Diavic

Leaflet accompanying the packaging: information for the user

DIAVIC, 6 mg/mL, solution for injection in a pre-filled pen

Liraglutide

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Diavic and what is it used for
• 2. Important information before using Diavic
• 3. How to use Diavic
• 4. Possible side effects
• 5. How to store Diavic
• 6. Contents of the packaging and other information

1. What is Diavic and what is it used for

Diavic contains the active substance liraglutide. It helps to lower blood sugar levels only when they are too high. It also slows down the passage of food through the stomach and can help prevent heart disease. Diavic is used as a single anti-diabetic drug when diet and exercise alone are not enough to control blood sugar levels in patients who cannot use metformin (another anti-diabetic drug). Diavic is used with other anti-diabetic drugs when these drugs alone are not enough to control blood sugar levels. These include oral anti-diabetic drugs (such as metformin, pioglitazone, sulfonylurea derivatives, sodium-glucose cotransporter 2 (SGLT2) inhibitors) and/or insulin.

• Oral anti-diabetic drugs (such as metformin, pioglitazone, sulfonylurea derivatives, sodium-glucose cotransporter 2 (SGLT2) inhibitors) and/or insulin.

2. Important information before using Diavic

When not to use Diavic

• If the patient is allergic to liraglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult a doctor, pharmacist, or nurse:

• before starting to use Diavic,
• if the patient has or has had pancreatitis in the past.

If the patient is to undergo surgery with anesthesia (general anesthesia), they should inform their doctor that they are taking Diavic. This medicine should not be used in patients with type 1 diabetes (when the body does not produce insulin at all) or in diabetic ketoacidosis (a complication of diabetes associated with high blood sugar levels and increased respiratory effort). This medicine is not insulin and should not be used as a substitute for insulin. The use of Diavic is not recommended in patients undergoing dialysis. The use of Diavic is not recommended in patients with severe liver disease. The use of Diavic is not recommended in patients with severe heart failure. The use of this medicine is not recommended in patients with severe gastrointestinal or intestinal disorders, resulting in delayed gastric emptying (gastroparesis) or non-specific intestinal inflammation. If the patient experiences symptoms of acute pancreatitis, such as persistent, severe abdominal pain, they should immediately contact their doctor (see section 4). If the patient has thyroid disease, including thyroid nodules and goiter, they should consult their doctor. When starting treatment with Diavic, the patient may experience fluid loss (dehydration) in some cases, e.g., due to vomiting, nausea, and diarrhea. It is essential to avoid dehydration by drinking plenty of fluids. In case of any questions or doubts, the patient should contact their doctor.

Children and adolescents

Diavic can be used in adolescents and children over 10 years of age. There is no data on the use of this medicine in children under 10 years of age.

Diavic and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take. In particular, tell your doctor, pharmacist, or nurse if you are taking medicines containing any of the following active substances:

• Sulfonylurea derivatives (such as glimepiride or glibenclamide) or insulin. Hypoglycemia (low blood sugar) may occur when using Diavic with a sulfonylurea derivative or insulin, as sulfonylurea derivatives and insulin increase the risk of hypoglycemia. When starting these medicines together for the first time, the doctor may recommend reducing the dose of the sulfonylurea derivative or insulin. Symptoms of low blood sugar, see section 4. If you are also taking a sulfonylurea derivative (such as glimepiride or glibenclamide) or insulin, your doctor may recommend checking your blood sugar levels. This will help your doctor decide whether to change the dose of the sulfonylurea derivative or insulin.
• If you are taking insulin, your doctor will tell you how to reduce the insulin dose and recommend more frequent blood sugar checks to avoid hyperglycemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose due to insufficient insulin).
• Warfarin or other oral anticoagulants. More frequent blood coagulation tests may be necessary.

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should inform their doctor. Diavic should not be used during pregnancy, as it is not known whether it can harm the unborn child. It is not known whether Diavic passes into breast milk, so this medicine should not be used during breastfeeding.

Driving and using machines

Low blood sugar (hypoglycemia) can reduce concentration. Avoid driving and using machines if symptoms of hypoglycemia occur. Symptoms of low blood sugar, see section 4. For further information, consult your doctor.

Important information about some ingredients of Diavic

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that the medicine is essentially 'sodium-free'.

3. How to use Diavic

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse.

• The initial dose is 0.6 mg once a day for at least one week.
• Your doctor will tell you when to increase the dose to 1.2 mg once a day.
• Your doctor may later recommend increasing the dose to 1.8 mg once a day if adequate blood sugar control is not achieved with the 1.2 mg dose. Do not change the dose without consulting your doctor.

Diavic is injected under the skin (subcutaneously). It should not be injected into a vein or muscle. The best places to inject yourself are the front of your thighs, the front of your waist (abdomen), or the top of your arm. Change the injection site every day to reduce the risk of lumps forming. You can inject yourself at any time of day, regardless of meals. Once you have chosen a convenient time of day, it is recommended to inject Diavic at approximately the same time every day. Before using the pen for the first time, your doctor or nurse will show you how to use it. Detailed instructions for use are on the back of this leaflet.

Using a higher dose of Diavic than recommended

If a higher dose of Diavic than recommended is used, contact your doctor immediately. You may need treatment. Nausea, vomiting, diarrhea, or low blood sugar (hypoglycemia) may occur. Symptoms of low blood sugar, see section 4.

Missing a dose of Diavic

If a dose is missed, use Diavic as soon as you remember. If more than 12 hours have passed since the time you should have used Diavic, skip the missed dose. The next day, use the next dose as usual. Do not take an extra dose or increase the dose to make up for the missed dose.

Stopping the use of Diavic

Do not stop using Diavic without consulting your doctor. If you stop using Diavic, your blood sugar levels may increase. If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe side effects

Common: may affect up to 1 in 10 people

• Hypoglycemia (low blood sugar). Symptoms of low blood sugar may appear suddenly and may include: cold sweats, cool pale skin, headache, fast heartbeat, nausea, feeling of extreme hunger, vision disturbances, drowsiness, feeling of weakness, nervousness, anxiety, confusion, difficulty concentrating, trembling. Your doctor will inform you how to treat low blood sugar and what to do if you notice symptoms of low blood sugar. The occurrence of these symptoms is more likely if you are also taking a sulfonylurea derivative or insulin. Your doctor may reduce the dose of these medicines before starting Diavic.

Rare: may affect up to 1 in 1,000 people

• Severe allergic reaction (anaphylactic reaction) with additional symptoms such as difficulty breathing, throat swelling, and rapid heartbeat, etc. If such symptoms occur, seek immediate medical attention and inform your doctor as soon as possible.
• Intestinal obstruction. Severe constipation with additional symptoms such as abdominal pain, bloating, vomiting, etc.

Very rare: may affect up to 1 in 10,000 people

• Pancreatitis (inflammation of the pancreas). Pancreatitis can be a severe, potentially life-threatening condition. Stop using Diavic and contact your doctor immediately if you experience any of the following severe side effects: severe and persistent abdominal pain (in the stomach area) that may radiate to the back, as well as nausea and vomiting, as these may be symptoms of pancreatitis.

Other side effects

Very common: may affect more than 1 in 10 people

• Nausea (vomiting). Usually transient.
• Diarrhea. Usually transient.

Common: may affect up to 1 in 10 people

• Vomiting.

When starting treatment with Diavic, the patient may experience fluid loss (dehydration) in some cases, e.g., due to vomiting, nausea, and diarrhea. It is essential to avoid dehydration by drinking plenty of fluids.

• Headache
• Nausea
• Gastritis (stomach inflammation). Symptoms include abdominal pain, nausea, and vomiting.
• Gastroesophageal reflux. Symptoms include heartburn.
• Painful or bloated abdomen
• Discomfort in the abdominal cavity
• Constipation
• Bloating with gas
• Decreased appetite
• Bronchitis
• Cold
• Dizziness
• Rapid heartbeat
• Fatigue
• Toothache
• Reactions at the injection site (such as bruising, pain, irritation, itching, and rash)
• Increased activity of pancreatic enzymes (such as lipase and amylase).

Uncommon: may affect up to 1 in 100 people

• Allergic reactions, such as itching (pruritus) and hives (a type of skin rash)
• Dehydration, sometimes with kidney function disorders
• Malaise
• Gallstones
• Cholecystitis
• Change in taste
• Delayed gastric emptying.

Frequency not known: cannot be estimated from the available data

• Subcutaneous lumps may be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; frequency not established).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diavic

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label of the pen and the carton after 'EXP'. The expiry date refers to the last day of the month stated. Before use: Store in a refrigerator (2°C–8°C). Do not freeze. Keep away from the freezer. After first use: The pen can be stored for 1 month at a temperature below 30°C or in a refrigerator (2°C–8°C), away from the freezer. Do not freeze. When the pen is not in use, to protect it from light, put the cap back on the pen. Do not use this medicine if the solution is not clear and colorless or almost colorless. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Diavic contains

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

What Diavic looks like and contents of the pack

Diavic is a clear and colorless or almost colorless solution and is supplied in a glass cartridge type I with a stopper made of bromobutyl rubber, enclosed in a pen injector with a light blue body, light blue button, and yellow dose knob with a gray cap, in a cardboard box. Each pen contains 3 mL of solution, sufficient for 30 doses of 0.6 mg, 15 doses of 1.2 mg, or 10 doses of 1.8 mg. Diavic is available in packs containing 1, 2, 3, 5, 10 pens or in multipacks containing 10 (2 packs of 5) pens. Not all pack sizes may be marketed.

Marketing authorization holder:

Ranbaxy (Poland) Sp. z o.o. ul. Idzikowskiego 16 00-710 Warsaw phone: 22 642 07 75

Manufacturer/Importer:

Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132 JH Hoofddorp Netherlands Terapia S.A. 124 Fabricii Street 400 632 Cluj Napoca Romania

Date of last revision of the leaflet:

INSTRUCTIONS FOR USE OF THE DIAVIC PEN

Before using the pen, read the following instructions carefully.

The pen contains 18 mg of liraglutide. You can choose doses of 0.6 mg, 1.2 mg, or 1.8 mg. The pen is designed for use with single-use needles for injection up to 8 mm in length and 32G (0.25/0.23 mm) in thickness.

Preparing the pen

Check the name and color label

of the pen to make sure it contains liraglutide. Using the wrong medicine can cause serious harm. Remove the pen cap.

Remove the paper tab from the new single-use needle. Tighten the needle onto the pen.

Remove the outer needle cap and keep it for later use.

Remove the inner needle cap and discard it.

Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of liraglutide, needle blockage, and inaccurate dosing. Be careful not to bend or damage the needle. Never put the inner needle cap back on. You may stick yourself with the needle.

Caring for the pen

• Do not try to repair or disassemble the pen.
• Keep the pen away from dust, dirt, and all kinds of liquids.
• Clean the pen with a cloth dampened with a mild detergent.
• Do not try to wash, soak, or lubricate the pen - this may damage the pen.

Important information

• Do not share the pen or needles with others.
• Keep the pen out of the reach of others, especially children.

Checking the flow with each new pen

With each new pen, check the flow before the first injection. If the pen is already

in use, proceed to section H "Setting the dose".

Turn the dose knob until the flow check symbol is aligned with the pointer.

Hold the pen with the needle pointing upwards. Gently tap the cartridge a few times with your finger. This will collect air bubbles in the top of the cartridge.

Hold the pen with the needle pointing upwards and press the dose button until the 0 mg marking is aligned with the pointer. A drop of liraglutide should appear at the tip of the needle. If the drop of liraglutide does not appear, repeat steps E to G up to four times. If the drop of liraglutide still does not appear, change the needle and repeat steps E to G again. Do not use the pen if the drop of liraglutide still does not appear. This means that the pen is faulty and you should use a new one.

If you drop the pen onto a hard surface or suspect that the pen is not working properly, always put a new single-use needle on and check the flow before injecting.

Setting the dose

Always make sure the pointer is aligned with the 0 mg mark.

Turn the dose knob until the mark of the desired dose (0.6 mg, 1.2 mg, or 1.8 mg) is aligned with the pointer. If you have chosen the wrong dose by mistake, turn the dose knob backwards or forwards until the mark of the desired dose is aligned with the pointer. When turning the dose knob back, be careful not to press the dose button, as this may cause liraglutide to leak out. If the dose knob stops before the desired dose is aligned with the pointer, this means that there is not enough liraglutide to deliver a full dose. You can then: Divide the dose into two injections:Turn the dose knob in any direction until the 0.6 mg or 1.2 mg mark is aligned with the pointer. Inject the dose. Then prepare a new pen and inject the remaining milligrams needed to complete the dose. The dose can be divided between the current pen and a new one only if you have received training or if it has been recommended by medical staff. You should use a calculator to plan the dose. If the dose is divided incorrectly, too much or too little liraglutide may be administered. Inject the full dose with a new pen:If the dose knob stops before the 0.6 mg mark is aligned with the pointer, prepare a new pen and inject the full dose with it.

Do not try to set doses other than 0.6 mg, 1.2 mg, or 1.8 mg. The numbers in the window must be exactly aligned with the pointer to ensure that the correct dose is delivered. When turning the dose knob, you will hear clicks. Do not use these to set the dose. Do not use the cartridge scale to measure the amount of liraglutide needed for injection, as it is not accurate enough.

Injecting the dose

Insert the needle into the skin using the injection technique shown by your doctor or nurse. Then follow the instructions below:

Press the dose button until the 0 mg mark is aligned with the pointer. Be careful not to touch the window or the dose knob with your fingers or press it from the side during injection. This may block the injection. Hold the dose button pressed and keep the needle in the skin for at least 6 seconds. This ensures that the full dose is delivered.

Remove the needle. A drop of liraglutide may appear at the tip of the needle. This is normal and does not affect the delivered dose.

Insert the tip of the needle into the outer needle cap without touching the needle or the outer needle cap.

Gently push the outer needle cap onto the needle until it clicks. Then unscrew the needle. Carefully remove the needle and put the pen cap back on the pen. If the pen is empty, dispose of it carefully without the attached needle. Dispose of the pen and needle according to local regulations.

After each injection, always remove the needle and store the pen without the needle attached. This reduces the risk of contamination, infection, leakage of liraglutide, needle blockage, and inaccurate dosing. Caregivers must handle used needles very carefully to avoid needlestick injury and transmission of infection.