SE MGLEE 100 UNITS/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN - patient leaflet, side effects, dosage

Package leaflet: Information for the user

insulin glargine

Th This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist.This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Semglee is and what it is used for

• 2. What you need to know before you use Semglee

• 3. How to use Semglee

• 4. Possible side effects

• 5. How to store Semglee

• 6. Contents of the pack and other information

1. what semglee is and what it is used for

Semglee contains insulin glargine.This is a modified insulin, very similar to human insulin.

Semglee is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action.

2. what you need to know before you use semglee

Do not use Semglee

• – if you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

Semglee in pre-filled pen is only suitable for injecting just under the skin (see also section 3). Speak to your doctor if you need to inject your insulin by another method.

alk to your doctor, pharmacist or nurse before using Semglee.

Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor.

Skin changes at the injection site:

he 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 (see How to use Semglee). 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 your insulin or your other antidiabetic medications dose.

If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).

Travel

Before travelling consult your doctor. You may need to talk about

• – the availability of your insulin in the country you are visiting,

• – supplies of insulin, needles etc.,

• – correct storage of your insulin while travelling,

• – timing of meals and insulin administration while travelling,

• – the possible effects of changing to different time zones,

• – possible new health risks in the countries to be visited,

• – what you should do in emergency situations when you feel unwell or become ill.

Illnesses and injuries

In the following situations, the management of your diabetes may require a lot of care (for example, adjustment to insulin dose, blood and urine tests):

• – If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).

• – If you are not eating enough your blood sugar level may become too low (hypoglycaemia).

In most cases you will need a doctor. Make sure that you contact a doctor early.

If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates. Always tell people who are caring for you or treating you that you require insulin.

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.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone (oral anti-diabetic medicine used to treat type 2 diabetes mellitus) and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Children

There is no experience with the use of Semglee in children below the age of 2 years.

Other medicines and Semglee

Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation). In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that are either too low or too high. Be careful 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 a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.

Medicines that may cause your blood sugar level to fall (hypoglycaemia) include:

• – all other medicines to treat diabetes,

• – angiotensin converting enzyme (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 lipids),

• – monoamine oxidase (MAO) inhibitors (used to treat depression),

• – pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and

lower fever),

• – sulfonamide antibiotics.

Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:

• – corticosteroids (such as „cortisone“ used to treat inflammation),

• – danazol (medicine acting on ovulation),

• – diazoxide (used to treat high blood pressure),

• – diuretics (used to treat high blood pressure or excessive fluid retention),

• – glucagon (pancreas hormone used to treat severe hypoglycaemia),

• – isoniazid (used to treat tuberculosis),

• – oestrogens and progestogens (such as in the contraceptive pill used for birth control),

• – phenothiazine derivatives (used to treat psychiatric disorders),

• – somatropin (growth hormone),

• – sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to

treat asthma),

• – thyroid hormones (used to treat thyroid gland disorders),

• – atypical antipsychotic medicines (such as clozapine, olanzapine),

• – protease inhibitors (used to treat HIV).

Your blood sugar level may either rise or fall if you take:

• – beta-blockers (used to treat high blood pressure),

• – clonidine (used to treat high blood pressure),

• – lithium salts (used to treat psychiatric disorders).

Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.

Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.

If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.

Semglee with alcohol

Your blood sugar levels may either rise or fall if you drink alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your insulin dose may need to be changed during pregnancy and after giving birth. Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.

If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.

Driving and using machines

Your ability to concentrate or react may be reduced if:

• – you have hypoglycaemia (low blood sugar levels),

• – you have hyperglycaemia (high blood sugar levels),

you have problems with your sight.

Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines). You should contact your doctor for advice on driving if: – you have frequent episodes of hypoglycaemia,

• – the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.

Semglee contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free’.

3. how to use semglee

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Although Semglee contains the same active substance as insulin glargine 300 units/ml, these medicines are not interchangeable. The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring. Please, consult your doctor for further information.

Dose

Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will

• – determine how much Semglee per day you will need and at what time,

• – tell you when to check your blood sugar level, and whether you need to carry out urine tests,

• – tell you when you may need to inject a higher or lower dose of Semglee.

Semglee is a long-acting insulin. Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.

Many factors may influence your blood sugar level. You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low. See the box at the end of this leaflet for further information.

Use in children and adolescents

Semglee can be used in adolescents and children aged 2 years and above. Use this medicine exactly as your doctor has told you.

Frequency of administration

You need one injection of Semglee every day, at the same time of the day.

Semglee pen delivers insulin in increments of 1 unit up to a maximum single dose of 80 units.

Method of administration

Semglee is injected under the skin. Do NOT inject Semglee in a vein, since this will change its action and may cause hypoglycaemia.

Your doctor will show you in which area of the skin you should inject Semglee. With each injection, change the puncture site within the particular area of skin that you are using.

How to handle Semglee pen

Semglee in pre-filled pen is only suitable for injecting just under the skin. Speak to your doctor if you need to inject your insulin by another method.

Read carefully the "Instructions for Use" included in this package leaflet. You must use the pen as described in these Instructions for Use.

A new needle must be attached before each use. Only use needles that are compatible with Semglee pen (see “Instructions for Use”).

A safety test must be performed before each injection.

Look at the cartridge before you use the pen. Do not use Semglee if you notice particles in the solution. Only use Semglee if the solution is clear and colourless. Do not shake or mix it before use.

To prevent the possible transmission of disease, never share your pen with anyone else. This pen is only for your use.

Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. If you think you may have a problem with Semglee pen, consult your doctor, pharmacist or nurse.

Empty pens must not be re-filled and must be properly discarded.

Do not use Semglee pen if it is damaged or not working properly (due to mechanical defects), it has to be discarded and a new Semglee pen has to be used.

Insulin mix-ups

You must always check the insulin label before each injection to avoid mix-ups between Semglee and other insulins.

If you use more Semglee than you should

If you have injected too much Semglee , your blood sugar level may become too low (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, see box at the end of this leaflet.

If you forget to use Semglee

If you have missed a dose of Semglee or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see box at the end of this leaflet.

Do not take a double dose to make up for a forgotten dose.

If you stop using Semglee

This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop Semglee without speaking to a doctor, who will tell you what needs to be done.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straight away (see the box at the end of this leaflet). Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (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 falls too low you may pass out (become unconscious). Serious hypoglycaemia may cause brain damage and may be life-threatening. For more information, see the box at the end of this leaflet.

Severe allergic reactions (rare, may affect up to 1 in 1,000 people) – the signs may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. Severe allergic reactions to insulins may become life-threatening. Tell a doctor straight away if you notice signs of severe allergic reaction.

Skin changes at the injection site

If you inject insulin too often at the same place, the fatty tissue may either shrink (lipoatrophy; may affect up to 1 in 100 people) or thicken (lipohypertrophy; may affect up to 1 in 10 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes.

Common reported side effects (may affect up to 1 in 10 people)

• Skin and allergic reactions at the injection site

The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear in a few days to a few weeks.

Rare reported side effect (may affect up to 1 in 1,000 people)

• Eye reactions

A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.

• General disorders

In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling in the calves and ankles.

Very rare reported side effects (may affect up to 1 in 10,000 people)

In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.

Use in children and adolescents

In general, the side effects in children and adolescents of 18 years of age or less are similar to those seen in adults.

Complaints of injection site reactions (injection site reaction, injection site pain) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults.

There is no experience in children under 2 years.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

United Kingdom

Yellow Card Scheme

Website:

Or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. how to store semglee

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 on the label of the pen after “EXP”. The expiry date refers to the last day of that month.

Not in-use pens

Store in a refrigerator (2°C-8°C). Do not freeze or place next to the freezer compartment of your refrigerator or a freezer pack.

Keep the pre-filled pen in the outer carton in order to protect from light.

In-use pens

Pre-filled pens in use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C and away from direct heat or direct light. Do not use it after this time period. The pen in use must not be stored in a refrigerator.

The pen cap must be put back on the pen after each injection in order to protect from light.

Remove the needle after the injection and store the pen without the needle. Also, be sure to remove the needle before disposing of the pen. Needles must not be re-used.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Semglee contains

• – The active substance is insulin glargine. Each ml of the solution contains 100 units of insulin

glargine (equivalent to 3.64 mg).

• – The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (for pH

adjustment) (see section 2 “Semglee contains sodium”), hydrochloric acid (for pH adjustment) and water for injections.

What Semglee looks like and contents of the pack

Semglee 100 units/ml solution for injection in a pre-filled pen is a clear colourless solution.

Each pen contains 3 ml of solution for injection (equivalent to 300 units).

Semglee is available in pack sizes of 1, 3, 5, 10 pens and in a multipack compromising of 2 cartons, each containing 5 pens.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Products Ltd

Station Close

Potters Bar

Hertfordshire,

EN6 1TL, UK

Manufacturer

McDermott Laboratories T/A Mylan Dublin Biologics

Newenham Court, Northern Cross, Malahide Road

17 Dublin

Ireland

This leaflet was last revised in May 2021.

HYPERGLYCAEMIA AND HYPOGLYCAEMIA

Always carry some sugar (at least 20 grams) with you. Carry some information with you to show you are diabetic.

HYPERGLYCAEMIA (high blood sugar levels)

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.

Why does hyperglycaemia occur?

Examples include:

• – you have not injected your insulin or not injected enough, or if it has become less effective, for example

through incorrect storage,

• – your insulin pen does not work properly,

• – you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have

an injury, operation, infection or fever,

• – you are taking or have taken certain other medicines (see section 2, „Other medicines and Semglee“).

Warning symptoms of hyperglycaemia

Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, and glucose and ketone bodies in urine. Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.

What should you do if you experience hyperglycaemia?

Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.

HYPOGLYCAEMIA (low blood sugar levels)

If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.

Why does hypoglycaemia occur?

Examples include:

• – you inject too much insulin,

• – you miss meals or delay them,

• – you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances

similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),

• – you lose carbohydrates due to vomiting or diarrhoea,

• – you drink alcohol, particularly if you are not eating much,

• – you are doing more exercise than usual or a different type of physical activity,

• – you are recovering from an injury or operation or other stress,

• – you are recovering from an illness or from fever,

• – you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and

Semglee").

Hypoglycaemia is also more likely to occur if

• – you have just begun insulin treatment or changed to another insulin preparation (when changing from your previous basal insulin to Semglee hypoglycaemia, if it occurs, may be more likely to occur in the morning than at night),

• – your blood sugar levels are almost normal or are unstable,

• – you change the area of skin where you inject insulin (for example from the thigh to the upper arm),

• – you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.

Warning symptoms of hypoglycaemia

– In your body

Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain.

• – In your brain

Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.

The first symptoms which alert you to hypoglycaemia („warning symptoms“) may change, be weaker or may be missing altogether if

• – you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of nervous

disease (diabetic autonomic neuropathy),

• – you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly,

• – you have almost normal or, at least, greatly improved blood sugar levels,

• – you have recently changed from an animal insulin to a human insulin such as Semglee,

• – you are taking or have taken certain other medicines (see section 2, „Other medicines and Semglee“).

In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the problem. Be familiar with your warning symptoms. If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked. If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.

What should you do if you experience hypoglycaemia?

• 1. Do not inject insulin. Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a

sugar-sweetened beverage. Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.

• 2. Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta).

Your doctor or nurse should have discussed this with you previously.

The recovery of hypoglycaemia may be delayed because Semglee has a long action.

• 3. If the hypoglycaemia comes back again take another 10 to 20 g sugar.

• 4. Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.