Insulin Human Winthrop
insulin human
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Insulin human
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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 Insulin Human Winthrop Rapid is and what it is used for
What you need to know before you use Insulin Human Winthrop Rapid
How to use Insulin Human Winthrop Rapid
Possible side effects
How to store Insulin Human Winthrop Rapid
Contents of the pack and other information
Medicinal product no longer authorised
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.
If you are allergic to insulin or any of the other ingredients of this medicine (listed in section 6).
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.
Medicinal product no longer authorised
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).
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.
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.
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).
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.
Your blood sugar levels may either rise or fall if you drink alcohol.
Medicinal product no longer authorised
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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.
If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
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.
This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free’.
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.
Insulin Human Winthrop Rapid is injected under the skin 15 to 20 minutes before a meal.
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.
Medicinal product no longer authorised
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.
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.
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 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 have missed a dose of Insulin Human Winthrop Rapid or if you have not injected
of this leaflet.
Do not take a double dose to make up for a forgotten dose.
Medicinal product no longer authorised
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.
You must always check the insulin label before each injection to avoid mix-ups between Insulin Human Winthrop Rapid and other insulins.
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.
Oedema
Insulin treatment may cause temporary build-up of water in the body with swelling in the calves and ankles.
Injection site reactions
Severe allergic reaction with low blood pressure (shock)
Injection site urticaria (itchy rash)
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.
Medicinal product no longer authorised
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
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 after “EXP”. The expiry date refers to the last day of that month.
Unopened vials
Store in a refrigerator (2°C – 8°C). Do not freeze. Do not put Insulin Human Winthrop Rapid next to the freezer compartment or a freezer pack. Keep the vial in the outer carton in order to protect from light.
Opened vials
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.
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.
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.
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:
Medicinal product no longer authorised
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00
UAB «SANOFI-AVENTIS LIETUVA» Tel: +370 5 2755224
sanofi-aventis Bulgaria EOOD
Тел.: +359 (0)2 970 53 00
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)
SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0050
sanofi-aventis Denmark A/S
Tlf: +45 45 16 70 00
Sanofi Malta Ltd.
Tel: +356 21493022
Zentiva Pharma GmbH Tel: +49 (0)180 20 200 10
sanofi-aventis Netherlands B.V.
Tel: +31 (0)182 557 755
sanofi-aventis Estonia OÜ
Tel: +372 627 34 88
Aventis Pharma NorgeAS
Tlf: +47 67 10 71 00
sanofi-aventis AEBE
Τηλ: +30 210 900 16 00
sanofi-aventis GmbH Tel: +43 1 80 185 – 0
sanofi-aventis, S.A. Tel: +34 93 485 94 00
sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00
sanofi-aventis France Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23
Sanofi - Produtos Farmacêuticos, Lda. Tel: +351 21 35 89 400
sanofi-aventis Croatia d.o.o. Tel: +385 1 600 34 00
Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00
sanofi-aventis d.o.o.
Tel: +386 1 560 48 00
Vistor hf.
Sími: +354 535 7000
sanofi-aventis Pharma Slovakia s.r.o.
Tel: +421 2 33 100 100
Sanofi S.p.A.
Tel: 800 13 12 12 (domande di tipo tecnico)
800 536389 (altre domande)
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300
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sanofi-aventis Cyprus Ltd.
Τηλ: +357 22 871600
Sanofi AB
Tel: +46 (0)8 634 50 00
sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
Sanofi
Tel: +44 (0) 845 372 7101
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").
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.
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.
Medicinal product no longer authorised
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").
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.
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").
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.
Medicinal product no longer authorised
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.
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.
If the hypoglycaemia comes back again take another 10 to 20 g sugar.
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.
