Toujeo™Approved Leaflet

300 units/ml
Solution for injection in a pre-filled pen
Insulin glargine

WHAT TOUJEO IS AND WHAT IT IS USED FOR:
Toujeo contains insulin called “insulin glargine”. This is a modified insulin, very similar to human insulin. Toujeo contains 3 times more insulin in 1 ml than standard insulin, which contains 100 unit/ml. It is used to treat diabetes mellitus in adults ,adolescents and children from the age of 6 years. Diabetes mellitus is an illness where your body does not make enough insulin to control your blood sugar. Toujeo lowers your blood sugar steadily over a long period of time. It is used for once daily dosing. You can change the time of your injection if you need to. This is because this medicine lowers your blood sugar over a long period of time.

WHAT YOU NEED TO KNOW BEFORE YOU USE TOUJEO:

Contraindications: Do not use Toujeo: If you are allergic to insulin glargine or to any of the other ingredients of this medicine.

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before using Toujeo.

Follow closely the instructions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) and injection technique , as discussed with your doctor. Be especially aware of the following: Too low blood sugar (hypoglycaemia). If your blood sugar is too low, follow the guidance for hypoglycaemia. If you switch from another type, brand or manufacturer of insulin your insulin dose may need to be changed. Pioglitazone. Ensure to use the right insulin. Medication errors due to mix-up between insulins, particularly between long acting insulins have been reported. You must always check the insulin label before each injection to avoid mix-ups between Toujeo and other insulins. Never use a syringe to remove Toujeo from your SoloStar pre-filled pen. This is to avoid dosing errors and potential overdose which may lead to low blood sugar.

If you are blind or have poor eye sight, do not use the pre-filled pen without help. This is because you will not be able to read the dose window on the pen.

Get help from a person with good eye sight who is trained in using the pen. If you have poor eyesight.

Skin Changes at the injection site:

The injection site should be rotated to prevent skin changes such as lumps under the skin The insulin may not work very well if you inject into a lumpy area Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely and to adjust adjust your insulin or your other antidiabetic medications dose.

Illnesses and injuries:

IIn the following situations, the management of your diabetes may require extra care (for example, blood and urine tests): If you are ill or have a major injury. Your blood sugar level may increase (hyperglycaemia). If you are not eating enough. Your blood sugar level may become too low (hypoglycaemia). If you have “Type 1” diabetes and you have an illness or injury: Do not stop your insulin. Always tell people who are caring or treating you. that you have diabetes. Keep eating enough carbohydrates. Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to your insulin dose.

Travel:

Talk to your doctor before travelling. You may need to talk about

• If your type of insulin is available in the country you are visiting
• How to arrange the supply of insulin, needles and other Items
• How to correctly store your insulin while travelling
• The time you eat meals and use your insulin.
• The possible e ects of changing to different time zones
• Any health risks in the countries you will visit
• What you should do in an emergency situation if you feel unwell or become ill.

Children and adolescents:

This medicine should not be used in children under 6 years of age. This is because there is no experience with Toujeo in this age group.

Other medicines and Toujeo:

Your blood sugar level may fall (hypoglycaemia) if you take:

Any other medicine to treat diabetes. Disopyramide – for some heart problems. Fluoxetine – for depression . Sulfonamide antibiotics. Fibrates – for lowering high levels of blood fats. Monoamine oxidase inhibitors (MAOIs) – for depression. Angiotensin converting enzyme (ACE) inhibitors– for heart problems or high blood pressure . Medicines to relieve pain and lower fever, such as pentoxifylline, propoxyphene and salicylates (such as acetylsalicylic acid). Pentamidine – for some infections caused by parasites. This may cause too low blood sugar which is sometimes followed by too high blood sugar. Your blood sugar level may rise (hyperglycaemia) if you take: Corticosteroids such as cortisone – for in ammation. Danazol – for endometriosis . Diazoxide – for high blood pressure. Protease inhibitors – for HIV. Diuretics – for high blood pressure or  uid retention. Glucagon – for very low blood sugar. Isoniazid – for tuberculosis. Somatropin – a growth hormone. Thyroid hormones – for thyroid gland problems. Oestrogens and progestogens – such as in the contraceptive pill for birth control. Clozapine, olanzapine and phenothiazine derivatives – for mental health problems. Sympathomimetic medicines such as epinephrine (adrenaline)  salbutamol and terbutaline – for asthma. Your blood sugar level may either rise or fall if you take: Beta-blockers or clonidine – for high blood pressure. Lithium salts – for mental health problems. Beta-blockers Beta- blockers like other “Sympatholytic medicines ” )such as clonidine, guanethidine, reserpine – for high blood pressure) may make it harder to recognize warning signs of your blood sugar being too low (hypoglycaemia). It can even hide or stop the first signs that your blood sugar is too low. Pioglitazone used together with 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. if you experience signs of heart failure such as unusual shortness of breath, a rapid increase in weight or localized swelling (oedema). Inform your doctor as soon as possible. If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Toujeo.

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby ,ask your doctor for advice before using this medicine. Your insulin dose may need to be changed during pregnancy and after giving birth. For the health of your baby, it is particularly important to carefully control your diabetes and to prevent hypoglycaemia. If you are breast-feeding, talk to your doctor, as your insulin doses and your diet might need to be changed.