Diavic

Package leaflet: Information for the user

DIAVIC, 6 mg/mL, solution for injection in a pre-filled pen
liraglutide
Read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Diavic is and what it is 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 pack and other information

1. What Diavic is and what it is used for

Diavic contains the active substance liraglutide. It helps reduce blood glucose levels when they are too high. It also slows down the passage of food through the stomach and may help prevent heart disease.
Diavic is used as a standalone antidiabetic medicine when diet and physical activity alone are not sufficient to control blood glucose levels in patients who cannot take metformin (another antidiabetic medicine).
Diavic is used in combination with other antidiabetic medicines when these medicines alone are not sufficient to control blood glucose levels. These include:

• Oral antidiabetic medicines (such as metformin, pioglitazone, sulfonylureas, sodium-glucose cotransporter 2 inhibitors (SGLT2i)) 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 your doctor, pharmacist, or nurse:

• before starting treatment with Diavic,
• if the patient has or has previously had pancreas disease.

If the patient is to undergo surgery under anaesthesia (general anaesthetic), they should inform
the doctor that they are using Diavic.
This medicine must not be used in patients with type 1 diabetes (when the body produces no
insulin at all) or in cases of diabetic ketoacidosis (a diabetes complication associated with
high blood sugar levels and increased respiratory effort). This medicine is not insulin and
therefore must not be used as a substitute for insulin.
Use of Diavic is not recommended in patients undergoing dialysis.
Use of Diavic is not recommended in patients with severe liver disease.
Use of Diavic is not recommended in patients with severe heart failure.
This medicine is not recommended for patients with severe gastrointestinal disorders or
intestinal disorders resulting in delayed gastric emptying (gastroparesis) or inflammatory bowel disease.
If the patient develops symptoms of acute pancreatitis, such as persistent, severe abdominal
pain, medical advice should be sought immediately (see section 4).
If the patient has thyroid disease, including thyroid nodules or goitre, consult a doctor.
When starting treatment with Diavic, the patient may in some cases experience fluid loss
(dehydration), for example due to vomiting, nausea, or diarrhoea. It is important to prevent
dehydration by drinking plenty of fluids. If in doubt or if you have any questions, consult your doctor.
Children and adolescents
Diavic may be used in adolescents and children aged 10 years and above. There is no data
available 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 the patient is currently taking or
has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor, pharmacist, or nurse if the patient is taking medicines containing any of the following active substances:

• Sulfonylurea derivatives (such as glimepiride or glyburide) or insulin. Hypoglycaemia (low blood sugar levels) may occur when Diavic is used together with a sulfonylurea derivative or insulin, as sulfonylurea derivatives and insulin increase the risk of hypoglycaemia. When starting treatment with these medicines together for the first time, the doctor may recommend reducing the dose of the sulfonylurea derivative or insulin. Symptoms indicating low blood sugar levels are described in section 4. If the patient is also taking a sulfonylurea derivative (such as glimepiride or glyburide) or insulin, the doctor may recommend regular blood glucose monitoring. This will help the doctor decide whether the dose of the sulfonylurea derivative or insulin needs to be adjusted.
• If the patient is taking insulin, the treating doctor will advise how to reduce the insulin dose and recommend more frequent blood glucose monitoring to prevent hyperglycaemia (high blood sugar levels) and diabetic ketoacidosis (a diabetes complication that occurs when the body cannot break down glucose due to insufficient insulin).
• Warfarin or other oral anticoagulants. More frequent blood clotting tests may be required.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant,
she should inform her doctor. Diavic must not be used during pregnancy, as it is not known
whether it could harm the unborn child.
It is not known whether Diavic passes into human milk, therefore this medicine must not be used
during breastfeeding.
Driving and operating machinery
Low blood sugar levels (hypoglycaemia) may impair concentration. Driving and operating
machinery should be avoided if symptoms of hypoglycaemia occur. Symptoms indicating low
blood sugar levels are described in section 4. For further information, consult your doctor.
Important information about certain ingredients of Diavic
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Diavic

This medicine should always be used exactly as your doctor has instructed. If you are unsure,
you should consult your doctor, pharmacist, or nurse.

• The starting dose is 0.6 mg once daily for at least one week.
• Your doctor will inform you when to increase the dose to 1.2 mg once daily.
• Your doctor may later recommend increasing the dose to 1.8 mg once daily if adequate blood glucose control has not been achieved with the 1.2 mg dose. Do not change the dose without your doctor's advice.

Diavic is administered by subcutaneous injection (under the skin). It must not be injected into a vein or into muscle. The best sites for self-injection are the front of the thighs, the front of the waist (abdomen), or the upper arm. The injection site should be changed each day to reduce the risk of developing lumps. The injection can be given at any time of day, regardless of meals. Once the most convenient time of day has been chosen, it is recommended to inject Diavic approximately at the same time each day.
Before using the injector for the first time, your doctor or nurse will show you how to use it.
Detailed instructions for use are provided on the reverse of this leaflet.

Use of more Diavic than recommended
If you use more Diavic than recommended, contact your doctor immediately. You may require treatment. Possible symptoms include nausea, vomiting, diarrhoea, or low blood sugar (hypoglycaemia). For symptoms indicating low blood sugar, see section 4.

Missed use of Diavic
If you miss a dose, take Diavic as soon as you remember.
However, if more than 12 hours have passed since the missed dose, skip the missed dose.
Take the next dose the following day as usual.
Do not take an extra dose or increase the dose the next day to make up for the missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Serious adverse reactions

Common: may occur in fewer than 1 in 10 people

• Hypoglycaemia (low blood sugar). Symptoms of low blood sugar may occur suddenly and may include: cold sweats, cold pale skin, headache, rapid heartbeat, nausea, intense hunger, blurred vision, drowsiness, feeling of weakness, nervousness, anxiety, confusion, difficulty concentrating, trembling. Your doctor will advise you on how to treat low blood sugar and what to do if you notice symptoms indicating this condition. The occurrence of the above symptoms is more likely if a sulfonylurea derivative or insulin is used concomitantly. Your doctor may reduce the dose of these medicines before starting treatment with Diavic.

Rare: may occur in fewer than 1 in 1,000 people

• Severe allergic reaction (anaphylactic reaction) with additional symptoms such as breathing difficulties, swelling of the throat and face, rapid heartbeat, etc. If such symptoms occur, seek immediate medical help 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 occur in fewer than 1 in 10,000 people

• Inflammation of the pancreas (pancreatitis). Pancreatitis may be a severe, potentially life-threatening condition. Treatment with Diavic must be discontinued and you should contact your doctor immediately if any of the following serious adverse reactions occur:

Severe and persistent abdominal pain (in the stomach area) radiating to the back,
as well as nausea and vomiting, as these may be symptoms of pancreatitis.

Other adverse reactions

Very common: may occur in more than 1 in 10 people

• Nausea. Usually transient.
• Diarrhoea. Usually transient.

Common: may occur in fewer than 1 in 10 people

• Vomiting.

During initiation of treatment with Diavic, loss of fluids (dehydration) may occur in some patients, for example due to vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids.

• Headache
• Indigestion
• Gastritis (stomach inflammation). Symptoms include: abdominal pain, nausea and vomiting.
• Gastro-oesophageal reflux. Symptoms include heartburn.
• Painful or bloated abdomen
• Feeling of discomfort in the abdominal cavity
• Constipation
• Bloating with flatulence
• Decreased appetite
• Bronchitis
• Common cold
• Dizziness
• Increased heart rate
• Fatigue
• Toothache
• Injection site reactions (such as bruising, pain, irritation, itching and rash)
• Increased activity of pancreatic enzymes (such as lipase and amylase).

Uncommon: may occur in fewer than 1 in 100 people

• Allergic reactions such as itching and urticaria (a type of skin rash)
• Dehydration, sometimes with impaired kidney function
• Malaise
• Gallstones
• Cholecystitis (inflamm of the gallbladder)
• Altered taste sensation
• Delayed gastric emptying.

Frequency unknown: cannot be estimated from available data

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

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diavic

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the injector label and cardboard
package after "EXP". The expiry date refers to the last day of the stated month.
Before use:
Store in a refrigerator (2°C–8°C). Do not freeze. Keep away from the freezer compartment.
After first use:
The injector may be stored for 1 month at a temperature below 30°C or in the refrigerator
(2°C–8°C), away from the freezer compartment. Do not freeze.
When the injector is not in use, replace the cap to protect it from light.
Do not use this medicine if the solution is not clear and colourless or almost colourless.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the package and other information

What Diavic contains

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

What Diavic looks like and contents of the pack
Diavic is a clear, colourless or almost colourless solution supplied in a colourless Type I glass cartridge with a plunger sealed with a bromobutyl rubber stopper, contained in a pen-type injector with a light blue body, a light blue button, and a yellow dose-dialing knob with a grey cap, all packed in a cardboard carton. Each injector 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, or 10 injectors, or in multipacks containing 10 (2 packs of 5) injectors.
Not all pack sizes may be marketed.
The pack does not include needles.

Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16 Street
00-710 Warsaw
Tel. 22 642 07 75

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

INSTRUCTION FOR USE OF THE INJECTOR

WITH DIAVIC MEDICINE
Before using the injector, carefully read
the instructions below.
The injector contains 18 mg of liraglutide. You can
select doses of 0.6 mg, 1.2 mg, or 1.8 mg.
The injector is designed to be used with single-use
injection needles up to 8 mm in length and 32G (0.25/0.23 mm) in thickness.

Preparing the injector

Check the name and coloured label of the
injector to confirm it contains liraglutide.
Using the wrong medicine may cause serious harm.
Remove the injector cap.
Peel off the paper label from the new single-use

needle. Firmly and carefully screw the needle onto
the injector.
Remove the outer needle shield and keep it for

later use.
Remove the inner needle shield and dispose of 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 re-cap the inner needle shield. You may prick yourself with the needle.

Caring for the injector

• Do not attempt to repair or disassemble the injector.
• Store the injector away from dust, dirt, and any liquids.
• Clean the injector with a cloth dampened with mild detergent.
• Do not attempt to wash, soak, or lubricate the injector – this may damage it.

Important information

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

Checking the flow for each new injector

For each new injector, check the flow before
the first injection. If the injector is already in
use, proceed to section H "Setting the dose".
Turn the dose-dialing knob until the flow check mark aligns with the indicator mark.
Hold the injector with the needle pointing upwards.

Gently tap the cartridge several times with your finger to collect any air bubbles at the top of the cartridge.
Holding the injector with the needle pointing upwards,

press the dose button until the 0 mg mark aligns with the indicator.
A drop of liraglutide should appear at the needle tip. If no drop appears, repeat steps E to G up to four times.
If still no drop appears, replace the needle and repeat steps E to G once more.
Do not use the injector if no drop of liraglutide appears. This indicates the injector is defective and a new one should be used.
If the injector is dropped on a hard surface or if you suspect it is not working properly, always attach a new single-use needle and check the flow before injecting.

Setting the dose

Always ensure that the indicator mark is aligned
with the 0 mg mark.
Turn the dose-dialing knob until the desired dose mark (0.6 mg, 1.2 mg, or 1.8 mg) aligns with the indicator.
If you accidentally select the wrong dose, turn the dose-dialing knob forward or backward until the correct dose mark aligns with the indicator.
While turning the dose-dialing knob back, be careful not to press the dose button, as this may cause liraglutide to leak.
If the dose-dialing knob stops before the desired dose aligns with the indicator, this means there is not enough liraglutide left to deliver the full dose. In this case, you may:

Split the dose into two injections:
Turn the dose-dialing knob in either direction until the 0.6 mg or 1.2 mg mark aligns with the indicator. Inject this dose. Then prepare a new injector and inject the remaining milligrams needed to complete the dose.
Splitting the dose between the current injector and a new one should only be done if you have been trained or specifically advised by healthcare personnel. Use a calculator to plan the dose. Incorrect splitting may result in too much or too little liraglutide being administered.

Inject the full dose with a new injector:
If the dose-dialing knob stops before the 0.6 mg mark aligns with the indicator, prepare a new injector and use it to administer the full dose.

Do not attempt to set doses other than 0.6 mg, 1.2 mg, or 1.8 mg. The numbers in the display window must align exactly with the indicator mark to ensure the correct dose is delivered.
While turning the dose-dialing knob, you may hear clicking sounds. Do not use these clicks to measure the dose.
Do not use the cartridge scale to measure the amount of liraglutide to inject, as it is not sufficiently accurate.

Administering the injection

Insert the needle into the skin using the
injection technique shown by your doctor or
nurse, then follow the instructions below:
To administer the injection, press the dose button until the 0 mg mark aligns with the indicator. Be careful not to touch the viewing window with your fingers or press the side of the dose-dialing knob during injection, as this may block the injection.
Keep the dose button fully pressed and leave the needle in the skin for at least 6 seconds to ensure the full dose is delivered.
Remove the needle.

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

without touching the needle or the outer shield.
Once the needle is covered, gently push the

outer needle shield firmly until it clicks into place. Then unscrew the needle. Carefully remove the used needle and replace the cap on the injector.
If the injector is empty, carefully remove it without the needle attached. Dispose of the injector and needle according to local regulations.
After each injection, always remove the needle and store the injector without a needle attached.
This reduces the risk of contamination, infection, leakage of liraglutide, needle blockage, and inaccurate dosing.
Caregivers must handle used needles with extreme care to avoid needlestick injuries and transmission of infection.