Diavic

Package leaflet: Information for the patient

Diavic 6 mg/mL injection solution in a pre-filled pen

Liraglutide
Generic Medicine
Please read this leaflet carefully before 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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Diavic is and what it is used for
2. What you need to know 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, which helps your body reduce blood sugar levels only when blood sugar is too high. It also slows down the passage of food through the stomach and may help prevent heart disease.
Diavic is used alone when blood sugar is not adequately controlled by diet and exercise alone and when you cannot use metformin (another diabetes medicine).
Diavic is used together with other diabetes medicines when these are not sufficient to control blood sugar levels. These other medicines may include:

• oral antidiabetic agents (such as metformin, pioglitazone, sulfonylurea, sodium-glucose cotransporter-2 inhibitor, i.e. SGLT2i) and/or insulin.

2. What you need to know before using Diavic

Do not use Diavic

• 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 Diavic.
• if you have or have had a disease of the pancreas.

This medicine must not be used if you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a diabetes complication with high blood sugar and increased breathing effort).
Diavic is not insulin and therefore must not be used as a substitute for insulin.
The use of Diavic is not recommended if you are on dialysis.
The use of Diavic is not recommended in case of severe liver disease.
The use of Diavic is not recommended in case of severe heart failure.
This medicine is not recommended if you have a serious stomach or intestinal problem causing delayed stomach emptying (called gastroparesis) or an inflammatory bowel disease.
If you experience symptoms of acute pancreatitis, such as persistent and severe stomach pain, you must consult your doctor immediately (see section 4).
If you suffer from thyroid diseases, including thyroid nodules and enlargement of the thyroid gland, consult your doctor.
When starting treatment with Diavic, fluid loss/dehydration may occur in some cases, for example due to vomiting, nausea and diarrhoea. It is important to prevent dehydration by drinking plenty of fluids.
Contact your doctor if you have any questions or doubts.

Children and adolescents
Diavic can be used in adolescents and children aged 10 years and older. There are no data available on use in children under 10 years of age.

Other medicines and Diavic
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor, pharmacist or nurse if you are taking medicines containing any of the following active substances:

• Sulfonylureas (such as glimepiride or glibenclamide) or insulin. You may experience hypoglycaemia (low blood sugar) when using Diavic together with a sulfonylurea or with insulin, because sulfonylureas and insulin increase the risk of hypoglycaemia. When you start using these medicines together, your doctor may tell you to reduce the dose of the sulfonylurea or insulin. Please refer to section 4 for warning signs of low blood sugar. If you are also taking a sulfonylurea (such as glimepiride or glibenclamide) or insulin, your doctor may tell you to monitor your blood sugar levels. This will help your doctor decide whether the dose of the sulfonylurea or insulin needs to be adjusted.
• If you are using insulin, your doctor will tell you how to reduce the insulin dose and will advise you to monitor your blood glucose more frequently, in order to avoid 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 anticoagulant medicines: more frequent blood tests may be needed to determine your blood's ability to clot.

Pregnancy and breastfeeding
Inform your doctor if you are pregnant, think you might be pregnant, or are planning a pregnancy. Diavic must not be used during pregnancy because it is not known whether it could harm the unborn baby.
It is not known whether Diavic passes into breast milk; therefore, do not use this medicine if you are breastfeeding.

Driving and using machines
Low blood sugar (hypoglycaemia) may impair your ability to concentrate. Avoid driving or operating machinery if you experience signs of hypoglycaemia.
Please refer to section 4 for warning signs of low blood sugar. Please contact your doctor for further information on this topic.

Important information about some of the excipients of Diavic
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially "sodium-free".

3. How to use Diavic

Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.

• The starting dose is 0.6 mg once daily for at least one week.
• Your doctor will tell you when to increase it to 1.2 mg once daily.
• Your doctor may instruct you to further increase the dose to 1.8 mg once daily if your blood sugar level is not adequately controlled with a 1.2 mg dose. Do not change the dose unless your doctor has told you to do so.

Diavic is administered by subcutaneous injection (under the skin). Do not inject it into a vein or into a muscle. The best injection sites are the front of the thighs, the front of the waist (abdomen), or the upper arm.
You may administer the injection at any time of day, regardless of meals. Once you have determined the most convenient time of day, it is preferable to inject Diavic at the same time each 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 provided on the reverse side of this patient information leaflet.

If you use more Diavic than you should
If you use more Diavic than prescribed, contact your doctor immediately. Medical treatment may be necessary. Symptoms such as nausea, vomiting, diarrhoea, or low blood sugar (hypoglycaemia) may occur.
Refer to section 4 for warning signs of low blood sugar.

If you forget to use Diavic
If you forget a dose, use Diavic as soon as you remember.
However, if more than 12 hours have passed since you were supposed to take Diavic, skip the missed dose. Then take the next dose as usual the following day.
Do not take a double dose and do not increase the dose the next day to make up for the missed dose.

If you stop using Diavic
Do not stop treatment with Diavic without first discussing it with your doctor. If you stop using this medicine, your blood sugar levels may rise.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Common: may affect up to 1 in 10 people

• Hypoglycaemia (low blood sugar level). Warning signs of low blood sugar may occur suddenly and may include: cold sweat, cold and pale skin, headache, rapid heartbeat, feeling unwell, hunger sensation, changes in vision, drowsiness, weakness, nervousness, anxiety, confusion, difficulty concentrating, tremors (shaking). Your doctor will advise you on how to treat low blood sugar and what to do if you notice these warning signs. These effects are more likely to occur if you are also taking a sulphonamide or insulin. Your doctor may reduce the dose of these medicines before starting you on Diavic.

Rare: may affect up to 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 you experience these symptoms, you must consult a doctor immediately and inform your doctor as soon as possible.
• Intestinal obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.

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

• Cases of inflammation of the pancreas (pancreatitis). Pancreatitis can be a serious medical condition and potentially life-threatening. Stop taking Diavic and contact a doctor immediately if you experience any of the following serious side effects:

severe and persistent pain in the abdomen (stomach area) which may radiate to the back, as well as nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).
Other side effects
Very common: may affect more than 1 in 10 people

• Nausea (feeling unwell). This usually resolves over time.
• Diarrhoea. This usually resolves over time.

Common: may affect up to 1 in 10 people

• Vomiting

When starting treatment with Diavic, fluid loss/dehydration may occur in some cases, for example due to vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids.

• Headache
• Indigestion
• Inflamed stomach (gastritis). Signs include stomach pain, nausea and vomiting.
• Gastroesophageal reflux disease (GORD). Signs include heartburn.
• Painful or bloated abdomen
• Abdominal discomfort
• Constipation
• Intestinal gas (flatulence)
• Decreased appetite
• Bronchitis
• Common cold
• Dizziness
• Increased pulse
• Fatigue
• Toothache
• Injection site reactions (such as bruising, pain, irritation, itching and skin rash)
• Increased pancreatic enzymes (such as lipase and amylase).

Uncommon: may affect up to 1 in 100 people

• Allergic reactions such as itching and urticaria (a type of skin rash)
• Dehydration, sometimes with reduced kidney function
• Malaise (feeling unwell)
• Gallstones
• Inflamed gallbladder
• Change in taste perception
• Delayed stomach emptying.

Reporting of side effects
If you experience any side effects, 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 Diavic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pen label and on the carton after "Exp.". The expiry date refers to the last day of the month.
Before opening:
Store in a refrigerator (2°C–8°C). Do not freeze. Keep away from the freezer compartment.
During use:
You may keep the pen for 1 month if stored at a temperature below 30°C or in the refrigerator (2°C–8°C), away from the freezer compartment. Do not freeze.
When not in use, store the pen with the pen cap on to protect it from light.
Do not use this 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 Diavic 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 excipients are disodium phosphate dihydrate, propylene glycol (E1520), phenol, sodium hydroxide (for pH adjustment), concentrated hydrochloric acid (for pH adjustment) and water for injections.

Description of the appearance of Diavic and contents of the pack
Diavic is supplied as a cartridge with a bromobutyl rubber stopper and a colourless glass cartridge of type I assembled into a pen injector, with a blue body assembled with a button with a blue light and a yellow dose-dialing knob with a grey cap. Each pen contains 3 mL of solution providing 30 doses of 0.6 mg, or 15 doses of 1.2 mg, or 10 doses of 1.8 mg.
Diavic is available in packs of 1, 2, 3, 5 or 10 pens.
Not all pack sizes may be marketed.
Needles are not included.

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Local representative:
SUN Pharma Italia S.r.l.
Viale Giulio Richard, 3
20143 Milan
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland)
under the following names:
Spain Diavic 6 mg/ml solución inyectable en pluma precargada EFG
Finland Diavic 6 mg/ml injektioneste, liuos, esitäytetty kynä
France LIRAGLUTIDE TERAPIA 6 mg/ml, solution injectable en stylo prérempl
Italy Diavic
Netherlands Diavic 6 mg/ml oplossing voor injectie in een voorgevulde pen
Poland Diavic
Romania Diavic 6 mg/ml soluţie injectabilă în stilou injector (pen) preumplut
Sweden Diavic 6 mg/ml injektionsvätska, lösning i förfylld injektionspenna or

INSTRUCTIONS FOR USING THE Diavic PEN Please read these instructions carefully before using the pen. The pen contains 18 mg of liraglutide. Doses of 0.6 mg, 1.2 mg, or 1.8 mg can be selected. The pen is designed to be used with single-use injection needles up to 8 mm in length and as thin as 32 G (0.25/0.23 mm).	Needle (example)
Prepare the pen Check the pen name and colored label to ensure it contains liraglutide. Using the wrong medicine could cause serious harm. Remove the pen’s closure cap.
Remove the paper tab from a new single-use needle. Screw the needle straight and securely 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, blocked needles, and inaccurate dosing. Be careful not to bend or damage the needle. Never attempt to reattach the inner needle cap onto the needle, as you may accidentally prick yourself with the needle.
How to care for the device Do not attempt to repair or disassemble the pen. Keep the pen away from dust, dirt, and any liquids. Clean the pen with a cloth moistened with a mild detergent. Do not try to wash, immerse, or lubricate the pen: this could damage it.
Important information Do not share the pen or needles with anyone else. Keep the pen out of reach of others, especially children.
Before using a new pen, check the flow. Check the flow before the first injection with every new pen. If the pen is already in use, go to "Select the dose", step H. Turn the dose selector until the flow check symbol aligns with the indicator.
Hold the pen with the needle pointing upward. Gently tap the cartridge several times with your finger. This will cause air bubbles to collect at the top of the cartridge.
With the needle pointing upward, press the dose button until 0 mg aligns with the indicator. A drop of liraglutide should appear at the tip of the needle. 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 pen if no drop of liraglutide appears. This indicates the pen is defective and a new pen must be used.
If you have dropped the pen onto a hard surface or suspect something is wrong, always attach a new single-use needle and check the flow before administering the injection.

Select the dose
Always check that the indicator is aligned with 0 mg.
Rotate the dose selector until the required dose aligns with the indicator (0.6 mg, 1.2 mg, or 1.8 mg).
If you have accidentally selected the wrong dose, simply change it by rotating the dose selector forwards or backwards until the correct dose aligns with the indicator.
Be careful not to press the dose button while turning the dose selector backwards, as this may cause liraglutide to leak out.
If the dose selector stops before the required dose aligns with the indicator, this means there is not enough liraglutide left for a complete dose. In this case, you may:

Split the dose into two injections:
Rotate the dose selector in both directions until either 0.6 mg or 1.2 mg aligns with the indicator. Inject this dose. Then prepare a new pen for injection and inject the remaining number of mg to complete the total dose.
Alternatively, you may split the dose between the current pen and a new pen, but only if you have been trained or instructed by your doctor. Use a calculator to plan the doses. If the dose is divided incorrectly, you may inject too much or too little liraglutide.

Inject the full dose using a new pen:
If the dose selector stops before 0.6 mg aligns with the pointer, prepare a new pen and inject the full dose using the new pen.

Do not attempt to select doses other than 0.6 mg, 1.2 mg, or 1.8 mg. The numbers on the display must be exactly aligned with the indicator to ensure you receive the correct dose. The dose selector clicks when rotated. Do not use these clicks to select the dose. Do not use the cartridge balance to measure the amount of liraglutide to inject: it is not sufficiently accurate.
Inject 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 to inject until 0 mg aligns with the indicator. Be careful not to touch the display with other fingers or press sideways on the dose selector during injection, as this may block the injection. Keep the dose button pressed and leave the needle under the skin for at least 6 seconds. This ensures you receive the full dose.
Remove the needle. After this, you may see a drop of liraglutide at the needle tip. This is normal and does not affect the dose.	a
Place the needle tip into the outer needle cap without touching the needle or the outer cap.
Once the needle is covered, carefully and completely push the outer needle cap on. Then unscrew the needle, dispose of it carefully, and replace the pen cap. When the pen is empty, dispose of it carefully without a needle attached. Please dispose of the pen and needle in accordance with local regulations.	à
Always remove the needle after each injection and store the pen without a needle attached. This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles, and inaccurate dosing. Healthcare providers must exercise great care when handling used needles to prevent needle-stick injuries and cross-infections.