What is it and how is it used?
Lantus is a solution for injection containing insulin glargine. Insulin glargine is a modified insulin, very similar to human insulin.
Lantus is used to reduce high blood sugar in adults, adolescents and children of 6 years or above with diabetes mellitus. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action.
What do you have to consider before using it?
Do not use Lantus
If you are allergic (hypersensitive) to insulin glargine or any of the other ingredients of Lantus. (for a full list of ingredients, see section 6 ”What Lantus contains”).
Take special care with Lantus
Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).
Travel
Before travelling consult your doctor. You may need to talk about
Illnesses and injuries
In the following situations, the management of your diabetes may require a lot of care (for example, adjustment to insulin dose, blood and urine tests):
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).
Using other medicines
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 too low or too high. Be careful when you start or stop taking another medicine.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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:
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
Your blood sugar level may either rise or fall if you take:
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.
Using Lantus with food and drink
Your blood sugar levels may either rise or fall if you drink alcohol.
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any 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.
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:
Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or operating machines). You should contact your doctor for advice on driving if:
Important information about some of the ingredients of Lantus
This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free’.
How is it used?
Dosage
Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will:
Lantus is a long-acting insulin. Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.
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.
Use in children
Lantus can be used in adolescents and children of 6 years and above.
There is limited experience with the use of Lantus in children less than 6 years old. Therefore, Lantus should only be used in children below this age under careful medical supervision.
Frequency of administration
You need one injection of Lantus every day, at the same time of the day . In children, only evening injection has been studied.
Method of administration
Lantus is injected under the skin. Do NOT inject Lantus in a vein, since this will change its action and may cause hypoglycaemia.
Your doctor will show you in which area of the skin you should inject Lantus. With each injection, change the puncture site within the particular area of skin that you are using.
How to handle the vials
Look at the vial before you use it. Only use it if the solution is clear, colourless and waterlike, and has no visible particles in it. Do not shake or mix it before use. Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin. Do not mix Lantus with any other insulins or medicines. Do not dilute it. Mixing or diluting may change the action of Lantus.
Always use a new vial if you notice that your blood sugar control is unexpectedly getting worse. This is because the insulin may have lost some of its effectiveness. If you think you may have a problem with Lantus, have it checked by your doctor or pharmacist
If you use more Lantus than you should
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 Lantus
If you stop using Lantus
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 Lantus without speaking to a doctor, who will tell you what needs to be done.
Insulin Mix-ups
You must always check the insulin label before each injection to avoid medication mix-ups between Lantus and other insulins.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, Lantus can cause side effects, although not everybody gets them.
Hypoglycaemia (low blood sugar) can be very serious. If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately.
If you experience the following symptoms, contact your doctor immediately:
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. These could be symptoms of severe allergic reactions to insulins and may become life-threatening.
Very common reported side effects (affects more than 1 user in 10)
- Hypoglycaemia
As with all insulin therapy, the most frequent side effect is hypoglycaemia.
Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood. For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Common reported side effects ( affects 1 to 10 users in 100)
- 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). Thickening of fatty tissue may occur in 1 to 2 % of patients while shrinking may occur uncommonly. 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
3 to 4 % of patients may experience reactions at the injection site (such as reddening, unusually intense pain on injection, itching, hives, swelling or inflammation). They can also spread around the injection site. Most minor reactions to insulins usually resolve in a few days to a few weeks.
Rare reported side effect ( affects 1 to 10 users in 1000)
- Severe allergic reactions to insulinsAssociated symptoms may include 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.These could be symptoms of severe allergic reactions to insulins and may become life-threatening.
- 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.
- General disorders
In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling in the calves and ankles.
Very rare reported side-effects (affects less than 1 user in 10 000)
In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.
Other side effects with frequency not known (frequency cannot be estimated from available data)
Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). Rarely, this may require a change to your insulin dose.
Use in children
In general, the side effects in children and adolescents of 18 years of age or less are similar to those seen in adults.
Complaints of injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults.
No clinical study safety data are available in children below 6 years of age.
Tell your doctor or pharmacist if any side effect become serious, or if you notice any side effects not listed in this leaflet.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Lantus 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 Lantus next to the freezer or next to 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 or direct light.
Do not use it after this time period. It is recommended that the date of the first use be noted on the label.
Do not use Lantus if you notice particles in it. Only use Lantus if the solution is clear, colourless and waterlike.
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.
