100 units/ml KwikPen solution for injection in a pre-filled pen
Insulin glargine
1. What ABASAGLAR is and what it is used for
ABASAGLAR contains insulin glargine. This is a modified insulin, very similar to human insulin.
ABASAGLAR is used to treat diabetes mellitus in adults, adolescents and children from 2 years of age.
Diabetes mellitus is a disease in which the body does not produce enough insulin to control blood sugar levels. Insulin glargine has a long and even blood sugar lowering effect.
2. What you need to know before using ABASAGLAR
Do not use ABASAGLAR
If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to a doctor, pharmacist or nurse before using ABASAGLAR.
Be sure to follow the dosing instructions and instructions for control (of blood and urine), diet and physical activities (physical work and exercise) as discussed with your doctor.
If your blood sugar is too low ( hypoglycaemia ), follow the instructions for treating hypoglycaemia (see box at the end of the package leaflet).
Skin changes at the injection site:
If you inject insulin too often in the same place, the adipose tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy). Nodules under the skin can also be caused by the accumulation of a protein called amyloid ( cutaneous amyloidosis). It may be that insulin et not work as well if you inject in an area with nodules. Change the injection site for each injection to prevent these skin changes.
Travel
Consult your doctor before setting out on a journey. You may need to raise questions about:
– availability of your insulin in the country you are visiting,
– availability of insulin, etc.,
– storage of insulin during the journey,
– times for meals and insulin use during the trip,
– possible effects of travel to other time zones,
– any new health risks in the countries you visit,
– what to do in an emergency if you feel unwell or become ill
Diseases and injuries
In the following situations, the management of your diabetes may require extra care (for example, adjustment of insulin dose, blood and urine tests):
– If you are ill or have a serious accident, your blood sugar may rise ( hyperglycaemia).
– If you do not eat enough, your blood sugar may become too low ( hypoglycaemia ).
In most cases, you will need medical attention. Contact a doctor at an early stage.
If you have type 1 diabetes (insulin-dependent diabetes mellitus ), you should not stop taking insulin and you should continue to add enough carbohydrates. Always tell those who see you or treat you that you need insulin.
Insulin treatment can cause the body to make antibodies against insulin (substances that react with insulin ). This will, although very unusual, require a change in your insulin dose.
Some patients with long-term type 2 diabetes mellitus and heart disease or previous stroke, treated with pioglitazone and insulin, developed heart failure. Tell your doctor as soon as possible if you get signs of heart failure such as increased shortness of breath, rapid weight gain or local swelling (oedema).
Insulin confusions
You must always check the package and insulin label before each injection, to avoid confusing ABASAGLAR with other insulins.
Children
There is no experience with the use of ABASAGLAR in children under 2 years of age.
Other medicines and ABASAGLAR
Some medicines affect the blood sugar level (lowering the blood sugar, raising the blood sugar or both, depending on the circumstances). In all cases, it may be necessary to adjust your insulin dose to avoid your blood sugar level becoming either too low or too high. Keep this in mind 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 any medicine, consult your doctor if it may affect your blood sugar level and if so, what to do.
Drugs that can lower your blood sugar ( hypoglycaemia ) include:
– all other medicines used to treat diabetes,
– ACE inhibitors (for the treatment of certain heart conditions or high blood pressure),
– disopyramide (for the treatment of certain heart conditions),
– fluoxetine (for treating depression),
– fibrates (used to lower high levels of blood fats),
– MAO inhibitors (for the treatment of depression),
– pentoxifylline, propoxyphene, salicylates (eg acetylsalicylic acid used as painkillers and
antipyretics),
somastotin analogues (as octreotide, used in the treatment of a less common disease involving the production of too much growth hormone ),
sulfonamide antibiotics.
Drugs that can raise your blood sugar ( hyperglycaemia ) include:
– corticosteroid s (e.g. corticosteroid used in the treatment of inflammation s),
– danazol (medicines that affect ovulation),
– diazoxide (for the treatment of hypertension ),
– diuretics (for the treatment of high blood pressure or if you have accumulated too much fluid),
– glucagon (a pancreatic hormone used in the treatment of severe hypoglycaemia ),
– isoniazid (for the treatment of tuberculosis ),
– estrogens and progestogens (eg birth control pills used for birth control),
– phenazine derivatives (for the treatment of mental illness),
somatropin ( growth hormone ),
– sympathomimetics (eg epinephrine ( adrenaline ) or salbutamol, terbutaline used in the treatment
of asthma ),
– thyroid hormones (for the treatment of thyroid diseases),
– atypical psychotropic drugs (eg clozapine, olanzapine),
– protease inhibitors (for the treatment of HIV ).
Blood sugar levels can sometimes increase and sometimes decrease if you use:
– beta-blockers (for the treatment of hypertension ),
– clonidine (for the treatment of hypertension ),
lithium salts (for the treatment of mental illness).
Pentamidine (used to treat certain infections caused by parasites) can cause hypoglycaemia, which can sometimes be followed by hyperglycaemia
In addition, beta-blockers, as well as other sympatholytic drugs (eg clonidine, guanethidine and reserpine), may cause the first warning signs that make you recognize hypoglycaemia to be weakened or absent.
If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist for advice.
ABASAGLAR with alcohol
Your blood sugar can either be raised or lowered if you drink alcohol.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor if you intend to become pregnant or if you are already pregnant. The insulin dose may need to be adjusted during pregnancy and after delivery. For the sake of the child, it is especially important that your diabetes is monitored and that hypoglycaemia is prevented.
If you are breast-feeding, your insulin dose and diet may need to be adjusted, consult your doctor.
Driving and using machines
Your ability to concentrate or react may be impaired if:
– you get hypoglycaemia (low blood sugar levels),
– you get hyperglycaemia (elevated blood sugar levels),
– you have vision problems.
Think of the risk of this in all situations where you can expose yourself and others to danger (eg when driving or using machines). Contact your doctor for advice on driving if:
– you often have episodes of hypoglycaemia,
– if the first warning signs that make you recognize hypoglycaemia are weakened or absent.
ABASAGLAR contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
3. How to use ABASAGLAR
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Although ABASAGLAR contains the same active substance as Toujeo ( insulin glargine 300 units/ml), these medicines are not interchangeable. Switching from one insulin treatment to another requires prescription, medical monitoring and blood glucose monitoring. Consult a physician for further information.
Dose
Depending on your lifestyle and the results of your blood glucose ( glucose ) test and your previous insulin therapy, your doctor will:
– determine how much ABASAGLAR you will need per day and at what time of day,
– tell you when to check your blood sugar level and if you need to take a urine sample,
– tell you when you may need to increase or decrease the dose of ABASAGLAR.
ABASAGLAR is a long-acting insulin. Your doctor may prescribe it in combination with fast-acting insulin or with tablets to treat high blood sugar.
There are many factors that can affect blood sugar levels. You need to know these factors to be able to react correctly when your blood sugar level changes and to prevent the level from becoming too high or too low. See the box at the end of the package leaflet for further information.
Use for children and adolescents
ABASAGLAR can be used by young people and children from 2 years of age. Use this medicine exactly as your doctor has told you.
Time of administration
You will need one injection of ABASAGLAR per day, at the same time.
Method of administration
ABASAGLAR is injected under the skin. You should NEVER inject ABASAGLAR into a blood vessel, as this would alter the effect and may cause hypoglycaemia.
Your doctor will show you in which area of skin you should inject ABASAGLAR. Change the injection site each time
area of the skin that you use for injection one.
Handling of ABASAGLAR KwikPen
ABASAGLAR KwikPen is a pre-filled disposable pen that contains insulin glargine.
Carefully read the “KwikPen User Manual” attached to this leaflet. You must use the pen as described in this manual.
A new needle must be fitted before each use. Use only needles approved for use with ABASAGLAR KwikPen (see “ABASAGLAR KwikPen Instructions for Use”).
A safety test should be performed before each injection.
View cartridge a prior use of the pen. Do not use ABASAGLAR if you detect particles in it. Only use ABASAGLAR if the solution is clear, colourless and water-like. Do not shake or mix before use.
To avoid possible transmission of disease, each pen should only be used by one patient.
It is important to make sure that insulin is not contaminated with alcohol, other disinfectants or other substances.
Always use a new pen if you notice that your blood sugar drops unexpectedly. If you have any problems with ABASAGLAR KwikPen, ask your doctor, pharmacist or nurse to check the pen.
Empty pens must not be refilled and must be discarded
Do not use ABASAGLAR KwikPen if it is damaged or does not work properly. It must then be discarded and a new KwikPen must be used.
If you use more ABASAGLAR than you should
- If you have injected too much ABASAGLAR or are unsure how much you have injected, your blood sugar level may become too low ( hypoglycaemia ). Check your blood sugar often. To avoid hypoglycaemia, you usually need to eat more food and control your blood sugar. For information on treating hypoglycaemia, see the box at the end of this leaflet.
If you forget to use ABASAGLAR
- If you have missed a dose of ABASAGLAR or if you have not injected enough insulin or are unsure how much you have injected, your blood sugar level may become too high ( hyperglycaemia ). Check your blood sugar often. For information on treating hyperglycaemia, see the box at the end of this leaflet.
- Do not take a double dose to make up for a forgotten dose.
After injection
If you are not sure how much you have injected, check your blood sugar before deciding to take another injection.
If you stop using ABASAGLAR
This can lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis(accumulation of acid in the blood because the body breaks down fat instead of sugar). Do not stop ABASAGLAR treatment without consulting your doctor, who will tell you what needs to be done.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice that your blood sugar is too low ( hypoglycaemia ), take immediate action to raise your blood sugar level. Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin therapy (may affect more than 1 user in 10). Low blood sugar means that there is not enough sugar in your blood. If your blood sugar level gets too low, you may faint (become unconscious). Severe hypoglycemia can cause brain damage and can be life-threatening. For more information, see the box at the end of this leaflet.
Severe allergic reaction (rare, may affect up to 1 in 1,000 people) – symptoms may include widespread skin reactions (rash and itching all over the body), severe swelling of the skin or mucous membranes ( angioedema ), shortness of breath, drop in blood pressure with rapid heartbeat and sweating. Severe allergic reaction to insulin can be life-threatening. Contact a doctor immediately if you notice signs of a severe allergic reaction.
– Skin changes at the injection site
If you inject insulin too often in the same place, the adipose tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Nodules under the skin can also be caused by the accumulation of a protein called amyloid ( cutaneous amyloidosis. How often this occurs is not known). It may be that insulin et not work as well if you inject in an area with nodules. Change the injection site for each injection to prevent these skin changes.
Common side effects are (may affect up to 1 in 10)
– Skin side effects and allergic reactions at the injection site
Reactions may include redness, unusually intense pain on injection, itching, hives, swelling and inflammation. These reactions can also spread around the injection site. Most less severe insulin reactions usually go away within a few days to a few weeks.
Rare side effects are (may affect up to 1 in 1000)
– Visual impact
A marked change (improvement or deterioration) in blood sugar control may temporarily impair your eyesight. If you have proliferative retinopathy (an eye disease associated with diabetes ), severe hypoglycaemic attacks can cause temporary loss of vision.
– General symptoms
In rare cases, insulin treatment may cause temporary accumulation of water in the body, with swelling of the calves and ankles.
Very rare side effects are (may affect up to 1 in 10 000 users)
In very rare cases, dysgeusia (taste change) and myalgia (muscle pain) may occur.
Use in children and adolescents
In general, the side effects in children and adolescents aged 18 or younger are the same as in adults.
Complaints of injection site reactions (injection site pain, injection site reactions) and skin reactions (rash, hives ) are comparatively more frequently reported in children and adolescents 18 years of age or younger than in adults.
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store ABASAGLAR
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 pen label after “EXP”. The expiration date is the last day of the specified month.
Unused pens
Store in a refrigerator (2º C-8º C). Do not freeze.
Do not store in direct contact with the freezer compartment or cooling lamp.
Keep the pre-filled pen in the outer carton. Sensitive to light.
Pencils during use
Pencils during use (in the insulin pen) or kept in reserve can be stored for a maximum of 28 days at a maximum of 30º C and in protection against direct heat or direct light. The pen used must not be stored in the refrigerator. Do not use the pen after this time. The pen cap must be put back on the pen after injection. Sensitive to light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
– The active substance is insulin glargine. Each millilitre solution contains 100 units of the active substance insulin glargine (equivalent to 3.64 mg).
The other ingredients are zinc oxide, meta-cresol, glycerol, sodium hydroxide (see section 2 “ABASAGLAR contains sodium”), hydrochloric acid and water for injections.
What the medicine looks like and contents of the pack
ABASAGLAR 100 units/ml injection in prefilled pen, KwikPen, is a clear and colourless solution.
ABASAGLAR is available in packs of 5 pre-filled pens and in a multipack consisting of 2 cartons with 5 pre-filled pens each.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Manufacturer
Lilly France SAS, rue du Colonel Lilly, F-67640 Fegersheim, France.