Lanreotide Zentiva

Package leaflet: Information for the user

Lanreotide Zentiva 60 mg injectable solution in pre-filled syringe, 90 mg injectable solution in pre-filled syringe, 120 mg injectable solution in pre-filled syringe

Lanreotide
Generic medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What is Lanreotide Zentiva and what is it used for

What Lanreotide Zentiva is and how it works
The name of this medicine is Lanreotide Zentiva.
It is a long-acting formulation of Lanreotide Zentiva.
Lanreotide – the active substance – belongs to a group of medicines called “growth hormone inhibitors”.
It is similar to another substance (a hormone) called “somatostatin”.
Lanreotide reduces the levels of certain hormones in the body, such as growth hormone (GH) and insulin-like growth factor type I (IGF-I), and inhibits the release of certain hormones in the gastrointestinal tract and intestinal secretions. Additionally, it has an effect on certain types of tumours (called neuroendocrine tumours) at an advanced stage in the intestine and pancreas, by blocking or slowing their growth.
Lanreotide Zentiva is used for:

• the long-term treatment of acromegaly (a condition in which the body produces too much growth hormone).
• relieving the symptoms associated with acromegaly – such as fatigue, headaches, sweating, joint pain, and numbness in the hands and feet.
• treating symptoms such as hot flushes and diarrhoea that sometimes occur in patients with neuroendocrine tumours (NET).
• treating and controlling the growth of certain advanced-stage tumours of the intestine and pancreas, known as gastroenteropancreatic neuroendocrine tumours or GEP-NET. It is used when these tumours cannot be surgically removed.

2. What you need to know before using Lanreotide Zentiva

Do not use Lanreotide Zentiva

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using this medicine:

• if you have diabetes, because lanreotide may alter blood glucose levels. Your doctor may monitor your blood glucose levels and may need to adjust your anti-diabetic treatment during therapy with lanreotide.
• if you have gallstones, as lanreotide may lead to the formation of gallstones in the gallbladder. In this case, periodic monitoring may be required. Your doctor may decide to discontinue treatment with lanreotide if complications due to gallstones occur.
• if you have thyroid function disorders, as lanreotide may slightly reduce thyroid function.
• if you have heart problems, because during treatment with lanreotide, sinus bradycardia (a slowing of the heart rate) may occur. Caution is required when starting treatment with lanreotide in patients with bradycardia (a heart rhythm disorder).

If any of the above conditions apply to you, consult your doctor or pharmacist before using Lanreotide Zentiva.
Contact your doctor or pharmacist during treatment:

• if you experience fatty stools, diarrhea, abdominal bloating, or weight loss, as lanreotide may affect the secretion of pancreatic enzymes involved in food digestion.

Children and adolescents
Lanreotide Zentiva is not recommended for use in children and adolescents.
Other medicines and Lanreotide Zentiva
Some medicines may interact with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Particular attention is required when administering Lanreotide Zentiva concomitantly with:

• cyclosporine (a medicine that suppresses the immune response, used after organ transplantation or for autoimmune diseases),
• bromocriptine (a dopamine agonist used in the treatment of certain types of brain tumors and Parkinson's disease, or to suppress lactation after childbirth),
• anti-diabetic treatment (medicines that lower elevated blood glucose levels),
• medicines that induce bradycardia (medicines that slow the heart rate, such as beta-blockers).

Your doctor may consider adjusting the dosage of these medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Lanreotide Zentiva should only be administered if strictly necessary.
Driving and using machines
It is unlikely that Lanreotide Zentiva will affect your ability to drive or operate machinery. However, Lanreotide Zentiva may cause side effects such as dizziness. If you experience such effects, you must not drive or operate machinery.

3. How to use Lanreotide Zentiva

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor
or pharmacist.
Recommended dose
Treatment of acromegaly
The recommended dose is one injection every 28 days. Your doctor may adjust the injection dose using one
of the three available strengths of Lanreotide Zentiva (60, 90 or 120 mg).
If your condition is well controlled with treatment, your doctor may recommend changing the injection frequency of Lanreotide Zentiva 120 mg to one injection every 42 or 56 days.
Your doctor will also decide how long you should be treated.

Treatment of symptoms associated with neuroendocrine tumours (such as hot flushes and diarrhoea)
The recommended dose is one injection every 28 days. Your doctor may adjust the injection dose using one
of the three available strengths of Lanreotide Zentiva (60, 90 or 120 mg).
If you are well controlled with a somatostatin analogue or with Lanreotide Zentiva 60 mg or 90 mg, your doctor
may recommend changing the injection frequency of Lanreotide Zentiva 120 mg to one injection
every 42 or 56 days.
Your doctor will also decide how long you should be treated.

Treatment of advanced-stage intestinal and pancreatic tumours, known as gastroenteropancreatic neuroendocrine tumours or GEP-NETs. Used when these tumours cannot be surgically removed.
The recommended dose is 120 mg every 28 days. Your doctor will also decide how long you should be
treated with Lanreotide Zentiva to control the tumour.

Method of administration
Lanreotide Zentiva must be administered via deep subcutaneous injection.
The injection should be given by a healthcare professional (HCP) or by a caregiver (a family member or friend), or by yourself after appropriate training by an HCP.
The decision regarding self-administration or administration by a trained person must be made by your doctor. If you have any doubts about how to administer this injection, contact your doctor or HCP at any time for advice or further instructions.
If the injection is administered by a healthcare professional or another appropriately trained person (relative or friend), it should be given in the upper outer quadrant of the buttock or the upper outer thigh (see below, Fig. 5a and 5b).
For self-administration, after appropriate training, the injection should be given in the upper outer thigh (see below, Fig. 5b).

Instructions for use
Warning: read all instructions carefully before administering the injection.
Administration is performed via a deep subcutaneous injection, which requires a specific technique different from standard subcutaneous injections.
The following instructions explain how to administer Lanreotide Zentiva.
Lanreotide Zentiva is supplied in a ready-to-use pre-filled syringe equipped with an automatic safety system. The needle will automatically retract after complete administration of the product to prevent needlestick injuries.

1. Remove Lanreotide Zentiva from the refrigerator 30 minutes before administration. Injecting a cold medication may be painful. Keep the sealed laminated pouch until just before injection.
2. Warning: Before opening the pouch, check that it is intact and that the medicine has not expired. Do not use the pre-filled syringe: • If you drop or damage the pre-filled syringe, or if the pre-filled syringe or pouch appear damaged in any way. • If the medicine has expired; the expiry date is printed on the outer carton and on the pouch. If any of the above conditions apply, contact your doctor or pharmacist.
3. Wash hands with soap.
4. Open the pouch along the dotted line and remove the pre-filled syringe. The contents of the pre-filled syringe is a semi-solid solution with a gel-like appearance, viscous in consistency, and ranging in colour from white to pale yellow. The supernatant solution may also contain	After opening the protective laminated pouch, the product must be

microbubbles that can be administered immediately.
disappear during
injection. These
differences are normal and
do not interfere with the
quality of the medicine.

5. Choose an injection
   site:
   5a. If the injection is given
   by a healthcare professional (HCP) or a trained family member or friend: use the
   upper outer quadrant of the buttock or the upper outer part of the thigh for
   the injection.
   5b. If self-administering: use the upper outer part of the thigh for the injection.
    Alternate the injection site between the right and left side each time
   an injection of Lanreotide Zentiva is administered. Avoid areas with
   moles, scars, redness, or skin that appears irregular.

6. Clean the injection site.

7. Before performing the
   injection, remove the pre-filled syringe from its container. Discard the
   container.

8. Remove the needle
   protector by pulling it off
   and dispose of it.

9. Stretch the injection area between the thumb and index finger of the hand not holding the pre-filled syringe to stretch the skin. Do not pinch the skin. Use a firm, straight motion to insert the needle quickly and perpendicularly into the skin (at a 90-degree angle), deeply into the subcutaneous tissue. It is very important that the needle be fully inserted. No part of the needle should be visible once it is completely inserted.	Do not aspirate (do not pull back)
10. Release the skin that was previously stretched at the injection site with your hand. Push the plunger with a firm, steady and decisive pressure. The medication is thicker and more difficult to push than one might expect.	Usually 20 seconds are required. Inject the full dose and give a final push, ensuring that no further plunger movement is possible. Note: Maintain pressure on the plunger with your thumb to prevent activation of the automatic safety system.
11. While maintaining pressure on the plunger, remove the needle from the injection site.
12. At this point, release the pressure applied to the plunger. The needle will automatically retract into its housing, where it will remain permanently locked.
permanently.
13. Apply light pressure to the injection site with a dry cotton ball or sterile gauze to prevent possible bleeding. Do not rub or massage the injection site after administration.
14. The syringe must be disposed of properly according to instructions provided by your doctor or other healthcare professional. Do not dispose of the device in household waste.

If you use more Lanreotide Zentiva than you should
If you have injected more Lanreotide Zentiva than you should, inform your doctor.
If you have injected or been administered too much Lanreotide Zentiva, you may experience additional or more severe adverse effects (see section 4 "Possible side effects").

If you forget to use Lanreotide Zentiva
As soon as you realize you have missed an injection, contact your healthcare provider, who will advise you on the timing of the next injection. Do not administer additional injections on your own initiative to make up for the missed dose without first discussing it with your healthcare provider.

If you stop using Lanreotide Zentiva
Interrupting treatment for more than one dose or stopping treatment with Lanreotide Zentiva prematurely may compromise the success of the therapy. Consult your doctor before stopping treatment.

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

4. Possible side effects

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

• unusual thirst or tiredness, dry mouth – these may be signs that you have high blood sugar levels or are developing diabetes.
• feeling hungry, shaky, sweating unusually, or feeling confused – these may be signs of low blood sugar levels.

The frequency of these side effects is common, affecting up to 1 in 10 people.
Contact your doctor immediately if you notice:

• your face becomes red or swollen, or you develop spots or skin rashes
• your chest feels heavy and you become short of breath or have wheezing
• you feel weak, possibly due to a drop in blood pressure.

These may be signs of an allergic reaction.
The frequency of these side effects is not known; it cannot be estimated based on available data.
Other side effects
Contact your doctor or pharmacist if you notice any of the following side effects.
The most common expected side effects are gastrointestinal disorders, gallbladder problems, and injection site reactions. The side effects that may occur with Lanreotide Zentiva are listed below by frequency:
Very common: may affect more than 1 in 10 people:

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

Common: may affect up to 1 in 10 people:

• weight loss
• lack of energy
• slow heart rate
• feeling extremely tired
• decreased appetite
• feeling generally weak
• excess fat in the stools
• dizziness, headache
• hair loss or reduced growth of body hair
• pain affecting muscles, ligaments, tendons, and bones
• reactions at the injection site such as pain, hardening of the skin, or itching
• abnormal liver and pancreas function tests, changes in blood sugar levels
• nausea, vomiting, constipation, flatulence, bloating or stomach discomfort, indigestion
• biliary dilation (enlargement of the bile ducts between the liver, gallbladder, and 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
• change in stool colour
• changes in blood levels of sodium and alkaline phosphatase.

Not known: frequency cannot be estimated from available data:

• severe and sudden pain in the lower abdomen – this may be a sign of inflammation of the pancreas (pancreatitis)
• redness, pain, warmth, and swelling at the injection site which may feel fluid-filled when pressed, fever – this may be a sign of abscess
• sudden and severe pain in the upper right or central abdomen, which may spread to the shoulder or back, abdominal tenderness, nausea, vomiting, and high fever – this may be a sign of inflammation of the gallbladder (cholecystitis)
• pain in the upper right part of the abdomen (abdomen), fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-coloured stools, dark urine, fatigue – these may be signs of inflammation of the bile duct (cholangitis)
• decrease in pancreatic enzymes. Since lanreotide can affect the release of pancreatic enzymes involved in food digestion, you may experience symptoms such as fatty stools, loose stools, abdominal bloating, or weight loss.

Since Lanreotide Zentiva may alter blood sugar levels, your doctor may wish to monitor your blood sugar levels, especially at the beginning of treatment.
Similarly, since gallbladder problems may occur with this medicine, your doctor may want to check your gallbladder at the start of treatment with Lanreotide Zentiva and periodically during therapy.
Contact your doctor or pharmacist if you notice any of the adverse events described above.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lanreotide Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Store Lanreotide Zentiva between 2°C and 8°C in the refrigerator, in its original packaging, to protect the medicine from light.
Once removed from the refrigerator, the medicine kept in its sealed bag may be returned to the refrigerator (the number of temperature excursions must not exceed three times) for continued storage and subsequent use, provided it has been kept for no more than 72 hours at a temperature below 30°C.
Each syringe is individually packaged.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Lanreotide Zentiva contains
The active substance is:
lanreotide 60 mg, 90 mg or 120 mg
The other components are:
water for injections
glacial acetic acid (for pH adjustment).

Description of the appearance of Lanreotide Zentiva and contents of the pack
Lanreotide Zentiva is a ready-to-use, viscous injectable solution in a pre-filled syringe equipped with an automatic safety system. It is a semi-solid formulation, white to pale yellow in colour.
Each pre-filled syringe is packed in a laminated pouch and placed in a cardboard box.

Packs:
Box containing one 0.5 mL pre-filled syringe with a safety system and one needle (1.2 mm x 20 mm).
Box containing three pouches, each containing one 0.5 mL pre-filled syringe and one needle (1.2 mm x 20 mm).
1x60 mg, 3x60 mg
1x90 mg, 3x90 mg
1x120 mg, 3x120 mg
Not all pack sizes may be marketed.

Translation of information on the pre-filled syringe:
The name of the medicinal product is stated as Lanreotide
Deep s.c. – deep subcutaneous injection

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Italy

Manufacturers
Terapia SA
124 Fabricii Street,
400632, Cluj-Napoca, Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH, Hoofddorp, The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Germany, Czech Republic, Denmark, Finland, Norway, Sweden, Slovak Republic: Lanreotid Zentiva
Spain, Portugal, Romania: Lanreotida Zentiva
France, Italy, Poland: Lanreotide Zentiva