Vylaer Spiromax

Informazzjoni prinċipali

  • Isem kummerċjali:
  • Vylaer Spiromax
  • Dominju tal-mediċina:
  • Bnedmin
  • Tip ta 'mediċina:
  • Droga allopatika

Dokumenti

Lokalizzazzjoni

  • Disponibbli fi:
  • Vylaer Spiromax
    Unjoni Ewropea
  • Lingwa:
  • Ingliż

Informazzjoni terapewtika

  • Grupp terapewtiku:
  • Inhalation powder
  • Żona terapewtika:
  • Pulmonary Disease, Chronic Obstructive, Asthma
  • Indikazzjonijiet terapewtiċi:
  • Vylaer Spiromax is indicated in adults 18 years of age and older only.AsthmaVylaer Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.COPDSymptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
  • Sommarju tal-prodott:
  • Revision: 3

Status

  • Sors:
  • EMA - European Medicines Agency
  • L-istatus ta 'awtorizzazzjoni:
  • Withdrawn
  • Numru ta 'awtorizzazzjoni:
  • EMEA/H/C/003952
  • Data ta 'l-awtorizzazzjoni:
  • 18-11-2014
  • Kodiċi EMEA:
  • EMEA/H/C/003952
  • L-aħħar aġġornament:
  • 31-03-2019

Rapport ta 'Valutazzjoni Pubblika

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Canary Wharf

London E14 5EU

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

EMA/601032/2014

EMEA/H/C/003952

EPAR summary for the public

Vylaer Spiromax

budesonide / formoterol

This is a summary of the European public assessment report (EPAR) for Vylaer Spiromax. It explains

how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of

use. It is not intended to provide practical advice on how to use Vylaer Spiromax.

For practical information about using Vylaer Spiromax, patients should read the package leaflet or

contact their doctor or pharmacist.

What is Vylaer Spiromax and what is it used for?

Vylaer Spiromax is a medicine that contains the active substances budesonide and formoterol. It is

used for the treatment of asthma in adults for whom a combination product is considered appropriate.

It can be used in patients whose disease is not adequately controlled by treatment with other asthma

medicines called corticosteroids and ‘short-acting beta-2 agonists’ taken by inhalation, or in patients

whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2

agonists’ taken by inhalation.

Vylaer Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease

(COPD) in adults who have had exacerbations (flare–ups) of the disease in the past despite regular

treatment. COPD is a long-term disease in which the airways and air sacs inside the lungs become

damaged or blocked, leading to difficulty in breathing.

Vylaer Spiromax is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’

containing the same active substances, but Vylaer Spiromax is given using a different inhaler. The

reference medicine for Vylaer Spiromax is Symbicort Turbohaler.

Medicinal product no longer authorised

Vylaer Spiromax

EMA/601032/2014

Page 2/3

How is Vylaer Spiromax used?

The medicine can only be obtained with a prescription. It is available as an inhalation powder in a

portable inhaler device, and each inhalation provides a fixed dose of the medicine. Vylaer Spiromax

160/4.5 microgram can be used for the regular treatment of asthma. It can also be used for the

treatment of COPD.

For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day,

depending on the strength being used and the severity of the asthma. For asthma reliever therapy,

patients should take a separate ‘reliever inhaler’ to relieve their symptoms. If patients need to take

more than 8 reliever inhalations per day, it is recommended they speak to their doctor to have their

asthma therapy reconsidered.

For the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the

strength being used.

For further information, see the package leaflet.

How does Vylaer Spiromax work?

The two active substances in Vylaer Spiromax are well known and are present in several medicines

used to treat asthma and COPD, either alone or in combination with other medicines.

Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a

similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system

by attaching to receptors in various types of immune cell. This leads to a reduction in the release of

substances that are involved in the inflammation process, such as histamine, thereby helping to keep

the airways clear and allowing the patient to breathe more easily.

Formoterol is a long-acting beta-2 agonist. It works by attaching to receptors known as beta-2

receptors found in the muscles of the airways. When inhaled it mainly attaches to the receptors in the

airways and causes the muscles to relax, which keeps the airways open and helps with the patient’s

breathing.

What are the benefits and risks of Vylaer Spiromax?

Studies were carried out to show that Vylaer Spiromax is bioequivalent to the reference medicine (i.e.

produces the same level of the active substance in the body) and that the two medicines act in the

same way. The benefits and risks of Vylaer Spiromax are therefore taken to be the same as those of

the reference medicine.

Why is Vylaer Spiromax approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Vylaer

Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and

to be equivalent to the corresponding strengths of Symbicort Turbohaler. Therefore, the CHMP’s view

was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk. The Committee

recommended that Vylaer Spiromax be given marketing authorisation.

Medicinal product no longer authorised

Vylaer Spiromax

EMA/601032/2014

Page 3/3

What measures are being taken to ensure the safe and effective use of

Vylaer Spiromax?

A risk management plan has been developed to ensure that Vylaer Spiromax is used as safely as

possible. Based on this plan, safety information has been included in the summary of product

characteristics and the package leaflet for Vylaer Spiromax, including the appropriate precautions to be

followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan

Other information about Vylaer Spiromax

The European Commission granted a marketing authorisation valid throughout the European Union for

Vylaer Spiromax on 19 November 2014.

The full EPAR and risk management plan summary for Vylaer Spiromax can be found on the Agency’s

website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For

more information about treatment with Vylaer Spiromax, read the package leaflet (also part of the

EPAR) or contact your doctor or pharmacist.

This summary was last updated in 11-2014.

Medicinal product no longer authorised

Fuljett ta 'Informazzjoni għall-Pazjent: prodott - kompożizzjoni, indikazzjonijiet, effetti sekondarji, dożaġġ, interazzjonijiet, reazzjonijiet avversi, tqala, treddigħ

B. PACKAGE LEAFLET

Medicinal product no longer authorised

Package leaflet: Information for the patient

Vylaer Spiromax 160 micrograms/4.5 micrograms, inhalation powder

(budesonide/formoterol fumarate dihydrate)

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, 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Vylaer Spiromax is and what it is used for (page 3)

What you need to know before you use Vylaer Spiromax (page 5)

How to use Vylaer Spiromax (page 9)

Possible side effects (page 18)

How to store Vylaer Spiromax (page 21)

Contents of the pack and other information (page 22)

1.

What Vylaer Spiromax is and what it is used for

Vylaer Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.

Budesonide belongs to a group of medicines called ‘corticosteroids’ also known as ‘steroids’. It works

by reducing and preventing swelling and inflammation in your lungs and helps you to breathe more

easily.

Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β

adrenoceptor

agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This will help to open

the airways and help you to breathe more easily.

Vylaer Spiromax is indicated for use in adults 18 years of age and older only.

Vylaer Spiromax is NOT indicated for use in children 12 years of age and younger or adolescents 13 to

17 years of age.

Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).

Asthma

To treat your asthma your doctor will prescribe two asthma inhalers: Vylaer Spiromax together with

a separate ‘reliever inhaler’ such as salbutamol.

Use Vylaer Spiromax every day. This helps to prevent asthma symptoms such as breathlessness and

wheezing from occurring.

Use the ‘reliever inhaler’ when you get asthma symptoms, to make it easier to breathe again.

Chronic obstructive pulmonary disease (COPD)

COPD is a long-term lung disease of the airways in the lungs, which is often caused by cigarette smoking.

Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus. Vylaer Spiromax

can also be used to treat the symptoms of severe COPD in adults.

2.

What you need to know before you use Vylaer Spiromax

Medicinal product no longer authorised

Do not use Vylaer Spiromax if:

You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed

in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Vylaer Spiromax if

you are diabetic.

you have a lung infection.

you have high blood pressure or you have ever had a heart problem (including an uneven heartbeat, a

very fast pulse, narrowing of the arteries or heart failure).

you have problems with your thyroid or adrenal glands.

you have low levels of potassium in your blood.

you have severe liver problems.

If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of

tablets that you take, once you start to use Vylaer Spiromax. If you have been taking steroid tablets for a long

time, your doctor may want you to have regular blood tests. When reducing steroid tablets, you may feel

generally unwell even though your chest symptoms may be improving. You might experience symptoms

such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms

bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur,

please contact your doctor

immediately

. You may need to take other medicines if you develop allergic or

arthritic symptoms. You should speak to your doctor if you are concerned as to whether you should continue

to use Vylaer Spiromax.

Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for

example, when you have a chest infection or before an operation).

Children and adolescents

This medicine should not be used in children or adolescents under the age of 18 years.

Other medicines and Vylaer Spiromax

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

β blockers (such as atenolol or propranolol for high blood pressure or a heart condition), including

eyedrops (such as timolol for glaucoma).

Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide and procainamide).

Medicines like digoxin, often used to treat heart failure.

Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood

pressure.

Steroid medicines that you take by mouth (such as prednisolone).

Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.

Other bronchodilators (such as salbutamol).

Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.

Medicines called monoamine oxidase inhibitors (such as phenelzine, furazolidone and procardazine).

Phenothiazine medicines (such as chlorpromazine and prochlorperazine).

Medicines called ‘HIV protease inhibitors’ (such as ritonavir) to treat HIV infection.

Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole,

clarithromycin and telithromycin).

Medicines for Parkinson’s disease (such as levodopa).

Medicines for thyroid problems (such as levothyroxine).

Medicines for allergies or antihistamines (such as terfenadine).

If any of the above applies to you, or if you are not sure, talk to your doctor, pharmacist or nurse before using

Vylaer Spiromax.

Medicinal product no longer authorised

Also tell your doctor, pharmacist or nurse if you are going to have a general anaesthetic for an operation or

for dental work.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor, pharmacist or nurse for advice before taking Vylaer Spiromax - do NOT use this medicine

unless your doctor tells you to.

If you get pregnant while using Vylaer Spiromax, do NOT stop using Vylaer Spiromax but talk to your

doctor

immediately.

Driving and using machines

Vylaer Spiromax is not likely to affect your ability to drive or to use tools or machines.

Vylaer Spiromax contains lactose

Lactose is a type of sugar found in milk. Lactose contains small amounts of milk protein which may cause

allergic reactions.If you have been told by your doctor that you have an intolerance to some sugars, talk to

your doctor before using this medicine.

3.

How to use Vylaer Spiromax

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor,

pharmacist or nurse if you are not sure.

It is important to use Vylaer Spiromax every day, even if you have no asthma or COPD symptoms at

the time.

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

Asthma

Using Vylaer Spiromax and a separate ‘reliever inhaler’

Use your Vylaer Spiromax every day.

This helps to prevent asthma symptoms from occurring.

Recommended dose:

Adults (18 years and older)

1 or 2 inhalations (actuations), twice a day.

Your doctor may increase this to 4 inhalations, twice a day.

If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.

Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose

that controls your asthma. If your doctor feels that you need a lower dose than is available from your Vylaer

Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your

Vylaer Spiromax but with a lower dose of the corticosteroid. However, do not adjust the number of

inhalations your doctor has prescribed without talking to your doctor first.

Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen.

Always keep your ‘reliever inhaler’ with you and use it to relieve sudden attacks of breathlessness and

wheezing. Do not use Vylaer Spiromax to treat these asthma symptoms.

Use of your ‘reliever inhaler’

should not exceed 8 inhalations (puffs) in any 24 hours

and you should

not use your ‘reliever inhaler’ more often than every 4 hours. If you are regularly using up to 8

inhalations a day or you need to increase the amount of ‘reliever inhaler’ you require, you should see

your doctor as soon as possible. Your doctor may need to change your treatment in order to reduce

your symptoms of asthma (breathlessness, wheezing and cough) and improve your asthma control and

make your breathing easier.

Medicinal product no longer authorised

If you are doing exercise and you get asthma symptoms, use your separate ‘reliever inhaler’ to relieve these

symptoms. Do not use Vylaer Spiromax just before exercise to stop asthma symptoms from occurring, use

your separate ‘reliever inhaler’.

Chronic Obstructive Pulmonary Disease (COPD)

Recommended dose:

Adults (18 years and older):

2 inhalations twice a day.

Your doctor may also prescribe another bronchodilator medicine, for example an anticholinergic (such as

tiotropium or ipratropium bromide) for your COPD disease.

Preparing your new Vylaer Spiromax

Before using your Vylaer Spiromax

for the first time

, you need to prepare it for use as follows:

Check the dose indicator to see that there are 120 inhalations in the inhaler.

Write the date you opened the foil pouch on the label of the inhaler.

Do not shake your inhaler before use.

How to take an inhalation

Every time you need to take an inhalation, follow the instructions below.

Hold your inhaler

with the semi-transparent wine red mouthpiece cover at the bottom.

Open the mouthpiece cover by folding it down until one loud click is heard. Your medicine is actively

metered. Your inhaler is now ready for use.

Breathe out gently (as far as is comfortable). Do not breathe out through your inhaler.

Medicinal product no longer authorised

4. Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the

mouthpiece. Take care not to block the air vents.

Breathe in through your mouth as deeply and as hard as you can.

5. Hold your breath for 10 seconds or as long as you comfortably can.

6. Remove your inhaler from your mouth. You may notice a taste when you take your inhalation.

Then breathe out gently

(do not breathe out through the inhaler).

Close the mouthpiece cover

If you are to take a second inhalation, repeat steps 1 to 7.

Rinse your mouth with water after every dose, and spit it out.

Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and

must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart

from your Spiromax. Do not open and close the mouthpiece cover unless you are about to use your inhaler.

Cleaning your Spiromax

Keep your Spiromax dry and clean.

If necessary you may wipe the mouthpiece of your Spiromax after use with a dry cloth or tissue.

When to start using a new Spiromax

The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120

inhalations when it is full.

Medicinal product no longer authorised

The dose indicator, on the rear of the device, shows the number of inhalations remaining in even

numbers only.

For inhalations remaining from 20 downwards to ‘8’, 6’,’4’,’2’ the numbers are displayed in red on a

white background. When the numbers become red in the window, you should consult your doctor and

obtain a new inhaler.

Note:

The mouthpiece will still ‘click’ even when your Spiromax is empty.

If you open and close the mouthpiece without taking an inhalation the dose indicator will still register it

as a count. This dose will be securely held inside the inhaler for when the next inhalation is due. It is

impossible to accidentally take extra medicine or a double dose in one inhalation.

Keep the mouthpiece closed all the time unless you are about to use your inhaler.

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using Vylaer Spiromax, you should continue to use

Vylaer Spiromax but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor

immediately

Your breathing is getting worse or you often wake up at night with breathlessness and wheezing.

Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

These signs could mean that your asthma or COPD is not being properly controlled and you may need

different or additional treatment

immediately

Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of

Vylaer Spiromax.

If you use more Vylaer Spiromax than you should

It is important that you take your dose as advised by your doctor. You should not exceed your prescribed

dose without seeking medical advice.

If you use more Vylaer Spiromax than you should, contact your doctor, pharmacist or nurse for advice.

The most common symptoms that may occur after if you use more Vylaer Spiromax than you should are

trembling, headache or a rapid heartbeat.

If you forget to use Vylaer Spiromax

If you forget to take a dose, take it as soon as you remember. However do

not

take a double dose to make up

for a forgotten dose. If it is nearly time for your next dose just take your next dose at the usual time.

If you become wheezy or breathless, or develop any other symptoms of an asthma attack,

use your ‘reliever

inhaler’,

then seek medical advice.

If you stop using Vylaer Spiromax

Do not stop using your inhaler without telling your doctor first.

Medicinal product no longer authorised

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

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

If

any

of

the

following

happen

to

you,

stop

using

Vylaer

Spiromax

and

talk

to

your

doctor

immediately:

Rare side effects: may affect up to 1 in 1,000 people

Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow)

or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness. This may

mean that you are having an allergic reaction, which may also include rash and itching.

Bronchospasm (tightening of the muscles in the airways which causes wheezing and shortness of

breath). If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor

immediately.

Very rare side effects: may affect up to 1 in 10,000 people

Sudden acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to

as ‘paradoxical bronchospasm’). If either of these symptoms occur,

stop using Vylaer Spiromax

straightaway

and use your ‘reliever inhaler’. Contact your doctor

immediately

as you may need to have

your treatment changed.

Other possible side effects:

Common: may affect up to 1 in 10 people

Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are

usually mild and usually disappear as you continue to use Vylaer Spiromax.

Thrush (a fungal infection) in the mouth. This is less likely to occur if you rinse your mouth out with

water after using your medicine.

Mild sore throat, coughing and a hoarse voice.

Headache.

Pneumonia (infection to the lung) in COPD patients.

Tell your doctor if you have any of the following while taking Vylaer Spiromax they could be symptoms of a

lung infection:

Fever or chills

Increased mucus production, change in mucus colour

Increased cough or increased breathing difficulties

Uncommon: may affect up to 1 in 100 people

Feeling restless, nervous, agitated, anxious or angry.

Disturbed sleep.

Feeling dizzy.

Nausea (feeling sick).

Fast heartbeat.

Bruising of the skin.

Muscle cra

Rare:

Low levels of potassium in your blood.

Uneven heartbeat.

Very rare:

Medicinal product no longer authorised

Depression.

Changes in behaviour, especially in children.

Chest pain or tightness in the chest (angina pectoris).

Disturbance of the heart’s electrical system (prolongation of the QTc-interval).

An increase in the amount of sugar (glucose) in your blood.

Taste changes, such as an unpleasant taste in the mouth.

Changes in your blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly

if you use high doses for a long time. The effects include:

changes in bone mineral density (thinning of the bones)

cataract (clouding of the lens in the eye)

glaucoma (increased pressure in the eye)

a slowing of the rate of growth of children and adolescents

an effect on the adrenal gland (a small gland next to the kidney)

These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with

corticosteroid tablets.

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 also report 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 Vylaer Spiromax

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

Do not use this medicine after the expiry date which is stated on the carton or on the label of your inhaler

after EXP. The expiry date refers to the last day of that month.

Do not store above 25

Keep the mouthpiece cover closed after removal of the foil wrapping.

Use within 6 months of removing from the foil wrapping.

Use the label on the inhaler to write down

the opening date of the foil pouch.

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 Vylaer Spiromax contains

The active substances are budesonide and formoterol fumarate dihydrate. Each delivered (inhaled) dose

contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate. This is

equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate

dihydrate.

The other ingredient is lactose monohydrate (see section 2 under ‘Vylaer Spiromax contains lactose’)

What Vylaer Spiromax looks like and contents of the pack

Vylaer Spiromax is an inhalation powder.

Each Vylaer Spiromax inhaler contains 120 inhalations and has a white body with a semi-transparent wine

red mouthpiece cover.

Packs of 1 and 3 inhalers. Not all pack sizes may be marketed in your country.

Medicinal product no longer authorised

Marketing Authorisation Holder

Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands

Manufacturer

Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland

Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland

Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poland.

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tel/Tél: +32 3 820 73 73

Luxembourg/Luxemburg

Teva Pharma Belgium N.V./S.A./AG

Tel/Tél: +32 3 820 73 73

България

Тева Фармасютикълс България ЕООД

Teл: +359 2 489 95 82

Magyarország

Teva Gyógyszergyár Zrt

Tel.: +36 1 288 64 00

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Malta

Teva Pharmaceuticals Irland

L-Irlanda

Τel: +353 51 321 740

Danmark

Teva Denmark A/S

Tlf: +45 44 98 55 11

Nederland

Teva Nederland B.V.

Tel: +31 800 0228 400

Deutschland

Teva GmbH

Tel: +49 731 402 08

Norge

Teva Norway AS

Tlf: +47 6677 55 90

Eesti

Teva Eesti esindus UAB Sicor Biotech Eesti

filiaal

Tel: +372 661 0801

Österreich

ratiopharm Arzneimittel Vertriebs GmbH

Tel: +43 1 97007 0

Ελλάδα

Teva Ελλάς Α.Ε.

Τηλ: +30 210 72 79 099

Polska

Teva Pharmaceuticals Polska Sp. z o.o.

Tel.: +48 22 345 93 00

España

Teva Pharma S.L.U.

Tél: +34 91 387 32 80

Portugal

Teva Pharma - Produtos Farmacêuticos Lda

Tel: +351 21 476 75 50

France

Teva Santé

Tél: +33 1 55 91 7800

România

Teva Pharmaceuticals S.R.L

Tel: +4021 230 6524

Medicinal product no longer authorised

Ireland

Teva Pharmaceuticals Ireland

Tel: +353 51 321 740

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Ísland

ratiopharm Oy

Puh/Tel: +358 20 180 5900

Slovenská republika

Teva Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 5726 7911

Italia

Teva Italia S.r.l.

Tel: +39 028 917 981

Suomi/Finland

ratiopharm Oy

Puh/Tel: +358 20 180 5900

Κύπρος

Teva Ελλάς Α.Ε.

Τηλ: +30 210 72 79 099

Sverige

Teva Sweden AB

Tel: +46 42 12 11 00

Latvija

Sicor Biotech filiāle Latvijā

Tel: +371 67 323 666

United Kingdom

Teva UK Limited

Tel: +44 1977 628 500

Lietuva

UAB “Sicor Biotech”

Tel: +370 5 266 02 03

Hrvatska

Pliva Hrvatska d.o.o

Tel: + 385 1 37 20 000

This leaflet was last revised in month YYYY

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web

site: http://www.ema.europa.eu.

Medicinal product no longer authorised

Package leaflet: Information for the patient

Vylaer Spiromax 320 micrograms/9 micrograms, inhalation powder

(budesonide/formoterol fumarate dihydrate)

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, 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Vylaer Spiromax is and what it is used for (page 3)

What you need to know before you use Vylaer Spiromax (page 5)

How to use Vylaer Spiromax (page 8)

Possible side effects (page 16)

How to store Vylaer Spiromax (page 19)

Contents of the pack and other information (page 19)

1.

What Vylaer Spiromax is and what it is used for

Vylaer Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.

Budesonide belongs to a group of medicines called ‘corticosteroids’ also known as ‘steroids’. It

works by reducing and preventing swelling and inflammation in your lungs and helps you to breathe

more easily.

Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β

adrenoceptor

agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This will help to

open the airways and help you to breathe more easily.

Vylaer Spiromax is indicated for use in adults 18 years of age and older only.

Vylaer Spiromax is NOT indicated for use in children, 12 years of age and younger or adolescents, 13

to 17 years of age.

Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).

Asthma

When used for asthma, your doctor will prescribe Vylaer Spiromax together with a separate ‘reliever inhaler’

such as salbutamol.

Use Vylaer Spiromax every day. This helps to prevent asthma symptoms such as breathlessness and

wheezing from occurring.

Use the ‘reliever inhaler’ when you get asthma symptoms, to make it easier to breathe again.

Do not use Vylaer Spiromax 320/9 micrograms as a ‘reliever inhaler’.

Chronic obstructive pulmonary disease (COPD)

COPD is a long-term lung disease of the airways in the lungs, which is often caused by cigarette smoking.

Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus. Vylaer Spiromax

can also be used to treat the symptoms of severe COPD in adults.

Medicinal product no longer authorised

2.

What you need to know before you use Vylaer Spiromax

Do not use Vylaer Spiromax if:

You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine

(listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Vylaer Spiromax if

you are diabetic.

you have a lung infection.

you have high blood pressure or you have ever had a heart problem (including an uneven heartbeat, a

very fast pulse, narrowing of the arteries or heart failure).

you have problems with your thyroid or adrenal glands.

you have low levels of potassium in your blood.

you have severe liver problems.

If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of

tablets that you take, once you start to use Vylaer Spiromax . If you have been taking steroid tablets for a

long time, your doctor may want you to have regular blood tests. When reducing steroid tablets, you may

feel generally unwell even though your chest symptoms may be improving. You might experience symptoms

such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms

bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur,

please contact your doctor

immediately

. You may need to take other medicines if you develop allergic or

arthritic symptoms. You should speak to your doctor if you are concerned as to whether you should continue

to use Vylaer Spiromax .

Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for

example, when you have a chest infection or before an operation).

Children and adolescents

This medicine should not be used in children or adolescents under the age of 18 years.

Other medicines and Vylaer Spiromax

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

β blockers (such as atenolol or propranolol for high blood pressure or a heart condition), including

eyedrops (such as timolol for glaucoma).

Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide and procainamide).

Medicines like digoxin, often used to treat heart failure.

Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood

pressure.

Steroid medicines that you take by mouth (such as prednisolone).

Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.

Other bronchodilators (such as salbutamol).

Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.

Medicines called monoamine oxidase inhibitors (such as phenelzine, furazolidone and procardazine).

Phenothiazine medicines (such as chlorpromazine and prochlorperazine).

Medicines called ‘HIV protease inhibitors’ (such as ritonavir) to treat HIV infection.

Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole,

clarithromycin and telithromycin).

Medicines for Parkinson’s disease (

such as levodopa).

Medicines for thyroid problems (such as levothyroxine).

Medicines for allergies or antihistamines (such as terfenadine).

Medicinal product no longer authorised

If any of the above applies to you, or if you are not sure, talk to your doctor, pharmacist or nurse before using

Vylaer Spiromax .

Also tell your doctor, pharmacist or nurse if you are going to have a general anaesthetic for an operation or

for dental work.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor, pharmacist or nurse for advice before taking Vylaer Spiromax - do NOT use this medicine

unless your doctor tells you to.

If you get pregnant while using Vylaer Spiromax , do NOT stop using Vylaer Spiromax but talk to your

doctor

immediately.

Driving and using machines

Vylaer Spiromax is not likely to affect your ability to drive or to use tools or machines.

Vylaer Spiromax contains lactose

Lactose is a type of sugar found in milk. Lactose contains small amounts of milk protein which may cause

allergic reactions.If you have been told by your doctor that you have an intolerance to some sugars, talk to

your doctor before using this medicine.

3.

How to use Vylaer Spiromax

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

pharmacist, or nurse if you are not sure.

It is important to use Vylaer Spiromax every day, even if you have no asthma or COPD symptoms at

the time.

If you are using Vylaer Spiromax for asthma, your doctor will want to regularly check your

symptoms.

Asthma

Using Vylaer Spiromax and a separate ‘reliever inhaler’

Use your Vylaer Spiromax every day.

This helps to prevent asthma symptoms from occurring.

Recommended dose:

Adults (18 years and older )

1 inhalation (actuation), twice a day.

Your doctor may increase this to 2 inhalations, twice a day. If your symptoms are well controlled, your

doctor may ask you to take your medicine once a day.

Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose

that controls your asthma. If your doctor feels that you need a lower dose than is available from your Vylaer

Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your

Vylaer Spiromax but with a lower dose of the corticosteroid. However, do not adjust the number of

inhalations your doctor has prescribed without talking to your doctor first.

Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen.

Always keep your ‘reliever inhaler’ with you and use it to relieve sudden attacks of breathlessness and

wheezing. Do not use Vylaer Spiromax to treat these asthma symptoms.

Medicinal product no longer authorised

Use of your ‘reliever inhaler’ should not exceed 8 inhalations (puffs) in any 24 hours and you should

not use your ‘reliever inhaler’ more often than every 4 hours. If you are regularly using up to 8

inhalations a day or you need to increase the amount of ‘reliever inhaler’ you require, you should see

your doctor as soon as possible. Your doctor may need to change your treatment in order to reduce

your symptoms of asthma (breathlessness, wheezing and cough) and improve your asthma control and

make your breathing easier.

If you are doing exercise and you get asthma symptoms, use your separate ‘reliever inhaler’ to relieve these

symptoms. Do not use Vylaer Spiromax just before exercise to stop asthma symptoms from occurring, use

your separate ‘reliever inhaler’.

Chronic Obstructive Pulmonary Disease (COPD)

Recommended dose:

Adults (18 years and older):

1 inhalation twice a day.

Your doctor may also prescribe another bronchodilator medicine for example an anticholinergic (such as

tiotropium or ipratropium bromide) for your COPD disease.

Preparing your new Vylaer Spiromax

Before using your Vylaer Spiromax

for the first time

, you need to prepare it for use as follows:

Check the dose indicator to see that there are 60 inhalations in the inhaler.

Write the date you opened the foil pouch on the label of the inhaler.

Do not shake your inhaler before use.

How to take an inhalation

Every time you need to take an inhalation, follow the instructions below.

Hold your inhaler

with the semi-transparent wine red mouthpiece cover at the bottom.

Open the mouthpiece cover by folding it down until one loud click is heard. Your medicine is actively

metered. Your inhaler is now ready for use.

Medicinal product no longer authorised

Breathe out gently (as far as is comfortable). Do not breathe out through your inhaler.

Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the

mouthpiece. Take care not to block the air vents.

Breathe in through your mouth as deeply and as hard as you can.

5. Hold your breath for 10 seconds or as long as you comfortably can.

6. Remove your inhaler from your mouth. You may notice a taste when you take your inhalation.

Then breathe out gently

(do not breathe out through the inhaler).

Close the mouthpiece cover.

If you are to take a second inhalation, repeat steps 1 to 7.

Rinse your mouth with water after every dose and spit it out.

Medicinal product no longer authorised

Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and

must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart

from your Spiromax. Do not open and close the mouthpiece cover unless you are about to use your inhaler.

Cleaning your Spiromax

Keep your Spiromax dry and clean.

If necessary you may wipe the mouthpiece of your Spiromax after use with a dry cloth or tissue.

When to start using a new Spiromax

The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 60

inhalations when it is full.

The dose indicator, on the rear of the device, shows the number of inhalations remaining in even

numbers only.

For inhalations remaining from 20 downwards to ‘8’, ‘6’, ‘4’, ‘2’ the numbers are displayed in red on a

white background. When the numbers become red in the window, you should consult your doctor and

obtain a new inhaler.

Note:

The mouthpiece will still ‘click’ even when your Spiromax is empty.

If you open and close the mouthpiece without taking an inhalation, the dose indicator will still register it

as a count. This dose will be securely held inside the inhaler for when the next inhalation is due. It is

impossible to accidentally take extra medicine or a double dose in one inhalation.

Keep the mouthpiece closed all the time unless you are about to use your inhaler.

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using Vylaer Spiromax , you should continue to use

Vylaer Spiromax but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor

immediately

Your breathing is getting worse or you often wake up at night with breathlessness and wheezing.

Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

These signs could mean that your asthma or COPD is not being properly controlled and you may need

different or additional treatment

immediately

Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of

Vylaer Spiromax.

If you use more Vylaer Spiromax than you should

It is important that you take your dose as advised by your doctor. You should not exceed your prescribed

dose without seeking medical advice.

Medicinal product no longer authorised

If you use more Vylaer Spiromax than you should, contact your doctor, pharmacist or nurse for advice.

The most common symptoms that may occur after if you use more Vylaer Spiromax than you should are

trembling, headache or a rapid heartbeat.

If you forget to use Vylaer Spiromax

If you forget to take a dose, take it as soon as you remember. However, do

not

take a double dose to make up

for a forgotten dose. If it is nearly time for your next dose just take your next dose at the usual time.

If you become wheezy or breathless, or develop any other symptoms of an asthma attack,

use your ‘reliever

inhaler’

, then seek medical advice.

If you stop using Vylaer Spiromax

Do not stop using your inhaler without telling your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

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

If

any

of

the

following

happen

to

you,

stop

using

Vylaer

Spiromax

and

talk

to

your

doctor

immediately:

Rare side effects: may affect up to 1 in 1,000 people

Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow)

or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness. This may

mean that you are having an allergic reaction, which may also include rash and itching.

Bronchospasm (tightening of the muscles in the airways which causes wheezing and shortness of

breath). If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor

immediately.

Very rare side effects: may affect up to 1 in 10,000 people

Sudden acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to

as ‘paradoxical bronchospasm’. If either of these symptoms occur,

stop using Vylaer Spiromax

straightaway

and use your ’reliever inhaler’ Contact your doctor

immediately

as you may need to have

your treatment changed.

Other possible side effects:

Common: may affect up to 1 in 10 people

Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are

usually mild and usually disappear as you continue to use Vylaer Spiromax.

Thrush (a fungal infection) in the mouth. This is less likely to occur if you rinse your mouth out with

water after using your medicine.

Mild sore throat, coughing and a hoarse voice.

Headache.

Pneumonia (infection to the lung) in COPD patients.

Tell your doctor if you have any of the following while taking Vylaer Spiromax they could be symptoms of a

lung infection:

Fever or chills

Increased mucus production, change in mucus colour

Increased cough or i

ncreased breathing

difficulties

Medicinal product no longer authorised

Uncommon: may affect up to 1 in 100 people

Feeling restless, nervous, agitated, anxious or angry.

Disturbed sleep.

Feeling dizzy.

Nausea (feeling sick).

Fast heartbeat.

Bruising of the skin.

Muscle cramps.

Rare:

Low levels of potassium in your blood.

Uneven heartbeat.

Very rare:

Depression.

Changes in behaviour, especially in children.

Chest pain or tightness in the chest (angina pectoris).

Disturbance of the heart’s electrical system (prolongation of the QTc-interval).

An increase in the amount of sugar (glucose) in your blood.

Taste changes, such as an unpleasant taste in the mouth.

Changes in your blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly

if you use high doses for a long time. The effects include:

changes in bone mineral density (thinning of the bones)

cataract (clouding of the lens in the eye)

glaucoma (increased pressure in the eye)

a slowing of the rate of growth of children and adolescents

an effect on the adrenal gland (a small gland next to the kidney)

These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with

corticosteroid tablets.

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 also report 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 Vylaer Spiromax

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

Do not use this medicine after the expiry date which is stated on the carton or on the label of your inhaler

after EXP. The expiry date refers to the last day of that month.

Do not store above 25

Keep the mouthpiece cover closed after removal of the foil wrapping.

Use within 6 months of removing from the foil wrapping.

Use the label on the inhaler to write down

the opening date of the foil pouch.

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.

Medicinal product no longer authorised

6.

Contents of the pack and other information

What Vylaer Spiromax contains

The active substances are budesonide and formoterol fumarate dihydrate. Each delivered (inhaled) dose

contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate. This is

equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol

fumarate dihydrate.

The other ingredient is lactose monohydrate (see section 2 under ‘Vylaer Spiromax contains lactose’)

What Vylaer Spiromax looks like and contents of the pack

Vylaer Spiromax is an inhalation powder.

Each Vylaer Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent wine red

mouthpiece cover.

Packs of 1 and 3 inhalers. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands

Manufacturer:

Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland

Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland

Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poland.

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tel/Tél: +32 3 820 73 73

Luxembourg/Luxemburg

Teva Pharma Belgium N.V./S.A./AG

Tel/Tél: +32 3 820 73 73

България

Тева Фармасютикълс България ЕООД

Teл: +359 2 489 95 82

Magyarország

Teva Gyógyszergyár Zrt

Tel.: +36 1 288 64 00

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Malta

Teva Pharmaceuticals Ireland

L-Irlanda

Τel: +353 51 321 740

Danmark

Teva Denmark A/S

Tlf: +45 44 98 55 11

Nederland

Teva Nederland B.V.

Tel: +31 800 0228 400

Deutschland

Teva GmbH

Tel: +49 731 402 08

Norge

Teva Norway AS

Tlf: +47 6677 55 90

Eesti

Teva Eesti esindus UAB Sicor Biotech Eesti

filiaal

Tel: +372 661 0801

Österreich

ratiopharm Arzneimittel Vertriebs GmbH

Tel: +43 1 97007 0

Medicinal product no longer authorised

Ελλάδα

Teva Ελλάς Α.Ε.

Τηλ: +30 210 72 79 099

Polska

Teva Pharmaceuticals Polska Sp. z o.o.

Tel.: +48 22 345 93 00

España

Teva Pharma S.L.U.

Tél: +34 91 387 32 80

Portugal

Teva Pharma - Produtos Farmacêuticos Lda

Tel: +351 21 476 75 50

France

Teva Santé

Tél: +33 1 55 91 7800

România

Teva Pharmaceuticals S.R.L

Tel: +4021 230 6524

Ireland

Teva Pharmaceuticals Ireland

Tel: +353 51 321 740

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Ísland

ratiopharm Oy

Puh/Tel: +358 20 180 5900

Slovenská republika

Teva Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 5726 7911

Italia

Teva Italia S.r.l.

Tel: +39 028 917 981

Suomi/Finland

ratiopharm Oy

Puh/Tel: +358 20 180 5900

Κύπρος

Teva Ελλάς Α.Ε.

Τηλ: +30 210 72 79 099

Sverige

Teva Sweden AB

Tel: +46 42 12 11 00

Latvija

Sicor Biotech filiāle Latvijā

Tel: +371 67 323 666

United Kingdom

Teva UK Limited

Tel: +44 1977 628 500

Lietuva

UAB “Sicor Biotech”

Tel: +370 5 266 02 03

Hrvatska

Pliva Hrvatska d.o.o

Tel: + 385 1 37 20 000

This leaflet was last revised in month YYYY

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web

site: http://www.ema.europa.eu.

Medicinal product no longer authorised