Package leaflet: Information for the patient

LiraTight 6 mg/mL solution for injection in pre-filled pen

Liraglutide
Generic Medicine
Please 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 questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What LiraTight is and what it is used for
What you need to know before using LiraTight
How to use LiraTight
Possible side effects
How to store LiraTight
Contents of the pack and other information

1. What LiraTight is and what it is used for

What LiraTight is
LiraTight is a weight-loss medicine containing the active substance liraglutide. It is similar to a naturally occurring hormone called glucagon-like peptide-1 (GLP-1), which is released from the intestine after a meal. This medicine acts on receptors in the brain that regulate appetite, producing a greater feeling of fullness and reduced hunger. This may help you eat less food and reduce body weight.

What LiraTight is used for
LiraTight is used for weight loss in addition to diet and exercise in adults aged 18 years and older with:

a body mass index (BMI) of 30 kg/m² or higher (obesity), or
a body mass index (BMI) of 27 kg/m² and below 30 kg/m² (overweight) and weight-related health problems (such as diabetes, high blood pressure, abnormal blood fat levels, or breathing problems known as obstructive sleep apnoea).

BMI is a measure of weight relative to height.
Continue using LiraTight only if you have lost at least 5% of your body weight after 12 weeks on a daily dose of 3.0 mg per day (see section 3). Consult your doctor before continuing.

This medicine is used for weight loss in addition to a healthy diet and increased physical activity in adolescents aged 12 years and older with:

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

Continue using LiraTight only if you have lost at least 4% of your BMI after 12 weeks on a daily dose of 3.0 mg or the maximum tolerated dose (see section 3). Consult your doctor before continuing.

Diet and physical activity
Your doctor will advise you to follow a diet and exercise programme. Continue this programme while taking this medicine.

2. What you need to know before using LiraTight

Do not use LiraTight

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using LiraTight.
The use of LiraTight is not recommended if you have severe heart failure.
There is limited experience with the use of this medicine in patients aged 75 years or older. The use of LiraTight is not recommended if you are 75 years of age or older.
There is limited experience with the use of this medicine in patients with kidney problems. If you have kidney disease or are on dialysis, consult your doctor.
There is limited experience with the use of this medicine in patients with liver problems. If you have liver disease, consult your doctor.
The use of this medicine is not recommended if you have severe stomach or intestinal problems, which manifest as delayed stomach emptying (called gastroparesis), or if you have inflammatory bowel disease.
If you know you will undergo surgery under anaesthesia (where you will be asleep), inform your doctor that you are taking LiraTight.

Diabetic patients
If you have diabetes, do not use LiraTight as a substitute for insulin.

Pancreatitis
Talk to your doctor if you have or have had a pancreatic disease.

Gallbladder inflammation and gallstones
If you lose weight substantially, you may be at risk of developing gallstones, which can lead to inflammation of the gallbladder. Stop treatment with LiraTight and contact your doctor immediately if you experience severe pain in the upper abdomen, usually worse on the right side under the ribs. The pain may radiate to your back or right shoulder. See section 4.

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

Heart rate
Talk to your doctor if you experience palpitations (awareness of your heartbeat) or a sensation of increased resting heart rate during treatment with LiraTight.

Fluid loss and dehydration
When you start treatment with LiraTight, you may lose body fluids or become dehydrated. This may be due to nausea, vomiting, or diarrhoea. It is important to prevent dehydration by drinking plenty of fluids.
If you have any questions or concerns, talk to your doctor, pharmacist, or nurse. See section 4.

Children and adolescents
The safety and efficacy of liraglutide have not been studied in children and adolescents under 12 years of age.

Other medicines and LiraTight
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, talk to your doctor, pharmacist, or nurse if:

you are taking diabetes medicines called ‘sulfonylureas’ (such as glimepiride or glibenclamide) or if you are taking insulin – your blood sugar level may decrease (hypoglycaemia) when using these medicines with LiraTight. Your doctor may adjust the dose of your diabetes medicines to prevent low blood sugar levels. See section 4 for warning signs of low blood sugar. If your insulin dose is adjusted, your doctor may recommend that you monitor your blood glucose levels more frequently.
you are taking warfarin or other oral medicines to reduce blood clotting (anticoagulants). More frequent blood tests may be needed to monitor your blood’s ability to clot.

Pregnancy and breastfeeding
Do not use LiraTight if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, as it is unknown whether this medicine may affect the unborn baby.
Do not breast-feed while using LiraTight, as it is unknown whether this medicine passes into breast milk.

Driving and using machines
LiraTight is unlikely to affect your ability to drive or operate machinery.
However, some patients may experience dizziness while taking LiraTight, mainly during the first 3 months of treatment (see section "Possible side effects"). If you feel dizzy, take special care when driving or operating machinery. For further information, consult your doctor.

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

3. How to use LiraTight

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your
doctor, pharmacist, or nurse.
Your doctor will have you start a diet and exercise programme. Continue this programme
while using LiraTight.

Dose to inject
Adults
Treatment will start at a low dose, which will be gradually increased over the first five
weeks of treatment.

When you first start using LiraTight, the initial dose is 0.6 mg once daily for at least one week.
Your doctor will instruct you to gradually increase the dose by 0.6 mg, usually every week, until reaching the recommended dose of 3.0 mg once daily. Your doctor will tell you how much LiraTight to use each week. Usually, you will be advised to follow the table below.

Once the recommended dose of 3.0 mg is reached in week 5 of treatment, continue using
this dose for the remainder of the treatment period. Do not increase the dose further.
Your doctor will evaluate your treatment at regular intervals.

Adolescents (≥ 12 years)
For adolescents aged 12 to less than 18 years, the dose should be increased similarly as described in the table above for adults. The dose should be increased until reaching 3.0 mg (maintenance dose) or the maximum tolerated dose. Daily doses higher than 3.0 mg are not recommended.

How and when to use LiraTight

Before using the pen for the first time, your doctor or nurse will show you how to do it.
You may use LiraTight at any time of day, with or without food and drinks.
Use LiraTight approximately at the same time each day; choose a time of day that is convenient for you.

Where to inject
LiraTight is administered by subcutaneous injection (injection under the skin).

The best areas for injection are the waist (abdomen), the front of the thighs, or the upper arms.
Change the injection site each day to reduce the risk of lumps forming.
Do not inject the medicine into a vein or into a muscle.

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

Patients with diabetes
Inform your doctor if you have diabetes. Your doctor may adjust the dose of your diabetes medicines
to prevent low blood sugar levels.

Do not mix LiraTight with other injectable medicines (e.g. insulins).
Do not use LiraTight together with other medicines containing GLP-1 receptor agonists (such as exenatide or lixisenatide).

If you use more LiraTight than you should
If you use more LiraTight than prescribed, inform your doctor immediately or go to the hospital. Bring
the medicine package with you. You may require medical treatment. The following effects may occur:

nausea
vomiting
low blood sugar levels (hypoglycaemia). See “Common side effects” for warning signs of low blood sugar levels.

If you forget to use LiraTight

If you forget a dose and remember within 12 hours of your usual dosing time, inject the missed dose as soon as you remember.
However, if more than 12 hours have passed since you should have taken LiraTight, skip the missed dose and inject the next dose the following day at your usual time.
Do not use a double dose or increase the dose the next day to make up for the missed dose.

If you stop using LiraTight
Do not stop treatment with LiraTight without first talking to your doctor.
If you have any questions about how to use 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
Rarely, some serious allergic reactions (anaphylaxis) have been reported in patients using liraglutide.
Contact your doctor immediately if you experience symptoms such as breathing difficulties, swelling of
the face and throat, or rapid heartbeat.
Pancreatitis (inflammation of the pancreas) has been reported uncommonly in patients using liraglutide.
Pancreatitis is a serious condition that may be life-threatening.
If you experience any of the following serious side effects, stop using LiraTight and contact your doctor
immediately:

Severe and persistent stomach (abdominal) pain that may extend to your back, as well as nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

Other side effects
Very common: affects more than 1 in 10 people

Nausea, vomiting, diarrhoea, constipation, headache – these generally disappear after a few days or weeks.

Common: affects up to 1 in 10 people

Stomach and intestinal problems such as indigestion (dyspepsia), inflammation of the stomach lining (gastritis), stomach discomfort, upper abdominal pain, heartburn, abdominal distension, gas (flatulence), burping, and dry mouth
Feeling weak or tired
Altered sense of taste
Dizziness
Difficulty sleeping (insomnia). This usually occurs during the first 3 months of treatment
Gallstones
Rash
Reactions at the injection site (such as bruising, pain, irritation, itching, and rash)
Low blood sugar (hypoglycaemia). Signs indicating low blood sugar may occur suddenly and may include: cold sweating, cold and pale skin, headache, rapid heartbeat, nausea, feeling very hungry, changes in vision, drowsiness, feeling weak, nervousness, anxiety, confusion, difficulty concentrating, and tremor. Your doctor will advise you on how to treat low blood sugar levels and what to do if you notice these signs
Increased levels of pancreatic enzymes such as lipase and amylase.

Uncommon: affects up to 1 in 100 people

Fluid loss (dehydration). This is more likely to occur at the beginning of treatment and may be caused by vomiting, nausea, and diarrhoea
Delayed stomach emptying
Inflammation of the gallbladder
Allergic reactions including rash
Feeling generally unwell
Rapid heartbeat.

Rare: affects up to 1 in 1,000 people

Reduced kidney function
Acute kidney failure. Signs may include reduced urine volume, metallic taste in the mouth, and easy bruising.

Not known (frequency cannot be estimated from the available data)

Bowel obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.
Subcutaneous nodules may be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency of which is unknown)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LiraTight

Keep this medicine out of the sight and reach of children.
Do not use LiraTight after the expiry date which is stated on the pen label and the 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.
After starting to use the pen:
The pen can be stored for up to 1 month below 30°C or in the refrigerator (2°C - 8°C). Do not freeze.
When not in use, keep the pen with the cap on to protect the medicine from light.
Do not use the medicine if the solution is not clear and colourless or almost colourless.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LiraTight contains

The active substance is liraglutide. 1 mL of injectable solution contains 6 mg of liraglutide. A pre-filled pen contains 18 mg of liraglutide.
The other excipients are: disodium phosphate dihydrate, propylene glycol (E1520), phenol, hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections.

Description of the appearance of LiraTight and contents of the pack
LiraTight is supplied as a clear, colourless or almost colourless injectable solution in a pre-filled pen. Each pen contains 3 mL of solution at a concentration of 6 mg/mL and is capable of delivering doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.
LiraTight is available in packs containing 3 or 5 pens. Not all pack sizes may be marketed.
Needles are not included.

Marketing Authorisation Holder and Manufacturer
Cipla Europe NV
De Keyserlei 60C, Bus 1301
2018 Antwerp
Belgium

This medicinal product is authorised in the European Economic Area member states under the following names:
Spain LiraTight 6 mg/mL solución inyectable en pluma precargada
Poland Triglyva
Italy LiraTight
Finland Triglyva 6 mg/mL injektioneste, liuos, esitäytetty kynä
Germany Liraglutid Cipla 6 mg/mL Injektionslösung im Fertigpen
Sweden Triglyva
Norway Triglyva

Instructions for use of LiraTight 6 mg/mL injectable solution in a pre-filled pen Carefully read these instructions before using the LiraTight pre-filled pen. Do not use the pen without having received adequate training from your doctor or nurse. Start by checking the pen to ensure it contains LiraTight 6 mg/mL, then review the illustrations below to learn about the different parts of the pen and needle. If you are blind or have severe vision problems, do not use this pen without assistance. Ask for help from someone with good eyesight who has been trained in the use of the LiraTight pre-filled pen. The pen is a pre-filled pen with adjustable dosing. It contains 18 mg of liraglutide and delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg. The pen is designed to be used with NovoFine or BD Ultra-Fine™ disposable needles up to 8 mm in length and as thin as 32 G. Needles are not included in the package. Important information Pay special attention to these notes, as they are important for the safe use of the pen. LiraTight pre-filled pen with needle (example)
1Preparing the pen with a new needle •Check the name and colored label on the pen to ensure it contains LiraTight. This is particularly important if you use more than one type of injectable medicine. Using the wrong medicine may be harmful to your health. •Remove the cap from the pen.
Check that the solution in the pen is clear and colorless. Look through the viewing window of the pen. If the solution appears cloudy or opalescent, do not use the pen.
Take a new needle and remove the protective seal.
Ensure the needle is properly inserted. •Press the needle straight onto the pen. •Rotate it until it is securely tightened.
The needle is covered by two caps. Both caps must be removed. If you forget to remove both caps, no solution will be injected. •Remove the outer needle cap and keep it for later use. You will need it after the injection to safely remove the needle from the pen.
Remove the inner needle cap and discard it. Do not attempt to reinsert it, as you may accidentally prick yourself with the needle. A drop of solution may appear at the tip of the needle. This is normal, but you should still perform a flow check if you are using a new pen for the first time. Do not attach a new needle to the pen until you are ready to administer the injection. Always use a new needle for each injection. This prevents needle blockage, contamination, infection, and incorrect dosing. Never use a bent or damaged needle.
2Flow check with each new pen •If the pen has already been used, go directly to step 3, “Dose selection.” Perform the flow check only before the first injection with each new pen. •Rotate the dose selector to the flow check symbol ( ) immediately after 0. Ensure the flow check symbol is aligned with the indicator.
Hold the pen with the needle pointing upward. Press and hold the injection button until the dose counter resets to 0. The 0 must align with the dose indicator. A drop of solution should appear at the needle tip. A small drop may remain at the tip, but it will not be injected. If no drop appears, repeat step 2 “Flow check with each new pen” up to 6 times. If still no drop appears, change the needle and repeat step 2 “Flow check with each new pen” once more. If no drop appears, discard the pen and use a new one. Always ensure a drop appears at the needle tip before using a new pen for the first time. The presence of a drop confirms proper solution flow. If no drop appears, no medicine will be injected, even if the dose counter moves. This may indicate a blocked or damaged needle.
If you do not perform the flow check before the first injection with each new pen, you may not receive the prescribed dose and may not achieve the desired effect of LiraTight.
3Dose selection •Rotate the dose selector until the dose counter displays the required 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 correct it by rotating the dose selector forward or backward. The maximum dose that can be selected on the pen is 3.0 mg. The dose selector changes the dose. Only the dose counter and dose indicator show how many mg have been selected for each dose. You can select up to 3.0 mg per dose. When the pen contains less than 3.0 mg, the dose counter will stop before reaching 3.0. The dose selector emits a different click when rotated forward, backward, or when exceeding the remaining mg. Do not count the clicks of the pen. Before injecting the medicine, always use the dose counter and dose indicator to verify how many mg have been selected. Do not count the clicks. Do not use the pen scale, which only approximately shows how much solution remains in the pen. Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg should be selected using the dose selector. The selected dose must precisely align with the dose indicator to ensure accurate dosing.
How much solution is left? •The pen scale approximately shows how much solution remains in the pen.
To precisely determine how much solution remains, use the dose counter: rotate the dose selector until the dose counter stops. If it shows 3.0, at least 3.0 mg remains in the pen. If the dose counter stops before 3.0 mg, it means there is not enough solution left for a full 3.0 mg dose. If you need more medicine than remains in the pen Only after receiving specific training or instructions from your doctor or nurse, may you split the dose between the pen currently in use and a new pen. Use a calculator to plan your doses according to your doctor’s or nurse’s instructions. Be very careful to calculate the correct dose. If you are unsure how to split the dose between two pens, select and inject the required dose using a new pen.
4Injecting the dose •Insert the needle into the skin as shown to you by your doctor or nurse. •Ensure you can see the dose counter. Do not cover it with your fingers to avoid interrupting the injection.
Press and hold the injection button. Watch as the dose counter returns to 0. The 0 must align with the dose indicator. You may hear or feel a click. •Continue holding the injection button while keeping the needle in the skin.
Count slowly to 6 while holding the injection button. •If the needle is removed before this, you may notice solution leaking from the needle tip. In this case, the full dose will not be delivered.
Remove the needle from the skin. You may then release the injection button. If bleeding occurs at the injection site, apply light pressure. After injection, you may see a drop of solution at the needle tip. This is normal and does not affect the administered dose. Always check the dose counter to know how many mg are being injected. Keep the injection button pressed until the dose counter shows 0. How to identify a blocked or damaged needle. •If the dose counter does not show 0 after continuously pressing the injection button, a blocked or damaged needle may have been used. •In this case - no medicine will have been administered - even if the dose counter moved from the originally set dose. How to handle a blocked needle? Replace the needle as described in step 5 “After injection” and repeat all steps starting from step 1 “Preparing the pen with a new needle”. Ensure you select the full required dose. Never touch the dose counter during injection to avoid interrupting the injection.
5After injection •Always dispose of the needle after each injection to ensure comfortable injection and to prevent needle blockage. If the needle is blocked, no medicine will be injected. •Insert the needle tip into the outer cap placed on a flat surface, without touching the needle or the outer needle cap.
Once the needle is covered, press the outer needle cap down completely, being careful. •Unscrew the needle and dispose of it carefully, according to instructions from your doctor, nurse, pharmacist, or local authorities.
Replace the pen cap on the pen after each use to protect the solution from light. When the pen is empty, discard it without the attached needle, as instructed by your doctor, nurse, pharmacist, or local authorities. Never try to reinsert the inner needle cap. You may prick yourself with the needle. Always remove the needle from the pen after each injection. This can prevent needle blockage, contamination, infection, solution leakage, and incorrect dosing.
Additional important information •Always keep the pen and needles out of sight and reach of others, especially children. •Never share the pen or needles with other people. •Exercise great care when handling used needles to prevent needle-stick injuries and cross-infections. •Change the injection site daily to reduce the risk of developing lumps
Pen maintenance •Do not leave the pen in a car or other places where it may overheat or become too cold. •Do not inject LiraTight if it has been frozen. Product that has been frozen may not produce the desired medicinal effect. •Do not expose the pen to dust, dirt, or liquids. •Do not wash, immerse, or lubricate the pen. It may be cleaned with a neutral detergent on a damp cloth. •Do not drop the pen or hit it against hard surfaces. If it is dropped or you suspect a problem, attach a new needle and check the solution flow before injection. •Do not attempt to refill the pen. When empty, it must be discarded. •Do not attempt to repair or disassemble the pen.