How Do You Know When Levemir Is Working

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Levemir FlexPen 100 units/ml solution for injection in pre-filled pen

Novo Nordisk Limited contact details

Active ingredient

insulin detemir

Legal Category

POM: Prescription only medicine

What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. Information technology is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large impress, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The production lawmaking(south) for this leaflet is: PLGB 04668/0368.

Levemir®

100 units/ml solution for injection in pre-filled pen

insulin detemir

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, nurse or pharmacist.
This medicine has been prescribed for you only. Do not laissez passer information technology on to others. It may harm them, even if their signs of disease are the same as yours.
If yous get whatever side effects, talk to your doctor, nurse or pharmacist. This includes any possible side furnishings not listed in this leaflet. Run into section iv.

1. What Levemir® is and what information technology is used for
2. What you need to know before yous use Levemir®
3. How to utilise Levemir®
iv. Possible side furnishings
five. How to store Levemir®
6. Contents of the pack and other information

Levemir® is a mod insulin (insulin analogue) with a long-acting consequence. Modern insulin products are improved versions of human insulin.

Levemir® is used to reduce the high blood carbohydrate level in adults, adolescents and children anile 1 twelvemonth and above with diabetes mellitus (diabetes). Diabetes is a affliction where your torso does not produce plenty insulin to control the level of your blood saccharide.

Levemir® can be used with meal-related rapid acting insulin medicines.

In handling of type 2 diabetes mellitus, Levemir® may besides be used in combination with tablets for diabetes and/or with injectable anti-diabetic products, other than insulin.

Levemir® has a long and steady claret-saccharide-lowering action inside three to iv hours after injection.

Levemir® provides up to 24 hours of basal insulin coverage.

If you lot are allergic to insulin detemir or any of the other ingredients in this medicine, run into section half-dozen, Contents of the pack and other data.
If you suspect hypoglycaemia (low blood sugar) is starting, come across a) Summary of serious and very common side effects in section iv.
In insulin infusion pumps.
If FlexPen® is dropped, damaged or crushed.
If it has non been stored correctly or been frozen, run into section 5, How to store Levemir®.
If the insulin does non appear water clear, colourless and aqueous.

If any of these applies, do not use Levemir®. Talk to your doctor, nurse or pharmacist for advice.

Check the label to make certain information technology is the correct type of insulin.
E'er utilise a new needle for each injection to foreclose contamination.
Needles and Levemir® FlexPen® must not be shared.
Levemir® FlexPen® is only suitable for injecting under the skin. Speak to your medico if you need to inject your insulin by another method.

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you accept problem with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
If you exercise more than usual or if yous desire to change your usual diet, as this may affect your claret carbohydrate level.
If you are ill, behave on taking your insulin and consult your doctor.
If you are going abroad, travelling over fourth dimension zones may affect your insulin needs and the timing of your injections.
If yous accept very low albumin you need to carefully monitor your claret carbohydrate level. Discuss this with your doc.

The injection site should exist rotated to assist prevent changes to the fat tissue under the skin, such as skin thickening, pare shrinking or lumps under the skin. The insulin may not piece of work very well if yous inject into a lumpy, shrunken or thickened expanse (see section three, How to utilise Levemir®). Tell your doctor if you find any skin changes at the injection site. Tell your dr. if you are currently injecting into these afflicted areas before you outset injecting in a unlike expanse. Your doctor may tell y'all to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Levemir® tin can exist used in adolescents and children anile ane year and to a higher place.

The rubber and efficacy of Levemir® in children below one year of historic period have not been established.

No data are available.

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. Listed beneath are the most common medicines which may touch on your insulin treatment.

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

Other medicines for the treatment of diabetes
Monoamine oxidase inhibitors (MAOI) (used to care for depression)
Beta-blockers (used to treat high blood pressure)
Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart weather or loftier blood pressure)
Salicylates (used to relieve pain and lower fever)
Anabolic steroids (such as testosterone)
Sulphonamides (used to treat infections).

Your blood sugar level may rise (hyperglycaemia) if you take:

Oral contraceptives (birth command pills)
Thiazides (used to care for loftier blood pressure or excessive fluid retention)
Glucocorticoids (such as 'cortisone' used to treat inflammation)
Thyroid hormones (used to care for thyroid gland disorders)
Sympathomimetics (such equally epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body's metabolic processes)
Danazol (medicine acting on ovulation).

Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-anile adults, caused by the pituitary gland producing backlog growth hormone) may either increase or decrease your blood saccharide level.

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the start alarm symptoms which help y'all to recognise low blood sugar.

Pioglitazone (tablets used for the handling of type ii diabetes)

Some patients with long-standing type 2 diabetes and heart affliction or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as presently every bit possible if you experience signs of middle failure such as unusual shortness of breath or rapid increment in weight or localised swelling (oedema).

If you lot have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

If you drinkable alcohol, your demand for insulin may change every bit your claret saccharide level may either ascent or fall. Conscientious monitoring is recommended.

If you are pregnant, think y'all may be pregnant or are planning to have a infant, inquire your doctor for communication before taking this medicine. Your insulin dose may demand to be inverse during pregnancy and subsequently delivery. Careful command of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.
If you are breast-feeding consult your doctor every bit you may require adjustments in your insulin doses.

Inquire your doctor, nurse or pharmacist for advice earlier taking any medicine while pregnant or breast-feeding.

Delight enquire your md whether you lot can drive a car or operate a car:
- If you have frequent hypoglycaemia.
- If you find information technology hard to recognise hypoglycaemia.

If your claret sugar is depression or high, information technology might bear on your concentration and ability to react and therefore too your ability to drive a car or operate a machine. Conduct in mind that y'all could endanger yourself or others.

Levemir® contains less than 1 mmol sodium (23 mg) per dose, i.e. Levemir® is substantially 'sodium-complimentary'.

Ever employ your insulin and adapt your dose exactly as your doctor has told you lot. Check with your physician, nurse or chemist if you are non certain.

Levemir® can be used with meal-related rapid interim insulin medicines.

In treatment of type 2 diabetes mellitus, Levemir® may also be used in combination with tablets for diabetes and/or with injectable anti-diabetic products, other than insulin.

Practise non alter your insulin unless your doctor tells y'all to.

Your dose may have to be adjusted past your dr. if:

your doctor has switched you from ane type or brand of insulin to another, or
your doc has added another medicine for the treatment of diabetes, in addition to your Levemir® treatment.

Levemir® tin can be used in adolescents and children aged ane year and above.

In that location is no feel with the use of Levemir® in children beneath the age of 1 year.

If you have reduced kidney or liver function, or if you are higher up 65 years of historic period, you lot need to check your blood sugar more regularly and hash out changes in your insulin dose with your doctor.

When Levemir® is used in combination with tablets for diabetes and/or in combination with injectable anti-diabetic products, other than insulin, Levemir® should be administered once a 24-hour interval. When Levemir® is used as function of a basal-bolus insulin regimen Levemir® should be administered one time or twice daily depending on patients' needs. Dose of Levemir® should be adjusted individually. The injection can be given at any time during the day, but at the same time each mean solar day. For patients who require twice daily dosing to optimise claret sugar control, the evening dose tin be administered in the evening or at bedtime.

Levemir® is for injection under the skin (subcutaneously). You must never inject Levemir® direct into a vein (intravenously) or muscle (intramuscularly). Levemir® FlexPen® is only suitable for injecting under the pare. Speak to your doctor if you need to inject your insulin by another method.

With each injection, change the injection site within the item area of skin that you lot use. This may reduce the take a chance of developing lumps or peel pitting (see section four, Possible side effects). The best places to give yourself an injection are: the forepart of your thighs, the forepart of your waist (abdomen), or the upper arm. You should always measure your blood sugar regularly.

Levemir® FlexPen® is a pre-filled, colour-coded, disposable pen containing insulin detemir.

Read advisedly the instructions for use included in this package leaflet. You must use the pen as described in the Instructions for use.

Always ensure you use the correct pen earlier you inject your insulin.

If you take likewise much insulin your claret carbohydrate gets too low (hypoglycaemia). Run into a) Summary of serious and very common side effects in department four.

If you forget to accept your insulin your blood sugar may get besides high (hyperglycaemia). See c) Effects from diabetes in section 4.

Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. Come across c) Effects from diabetes in section 4.

If you have any farther questions on the use of this medicine, inquire your doctor or chemist.

Similar all medicines, this medicine tin cause side effects, although not everybody gets them.

Low claret saccharide (hypoglycaemia) is a very mutual side effect. It may touch on more 1 in 10 people.

Low blood sugar may occur if you:

Inject too much insulin.
Consume too little or miss a meal.
Exercise more than usual.
Drink booze (see department 2 Drinking booze and taking Levemir®).

Signs of low blood sugar: Common cold sweat; cool pale pare; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

Astringent low blood sugar tin pb to unconsciousness. If prolonged astringent low blood saccharide is non treated, it can cause brain damage (temporary or permanent) and even death. You may recover more than chop-chop from unconsciousness with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon you will need glucose or a sugar snack every bit soon as you are conscious. If y'all do not respond to glucagon treatment, yous will have to be treated in a hospital.

What to do if you experience depression blood carbohydrate:

If you experience low blood sugar, eat glucose tablets or another loftier saccharide snack (east.1000. sweets, biscuits, fruit juice). Measure out your blood sugar if possible and rest. E'er carry glucose tablets or high carbohydrate snacks with you, just in case.
When the symptoms of depression blood sugar accept disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual.
If you have such low blood sugar that makes yous pass out, if yous accept had the need for an injection of glucagon, or if y'all have experienced many incidents of depression blood carbohydrate, talk to a dr.. The amount or timing of insulin, food or exercise may demand to be adjusted.

Tell relevant people that you take diabetes and what the consequences may be, including the risk of passing out (becoming unconscious) due to low blood sugar. Permit them know that if you laissez passer out, they must turn yous on your side and get medical help straight away. They must not give you whatever food or drink considering you may asphyxiate.

Serious allergic reaction to Levemir® or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially exist life threatening. It may impact less than i in x,000 people.

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.
If you suddenly feel unwell, and you: start sweating; kickoff being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.

If you observe any of these signs, seek medical advice immediately.

Skin changes at the injection site: If you inject insulin at the aforementioned place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect less than ane in 100 people). Lumps nether the pare may also be acquired by build-up of a poly peptide chosen amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not piece of work very well if yous inject into a lumpy, shrunken or thickened expanse. Alter the injection site with each injection to help prevent these skin changes.

Uncommon side furnishings

May affect less than 1 in 100 people.

Signs of allergy: Local allergic reactions (hurting, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These commonly disappear after a few weeks of taking your insulin. If they do non disappear, or if they spread throughout your body, talk to your doctor immediately. See as well Serious allergic reaction above.

Vision bug: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, contact your md.

Diabetic retinopathy (an eye disease related to diabetes which can pb to loss of vision): If yous take diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may go worse. Ask your doctor about this.

Rare side furnishings

May impact less than 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nervus related hurting, this is called acute painful neuropathy and is usually transient.

If yous get any side effects, talk to your doctor, pharmacist or nurse. This includes whatever possible side furnishings non listed in this leaflet. Y'all can too report side effects directly via

United Kingdom

or search for MHRA Yellow Carte du jour in the Google Play or Apple App Shop

Republic of ireland

By reporting side effects you tin help provide more than information on the safety of this medicine.

Loftier claret sugar (hyperglycaemia)

High claret saccharide may occur if you:

Have non injected enough insulin.
Forget to take your insulin or stop taking insulin.
Repeatedly take less insulin than y'all need.
Get an infection and/or a fever.
Eat more than usual.
Practice less than usual.

Warning signs of loftier claret saccharide:

The warning signs announced gradually. They include: increased urination; feeling thirsty; losing your ambition; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a fruity (acetone) smell of the breath.

What to do if y'all experience high blood carbohydrate:

If yous get any of to a higher place signs: test your blood carbohydrate level, examination your urine for ketones if you can, then seek medical advice immediately.
These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). If y'all practice not treat it, this could lead to diabetic blackout and eventually death.

Keep this medicine out of the sight and achieve of children.

Exercise not use this medicine later the decease date which is stated on the FlexPen® characterization and carton later on 'EXP'. The expiry date refers to the last day of that month.

Always keep the pen cap on your FlexPen® when y'all are non using it in order to protect information technology from calorie-free.

Levemir® must exist protected from excessive heat and calorie-free.

Before opening: Levemir® FlexPen® that is not being used is to exist stored in the refrigerator at 2°C to 8°C, abroad from the cooling element. Do not freeze.

During employ or when carried every bit a spare: Y'all can carry your Levemir® FlexPen® with you lot and keep information technology at a temperature beneath 30°C or in a fridge (ii°C to 8°C) for up to 6 weeks. If refrigerated, go on away from the cooling chemical element. Do non freeze.

Practice non throw away whatever medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines y'all no longer use. These measures will help protect the environment.

The active substance is insulin detemir. Each ml contains 100 units of insulin detemir. Each pre-filled pen contains 300 units of insulin detemir in 3 ml solution for injection. i unit insulin detemir corresponds to 1 international unit of homo insulin.
The other ingredients are glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and h2o for injections.

Levemir® is presented as a solution for injection.

Pack sizes of 1 (with or without needles), v (without needles) and 10 (without needles) pre-filled pens of iii ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Kingdom of denmark

Manufacturer

The manufacturer tin be identified by the batch number printed on the slip of the carton and on the label:

If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is
Novo Nordisk A/Due south
Novo Allé
DK-2880 Bagsværd
Denmark
If the 2d and third characters are H7 or T6, the manufacturer is
Novo Nordisk Production SAS
45 Avenue d'Orléans
F-28000 Chartres
France

Now turn over for information on how to apply your FlexPen®.

This leaflet was last revised in 09/2020

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Levemir®, FlexPen®, NovoFine® and NovoTwist® are trademarks owned by Novo Nordisk A/S, Denmark

Novo Nordisk A/S

Read the following instructions advisedly earlier using your FlexPen®. If you practice not follow the instructions advisedly, you lot may get as well trivial or also much insulin, which can lead to besides high or too low claret carbohydrate level.

Your FlexPen® is a pre-filled punch-a-dose insulin pen. You can select doses from 1 to 60 units in increments of ane unit of measurement. FlexPen® is designed to be used with NovoFine® or NovoTwist® disposable needles up to a length of 8 mm. As a precautionary measure, always behave a spare insulin delivery device in case your FlexPen® in employ is lost or damaged.

Your FlexPen® must be handled with care.

If information technology is dropped, damaged or crushed, at that place is a take a chance of insulin leakage. This may cause inaccurate dosing, which can lead to too high or too low blood sugar level.

You can make clean the exterior of your FlexPen® by wiping it with a medicinal swab. Practice not soak it, launder or lubricate it as information technology may damage the pen.

Do non refill your FlexPen®.

Cheque the name and coloured label of your pen to brand certain that it contains the right type of insulin. This is specially important if you take more than one blazon of insulin. If you take the wrong type of insulin, your blood sugar level may go likewise high or as well low.

Pull off the pen cap.

Remove the newspaper tab from a new disposable needle.

Spiral the needle straight and tightly onto your FlexPen®.

Pull off the big outer needle cap and keep it for later.

Pull off the inner needle cap and dispose of it.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.

Be careful non to bend or damage the needle before use.

Prior to each injection small amounts of air may collect in the cartridge during normal utilize. To avert injection of air and ensure proper dosing:

Plow the dose selector to select 2 units.

Concur your FlexPen® with the needle pointing upwards and tap the cartridge gently with your finger a few times to brand any air bubbling collect at the tiptop of the cartridge.

Keeping the needle upwards, printing the push button-push all the way in. The dose selector returns to 0.

A drop of insulin should appear at the needle tip. If non, change the needle and repeat the procedure no more 6 times.

If a drop of insulin still does not appear, the pen is defective, and you must use a new ane.

Always make sure that a drop appears at the needle tip before you inject. This makes certain that the insulin flows. If no drib appears, y'all will not inject any insulin, fifty-fifty though the dose selector may move. This may point a blocked or damaged needle.

Always cheque the menstruation earlier you inject. If you do not check the flow, you may become besides picayune insulin or no insulin at all. This may lead to too loftier blood sugar level.

Cheque that the dose selector is prepare at 0.

Turn the dose selector to select the number of units you lot demand to inject.

The dose can exist corrected either up or down past turning the dose selector in either direction until the right dose lines up with the pointer. When turning the dose selector be conscientious not to push the button-button equally insulin volition come out.

You cannot select a dose larger than the number of units left in the cartridge.

Always utilize the dose selector and the pointer to see how many units you have selected before injecting the insulin.

Exercise not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may get too high or too depression. Do not use the balance scale, it only shows approximately how much insulin is left in your pen.

Insert the needle into your skin. Use the injection technique shown past your doctor or nurse.

Inject the dose past pressing the push button-button all the way in until 0 lines upwardly with the pointer. Exist careful only to push button the push-button when injecting.

Turning the dose selector will not inject insulin.

Keep the button-button fully depressed and let the needle remain under the peel for at least half dozen seconds. This will make certain you lot go the full dose.

Withdraw the needle from the peel and so release the pressure on the push-button.

Always brand sure that the dose selector returns to 0 later the injection. If the dose selector stops before it returns to 0, the full dose has non been delivered, which may result in too high blood sugar level.

1000

Pb the needle into the large outer needle cap without touching it. When the needle is covered, advisedly push the big outer needle cap completely on and then unscrew the needle.

Dispose of it carefully and put the pen cap back on your FlexPen®.

Always remove the needle later each injection and store your FlexPen® without the needle fastened. This reduces the risk of contagion, infection, leakage of insulin, blocked needles and inaccurate dosing.

Caregivers must exist very careful when treatment used needles – to reduce the risk of needle sticks and cross-infection.

Dispose of your used FlexPen® carefully without the needle attached.

Never share your pen or your needles with other people. It might lead to cross-infection.

Never share your pen with other people. Your medicine might be harmful to their health.

Always keep your pen and needles out of sight and reach of others, especially children.

Levemir FlexPen PIL UK/IE

Company contact details

Novo Nordisk Limited

Address

3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA

Telephone

+44 (0)1293 613555

Medical Information Direct Line

+44 (0)800 023 2573

Customer Intendance directly line

+44 (0)800 023 2573

Www

Fax

+44 (0)1293 613535

Medical Information email

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Source: https://www.medicines.org.uk/emc/product/5536/pil

Pritchett Prilese