Lanreotide zentiva

Package leaflet: Information for the user

Lanreotide Zentiva, 60 mg, solution for injection in pre-filled syringe
Lanreotide Zentiva, 90 mg, solution for injection in pre-filled syringe
Lanreotide Zentiva, 120 mg, solution for injection in pre-filled syringe
Lanreotidum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

• 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 a specific person. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the 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 Lanreotide Zentiva is and what it is used for

What Lanreotide Zentiva is and how it works
This medicine is called Lanreotide Zentiva.
The active substance in this medicine provides long-acting effects.
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 reduction in the activity of certain hormones in the body, such as growth hormone (GH) and insulin-like growth factor-1 (IGF-1). It also inhibits the release of certain gastrointestinal hormones and intestinal secretion. In addition, it has an effect on certain advanced types of tumours (called neuroendocrine tumours) located in the intestine and pancreas, by inhibiting or delaying their growth.

What Lanreotide Zentiva is used for:

• Long-term treatment of patients with acromegaly (a condition in which the body produces too much growth hormone)
• Relief of symptoms associated with acromegaly, such as fatigue, headaches, sweating, joint pain, and tingling sensations in the feet and hands
• Relief of symptoms such as flushing and diarrhoea, which sometimes occur in patients with neuroendocrine tumours (NETs)
• Treatment and inhibition of growth of certain advanced tumours of the intestine and pancreas, called gastroenteropancreatic neuroendocrine tumours (GEP-NETs). It is used when these tumours 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Lanreotide Zentiva, discuss this with your doctor or
pharmacist:

• if the patient has diabetes, because lanreotide may cause fluctuations in blood sugar levels. During treatment with lanreotide, the doctor may recommend monitoring blood glucose levels and may need to adjust the diabetes treatment regimen.
• if the patient has been diagnosed with gallstones, because lanreotide may promote the formation of gallstones. In such cases, periodic monitoring is recommended. The doctor may decide to discontinue treatment with lanreotide if complications related to gallstone formation occur.
• if the patient has any thyroid function disorders, because lanreotide may slightly affect the function of this organ.
• if the patient has heart function disorders, because sinus bradycardia (slow heart rate) may occur during treatment with lanreotide. Lanreotide should be used with particular caution in patients who already have bradycardia.

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

• the patient experiences fatty stools, diarrhoea, abdominal bloating, or weight loss, because 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 may affect the action of other medicines. Inform your doctor or pharmacist about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take.
Particular caution is required when using Lanreotide Zentiva concomitantly with:

• cyclosporine (an immunosuppressive medicine used after transplantation or in autoimmune diseases),
• bromocriptine (a dopamine receptor agonist used in the treatment of certain types of brain tumours, Parkinson’s disease, or to suppress lactation after childbirth),
• antidiabetic medicines (medicines that lower high blood glucose levels),
• medicines causing bradycardia (medicines that slow heart rate, e.g. beta-blockers).

The doctor may consider adjusting the dosage of the above-mentioned concomitant medicines.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. Lanreotide Zentiva should only be administered if clearly necessary.
Driving and operating machinery
It is unlikely that Lanreotide Zentiva will affect the ability to drive or operate machinery. However, during treatment with Lanreotide Zentiva, adverse effects such as dizziness may occur. If such an adverse effect occurs, the patient should not drive or operate machinery.

3. How to use Lanreotide Zentiva
Always use Lanreotide Zentiva exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
Recommended dose
Treatment of acromegaly
The recommended dose is one injection every 28 days. The dose of the medicine to be injected will be selected by the doctor from among the three available strengths of Lanreotide Zentiva (60 mg, 90 mg, or 120 mg).
If the desired response is achieved, the doctor may recommend changing the frequency of administration of Lanreotide Zentiva 120 mg to one injection every 42 or 56 days.
The doctor will also decide on the duration of treatment.
Symptom relief (such as hot flashes and diarrhoea) associated with neuroendocrine tumours
The recommended dose is one injection every 28 days. The dose to be injected will be selected by the doctor from among the three available strengths of Lanreotide Zentiva (60 mg, 90 mg, or 120 mg).
If the desired treatment response is achieved with a somatostatin analogue or with Lanreotide Zentiva 60 mg or 90 mg, the doctor may recommend changing the frequency of administration 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 gastrointestinal and pancreatic tumours known as gastroenteropancreatic neuroendocrine tumours (GEP-NETs), when surgical removal of the tumours is not possible.
The recommended dose is 120 mg every 28 days. The doctor will decide on the duration of treatment with Lanreotide Zentiva to inhibit tumour growth.
Method of administration
Lanreotide Zentiva should be administered as a deep subcutaneous injection.
The injection should be given by a healthcare professional or by a trained person (family member or friend), or self-administered by the patient after appropriate training by a healthcare professional.
The decision on self-administration or administration by another trained person should be made by the doctor. If the patient has any doubts about how to administer the injection, they should consult the doctor or healthcare professional for advice or further training.
If the injection is administered by a healthcare professional or a trained person (family member or friend), the injection should be given into the upper outer quadrant of the buttock or into the upper outer part of the thigh (see Figures 5a and 5b below).
If the patient self-administers the injection after appropriate training, the injection should be given into the upper outer part of the thigh (see Figure 5b below).
Instructions for use
Note: Carefully read the entire instruction before administering the
injection. Deep subcutaneous injection requires a special technique, different from that used for standard subcutaneous injection.
The following instructions explain how to administer an injection of Lanreotide Zentiva.
Lanreotide Zentiva is supplied as a ready-to-use pre-filled syringe equipped with an automatic safety system. The needle retracts automatically after the full content has been injected, to prevent injury to the patient.

1. Remove Lanreotide Zentiva from the refrigerator 30

minutes before administration.
Injecting cold medication may be painful. Keep the laminated pouch sealed 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 it is damaged or if the pre-filled syringe or its packaging appears damaged in any way.
   • If the expiry date has passed; the expiry date is printed on the pouch and the carton.

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

3. Wash your hands with soap.
4. Open the

protective laminated pouch along the dotted line and remove the pre-filled syringe. The content of the pre-filled syringe is a semi-solid substance resembling a sticky gel, white to pale yellow in colour. The supersaturated solution may also contain microbubbles, which may disappear during injection. These variations are normal and do not affect the quality of the product.
After opening the protective laminated pouch, the medicine must be administered immediately.

5. Choose the injection site:

If the injection is administered by a healthcare professional or another trained 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 upper outer part of the thigh (5b).

• The injection site for Lanreotide Zentiva should be rotated with each administration, alternating between left and right sides. Avoid areas with 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. Pull off and discard the needle cap.

9. Flatten the skin at the

injection site using the thumb and index finger of the hand not holding the pre-filled syringe, to stretch it. Do not create a skin fold.
With a firm, smooth motion, quickly insert the entire needle perpendicularly into the skin (at a 90º angle).
It is important that the needle is fully inserted into the body. After insertion, no part of the needle should be visible.
Do not withdraw the needle.

10. Release the injection site, which was flattened by your hand. The injection of the content usually takes 20 seconds. Inject the full dose and push the plunger completely to ensure that no medicine remains in the syringe. Press the plunger with a steady,

firm motion.
The medicine is thicker and more difficult to inject than expected.
WARNING: Do not release pressure on the plunger to prevent activation of the
automatic safety system.

11. Without releasing pressure on the plunger, withdraw the needle from the injection site.
12. Then release pressure on the plunger. The needle will automatically retract into the needle guard and be permanently locked.
13. Gently press a dry cotton swab or sterile gauze pad against the injection site to prevent bleeding. Do not rub or massage the injection site.
14. Dispose of the used syringe according to your doctor's or healthcare professional's instructions. Do not throw the syringe or needle into household waste bins.

Use of a higher than recommended dose of Lanreotide Zentiva
If a higher than recommended dose of Lanreotide Zentiva has been administered, a doctor should be informed.
If a higher than recommended dose of Lanreotide Zentiva has been injected, there is a risk of additional or more severe adverse reactions (see section 4. Possible side effects).

Missed administration of Lanreotide Zentiva
As soon as the patient realizes that a dose has been missed, they should contact their doctor, who will provide information regarding the timing of the next dose.
Do not administer additional injections to make up for the missed dose without discussing it with a doctor.

Stopping treatment with Lanreotide Zentiva
Missing more than one dose or stopping treatment with Lanreotide Zentiva prematurely may affect the effectiveness of therapy. Patients should consult their doctor before discontinuing the medication.

If there are any further doubts concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences any of the following adverse effects, contact a doctor immediately:

• feeling more thirsty than usual or fatigue and dry mouth – this may indicate that the patient has high blood sugar levels or is developing diabetes.
• feeling hungry, trembling, excessive sweating or confusion – these may be symptoms of low blood sugar levels.

The above adverse effects are common and may affect up to 1 in 10 people.
Contact a doctor immediately if the patient notices:

• redness or swelling of the face, rash or hives
• chest tightness, shortness of breath or wheezing
• fainting, which may be due to low blood pressure.

These may be symptoms of an allergic reaction.
The frequency of this adverse effect is unknown; it cannot be estimated based on available data.
Other adverse effects
If the patient experiences any of the following adverse effects, contact a doctor or pharmacist immediately.
The most commonly expected adverse effects during treatment with Lanreotide Zentiva are gastrointestinal disorders, gallbladder function disorders, and injection site reactions. Below are the adverse effects associated with the use of Lanreotide Zentiva, classified according to frequency of occurrence.
Very common (may affect more than 1 in 10 people):

• diarrhoea, loose stools, abdominal pain
• gallstones and other gallbladder-related problems. These may cause severe and sudden abdominal pain, high fever, jaundice (yellowing of the skin and whites of the eyes), chills, loss of appetite, itching of the skin.

Common (may affect up to 1 in 10 people):

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

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

• hot flushes
• difficulty falling asleep
• change in stool colour
• changes in blood sodium levels and alkaline phosphatase levels shown in blood tests.

Frequency unknown: frequency cannot be estimated based on available data

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

Because Lanreotide Zentiva may cause fluctuations in blood sugar levels, the doctor may recommend regular blood sugar monitoring, especially at the beginning of treatment.
Similarly, due to the possibility of gallbladder disorders occurring during treatment with this type of medicine, the doctor may recommend regular monitoring of the gallbladder at the beginning of treatment with Lanreotide Zentiva and subsequently at regular intervals.
If any of the above adverse effects occur, inform the doctor or pharmacist.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform the doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse effects helps to gather more information on the safety of the medicine.
5. How to store Lanreotide Zentiva
Keep the 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 stated month.
Lanreotide Zentiva should be stored in a refrigerator at 2°C - 8°C in the original packaging to protect from light.
After removal from the refrigerator, the product may be returned to the refrigerator (the number of temperature changes must not exceed three times) for further storage and later use, provided it has been stored for no longer than a total of 72 hours at a temperature below 30°C.
Each syringe is individually packaged.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

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 components are:
water for injections
glacial acetic acid (to adjust pH)

What Lanreotide Zentiva looks like and contents of the pack
Lanreotide Zentiva is a viscous solution for injection in a ready-to-use pre-filled syringe equipped with an automatic safety system. The medicine is a white to pale yellow semi-solid preparation.

Each pre-filled syringe is packed in a laminated pouch and a cardboard box.

Pack sizes:
Box containing one 0.5 mL pre-filled syringe with automatic 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).

Available pack configurations:
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 Authorisation 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
The Netherlands

This medicinal product is authorised in the European Economic Area under the following names:
Czech Republic, Denmark, Finland, Norway, Sweden: Lanreotid Zentiva
Poland, Italy: Lanreotide Zentiva
Germany: Lanreotid Zentiva 60 mg, 90 mg, 120 mg Injektionslösung in einer Fertigspritze
Estonia: Lanreotida Zentiva 60 mg, 90 mg, 120 mg solución inyectable en jeringa precargada EFG
France: LANREOTIDE ZENTIVA LP 60 mg, 90 mg, 120 mg solution injectable à libération prolongée en seringue préremplie
Romania: Lanreotidă Zentiva 120 mg soluţie injectabilă în seringă preumplută
Slovakia: Lanreotid Zentiva 60 mg, 120 mg injekčný roztok v naplnenej injekčnej striekačke

For further information, contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland
Tel.: +48 22 375 92 00