Insulin Human Winthrop Comb 50 100 IU/ml suspension forinjection in a pre-filled pen

Insulin Human Winthrop Comb 50 is a fluid (suspension) for injection under the skin. The insulin contained in Insulin Human Winthrop Comb 50 is made by a biotechnology process and is identical with the body's own insulin.

Insulin Human Winthrop Comb 50 is an insulin preparation with a rapid onset and moderately long duration of action. It comes in cartridges sealed in disposable pen injectors, OptiSet.

Insulin Human Winthrop Comb 50 is used to reduce high blood sugar in patients with diabetes mellitus. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.

Do not use Insulin Human Winthrop Comb 50

If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Comb 50.

Take special care with Insulin Human Winthrop Comb 50

Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor.

Special patient groups

If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.

Travel

Before travelling, consult your doctor. You may need to talk about

• the availability of your insulin in the country you are visiting,
• supplies of insulin, injection syringes etc.,
• correct storage of your insulin while travelling,
• timing of meals and insulin administration while travelling,
• the possible effects of changing to different time zones,
• possible new health risks in the countries to be visited,
• what you should do in emergency situations when you feel unwell or become ill.

Illnesses and injuries

In the following situations, the management of your diabetes may require a lot of care:

• If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).
• If you are not eating enough, your blood sugar level may become too low (hypoglycaemia). In most cases you will need a doctor. Make sure that you contact a doctor early.

If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates. Always tell people who are caring for you or treating you that you require insulin.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Using other medicines

Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation). In each case, it may be necessary to adjust your insulin dosage to avoid blood sugar levels that are either too low or too high. Be careful when you start or stop taking another medicine.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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 level to fall (hypoglycaemia) include:

• all other medicines to treat diabetes,
• angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure),
• disopyramide (used to treat certain heart conditions),
• fluoxetine (used to treat depression),
• fibrates (used to lower high levels of blood lipids),
• monoamine oxidase (MAO) inhibitors (used to treat depression),
• pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever),
• sulfonamide antibiotics.

Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:

• corticosteroids (such as "cortisone", used to treat inflammation),
• danazol (medicine acting on ovulation),
• diazoxide (used to treat high blood pressure),
• diuretics (used to treat high blood pressure or excessive fluid retention),
• glucagon (pancreas hormone used to treat severe hypoglycaemia),
• isoniazid (used to treat tuberculosis),
• oestrogens and progestogens (such as in the contraceptive pill used for birth control),
• phenothiazine derivatives (used to treat psychiatric disorders),
• somatropin (growth hormone),
• sympathomimetic medicines (such as epinephrine [adrenaline] or salbutamol, terbutaline used to treat asthma),
• thyroid hormones (used to treat the thyroid gland disorders),
• protease inhibitors (used to treat HIV),
• atypical antipsychotic medications (such as olanzapine and clozapine).

Your blood sugar level may either rise or fall if you take:

• beta-blockers (used to treat high blood pressure),
• clonidine (used to treat high blood pressure),
• lithium salts (used to treat psychiatric disorders). Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.

Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.

If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.

Using Insulin Human Winthrop Comb 50 with food and drink

Your blood sugar levels may either rise or fall if you drink alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your insulin dosage may need to be changed during pregnancy and after giving birth. Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby. However, there is no experience with the use of Insulin Human Winthrop Comb 50 in pregnant women.

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 hypoglycaemia (low blood sugar levels),
• you have hyperglycaemia (high blood sugar levels),
• you have problems with your sight. Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or operating machines). You should contact your doctor for advice on driving if:
• you have frequent episodes of hypoglycaemia,
• the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.

Important information about some of the ingredients of Insulin Human Winthrop Comb 50

This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ?sodium-free?.

Dosage

Based on your life-style and the results of your blood sugar (glucose) tests, your doctor will

• determine how much Insulin Human Winthrop Comb 50 per day you will need,
• tell you when to check your blood sugar level, and whether you need to carry out urine tests,
• tell you when you may need to inject a higher or lower dose of Insulin Human Winthrop Comb 50.

Many factors may influence your blood sugar level. You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low. See the box at the end of this leaflet for further information.

Frequency of administration

Insulin Human Winthrop Comb 50 is injected under the skin 20 to 30 minutes before a meal.

Method of administration

Do NOT inject Insulin Human Winthrop Comb 50 into a vein.

OptiSet delivers insulin in increments of 2 units up to a maximum single dose of 40 units.

Your doctor will show you in which area of the skin you should inject your insulin. With each injection, change the puncture site within the particular area of skin that you are using.

How to handle OptiSet

Insulin Human Winthrop Comb 50 comes in cartridges sealed in disposable pen injectors, OptiSet.

Read carefully the "OptiSet Instructions for Use" included in this package leaflet. You must use the pen as described in these Instructions for Use.

A new injection needle must be attached before each use. Only use needles that have been approved for use with OptiSet.
A safety test must be performed before each injection.

Mix the insulin well and check it before first use. Later, you must mix the insulin well again immediately before each injection.

Mixing is best done by gently tilting the pen back and forth at least 10 times. To assist in mixing, three tiny metal balls are present in the cartridge.

After mixing, the suspension must have a uniform milky-white appearance. It must not be used if it remains clear or if, for example, clumps, flakes, particles or anything similar are in the suspension or on the sides or bottom of the cartridge in the pen. A new pen with a uniform suspension on mixing must then be used.

Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. If you think you may have a problem with OptiSet, refer to the Questions and Answers section of the attached OptiSet Instructions for Use, or have it checked by your doctor or pharmacist.

To prevent the possible transmission of disease, each pen must be used by one patient only.

Special care before injection

Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.

Do not mix insulin with any other medicines. Insulin Human Winthrop Comb 50, pre-filled pen,OptiSet, is not designed to allow any other insulin to be mixed in the cartridge.

Empty pens must not be re-filled and must be properly discarded.

Do not use the OptiSet if it is damaged or not working properly (due to mechanical defects), it has to be discarded and a new OptiSet has to be used.

Mistakes in dosage

If you use more Insulin Human Winthrop Comb 50 than you should

• If you have injected too much Insulin Human Winthrop Comb 50, your blood sugar level may become too low (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 box at the end of this leaflet.

If you forget to use Insulin Human Winthrop Comb 50

• If you have missed a dose of Insulin Human Winthrop Comb 50 or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
• Do not take a double dose to make up for a forgotten dose.

If you stop using Insulin Human Winthrop Comb50
This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop Insulin Human Winthrop Comb 50 without speaking to a doctor, who will tell you what needs to be done.

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

Insulin Mix-ups

You must always check the insulin label before each injection to avoid medication mix-ups between Insulin Human Winthrop Comb 50 and other insulins.

Like all medicines, Insulin Human Winthrop Comb 50 can cause side effects, although not everybody gets them.

As with all insulin therapy, the most frequent side effect is hypoglycaemia (low blood sugar). Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.

Severe allergic reactions to insulin may occur which may become life-threatening. Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body); severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.

Side effects reported commonly (Seen in less than 1 in 10 but more than 1 in 100 patients)

- Oedema
Insulin treatment may cause temporary build-up of water in the body with swelling in the calves and ankles.
- Injection site reactions

Side effects reported uncommonly (Seen in less than 1 in 100 but more than 1 in 1000 patients)- Severe allergic reaction with low blood pressure (shock)
- Injection site urticaria (itchy rash)

Other side effects include

- Systemic allergic reactions
Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema, shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
- Eye reactions
A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
- Skin changes at the injection site (lipodystrophy)
If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken. Insulin that you inject in such a site may not work very well. Changing the injection site with each injection may help to prevent such skin changes.
- Skin and allergic reactions
Other mild reactions at the injection site (such as injection site redness, unusually intense pain on injection site, itching, injection site swelling or injection site inflammation) may occur. They can also spread around the injection site. Most minor reactions to insulins usually resolve in a few days to a few weeks.

Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to your insulin dosage.

Tell your doctor or pharmacist if you notice any of the side effects listed above or any other unwanted or unexpected effects. To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurs suddenly or gets worse rapidly.

Keep out of the reach and sight of children.

Do not use Insulin Human Winthrop Comb 50 after the expiry date which isstated on the carton and on the label of the cartridge. The expiry date refers to the last day of that month.

Not in-use pens
Store in a refrigerator (2°C ? 8°C). Do not freeze. Do not put the pre-filled pen next to the freezer compartment or a freezer pack. Keep the pen in the outer carton in order to protect from light.

In-use pens
Pre-filled pens in-use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C and away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp). The pen in-use must not be stored in a refrigerator. Do not use the pen after this time period.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Insulin Human Winthrop Comb 50 contains

• The active substance is insulin human. One ml of Insulin Human Winthrop Comb 50 contains 100 IU (International Units) of the active substance insulin human. 50% of the insulin is dissolved in water; the other 50% is present as tiny crystals of insulin protamine.
• The other ingredients are: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment) and water for injections.

What Insulin Human Winthrop Comb 50 looks like and contents of the pack

After mixing, Insulin Human Winthrop Comb 50 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.

Insulin Human Winthrop Comb 50 is supplied in pre-filled pens, OptiSet, containing 3 ml suspension, (300 IU). Packs of 3, 4, 5, 6, 9 and 10 pens of 3 ml are available. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main
Germany

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

BelgiëBelgiqueBelgien sanofi-aventis Belgium TélTel 32 02 710 54 00 LuxembourgLuxemburg sanofi-aventis Belgium TélTel 32 02 710 54 00 BelgiqueBelgien

sanofi-aventis Bulgaria EOOD . 359 02 970 53 00 Magyarország sanofi-aventis zrt., Magyarország Tel. 36 1 505 0050

eská republika sanofi-aventis, s.r.o. Tel 420 233 086 111 Malta sanofi-aventis Malta Ltd. Tel 356 21493022

Danmark sanofi-aventis Denmark AS Tlf 45 45 16 70 00 Nederland sanofi-aventis Netherlands B.V. Tel 31 0182 557 755

Deutschland Sanofi-Aventis Deutschland GmbH Tel 49 0180 2 222010 Norge Aventis Pharma Norge AS Tlf 47 67 10 71 00

Eesti sanofi-aventis Estonia OÜ Tel 372 627 34 88 Österreich sanofi-aventis GmbH Tel 43 1 80 185 0

sanofi-aventis AEBE 30 210 900 16 00 Polska sanofi-aventis Sp . z o.o. Tel. 48 22 280 00 00

España sanofi-aventis, S.A. Tel 34 93 485 94 00 Portugal sanofi-aventis - Produtos Farmacêuticos, Lda. Tel 351 21 35 89 400

România sanofi-aventis România S.R.L. Tel 40 0 21 317 31 36 France sanofi-aventis France Tél 0 800 222 555 Appel depuis létranger 33 1 57 63 23 23

Ireland sanofi-aventis Ireland Ltd. Tel 353 0 1 403 56 00 Slovenija sanofi-aventis d.o.o. Tel 386 1 560 48 00

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika sanofi-aventis Pharma Slovakia s.r.o. Tel 421 2 33 100 100

SuomiFinland sanofi-aventis Oy PuhTel 358 0 201 200 300 Italia sanofi-aventis S.p.A. Tel 800 13 12 12 domande di tipo tecnico 39 02 393 91 altre domande e chiamate dallestero sanofi-aventis Cyprus Ltd. 357 22 871600 Sverige sanofi-aventis AB Tel 46 08 634 50 00

Latvija sanofi-aventis Latvia SIA Tel 371 67 33 24 51 United Kingdom sanofi-aventis Tel 44 0 1483 505 515

Lietuva

UAB sanofi-aventis Lietuva
Tel: +370 5 2755224

This leaflet was last approved on {date}

HYPERGLYCAEMIA AND HYPOGLYCAEMIA

Always carry some sugar (at least 20 grams) with you. Carry some information with you to show you are diabetic.

HYPERGLYCAEMIA (high blood sugar levels)

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.

Why does hyperglycaemia occur?

Examples include:

• you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage,
• your insulin pen does not work properly,
• you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever,
• you are taking or have taken certain other medicines (see section 2, "Using other medicines").

Warning symptoms of hyperglycaemia

Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, and glucose and ketone bodies in urine. 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.

What should you do if you experience hyperglycaemia

Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.

HYPOGLYCAEMIA (low blood sugar levels)

If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.

Why does hypoglycaemia occur?

Examples include:

• you inject too much insulin,
• you miss meals or delay them,
• 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 carbohydrates due to vomiting or diarrhoea,
• you drink alcohol, particularly if you are not eating much,
• you are doing more 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 an illness or from fever,
• you are taking or have stopped taking certain other medicines (see section 2, "Using other medicines").

Hypoglycaemia is 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 change the area of skin where you inject insulin (for example from the thigh to the upper arm),
• you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.

Warning symptoms of hypoglycaemia

• In your body Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain.
• In your brain Examples of symptoms that 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, if you have had diabetes for a long time or if you suffer from a certain type of nervous disease (diabetic autonomic neuropathy),
• you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly,
• you have almost normal or, at least, greatly improved blood sugar levels,
• you have recently changed from an animal insulin to a human insulin such as Insulin Human Winthrop,
• you are taking or have taken certain other medicines (see section 2, "Using other medicines").

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

What should you do if you experience hypoglycaemia

1. Do not inject insulin. Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage. Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.

2. Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta). Your doctor or nurse should have discussed this with you previously.

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

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

Tell your relatives, friends and close colleagues the following:
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 are 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.

Insulin Human Winthrop Comb 50 suspension for injection in a pre-filled pen. OptiSet. Instructions for Use.

OptiSet is a pre-filled pen for the injection of insulin.

Your healthcare professional has decided that OptiSet is appropriate for you. Talk with your healthcare professional about proper injection technique before using OptiSet.

Read these instructions carefully before using your OptiSet. If you are not able to follow all the instructions completely on your own, use OptiSet only if you have help from a person who is able to follow the instructions. Hold the pen as shown in this leaflet. To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.

Follow these instructions completely each time you use OptiSet to ensure that you get an accurate dose. If you do not follow these instructions completely, you may get too much or too little insulin, which may affect your blood glucose.

You can set doses from 2 to 40 units in steps of 2 units. Each pen contains multiple doses.

If you have any questions about OptiSet or about diabetes, ask your healthcare professional or call the local sanofi-aventis number on the front of this leaflet.

Keep this leaflet for future reference each time you use OptiSet.

Schematic diagram of the pen

New information for use:

- Name of the insulin is printed on the pen.
- Dosage selector can only be turned in one direction.

Important information for use of OptiSet:

Always attach a new needle before each use. Only use needles that are compatible for use with OptiSet. Always perform the safety test before each injection see Step 3. If you are using a new OptiSet the initial safety test must be done with the 8 units preset by the manufacturer. The dosage selector can only be turned in one direction. Never turn the dosage selector i.e. never change the dose after injection button has been pulled out. This pen is only for your use. Do not share it with anyone else. If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. Never use OptiSet if it is damaged or if you are not sure that it is working properly. Always have a spare OptiSet in case your OptiSet is lost or damaged.

Step 1. Check and mix the insulin

A. Take off the pen cap.

B. Check the label on your OptiSet and insulin reservoir to make sure you have the correct insulin.

C. Check the appearance of your insulin. Mix the insulin by turning OptiSet slowly up and down at

least 10 times (do not shake the
OptiSet).

D. Check the appearance of your insulin. It must have an evenly milky-white appearance.

Step 2. Attach the needle

Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.
Before use of needle, carefully read the ?Instructions for Use? accompanying the needles. Please note: The needles shown are for illustrative purposes only.

A. Remove the protective seal from a new needle.

B. Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending

on the needle type).

If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.

Step 3. Perform a safety test

Always perform the safety test before each injection. This ensures that you get an accurate dose by: - making sure that pen and needle work properly
- removing air bubbles
If you are using a new OptiSet the initial safety test must be done with the 8 units preset by the manufacturer, otherwise the pen will not function properly.

A. Make sure the injection button is pressed in.

B. Select the dose for the Safety Test.

New and unused OptiSet a dose of 8 units is already preset by the manufacturer for the first safety test. In-use OptiSet select a dose of 2 units by turning the dosage selector forward till the dose arrow points to 2. The dosage selector will only turn in one direction.

C. Pull out the injection button completely in order to load the dose. Never turn the dosage selector

after injection button has been pulled out.

D. Take off the outer needle cap and keep it to remove the used needle after injection. Take off the

inner needle cap and discard it.

discard

keep

E. Hold the pen with the needle pointing upwards.

F. Tap the insulin reservoir so that any air bubbles rise up towards the needle.

G. Press the injection button all the way in. Check if insulin comes out of the needle tip.

You may have to perform the safety test several times before insulin is seen.
- If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
- If still no insulin comes out, the needle may be blocked. Change the needle and try again. - If no insulin comes out after changing the needle, your OptiSet may be damaged. Do not use this OptiSet.

Step 4. Select the dose

You can set the dose in steps of 2 units, from a minimum of 2 units to a maximum of 40 units. If you need a dose greater than 40 units, you should give it as two or more injections.

A. Check if you have enough insulin for your dose.

The residual insulin scale on the transparent insulin reservoir shows approximately how much insulin remains in the OptiSet. This scale must not be used to set the insulin dose.

If the black plunger is at the beginning of the coloured bar, then there are approximately 40 units of insulin available.

If the black plunger is at the end of the coloured bar, then there are approximately 20 units of insulin available.

B. Select your required dose by turning the dose selector forward.

If you turned past your dose,
- and you have not yet pulled the injection button, you can keep turning forward till you reach your dose again,
- and you have already pulled the injection button out, you must discard the dose that has been loaded before you turn the dosage selector again.

Step 5. Load the dose

A. Pull out the injection button completely in order to load the dose.

B. Check if the selected dose is fully loaded. Note that the injection button only goes out as far as the

amount of insulin that is left in the reservoir.
- The injection button must be held out under tension during this check.
- The last thick line visible on the injection button shows the amount of insulin loaded. When the injection button is held out only the top part of this thick line can be seen. - In this example, 12 units are loaded.

• if you have selected 12 units you can inject your dose.
• if you have selected more than 12 units then only 12 units of your total insulin dose can be injected with this pen.

In this case what should you do:
- either you can inject what is remaining in the pen and complete your dose with a new OptiSet. - or use a new OptiSet for your full dose.

Step 6. Inject the dose

A. Use the injection method as instructed by your health care professional.

B. Insert the needle into the skin.

C. Deliver the dose by pressing the injection button in all the way. A clicking sound can be heard,

which will stop when the injection button has been pressed in completely.

D. Keep the injection button pressed in and slowly count to 10 before you withdraw the needle from

the skin. This ensures that the full dose will be delivered.
The pen plunger moves with each dose. The plunger will reach the end of the cartridge when the total of 300 units of insulin has been used.

Step 7. Remove and discard the needle

Always remove the needle after each injection and store OptiSet without a needle attached. This helps prevent:
- Contamination and/or infection
- Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.

A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To

reduce the risk of accidental needle injury, never replace the inner needle cap.

If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle. Follow recommended safety measures for removal and disposal of needles e.g. contact your healthcare professional in order to reduce the risk of accidental needle injury and transmission of infectious diseases.

B. Dispose of the needle safely, as instructed by your healthcare professional.

C. Put the pen cap back on, then store the pen until your next injection.

Storage Instructions

Please check section 5 ? How to store Insulin Human Winthrop Comb 50 - of the reverse (insulin) side of this leaflet for OptiSet storage instructions.

If your OptiSet is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up to room temperature. Cold insulin is more painful to inject.

Discard your used OptiSet as required by your local regulations.

Maintenance

Protect your OptiSet from dust and dirt.

You can clean the outside of your OptiSet by wiping it with a damp cloth.

Do not soak, wash or lubricate the pen as this may damage it.

Your OptiSet is designed to work accurately and safely. It should be handled with care. Avoid situations where OptiSet might be damaged. If you are concerned that your OptiSet may be damaged, discard it and use a new one.

Questions and Answers

Wrong dose selected. Follow the instructions in Step 4 to select the correct dose. Dose has been selected and the injection button has been pulled out and pressed in again without a needle attached. 1. Attach a new needle. 2. Press the injection button completely in and discard the insulin. 3. Perform the safety test. If the safety test is successful OptiSet is ready for use. If test is not successful, the pen might be damaged. Use a new OptiSet. If in any doubt whether the pen is working correctly use a new OptiSet. The dosage selector does not turn. You are turning in the wrong direction. The dosage selector can only be turned forward. You are turning forward while the injection button is pulled out. Press the injection button in completely to discard the dose and select again. The amount indicated on the injection button is higher than the dose selected. Difference is 2 units. Discard insulin, then set your dose and check again. If the same error occurs again, OptiSet may be damaged, use a new OptiSet. Difference is more than 2 units. OptiSet is damaged, use a new OptiSet.

The amount indicated on the injection button is lower than the dose required. There is not enough insulin in the reservoir, you can do one of the following inject the amount indicated on the injection button from this OptiSet and then inject the remaining dose using a new OptiSet, or inject the entire dose using a new OptiSet. The injection button cannot be pressed in. 1. Make sure you pulled out the injection button completely. 2. Attach a new needle. 3. Press the injection button completely in to discard the insulin. 4. Perform the safety test. OptiSet is damaged, use a new OptiSet. You dont hear clicking while injecting. Insulin is leaking from the pen. Needle may have been attached imprecisely e.g. at a slant. Remove needle and replace with a new needle attaching it straight see step 2. Perform the safety test see step 3. Air bubbles are present in the reservoir. Small amounts of air may be present in the needle and insulin reservoir during normal use. You must remove this air by performing the safety test see step 3. The tiny air bubbles in the insulin reservoir that do not move with tapping will not interfere with the injection and dosage. OptiSet is damaged or is not working properly. Do not force it. Do not try to repair or use tools on it. Use a new OptiSet. OptiSet has been dropped or subjected to impact. If in any doubt whether the pen is working correctly use a new OptiSet.