Patient leaflet - Lobezyl 6 mg/ml solution for injection in Pre-filled pen

1. What Lobezyl is and what it is used for What Lobezyl is

Lobezyl is a weight loss medicine that contains the active substance liraglutide. It is similar to a natural occurring hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal. Lobezyl works by acting on receptors in the brain that control your appetite, causing you to feel fuller and less hungry. This may help you eat less food and reduce your body weight.

What Lobezyl is used for

Lobezyl is used for weight loss in addition to diet and exercise in adults aged 18 and above who have

a BMI of 30 kg/m² or greater (obesity) or
a BMI of 27 kg/m² and less than 30 kg/m² (overweight) and weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood or breathing problems during sleep called ‘obstructive sleep apnoea’).

BMI (Body Mass Index) is a measure of your weight in relation to your height.

You should only continue using Lobezyl if you have lost at least 5% of your initial body weight after 12 weeks on the 3.0 mg/day dose (see section 3). Consult your doctor before you continue.

Lobezyl can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescents from the age of 12 years and above who have:

obesity (diagnosed by your doctor)
body weight above 60 kg

You should only continue using Lobezyl if you have lost at least 4% of your BMI after 12 weeks on the 3.0 mg/day dose or maximum tolerated dose (see section 3). Consult your doctor before you continue.

Diet and exercise

Your doctor will start you on a diet and exercise programme. Stay on this programme while you are using Lobezyl.

2. What you need to know before you use Lobezyl

Do not use Lobezyl

if you are allergic to liraglutide or any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using liraglutide:

The use of Lobezyl is not recommended if you have severe heart failure.

There is little experience with this medicine in patients of 75 years and older. It is not recommended if you are 75 years or older.

There is little experience with this medicine in patients with kidney problems. If you have kidney disease or are on dialysis, consult your doctor.

There is little experience with this medicine in patients with liver problems. If you have liver problems, consult your doctor.

This medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease.

If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are taking Lobezyl.

People with diabetes

If you have diabetes, do not use Lobezyl as a replacement for insulin.

If you have ever had pancreatitis (inflammation of the pancreas which
may cause severe pain in the stomach and back which does not go away; see section 4).

Inflamed gall bladder and gallstones

If you lose substantial weight, you are at a risk of gallstones and thereby inflamed gall bladder. Stop taking Lobezyl and contact a doctor immediately if you experience severe pain in your upper abdomen, usually worst on the right side under the ribs. The pain may be felt through to your back or right shoulder. See section 4.

Thyroid disease

If you have thyroid disease, including thyroid nodules and enlargement of the thyroid gland, consult your doctor.

Heart rate

Talk to your doctor if you have palpitations (you feel aware of your heartbeat) or if you have feelings of a racing heartbeat while at rest during Lobezyl treatment.

Loss of fluid and dehydration

When starting treatment with Lobezyl, you may lose body fluid or become dehydrated. This may be due to feeling sick (nausea), being sick (vomiting) and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids. Talk to your doctor, pharmacist or nurse if you have any questions or concerns. See section 4.

Children and adolescents

The safety and efficacy of Lobezyl in children below 12 years of age has not been studied.

Other medicines and Lobezyl

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

In particular, tell your doctor, pharmacist or nurse if:

you are taking medicines for diabetes called ‘sulfonylurea’ (such as
glimepiride or glibenclamide) or if you are taking insulin – you may get low blood sugar (hypoglycaemia) when you use these medicines with Lobezyl. Your doctor may adjust the dose of your diabetes medicine to prevent you from getting low blood sugar. See section 4 for the warning signs of low blood sugar. If you adjust your insulin dose your doctor may recommend you to monitor your blood sugar more frequently.
you are taking warfarin or other medicines by mouth that reduce
your blood clotting (anticoagulants). More frequent blood testing to determine the ability of your blood to clot may be required.

Pregnancy and breast-feeding

Do not use Lobezyl if you are pregnant, think that you might be pregnant or are planning to have a baby. This is because it is not known if Lobezyl may affect the baby.

Do not breast-feed if you are using Lobezyl. This is because it is not known if liraglutide passes into breast milk.

Driving and using machines

Lobezyl is unlikely to affect your ability to drive and use machines. Some patients may feel dizziness when taking Lobezyl mainly during the first 3 months of treatment (see section ‘Possible side effects’). If you feel dizziness be extra careful while driving or using machines. If you need any further information, talk to your doctor.

Important information about some of the ingredients of Lobezyl

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

This medicine contains 42 mg propylene glycol in each 3 ml pre-filled multidose pen which is equivalent to 14 mg/ml.

If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

3. How to use Lobezyl

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

Your doctor will start you on a diet and exercise programme. Stay on this programme while you are using Lobezyl.

How much to inject

Adults

Your treatment will start at a low dose which will be gradually increased over the first five weeks of treatment.

When you first start using Lobezyl, the starting dose is 0.6 mg once a
day, for at least one week.
Your doctor will instruct you to gradually increase your dose by 0.6 mg
usually each week until you reach the recommended dose of 3.0 mg once a day.
Your doctor will tell you how much Lobezyl to use each week. Usually, you will be told to follow the table below.
Week Dose injected
Week 1 0.6 mg once a day
Week 2 1.2 mg once a day
Week 3 1.8 mg once a day
Week 4 2.4 mg once a day
Week 5 onwards 3.0 mg once a day
Once you reach the recommended dose of 3.0 mg in week 5 of treatment, keep using this dose until your treatment period ends. Do not increase your dose further.
Your doctor will assess your treatment on a regular basis.
Adolescents (≥ 12 years)
For adolescents from the age of 12 to below 18 years old a similar dose escalation schedule as for adults should be applied (see above table for adults). The dose should be increased until 3.0 mg (maintenance dose) or maximum tolerated dose has been reached. Daily doses higher than 3.0 mg are not recommended.
How and when to use Lobezyl
- Before you use the pen for the first time, your doctor or nurse will show you how to use the pen.
- You can use Lobezyl at any time of the day, with or without food and drink.
- Use Lobezyl at about the same time each day – choose a time of the day that works best for you.

Where to inject

Lobezyl is given as an injection under the skin (subcutaneous injection).

The best places to inject are the front of your waist (abdomen), the front of your thighs or your upper arm.
Change the place where you inject each day to reduce the risk of developing lumps.
Do not inject into a vein or muscle.

Injection needles are not included with the pen. For example, BD Ultra-Fine^TMdisposable needles or NovoFine^®disposable needles as thin as 32 G and length up to 8 mm can be used.

Detailed instructions for use are provided on the other side of this leaflet.

People with diabetes

Tell your doctor if you have diabetes. Your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar.

Do not mix Lobezyl up with other medicines that you inject (e.g.
insulins).
Do not use Lobezyl in combination with other medicines that contain
GLP-1 receptor agonists (such as exenatide or lixisenatide).

If you use more Lobezyl than you should

If you use more Lobezyl than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. You may need medical treatment. The following effects may happen:

feeling sick (nausea)
being sick (vomiting)
low blood sugar (hypoglycaemia). Please refer to ‘Common side effects’ for warning signs of low blood sugar.

If you forget to use Lobezyl

If you forget a dose and remember it within 12 hours from when you usually use the dose, inject it as soon as you remember.
However, if more than 12 hours have passed since you should have used Lobezyl, skip the missed dose and inject your next dose the following day at the usual time.
Do not use a double dose or increase the dose on the following day to make up for the missed dose.

If you stop using Lobezyl

Do not stop using Lobezyl without talking to your doctor.

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.

Serious side effects

Some severe allergic reactions (anaphylaxis) have been reported rarely in patients using Lobezyl. You should see your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat and a fast heartbeat.

Inflamed pancreas (acute pancreatitis), which could cause severe pain in the stomach and back which does not go away. Acute pancreatitis has been reported uncommonly in patients using Lobezyl. This is a serious, potentially life-threatening condition. You should see a doctor immediately if you experience such symptoms.

Stop using Lobezyl and contact a doctor immediately if you notice any of the following serious side effects:

Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, with or without nausea and vomiting. This could be a sign of acute pancreatitis, which is serious and potentially life-threatening.

Other side effects

Very common: may affect more than 1 in 10 people

Feeling sick (nausea), being sick (vomiting), diarrhoea, constipation, headache – these usually go away after a few days or weeks.

Common: may affect up to 1 in 10 people

Problems affecting the stomach and intestines, such as indigestion
(dyspepsia), inflammation in the lining of the stomach (gastritis), stomach discomfort, upper stomach pain, heartburn, feeling bloated, wind (flatulence), belching and dry mouth
Feeling weak or tired
Changed sense of taste
Dizziness
Difficulty sleeping (insomnia). This usually occurs during the first 3 months of treatment
Gallstones
Rash
Injection site reactions (such as bruising, pain, irritation, itching and rash)
Low blood sugar (hypoglycaemia). The warning signs of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick, feeling very hungry, changes in vision, feeling sleepy, feeling weak, being nervous, being anxious, confusion, difficulty concentrating and shaking (tremor). Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs
increase of pancreatic enzymes, such as lipase and amylase.

Uncommon: may affect up to 1 in 100 people

Loss of fluids (dehydration). This is more likely to occur at the start of treatment and may be due to being sick (vomiting), feeling sick (nausea) and diarrhoea
Delay in the emptying of the stomach
Inflamed gall bladder
Allergic reactions including skin rash
Feeling generally unwell
Faster pulse.

Rare: may affect up to 1 in 1 000 people

Reduced kidney function
Acute kidney failure. Signs may include reduction in urine volume, metallic taste in mouth and easily bruising.

Not Known: frequency cannot be estimated from the available data

Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.
Lumps under the skin may be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known).

Reporting of side effects

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

5. How to store Lobezyl

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 pen label and carton after ‘EXP’. The expiry date refers to the last day of that month.

Before first use:

Store in a refrigerator (2°C - 8°C). Do not freeze. Keep away from the freezer compartment.

Once you start using the pen:

You can keep the pen for 1 month when stored at a temperature below 30°C or in a refrigerator (2°C - 8°C). Do not freeze. Keep away from the freezer compartment.

When you are not using the pen, keep the pen cap on in order to protect it from light.

Do not use this medicine if the solution is not clear and colourless or almost colourless.

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 Lobezyl contains

The active substance is liraglutide. 1 ml solution for injection contains
6 mg liraglutide. One pre-filled pen contains 18 mg liraglutide.
The other ingredients are sodium citrate dihydrate, propylene glycol, phenol and water for injection. In addition, hydrochloric acid and/or sodium hydroxide solution may have been added for pH adjustment.

What Lobezyl looks like and contents of the pack.

Lobezyl is supplied as a clear, and colourless or almost colourless, solution for injection in a pre-filled pen. Each pen contains 3 ml of solution, and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.

Lobezyl is available in pack sizes containing 1, 3 or 5 pens. Not all pack sizes may be marketed.

Needles are not included.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Biocon Pharma UK Limited

16, Great Queen Street

Covent Garden

London, WC2B 5AH

United Kingdom

Manufacturer:

Biocon Pharma UK Limited

Hamilton House, Mabledon Place,

London, WC1H 9BB, United Kingdom or

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola, PLA 3000,

Malta or

KM Biosciences Ltd,

Hamilton House, Mabledon Place, London, WC1H 9BB, United Kingdom

This leaflet was last revised in 05/2026

Other sources of information

For information on large print, Braille or audio CD call emc accessibility on 0800 198 5000

D C 1 Prepare your pen with a new needle

Check the name and coloured label of your
pen, to make sure that it contains liraglutide. This is
especially important if you take more than one type
of injectable medicine. Using the wrong medicine
could be harmful to your health.
Pull off the pen cap.
Check that the solution in your pen is clear
and colourless. Look through the pen window. If the
solution looks cloudy, do not use the pen.
Take a new needle and tear off the paper tab.
Make sure to attach the needle correctly.
Push the needle straight onto the pen.
Turn until it is on tight.

Lobezyl Injection pen and needle (example)

® Instructions on how to use Lobezyl 6 mg/ml solution for injection in pre-ﬁlled pen

Please read these instructions carefully before using your Lobezyl pre-ﬁlled pen.

Do not use the pen without proper training from your doctor or nurse.

Start by checking your pen to make sure that it contains Lobezyl 6 mg/ml, then look at the illustrations below to get to know the different parts of your pen and needle.

If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the Lobezyl pre-ﬁlled pen. Your pen is a pre-ﬁlled dial-a-dose pen. It contains 18 mg of liraglutide and delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg

TM ® and 3.0 mg. BD Ultra ﬁne or NovoFine disposable needles are recommended for use with this device.

Needles are not included in the pack.

Important information

Pay special attention to these notes as they are important for safe use of the pen.

A E

The needle is covered by two caps. You must
remove both caps. If you forget to remove both caps, you will not inject any solution.
Pull off the outer needle cap and keep it for
later. You will need it after the injection, to safely remove the needle from the pen.
Pull off the inner needle cap and throw it
away. If you try to put it back on, you may accidentally stick yourself with the needle.
A drop of solution may appear at the needle tip. This is normal, but you must still check the ﬂow if you use a new pen for the ﬁrst time.
Do not attach a new needle to your pen until you are ready to take your injection.
Always use a new needle for each injection.
This may prevent blocked needles, contamination,
infection and inaccurate dosing.
Never use a bent or damaged needle.

2 Check the ﬂow with each new pen

Before your ﬁrst injection with each new pen,
check the ﬂow. If your pen is already in use, go to step 3 'Select your dose'.
Turn the dose selector until the dose counter
shows the ﬂow check symbol ( ).
Hold the pen with the needle pointing up.
Press and hold in the dose button until the
dose counter returns to 0. The 0 must line up with the dose pointer.
A drop of solution should appear at the needle tip.
A small drop may remain at the needle tip, but it
will not be injected.
If no drop appears, repeat step 2 'Check the ﬂow with each new pen’ up to 6 times. If there is still no drop, change the needle and repeat step 2 'Check the ﬂow with each new pen’ once more.
If a drop still does not appear, dispose of the
pen and use a new one.
Always make sure that a drop appears at the
needle tip before you use a new pen for the ﬁrst time.
This makes sure that the solution ﬂows.
If no drop appears, you will not inject any medicine, even though the dose counter may move. This may indicate a blocked or damaged needle.
If you do not check the ﬂow before your ﬁrst
injection with each new pen, you may not get the prescribed dose and the intended effect of Lobezyl.

3 Select your dose

Turn the dose selector until the dose
counter shows your dose (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg).
If you select the wrong dose, you can turn the dose
selector forward or backwards to the correct dose.
The pen can dial up to a maximum of 3.0 mg.
The dose selector changes the dose. Only the dose
counter and dose pointer will show how many mg you select per dose.
You can select up to 3.0 mg per dose. When your
pen contains less than 3.0 mg the dose counter stops before 3.0 is shown.
The dose selector clicks differently when turned
forward, backwards or past the number of mg left. Do not count the pen clicks.
Always use the dose counter and the dose
pointer to see how many mg you have selected before injecting this medicine. Do not count the pen clicks.
Do not use the pen scale. It only shows approximately
how much solution is left in your pen.
Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg

B A

A or 3.0 mg must be selected with the dose selector. The selected dose must line up precisely with the dose pointer to ensure that you get a correct dose.

How much solution is left?

The pen scale shows you approximately how much solution is left in your pen.
To see precisely how much solution is left, use the dose counter:
Turn the dose selector until the dose counter stops.
If it shows 3.0, at least 3.0 mg are left in your pen. If the dose counter stops before 3.0 mg, there is not enough solution left for a full dose of 3.0 mg.

If you need more medicine than what is left in your pen

Only if trained or advised by your doctor or nurse, you may split your dose between your current pen and a new pen. Use a calculator to plan the doses as instructed by your doctor or nurse.

Be very careful to calculate correctly.

If you are not sure how to split your dose using two pens, then select and inject the dose you need with a new pen.

4 Inject your dose

Insert the needle into your skin as your doctor or nurse has shown you.
Make sure you can see the dose counter. Do not cover it with your ﬁngers. This could interrupt the injection.
Press and hold down the dose button until the dose counter shows 0. The 0 must line up with the dose pointer. You may then hear or feel a click. B
Continue pressing the dose button while keeping the needle in your skin.
Count slowly to 6 while keeping the dose button pressed.
If the needle is removed earlier, you may see a stream of solution coming from the needle tip. If so, the full dose will not be delivered.
Remove the needle from your skin. You can then release the dose button.
If blood appears at the injection site, press lightly.
Do not rub the area.
You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your dose. Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter shows 0.
How to identify a blocked or damaged needle?
- If 0 does not appear in the dose counter after continuously pressing the dose button, you may

have used a blocked or damaged needle.

In this case – you have not received any medicine – even though the dose counter has moved from the original dose that you have set.

How to handle a blocked needle? D

Change the needle as described in step 5 'After your injection' and repeat all steps starting with step 1 'Prepare your pen with a new needle'. Make sure you select the full dose you need.

Never touch the dose counter when you inject. This can interrupt the injection.

5 After your injection

Lead the needle tip into the outer needle cap on a ﬂat surface without touching the needle or the outer needle cap.
Once the needle is covered, carefully push the outer needle cap completely on.
Unscrew the needle and dispose of it carefully.
Put the pen cap on your pen after each use to protect the solution from light.
Always dispose the needle after each injection to ensure convenient injections and prevent blocked needles. If the needle is blocked, you will not inject any medicine.
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Always remove the needle from your pen after each injection.
This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Further important information
Always keep your pen and needles out of sight and reach of others, especially children.
Never share your pen or your needles with other people.
Caregivers must be very careful when handling used needles - to prevent needle injury and cross-infection.
Change the place where you inject each day to reduce the risk of developing lumps.

Caring for your pen

Do not leave the pen in a car or other place where it can get too hot or too cold.
Do not inject Lobezyl Injection which has been frozen. If you do that, you may not get the intended effect of this medicine.
Do not expose your pen to dust, dirt or liquid.
Do not wash, soak or lubricate your pen. If necessary, clean it with a mild detergent on a moistened cloth.
Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the ﬂow before you inject.
Do not try to reﬁll your pen. Once empty, it must be disposed of.
Do not try to repair your pen or pull it apart.

This product is subject to medical prescription only.

® Lobezyl 6 mg/ml solution for injection in pre-ﬁlled pen

BFXXXXX/XX BPCMXXXX/XX