What it is and what it is used for

for

Lanreotide Solution for Injection contains the active substance lanreotide, which belongs to a group of medicines called "Antigrowth hormones". It is similar to another substance (a hormone) called "somatostatin". Lanreotide lowers the levels of hormones 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 advanced type of tumours (called neuroendocrine tumours) of the intestine and pancreas by stopping or delaying their growth. What Lanreotide Solution for Injection is used for:

• The treatment of acromegaly (a condition where your body produces too much growth hormone)
• The relief of symptoms such as flushing and diarrhoea that sometimes occur in patients with neuroendocrine tumours (NETs)
• The treatment and control of the growth of some advanced tumours of the intestine and pancreas called gastroenteropancreatic neuroendocrine tumours or GEP-NETs. It is used when these tumours cannot be removed by surgery. 2.

What you need to know before you take it

e Lanreotide Solution for Injection

Do not use Lanreotide Solution for Injection:

• if you are allergicto lanreotide, somatostatin or drugs from the same family (analogues of somatostatin) or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before using Lanreotide Solution for Injection:

–

If you are diabetic, as Lanreotide Solution for Injection may affect your blood sugar levels. Your doctor may check your blood sugar levels and possibly alter your anti-diabetic treatment while you are receiving Lanreotide Solution for Injection If you have gallstones, as Lanreotide Solution for Injection may lead to gallstone formation in the gallbladder. In this case, you may need to be monitored periodically. Your doctor may decide to stop treatment with lanreotide if complications arising from gallstones occur If you have any thyroid problems, as Lanreotide Solution for Injection may slightly decrease your thyroid function If you have cardiac disorders, as sinus bradycardia (slower heart beat) may occur under Lanreotide Solution for Injection treatment. Special care should be taken when initiating treatment with Lanreotide Solution for Injection in patients with bradycardia.

If any of the above applies to you, talk to your doctor or pharmacist before using Lanreotide Solution for Injection. Children and adolescents Lanreotide Solution for Injection is not recommended in children and adolescents. Other medicines and Lanreotide Solution for Injection Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Special care should be taken in case of co-administration with:

• Ciclosporin (a drug reducing immune reactions e.g. after transplantation or in cases of autoimmune disease)
• Bromocriptine (dopamine agonist used in the treatment of certain types of tumours of the brain and Parkinson's disease, or to prevent lactation following childbirth)
• Bradycardia inducing drugs (drugs slowing the heart beat, e.g beta blockers). Dose adjustments of such concomitant medications may be considered by your doctor. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If so, Lanreotide Solution for Injection should be given to you only if clearly needed. Driving and using machines Lanreotide solution for injection has minor or moderate influence on the ability to drive or use machines, however possible side effects such as dizziness may occur with Lanreotide Solution for Injection. If you are affected be careful when driving or using machinery. 3.

How to take it

Lanreotide Solution for Injection

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. 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 strengths of Lanreotide Solution for Injection (60, 90 or 120mg). If you are well controlled on your treatment, your doctor can recommend a change in the frequency of your Lanreotide120 mg injections to one injection every 42 or 56 days. Any change in dose will depend on your symptoms and how you respond to the medicine.

Your doctor will also decide how long you should be treated for. Relief of symptoms (such as flushing and diarrhoea) associated with neuroendocrine tumours The recommended dose is one injection every 28 days. Your doctor may adapt the dose of your injection using one of the three available strengths of Lanreotide Solution for Injection (60, 90 or 120 mg). If you are well-controlled on your treatment, your doctor can recommend a change in the frequency of your Lanreotide120 mg injections to one injection every 42 or 56 days. Your doctor will also decide how long you should be treated for. Treatment of advanced tumours of the intestine and pancreas called gastroenteropancreatic neuroendocrine tumours or GEP-NETs. Used when these tumours cannot be removed by surgery. The recommended dose is 120 mg every 28 days. Your doctor will decide how long you should be treated with Lanreotide Solution for Injection for tumour control. Method of administration Lanreotide Solution for Injection should be administered by deep subcutaneous injection. If the injection is being given by a healthcare professional (HCP) or someone else or a caregiver (family member or friend), the injection will be given in the upper, outer external quadrant of the buttock (see figures in section B6 below). If you are injecting yourself after appropriate training from an HCP, the injection should be given in the upper outer thigh. The decision regarding self-administration or administration by another trained person should be taken by your doctor. If you have any doubt on how to administer this injection at any time please contact your doctor or HCP for advice or further training. INSTRUCTION FOR USE Attention: Please read all the instructions carefully before starting the injection. The injection is a deep subcutaneous injection that requires a specific technique different to normal subcutaneous injections. Detailed and up-to-date information on the instructions for use of this medicine is available by scanning the QR code included in the PL with a smartphone/device. The same information is also available at the following URL: https://www.advanzpharma.com/lanreotideadvanzpharmapil A. What's in the box The following instructions explain how to inject Lanreotide Solution for Injection Please read all instructions carefully before starting the injection.

The content of the prefilled syringe is a semi-solid phase having a gel-like appearance, with viscous characteristics and a colour varying from white to pale yellow. The supersaturated solution can also contain micro bubbles that can clear up during injection. These differences are normal and do not interfere with the quality of the product. B. Before your start B1. Remove Lanreotide Solution for Injection from the refrigerator 30 minutes prior to injecting. This allows the lanreotide solution to reach room temperature, to minimize pain reaction to cold medication. Keep the laminated pouch sealed until just before the injection.

30 minutes B2. Before opening the pouch, check that it is intact and that the medication has not expired. The expiry date is printed on the outer carton and the pouch – Do not use if the medication has expired or if the pouch is damaged. B3. Wash hands with soap and dry hands thoroughly before starting. B4. Make sure there is a clean surface for preparation. B5. Tear open the pouch and take out the pre-filled syringe.

After opening the protective laminated pouch, the product should be administered immediately. B6. Choose injection site – the sites are shown below.

If you are injecting someone else: Inject into the upper outer area of the buttock.

If you are injecting yourself: Inject into the upper outer part of your thigh.

Alternate the injection site between the right and left side each time you have an injection of Lanreotide Solution for Injection. Avoid areas with moles, scar tissue, reddened skin, or skin that feels bumpy. Please note that the injection site cannot be changed once the needle has been inserted. B7. Make sure to clean the injection site. C. Get the syringe ready C1: Open the needle pack

• Hold the needle pack and pull the lid off.
• Caution: Do not touch the open end of the needle pack. This needs to stay clean.

C2: Remove the cap from the syringe

• With one hand, hold the syringe barrel steady (not the plunger).
• With the other hand, remove the cap by twisting it.

C3: Put the end of the syringe into open end of the needle pack

• Hold the needle pack with one hand.
• With the other, hold the syringe barrel steady (not the plunger) and screw the syringe in clockwise direction onto the needle until the syringe and needle are fully locked together. Ensure that the needle pack is in line with the syringe barrel while screw.
• They are fully locked when you cannot turn it any further. Important: Tight the syringe firmly to avoid drug leakage.

C4: Remove the needle from the pack

• Hold the syringe barrel (not the plunger).
• Pull the needle straight out from the needle pack without

twisting or turning to make sure that the syringe is well connected to the safety needle. Caution: The needle is partially exposed from this step onwards.

• NEVER TOUCH OR TRY TO OPEN THE GREEN NEEDLE

SHIELD

• GREEN NEEDLE SHIELD is NOT a removable cap or cover

for the needle.

• GREEN NEEDLE SHIELD will automatically activate during

the needle insertion.

• GREEN NEEDLE SHIELD will automatically cover and lock

around the needle once the injection is complete.

• GREEN NEEDLE SHIELD is a self-operating safety lock

mechanism.

D. Perform injection D1: Position the syringe

• To check which site you should use, refer to section B.
• Stretch the skin around the injection site flat and tight using your thumb and index finger. Do not pinch the skin
• Hold the lower part of the syringe barrel (not the plunger) with your other hand.
• Position the syringe at a 90-degree angle to the skin.

D2: Insert the needle

• Without folding or pressing on the skin at the injection site,

push the needle firmly against the skin.

• Insert the needle perpendicular to the skin (90-degree angle),

all the way into the skin. The Green needle shield will retract, and the safety mechanism will activate.

• Continue to insert the needle until only the collar of the Green needle shield is visible.
• Note: Maintain this position until the injection is completed. Avoid pulling the needle back/outward, as the safety functions may be triggered prematurely.
• Do not push the plunger in this step. Hold the syringe in this position for the next step. Note: during injection, maintain pressure on the needle to avoid activation of the automatic safety system

D3: Push the top of the plunger

• Release injection site that has been flattened by your hand.
• Move your hand from the skin to the plunger.
• Push the plunger slowly but steady with very firm pressure without interruption until the top touches the syringe barrel (it is easier to depress the plunger with your dominant hand).
• The medication is thicker and harder to push than you might expect. Inject the full dose and give a final push to make sure you cannot depress it any further.

• This should take around 20 seconds.

E. Remove and throw away syringe

E1: Remove from the skin Lift the syringe straight up and away from your body. The Green needle shield will cover the needle.

• •

E2: Apply gentle pressure

• Apply gentle pressure to the injection site with a dry cotton

ball or sterile gauze to prevent any bleeding.

• Do not rub or massage the injection site after administration.

E3: Throw away

• Dispose of the used syringe and needle according to your

local laws and regulations or how your doctor has shown you.

• The needles are not reusable.
• Do not dispose of the syringe or needle in your general

household rubbish.

If you use more Lanreotide Solution for Injection than you should If you have injected more Lanreotide Solution for Injection than you should, please tell your doctor. If you have injected or if you are given too much Lanreotide Solution for Injection you may experience additional or more severe side effects (see section 4 "Possible Side Effects"). If you forget to use Lanreotide Solution for Injection As soon as you realise that you have missed an injection, contact your healthcare professional, who will give you advice about the timing of your next injection. Do not self-inject extra injections to make up for a forgotten injection, without discussing with your healthcare professional. If you stop using Lanreotide Solution for Injection

An interruption of more than one dose or early termination of the Lanreotide Solution for Injection treatment can affect the success of the treatment. Please talk to your doctor before you stop the treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.

Possible side effects

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

• Feeling more thirsty or tired than usual, and having a dry mouth. These may be signs that you have high blood sugar levels or are developing diabetes.
• Feeling hungry, shaky, sweating more than usual or feeling confused. These may be signs of low blood sugar levels. The frequency of these side effects is common, it may affect up to 1 in 10 people. Tell your doctor immediately if you notice that:
• Your face becomes flushed or swollen or you develop spots or a rash
• Your chest feels tight, you become short of breath or wheezy
• You feel faint, possibly as a result of a drop in blood pressure. These might be the result of an allergic reaction. The frequency of these side effects is not known; it cannot be estimated from the available data. Other side effects Tell your doctor or pharmacist if you notice any of the following side effects. The most commonly expected side effects are gastrointestinal disorders, gallbladder problems and injection site reactions. The side effects that could occur with Lanreotide Solution for Injection are listed according to their frequencies below. Very common: may affect more than 1 in 10 people:
• Diarrhoea, loose stools, abdominal pain
• Gallstones and other gallbladder problems. 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, itchy skin. Common: may affect up to 1 in 10 people:
• Weight loss
• Lack of energy
• Slow heart beat
• Feeling very tired
• Decrease in appetite
• Feeling generally weak
• Excess fat in the stools
• Feeling dizzy, having a headache
• Loss of hair or less development of body hair
• Pain that affects muscles, ligaments, tendons and bones
• Reactions where the injection is given such as pain, hard skin or itching
• Abnormal liver and pancreas test results and changes in blood sugar levels
• Nausea, vomiting, constipation, passing wind, stomach bloating or discomfort, indigestion
• Biliary dilatation (enlargement of the bile ducts between your liver and 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 flushes

–

Difficulty sleeping A change in the colour of the stools Changes to sodium and alkaline phosphatase levels, shown in blood tests

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

• Sudden, severe pain in your lower stomach. This may be a sign of an inflamed pancreas (pancreatitis).
• Abscess at the site of injection which may feel fluid-filled when pressed (redness, pain, warmth and swelling which may be associated with fever)
• Inflammation of the gallbladder (cholecystitis) – you may have symptoms such as severe and sudden pain in the upper right or centre abdomen, the pain may spread to the shoulder or back, tenderness of the abdomen, nausea, vomiting and high fever
• Pain in the upper right part of your belly (abdomen), fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-coloured stools, dark urine, tiredness – these may be signs of inflammation of the bile duct (cholangitis). Since Lanreotide Solution for Injection may alter your blood sugar levels, your doctor may want to monitor your blood sugar levels especially at the initiation of the treatment. Similarly, as gallbladder problems can occur with this type of medicine, your doctor may want to monitor your gallbladder when you start receiving Lanreotide Solution for Injection, and from time to time afterwards. Tell your doctor or pharmacist if you notice any of the side effects above. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.

How to store it

Lanreotide Solution for Injection

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 label after [EXP]. The expiry date refers to the last day of that month. After opening the protective aluminum pouch, the product should be administered immediately. Store Lanreotide Solution for Injection in a refrigerator (2°C – 8°C) in the original package in order to protect from light. Once removed from the refrigerator, product left in its sealed pouch may be returned to the refrigerator (the number of temperature excursions must not exceed three times) for continued storage and later use, provided it has been stored for no longer than a total of 72 hours at a maximum temperature of 40 °C. Each syringe is packed individually. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.

Contents of the pack and other information

What Lanreotide Solution for Injection contains The active substance is lanreotide (60 mg, 90 mg or 120 mg) The other ingredients are water for injection and glacial acetic acid (for pH adjustment) What Lanreotide Solution for Injection looks like and contents of the pack Lanreotide Solution for Injection is a viscous solution for injection in a 0.5 mL semi-transparent plastic syringe accompanied with a single use needle-safe device. It is a white to pale yellow semisolid formulation. Each pre-filled syringe is packed in an aluminium pouch and in a carton box. Box of 0.5 mL syringe with one co-packaged safety needle (1.2 mm x 20 mm). Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder ADVANZ PHARMA Limited Unit 17, Northwood House, Northwood Crescent, Dublin 9, D09 V504, Ireland Manufacturer Pharmathen S.A Dervenakion 6, Pallini Attiki, 15351, Greece Pharmathen International S.A Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece ADVANZ PHARMA Limited is part of the ADVANZ PHARMA Group This leaflet was last revised in 02/2025.