How does it work?

People with diabetes have a deficiency or absence of a hormone manufactured by the pancreas called insulin. Insulin is the main hormone responsible for the control of sugar (glucose) in the blood.

People with type one diabetes need to have injections of insulin to control the amount of glucose in their bloodstream. Insulin injections act as a replacement for natural insulin, and allow people with diabetes to achieve normal blood glucose levels.

Insulin injections work in the same way as natural insulin, by binding to insulin receptors on cells in the body. Insulin causes cells in the liver, muscle and fat tissue to increase their uptake of glucose from the bloodstream. It also decreases the production of glucose by the liver, and has various other effects that lower the amount of glucose in the blood.

The type of insulin in Lantus is called insulin glargine. This is known as a long acting insulin. It is injected under the skin in the evening, where it forms a reservoir of insulin that is released slowly over the next 24 hours to help control blood glucose levels throughout a 24 hour period.

It is important to monitor your blood glucose regularly and adjust your insulin dose as required. Your doctor or diabetic team will explain how to do this. Keeping your blood glucose level as close to normal as possible, and not too high or too low, significantly reduces the risk of developing late-stage diabetic complications.

What is it used for?

• Diabetes

Warning!

• This medicine is not recommended for children under six years of age.
• This medicine must not be injected into a vein (intravenously).
• Your insulin requirements may increase when you are ill, especially if you have an infection or fever. Your insulin dose may also need adjusting during periods of emotional disturbance, or if you increase your physical activity or change your usual diet. Insulin requirements may be reduced if you have impaired kidney or liver function. Discuss this with your doctor or diabetes nurse to make sure you optimise control of your blood sugar.
• People with diabetes who are on insulin should only drink alcohol in moderation and accompanied by food. This is because alcohol can make your warning signs of low blood sugar less clear, and can cause delayed low blood sugar, even several hours after drinking.
• Your ability to concentrate or react may be reduced if you have low blood sugar, and this can cause problems driving or operating machinary. You should take precautions to avoid low blood sugar when driving - discuss this with your doctor.
• Each time you inject your insulin make sure you use a different site within the area you use. This helps to prevent the skin thickening and pitting, which can occur if the injection is repeatedly given in the same site.
• The warning symptoms of low blood sugar (hypoglycaemia) may be changed or reduced if you are elderly, if you have a long history of diabetes, or if you suffer from a psychiatric illness or nerve disease (autonomic neuropathy). The signs may also be reduced if low blood sugar levels develop gradually in your case, or if your blood sugar control becomes much improved. If these cases apply to you, you should always try to remain aware of your warning symptoms, and if necessary, perform more frequent monitoring of your blood sugar so that you can avoid hypoglycaemia. Discuss this with your doctor.
• Low blood sugar (hypoglycaemia) can occur as a side effect of insulin therapy. With this particular type of insulin, hypoglycaemia may be less common at night, but more likely early in the morning. Symptoms of hypoglycaemia usually occur suddenly and may include cold sweats, cool pale skin, tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, excessive hunger, temporary vision changes, headache, nausea and palpitations. You should discuss this with your doctor to ensure you know what to do if you experience these symptoms.
• Before opening, Lantus vials, cartridges and pens should be stored in their outer cartons in a refrigerator at 2-8°C. Do not freeze. Make sure the containers do not directly touch the freezer compartment. After opening they may be kept outside the fridge, but must be kept below 25°C. Lantus pens and cartridges must not be refrigerated once in use. Lantus vials must be kept in their outer container to protect them from light. Any unused medicine should be discarded four weeks after the first use. You may find it helpful to write the date of first use on the label.
• Look at your insulin cartridge or vial before you use it. Only use it if the solution is clear, colourless and waterlike, and has no visible particles in it. This insulin is a solution and does not require shaking or mixing before use. It must not be mixed with any other insulin or diluted, as this may change its action.

Not to be used in

• Low blood sugar levels (hypoglycaemia)

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The manufacturer has not studied this type of insulin in pregnant women, and it should be used with caution. Blood sugar levels need to be maintained as stable as possible during pregnancy, and you should consult your diabetic specialist to discuss how to achieve this. Your insulin requirements are likely to decrease in the first trimester and subsequently increase in the second and third trimesters. Discuss this with your doctor.
• There is no risk to nursing infants from insulin taken by the mother. However, your insulin dose may need to be decreased during breastfeeding. Discuss this with your doctor.

Label warnings

• Follow the printed instructions you have been given with this medication.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• Allergic reaction to active ingredient
• Low blood glucose level (hypoglycaemia)
• Pain at injection site
• Excessive fluid retention in the body tissues, resulting in swelling (oedema)
• Skin thickening or pitting (lipodystrophy) if injection given too frequently into the same site
• Redness, swelling or itching at the injection site
• Nausea

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

Some medicines can affect your blood sugar levels and may therefore alter your insulin requirements. You should tell your doctor if you are taking any other medicines, including herbal medicines and those bought without a prescription, before starting treatment with this medicine. You should also take care when starting and stopping any new medicines. Always ask your doctor or pharmacist before taking a new medicine to check whether it can affect your blood sugar, and if so what action, if any, you need to take.

The following medicines may decrease blood sugar levels and people taking these medicines may therefore need a decrease in their insulin dose:

• antidiabetic medicines taken by mouth
• octreotide
• disopyramide
• fibrates for high cholesterol levels, eg bezafibrate
• anabolic steroids, eg testosterone, nandrolone, stanozolol
• ACE inhibitors, eg captopril (these can cause unpredictable drops in blood sugar)
• MAOI antidepressants, eg phenelzine
• fluoxetine
• large doses of salicylates, eg aspirin (small pain relieving doses do not normally have this effect).

Beta-blockers, eg propranolol (including eye drops containing beta-blockers) can mask some of the signs of low blood sugar, such as increased heart rate and tremor. They also prolong episodes of low blood sugar and impair recovery back to normal glucose levels.

The following medicines may increase blood glucose levels and people taking these may need increased doses of insulin:

• corticosteroids, eg hydrocortisone, prednisolone
• diuretics, especially thiazide diuretics, eg bendrofluazide
• danazol
• diazoxide
• isoniazid
• some antipsychotic medicines, eg chlorpromazine
• somatropin (human growth hormone)
• lithium.

Oestrogens and progesterones, such as those contained in oral contraceptives, may affect blood sugar levels, and women taking these may need small adjustments up or down in their insulin dose.

People with diabetes who smoke normally need more insulin, as smoking reduces the amount of insulin that is absorbed into the blood from an injection under the skin. If you give up smoking, you may subsequently need a reduction in your insulin dose. Discuss this with your doctor.