Lanreotide zentiva
PolandTable of Contents
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 this leaflet carefully before using this medicine because it contains important
information for you.
- Keep this leaflet. 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, please tell your doctor or pharmacist. See section 4.
Contents of the leaflet
- What Lanreotide Zentiva is and what it is used for
- What you need to know before using Lanreotide Zentiva
- How to use Lanreotide Zentiva
- Possible side effects
- How to store Lanreotide Zentiva
- 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 known as growth hormone inhibitors. It is similar to another substance (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 secretions. Furthermore, it affects 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:
- 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 the following 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 blood glucose monitoring and may need to adjust the diabetes treatment regimen.
- if the patient has been diagnosed with gallstones, because lanreotide may promote gallstone formation. In such cases, periodic monitoring is recommended. The doctor may decide to discontinue lanreotide treatment if complications related to gallstone formation occur.
- if the patient has any thyroid function disorders, because lanreotide may slightly affect thyroid function.
- if the patient has heart function disorders, because sinus bradycardia (slow heart rate) may occur during lanreotide treatment. Lanreotide should be used with particular caution in patients with 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 used or recently taken, as well as any medicines planned for future use.
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 to treat 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 concomitantly administered 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
Lanreotide Zentiva should always be used 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.
Relief of symptoms (such as flushing 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 therapeutic 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). 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 suppress tumour growth.
Method of administration
Lanreotide Zentiva should be administered as a deep subcutaneous injection.
The injection should be administered by a healthcare professional or a trained person (family member or friend), or by the patient himself/herself 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 injection technique, he/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), it 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 self-administers the injection after appropriate training, it should be given in 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 Lanreotide Zentiva injection.
Lanreotide Zentiva is supplied as 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.
- Remove Lanreotide Zentiva from the refrigerator 30 minutes before administration.
Injecting cold medication may be painful. Keep the laminated protective pouch sealed until just before injection.
- 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 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 occur, contact your doctor or pharmacist.
- Wash your hands with soap.
- Open the laminated protective 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 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.
- Select the injection site:
If the injection is administered by a healthcare professional or trained person:
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 rotated with each administration, alternating between left and right sides. Avoid areas with moles, scars, redness, or skin irregularities.
-
Clean the injection site.
-
Before injection, remove the pre-filled syringe from the tray.
Discard the tray. -
Pull off the needle protector and discard it.
-
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. -
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.
WARNING: Do not release pressure on the plunger to prevent activation of the automatic safety system.
|  |
| |
 | |
| |
Use of a higher than recommended dose of Lanreotide Zentiva
If a higher dose of Lanreotide Zentiva has been administered than recommended, you should
inform your doctor.
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 dose of Lanreotide Zentiva
As soon as the patient realizes that a dose has been missed, they should contact their doctor,
who will provide advice on when the next dose should be administered.
Do not administer additional injections on your own to make up for the missed dose without
discussing it with your doctor.
Stopping treatment with Lanreotide Zentiva
Missing more than one dose or stopping treatment with Lanreotide Zentiva earlier than advised may
affect the effectiveness of therapy. You should consult your doctor before discontinuing the
medication.
If you have any further questions regarding the use of this medicine, please consult 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, contact a doctor immediately:
- feeling more thirsty than usual, fatigue and dry mouth – these may indicate high blood sugar levels or developing diabetes.
- hunger, trembling, excessive sweating or confusion – these may be symptoms of low blood sugar levels.
The above side 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 side effect is not known; it cannot be estimated from the available data.
Other side effects
If the patient experiences any of the following side effects, contact a doctor or pharmacist immediately.
The most commonly expected side effects during treatment with Lanreotide Zentiva include gastrointestinal disorders, gallbladder function disorders and injection site reactions. The side effects associated with the use of Lanreotide Zentiva, classified by frequency, are listed below.
Very common (may affect 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, 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 the 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 levels of sodium and alkaline phosphatase.
Frequency not known: frequency cannot be estimated from the available data
- sudden, severe lower abdominal pain – this may be a symptom of pancreatitis
- redness, pain, warmth, swelling or fluid-filled feeling upon pressing, fever at the injection site – these may be symptoms 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 – these may be symptoms of cholecystitis (inflammation of the gallbladder)
- pain in the upper right part of the abdomen, fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, pale-coloured stools, dark urine, fatigue – these may be symptoms of cholangitis (inflammation of the bile ducts)
- 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 side effects occur, inform the doctor or pharmacist.
Reporting of side effects
If any adverse reactions occur, including any not listed in this leaflet, inform the doctor or pharmacist. Side 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
Side effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting side effects helps provide 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 kept in a tightly sealed bag 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 packed.
Do not dispose of medicines via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. 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 ingredients 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-pen equipped with an automatic safety system. The medicine is a white to pale yellow semi-solid preparation.
Each pre-filled syringe-pen is packed in a laminated pouch and a cardboard box.
Pack sizes:
Box containing one 0.5 mL pre-filled syringe-pen 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-pen and one needle (1.2 mm x 20 mm).
Available pack configurations:
1 pre-filled syringe-pen of 0.5 mL (60 mg), 3 pre-filled syringe-pens of 0.5 mL (60 mg)
1 pre-filled syringe-pen of 0.5 mL (90 mg), 3 pre-filled syringe-pens of 0.5 mL (90 mg)
1 pre-filled syringe-pen of 0.5 mL (120 mg), 3 pre-filled syringe-pens 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 European Economic Area (EEA) 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 more detailed 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