Lanreotide Zentiva

Leaflet accompanying the packaging: information for the user

Lanreotide Zentiva, 60 mg, solution for injection in a pre-filled syringe

Lanreotide Zentiva, 90 mg, solution for injection in a pre-filled syringe

Lanreotide Zentiva, 120 mg, solution for injection in a pre-filled syringe

Lanreotide

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lanreotide Zentiva and what is it used for
• 2. Important information 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 is Lanreotide Zentiva and how does it work

This medicine is called Lanreotide Zentiva.
The active substance of this medicine provides long-lasting action.
Lanreotide - the active substance - belongs to a group of medicines called growth hormone inhibitors. It
is similar to another substance (hormone) called somatostatin.
Lanreotide causes a decrease in the activity of hormones such as growth hormone (GH) and insulin-like growth factor 1 (IGF-1), as well as inhibiting the release of certain gastrointestinal hormones and intestinal secretion. Additionally, it also has an effect on certain advanced types of tumors (called neuroendocrine tumors) occurring in the intestines and pancreas, by inhibiting or slowing their growth.

What is Lanreotide Zentiva used for:

• for the long-term treatment of patients with acromegaly (a condition in which the body produces too much growth hormone)
• to alleviate symptoms associated with acromegaly - such as fatigue, headaches, sweating, joint pain, numbness of hands and feet
• to alleviate symptoms such as hot flashes and diarrhea, which sometimes occur in patients with neuroendocrine tumors (NETs)
• for the treatment and inhibition of growth of certain advanced tumors occurring in the intestines and pancreas, called gastroenteropancreatic neuroendocrine tumors (GEP-NET). It is used when these tumors cannot be surgically removed.

2. Important information before using Lanreotide Zentiva

When not to use Lanreotide Zentiva

• if the patient is allergic (hypersensitive) to lanreotide, somatostatin or medicines belonging to the same group (somatostatin analogues) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Lanreotide Zentiva, discuss with your doctor or pharmacist:

• if the patient has diabetes, as lanreotide can cause fluctuations in blood sugar levels. During treatment with lanreotide, the doctor may recommend checking blood sugar levels and possibly changing the diabetes treatment regimen.
• if the patient has been diagnosed with gallstones, as lanreotide can contribute to the formation of gallstones. In this case, periodic examination is recommended. The doctor may decide to discontinue treatment with lanreotide if complications arise from gallstone formation.
• if the patient has any thyroid function disorders, as lanreotide may slightly disrupt the function of this organ.
• if the patient has heart function disorders, as lanreotide may cause sinus bradycardia (slow heart rate). In patients with bradycardia, lanreotide should be used with particular caution.

If any of the above points apply to the patient, before taking Lanreotide Zentiva, discuss it with your doctor or pharmacist.
Consult a doctor or pharmacist if, during treatment:

• The patient experiences fatty stools, loose stools, 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 children and adolescents.

Lanreotide Zentiva and other medicines

Some medicines can affect the action of other medicines. Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Particular caution should be exercised when used concomitantly with:

• Cyclosporin(a medicine that reduces the immune system's response, used after transplantation or in the case of an autoimmune disease),
• Bromocriptine(a dopamine receptor agonist, used to treat certain types of brain tumors and Parkinson's disease or to inhibit lactation after childbirth),
• Antidiabetic medicines(medicines that lower high blood sugar levels),
• Medicines that cause bradycardia(medicines that slow down heart rate, e.g. beta-blockers).

The doctor may consider modifying the dosage of the above medicines used concomitantly.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before using this medicine. Lanreotide Zentiva should only be used if clearly necessary.

Driving and using machines

It is unlikely that Lanreotide Zentiva will affect the ability to drive or use machines, however, during treatment with Lanreotide Zentiva, side effects such as dizziness may occur. If such a side effect occurs in the patient, they should not drive or operate machinery.

3. How to use Lanreotide Zentiva

Lanreotide Zentiva should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Recommended dose

Treatment of acromegaly
The recommended dose is one injection every 28 days. The dose of the medicine used for injection will be chosen by the doctor from the three available strengths of Lanreotide Zentiva (60 mg, 90 mg or 120 mg).
If a satisfactory response is achieved, the doctor may recommend changing the frequency of injections of Lanreotide Zentiva 120 mg to one injection every 42 or 56 days.
The 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 of the medicine every 28 days. The dose of the medicine used for injection will be chosen by the doctor from the three available strengths of Lanreotide Zentiva (60 mg, 90 mg or 120 mg).
If a satisfactory response is achieved to treatment with a somatostatin analogue or Lanreotide Zentiva 60 mg or 90 mg, the doctor may recommend changing the frequency of injections of Lanreotide Zentiva 120 mg to one injection every 42 or 56 days.
The doctor will also decide on the duration of treatment.
Treatment of advanced tumors occurring in the intestines and pancreas, called gastroenteropancreatic neuroendocrine tumors (GEP-NET). The medicine is used when these tumors cannot be surgically removed.
The recommended dose is 120 mg every 28 days. The doctor will decide on the duration of treatment with Lanreotide Zentiva to inhibit tumor growth.

Method of administration

Lanreotide Zentiva should be administered by deep subcutaneous injection.
The injection should be performed by a healthcare professional or a trained person (family member or friend) or by the patient themselves after proper training by a healthcare professional.
The decision to self-administer or administer by another trained person should be made by the doctor. If the patient has any doubts about the method of injection, they should consult a doctor or healthcare professional for advice or further training.
If the injection is performed by a healthcare professional or a trained person (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 the patient is self-administering the injection after proper training, the injection should be given in the upper outer part of the thigh (see figure 5b below).

Instructions for use

Important: Read the entire instructions before performing the injection. Deep subcutaneous injection requires a special technique, different from that used for standard subcutaneous injection.

The following instructions explain how to perform the injection of Lanreotide Zentiva.
Lanreotide Zentiva is provided in a ready-to-use pre-filled syringe with an automatic safety system. The needle will retract automatically after completing the full injection of the contents, to prevent the patient from being injured.

• 1. Remove Lanreotide Zentiva

from the refrigerator 30 minutes before administration.

The injection of cold
contents may be
painful. Store the
laminated pouch
tightly closed until
the moment just before
injection.

• 2. Important: Before opening the pouch, check that it is intact and that the medicine has not expired.

Do not use the pre-filled syringe:

• If it has been damaged or if the pre-filled syringe or its packaging appears to be damaged in any way.
• If the expiry date of the medicine has passed; the expiry date is printed on the pouch and carton.

If any of the above situations occur, contact your doctor or pharmacist.

• 3. Wash your hands with soap.

• 4. Open the pouch along the perforated line and remove the pre-filled syringe. The contents of the pre-filled syringe are a semi-solid substance resembling a thick gel, white to pale yellow in color. The concentrated solution may also contain microbubbles, which may disappear during injection. These differences are normal and do not affect the quality of the product.

After opening the protective laminated pouch, the medicine should be administered immediately.

• 5. Choose the injection site:

If the injection is performed by a healthcare professional or another trained person (family member or friend):
the upper outer quadrant of the buttock (5a) or the upper outer part of the thigh (5b).
If the patient is self-administering the injection: the upper outer part of the thigh (5b).

• The injection siteof Lanreotide Zentiva should be changedwith each administration, injecting alternately on one side and then the other. Avoid areas where there are moles, scars, redness, or skin irregularities.
• 6. Clean the injection site.
• 7. Before injection, remove the pre-filled syringe from the tray. Discard the tray.

• 8. Pulling, remove the needle cap and discard it.

• 9. Flattenthe skin at the injection site using your thumb and index finger of the hand not holding the pre-filled syringe, to stretch it. Do not create a foldin the skin. With a firm, smooth motion, quickly insertthe entire needle perpendicularto the skin surface (at a 90-degree angle). It is important that the needle is completelyin the body. After inserting the needle, no part of it should be visible.

Do notwithdrawthe needle.

• 10. Release the injection site, which was flattened by your hand. Press the plunger with a smooth, firm motion. The medicine is thicker and more difficult to administer than expected. Usually, the injection of the contents takes 20 seconds. Make sure to inject the full dose and push the plungerto ensure that no medicine remains in the packaging.

WARNING: Do not release the pressure on the plunger to prevent activation of the automatic safety system.

11. Without releasing the pressure on the plunger, withdraw the needle from the injection site.
12. Then release the pressure on the plunger. The needle will automatically retract into the protective sleeve, where it will be permanently locked.
13. Gently press the injection site with a dry swab or sterile gauze to prevent bleeding. Do not rub or massage the injection site.
14. Dispose of the used syringe in accordance with the doctor's or healthcare professional's instructions. Do not throw the syringe or needle into the household waste bin.

Using a higher dose of Lanreotide Zentiva than recommended

If a higher dose of Lanreotide Zentiva than recommended has been injected, inform your doctor.
If a higher dose of Lanreotide Zentiva than recommended has been injected, there is a risk of additional or more severe side effects (see section 4. Possible side effects).

Missing a dose of Lanreotide Zentiva

As soon as the patient realizes they have missed an injection, they should contact their doctor, who will provide information on the next injection date.
Do not administer additional injections to make up for a missed dose without consulting your doctor.

Stopping treatment with Lanreotide Zentiva

Missing more than one dose or stopping treatment with Lanreotide Zentiva prematurely may affect the effectiveness of therapy. Consult your doctor before stopping treatment with this medicine.
If you have any further questions about 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.

If the patient experiences any of the following side effects, they should contact their doctor immediately:

• increased thirst or fatigue, and dry mouth - this may indicate that the patient has high blood sugar levels or is developing diabetes.
• hunger, trembling, excessive sweating or confusion - these may be symptoms of low blood sugar levels.

These side effects are common, they may occur in up to 1 in 10 people.

The patient should contact their doctor immediately if they notice:

• redness or swelling of the face, rash or hives
• chest pain, shortness of breath or wheezing
• fainting, which may be due to a drop in blood pressure.

These may be symptoms of an allergic reaction.
The frequency of this side effect is unknown; it cannot be estimated from the available data.

Other side effects

If the patient experiences any of the following side effects, they should contact their doctor or pharmacist immediately.
The most common side effects expected with Lanreotide Zentiva are gastrointestinal disorders, gallbladder disorders, and reactions at the injection site. The following side effects are related to the use of Lanreotide Zentiva, including their frequency.

• diarrhea, loose stools, abdominal pain
• gallstones and other gallbladder disorders. Severe and sudden abdominal pain, high fever, jaundice (yellowing of the skin and eyes), chills, loss of appetite, itching of the skin may occur.

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

• weight loss
• lack of energy
• slow heart rate
• feeling very tired
• decreased appetite
• general weakness
• excess fat in the stool
• dizziness, headache
• hair loss or reduced body hair
• muscle, tendon, or bone pain
• reactions at the injection site, such as pain, skin thickening, or itching
• abnormal liver and pancreas function test results and changes in blood sugar levels
• nausea, vomiting, constipation, gas, bloating, or abdominal discomfort, indigestion
• enlargement of the bile ducts (enlargement of the bile ducts between the liver and the gallbladder and intestine). Abdominal pain, nausea, jaundice, and fever may occur.

Uncommon (may occur in up to 1 in 100 people):

• hot flashes
• difficulty sleeping
• change in stool color
• changes in sodium and alkaline phosphatase levels shown in blood tests.

Frequency not known: frequency cannot be estimated from the available data

• sudden, severe abdominal pain - may be a symptom of pancreatitis
• redness, pain, heat, swelling, or fluid-filled swelling at the injection site, fever - may be symptoms of an abscess
• sudden, severe pain in the upper right or middle abdomen, radiating to the arm or back, abdominal tenderness, nausea, vomiting, and high fever - may be symptoms of cholecystitis
• abdominal pain, fever, chills, jaundice (yellowing of the skin and eyes), nausea, vomiting, clay-colored stools, dark urine, fatigue - may be symptoms of bile duct inflammation
• decreased activity of pancreatic enzymes. Since lanreotide may affect the secretion of pancreatic enzymes involved in food digestion, the patient may experience symptoms such as fatty stools, loose stools, abdominal bloating, or weight loss.

As Lanreotide Zentiva may cause fluctuations in blood sugar levels, the doctor may recommend regular blood sugar checks, especially at the beginning of treatment.
Similarly, due to the possibility of gallbladder disorders during treatment with this type of medicine, the doctor may recommend regular gallbladder checks at the beginning of treatment with Lanreotide Zentiva, and then at regular intervals.
If any of the above side effects occur, tell your doctor or pharmacist.

Reporting side effects

If side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather 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 the month stated.
Lanreotide Zentiva should be stored in a refrigerator at a temperature of 2°C - 8°C in the original packaging to protect from light.
After removal from the refrigerator, the product can be stored in the sealed pouch for a maximum of 72 hours below 30°C, and then returned to the refrigerator for further storage and later use, provided it has not been stored for more than 72 hours in total.

6. Contents of the pack and other information

What Lanreotide Zentiva contains

The active substance is:
lanreotide 60 mg, 90 mg or 120 mg
The other ingredients are:
water for injections
acetic acid (to adjust pH)

What Lanreotide Zentiva looks like and contents of the pack

Lanreotide Zentiva is a thick solution for injection in a pre-filled syringe with an automatic safety system. The medicine is a semi-solid substance, white to pale yellow in color.
Each pre-filled syringe is packaged in a laminated pouch and a carton.
Pack sizes:
Carton with one 0.5 mL pre-filled syringe with automatic safety system and one needle (1.2 mm x 20 mm).
Carton with three pouches, each containing one 0.5 mL pre-filled syringe and one needle (1.2 mm x 20 mm).
1 pre-filled syringe of 0.5 mL (60 mg), 3 pre-filled syringes of 0.5 mL (60 mg)
1 pre-filled syringe of 0.5 mL (90 mg), 3 pre-filled syringes of 0.5 mL (90 mg)
1 pre-filled syringe of 0.5 mL (120 mg), 3 pre-filled syringes of 0.5 mL (120 mg)
Not all pack sizes may be marketed.

Marketing authorization holder:

Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Importer:

Terapia S.A.
124 Fabricii Street
400632 Cluj-Napoca
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic, Denmark, Finland, Norway, Sweden: Lanreotide Zentiva
Poland, Italy: Lanreotide Zentiva
Germany: Lanreotide Zentiva 60 mg, 90 mg, 120 mg Injektionslösung in einer Fertigspritze
Estonia: Lanreotide Zentiva 60 mg, 90 mg, 120 mg solution for injection in a pre-filled syringe
France: LANREOTIDE ZENTIVA LP 60 mg, 90 mg, 120 mg solution injectable à libération prolongée en seringue préremplie
Romania: Lanreotide Zentiva 120 mg solution injectable în seringă preumplută
Slovakia: Lanreotide Zentiva 60 mg, 120 mg injekčný roztok v naplnenej injekčnej striekačke

For further information, please contact your local representative of the marketing authorization holder:

Zentiva Poland Sp. z.o.o.
Bonifraterska Street 17
00-203 Warsaw, Poland
phone: +48 22 375 92 00

Date of last revision of the leaflet: