Prospecto: information for the user

SOMATULINA AUTOGEL 120 mg injectable solution preloaded syringe

Lanreotide

Read the entire prospect carefully before starting to use the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

Content of theprospect:

1. What SOMATULINA AUTOGEL 120 mg is and for what it is used.
2. What you need to know before starting to use SOMATULINA AUTOGEL 120 mg.
3. How to use SOMATULINA AUTOGEL 120 mg.
4. Possible adverse effects.
5. Storage of SOMATULINA AUTOGEL 120 mg.

6. Content of the package and additional information

The name of the medication is SOMATULINA AUTOGEL 120 mg.

It is a prolonged-release formulation of lanreotide. It is an injectable solution for exclusive administration via deep subcutaneous injection. This supersaturated solution is packaged in a preloaded 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 some types of tumors (called neuroendocrine tumors) of the intestine and pancreas, advanced, by stopping or delaying their growth.

What is SOMATULINA AUTOGEL 120 mg 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 some tumors of the intestine and pancreas, called gastroenteropancreatic neuroendocrine tumors or NETs-GEP. It is used when these tumors are advanced and cannot be removed by surgery.

Do not use SOMATULINA AUTOGEL:

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

Warnings and precautions

Consult your doctor before starting to use this medication:

• If you arediabetic, 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 havegallstones(stones in the gallbladder), as lanreotide may promote the formation of gallstones in the gallbladder. In this case, you may need to undergo regular check-ups. Your doctor may decide to suspend lanreotide treatment if complications arise from gallstones.

• If you havethyroid problems, as lanreotide may slightly decrease your thyroid function.

• If you suffer fromheart problems, as lanreotide treatment may cause sinus bradycardia (decreased heart rate). Caution should be exercised when starting lanreotide treatment in patients with bradycardia.

Speak with your doctor or pharmacist if you experience any of the above before using SOMATULINA AUTOGEL.

Speak with your doctor or pharmacist during treatment:

• If you have fatty 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 medications and SOMATULINA AUTOGEL

Some medications may affect the action of other medications.Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

You should exercise special caution in the case of concomitant administration with:

• Ciclosporin(a medication that reduces immune reactions, often used after a transplant or in 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).
• Medications that induce bradycardia(medications that decrease heart rate such as beta-blockers).

Your doctor will decide if adjustments should be made to the dose of these medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Lanreotide should only be administered if it is truly necessary.

Driving and operating machinery

It is unlikely that treatment withSOMATULINA AUTOGELwill affect your ability to drive vehicles or operate machinery, but it is possible that adverse effects such as dizziness may occur. If you experience them, be careful when driving or operating machinery.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Recommended dose

Treatment of acromegaly

The recommended dose is an injection every 28 days. Your doctor may adjust 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 a change in the frequency of your SOMATULINA AUTOGEL 120 mg injections to every 42 or 56 days.

Your doctor will also decide the duration of treatment.

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

The recommended dose is an injection every 28 days. Your doctor may adjust 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 the duration of treatment.

Treatment of tumors of the intestine and pancreas, called gastroenteropancreatic neuroendocrine tumors (TNEs-GEP). 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 the duration of treatment with SOMATULINA AUTOGEL for tumor control.

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

Administration method:

SOMATULINA AUTOGEL must be administered by subcutaneous injection.

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

Your doctor must be the one to decide on self-administration of the medication or have it administered by another instructed person. If you have any doubt on how to administer this injection at any time, contact your doctor or healthcare professional for advice or additional training.

If administered by a healthcare professional or an instructed person (family member or friend), the injection will be administered in the upper outer quadrant of the buttock or in the upper outer part of the thigh (see figure 5a and 5b below).

If you inject it yourself after proper training, inject it in the upper outer part of the thigh (see figure 5b below).

Instructions for use:

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

The following instructions explain how to inject SOMATULINA AUTOGEL.

SOMATULINA AUTOGEL is supplied in the form of 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 needlesticks.

1. TakeSOMATULINA AUTOGELout of the refrigerator 30 minutes before administration. The injection of the cold medication could be painful. Keep the laminated packagecloseduntil just before the injection.

1. Attention: before opening the package, 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 fallen or been damaged, or if the pre-filled syringe or package appears to be damaged in any way.
• If the product has expired; the expiration date is printed on the outer box and on the package.

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

1. Wash your hands with soap.
2. Open the package by tearing 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 microbubbles that may disappear during injection. These differences are normal and do not affect the quality of the product.

After opening the laminated package, the product must 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 in the upper outer part of the thigh.
   2. If you are administering the injection yourself: 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 a SOMATULINA AUTOGEL injection. 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 at the injection site using the 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 an arrow) torapidlyinsert the needle perpendicularly into the skin (90° angle) in its entire length.
   It is very important to insert the needlecompletely. You should not see any part of the needle once it has been inserted completely.

Do not aspirate(do not withdraw)

1. Release the stretched injection site. Press the plunger with afirm and constant pressure. The medication is denser and more difficult to push than you might expect.It usually takes about 20 seconds. Inject theentire doseand press one last time to ensure that the plunger has reached the end.

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

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

1. Once the needle is withdrawn, stop pressing on the plunger. The needle will automatically retract into the safety device where it will remain permanently closed.

1. Apply a light pressure to the injection site with a dry cotton swab or a sterile gauze to prevent any 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:

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

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

If you forgot to useSOMATULINA AUTOGEL:

As soon as you realize you have forgotten a dose, consult your doctor and he will decide when you should administer the next dose. Do not self-administer additional doses to compensate for the missed doses without consulting your healthcare professional.

If you interrupt treatment with SOMATULINA AUTOGEL

A break of more than one dose or premature termination of treatment with SOMATULINA AUTOGEL may affect the effectiveness of treatment. Consult your doctor before interrupting treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you notice any of the following side effects:

• Feeling more thirsty or more tired than normal, and having a dry mouth. These may be signs that you have high blood sugar levels or are developing diabetes.
• Feeling hungry, trembling, excessive sweating, or feeling confused. These may be signs of low blood sugar levels.

The frequency of these side effects is common, and they can affect up to 1 in 10 people.

Inform your doctor immediately if you notice that:

• Your face becomes red or swollen, or you develop rashes or an eruption.
• You feel pressure in your chest, have difficulty breathing, or experience wheezing.
• You feel dizzy, possibly due to a drop in blood pressure.

These symptoms may be the result of an allergic reaction.

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

Other side effects

Inform your doctor or pharmacist if you experience any of the following side effects.

The most common side effects are gastrointestinal disturbances, gallbladder problems, and reactions at the injection site. The side effects that can occur with SOMATULINA AUTOGEL are listed below, according to their frequencies.

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

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

Common (may affect up to 1 in 10 people)

• Weight loss
• Lack of energy
• Slow heart rate
• Feeling extremely tired
• Decreased appetite
• Feeling weak
• Excess fat in the stool
• Sensation of dizziness, having a headache
• Loss of hair or decreased body hair
• Muscle, ligament, tendon, and bone pain
• Reactions at the injection site, such as pain, skin hardening, or itching
• Abnormalities in liver and pancreas analytical results and changes in blood sugar levels
• Nausea, vomiting, constipation,gas, bloated stomach, or discomfort, indigestion
• Biliary dilation (enlargement of the bile ducts between the liver and the gallbladder and the intestine). You may have symptoms such as abdominal pain, nausea, jaundice, and fever

Rare (may affect up to 1 in 100 people)

• Headaches
• Difficulty sleeping
• Change in stool color
• Changes in blood sodium and alkaline phosphatase levels

Unknown frequency: the frequency cannot be calculated from the available data

• Sudden, sharp pain in the lower part of the stomach. This may 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 may be a sign of abscess.
• Sudden and sharp pain in the upper right or central part of the abdomen, which may extend to the shoulder or back, abdominal sensitivity, nausea, vomiting, and high fever. This may be a sign of gallbladder inflammation (cholecystitis).
• Pain in the upper right part of the abdomen (abdomen), fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-colored stools, dark urine, fatigue. These may 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 beginning of treatment.

Similarly, as gallbladder disturbances can occur with this type of medication, your doctor may want to monitor your gallbladder at the beginning of treatment and occasionally once treatment has started.

Inform your doctor or pharmacistif you experience any of the side effects mentioned above.

Reporting side effects:

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

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

Do not use this medication after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

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

Once removed from the refrigerator, the product that remains in its sealed pouch may 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 medication if the packaging is damaged or open.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of SOMATULINA AUTOGEL

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

Appearance of the product and contents of the packaging

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 and attached needle (1.2 mm x 20 mm).

Holder of the marketing authorization and responsible manufacturer

- Holder of the marketing authorization:

IPSEN PHARMA, S.A.U.

Gran Via de les Corts Catalanes 130-136

08038 Barcelona

Spain

- Responsible manufacturer:

IPSEN PHARMA BIOTECH

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

83870 Signes

France

Review date of this leaflet: February 2025

Other sources of information

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es