Optisulin SoloStar 100 units/ml solution for injection in apre-filled pen

Optisulin is a solution for injection containing insulin glargine. Insulin glargine is a modified insulin, very similar to human insulin.

Optisulin is used to reduce high blood sugar in adults, adolescents and children of 6 years or above with diabetes mellitus. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action.

Do not use Optisulin

If you are allergic (hypersensitive) to insulin glargine or to any of the other ingredients of Optisulin (for a full list of ingredients, see section 6?What Optisulin contains?).

Take special care with Optisulin

Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor. If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).

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, 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 (for example, adjustment to insulin dose, blood and urine tests) :

• 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 dose to avoid blood sugar levels that are too low or too high. Be careful when you start or stop taking another medicine. Please 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 thyroid gland disorders),
• atypical antipsychotic medicines (such as clozapine, olanzapine),
• protease inhibitors (used to treat HIV).

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 (usedto 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 Optisulin 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 dose 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.

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 Optisulin

This medicine 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 and your previous insulin usage, your doctor will

• determine how much Optisulin per day you will need and at what time,
• 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 Optisulin.

Optisulin is a long-acting insulin. Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.

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.

Use in children

Optisulin can be used in adolescents and children of 6 years and above.

There is limited experience with the use of Optisulin in children less than 6 years old. Therefore, Optisulin should only be used in children below this age under careful medical supervision.

Frequency of administration

You need one injection of Optisulin every day, at the same time of the day. In children, only evening injection has been studied.

Method of administration

Optisulin is injected under the skin. Do NOT inject Optisulin in a vein, since this will change its action and may cause hypoglycaemia.

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

How to handle SoloStar

SoloStar is a pre-filled disposable pen containing insulin glargine.

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

A new needle must be attached before each use. Only use needles that are compatible for use with SoloStar (see ?SoloStar Instructions for Use?).
A safety test must be performed before each injection.

Look at the cartridge before you use the pen. Do not use SoloStar if you notice particles in it. Only use SoloStar if the solution is clear, colourless and waterlike. Do not shake or mix it before use.

To prevent the possible transmission of disease, each pen must be used by one patient only. Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.

Always use a new penif you notice that your blood sugar control is unexpectedly getting worse. If you think you may have a problem with SoloStar, consult your Health Care Professional.

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

Do not use SoloStar if it is damaged or not working properly, it has to be discarded and a new SoloStar has to be used.

If you use more Optisulin than you should

• If you have injected too much Optisulin, 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 Optisulin

• If you have missed a dose of Optisulin 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 Optisulin

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 Optisulin without speaking to a doctor, who will tell you what needs to be done.

Insulin Mix-ups

You must always check the insulin label before each injection to avoid medication mix-ups between Optisulin and other insulins.

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

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

Hypoglycaemia (low blood sugar) can be very serious. If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately.

If you experience the following symptoms, contact your doctor immediately:

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. These could be symptoms of severe allergic reactions to insulins and may become life-threatening.

Very common reported side effects (affects more than 1 user in 10)
- Hypoglycaemia
As with all insulin therapy, the most frequent side effect is hypoglycaemia.
Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood. For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.

Common reported side effects (affects 1 to 10 users in 100)
- Skin changes at the injection site
If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink (lipoatrophy) or thicken (lipohypertrophy). Thickening of fatty tissue may occur in 1 to

2 % of patients while shrinking may occur uncommonly. 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
3 to 4 % of patients may experience reactions at the injection site (such as reddening, unusually intense pain on injection, itching, hives, swelling or inflammation). They can also spread around the injection site. Most minor reactions to insulins usually resolve in a few days to a few weeks.

Rare reported side effect (affects 1 to 10 users in 1000)
- Severe allergic reactions to insulinsAssociated 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. These could be symptoms of severe allergic reactions toinsulins and may becomelife-threatening.
- 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.

- General disorders
In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling in the calves and ankles.

Very rare reported side-effects (affects less than 1 user in 10 000)
In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.

Other side effects with frequency not known (frequency cannot be estimated from available data)

Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). Rarely, this may require a change to your insulin dose.

Use in children

In general, the side effects in children and adolescents of 18 years of age or less are similar to those seen in adults.
Complaints of injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults.
No clinical study safety data are available in children below 6 years of age.

Tell your doctor or pharmacist if if any side effect become serious, or if you notice any side effects not listed in this leaflet.

Keep out of the reach and sight of children.
Do not use Optisulin after the expiry date which is stated on the carton and on the label of the pen after ?EXP?. 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 SoloStarnext to the freezer compartment or a freezer pack.
Keep the pre-filled 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 or direct light. The pen in use must not be stored in the refrigerator Do not use it 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 Optisulin contains

• The active substance is insulin glargine. Each millilitre of the solution contains 100 units of the active substance insulin glargine (equivalent to 3.64 mg).
• Other ingredients of Optisulin are: zinc chloride, m-cresol, glycerol, sodium hydroxide, hydrochloric acid and water for injections.

What Optisulin looks like and contents of the pack

Optisulin SoloStar100 units/ml solution for injection in a pre-filled pen, is a clear and colourless solution.
Each pencontains 3 ml of solution for injection (equivalent to 300 units). Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens of 3 ml are available. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

Manufacturer
Sanofi-Aventis Deutschland GmbH,
D-65926 Frankfurt am Main,
Germany.

Aventis Pharma (Sanofi-aventis group)

Rainham Road South

Dagenham, Essex RM10 7XS

United Kingdom

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

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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 (when changing from your previous basal insulin to Optisulin hypoglycaemia, if it occurs, may be more likely to occur in the morning than at night),
• 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 Optisulin,
• 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. The recovery of hypoglycaemia may be delayed because Optisulin has a long action.

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.

OPTISULIN solution for injection in a pre-filled pen. SoloStar. Instructions for use

SoloStar is a pre-filled pen for the injection of insulin. Your healthcare professional has decided that SoloStar is right for you. Talk with your healthcare professional about proper injection technique before using SoloStar.

Read these instructions carefully before using your SoloStar. If you are not able to follow all the instructions completely on your own, use SoloStar 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.

You can set doses from 1 to 80 units in steps of 1 unit. Each pen contains multiple doses.

Keep this leaflet for future reference.

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

Schematic diagram of the pen

Important information for use of SoloStar:

Always attach a new needle before each use. Only use needles that are compatible for use with SoloStar. Always perform the safety test before each injection see Step 3. 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 SoloStar if it is damaged or if you are not sure that it is working properly. Always have a spare SoloStar in case your SoloStar is lost or damaged.

Step 1. Check the insulin

A. Check the label on your SoloStar to make sure you have the correct insulin. The Optisulin SoloStar is grey with a purple injection button.

B. Take off the pen cap.

C. Check the appearance of your insulin. Optisulin is a clear insulin. Do not use this SoloStar if the insulin is cloudy, coloured or has particles.

Step 2. Attach the needle

Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.

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:

ensuring that pen and needle work properly removing air bubbles

A. Select a dose of 2 units by turning the dosage selector.

B. 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.

C. Hold the pen with the needle pointing upwards.

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

E. 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 SoloStar may be damaged. Do not use this SoloStar.

Step 4. Select the dose

You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.

A. Check that the dose window shows ?0? following the safety test.

B. Select your required dose (in the example below, the selected dose is 30 units). If you turn past

your dose, you can turn back down.

Do not push the injection button while turning, as insulin will come out.

You cannot turn the dosage selector past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar or use a new SoloStar for your full dose.

Step 5. Inject the dose

A. Use the injection method as instructed by your healthcare professional.

B. Insert the needle into the skin.

C. Deliver the dose by pressing the injection button in all the way. The number in the dose window will return to 0 as you inject.

D. Keep the injection button pressed all the way in. 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 6. Remove and discard the needle

Always remove the needle after each injection and store SoloStar 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 contact your health care 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. Always put the pen cap back on the pen, then store the pen until your next injection.

Storage Instructions

Please check the reverse (insulin) side of this leaflet for instructions on how to store SoloStar.

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

Discard your used SoloStar as required by your local authorities.

Maintenance

Protect your SoloStar from dust and dirt.

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

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

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