Insuman - patient leaflet, side effects, dosage

Patient leaflet - Insuman

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Insuman Rapid is and what it is used for
2. What you need to know before you use Insuman Rapid
3. How to use Insuman Rapid
4. Possible side effects
5. How to store Insuman Rapid
6. Contents of the pack and other information

1. What Insuman Rapid is and what it is used for

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

Insuman Rapid is an insulin solution with a rapid onset and short duration of action.

Insuman 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. Insuman 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 Insuman Rapid

Do not use Insuman 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 Insuman Rapid.

Follow closely the instructions for dose, 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.

Skin changes at the injection site

The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (see How to use Insuman Rapid). Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications 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 Insuman 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 dose 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], 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.

Insuman Rapid with alcohol

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

Pregnancy and breast-feeding

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 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. However, there is no experience with the use of Insuman Rapid 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 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 Insuman Rapid

This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free’.

3. How to use Insuman 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 Insuman 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 Insuman 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

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

Method of administration

Insuman 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 Insuman 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

Insuman 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 lid on the vial.

Insuman 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.

Insuman 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 Insuman 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 Insuman Rapid than you should

– If you have injected too much Insuman 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 Insuman Rapid

– If you have missed a dose of Insuman 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 Insuman 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 Insuman 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 Insuman Rapid and other insulins.

4. Possible side effects

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

Most serious side effects

Side effects reported uncommonly (may affect up to 1 in 100 people)

Severe allergic reaction with low blood pressure (shock)

Side effects reported with a frequency not known (cannot be estimated from the available data)

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.

Other side effects

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

Injection site urticaria (itchy rash)

Side effects reported with a frequency not known

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

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). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these 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 antibodies

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 dose.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Insuman 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 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 Insuman 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.

6. Contents of the pack and other information

What Insuman Rapid contains

– The active substance is insulin human. One ml of Insuman 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 Insuman Rapid”), hydrochloric acid (for pH adjustment) and water for injections.

What Insuman Rapid looks like and contents of the pack

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

Insuman 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:

Belgie/Belgique/Belgien

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00

Lietuva

Swixx Biopharma UAB

Tel: +370 5 236 91 40

Etnrapua

Swixx Biopharma EOOD

Ten.: +359 (0)2 4942 480

Luxembourg/Luxemburg

Sanofi Belgium

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

(Belgique/Belgien)

Česká republika sanofi-aventis, s.r.o.

Tel: +420 233 086 111

Magyarorszag

SANOFI-AVENTIS Zrt.

Tel.: +36 1 505 0050

Danmark

Sanofi A/S

Tlf: +45 45 16 70 00

Malta

Sanofi S.r.l.

Tel: +39 02 39394275

Deutschland

Sanofi-Aventis Deutschland GmbH Tel:

Nederland

Genzyme Europe B.V.

0800 52 52 010

Tel. aus dem Ausland: +49 69 305 21 131

Tel: +31 20 245 4000

Eesti

Swixx Biopharma OÜ

Tel: +372 640 10 30

Norge

sanofi-aventis Norge AS

Tlf: +47 67 10 71 00

EZZáSa

sanofi-aventis AEBE

Tql: +30 210 900 16 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 Farmacêuticos, Lda.

Tel: +351 21 35 89 400

Hrvatska

Swixx Biopharma d.o.o.

Tel: +385 1 2078 500

Romania

Sanofi Romania SRL

Tel: +40 (0) 21 317 31 36

Ireland

sanofi-aventis Ireland Ltd. T/A SANOFI

Tel: +353 (0) 1 403 56 00

Slovenija

Swixx Biopharma d.o.o.

Tel: +386 1 235 51 00

Island

Vistor hf.

Simi: +354 535 7000

Slovenská republika

Swixx Biopharma s.r.o.

Tel: +421 2 208 33 600

Italia

Sanofi S.r.l.

Tel: 800 13 12 12 (domande di tipo tecnico)

800 536389 (altre domande)

Suomi/Finland

Sanofi Oy

Puh/Tel: +358 (0) 201 200 300

Kùnpoç

C.A. Papaellinas Ltd.

Tql: +357 22 741741

Sverige

Sanofi AB

Tel: +46 (0)8 634 50 00

Latvija

Swixx Biopharma SIA

Tel: +371 6 616 47 50

United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

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

Insuman 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 Insuman 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 heartbeat, 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 Insuman,
– you are taking or have taken certain other medicines (see section 2, "Other medicines and