SOMATULINA AUTOGEL 60 mg INJECTABLE SOLUTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

SOMATULINA AUTOGEL 60 mg solution for injection in pre-filled syringe

Lanreotide

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 SOMATULINA AUTOGEL 60 mg is and what it is used for
2. What you need to know before you use SOMATULINA AUTOGEL 60 mg
3. How to use SOMATULINA AUTOGEL 60 mg
4. Possible side effects
5. Storage of SOMATULINA AUTOGEL 60 mg
6. Contents of the pack and other information

1. What SOMATULINA AUTOGEL 60 mg is and what it is used for

The name of the medicine is SOMATULINA AUTOGEL 60 mg.

It is a prolonged-release formulation of lanreotide. It is an injectable solution for exclusive subcutaneous administration. This supersaturated solution is packaged in a pre-filled syringe ready for use.

The active substance, lanreotide, belongs to a group of drugs 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 a type of tumor (called neuroendocrine tumors) of the intestine and pancreas, advanced, by stopping or delaying their growth.

What SOMATULINA AUTOGEL 60 mg is used for:

• Treatment of acromegaly (a condition in which the body produces too much growth hormone) in patients for whom conventional treatment is inadequate or ineffective.
• Relief of symptoms such as hot flashes and diarrhea that 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 eliminated by surgery.

2. What you need to know before you use SOMATULINA AUTOGEL 60mg

Do not use SOMATULINA AUTOGEL:

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

Warnings and precautions

Consult your doctor before starting to use this medicine:

• If you are diabetic, as lanreotide may affect your blood sugar levels. Your doctor will review your blood sugar levels and may modify your antidiabetic treatment while you are receiving lanreotide.

• If you have gallstones(stones in the gallbladder), 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 cardiac disorders, as treatment with lanreotide may cause sinus bradycardia (decrease in heart rate). Caution should be exercised when initiating treatment with lanreotide in patients with bradycardia.

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

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

SOMATULINA AUTOGEL is not recommended for use in children and adolescents due to the lack of safety and efficacy data.

Other medicines and SOMATULINA AUTOGEL

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 may need to take any other medicine.

You should be especially careful in case of concomitant administration with:

• Ciclosporin(a medicine that reduces immune reactions, 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)
• 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 SOMATULINA AUTOGEL will affect your ability to drive vehicles or use machinery, but you may experience side effects such as dizziness. If you do, be careful when driving or using machines.

3. How to use SOMATULINA AUTOGEL 60 mg, solution for injection

Follow exactly the administration instructions of this medicine 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 SOMATULINA AUTOGEL (60, 90, or 120 mg). Do not interrupt treatment without your doctor's authorization.

If you are well-controlled with your treatment, your doctor may recommend changing the frequency of your SOMATULINA AUTOGEL 120 mg injections to one injection 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 SOMATULINA AUTOGEL (60, 90, or 120 mg).

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 eliminated by surgery.

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

No dose adjustment is necessary in patients with renal, hepatic, or elderly patients.

Method of administration:

SOMATULINA AUTOGEL 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.

Your doctor should decide whether the medicine should be self-administered or administered by another person instructed to do so. 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 administration is carried out by a healthcare professional or someone instructed to do so (family member or friend), the injection should 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 after adequate training, inject into the upper outer part of the thigh (see figure 5b below).

Instructions for use:

Attention: 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 SOMATULINA AUTOGEL.

SOMATULINA AUTOGEL 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.

1. RemoveSOMATULINA AUTOGEL from the refrigerator 30 minutes before administration. Injection of cold medication could be painful. Keep the laminated pouch closeduntil just before injection.

1. Attention: before opening the pouch, check that it is intact and that the medication has not expired.

Do not use the pre-filled syringe:

• If the pre-filled syringe has been dropped or damaged or if the pre-filled syringe or pouch appears to be damaged in any way.
• If the product has expired; the expiration date is printed on the outer box and on the pouch.

If any of the above applies, you should contact your doctor or pharmacist.

1. Wash your hands with soap.
2. Tear the pouch along the dotted line to open it and remove the pre-filled syringe. The content of the pre-filled syringe is a semi-solid phase with a gel-like appearance, viscous characteristics, and a color that varies from white to pale yellow. The supersaturated solution may also contain micro-bubbles that may disappear during injection. These differences are normal and do not interfere with the quality of the product.

After opening the laminated pouch, the product should be administered immediately.

1. Select an injection site:
   1. If a healthcare professional or a trained family member or friend is administering the injection: use the upper outer quadrant of the buttock or the upper outer part of the thigh.
   2. If you are self-administering: use the upper outer part of the thigh.

or injection by a healthcare professional

• Alternate the injection sitebetween the left and right side each time you receive an injection of SOMATULINA AUTOGEL. Avoid areas with moles, scars, red skin, or irregular skin.

1. Clean the injection site.
2. Before injecting, remove the pre-filled syringe from the tray. Discard the tray.

1. Remove the needle cap by pulling it and discard it.

1. Stretchthe skin in the injection area using your thumb and index finger of the hand that is not holding the pre-filled syringe. Do not pinchthe skin. Use a firm and direct movement (like a dart) to quickly insertthe needle perpendicularto the skin (at a 90° angle) in its entirety. It is very important to insert the needle completely. You should not see any part of the needle once it is fully inserted.

Do not aspirate(do not withdraw)

1. Release the injection area that was tense. Press the plunger with constant firm pressure. The medication is denser and harder to push than you might expect. It usually takes about 20 seconds. Inject the full dose and press one last timeto ensure that the plunger has reached the end.

Note: keep pressing the plunger with your thumb to avoid activating the automatic safety system.

1. Without releasing pressure on the plungerwith your thumb, remove the needle from the injection site.

1. Once the needle is removed, stop pressing the plunger. The needle will automatically retract into the sheath where it will remain permanently closed.

1. Apply gentle pressure to the injection site with a dry cotton ball or a sterile gauze to prevent possible bleeding. DO NOT rub or massage the injection site after administration.
2. Dispose of the used syringe according to your doctor's instructions. DO NOT throwthe device in the trash.

If you use moreSOMATULINA AUTOGELthan you should:

Consult your doctor or pharmacist immediately or the Toxicology Information Service, phone 91.562.04.20.

If you have been injected or have been administered too much SOMATULINA AUTOGEL, you may experience additional or more severe side effects (see section 4 "Possible side effects").

If you forget to useSOMATULINA AUTOGEL:

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-inject additional injections to make up for forgotten injections without consulting your healthcare professional.

If you interrupt treatment with SOMATULINA AUTOGEL

An interruption of more than one dose or premature termination of treatment with SOMATULINA AUTOGEL may affect the efficacy of the treatment. Consult your doctor before interrupting 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 may cause adverse effects, although not all people suffer from them.

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

• Being more thirsty 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 a feeling of confusion. 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 as a result of 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, gallbladder problems, and reactions at the injection site. The adverse effects that may occur with SOMATULINA AUTOGEL 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.
• Dizziness, 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 unknown: the frequency cannot be calculated from the available data.

• Sudden, severe pain in the lower abdomen. This can be a sign of pancreatitis (inflammation of the pancreas).
• 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, severe pain in the upper right or central abdomen, which may extend to the shoulder or back, abdominal tenderness, nausea, vomiting, and high fever. This can be a sign of gallbladder inflammation (cholecystitis).
• Pain in the upper right abdomen (abdomen), fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-colored stools, dark urine, fatigue. These can be signs of bile duct inflammation (cholangitis).
• Decreased 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 them 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 SOMATULINA AUTOGEL 60 mg, injectable solution

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after EXP. 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 package can be returned to the refrigerator (the number of temperature excursions will not exceed three) for storage and subsequent use, provided it has been stored for no more than a total of 72 hours at less than 40°C.

Each syringe is individually packaged.

Do not use this medicine if the packaging is damaged or open.

Medicines should not be disposed of via wastewater or household waste. 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 SOMATULINA AUTOGEL

• The active ingredient is lanreotide.
• The other components are: water for injectable preparations, glacial acetic acid.

Appearance of the Product and Package Contents

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

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

The box contains a 0.5 ml pre-filled syringe with an automatic safety system with an attached needle (1.2 mm x 20 mm).

Marketing Authorization Holder and Manufacturer

• Marketing Authorization Holder:

IPSEN PHARMA, S.A.U.

Gran Via de les Corts Catalanes 130-136

08038 Barcelona

Spain

• Manufacturer:

IPSEN PHARMA BIOTECH

Parc d'Activité du Plateau de Signes, C.D. 402,

83870 Signes

France

Date of Revision of this Prospectus: February 2025

Other Sources of Information

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