Lanreotide Sun

Patient Information Leaflet: Information for the User

Lanreotide SUN 60 mg injectable solution in pre-filled syringe, 90 mg injectable solution in pre-filled syringe, 120 mg injectable solution in pre-filled syringe

Lanreotide
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 or pharmacist.
• 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 could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contents of this Patient Information Leaflet:
  1. What Lanreotide SUN is and what it is used for
  2. What you need to know before using Lanreotide SUN
  3. How to use Lanreotide SUN
  4. Possible side effects
  5. How to store Lanreotide SUN
  6. Contents of the pack and other information

1. What Lanreotide SUN is and what it is used for

What Lanreotide SUN is and how it works
The name of this medicine is Lanreotide SUN.
It is a long-acting formulation of lanreotide.
Lanreotide – the active substance – belongs to a group of medicines called "growth hormone inhibitors".
It is similar to another substance (a hormone) called "somatostatin".
Lanreotide reduces levels of hormones in the body such as growth hormone (GH) and insulin-like growth factor 1 (IGF-1), and inhibits the release of certain hormones in the gastrointestinal tract and intestinal secretions. In addition, it has an effect on certain advanced types of tumours (called neuroendocrine tumours) of the intestine and pancreas, stopping or slowing their growth.

What Lanreotide SUN is used for:

• For the long-term treatment of acromegaly (a condition in which the body produces too much growth hormone).
• To relieve symptoms associated with acromegaly, such as fatigue, headache, sweating, joint pain, and numbness in the hands and feet.
• To relieve symptoms such as hot flushes and diarrhoea that sometimes occur in patients with neuroendocrine tumours (NET).
• For the treatment and control of the growth of certain advanced tumours of the intestine and pancreas, called gastroenteropancreatic neuroendocrine tumours or GEP-NET. It is used when these tumours cannot be surgically removed.

2. What you need to know before using Lanreotide SUN

Do not use Lanreotide SUN

• if you are allergic (hypersensitive) to lanreotide, somatostatin, or medicines of the same family (somatostatin analogues), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using this medicine:

• if you have diabetes, because lanreotide may affect your blood sugar levels. Your doctor may monitor your blood sugar levels and may need to adjust your antidiabetic treatment during treatment with lanreotide.
• if you have gallstones, because lanreotide may lead to the formation of gallstones in the gallbladder. In this case, periodic monitoring may be required. Your doctor may decide to discontinue treatment with lanreotide if complications related to gallstones occur.
• if you have thyroid function disorders, because lanreotide may slightly reduce thyroid function.
• if you have heart problems, because sinus bradycardia (slower heart rate) may occur during treatment with lanreotide. Particular caution is required when starting treatment with lanreotide in patients with bradycardia (a heart rhythm disorder).

If any of the above conditions apply to you, talk to your doctor or pharmacist before using
Lanreotide SUN.
Talk to your doctor or pharmacist during treatment:

• if you have fatty stools, diarrhoea, abdominal bloating, or weight loss, because lanreotide may affect the secretion of pancreatic enzymes involved in food digestion.

Children and adolescents
Lanreotide SUN is not recommended in children and adolescents.
Other medicines and Lanreotide SUN
Some medicines may affect the action of other medicines. Inform your doctor or pharmacist if
you are taking, have recently taken, or might take any other medicines.
Particular attention should be paid when co-administering the following:

• cyclosporine (a medicine that reduces the immune response, used after organ transplantation or in autoimmune diseases),
• bromocriptine (a dopamine agonist used in the treatment of certain types of brain tumours and Parkinson's disease, or to suppress lactation after childbirth),
• antidiabetic treatment (medicines that reduce high blood glucose levels),
• medicines that induce bradycardia (medicines that slow heart rate, such as beta-blockers).

Your doctor may consider adjusting the dosage of these concomitant medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning a
pregnancy, consult your doctor or pharmacist before taking this medicine.
Lanreotide SUN should only be administered if strictly necessary.
Driving and using machines
It is unlikely that Lanreotide SUN affects the ability to drive or operate machinery; however,
Lanreotide SUN may cause possible side effects such as dizziness. If you experience this, you must not drive or operate machinery.

3. How to use Lanreotide SUN

Always use Lanreotide SUN exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
Recommended dose
Treatment of acromegaly
The recommended dose is one injection every 28 days. Your doctor may adjust the injection dose
using one of the three available strengths of Lanreotide SUN (60, 90 or 120 mg).
If your condition is well controlled with treatment, your doctor may recommend changing the injection frequency of Lanreotide SUN 120 mg to one injection every 42 or 56 days.
Your doctor will also decide how long you should be treated.
Relief of symptoms (such as hot flashes and diarrhoea) associated with neuroendocrine tumours
The recommended dose is one injection every 28 days. Your doctor may adjust the injection dose
using one of the three available strengths of Lanreotide SUN (60, 90 or 120 mg).
If you are well controlled with a somatostatin analogue or with Lanreotide SUN 60 mg or 90 mg, your doctor may recommend changing the injection frequency of the 120 mg dose to one injection every 42 or 56 days.
Your doctor will also decide how long you should be treated.
Treatment of advanced intestinal and pancreatic tumours, called gastroenteropancreatic neuroendocrine tumours or GEP-NETs. Used when these tumours cannot be surgically removed.
The recommended dose is 120 mg every 28 days. Your doctor will also decide how long you should be treated with Lanreotide SUN to control the tumour.
Method of administration
Lanreotide SUN must be administered by deep subcutaneous injection.
The injection should be given by a healthcare professional, or by a caregiver (family member or friend), or by yourself after proper training by a healthcare professional.
The decision on self-administration or administration by another trained person must be made by your doctor. If you have any doubts at any time about how to administer this injection, contact your doctor or healthcare professional for advice or further information.
If the injection is administered by a healthcare professional or by another trained person (family member or friend), the injection should be given into the upper outer quadrant of the buttock or the upper outer thigh (see figures 5a and 5b below).
If you are self-injecting after appropriate training, the injection should be given into the upper outer thigh (see figure 5b below).
Instructions for use
Warning: Please read all instructions carefully before starting the injection.
The injection is a deep subcutaneous injection requiring a specific technique different from standard subcutaneous injections.
The following instructions explain how to inject Lanreotide SUN.
Lanreotide SUN is supplied in a ready-to-use pre-filled syringe equipped with an automatic safety system. The needle will automatically retract after complete administration of the product to prevent needlestick injuries.

1. Remove Lanreotide SUN from the refrigerator 30 minutes before administration. Injections of refrigerated medication may be painful. Keep the sealed laminated pouch until just before injection.
2. Check carefully before opening the pouch: ensure that it is intact and that the medication has not expired. Do not use the pre-filled syringe:  If you drop or damage the pre-filled syringe, or if the pre-filled syringe or pouch appears damaged in any way. If the product is expired; the expiration date is printed on the outer packaging and on the pouch.If any of the above conditions occur, contact your doctor or pharmacist.
3. Wash your hands with soap.
4. Open the pouch along the dotted line and remove the pre-filled syringe. The contents of the pre-filled syringe consist of a semi-solid phase with a gel-like appearance, viscous characteristics, and a color ranging from white to pale yellow. The supernatant solution may also contain microbubbles, which may disappear during injection. These
differences are normal and do not affect the quality of the product.	After opening the protective laminated pouch, the product must be administered immediately.
5. Select an injection site: 5a. If the injection is administered by a healthcare professional or another person, such as a trained family member or friend: use the upper outer quadrant (upper, outer) of the buttock or the upper outer part of the thigh for injection. 5b. For self-administration, inject into the upper outer part of the thigh	Alternate the injection site between the right and left sides each time you receive a Lanreotide SUN injection. Avoid areas with moles, scar tissue, red skin, or irregular skin.-
6. Clean the injection site.
7. Before injection, remove the pre-filled syringe from its tray. Discard the tray.
8. Remove the needle cap by pulling it off and discard it.
9. Stretch the injection area between the thumb and index finger of the hand not holding the pre-filled syringe to tighten the skin. Do not pinch the skin. Use a firm, straight motion to quickly insert the needle perpendicularly into the skin (at a 90-degree angle), deeply into the tissue. It is very important that the needle is fully inserted. No part of the needle should be visible once fully inserted. Do not aspirate (do not pull back).	Do not aspirate (do not pull back)
10. Release the stretched skin at the injection site previously held by the hand. Push the plunger with a firm, steady pressure. The medication is denser and more difficult to push than you might expect.	Typically, this takes about 20 seconds. Inject the entire dose and give a final push to ensure it cannot be pressed further. Note: maintain pressure on the plunger with your thumb to prevent activation of the automatic safety system.
11. Without releasing pressure on the plunger, withdraw the needle from the injection site.
12. Release pressure on the plunger. The needle will automatically retract into the needle guard where it will be permanently locked.
13. Apply light pressure to the injection site with a dry cotton ball or gauze

sterile to prevent potential bleeding. Do not rub or massage the injection site
after administration.

14. Dispose of the used syringe as instructed by your doctor or healthcare provider. Do not dispose of the device with ordinary household waste.

If you use more Lanreotide SUN than you should
If you have injected more Lanreotide SUN than you should, inform your doctor.
If you have injected or been administered too much Lanreotide SUN, you may experience additional or more severe adverse effects (see section 4. "Possible side effects").
If you forget to use Lanreotide SUN
As soon as you realize you have missed an injection, contact your healthcare provider, who will advise you on the timing of the next injection. Do not inject extra doses to make up for a missed injection without first discussing it with your healthcare provider.
If you stop using Lanreotide SUN
Missing more than one dose or prematurely stopping treatment with Lanreotide SUN may affect the success of the treatment. Consult your doctor before stopping treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately inform your doctor if you notice any of the following side effects:

• unusual thirst or tiredness, dry mouth – these may be signs that you have high blood sugar levels or are developing diabetes
• feeling hungry, shaky, sweating abnormally, or confused – these may be signs of low blood sugar levels
• The frequency of these side effects is common and may affect up to 1 in 10 people

Immediately inform your doctor if you notice:

• your face becomes red or swollen, or you develop spots or skin rashes
• your chest feels heavy, you have shortness of breath, or wheezing
• you feel faint, possibly due to a drop in blood pressure
• These may be signs of an allergic reaction

The frequency of these side effects is not known; the frequency cannot be estimated from the available data.
Other side effects
Inform your doctor or pharmacist if you notice any of the following side effects.
The most common expected side effects are gastrointestinal disorders, gallbladder problems, and injection site reactions. The side effects that may occur with Lanreotide SUN are listed below by frequency.

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

• diarrhoea, loose stools, abdominal pain
• gallstones and other gallbladder problems. You may experience symptoms such as sudden and severe abdominal pain, high fever, jaundice (yellowing of the skin and whites of the eyes), chills, loss of appetite, skin itching

Common: may affect up to 1 in 10 people:

• weight loss
• lack of energy
• slow heartbeat
• feeling very tired
• reduced appetite
• feeling generally weak
• excess fat in the stools
• dizziness, headache
• hair loss or reduced body hair growth
• pain affecting muscles, ligaments, tendons, and bones
• reactions at the injection site, such as pain, skin hardening, or itching
• abnormal liver and pancreas function test results and changes in blood sugar levels
• nausea, vomiting, constipation, flatulence, bloating, or stomach discomfort, indigestion
• biliary dilation (enlargement of the bile ducts between the liver, gallbladder, and intestine). You may experience symptoms such as stomach pain, nausea, jaundice, and fever

Uncommon: may affect up to 1 in 100 people:

• hot flushes
• difficulty sleeping
• changes in stool colour
• changes in blood levels of sodium and alkaline phosphatase, detected by blood tests

Not known: frequency cannot be estimated from the available data:

• sudden, severe pain in the lower abdomen – this may be a sign of an inflamed pancreas (pancreatitis)
• redness, pain, warmth, and swelling at the injection site that may feel fluid-filled when pressed, with fever – this may be a sign of an abscess
• sudden, severe pain in the upper right or central abdomen that may spread to the shoulder or back, abdominal tenderness, nausea, vomiting, and high fever – this may be a sign of gallbladder inflammation (cholecystitis)
• pain in the upper right part of the abdomen, fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, pale-coloured stools, dark urine, fatigue – these may be signs of bile duct inflammation (cholangitis)
• decreased pancreatic enzymes. Since lanreotide may affect the release of pancreatic enzymes involved in food digestion, you may experience symptoms such as fatty stools, diarrhoea, bloating, or weight loss

Since Lanreotide SUN may alter blood sugar levels, your doctor may wish to monitor your blood sugar levels, especially at the beginning of treatment.
Similarly, since gallbladder problems may occur with this type of medicine, your doctor may wish to monitor your gallbladder at the start of Lanreotide SUN therapy and periodically during treatment.
Inform your doctor or pharmacist if you notice any of the side effects listed above.
Reporting of side effects
If you get 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 Lanreotide SUN

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 carton and labels after
. The expiry date refers to the last day of that month.
Store Lanreotide SUN between 2°C and 8°C in the refrigerator, in its original packaging to protect it
from light.
Once removed from the refrigerator, the product remaining in its sealed bag may be returned to the
refrigerator (the number of temperature excursions must not exceed three times) for continued storage and subsequent use, provided it has been stored for no longer than 72 hours at a temperature below 30°C.
Each syringe is individually packaged.
Do not dispose of medicines 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 Lanreotide SUN contains
The active substance is:
lanreotide 60 mg, 90 mg or 120 mg
The other components are:
water for injections
glacial acetic acid (for pH adjustment)

Description of the appearance of Lanreotide SUN and contents of the pack
Lanreotide SUN is a viscous injectable solution in a ready-to-use pre-filled syringe equipped with an automatic safety system. It is a semi-solid formulation with a colour ranging from white to pale yellow.
Each pre-filled syringe is packaged in a laminated pouch and a cardboard box.

Pack sizes:
Box containing one 0.5 mL syringe with automatic safety system and one needle (1.2 mm x 20 mm).
Box containing three pouches, each containing one 0.5 mL pre-filled syringe and one needle (1.2 mm x 20 mm).

1 x 60 mg, 3 x 60 mg
1 x 90 mg, 3 x 90 mg
1 x 120 mg, 3 x 120 mg

Not all pack sizes may be marketed.

Translation of information on the pre-filled syringe:
The product name is indicated as Lanreotide
Deep s.c. - deep subcutaneous injection

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.
Via Giulio Richard, 3
20143 Milano
Italy

Manufacturer
Terapia SA
124 Fabricii Street,
400632, Cluj-Napoca,
Romania

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH, Hoofddorp
The Netherlands

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Italy: Lanreotide SUN
Netherlands: Lanreotide SUN 60 mg oplossing voor injectie in een voorgevulde spuit
Lanreotide SUN 90 mg oplossing voor injectie in een voorgevulde spuit
Lanreotide SUN 120 mg oplossing voor injectie in een voorgevulde spuit
Norway: Lanreotid SUN
Poland: Lanreotide Ranbaxy
Romania: Lanreotida Terapia 60 mg soluţie injectabilă în seringă preumplută
Lanreotida Terapia 90 mg soluţie injectabilă în seringă preumplută
Lanreotida Terapia 120 mg soluţie injectabilă în seringă preumplută
Sweden: Lanreotid SUN 60 mg injektionsvätska, lösning i förfylld spruta
Lanreotid SUN 90 mg injektionsvätska, lösning i förfylld spruta
Lanreotid SUN 120 mg injektionsvätska, lösning i förfylld spruta
Slovakia: Lanreotid SUN 60 mg injekčný roztok v naplnenej injekčnej striekačke
Lanreotid SUN 90 mg injekčný roztok v naplnenej injekčnej striekačke
Lanreotid SUN 120 mg injekčný roztok v naplnenej injekčnej striekačke
Germany: Lanreotid SUN 60 mg Injektionslösung in einer Fertigspritze
Lanreotid SUN 90 mg Injektionslösung in einer Fertigspritze
Lanreotid SUN 120 mg Injektionslösung in einer Fertigspritze
Austria: Lanreotid SUN 60 mg Injektionslösung in einer Fertigspritze
Lanreotid SUN 90 mg Injektionslösung in einer Fertigspritze
Lanreotid SUN 120 mg Injektionslösung in einer Fertigspritze
Belgium: Lanréotide SUN 60 mg solution injectable en seringue préremplie
Lanréotide SUN 90 mg solution injectable en seringue préremplie
Lanréotide SUN 120 mg solution injectable en seringue préremplie
Czech Republic: Lanreotid SUN
Denmark: Lanreotid SUN 60 mg injektionsvæske, opløsning i fyldt injektionssprøjte
Lanreotid SUN 90 mg injektionsvæske, opløsning i fyldt injektionssprøjte
Lanreotid SUN 120 mg injektionsvæske, opløsning i fyldt injektionssprøjte
Spain: Lanreotida SUN 60 mg solución inyectable en jeringa precargada EFG
Lanreotida SUN 90 mg solución inyectable en jeringa precargada EFG
Lanreotida SUN 120 mg solución inyectable en jeringa precargada EFG
Finland: Lanreotidi SUN 60 mg Injektioneste, liuos, esitäytetyssä ruiskussa
Lanreotidi SUN 90 mg Injektioneste, liuos, esitäytetyssä ruiskussa
Lanreotidi SUN 120 mg Injektioneste, liuos, esitäytetyssä ruiskussa
France: Lanreotide SUN L.P. 60 mg solution injectable à libération prolongée en seringue préremplie
Lanreotide SUN L.P. 90 mg solution injectable à libération prolongée en seringue préremplie
Lanreotide SUN L.P. 120 mg solution injectable à libération prolongée en seringue préremplie
Hungary: Lanreotid SUN 60 mg oldatos injekció előretöltött fecskendőben
Lanreotid SUN 90 mg oldatos injekció előretöltött fecskendőben
Lanreotid SUN 120 mg oldatos injekció előretöltött fecskendőben
Ireland: Lanreotide SUN 60 mg solution for injection in a pre-filled syringe
Lanreotide SUN 90 mg solution for injection in a pre-filled syringe
Lanreotide SUN 120 mg solution for injection in a pre-filled syringe