100 units/ml solution for injection in a pre-filled pen
Insulin glargine
What Lantus is and what it is used for
Lantus contains insulin glargine. This is a modified insulin, very similar to human insulin.
Lantus 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.
What you need to know before using Lantus
Do not use Lantus
- If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Lantus in a pre-filled pen should only be injected under the skin (see also section 3). Talk to your doctor if you need to inject your insulin using another method.
Talk to your doctor, pharmacist or nurse before using Lantus.
Be sure to follow the dosing instructions and instructions for control (of blood and urine), diet, physical activities (physical work and exercise) and injection technique as discussed with your doctor. Follow the hypoglycaemic information (see box at the end of the package leaflet) if your blood sugar is too low ( hypoglycaemia ).
Skin changes at the injection site:
To prevent skin changes, e.g. nodules under the skin, you should constantly change the injection site. It may be that insulin et not work as well if you inject in an area of nodules (see How to use Lantus). Contact your doctor before changing the injection site if you are currently injecting in an area with lumps. Your doctor may advise you to check your blood sugar more often and to adjust your insulin dose or the dose of other diabetes medicines.
Travel
Consult your doctor before travelling. You may need to raise questions about:
- the availability of your insulin in the country you are visiting,
- the availability of insulin , needles, etc.,
- the storage of insulin during the journey,
- times for meals and insulin use during the trip,
- possible consequences 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:
- If you are ill or have a serious accident, your blood sugar level may rise ( hyperglycaemia ).
- If you do not eat enough, your blood sugar level 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 ). Only in very rare cases is a change in insulin dose required.
Some patients with long-standing diabetes mellitus type 2 and heart disease or previous stroke, treated with pioglitazone (a drug against diabetes taken by mouth for the treatment of diabetes mellitus type 2), 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).
Children
There is no experience with the use of Lantus in children under 2 years of age.
Other drugs and Lantus
Some medicines affect the blood sugar level (lowering the blood sugar, raising the blood sugar or both, depending on the circumstances). In any case, it may be necessary to adjust your insulin dose to prevent your blood sugar levels from 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 (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 fats),
- MAO inhibitors (used to treat depression),
- pentoxifylline, propoxyphene, salicylates (eg acetylsalicylic acid used as painkillers and antipyretics),
- sulfonamide antibiotics.
Drugs that can raise your blood sugar ( hyperglycaemia ) include:
- corticosteroids (eg cortisone used to treat inflammation ),
- danazol (medicines that affect ovulation),
- diazoxide (used to treat high blood pressure ),
- diuretics (used to treat high blood pressure or if you have accumulated too much fluid),
- glucagon (pancreatic hormone used to treat severe hypoglycaemia ),
- isoniazid (used to treat tuberculosis ),
- estrogens and progestogens (eg birth control pills used for birth control),
- phentiazine derivatives (used to treat mental illness),
- somatropin ( growth hormone ),
- sympathomimetics (eg epinephrine ( adrenaline ) or salbutamol , terbutaline used in the treatment of asthma ),
- thyroid hormones (used in the treatment of thyroid disease),
- atypical psychotropic drugs (eg clozapine, olanzapine),
- protease inhibitor (used in the treatment of HIV ).
Blood sugar levels can sometimes increase and sometimes decrease if you use:
- beta-blockers (used to treat high blood pressure ),
- clonidine (used to treat high blood pressure ),
- lithium salts (used in 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.
Lantus 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 breastfeeding, your insulin dose and diet may need to be adjusted.
Driving and using machines
Your ability to concentrate or react may be impaired if:
- you get hypoglycaemia (low blood sugar),
- you get hyperglycemia (elevated blood sugar levels),
- you have vision problems.
Always remember the risk of this in all situations where you may 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.
Important information about some of the ingredients of Lantus
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free.
How to use Lantus
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Although Lantus 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 a prescription, medical monitoring and blood sugar control. Consult a physician for further information.
Dose
Depending on your lifestyle and the results of your blood glucose ( glucose ) test and your previous insulin treatment, your doctor will:
- determine how much Lantus 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 a Lantus.
Lantus is a long-acting insulin. Your doctor may prescribe it in combination with fast-acting insulin or with tablets to treat high blood sugar.
Many factors can affect blood sugar levels. You need to know these factors to be able to react correctly when the blood sugar level changes and to prevent the level from becoming too high or too low. See the box at the end of this leaflet.
Use for children and adolescents
Lantus can be used in adolescents 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 Lantus daily, at the same time.
Method of administration
Lantus is injected under the skin. NEVER inject Lantus into a blood vessel, as it would alter the effect and may cause hypoglycemia.
Your doctor will show you in which area of skin you should inject Lantus. Change the injection site each time in the area of the skin that you use for injection.
Management of SoloStar
SoloStar is a pre-filled disposable pen containing insulin glargine. Lantus in a pre-filled pen should only be injected under the skin. Talk to your doctor if you need to inject your insulin using another method.
Carefully read the SoloStar user manual attached at the end of this leaflet. You must use the pen as described in this manual.
Attach a new needle before each use. Use only needles that are intended for use with SoloStar (see SoloStar Instructions for Use).
A safety test should be performed before each injection.
Check the cartridge one before using the pen. Do not use SoloStar if you notice particles in it. Only use SoloStar if the solution is clear, colorless, and water-like.
Do not shake or mix before use.
To avoid possible transmission of disease, never share your pen with anyone else. The pen should only be used by you.
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 control unexpectedly deteriorates. If you have any problems with SoloStar, consult your doctor, pharmacist, or nurse.
Empty pens must not be refilled and must be discarded.
Do not use SoloStar if it is damaged or does not work properly (due to mechanical failure). It will then be discarded and a new SoloStar will be used.
Insulin confusions
You must always check the insulin label before each injection, to avoid confusing Lantus with other insulins.
If you use more Lantus than you should
- If you have injected too much Lantus , 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 the treatment of hypoglycaemia , see the box at the end of the leaflet.
If you forget to use Lantus
- If you miss a dose of Lantus or if you have not injected enough insulin , 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 .
If you stop using Lantus
This can lead to severe hyperglycemia (very high blood sugar) and ketoacidosis (accumulation of acid in the blood because the body breaks down fat instead of sugar). Do not stop treatment with Lantus 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.
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 getting too low (hypoglycemia), take immediate action to raise your blood sugar (see the box at the end of this leaflet). Hypoglycemia (low blood sugar) can be very serious and is very common with insulin therapy (may affect more than 1 in 10 people). 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 reactions to insulin may be life-threatening. Contact a doctor immediately if you notice signs of severe allergic reactions.
- Skin changes at the injection site:If you inject insulin too often in the same place, the skin may either shrink (lipoatrophy) ( may occur in up to 1 in 100 people ) or thicken (lipohypertrophy) ( may occur in up to 1 in 10 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.
Side effects are reported as common (may affect up to 1 in 10 people)
- Skin side effects and allergic reactions at the injection siteReactions may include redness , unusually intense pain on injection , pruritus , hives , swelling and inflammation ). These reactions may spread around the injection site. Most less severe insulin reactions usually go away within a few days to a few weeks.
Side effects are reported as rare (may affect up to 1 in 1,000 people)
- Visual impactA 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 symptomsIn rare cases, insulin treatment may cause temporary storage of water in the body, with swelling of the calves and ankles.
Side effects are reported as very rare (may affect up to 1 in 10,000 people)
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 who are 18 years or younger are similar to those seen 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.
There is no experience of use in children younger than 2 years.
How to store Lantus
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 the pen label after “EXP”. The expiration date is the last day of the specified month.
Unused pens
Store in a refrigerator (2ºC-8ºC).
Do not freeze or 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 or in reserve can be stored for a maximum of 4 weeks at a maximum of 30 ° C and in protection against direct heat and direct light. The pen used must not be stored in the refrigerator. Do not use the pen after this time.
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.
Contents of the pack and other information
Content declaration
- The active substance is insulin glargine. Each ml of solution contains 100 units of insulin glargine (equivalent to 3.64 mg).
- The other ingredients are: zinc chloride, metacresol, glycerol , sodium hydroxide (see section 2 “Important information about some of the excipients in Lantus”) and hydrochloric acid (for pH adjustment) and water for injections.
What the medicine looks like and contents of the pack
Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen is a clear and colorless solution.
Each pen contains 3 ml of solution for injection (equivalent to 300 units). Packs of 1, 3, 4, 5, 6, 8, 9, and 10 pens.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
Contact the representative of the marketing authorization holder to find out more about this medicine:
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