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 using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 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 (a hormone) called somatostatin.
Lanreotide reduces 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 affects certain advanced types of tumours (called neuroendocrine tumours) in the intestine and pancreas by inhibiting or delaying their growth.

What Lanreotide Zentiva is used for:

• for the long-term treatment of patients with acromegaly (a condition in which the body produces too much growth hormone)
• to relieve symptoms associated with acromegaly, such as fatigue, headaches, sweating, joint pain, and tingling sensations in the feet and hands
• to relieve symptoms such as flushing and diarrhoea, which sometimes occur in patients with neuroendocrine tumours (NETs)
• for the treatment and inhibition of growth of certain advanced tumours of the gastrointestinal tract and pancreas, known as 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 regular monitoring of blood glucose 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 any heart function disorders, because sinus bradycardia (slow heart rate) may occur during treatment with lanreotide. In patients with bradycardia, lanreotide should be used with particular caution.

If any of the above conditions apply to the patient, discuss this with your doctor or pharmacist before taking Lanreotide Zentiva.
Consult your 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 use in 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 taken or recently used, as well as any medicines the patient intends to take.
Particular caution is required when using Lanreotide Zentiva concomitantly with:

• cyclosporine (an immunosuppressive medicine used after organ 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 postpartum lactation),
• 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 medicines when used concomitantly.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 affects 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
Lanreotide Zentiva should always be used exactly as prescribed by the doctor. If in doubt, 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 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 flushes and diarrhoea) associated with neuroendocrine tumours
The recommended dose is one injection every 28 days. The dose of the medicine used for injection 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 with somatostatin analogue therapy 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 neuroendocrine tumours (GEP-NETs)
The medicine is used when these tumours 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 tumour growth.

Method of administration
Lanreotide Zentiva should be administered as a deep subcutaneous injection.
The injection should be performed 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 regarding self-administration or administration by another trained person should be made by the doctor. If the patient has any doubts about the method of injection, he or she 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: Read the entire instruction carefully 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 the injection of Lanreotide Zentiva.
Lanreotide Zentiva is supplied in a ready-to-use pre-filled syringe equipped with an automatic safety system. The needle retracts automatically after complete injection of the contents to prevent accidental needlestick injury.

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. Note: Before opening the pouch, check that it is intact and that the expiry date of the medicine has not passed. Do not use the pre-filled syringe:
   • If it is damaged or if the pre-filled syringe or its packaging appears in any way damaged.
   • If the expiry date has passed; the expiry date is printed on the pouch and the box.

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,
After opening the protective laminated pouch, the medicine should be administered immediately.
which may disappear during injection.
These variations are normal and do not affect the quality of the product.

5. Select the injection site:

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

• The injection site for Lanreotide Zentiva should be changed 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

protector.

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 (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 usually takes about 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.
    NOTE: 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 the injection site with a dry cotton swab or sterile gauze to prevent bleeding. Do not rub or massage the injection site.
14. Dispose of the used syringe according to your doctor’s or healthcare provider’s instructions. Do not throw the syringe or needle into your household waste bin.

Use of a higher than recommended dose of Lanreotide Zentiva
If a higher dose of Lanreotide Zentiva has been administered than recommended, a doctor should be
notified.
If a higher than recommended dose of Lanreotide Zentiva has been administered, 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.
Additional injections should not be administered independently to make up for the missed
dose without discussing it with the doctor.

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

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 unusually thirsty or tired, and having a 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 occur in 1 out of 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 result from 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 include gastrointestinal disorders, gallbladder function disorders, and injection site reactions. The adverse effects associated with the use of Lanreotide Zentiva, categorized by frequency, are listed below.
Very common (may occur in more than 1 in 10 people):

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

Common (may occur in no more than 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 occur in no more than 1 in 100 people):

• hot flushes
• difficulty sleeping
• change in stool colour
• changes in blood levels of sodium and alkaline phosphatase.

Frequency unknown: frequency cannot be estimated based on available data

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

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 during treatment with this type of medicine, the doctor may recommend regular gallbladder monitoring at the beginning of Lanreotide Zentiva treatment and at regular intervals thereafter.
If any of the above adverse effects occur, inform the doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring 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 authorization 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 the 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 continued storage and later use, provided it has been stored for no longer than a total of 72 hours at a temperature below 30°C, while kept in a tightly sealed bag.
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. This will 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.
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

Importers:
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 following names in the European Economic Area countries:
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, please 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