2. What you need to know before you use Insuman Comb 25
Do not use Insuman Comb 25
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 Comb 25.
Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor. 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.
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 Comb 25
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], 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 Comb 25 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 dosage may need to be changed during pregnancy and after giving birth. Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby. However, there is no experience with the use of Insuman Comb 25 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 Comb 25
This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium free’.
3. How to use Insuman Comb 25
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 Comb 25 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 Comb 25.
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 Comb 25 is injected under the skin 30 to 45 minutes before a meal.
Method of administration
Insuman Comb 25 is a fluid (suspension) for injection under the skin
Do NOT inject Insuman Comb 25 into a vein (blood vessel).
SoloStar delivers insulin in doses from 1 to 80 units in steps of 1 unit. Each pen contains multiple doses.
Your doctor will show you in which area of the skin you should inject your insulin. With each injection, change the puncture site within the particular area of skin that you are using.
How to handle SoloStar
SoloStar is a pre filled disposable pen containing insulin human.
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 injection needle must be attached before each use. Only use needles that have been approved for use with SoloStar.
A safety test must be performed before each injection.
Mix the insulin well and check it before first use. Later, you must mix the insulin well again immediately before each injection.
Mixing is best done by gently tilting the pen back and forth at least 10 times. To assist in mixing, three tiny metal balls are present in the cartridge. After mixing, the suspension must have a uniform milky white appearance. It must not be used if it remains clear or if, for example, clumps, flakes, particles or anything similar are in the suspension or on the sides or bottom of the cartridge in the pen. A new pen with a uniform suspension on mixing must then be used.
Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. If you think you may have a problem with SoloStar, consult your doctor, pharmacist or nurse. To prevent the possible transmission of disease, each pen must be used by one patient only.
Special care before injection
Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Do not mix insulin with any other medicines. Insuman Comb 25 SoloStar, pre filled pen, is not designed to allow any other insulin to be mixed in the cartridge.
Empty pens must not be re filled and must be properly discarded.
Do not use 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 Insuman Comb 25 than you should
- If you have injected too much Insuman Comb 25, 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 Comb 25
- If you have missed a dose of Insuman Comb 25 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 Comb 25
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 Comb 25 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 Insuman Comb 25 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)
Insulin treatment may cause temporary build up of water in the body with swelling in the calves and ankles.
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 Insuman Comb 25
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 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 the pre filled pen next to the freezer compartment or a freezer pack. Keep the prefilled pen in the outer carton in order to protect from light.
In use pens
Pre filled pens in use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C and away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp). The pen in use must not be stored in a refrigerator. Do not use the pen after this time period.
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 Comb 25 contains
- The active substance is insulin human. One ml of Insuman Comb 25 contains 100 IU (International Units) of the active substance insulin human. 25% of the insulin is dissolved in water; the other 75% is present as tiny crystals of insulin protamine.
- The other ingredients are: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide (see section 2 under “Important information about some of the ingredients of Insuman Comb 25”), hydrochloric acid (for pH adjustment) and water for injections.
What Insuman Comb 25 looks like and contents of the pack
After mixing, Insuman Comb 25 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Insuman Comb 25 is supplied in pre filled pens, SoloStar, containing 3 ml suspension, (300 IU). Packs of 3, 4, 5, 6, 9 and 10 pens of 3 ml are available. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Tel:+44 (0) 1483 505 515
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
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?
- 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, “Other medicines and Insuman Comb 25”).
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?
- 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 Comb 25”).
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 Insuman,
- you are taking or have taken certain other medicines (see section 2, “Other medicines and Insuman Comb 25”).
In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the problem. Be familiar with your warning symptoms. If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked. If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
What should you do if you experience hypoglycaemia
1. Do not inject insulin. Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar sweetened beverage. Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
2. Then eat something that has a long acting effect in raising your blood sugar (such as bread or pasta). Your doctor or nurse should have discussed this with you previously.
3. If the hypoglycaemia comes back again take another 10 to 20 g sugar.
4. Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.
Tell your relatives, friends and close colleagues the following:
If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar). These injections are justified even if it is not certain that you have hypoglycaemia.
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Insuman® Comb 25 SoloStar® suspension for injection in a pre-filled pen INSTRUCTIONS FOR USE
SoloStar is a prefilled pen for the injection of insulin. Your doctor has decided that SoloStar is appropriate for you based on your ability to handle SoloStar. Talk with your doctor, pharmacist or nurse about proper injection technique before using SoloStar.
Read these instructions carefully before using your SoloStar. If you are not able to use SoloStar or follow all the instructions completely on your own, you must use SoloStar only if you have help from a person who is able to follow the instructions completely. Hold the pen as shown in this leaflet. To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.
Follow these instructions completely each time you use SoloStar to ensure that you get an accurate dose. If you do not follow these instructions completely, you may get too much or too little insulin, which may affect your blood glucose.
You can set doses from 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 doctor, pharmacist or nurse or call the local sanofi-aventis number on the front of this leaflet.
Important information for use of SoloStar:
- Always attach a new needle before each use. Only use needles that have been approved for use with SoloStar.
- Do not select a dose and/or press the injection button without a needle attached.
- 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. Insuman SoloStar is white with a colour on the injection button. The injection button colour will vary based on the formulation of Insuman insulin used. The pictures below are for illustrative purposes only.
B. Take off the pen cap.
C. Check the appearance of your insulin
If you are using a suspension insulin (Insuman Basal or Insuman mixtures), turn the pen up and down at least 10 times to resuspend the insulin. Turn the pen gently to avoid foaming in the cartridge.
After mixing check the appearance of your insulin. Insulin suspensions must have an evenly milky white appearance.
Step 2. Attach the needle
Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.
Before use of the needle, carefully read the “Instructions for Use” accompanying the needles.
Please note: The needles shown are for illustrative purposes only.
A. Remove the protective seal from a new needle.
B. Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).
- If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.
Step 3. Perform a safety test
Always perform the safety test before each injection. This ensures that you get an accurate dose by:
- 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 doctor, pharmacist or nurse.
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 (e.g. contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
B. Dispose of the needle safely.
C. Always put the pen cap back on the pen, then store the pen until your next injection.
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 to room temperature. Cold insulin is more painful to inject.
Discard your used SoloStar as required by your local authorities.
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.