Exubera - patient leaflet, side effects, dosage

1. WHAT EXUBERA IS AND WHAT IT IS USED FOR

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.

EXUBERA 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.

• 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.

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 doc immediately if you take EXUBERA and resume smoking or have smoked in the last 6 m 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 Dis

Take special care with EXUBERA

Please follow closely the instructions for dosage, monitoring (blood and urin activity (physical work and exercise) as discussed with your doctor or nurse.

Before you start taking EXUBERA your doctor or nurse will tell

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

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.

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 hitis. EXUBERA is not recommended for patients with lung disease. Also, if you experience 1 ing 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 your lung function again after 6 months and at other times to see how well you are tolerating EXUBERA.

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.

If you are ill or have a major injury, then your blood sugar may increase (hyperglycaemia) or if you are not eating enough your b d sugar may become too low (hypoglycaemia). In such situations, the management of your diab ay require a lot of care and you may need to seek advice from your doctor or nurse.

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

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 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), thyroid hormones (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”).

Your blood sugar level may either fall or rise if you take beta-blockers or drink alcohol. Betablockers may weaken the warning symptoms of a hypoglycaemic reaction or suppress them entirely. Alcohol may increase the action of insulin and cause low blood sugar levels. Octreotide/lan­reotide (used in special endocrine conditions) may change the need for insulin.

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 absorbs.

Pregnancy 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.

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

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

Your doctor will decide how much EXUBERA you will initially need based on your we 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 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 need dose titrations of less than 1 mg it is recommended you do not use EXUBERA.

Always make sure you have the correct strength and number taking your dose. It is important that you take the number of recommends in the combination that he or she recommends.

Do not use three 1 mg blisters in place of one dose of insulin. If you temporarily run out of

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

Preparing to take EXUBERA

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

Do 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.

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).

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).

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.

A 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,

• – you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substanc 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 falling too 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). These symptoms often develop before the symptoms of a low sugar level in the brain.

The following symptoms indicate 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”).

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 gluco 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.

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”).

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 of a serious condition (ketoacidosis) resulting from lack 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.

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 looks like and contents of the pack

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

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

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 × 1 of 1 mg PVC/Aluminium perforated unit dose blisters

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

A pack containing 60 × 1 of 1 mg PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU)

A pack containing 270 × 1 of 1 mg PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU)

A pack containing 60 × 1 of 3 mg PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU)

A pack containing 90 × 1 of 3 mg PVC/Aluminium perforated unit dose blisters (3 pouches) and 2 spare Insulin Release Units (IRU)

A pack containing 180 × 1 of 3 mg PVC/Aluminium perforated unit dose blisters (6 pouches) and 2 spare Insulin Release Units (IRU)

A pack containing 270 × 1 of 3 mg PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU)

A kit containing 90 × 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 × 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)

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.

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

EBarapna

EXUBERA-peHTtp 3a pa6oTa c KaneHTH

Tea:080014441

Tea: +359 2 970 4333

Luxembourg/Lu­xemburg

Service Client local EXUBERA/EXUBERA-

Service-Center

Tél/Tel: 8002 5350

Tél/Tel: + 32 (0)2 554 6

Magyarország

EXUBERA ügyfélszolgâlat

Tel. 06–80–203–279

Tel.: +

488 37 00

Česká republika

EXUBERA centrum péče o zákazníky

Tel: 800106108

Tel: + 420 283 004 111

Deutschland

EXUBERA-Service-Cente

Tel: 0800 3982372

Tel: + 49 (0)721 6101 9000

Malta

EXUBERA 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

Osterreich

EXUBERA-Service-Center

Tel: 0800 80 80 42

Tel: + 43 (0)1 521 15 0

EXXáóa

Kévapo Eçua^pét^o^ç Kat Evqpépocqg naXaióv tou EXUBERA

Tql: 80011 83333

Tql: + 30 210 6785 797

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

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 predispensed.

REPLACING YOUR INHALER AND THE INSULIN RELEASE (IRU)

HOW TO STORE YOUR INSULIN INHALER

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

Keep out of the reach and sight of children.

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

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.

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.

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

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

5. After your dose
Turn the mouthpiece back to its closed position.			w
Press the grey button and pull out the insulin blister.				1
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		.0
back into the chamber to store.	p

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.

Take your insulin inhaler apart

Hold the insulin inhaler in your hand. Be sure that the word “EXUBERA” at the top faces you.

1

Hold the black ring at the bottom of the base and use it to pull the base out of the chamber.		/ AW	J
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.			r
	J
	\C

Cleaning	v J
Chamber and mouthpiece – once a week	®_J#>
How Take your insulin inhaler apart.
Turn the mouthpiece to the open position. See above.

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.
Base – once a week	1

How _____________­_______

Do not put the base in water.

Do not get the inside of the IRU wet.

Do not use soap or any other cleanse

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 IRU out at this time. Keep the blue handle closed

Wipe only the TOP and OUTSIDE surfaces of the Base. Do not wipe the blister slot

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.	w J ir ™ r
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 insulin dose than you need (see package leaflet on the blisters for advice). 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 IRU prior to you next inhalation.	d $
How
Take out the used IRU While the chamber is removed from the base (see “Take your insulin inhaler apart”), hold the base in your hand with the grey button facing you. Turn the used IRU about a one-quarter turn counter clockwise towards the unlock symbol.	1 jy 1 1 I

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