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Exubera (insulin human) – Package leaflet - A10AF01

Updated on site: 06-Oct-2017

Medication nameExubera
ATC CodeA10AF01
Substanceinsulin human
ManufacturerPfizer Limited

PACKAGE LEAFLET: INFORMATION FOR THE USER

EXUBERA 1 mg inhalation powder pre-dispensed

EXUBERA 3 mg inhalation powder pre-dispensed

 

Insulin human

 

Read all of this leaflet carefully before you start taking this medicine.

 

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Keep this leaflet. You may need to read it again.

 

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If you have further questions, please ask your doctor, diabetes nurse or pharmacist.

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

 

if their symptoms are the same as yours.

 

-

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,

 

please tell your doctor or pharmacist.

 

In this leaflet:

 

1.

What EXUBERA is and what it is used for

 

2.

Before you take EXUBERA

 

3.

How to take EXUBERA

 

4.

Possible side effects

 

How to store EXUBERA

 

6.

Further information

 

section 2, “Take special care with EXUBERA”, section 3, “How to take EXUBERA” and section 6 “Further information”).

Taking three separate 1 mg unit dose blisters delivers morelongerinsulin to your lungs than a single 3 mg unit dose blister does. Three 1 mg unit dose blisters should not be substituted for one 3mg blister (see

 

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1. WHAT EXUBERA IS AND WHAT IT IS USED FOR

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A unit dose blister is the individual container in which the insulin powder is packaged and will be called a blister in the rest of this leaflet.

EXUBERA is an inhalation powder contained in blisters. The contents of the blisters should be breathed in through your mouth into your lungs using the insulin inhaler.

EXUBERA is an anti-diabetic agent that lowers your blood sugar.

MedicinalEXUBERA is a fast-acting insulin. This means that it will start to lower your blood sugar 10-20 minutes after you take it, with a maximum effect at 2 hours and the effect will last for around 6 hours.

EXUBERA is often given in combination with other diabetes treatments.

EXUBERA is used to reduce high blood sugar in adult patients with type 2 diabetes mellitus who need insulin.

EXUBERA can also be used to treat type 1 diabetes in adults whose level of blood sugar is not well- controlled by insulin injections.

Diabetes is a disease in which your body does not produce enough insulin to control the level of blood sugar.

Take special care with EXUBERA

2. BEFORE YOU TAKE EXUBERA

Do not take EXUBERA

If you feel hypoglycaemia (low blood sugar) coming on. See the information at the end of

section 4 “Possible side effects” of this leaflet for further advice.

 

If you are allergic to insulin, the active ingredient contained in EXUBERA or any of the other

 

ingredients of EXUBERA. If you suspect an allergy to EXUBERA, speak to your doctor

immediately.

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If you smoke, or if you have smoked in the last six months you must not take EXUBERA as

 

you may have extra risk of hypoglycaemia (very low blood sugar). Please speak to your doctor

 

immediately if you take EXUBERA and resume smoking or have smoked in the last 6 months

before starting to take EXUBERA.

 

If you have poorly controlled , unstable, or severe asthma.

 

If you have severe (GOLD stage III or IV), Chronic Obstructive Pulmonary Disease (COPD).

Please follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical

activity (physical work and exercise) as discussed with your doctor or nurse.

Please also read the “Instructions for Use” of the inhaler at the end of the package leaflet carefully

Before you start taking EXUBERA your doctor or nurselongerwill tell you how to use the inhaler properly.

before taking EXUBERA. Make sure that you can use the inhaler properly as this could affect the amount of insulin you breathe in.

You should avoid taking EXUBERA in moist conditions e.g. a bathroom following a steamy shower

 

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as this will usually give you a lower insulin dose than you need (see “Instructions for Use” at the end

of the package leaflet for advice).

 

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If you accidentally expose your inhaler to moist conditions during use, this will usually decrease the

dose of insulin you take. In this case you must change the Insulin Release Unit (IRU) prior to your next inhalation.

Dosing

Your doctor will prescribe your starting pre-meal dose of EXUBERA based on your body weight.

MedicinalThis may include a mix of 1 mg (green coloured) and 3 mg (blue coloured) blisters. It is important to follow your doctor’s instructions exactly.

A 1 mg unit dose blister is approximately equal to 3 IU of fast-acting subcutaneous insulin and a 3 mg unit dose blister is approximately equal to 8 IU of fast-acting subcutaneous insulin.

Dose adjustments may be required based on meal size and nutrient composition, time of day (higher insulin requirements in the morning), pre-meal blood glucose concentration, recent or planned exercise.

Do not use three separate 1 mg blisters in place of one 3 mg blister, as this will give you a much higher insulin dose (see “How to take EXUBERA” for further advice).

If you have low body weight check with your doctor if you can use EXUBERA. If you need dose titrations of less than 1 mg it is recommended you do not use EXUBERA (see section 3 “How to take EXUBERA” for further advice and section 6 “Further information”).

Special patient groups

If your liver or kidneys do not function well speak to your doctor, who may advise that you use lower insulin doses.

If you are under 18 years of age, please speak to your doctor, as use of EXUBERA is not recommended for patients under 18 years of age.

There is little experience with EXUBERA in patients older than 75 years.

There is very little experience with EXUBERA in patients with congestive heart failure. EXUBERA is not recommended if you have breathing difficulties with congestive heart failure.

Lung diseases

Talk to your doctor if you have any lung disease such as asthma, emphysema or chronic bronchitis. EXUBERA is not recommended for patients with lung disease. Also, if you experience breathing difficulties that you have not previously discussed with your doctor, you should discuss them before starting EXUBERA treatment.

Before starting treatment your doctor will carry out a simple test on your lung function to decide

whether EXUBERA is the right treatment for you. Once you start treatment, your doctor will check

 

 

 

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your lung function again after 6 months and at other times to see how well you are tolerating

EXUBERA.

 

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If you notice an immediate and severe worsening of your breathing soon after taking a dose of

EXUBERA, you should stop taking EXUBERA and tell your doctor immediately or go to the casualty

department at your nearest hospital.

 

 

 

You should also tell your doctor if you develop any other increasing breathing difficulties while

taking EXUBERA.

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Illness and injuries

 

 

 

 

 

management of your diabetes may require a lot of care and you may need to seek advice from your doctor or nurse.

If you are ill or have a majorproductinjury, then your blood sugar may increase (hyperglycaemia) or if you are not eating enough your blood sugar may become too low (hypoglycaemia). In such situations, the

MedicinalIf you have infection in your airways (such as bronchitis or upper respiratory tract infection) while taking EXUBERA you should monitor your blood glucose frequently and you may need to adjust

your EXUBERA dose. Please talk to your doctor if you have problems administering EXUBERA or controlling your blood glucose. There is no experience with EXUBERA in patients with infection of the deep lung (pneumonia).

Please see the end of section 4 for important information about hypoglycaemia and hyperglycaemia and its treatment.

Travel

Before travelling, consult your doctor or nurse to talk about timings of meals and insulin administration while travelling, the possible effects of changing to different time zones on blood sugar levels and control and the availability of EXUBERA in the countries you are visiting.

Taking other medicines

Some medicines cause the blood sugar level to fall, some cause it to rise, others may have both effects, depending on the situation. In each case, it may be necessary to adjust your insulin dosage to avoid too low or too high blood sugar levels. Be careful not only when you start another medicine, but also when you stop it.

Tell your doctor about all medicines that you are taking, including those you have bought without a prescription (such as from a Pharmacy or other shop). Before taking a medicine ask your doctor if it

Medicines that may cause your blood sugar to fall include diabetes tablets, angiotensin converting enzyme (ACE) inhibitors (used for the treatment of certain heart conditions, high blood pressure or elevated protein/albumin in the urine), monoamine oxidase (MAO) inhibitors (used

can affect your blood sugar level, and what action, if any, you need to take.authorised

for the treatment of depression), certain beta-blockers (used for the treatment of certain heart conditions and high blood pressure), salicylates (e.g. aspirin, used to relieve pain and lower fever) and sulphonamide antibiotics.

Medicines that may cause your blood sugar to rise include corticosteroids (used to treat inflammatory conditions, except topical administration), danazol (used for the treatment of some female hormonal disorders), oral contraceptives (used for birth control), thyroidlongerhormones (used for the treatment of

malfunction of the thyroid gland), growth hormones (used in endocrine conditions), sympathomimetic agents (used for the treatment of asthma) and thiazides (used in special endocrine conditions).

The use of a bronchodilator (reliever inhaler) for asthma or other airway conditions may cause a more pronounced fall in blood sugar in response to inhaled insulin (see section 2 “Do not take EXUBERA” and section 2 “Take special care with EXUBERA”).

Alcohol may increase the action of insulin andnocause low blood sugar levels. Octreotide/lanreotide (used in special endocrine conditions) may change the need for insulin.

Your blood sugar level may either fall or rise if you take beta-blockers or drink alcohol. Beta-

blockers may weaken the warning symptoms of a hypoglycaemic reaction or suppress them entirely.

absorbs.

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If you smoke, the amount of insulin your body absorbs will be increased and you will have a greater risk of hypoglycaemia. If you are taking EXUBERA, do not smoke (see section 2, “Do not take EXUBERA”).

In contrast, exposure to other people’s cigarette smoke may decrease the amount of insulin your body

MedicinalPregnancy and breast-feeding

There is no experience on the use of EXUBERA in pregnant women. EXUBERA should not be taken during pregnancy. Inform your doctor or nurse if you are planning to become pregnant or if you are already pregnant. Your doctor may replace EXUBERA with an injectable insulin for your diabetes. Your insulin dosage may need to be changed during pregnancy and after giving birth. Careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.

If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.

nurse or pharmacist.
EXUBERA should be taken within 10 minutes before the start of a meal.

Driving and using machines

Your ability to concentrate or react may be reduced if you have too low blood sugar (hypoglycaemia). Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:

-frequent episodes of hypoglycaemia,

-reduced or absent warning signs of hypoglycaemia.

3.HOW TO TAKE EXUBERA

Your doctor will decide how much EXUBERA you will initially need basedauthorisedon your weight and recommend any changes after that based on your diet and amount of exercise.

A 1 mg blister of EXUBERA gives you about the same insulin dose as 3 IU of subcutaneously injected fast-acting insulin human. A 3 mg blister of EXUBERA gives you about the same insulin

Always make sure you have the correct strength and number of EXUBERA blisters available before taking your dose. It is important that you take the number of 1 mg and 3 mg blisters that your doctor recommends in the combination that he or she recommends.

dose as 8 IU of subcutaneously injected fast-acting insulin human. If you have low body weight check with your doctor if you can use EXUBERA. If you needlongerdose titrations of less than 1 mg it is recommended you do not use EXUBERA.

Do not use three 1 mg blisters in place of oneno3 mg blister, as this will give you a much higher dose of insulin. If you temporarily run out of 3 mg blisters, two 1 mg blisters should be used and

Preparing to take EXUBERA

you should monitor your blood glucose levels closely. You should contact your doctor or pharmacist as soon asproductpossible to get more 3 mg blisters. If you are unsure contact your doctor,

To use an EXUBERA blister, first separate the blister from the spine by tearing along the tear line (perforation).

MedicinalDo not open the blister containing EXUBERA. The blister will be punctured inside the inhaler when you use it. Do not swallow the contents of the blister.

EXUBERA should only be breathed in through your mouth and should only be taken with your insulin inhaler.

Always follow your doctor’s instructions about when and how to take EXUBERA. Please see the “Instructions for Use” at the end of the package leaflet for advice on how to use your insulin inhaler, and how to care for it. Check with your doctor, nurse or pharmacist if you have any questions regarding EXUBERA or the insulin inhaler.

Mistakes in dosage

Please discuss with your doctor what you should do if you were to take too much or too little EXUBERA, or if you miss a dose, so that you know what to do.

–If you have taken too much insulin, you may develop hypoglycaemia. Check your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more food and monitor your blood

sugar. For information on the treatment of hypoglycaemia, see the end of section 4 “Possible side effects”.

–If you have missed a dose of insulin or if you have taken too low a dose, your blood sugar level may become too high. Check your blood sugar frequently. For further information on hyperglycaemia, see the end of section 4 “Possible side effects”.

4.POSSIBLE SIDE EFFECTS

Like all medicines, EXUBERA can have side effects, although not everybody gets them.

Side effects reported very commonly

(Seen in more than 1 in 10 patients)

Hypoglycaemia - As with all insulin therapy, the most common side effect with EXUBERA is hypoglycaemia (too low blood sugar). Please see the end of this section for important further information about hypoglycaemia and its treatment.

Cough - A cough may occur within seconds to minutes after inhaling EXUBERA. The cough is

usually mild and often gets better over time.

 

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Side effects reported commonly

 

 

 

 

 

(Seen in less than 1 in 10 but more than 1 in 100 patients)

 

Commonly reported side effects are mild to moderate shortness of breath (dyspnoea), productive

cough, throat irritation and dry throat.

 

 

 

Side effects reported uncommonly

 

 

 

(Seen in less than 1 in 100 but more than 1 in 1000 patients).

 

 

 

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Uncommon side effects are inflammation of the throat (pharyngitis), nose bleed (epistaxis), airway

constriction with difficulties breathing (bronchospasm), wheezing, voice alteration (dysphonia), throat

pain (pharyngolaryngeal pain), tonsillar disorder, dry mouth and chest pain.

Other side effects

 

 

 

 

Some patients have experienced fluid in the lung lining (pleural effusion).

 

 

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Insulin treatment can cause the body to produce antibodies to insulin (substances that bind to insulin).

Development of such antibodies is seen more commonly in patients treated with EXUBERA

compared to subcutaneous insulin. Although these antibodies may be produced, they do not have any

effect on your blood glucose control.

 

 

 

MedicinalA small decrease in your lung function may occur during EXUBERA treatment, although you should not notice any symptoms. This change occurs within the first months of treatment and usually doesn’t

worsen as you continue treatment. If you stop therapy with EXUBERA, your lung function will usually return to your normal level. If you notice a change in your breathing while taking EXUBERA inform your doctor.

Severe allergic reactions to insulin are very rare. Such reactions to insulin or to the other ingredients can cause skin reactions, severe swelling of skin or mucous membranes (angio-oedema), shortness of breath, a fall in blood pressure and may become life threatening.

Changes to your sight may occur upon starting insulin therapy. These changes are usually mild and go away with time.

Insulin treatment may also cause temporary build-up of water in the body with swelling in the calves and ankles.

If any of these side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If your blood sugar is too low (hypoglycaemia)

Your blood sugar levels may fall too much, if for example:

you take too much insulin,

you miss meals or delay them,authorised

you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),

you lose or are unable to consume carbohydrates due to vomiting or diarrhoea,

you drink alcohol, particularly if you are not eating much,

you take more physical exercise than usual or a different type of physical activity,

you are recovering from an injury or operation or other stress,

you are recovering from a feverish illness or from another illness,

you are taking or have stopped taking certain other medicines (see section 2, “Taking other medicines”).Hypoglycaemia (low blood sugar levels) are also more likely to occur if:

you have just begun insulin treatment or changed to another insulin preparation,

your blood sugar levels are almost normal or are unstable,

you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.

Symptoms that tell you that your blood sugar level is fallinglongertoo much or too fast may be, for example: sweating, clammy skin, anxiety, fast heartbeat, high blood pressure, palpitations and

irregular heartbeat, chest pain (angina pectoris)no. These symptoms often develop before the symptoms of a low sugar level in the brain.

The following symptomsproductindicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in

concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.

The first symptoms which alert you to hypoglycaemia (“warning symptoms”) may change, be weaker or may be missing altogether if:

you are elderly,

you have had diabetes for a long time

due to diabetes, you suffer from a certain type of nervous disease (autonomic neuropathy),

you have recently suffered hypoglycaemia (e.g. the day before) or if it develops slowly,

you have almost normal or, at least, greatly improved blood sugar levels,

you are taking or have taken certain other medicines (see section 2, “Taking other medicines”).Medicinal

In such a case, you may develop severe hypoglycaemia (and even lose consciousness) before you are aware of the problem. Try always to keep familiar with your warning symptoms. If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that might otherwise be overlooked. While you are not confident about recognising your warning symptoms, avoid situations (e.g. driving a car) in which you or others would be put at risk by hypoglycaemia.

What to do in case of hypoglycaemia

 

1.

Do not take more insulin. Immediately take about 10 to 20 gram sugar, e.g. as glucose, sugar cubes

or a sugar-sweetened drink. (Measure once as spoonfuls or lumps of sugar or glucose tablets to see

how much this means). Caution: please remember that artificial sweeteners and foods with artificial

sweeteners (e.g. diet drinks) are of no help in hypoglycaemia.

 

2.

Then eat something that has a long-acting effect in raising your blood sugar (e.g. bread). Your

doctor or nurse will have discussed this with you.

 

3.

If the hypoglycaemia comes back again take another 10 to 20 gram sugar.

4.

Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.

Always carry some sugar (at least 20 grams) with you.

 

If you are not able to swallow or if you are unconscious, you will require an injection of glucose or

glucagon (a medicine which increases blood sugar). These injections may be justified even if it is not

certain that you have hypoglycaemia.

 

It is advisable to test your blood sugar immediately after taking glucose to check that you really have

hypoglycaemia.

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If your blood sugar is too high (hyperglycaemia)

Your blood sugar level may be too high, if for example:

you have not taken enough insulin, or if it has become less effective, e.g. through incorrect storage,

you are doing less physical exercise, you are under stress (emotional distress, excitement), or if you have an injury, operation, feverish illness or certain other diseases,

you are taking or have taken certain other medicines (see section 2, “Taking other medicines”).longer

 

Symptoms that may tell you that your blood sugar levels are too high:

 

thirst, increased need to pass water, tiredness, dry skin, reddening of the face, loss of appetite, low

 

blood pressure, fast heartbeat, and glucose and ketone bodies in urine may be signs of too high blood

 

sugar. Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs

 

 

 

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of a serious condition (ketoacidosis) resulting fromnolack of insulin.

 

Test your blood sugar level and your urine for ketones as soon as any such symptoms of

 

hyperglycaemia occur as described above. Severe hyperglycaemia or ketoacidosis must always be

 

treated by a doctor, normally in a hospital.

 

Carry some information with you to show you are diabetic.

Medicinal

 

5.

HOW TO STORE EXUBERA

Keep out of the reach and sight of children.

Store below 30°C. Store in the original package in order to protect from moisture.

After opening the foil overwrap: store below 25oC and use within 3 months of opening. Do not refrigerate or freeze the blisters.

Do not use EXUBERA if you notice that a blister is not properly sealed or damaged.

Do not use EXUBERA after the expiry date (EXP) stated on the pack or unit dose blisters.

For instructions on how to look after your insulin inhaler see “Instructions for Use” at the end of the package leaflet.

6. FURTHER INFORMATION

What EXUBERA contains

-The active substance is insulin human. Each unit dose blister contains 1 mg or 3 mg of the active substance insulin human.

-The other ingredients are: mannitol, glycine, sodium citrate (as dihydrate) and sodium hydroxide.

Taking three separate 1 mg blisters delivers more insulin to your lungs than a single 3 mg blister does. Three 1 mg blisters should not be substituted for one 3 mg blister (see section 2, “Take special care with EXUBERAand section 3, “How to take EXUBERA”).

What EXUBERA looks like and contents of the pack

EXUBERA is an inhalation powder, pre-dispensed, and is supplied as tear-off unit dose blisters marked with either ‘1 mg EXUBERA’ with green ink or ‘3 mg EXUBERA’ with blue ink. For the

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1 mg product, the spine of the blister card has one raised ridge with the individual blisters embossed with one raised dot each. For the 3 mg product, the spine of the blister card has three raised ridges with the individual blisters embossed with three raised dots each. There are 6 blisters on each card and 5 cards per tray. The tray is sealed in a plastic foil pouch with a desiccant, which keeps the medicine dry and should not be eaten.

EXUBERA is available in the following pack sizes:

 

A pack containing 30, 60, 90, 180 and 270 x 1 of 1 mg PVC/Aluminium perforated unit dose

 

blisters

 

 

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A pack containing 30, 60, 90, 180 and 270 x 1 of 3 mg PVC/Aluminium perforated unit dose

 

blisters

 

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A pack containing 60 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (2 pouches)

 

and 2 spare Insulin Release Units (IRU)

 

 

A pack containing 270 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (9 pouches)

 

and 6 spare Insulin Release Units (IRU)

 

 

A pack containing 60 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (2 pouches)

 

 

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and 2 spare Insulin Release Units (IRU)

 

 

A pack containing 90 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (3 pouches)

 

and 2 spare Insulin Release Units (IRU)

 

 

A pack containing 180 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (6 pouches)

 

and 2 spare Insulin Release Units (IRU)

 

 

A pack containing 270 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (9 pouches)

 

and 6 spare Insulin Release Units (IRU)

 

 

Medicinal

 

 

 

A kit containing 90 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (3 pouches), 1

 

insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU)

A kit containing 90 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (3 pouches), 1

 

insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU)

EXUBERA-
: 080014441
: +359 2 970 4333
eská republika
EXUBERA centrum pé e o zákazníky Tel: 800106108
Tel: + 420 283 004 111
Danmarkproduct
EXUBERA kundecenter Tlf: 80 60 10 40
Tlf: + 45 44 20 11 00
Deutschland
EXUBERA-Service-Center MedicinalTel: 0800 3982372
Tel: + 49 (0)721 6101 9000
Eesti
EXUBERA Kliendi Tugikeskus Tel: + 372 6 405 328
!" #
$%& ' EXUBERA
( &: 80011 83333 ( &: + 30 210 6785 797
België /Belgique / Belgien
Klanteninformatiedienst voor EXUBERA/ EXUBERA-Service-Center/Service Client local EXUBERA
Tél/Tel: 0800 30432 Tél/Tel: + 32 (0)2 554 62 11

Additional insulin inhaler, insulin release units and chamber packages are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom.

The manufacturer is Heinrich Mack Nachf. GmbH & Co. KG, Heinrich Mack Strasse 35, 89257, Illertissen, Germany.

For any information about this medicine, please contact the local EXUBERA Customer Care Centre.

Luxembourg/Luxemburg

Service Client local EXUBERA/EXUBERA-

Service-Center

Tél/Tel: 8002 5350

Tél/Tel: + 32 (0)2 554 62 11

Magyarországlonger

authorised

EXUBERA ügyfélszolgálat

Tel. 06-80-203-279

Tel.: + 36 1 488 37 00

Malta

noEXUBERA Customer Care Centre Tel: 800 62451

Tel: + 356 21 220717

Nederland

Klanteninformatiedienst voor EXUBERA

Tel: 0800 3982372

Tel: + 31 (0)10 406 43 01

Norge

EXUBERA kundetelefon

Tlf: 800 74444

Tlf: + 47 67 52 61 00

Österreich

EXUBERA-Service-Center Tel: 0800 80 80 42

Tel: + 43 (0)1 521 15 0

Polska

Lokalne telefoniczne centrum informacyjne dla pacjenta

Tel.: 0800 80 88 80 Tel.: + 48 22 335 61 00

España

Centro local de Atención al Cliente de Exubera Tel: 900 900866

Tel: + 34 91 490 99 00

Portugal

Serviço local de Atendimento ao utilizador de EXUBERA

Tel: 800 206746

Tel: + 351 21 423 5500

France

Service Client local EXUBERA

Tél: 0800 438 438

Tél: + 33 (0)1 58 07 34 40

Ireland

EXUBERA Customer Care Centre

Tel: 1 800 882 392

Tel: + 44 (0)1737 331111

Ísland

EXUBERA neytendaþjónusta Tel: 044 20 11 00

Tel: + 354 535 7000

Italia

Customer Care locale di EXUBERA

Tel: 0800 021354

Tel: + 39 06 33 18 21

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$%& ' EXUBERA

( &:

800 92656

product

( &:

+30 210 6785 798

Latvija

EXUBERA pacientu atbalsta centrs

Tel: + 371 670 35 775

Lietuva

EXUBERA pacient prieži ros centras MedicinalTel: 8 800 22000 * +

Tel. + 3705 2514000

This leaflet was last approved in

România

EXUBERA – Centrul de Rela)ii cu Clien)ii

Tel.: 0800 390 000

Tel.: +40 (0)21 207 28 00authorised

Slovenija

Center za svetovanje o zdravilu EXUBERA Tel: 080 2682

Tel: + 386 1 52 11 400

Slovenská republika

EXUBERA Centrum starostlivosti o pacientov Tel: 0800 101 001

Tel: +421-2-3355 5500

Suomi/Finlandlonger

EXUBERA-asiakaspalvelunumero

Puh/Tel: 0800 915 133

Puh/Tel: + 358 (0)9 43 00 40

Sverige

noKundservice för EXUBERA Tel: 020 88 80 80

Tel: + 46 (0)8 5505 2000

United Kingdom

EXUBERA Customer Care Centre

Tel: 0845 850 0198

Tel: + 44 (0)1737 331111

Insulin Inhaler Instructions for Use

Read all of this leaflet carefully before starting to use your insulin inhaler

Keep this leaflet. You may need to read it again.

Always make sure you have the correct blisters available before using your insulin inhaler.

Also, read the Patient Information Leaflet for, EXUBERA 1 mg and 3 mg powder for inhalation pre- dispensed.

REPLACING YOUR INHALER AND THE INSULIN RELEASE (IRU)

You should change your insulin inhaler once a year from the date you first use the inhaler.

You should change the IRU in your insulin inhaler every 2 weeks. The IRU must be changed after accidental exposure to extremely moist conditions, e.g. steamy bathroom.

HOW TO STORE YOUR INSULIN INHALER

 

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Keep out of the reach and sight of children.

 

 

Store the insulin inhaler in a dry place at room temperature.

Do not store the insulin inhaler in the refrigerator or freezer.

 

 

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Mouthpiece

Exubera Label

Chamber

KNOW THE PARTS OF YOUR

INSULIN INHALER

 

 

 

 

Blue button

 

 

 

 

(not visible)

 

 

 

 

Chamber Release

 

 

 

 

 

 

 

 

 

 

 

 

Button

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Base

 

 

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HOW TO TAKE YOUR DOSE

 

 

 

1. Set up your insulin inhaler

 

 

 

Hold your insulin inhaler in your hand. Be sure

 

 

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that the word “EXUBERA” at the top faces you.

 

 

 

 

 

 

 

 

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Chamber Release Button

Grey Button

Insulin Blister

Blue Handle

Black Ring

Hold the black ring at the bottom of the base and use it to pull the base out of the chamber.

You will hear a click when the inhaler is fully extended and locked into place. The bottom of the chamber MUST be above the grey button.

 

2.

Load your insulin blister

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Hold the insulin blister by the tab with printed

 

 

side up with the notch pointed towards the

 

 

 

 

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insulin inhaler, insert the blister.

 

 

The 1 mg blister is printed with green ink and

 

 

has one raised dot on the protruding end of each

 

blister.

 

 

 

The 3 mg blister is printed with blue ink and has

 

three raised dots on the protruding end of each

 

 

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blister.

 

 

 

The raised dots can be felt even when the blister

 

is already inserted for reassurance that the

 

 

correct dose is used.

 

 

 

Slide the insulin blister straight into the blister

 

 

slot as far as it will go.

 

 

 

 

 

 

 

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3. Getting ready to take your dose

Make sure that the mouthpiece is closed.

Pull out the blue handle as far as it will go.

Squeeze the handle until it snaps shut.

Stand or sit up straight.

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Breathe out normally.

 

 

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4.Inhale your insulin dose

Perform the following steps in immediate sequence.

Hold the insulin inhaler upright with the blue button facing towards you. Push the blue button until it clicks and watch for the insulin cloud to appear in the chamber.

After the cloud appears, immediately turn the mouthpiece around. The mouthpiece should now be facing towards you.

 

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Quickly form a seal with your lips around the

mouthpiece so the insulin will not leak out.

 

Do not block the opening of the mouthpiece with

your tongue or teeth. Do not blow into the

 

mouthpiece.

 

 

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Slowly and deeply breathe in the insulin cloud

 

through your mouth in one breath.

 

Do not blow into the mouthpiece.

 

Take the mouthpiece out of your mouth.

 

Close your mouth and hold your breath for 5

 

seconds.

 

 

Breathe out normally.

 

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5.After your dose

Turn the mouthpiece back to its closed position.

Press the grey button and pull out the insulin blister.

If you need another blister(s) as part of your dose, repeat steps 2, 3 and 4.

6. After your dosing is completed

 

Squeeze the two chamber release buttons at the

same time on the side of the base. Push the base

back into the chamber to store.

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HOW TO TAKE CARE OF YOUR INSULIN

INHALER

 

 

It is important to follow these steps so that your

insulin inhaler stays clean and works properly.

 

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Take your insulin inhaler apart

 

Hold the insulin inhaler in your hand. Be sure

 

that the word “EXUBERA” at the top faces you.

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Hold the black ring at the bottom of the base and use it to pull the base out of the chamber.

With one hand, squeeze the two chamber release Buttons at the same time on the side of the base while pulling the base all the way out of the chamber with the other hand.

 

Cleaning

 

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Chamber and mouthpiece – once a week

 

 

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How

 

 

 

Take your insulin inhaler apart.

 

 

Turn the mouthpiece to the open position. See

 

 

above.

 

 

 

 

 

 

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Dampen a clean soft cloth and use mild liquid soap to wipe the outside and inside of the chamber and mouthpiece. Do NOT put the chamber in the dishwasher.

Thoroughly rinse the soap out of the chamber and mouthpiece with warm water.

Allow to air dry. Ensure that no water droplets remain, and then close the mouthpiece. Reattach the chamber to the base.

For instructions on how to attach the chamber to the base refer to the section “Put your insulin inhaler together”.

If the washed chamber is not dry prior to taking your next dose, use your spare chamber.

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Do not put the base in water.

 

IRU out at this time. Keepproductthe blue handle

 

Do not get the inside of the IRU wet.

 

Do not use soap or any other cleanser.

 

 

Dampen a clean soft cloth with water.

 

 

While cleaning the top of the base be careful not

 

to get any water into the IRU. Do not take the

 

 

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closed

 

 

Wipe only the TOP and OUTSIDE surfaces of

 

the Base. Do not wipe the blister slot

 

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Put your insulin inhaler together

Line the top of the base with the open end of the chamber. The blue dot on the bottom of the chamber must be on the same side as the blue button.

Squeeze the two chamber release buttons at the same time on the side of the base. Push the base back into the chamber to store.

Store your insulin inhaler in a dry place at room

temperature.

 

REPLACING YOUR INSULIN RELEASE

 

UNIT (IRU)

 

Change the IRU

 

Every 2 weeks

 

You should avoid taking EXUBERA in moist

 

conditions e.g. a bathroom following a steamy

 

shower as this will usually give you a lower

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insulin dose than you need (see package leaflet

on the blisters for advice).

 

If you accidentally expose your inhaler to moist

base in your hand with theproductgrey button facing

 

conditions during use, this will usually decrease

the dose of insulin you take. In this case you

 

must change the IRU prior to you next

 

inhalation.

 

How

 

Take out the used IRU

 

While the chamber is removed from the base

 

(see “Take your insulin inhaler apart”), hold the

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counter clockwise towards the unlock symbol.

 

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Pull the used IRU up and out of the base and discard.

Dispose of the used IRU safely according to local requirements or check with your healthcare professional.

Put in a new IRU

Remove the IRU from its packaging.

Hold the new IRU so the top is facing you. You will see a blue line on it. While holding the IRU with one hand, turn the top counter-clockwise as far as it will go.

Line up the blue line on the top of the IRU with the unlock symbol on the top of the base.

Push the IRU gently into the base. Do not force,

 

 

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it should easily drop into place. (If the new IRU

does not drop into place or fits tightly, remove

 

and try again).

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Turn the top of the IRU clockwise until the blue

line points to the lock symbol on the top of the

 

base. The new IRU is now locked in place.

 

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