Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Lantus (Insulin-glargine-long-acting). If you are concerned about side effects, discuss the risks and benefits of Lantus (Insulin-glargine-long-acting) with your doctor.

The following side effects have been reported by at least 1% of people taking Lantus (Insulin-glargine-long-acting). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• redness, itching, or swelling at the site of the injection

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• signs of low blood glucose:
• anxiety
• blurred vision
• confusion
• difficulty concentrating
• difficulty speaking
• dizziness
• drowsiness
• fast heartbeat
• headache
• hunger
• nausea
• nervousness
• numbness or tingling of the lips, fingers, or tongue
• sweating
• tiredness
• trembling
• weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

• rash or blisters all over the body
• seizures
• symptoms of a serious allergic reaction (e.g., swelling of the face or throat, difficulty breathing, wheezing, or itchy skin rash)
• unconsciousness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Lantus (Insulin-glargine-long-acting).

Vial
Each mL of sterile solution contains 100 units of insulin glargine. Nonmedicinal ingredients: glycerol, m-cresol, polysorbate 20 (10 mL vial only), water for injection, and zinc. Hydrochloric acid and sodium hydroxide may have been added to adjust for pH.

Cartridge
Each mL of sterile solution contains 100 units of insulin glargine. Nonmedicinal ingredients: glycerol, m-cresol, polysorbate 20 (10 mL vial only), water for injection, and zinc. Hydrochloric acid and sodium hydroxide may have been added to adjust for pH.

SoloSTAR disposable pen
Each mL of sterile solution contains 100 units of insulin glargine. Nonmedicinal ingredients: glycerol, m-cresol, polysorbate 20 (10 mL vial only), water for injection, and zinc. Hydrochloric acid and sodium hydroxide may have been added to adjust for pH.

Do not use insulin glargine if you:

• are allergic to insulin or to any of the ingredients of the medication
• have diabetic coma
• have low blood sugar (Hypoglycemia)

There may be an interaction between insulin glargine and any of the following:

• ACE inhibitors (e.g., Ramipril, Enalapril, Lisinopril)
• alcohol
• anabolic steroids (e.g., testosterone)
• antipsychotics (e.g., Aripiprazole, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• beta-blockers (e.g., Atenolol, Metoprolol, Pindolol, Propranolol, Sotalol)
• birth control pills
• Bismuth Subsalicylate
• Bromocriptine
• Buserelin
• certain diuretics (e.g., Hydrochlorothiazide)
• corticosteroids (e.g., Prednisone, Prednisolone)
• Danazol
• decongestants (e.g., Pseudoephedrine)
• Epinephrine
• estrogens
• Everolimus
• glucagon
• growth hormone
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Lanreotide
• Linezolid
• Liraglutide
• MAO inhibitors (e.g., Phenelzine, Tranylcypromine)
• mifepristone
• Niacin
• Octreotide
• oral medications for diabetes (e.g., Gliclazide, Glyburide, Pioglitazone, Rosiglitazone)
• Phenytoin
• Progesterone
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin)
• salicylates (e.g., Asa) in daily doses greater than 1.5 g
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Duloxetine, Fluoxetine, Paroxetine, Sertraline)
• Sirolimus
• Somatropin
• sulfa antibiotics (e.g., sulfamethoxazole, sulfadiazine)
• Tacrolimus
• testosterone
• thyroid replacement therapy (if beginning or changing dose)
• Triptorelin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Lantus (Insulin-glargine-long-acting). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Lantus (Insulin-glargine-long-acting).

Allergic reactions: If you notice signs of a serious allergic reaction (swelling of the face or throat, difficulty breathing, wheezing, or itchy skin rash), stop using the medication and seek immediate medical attention.

Appearance of insulin: The contents of the vial of insulin glargine should be clear and colourless. Do not use Lantus (Insulin-glargine-long-acting) if you notice anything unusual about its appearance, such as cloudiness, discoloration, or clumping.

Blood glucose monitoring: It is important for anyone using insulin to monitor their blood glucose levels regularly, as recommended by their doctor or diabetes educator. It is especially important to test blood glucose more often when your insulin dose or schedule changes, or when you are ill or under stress. If blood tests consistently show high or low blood glucose levels, contact your doctor or diabetes educator.

Changes at injection site: Fatty tissue under the skin at the injection site may shrink or thicken if you inject yourself too often at the same site. To help avoid this effect, change the site with each injection. Talk to your doctor or diabetes educator if you notice your skin pitting or thickening at the injection site.

Changes in insulin requirements: Many things can affect blood glucose levels and insulin requirements. These include:

• certain medical conditions (e.g., infections, Thyroid conditions, or kidney or liver disease)
• certain medications that increase or decrease blood glucose levels
• diet
• exercise
• illness
• injury
• stress
• surgery
• travelling over time zones

It is important your doctor know your current health situation and any changes that may affect the amount of insulin you need. Blood glucose should be monitored regularly as recommended by your doctor or diabetes educator.

Diabetes identification: It is important to either wear a bracelet (or necklace) or carry a card indicating you have diabetes and are taking insulin.

Family and friends: Educate your family and friends about the signs and symptoms of hypoglycemia (low blood glucose). Keep a Glucagon kit available and instruct them on its proper use in case you experience severe low blood glucose and you lose consciousness.

High blood glucose (hyperglycemia): Hyperglycemia may occur if your insulin dose is too low or you miss a dose of insulin. Symptoms of hyperglycemia generally build up over hours or days. If you experience symptoms of hyperglycemia, such as increased need to urinate, nausea, vomiting, drowsiness, Dry Mouth, flushed dry skin, loss of appetite, and a fruity odour to your breath, contact your doctor or diabetes educator immediately.

If hyperglycemia is allowed to continue, a condition known as diabetic ketoacidosis may occur. In this condition, your body starts to use body fat as fuel, eventually leading to a large concentration of acid in the blood stream. This can result in unconsciousness, coma, or death. To prevent this from occurring, you may need to have your insulin dose adjusted.

Kidney function: Kidney Disease or reduced kidney function may change the amount of insulin needed by the body. If you have kidney problems, discuss with your doctor how Lantus (Insulin-glargine-long-acting) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lantus (Insulin-glargine-long-acting), and whether any special monitoring is needed. Your doctor may want to test your kidney function regularly with blood tests while you are taking Lantus (Insulin-glargine-long-acting).

Liver function: Liver disease or reduced liver function may change the amount of insulin needed by the body. If you have liver problems, discuss with your doctor how Lantus (Insulin-glargine-long-acting) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lantus (Insulin-glargine-long-acting), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Lantus (Insulin-glargine-long-acting).

Low blood glucose (hypoglycemia): Hypoglycemia may occur if too much insulin is used, if meals are missed, or if you exercise more than usual. Symptoms of mild to moderate hypoglycemia may occur suddenly and can include cold sweat, nervousness or shakiness, fast heartbeat, headache, hunger, confusion, lightheadedness, weakness, and numbness or tingling (tongue, lips, or fingers). Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. People taking insulin should always carry a quick source of sugar, such as hard candies, glucose tablets, juice, or regular soft drinks (not diet soft drinks).

Signs of severe hypoglycemia can include disorientation, loss of consciousness, and seizures. People who are unable to take sugar by mouth or who are unconscious may require an injection of glucagon or treatment with intravenous (into the vein) glucose.

Pregnancy: It is essential to maintain good blood glucose control throughout pregnancy. Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters. Therefore, contact your doctor if you are pregnant or are thinking about pregnancy.

Breast-feeding: It is not known if insulin glargine passes into breast milk. If you are a breast-feeding mother and are using Lantus (Insulin-glargine-long-acting), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. Breast-feeding mothers may require adjustments in insulin dose or diet.

Children: The safety and effectiveness of using Lantus (Insulin-glargine-long-acting) have not been established for children under 6 years of age.

Seniors: The signs and symptoms of hypoglycemia may be more difficult to recognize in seniors.