Insulin Human Winthrop - patient leaflet, side effects, dosage

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

• 1. What Insulin Human Winthrop Rapid is and what it is used for

• 2. What you need to know before you use Insulin Human Winthrop Rapid

• 3. How to use Insulin Human Winthrop Rapid

• 4. Possible side effects

• 5. How to store Insulin Human Winthrop Rapid

• 6. Contents of the pack and other information

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1. What Insulin Human Winthrop Rapid is and what it is used for

Insulin Human Winthrop Rapid contains the active substance insulin human which is made by a biotechnology process and is identical with the body's own insulin.

Insulin Human Winthrop Rapid is an insulin solution with a rapid onset and short duration of action.

Insulin Human Winthrop Rapid is used to reduce high blood sugar in patients with diabetes mellitus who need treatment with insulin. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insulin Human Winthrop Rapid may also be used for treating hyperglycaemic coma (coma caused by too much blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar) as well as for controlling blood sugar before, during and after surgery.

2. What you need to know before you use Insulin Human Winthrop Rapid

Do not use Insulin Human Winthrop Rapid

If you are allergic to insulin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Insulin Human Winthrop Rapid.

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

If you are allergic to this medicine or to animal insulins, talk to 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).

Other medicines and Insulin Human Winthrop Rapid

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, have recently taken or might take any other medicines, 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 medicines (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.

Insulin Human Winthrop Rapid with alcohol

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

Pregnancy and breast-feeding

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.

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 using 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 Rapid

This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free’.

3. How to use Insulin Human Winthrop Rapid

Dose

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

• – determine how much Insulin Human Winthrop Rapid 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 Rapid.

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 Rapid is injected under the skin 15 to 20 minutes before a meal.

Method of administration

Insulin Human Winthrop Rapid is a solution for injection under the skin or, in exceptional circumstances, into a vein (blood vessel).

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.

Insulin administration into a vein for example to treat severe hyperglycaemia and ketoacidosis, requires experience and special safety precautions. For these reasons, it must be done in a clinic or a similar setting.

Do not use Insulin Human Winthrop Rapid in insulin pumps – special insulin preparations are available for use in such devices. Also do not use it in peristaltic pumps with silicone tubing.

How to handle the vials

Insulin Human Winthrop Rapid contains 100 IU insulin per ml. Only injection syringes designed for this insulin concentration (100 IU per ml) must be used. The injection syringes must not contain any other medicines or traces of medicines (such as traces of heparin).

Before the first withdrawal of insulin you must remove the safety tear-off cap on the vial.

Insulin Human Winthrop Rapid must only be used if the solution is clear, colourless, with no solid particles visible, and has a water-like consistency.

Do not shake the vial vigorously as this could cause froth to form. Froth can make it difficult for you to measure the correct dose.

Special care before injection

Before injection remove any air bubbles. Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin. Do not mix insulin with any other medicines except with insulin human preparations as detailed below.

Insulin Human Winthrop Rapid may be mixed with all insulin human preparations, EXCEPT those specially designed for use in insulin pumps. Also, it must NOT be mixed with animal source insulins or insulin analogues.

Your doctor will tell you if you have to mix insulin human preparations. If you need to inject a mixture, draw Insulin Human Winthrop Rapid into the injection syringe before the other insulin. Inject as soon as you have mixed them. Do not mix insulins of different strengths (for example 100 IU per ml and 40 IU per ml).

If you use more Insulin Human Winthrop Rapid than you should

• – If you have injected too much Insulin Human Winthrop Rapid , 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 Rapid

• – If you have missed a dose of Insulin Human Winthrop Rapid 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 Rapid

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 Rapid 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 medicine, ask your doctor, pharmacist or nurse.

Insulin Mix-ups

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

4. Possible side effects

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

The most frequent side effect is hypoglycaemia (low blood sugar). The specific frequency cannot be estimated from available data (frequency not known). 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. Frequency of these reactions cannot be estimated from available data.

Side effects reported commonly (may affect up to 1 in 10 people)

• 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 (may affect up to 1 in 100 people)

• Severe allergic reaction with low blood pressure (shock)
• Injection site urticaria (itchy rash)

Other side effects include (frequency cannot be estimated from the available data)

• Sodium retention
• 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Insulin Human Winthrop Rapid

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

Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial

s to the last day of that month.

o not freeze. Do not put Insulin Human Winthrop Rapid next to pack. Keep the vial in the outer carton in order to protect from

Opened vials VJO

Once in-use, the vial may be stored for a maximum of 4 weeks in the outer carton 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). Do not use the vial after this time period. It is recommended that the date of the first use be noted on the label.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Insulin Human Winthrop Rapid contains

• – The active substance is insulin human. One ml of Insulin Human Winthrop Rapid contains 100 IU (International Units) of the active substance insulin human.

• – The other ingredients are: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide (see section 2 under “Important information about some of the ingredients of Insulin Human Winthrop Rapid”), hydrochloric acid (for pH adjustment) and water for injections.

What Insulin Human Winthrop Rapid looks like and contents of the pack

Insulin Human Winthrop Rapid is a clear, colourless solution for injection, with no solid particles visible, and of a water-like consistency.

Insulin Human Winthrop Rapid is supplied in vials containing 5 ml of solution for injection (equivalent to 500 IU) or 10 ml of solution for injection (equivalent to 1000 IU). Packs of 1 and 5 vials of 5 ml or 10 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:

Lietuva

UAB «SANOFI-AVENTIS LIETUVA»

Tel: +370 5 2755224

Luxembourg/Lu­xemburg

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Danmark

sanofi-aventis Denmark A/S

Tlf: +45 45 16 70 00

Nederland

sanofi-aventis Netherlands B.V.

Tel: +31 (0)182 557 755

Norge

Aventis Pharma NorgeAS

Tlf: +47 67 10 71 00

Österreich

sanofi-aventis GmbH

Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A. Tel: +34 93 485 94 00	Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00
France sanofi-aventis France Tél: 0 800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23	Portugal Sanofi – Produtos Farmacéuticos, Lda. Tel: +351 21 35 89 400
Hrvatska sanofi-aventis Croatia d.o.o. Tel: +385 1 600 34 00	Romania Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI	Slovenija sanofi-aventis d.o.o.
Tel: +353 (0) 1 403 56 00 Ísland Vistor hf. Sími: +354 535 7000	Tel: +386 1 560 48 00 Slovenská republika sanofi-aventis Pharma Slovakia s.r.o. Tel: +421 2 33 100 100
Italia Sanofi S.p.A. Tel: 800 13 12 12 (domande di tipo tecnico) 800 536389 (altre domande)	Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300 rď
Kùnpoç sanofi-aventis Cyprus Ltd. Tql: +357 22 871600	Sverige Sanofi AB Tel: +46 (0)8 634 50 00
Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51 XT	United Kingdom Sanofi Tel: +44 (0) 845 372 7101

This leaflet was last revised in {date}

Other source of information

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

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,

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, „Other medicines and Insulin Human Winthrop Rapid“).

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, „Other medicines and Insulin Human Winthrop Rapid“).

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, „Other medicines and Insulin Human Winthrop Rapid“).