible just before using the inhaler.

1. Stand or sit upright when using the inhaler.
2. Remove the mouthpiece cover. Check the inside and outside of the mouthpiece to make sure it is clean and free from foreign objects (Figure A).

3. Shake the inhaler 4 or 5 times to ensure any foreign objects are removed and the contents of the inhaler are well mixed (Figure B).

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

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

6. Breathe in slowly and deeply through your mouth. Just after starting to inhale, press firmly on the top of the canister to release one dose of medicine. Do this while you are still breathing in steadily and deeply (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 possible (Figure E).

8. Wait about half a minute before taking the second dose, then repeat steps 3 to 7.
9. Afterwards, rinse your mouth with water and spit out and/or brush your teeth. This may help prevent developing oral thrush and having a hoarse voice.
10. Immediately after use, and to keep out dust, always replace the mouthpiece cap. When the mouthpiece cap is correctly positioned, it will click into place. If you do not hear a click, turn the mouthpiece cap to the other side and try again. Do not use excessive force.

Do not rush steps 4, 5, 6 and 7. It is important that you breathe as slowly as possible just before using the inhaler. The first few times, use the inhaler while facing a mirror. If you see a 'mist' coming out from the top of your inhaler or from the sides of your mouth, go back to step 3.
As with all inhalers, parents must ensure that children prescribed this medicine use the correct inhalation technique as described above.
If you find it difficult to use the inhaler, you may use a spacer device such as Volumatic or Aerochamber Plus, or other spacers (depending on national guidelines).
Before using a spacer device for the first time, or if you need to change the brand of spacer device, consult your doctor, nurse or pharmacist.
You should get a new inhaler when the dose indicator shows '40' and the dose indicator changes colour from green to red. Stop using the inhaler when the indicator shows '0', as the remaining product in the device may not be enough to deliver a complete dose. Never try to alter the numbers on the dose indicator or remove the indicator from the inhaler. The dose indicator cannot be reset and is permanently attached to the inhaler.

Cleaning the inhaler
To prevent the inhaler from becoming blocked, it is important to clean it at least once a week.
To clean the inhaler:

• Remove the mouthpiece cap.
• Never remove the metal canister from the plastic casing. Clean the outside and inside of the mouthpiece and the plastic casing with a dry cloth or tissue.
• Replace the mouthpiece cap. If correctly positioned, it will click into place. If no click is heard when in position, turn the mouthpiece cap to the other side and try again. Do not use excessive force.

Do not put the metal canister in water.

If you take more Salmeterol and Fluticasone Teva than you should
It is important to use the inhaler as shown. If you accidentally take more than the recommended dose, consult your doctor or pharmacist. You may notice your heart beating faster than usual and feel tremors. You may also experience dizziness, headache, muscle weakness and joint pain.
If you have taken higher doses for a long period of time, you should consult your doctor or pharmacist. This is because higher doses of Salmeterol and Fluticasone Teva may reduce the amount of steroid hormones produced by the adrenal glands.

If you forget to take Salmeterol and Fluticasone Teva
If you forget to use the inhaler, take the next dose as scheduled. Do not take a double dose to make up for the missed dose.

If you stop treatment with Salmeterol and Fluticasone Teva
It is very important that you take Salmeterol and Fluticasone Teva every day as prescribed. Continue using it until your doctor tells you to stop. Do not stop taking it or suddenly reduce your dose of Salmeterol and Fluticasone Teva. This could worsen your breathing problem.
Additionally, if you suddenly stop treatment with Salmeterol and Fluticasone Teva or reduce the dose, (very rarely) problems with the adrenal glands (adrenal insufficiency) may occur, which can sometimes cause side effects.
These side effects may include one of the following:

• Stomach pain
• Tiredness, loss of appetite and feeling unwell
• Vomiting and diarrhoea
• Weight loss
• Headache or drowsiness
• Low levels of potassium in the blood
• Low blood pressure and seizures (fits)
• Low blood sugar levels.

When your body is under stress, e.g. due to fever, trauma (such as a car accident), infection or surgery, adrenal insufficiency may worsen and cause any of the side effects listed above. If you experience any side effect, contact your doctor or pharmacist.
To prevent these symptoms from occurring, your doctor may prescribe additional 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 everyone gets them.
To reduce the possibility of side effects, your doctor will prescribe the lowest dose of Salmeterol and Fluticasone Teva able to control your asthma.

Allergic reactions: You may notice that your breathing suddenly worsens immediately after taking Salmeterol and Fluticasone Teva. 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), or your heartbeat may suddenly become very rapid, or you may feel faint or dizzy (which could lead to collapse or loss of consciousness). If you experience any of these effects, or if they occur suddenly after using Salmeterol and Fluticasone Teva, stop using Salmeterol and Fluticasone Teva immediately and contact your doctor without delay. Allergic reactions to Salmeterol and Fluticasone Teva are uncommon (may affect less than 1 in 100 people).

Other side effects are listed below:

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

• Headache – this usually improves with continued treatment
• Increased frequency of colds in patients with COPD

Common (may affect up to 1 in 10 people)

• Oral thrush (raised, painful, yellow-cream coloured patches) in the mouth and throat. Also 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 may help. Your doctor may prescribe an antifungal medicine to treat thrush
• Joint pain, joint swelling and muscle pain
• Muscle cramps

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

• Pneumonia (lung infection) in patients with COPD

Inform your doctor if you experience any of the following symptoms while taking Salmeterolo and Fluticasone Teva. These may be signs of a lung infection:

• Fever or chills
• Increased production of mucus, change in the colour of mucus
• Worsening cough or worsening breathing difficulties
• Throat irritation: rinsing the mouth with water and spitting it out immediately after each dose may help
• 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 (may affect up to 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, more frequent blood glucose monitoring may be required and your anti-diabetic treatment may need to be adjusted
• Clouding of the eye’s lens (cataract)
• Very fast heartbeat (tachycardia)
• Trembling (tremor) and rapid or irregular heartbeat (palpitations) – these side effects are usually harmless and tend to decrease with continued treatment
• Chest pain
• Feeling of anxiety (this effect occurs particularly in children)
• Disturbed sleep
• Allergic skin rash

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

• Breathing difficulties or wheezing that worsens immediately after taking Salmeterol and Fluticasone Teva. If this occurs, stop using Salmeterol and Fluticasone Teva. Use your fast-acting reliever medicine to help breathing and contact your doctor immediately.
• Salmeterol and Fluticasone Teva may alter the normal production of steroid hormones in the body, particularly if taken at high doses for a prolonged period. Effects include:
  • Slowed growth in children and adolescents
  • Thinning of the bones
  • Glaucoma (an eye disorder affecting vision)
  • 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 effective dose of Salmeterol and Fluticasone Teva to control your asthma.
• Irregular heartbeat or extra heartbeats (arrhythmias). Inform your doctor, but do not stop taking Salmeterol and Fluticasone Teva unless your doctor tells you to.
• Behavioural changes, such as being unusually active and irritable (these effects occur mainly in children).
• Fungal infection of the oesophagus, which may cause difficulty swallowing.

Not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Salmeterol and Fluticasone Teva

• Keep this medicine out of the sight and reach of children.
• Immediately after use, firmly replace the mouthpiece cap, twisting it until it clicks into place. Do not use excessive force. Do not store at temperatures above 25°C. Do not expose to temperatures exceeding 50°C.
• Do not store Salmeterol and Fluticasone Teva in a cold place, as the medicine may not work properly.
• Do not use this medicine after the expiry date stated on the label and packaging after EXP. The expiry date refers to the last day of that month.
• The canister contains pressurised liquid. Do not pierce, break or burn it, even if you think it is empty.
• Do not dispose of any medicine 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 Salmeterol and Fluticasone Teva contains

• The active substances are 25 micrograms of salmeterol (as salmeterol xinafoate) and 125 or 250 micrograms of fluticasone propionate.
• The other component is norflurane (HFA 134a).

Description of the appearance of Salmeterol and Fluticasone Teva and contents of the pack

• Salmeterol and Fluticasone Teva consists of an aluminium foil pouch containing a silica gel sachet, which holds an aluminium pressurised canister fitted with a suitable metering valve and a plastic actuator with a dose indicator and a dust-protective cap.
• Each inhaler delivers 120 doses.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturer
S&D Pharma CZ, spol. sr.o
Theodor 28,
273 08 Pchery (Pharmos a.s. facility)
Czech Republic
Cipla Europe NV
De Keyserlei 58-60, Box-19
2018 Antwerp
Belgium
Orion Corporation
Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation
Orion Pharma
Joensuunkatu 7
24100 Salo
Finland
AMRING FARMA S.r.l.
Bulevardul Mircea Eliade Nr. 7
Bloc 1, Etaj 1, Ap. 3
Sectorul 1, Bucharest
Romania
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

This patient information leaflet was approved on