Tresiba Flex Touch 100iu/1ml 5 Pens 3ml

Description

Tresiba® is a long-acting basal insulin called insulin degludec. It is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Tresiba® helps your body reduce your blood sugar level. It is used for once-daily dosing. On occasions when you cannot follow your regular dosing schedule, you can change the time of dosing because Tresiba® has a long blood sugar-lowering effect. Tresiba® can be used with meal-related rapid-acting insulin products. In type 2 diabetes mellitus, Tresiba® may be used in combination with tablets for diabetes or with injectable antidiabetic products other than insulin. In type 1 diabetes mellitus, Tresiba® must always be used in combination with meal-related rapid-acting insulin products. How to use Flexibility in dosing time Always follow your doctor’s recommendation for dose. Use Tresiba® once each day, preferably at the same time every day. On occasions when it is not possible to take Tresiba® at the same time of the day, it can be taken at a different time of day. Make sure to have a minimum of 8 hours between the doses. There is no experience with flexibility in dosing time of Tresiba® in children and adolescents. If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin. How to inject Tresiba® is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle. The best places to inject are the front of your thighs, upper arms or the front of your waist (abdomen). Change the place within the area where you inject each day to reduce the risk of developing lumps and skin pitting. Always use a new needle for each injection. Re-use of needles may increase the risk of blocked needles leading to inaccurate dosing. Dispose of the needle safely after each use. Do not use a syringe to remove the solution from the pen to avoid dosing errors and potential overdose. Warnings and precautions Do not use Tresiba® If you are allergic to insulin degludec or any of the other ingredients of this medicine Warnings and precautions Talk to your doctor, pharmacist or nurse before using Tresiba®. Be especially aware of the following: Low blood sugar (hypoglycaemia) – if your blood sugar is too low, follow the guidance for low blood sugar High blood sugar (hyperglycaemia) – if your blood sugar is too high, follow the guidance for high blood sugar. Switching from other insulin products – the insulin dose may need to be changed if you switch from another type, brand or manufacturer of insulin. Talk to your doctor. Thiazolidinediones used together with insulin, see Thiazolidinediones below. Eye disorder – fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder. If you experience eye problems, talk to your doctor. Side Effects If you have a serious allergic reaction (seen rarely) to the insulin or any of the ingredients in Tresiba®, stop using Tresiba® and see a doctor straight away. The signs of a serious allergic reaction are: The local reactions spread to other parts of your body You suddenly feel unwell with sweating You start being sick (vomiting) You experience difficulty in breathing You experience rapid heartbeat or feeling dizzy. Other side effects include: Common (may affect up to 1 in 10 people) Local reactions: Local reactions at the place you inject yourself may occur. The signs may include: pain, redness, hives, swelling and itching. The reactions usually disappear after a few days. See your doctor if they do not disappear after a few weeks. Stop using Tresiba® and see a doctor straight away if the reactions become serious. For more information, see serious allergic reaction above. Storage Information Before first use Store in a refrigerator (2°C to 8°C). Keep away from the freezing element. Do not freeze. Keep the cap on the pen in order to protect it from light. After first opening or if carried as a spare You can carry your Tresiba® pre-filled pen (FlexTouch®) with you and keep it at room temperature (not above 30°C) or in a refrigerator (2°C to 8°C) for up to 8 weeks. Drug Interactions Listed below are the most common medicines which may affect your insulin treatment. Your blood sugar level may fall (hypoglycaemia) if you take: Other medicines for diabetes (oral and injectable) Sulfonamides Anabolic steroids Beta-blockers Acetylsalicylic acid (and other salicylates) Monoamine oxidase (mao) inhibitors Angiotensin converting enzyme (ace) inhibitors Your blood sugar level may rise (hyperglycaemia) if you take: Danazol Oral contraceptives Thyroid hormones Growth hormone Glucocorticoids such as ‘cortisone’ Sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline Ingredients The active substance is insulin degludec. The other ingredients are glycerol, metacresol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections. Specifications Tresiba® is presented as a clear and colourless solution for injection in a pre-filled pen.