Leaflet: information for the user

Myrelez 60mg pre-filled syringe EFG

Myrelez 90mg pre-filled syringe EFG

Myrelez 120mg pre-filled syringe EFG

lanreotida

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Myrelez and what it is used for

2. What you need to know before using Myrelez

3. How to use Myrelez

4. Possible side effects

5. Storage of Myrelez

6. Contents of the pack and additional information

Myrelez contains the active ingredient lanreotide, which belongs to a group of medications calledgrowth hormone inhibitors. It is similar to another substance (a hormone) calledsomatostatin.

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 (calledneuroendocrine tumors) of the intestine and pancreas, advanced, by stopping or delaying their growth.

What is Myrelez used for:

• Treatment of acromegaly (a condition in which the body produces too much growth hormone).
• 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, in an advanced stage, calledgastroenteropancreatic neuroendocrine tumorsor NETs-GEP. It is used when these tumors cannot be removed.

Do not use Myrelez:

-if you are allergic to lanreotide, somatostatin, or other medications in the same family (somatostatin analogs) or to any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Myrelez:

• If you arediabetic, as lanreotide may affect your blood sugar levels. Your doctor will check your blood sugar levels and may adjust 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.

Talk to your doctor or pharmacist if you experience any of the above before using Myrelez.

Children

Myrelez is not recommended for use in children.

Other medications and Myrelez

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 when taking:

• Ciclosporin(a medication that reduces immune reactions; often used after a transplant or in autoimmune diseases).
• 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 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 Myrelez treatment will 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 as 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 28days. Your doctor may adjust the dose of your injection using one of the three available doses of Myrelez (60, 90 or 120mg).

If you are well controlled with your treatment, your doctor may recommend a change in the frequency of your Myrelez 120mg injections to every 42 or 56days. Any change in dose will depend on the symptoms you experience and how you respond to the medication.

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 28days. Your doctor may adjust the dose of your injection using one of the three available doses of Myrelez (60, 90 or 120mg).

If you are well controlled with your treatment, your doctor may recommend a change in the frequency of your Myrelez 120mg injections to every 42 or 56days.

Your doctor will also decide the duration of treatment.

Treatment of tumors of the intestine and pancreas, calledgastroenteropancreatic neuroendocrine tumors (GEP-NETs)when these tumors are advanced and cannot be removed by surgery.

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

Method of administration

Myrelez must be administered by subcutaneous injection.

The injection should be administered in the upper outer quadrant of the buttock by a healthcare professional or a trained caregiver (family member or friend).

If after being taught how to self-administer the injection, you administer it yourself, the injection should be placed in the upper outer thigh.

Your doctor should decide whether to administer the medication yourself or have it administered by another trained person.

INSTRUCTIONS FOR USE

If you use more Myrelez than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have injected or have been given too much Myrelez, you may experience additional or more severe side effects (see section4 «Possible side effects»).

If you forget to use Myrelez

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 missed doses without consulting your healthcare professional.

If you interrupt treatment with Myrelez

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

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

Like all medicines, this medicine may 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.

These side effects are frequent and may affect up to 1 in 10 people.

Inform your doctor immediately if you notice that:

• Your face becomes red or swollen or you develop 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 may be a sign 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 immediately 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 Myrelez are listed below, according to their frequencies.

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

• Weight loss
• Lack of energy
• Slow heart rate
• Feeling very tired
• Loss of 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 and skin hardening
• 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

Uncommon: may affect up to 1 in 100 people:people:

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

Frequency not known: the frequency cannot be estimated 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, sharp pain in the upper right or central part of the abdomen, which may radiate 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).

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 pharmacist if you experience any of the side effects mentioned above.

Reporting side effects

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

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

Do not use this medication after the expiration date that appears on the box and label after "CAD". The expiration date is the last day of the month indicated.

The product must be administered immediately after opening the aluminum protective pouch.

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

Each syringe is individually packaged.

Medicines should not be thrown down the drain or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Myrelez

• The active ingredient is lanreotide (60 mg, 90 mg or 120 mg).
• The other components are water for injection and glacial acetic acid (for pH adjustment).

Appearance of the product and contents of the package

Myrelez is an injectable viscous solution, contained in a semi-transparent plastic syringe of 0.5 ml volume and accompanied by a single-use needle with a safety device. Myrelez is presented in a semi-solid formulation of a light yellow color.

Each preloaded syringe is packaged in an aluminum bag and a cardboard box.

Box with a 0.5 ml syringe and a safety needle co-packaged (1.2 mm × 20 mm).

Multiple packaging with three boxes, each containing a 0.5 ml syringe with a co-packaged safety needle (1.2 mm × 20 mm).

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Amdipharm Limited

3 Burlington Road

Dublin 4,

Ireland

Responsible for manufacturing

Pharmathen S.A

Dervenakion 6,

Pallini Attiki, 15351,

Greece

Pharmathen International S.A

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

Local representative:

Advanz Pharma Spain S.L.U.

Paseo de la Castellana 135, 7ª

28046 Madrid (Spain)

Tel. +34 900 834 889

[email protected]

Last review date of this leaflet:June 2024.

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