LANREOTIDE SUN 120 mg INJECTABLE SOLUTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

Lanreotida Sun 60 mg solution for injection in pre-filled syringe EFG

Lanreotida Sun 90 mg solution for injection in pre-filled syringe EFG

Lanreotida Sun 120 mg solution for injection in pre-filled syringe EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lanreotida Sun and what is it used for
2. What you need to know before you use Lanreotida Sun
3. How to use Lanreotida Sun
4. Possible side effects
5. Storing Lanreotida Sun
6. Contents of the pack and other information

1. What is Lanreotida Sun and what is it used for

The name of the medicine is Lanreotida Sun.

It is a prolonged-release formulation of lanreotide.

The active substance, lanreotide, belongs to a group of medicines called “growth hormone inhibitors”. It is similar to another substance (a hormone) called “somatostatin”.

Lanreotide decreases hormone levels in the body, such as growth hormone (GH) and insulin-like growth factor-1 (IGF-1), and inhibits the release of some hormones in the gastrointestinal tract and intestinal secretions. Additionally, it has an effect on certain types of tumors (called neuroendocrine tumors) of the intestine and pancreas, advanced, by stopping or slowing their growth.

What Lanreotida Sun is used for:

• Long-term treatment of acromegaly (a condition in which the body produces too much growth hormone).
• Relief of symptoms associated with acromegaly – such as feeling tired, headache, sweating, joint pain, and numbness of hands and feet.
• Relief of symptoms such as hot flashes and diarrhea, which sometimes occur in patients with neuroendocrine tumors (NETs).
• Treatment and control of the growth of certain tumors of the intestine and pancreas, called gastroenteropancreatic neuroendocrine tumors or GEP-NETs. It is used when these tumors are advanced and cannot be removed by surgery.

2. What you need to know before you use Lanreotida Sun

Do not use Lanreotida Sun

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with this medicine:

• If you are diabetic, as lanreotide may affect your blood sugar levels. Your doctor will check your blood sugar levels and may modify your antidiabetic treatment while you are receiving lanreotide.
• If you have gallstones, as lanreotide may favor the formation of gallstones in the gallbladder. In this case, you may need to undergo periodic checks. Your doctor may decide to suspend treatment with lanreotide if complications arise from gallstones.
• If you have thyroid problems, as lanreotide may slightly decrease your thyroid function.
• If you suffer from heart problems, as treatment with lanreotide may cause sinus bradycardia (decreased heart rate). Caution should be exercised when starting treatment with lanreotide in patients with bradycardia (heart rhythm disorder).

Talk to your doctor or pharmacist if you have any of the above before using lanreotide.

Talk to your doctor or pharmacist during treatment:

• If you have greasy stools, soft stools, abdominal distension, or weight loss, as lanreotide may affect the secretion of pancreatic enzymes involved in food digestion.

Children and adolescents

The use of lanreotide is not recommended in children and adolescents.

Other medicines and Lanreotida Sun

Some medicines may have an effect on the action of other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

You should be especially careful when administering together with:

• Ciclosporin(a medicine that reduces immune reactions and is usually used after a transplant or in case of autoimmune disease),
• Bromocriptine(a dopamine agonist used in the treatment of certain types of brain tumors and Parkinson's disease or to prevent lactation after childbirth),
• Antidiabetic medicines(medicines that reduce high blood sugar levels),
• Medicines that induce bradycardia(medicines that decrease heart rate, such as beta-blockers).

Your doctor will decide if adjustments need to be made to the dose of these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Lanreotide should only be administered if it is really necessary.

Driving and using machines

It is unlikely that treatment with lanreotide will affect your ability to drive vehicles or use machinery, but you may experience side effects such as dizziness. If you do, you should not drive or use machines.

3. How to use Lanreotida Sun

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose

Treatment of acromegaly

The recommended dose is one injection every 28 days. Your doctor may adapt the dose of your injection using one of the three available doses of Lanreotida Sun (60, 90, or 120 mg).

If you are well-controlled with your treatment, your doctor may recommend changing the frequency of your Lanreotida Sun injections to one injection of 120 mg every 42 or 56 days.

Your doctor will also decide on the duration of treatment.

Relief of symptoms (such as hot flashes and diarrhea) associated with neuroendocrine tumors

The recommended dose is one injection every 28 days. Your doctor may adapt the dose of your injection using one of the three available doses of Lanreotida Sun (60, 90, or 120 mg).

If you are well-controlled with a somatostatin analogue or with Lanreotida Sun 60 mg or 90 mg, your doctor may recommend changing the frequency of your injections to one injection of Lanreotida Sun 120 mg every 42 or 56 days.

Your doctor will also decide on the duration of treatment.

Treatment of tumors of the intestine and pancreas, called gastroenteropancreatic neuroendocrine tumors or GEP-NETs. It is used when these tumors are advanced and cannot be removed by surgery.

The recommended dose is 120 mg every 28 days. Your doctor will decide on the duration of treatment with lanreotide for tumor control.

Method of administration

Lanreotida Sun should be administered by deep subcutaneous injection.

The injection should be administered by a healthcare professional or by a caregiver (family member or friend) or by yourself after receiving adequate training from a healthcare professional.

The decision to self-administer or have someone else administer it should be made by your doctor. If you have any doubts about how to administer this injection at any time, contact your doctor or healthcare professional for advice or additional training.

If a healthcare professional or someone trained to do so (family member or friend) is administering the injection, it will be given in the upper outer quadrant of the buttock or in the upper outer part of the thigh (see figures 5a and 5b below).

If you are self-administering the injection after adequate training, inject it into the upper outer part of the thigh (see figure 5b below).

Instructions for use:

Caution: please read all the instructions carefully before starting the injection of the product. The injection is deep subcutaneous and requires a specific technique different from normal subcutaneous injections.

The following instructions explain how to inject Lanreotida Sun.

Lanreotida Sun is supplied in a pre-filled syringe ready for use with a safety system. The needle will be automatically hidden after complete administration of the product to prevent possible needlestick injuries.

If you use more Lanreotida Sun than you should:

If you have injected more Lanreotida Sun than you should, inform your doctor.

If you have injected or have been administered too much Lanreotida Sun, you may experience additional or more severe side effects (see section 4. “Possible side effects”).

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Lanreotida Sun

As soon as you realize you have forgotten an injection, consult your doctor and they will decide when you should receive the next injection. Do not self-administer additional injections to make up for forgotten injections without consulting your healthcare professional.

If you stop treatment with Lanreotida Sun

A break of more than one dose or premature termination of treatment with Lanreotida Sun may affect the efficacy of the treatment. Consult your doctor before stopping treatment.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Tell your doctor immediately if you notice any of the following adverse effects:

• Being thirstier or more tired than usual, and having a dry mouth. These can be signs that you have high blood sugar levels or are developing diabetes.
• Feeling hungry, trembling, increased sweating, or feeling confused. These can be signs of low blood sugar levels.

The frequency of these adverse effects is frequent, they can affect up to 1 in 10 people.

Tell your doctor immediately if you notice that:

• Your face turns red or swollen or you get spots or a rash
• You feel pressure in your chest, have difficulty breathing, or wheezing
• You feel dizzy, possibly due to a drop in blood pressure.

These symptoms can be the result of an allergic reaction.

The frequency of these secondary effects is unknown; it cannot be estimated from the available data.

Other Adverse Effects

Tell your doctor or pharmacist if you experience any of the following adverse effects.

The most frequent adverse effects are gastrointestinal disorders, problems with the gallbladder, and reactions at the injection site. The adverse effects that may occur with Lanreotide Sun are listed below according to their frequencies.

Very frequent (may affect more than 1 in 10 people):

• Diarrhea, soft stools, abdominal pain
• Gallstones, and other gallbladder disorders. You may have symptoms such as severe and sudden abdominal pain, high fever, jaundice (yellowing of the skin and whites of the eyes), chills, loss of appetite, itching of the skin.

Frequent (may affect up to 1 in 10 people)

• Weight loss
• Lack of energy
• Slow heartbeats
• Feeling very tired
• Decreased appetite
• Feeling weak
• Excess fat in the stool
• Feeling dizzy, having a headache
• Hair loss or decreased body hair
• Pain in the muscles, ligaments, tendons, and bones
• Reactions at the injection site such as pain, skin hardening, or itching
• Anomalies in liver and pancreas test results and changes in blood sugar levels
• Nausea, vomiting, constipation, gas, bloated stomach, or discomfort, indigestion
• Bile duct dilation (enlargement of the bile ducts between the liver and the gallbladder and the intestine). You may have symptoms such as stomach pain, nausea, jaundice, and fever.

Uncommon (may affect up to 1 in 100 people)

• Hot flashes
• Difficulty sleeping
• Change in stool color
• Changes in blood test results for sodium and alkaline phosphatase levels

Frequency not known: the frequency cannot be estimated from the available data

• Sudden, severe pain in the lower abdomen. This can be a sign of pancreatitis.
• Redness, pain, heat, and swelling at the injection site that may feel filled with fluid when pressed, fever. This can be a sign of an abscess.
• Sudden and severe pain in the upper right or central abdomen, which can extend to the shoulder or back, abdominal tenderness, nausea, vomiting, and high fever. This can be a sign of cholecystitis.
• Pain in the upper right abdomen, fever, chills, yellowing of the skin and eyes, nausea, vomiting, clay-colored stools, dark urine, fatigue. These can be signs of cholangitis.
• Decrease in pancreatic enzymes. Since lanreotide can affect the release of pancreatic enzymes involved in food digestion, you may have symptoms such as fatty stools, soft stools, abdominal distension, or weight loss.

Since lanreotide can alter your blood sugar levels, your doctor may want to monitor your blood sugar levels, especially at the start of treatment.

Similarly, as gallbladder disorders can occur with this type of medication, your doctor may want to monitor your gallbladder at the start of treatment and from time to time once treatment has begun.

Tell your doctor or pharmacist if you experience any of the above-mentioned adverse effects.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lanreotide Sun

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiration date that appears on the packaging and label after CAD. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C) in the original packaging to protect it from light.

Once out of the refrigerator, the product that remains in its sealed pouch can be returned to the refrigerator (the number of temperature excursions should not exceed three) for storage and subsequent use, provided it has been stored for no more than a total of 72 hours below 30 °C.

Each syringe is packaged individually.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lanreotide Sun

Each pre-filled syringe contains a supersaturated solution of lanreotide acetate corresponding to 0.246 mg of lanreotide base/mg of solution, which ensures a real injection dose of 60 mg, 90 mg, and 120 mg of lanreotide, respectively.

The other components are:

Water for injectable preparations

Glacial acetic acid (for pH adjustment)

Appearance of the Product and Package Contents

Lanreotide Sun is a viscous injectable solution in a pre-filled syringe, ready for use, with an automatic safety system. Semi-solid formulation with a white to pale yellow color.

Each pre-filled syringe is packaged in a laminated pouch and a cardboard box. Package sizes:

Box containing a 0.5 ml syringe with an automatic safety system and a needle (1.2 mm x 20 mm).

Box with three pouches, each containing a pre-filled syringe of 0.5 ml and a needle (1.2 mm x 20 mm).

1 syringe of 60 mg, 3 syringes of 60 mg

1 syringe of 90 mg, 3 syringes of 90 mg

1 syringe of 120 mg, 3 syringes of 120 mg

Only some package sizes may be marketed.

Translation of the Information on the Pre-filled Syringe:

The product name is Lanreotide

Deep s.c. - deep subcutaneous injection

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH, Hoofddorp

Netherlands

Manufacturer:

Terapia SA

124 Fabricii Street,

400632, Cluj-Napoca,

Romania

or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH, Hoofddorp

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Sun Pharma Laboratories, S.L.

Rambla de Catalunya 53-55

08007-Barcelona

Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

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 eloretöltött fecskendoben

Lanreotid SUN 90 mg oldatos injekció eloretöltött fecskendoben

Lanreotid SUN 120 mg oldatos injekció eloretöltött fecskendoben

Ireland: Lanreotide SUN 60 mg solution for injection in a prefilled syringe

Lanreotide SUN 90 mg solution for injection in a prefilled syringe

Lanreotide SUN 120 mg solution for injection in a prefilled syringe

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 solutie injectabila în seringa preumpluta

Lanreotida Terapia 90 mg solutie injectabila în seringa preumpluta

Lanreotida Terapia 120 mg solutie injectabila în seringa preumpluta

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 injekcný roztok v naplnenej injekcnej striekacke

Lanreotid SUN 90 mg injekcný roztok v naplnenej injekcnej striekacke

Lanreotid SUN 120 mg injekcný roztok v naplnenej injekcnej striekacke

Revision Date of this Prospectus: 10/2024

Other Sources of Information

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es