What it is and what it is used for

for

Semglee with alcohol

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

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

Semglee is used to treat diabetes mellitus in adults,

Pregnancy and breast-feeding

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.

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

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

produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action.

What you need to know before you take it

e 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.

Talk 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: 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 (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.

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'.

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

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

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

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

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.

these Instructions for Use,

Tell your doctor or pharmacist if you are taking, have

A new needle must be attached before each use. Only

recently taken or might take any other medicines. Before

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

use needles that are compatible with Semglee pen (see

taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.

"Instructions for Use"), A safety test must be performed before each injection.

Medicines that may cause your blood sugar level to fall

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.

(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.

99 |Gwas

[w/s}un QOL

• diuretics (used to treat high blood pressure or excessive fluid retention),
• glucagon (pancreas hormone used to treat severe

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).

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.

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.

¢ Skin and allergic reactions at the injection site

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.

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").

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.

• Inyour brain Examples of symptoms that indicate a low sugar level in

Reporting of side effects

the brain: headaches, intense hunger, nausea, vomiting,

If you get any side effects, talk to your doctor or

tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired

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: www.mhra.gov.uk/yellowcard 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.

How to take it

Semglee

DO9 C6X8

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom (Northern Ireland) Biosimilars Newco Limited Tel: 0080008250910

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

Diabetes mellitus is a disease where your body does not

Dublin

insulins.

If you are not sure whether you are taking one of those

as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help

Block B, The Crescent Building, Santry Demesne

Ireland

you to recognise a hypoglycaemia.

Beta-blockers like other sympatholytic medicines (such

D13 R20R

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

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.

adolescents and children aged 2 years and above.

woqoaup Bupeas 'poseuieud

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

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.

It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.

gS Biocon Biologics

Possible side effects

5. How to store Semglee 6. Contents of the pack and other information

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

Marketing Authorisation Holder Biosimilar Collaborations Ireland Limited

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.

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 DUBLIN

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

Ireland

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.

Manufacturer Biosimilar Collaborations Ireland Limited

Insulin mix-ups

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

medicines ask your doctor or pharmacist.

If you stop using Semglee

How to store it

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

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

to the freezer compartment of your refrigerator or a freezer pack. Keep the pre-filled pen in the outer carton in order to

(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.

protect from light.

Be familiar with your warning symptoms. If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be

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

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.

injection in order to protect from light.

What should you do if you experience hypoglycaemia?

Remove the needle after the injection and store the pen without the needle. Also, be sure to remove the needle

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. Tell your relatives, friends and close colleagues the following: If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar). These injections are justified even if it is not certain that you have hypoglycaemia.

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.

• 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

Zanes 99 |Gwas ®

• thyroid hormones (used to treat thyroid gland disorders),
• atypical antipsychotic medicines (such as clozapine, olanzapine),
• protease inhibitors (used to treat HIV).

reactions (rash and itching all over the body), severe

What Semglee contains

• somatropin (growth hormone),
• sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma),

Severe allergic reactions (rare, may affect up to 1 in 1,000 people) – the signs may include large-scale skin

Contents of the pack and other information

10/66900448

phenothiazine derivatives (used to treat psychiatric disorders),

end of this leaflet.

®

• danazol (medicine acting on ovulation),
• diazoxide (used to treat high blood pressure),

–

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

period. The pen in use must not be stored in a refrigerator. The pen cap must be put back on the pen after each

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

• corticosteroids (such as "cortisone" used to treat inflammation),

hypoglycaemia),

• isoniazid (used to treat tuberculosis),
• oestrogens and progestogens (such as in the contraceptive pill used for birth control),

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

when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions

Frequency of administration

as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or

(hypoglycaemia), take action to increase your blood sugar

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

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.

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

If you notice signs of your blood sugar being too low

The signs may include reddening, unusually intense pain

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.

HYPOGLYCAEMIA

Thirst, increased need to urinate, tiredness, dry skin,

Dose

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.

AND

Warning symptoms of hyperglycaemia

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

• 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.

HYPERGLYCAEMIA

Like all medicines, this medicine can cause side effects,

and blood glucose monitoring. Please, consult your doctor for further information,

at what time,

This leaflet was last revised in June 2024

although not everybody gets them.

tissue may either shrink (lipoatrophy; may affect up to 1 in

Always use this medicine exactly as your doctor has told you.

Use in children and adolescents

and heart disease or previous stroke who were treated

elo)

If you inject insulin too often at the same place, the fatty

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.

Some patients with long-standing type 2 diabetes mellitus

Ce ool

Skin changes at the injection site