Document: Zoreeda pressurised inhalation, suspension ENG PL change

• Zoreeda pressurized inhalation suspension PL
• Zoreeda pressurised inhalation, suspension ENG PL

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Package leaflet: Information for the patient

Zoreeda 25 micrograms /125 micrograms /dose pressurised inhalation, suspension

Zoreeda 25 micrograms /250 micrograms /dose pressurised inhalation, suspension

Salmeterol/fluticasone propionate

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 further questions, ask your doctor or pharmacist or nurse.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

What is in this leaflet

Zoreeda contains two medicines, salmeterol and fluticasone propionate

• Salmeterol is a long- acting bronchodilator. Bronchodilators help the airways in the lung to stay open. This makes it easier for air to get in and out. The effects last for at least 12 hours.

• Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.

The doctor has precribed this medicine to help prevent breathing problems such as asthma.

You must use Zoreeda every day as directed by your doctor. This will make sure that it works properly in controlling your asthma.

Zoreeda helps to stop breathlessness and wheeziness coming on. It does not work once you are breathless or wheezy. If that happens you need to use a fast acting ‘reliever’ medication, such as salbutamol.

Do not take Zoreeda:

If you are allergic(hypersensitive) to salmeterol, fluicasone propionate or any of the other ingredients

of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Zoreeda. Your doctor will supervise your treatment more closely if you have medical conditions such as:

• heart disease, including an irregular or fast heartbeat

• overactive thyroid gland

• high blood pressure

• diabetes mellitus (Zoreeda may increase your blood sugar)

• low potassium in your blood

• tuberculosis (TB) now, or in the past

If you have ever had any of these conditions, tell your doctor before you use Zoreeda

Other medicines and Zoreeda

Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines. This includes medicine for asthma or any medicines obtained without a prescription. This is because Zoreeda may not be suitable to be taken with some other medicines.

Tell your doctorif you are taking the following medicines, before starting to use Zoreeda

• Beta-blockers (such as atenolol, propranolol and sotalol). Beta- blockers are mostly used for high blood pressure or other heart conditions

• Antiviral and antifungal medicines (such as ritonavir, ketoconazoleand itraconazole). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This can increase your risk of experiencing side effects with Zoreeda including irregular heart beats, or may make side effects worse.

• Corticosteroids (by mouth or by injection). If you have had these medicines recently, this might increase the risk of this medicine affecting your adrenal gland.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planing to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Zoreeda is not likely to affect your ability to drive or use machines.

3. How to use Zoreeda

Always use this medicine exactly as your doctor or pharmacist has told you. Don’t exceed the recommended dose.Check with your doctor or pharmacist if you are not sure.

Adults and adolescents aged 12 years and over

• Zoreeda 25 mcg /125 mcg /dose - 2 puffs twice a day

• Zoreeda 25 mcg /250 mcg /dose - 2 puffs twice a day

Use in children and adolescents

Zoreeda 125 mcg/25mcg and 250 mcg/25mcg

is not recommended for use in children below 12 years of age.

The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

Where the control of symptoms is maintained with the lowest strength of Zoreeda(25/125 microgram), the next step could include a switch to a different inhaled salmeterol fluticasone product available in a lower strength (25/50 micrograms).

It is very important to follow your doctor’s instructions onhow many puffs to take and how often to take your medicine.

If you are using Zoreeda for asthma, your doctor will want to regularly check your symptoms.

If your asthma or breathing gets worse, tell your doctor straight away. You may find that you feel more wheezy, your chest feels tight more often or you may need to use more of your fast acting ‘reliever’ medicine. If any of these happen, you should continue to take Zoreeda but do not increase the number of puffs you take. Your chest condition may be getting worseand you could become seriously ill. See 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 check how you use it from time to time. Not using the Zoreeda properly or asprescribed may mean that it will not help your asthma as it should.

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

• There is an indicator in front of the Inhaler which tells you how many doses are left. As you use the inhaler the dose indicator will typically rotate during every five to seven puffs towards next decreasing number. The dose indicator will show the approximate no of puffs remaining in the inhaler

• Take care not to drop the Inhaler as this may cause the indicator to count down.

Testing your Inhaler

1. When using the Inhaler for the first time, test that it is working. Remove the mouthpiece cover by gently squeezing the sides with your thumb and forefinger and pull apart.

2. To make sure that it works, shake it well, point the mouthpiece away from you and press the canister to release four puffs into the air. The dose indicator will show the number ‘120’ indicating the number of puffs in the inhaler. If you have not used your inhaler for a week or more, shake well and release two puffs of medicine into the air.

Using your Inhaler

It is important to start to breathe as slowly as possible just before using inhaler.

clean and free of objects (figure A).

contents of the inhaler are evenly mixed (figure B).

as is comfortable (figure C).

canister to release a puff of medicine. Do this while still breathing in steadily and deeply (figure D).

inhaler. Continue holding your breathe for a few seconds, or as long as is comfortable (figure E).

thrush and being hoarse.

10. After use always replace the mouthpiece cover straight away to keep out dust. When the mouthpiece cover is fitted correctly it will ‘click’ into position. If it does not ‘click’ into place, turn the mouthpiece cover the other way round and try again. Do not use too much force.

If you find it difficult to use the inhaler, aspacer device may be used such as the Volumatic or AeroChamber Plus or other spacer devices (depending on National Guidance). Before starting to use a spacer device for the first time or if you need to change your make of spacer device, talk to your doctor, nurse or pharmacist.

You should get a replacement when the indicator shows the number ‘40’ and the color on the dose indicator will change from green to red. Stop using the Inhaler when the indicator shows ‘0’ as any puffs left in the device may not be enough to give you a full dose. Never try to alter the numbers on the indicator or detach the indicator from the actuator. The indicator cannot be reset and is permanently attached to the actuator.

Cleaning your Inhaler

To stop your inhaler blocking, it is important to clean it at least once a week.

To clean your inhaler:

• Remove the mouthpiece cover.

• Do not remove the metal canister from the plastic casing at any time.

tissue.

‘click’ into place, turn the mouthpiece cover the other way round and try again. Do not use

too much force.

Do not put the metal canister in water.

If you use more Zoreedathan you should

It is important to use the inhaler as instructed. If you accidentally take a larger dose than

recommended, talk to your doctor or pharmacist. You may notice your heart beating faster

than usual and that you feel shaky. You may also have a headache, muscle weakness and

aching joints.

If you have used larger doses for a long period of time, you should talk to your doctor or

pharmacist for advice. This is because larger doses of Zoreeda may reduce the amount of steroid hormones produced by the adrenal gland.

If you forget to use Zoreeda

If you forget to use your inhaler, take your next dose when it is due. Do not take a double dose to replace the one you forgot.

If you stop using Zoreeda

It is very important that you take your Zoreeda every day as directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of Zoreeda. This could make your breathing problem worse and very rarely side effects could occur.

These include:

• Stomach pain

• Tiredness and loss of appetite

• Sickness and diarrhoea

• Weight loss

• Headache or drowsiness

• Low levels of potassium in your blood

• Low blood pressure and seizures.

Very rarely, if you get an infection or at times of extreme stress (such as after a serious accident or if you have surgery), you may get similar side effects.

To prevent these symptoms occurring, your doctor may prescribe extra corticosteroids (like

prednisolone).

If you have any further questions on using your Inhaler, ask 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 chance of side effects, your doctor will prescribe the lowest dose of Zoreeda tocontrol your asthma.

Allergic reactions: you may notice your breathing suddenly gets worse after using Zoreeda .You may be very wheezy and cough. You may also notice itching and swelling (usually of the face, lips, tongue or throat). If you get these effects or if they happen suddenly after using Zoreeda tell your doctor straight away. Allergic reactions to Zoreeda are uncommon (they affect less than 1 person in 100).

Other side effects are listed below:

Very Common (affects more than 1 person in 10)

• Headache - this usually gets better as treatment continues.

• Increased number of colds have been reported in patients with COPD.

Common (affects less than 1 person in 10)

• Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also sore tongue and hoarse voice. Rinsing your mouth out with water and spitting it out immediately after taking each puff may help. Your doctor may prescribe an antifungal medication to treat the thrush.

• Aching, swollen joints and muscle pain.

• Muscle cramps

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

Tell your doctor if you have any of the following while taking Zoreedathey could be symptoms of a lung infection:

• fever or chills,

• increased mucus production, change in mucus colour,

• increased cough or increased breathing difficulties.

• Throat irritation. Rinsing your mouth out with water and spitting it out immediately after taking each puff may help

• Bruising and fractures.

• Inflammation of sinuses (a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache).

• A reduction in the amount of potassium in the blood (you may get an uneven heartbeat, muscle weakness, cramp).

Uncommon (affects less than 1 person in 100)

• Increases in the amount of sugar (glucose) in your blood (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.

• Cloudy lens in the eye (cataract)

• Very fast heartbeat (tachycardia).

• Feeling shaky and fast or uneven heart beat (palpitations) - these are usually harmless and get less as treatment continues.

• Chest pain

• Feeling worried (this effect mainly occurs in children).

• Disturbed sleep

• Rash

• .

Rare (affects less than 1 person in 1000)

• slowing of growth in children and adolescents

• thinning of the bones

• damage to eye’s optic nerve (glaucoma)

• weight gain

• rounded (moon shaped) face (Cushing’s Syndrome).

Your doctor will check you regularly for any of these side effects and make sure you are

taking the lowest dose of Zoreeda to control your asthma.

• Behavioural changes, such as being unusually active and irritable (these effects mainly occur in children).

• Uneven heartbeat or heart gives an extra beat (arrhythmias). Tell your doctor, but do not stop taking Zoreeda unless they tell you to stop.

• .

Frequency not known, but may also occur:

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can report the side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Zoreeda

• Keep this medicine out of the sight and reach of children.

• Straight after use, replace the mouthpiece cover firmly and click it into position. Do not use

excessive force.

• Do not expose to temperatures higher than 50°C. Do not store Zoreeda in a cold place, as your medicine may not work as well.

• Do not use Zoreeda after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

The metal canister contains a pressurised liquid. Do not pierce the canister.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Zoreeda contains

Each metered dose of Zoreedaprovides:

25 micrograms of salmeterol (as salmeterol xinafoate) and 125 or 250 micrograms of fluticasone propionate (delivered from the valve). This is equivalent to 21 micrograms of salmeterol and 110 or 220 micrograms of fluticasone propionate delivered from the actuator (delivered dose).

What Zoreeda looks like and contents of the pack

• Aluminium canister with a suitable metering valve and a polypropylene actuator with dust cap having dose indicator in a sealed pouch containing desiccant.

• Each container is filled to deliver 120 puffs.

Pack sizes:

1, 2 (bundled package 2x1) or 3 (bundled package 3x1) canisters containing 120 puffs.

10 (bundled package 10x1) canisters containing 120 doses -hospital use only

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Cipla Europe NV

Uitbreidingstraat 80,

2600 Antwerp,

Belgium

Manufacturer

S&D Pharma CZ, spol. s r.o,

Theodor 28, 273 08

Pchery (Pharmos a.s. facility),

Ceská Republika.

Cipla (EU) Ltd,

20 Balderton Street, London W1K 6TL,

United Kingdom

Cipla Europe NV

Uitbreidingstraat 80, 2600 Antwerp,

Belgium

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, Barleben, Sachsen-Anhalt, 39179

Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden	Zoreeda 25 mikrogram/125 mikrogram/dos inhalationsspray, suspension Zoreeda 25 mikrogram/250 mikrogram/dos inhalationsspray, suspension
Czech Republic	Salmeterol/Fluticason Cipla 25 mikrogramů/125 mikrogramů /dávka Salmeterol/Fluticason Cipla 25 mikrogramů/250 mikrogramů /dávka
Germany	Airflusal® Dosieraerosol 25 Mikrogramm/125 Mikrogramm pro Sprühstoß Druckgasinhalation, Suspension Airflusal® Dosieraerosol 25 Mikrogramm/250 Mikrogramm pro Sprühstoß Druckgasinhalation, Suspension
Greece	Salmeterol and Fluticasone Cipla 25/125 μικρογραμμάρια ανά δόση Εναιώρημα για εισπνοή υπό πίεση Salmeterol and Fluticasone Cipla 25/250 μικρογραμμάρια ανά δόση Εναιώρημα για εισπνοή υπό πίεση
Island	Zoreeda 25/125 míkróg/skammt, innúðalyf, dreifa Zoreeda 25/250 míkróg/skammt, innúðalyf, dreifa
Luxumburg	Salmétérol et fluticasone Cipla 25/125 microgrammes par dose suspension pour inhalation en flacon pressurise Salmétérol et fluticasone Cipla 25/250 microgrammes par dose suspension pour inhalation en flacon pressurise
Slovak	Salmeterol/Flutikazón Cipla 25 mikrogramov/125 mikrogramov/dávka Salmeterol/Flutikazón Cipla 25 mikrogramov/250 mikrogramov/dávka

This leaflet was last revised in 4 November 2016