Lanreotide ranbaxy

Patient Information Leaflet

Lanreotide Ranbaxy, 60 mg, solution for injection in prefilled syringe
Lanreotide Ranbaxy, 90 mg, solution for injection in prefilled syringe
Lanreotide Ranbaxy, 120 mg, solution for injection in prefilled syringe
Lanreotidum
Please read all of 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, 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

What Lanreotide Ranbaxy is and how it works
This medicine is called Lanreotide Ranbaxy.
It contains a substance called lanreotide in a long-acting release form.
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 GH (growth hormone) and IGF-1 (insulin-like growth factor 1). It also inhibits the release of certain gastrointestinal hormones and intestinal secretion. It additionally affects certain advanced types of tumours (called neuroendocrine tumours) located in the intestine and pancreas by inhibiting or delaying their growth.

What Lanreotide Ranbaxy 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 hands and feet;
• to relieve symptoms such as flushing and diarrhoea, which sometimes occur in patients with neuroendocrine tumours (NET tumours);
• for the treatment and inhibition of growth of certain advanced tumours of the gastrointestinal tract and pancreas, known as gastroenteropancreatic neuroendocrine tumours (GEP-NET). It is used when these tumours cannot be surgically removed.

2. Important information before using Lanreotide Ranbaxy

When not to use Lanreotide Ranbaxy

• 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 Ranbaxy, 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 possibly 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. Particular caution is advised when initiating lanreotide therapy in patients with bradycardia (a heart rhythm disorder).

If any of the above conditions apply to the patient, discuss this with your doctor or pharmacist before taking Lanreotide Ranbaxy.

Consult your doctor or pharmacist if, during treatment:

• the patient experiences fatty stools, loose stools, abdominal bloating, or weight loss, because lanreotide may affect the secretion of pancreatic enzymes involved in food digestion.

Children and adolescents
Lanreotide Ranbaxy is not recommended for children and adolescents.

Lanreotide Ranbaxy and other medicines
Some medicines may affect the action of other medicines. Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Particular caution is required when using Lanreotide Ranbaxy concomitantly with the
following medicines:

• 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 lactation after childbirth);
• antidiabetic medicines (medicines that lower high blood glucose levels);
• medicines causing bradycardia (medicines that slow heart rate, such as beta-blockers).

Your doctor may consider adjusting the dosage of the above-mentioned concomitantly administered medicines.

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 Ranbaxy should be administered only if clearly necessary.

Driving and using machines
It is unlikely that Lanreotide Ranbaxy affects the ability to drive or operate machinery. However, during treatment with this medicine, there is a risk of experiencing adverse effects such as dizziness. If such adverse effects occur, the patient should not drive or operate machinery.

3. How to use Lanreotide Ranbaxy

This medicine should always be used exactly as your doctor has told you. If you are unsure,
you should consult your doctor or pharmacist.
Recommended dose
Treatment of acromegaly
The recommended dose is one injection of the medicine every 28 days. The dose of the medicine to be injected
will be selected by your doctor from among the three available strengths of Lanreotide Ranbaxy
(60 mg, 90 mg or 120 mg).
If the desired response is achieved, your doctor may recommend changing the injection frequency of
Lanreotide Ranbaxy 120 mg to one injection every 42 or 56 days.
Your doctor will also decide on the duration of treatment.
Palliation of symptoms (such as hot flushes and diarrhoea) associated with neuroendocrine tumours
The recommended dose is one injection of the medicine every 28 days. The dose of the medicine to be injected
will be selected by your doctor from among the three available strengths of Lanreotide Ranbaxy (60 mg, 90 mg or 120 mg).
If the desired response to somatostatin analogue or to Lanreotide Ranbaxy 60 mg or 90 mg is achieved,
your doctor may recommend changing the injection frequency of Lanreotide Ranbaxy 120 mg to one injection every 42 or 56 days.
Your doctor will also decide on the duration of treatment.
Treatment of advanced tumours of the gastrointestinal tract and pancreas called gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
This medicine is used when these tumours cannot be surgically removed.
The recommended dose is 120 mg every 28 days. Your doctor will decide on the duration of treatment with
Lanreotide Ranbaxy to suppress tumour growth.
Method of administration
Lanreotide Ranbaxy should be administered as a deep subcutaneous injection.
The injection should be given by a healthcare professional, a trained person (family member or friend),
or by the patient themselves 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 the injection technique, they should contact their doctor or healthcare professional
for advice or further training.
When the injection is given by a healthcare professional or a trained person (family member or friend),
the injection should be administered into the upper outer quadrant of the buttock or into the upper outer thigh (see Figures 5a and 5b below).
When self-administering the injection after appropriate training, the injection should be given into the upper outer thigh (see Figure 5b below).
Instructions for use
Note: Please 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 an injection of Lanreotide Ranbaxy.
Lanreotide Ranbaxy is available as a ready-to-use pre-filled syringe with an automatic safety system.
The needle retracts automatically after complete injection of the contents to prevent injury to the patient.

1. Remove the Lanreotide Ranbaxy medicine from the refrigerator 30 minutes before injection. Injecting cold medicine may be painful. Remove the laminated pouch immediately before use.
2. Warning: Before opening the pouch, check the integrity of the packaging and the expiry date of the medicine. Do not use the medicine if: The pre-filled syringe has been dropped or damaged, or if the pre-filled syringe or pouch appears in any way damaged. The medicine has expired; the expiry date is printed on the carton and pouch. If any of the above situations 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 substance resembling a sticky gel, white to pale yellow in colour. The supersaturated solution may also contain microbubbles, which may disappear during immediate injection. These differences are normal and do not affect the quality of the product.

5. Select the injection site: 5a

5a. If the injection is administered by a healthcare professional or another trained person (family member or friend):

the injection should be given into the upper outer quadrant of the buttock or the upper outer area of the thigh.
or
5b. If the patient is self-administering:

 The injection site for Lanreotide Ranbaxy must be rotated with each dose, alternating between left and right sides. Avoid areas with moles, scars, redness, or skin irregularities.

6. Clean the injection site.

7. Prior to injection, remove the pre-filled syringe from the tray. Discard the tray.

8. Pull off the needle cap and discard it.

9. Flatten the skin at the injection site using the thumb and index finger of the hand not holding the cartridge-syringe to stretch the skin. Do not create a skin fold. Insert the entire needle firmly and smoothly at a perpendicular angle to the skin surface (90º angle). It is very important that the entire needle enters the body. After insertion, no part of the needle should be visible.	Do not remove the needle.
10. Remove the thumb and index finger from the area of skin previously flattened. Press the plunger with a steady, firm motion. The content of the cartridge-syringe is thicker and more difficult to inject than it appears.	Injection usually takes 20 seconds. Inject the full dose and push the plunger completely to ensure no medication remains in the device. 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 shield and will 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 instructions provided by your doctor or healthcare professional. Do not throw it in the household trash.

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

Missed dose of Lanreotide Ranbaxy
As soon as the patient realizes that a dose has been missed, they should contact a healthcare professional for advice on when to take the next dose. Do not administer additional injections to make up for the missed dose without discussing this with a healthcare professional.

Stopping treatment with Lanreotide Ranbaxy
Missing more than one dose or stopping treatment with Lanreotide Ranbaxy prematurely 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, consult your doctor or pharmacist.

4. Possible adverse reactions

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

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

The above adverse reactions are common and may occur in 1 in 10 people.
Contact a doctor immediately if the patient notices:

• redness or swelling of the face, rash or skin eruption;
• 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 reaction is unknown; it cannot be estimated based on available data.

Other adverse reactions
If the patient experiences any of the following adverse reactions, contact a doctor or pharmacist.
The most commonly expected adverse reactions include gastrointestinal disorders, gallbladder function disorders and injection site reactions. Below are the adverse reactions associated with the use of Lanreotide Ranbaxy, categorized by frequency of occurrence.

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• weight loss;
• lack of energy;
• slow heart rate;
• severe fatigue;
• reduced appetite;
• general weakness;
• excess fat in the stool;
• dizziness and 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, flatulence, bloating or abdominal discomfort, indigestion;
• dilatation of bile ducts (enlargement of the bile ducts between the liver, gallbladder and intestine). There may be 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 not known: frequency cannot be estimated from available data

• sudden, severe pain in the lower abdomen – this may be a symptom of pancreatitis;
• redness, pain, warmth and swelling at the injection site, which may feel fluid-filled when pressed, accompanied by fever – these may be symptoms of an abscess;
• sudden, severe pain in the upper right or middle abdomen, which may radiate to the shoulder or back, abdominal tenderness, nausea, vomiting and high fever – these may be symptoms of cholecystitis;
• pain in the upper right abdomen, fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, pale-coloured stools, dark urine, fatigue – these may be symptoms of cholangitis;
• 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, abdominal bloating or weight loss.

Because Lanreotide Ranbaxy may alter blood sugar levels, the doctor may recommend monitoring blood sugar levels, especially at the beginning of treatment.
Similarly, due to the possibility of gallbladder disorders during treatment with Lanreotide Ranbaxy, the doctor may recommend monitoring the gallbladder at the start of treatment and then at regular intervals.
Inform a doctor or pharmacist if the patient notices any of the above adverse reactions.

Reporting adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, tell a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C,
02-222 Warsaw,
tel.: 22 49 21 301,
fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lanreotide Ranbaxy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and label following "EXP". The expiry date refers to the last day of the specified month.
Lanreotide Ranbaxy must be stored in a refrigerator, at a temperature between 2°C and 8°C, in the original packaging to protect it from light.
After removal from the refrigerator, if kept sealed in its pouch, the medicine may be returned to the refrigerator (the number of such temperature excursions must not exceed three times) for continued storage and subsequent use, provided that it has been stored at a temperature below 30°C for a total duration not exceeding 72 hours.
Each pre-filled syringe is individually packaged.
Medicines must not be disposed of via wastewater or household waste. Ask your 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 Ranbaxy 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 Ranbaxy looks like and contents of the pack
Lanreotide Ranbaxy is a viscous solution for injection in a ready-to-use pre-filled syringe 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).

Lanreotide Ranbaxy is available in packs containing 1 or 3 pre-filled syringes, or in multi-packs containing 3 (3 x 1) pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
tel. 22 642 07 75

Manufacturer/Importer:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Terapia S.A.
124 Fabricii Street
400 632 Cluj Napoca
Romania

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Lanreotid SUN 60 mg, 90 mg, 120 mg Injektionslösung in einer Fertigspritze
Belgium: Lanréotide SUN 60 mg, 90 mg, 120 mg solution injectable en seringue préremplie
Czech Republic: Lanreotid SUN
Denmark: Lanreotid SUN 60 mg, 90 mg, 120 mg injektionsvæske, opløsning i fyldt injektionssprøjte
Finland: Lanreotidi SUN 60 mg, 90 mg, 120 mg Injektioneste, liuos, esitäytetyssä ruiskussa
France: LANREOTIDE BIOGARAN L.P. 60 mg, 90 mg, 120 mg solution injectable à libération prolongée en seringue préremplie
Spain: Lanreotida SUN 60 mg, 90 mg, 120 mg solución inyectable en jeringa precargada EFG
The Netherlands: Lanreotide SUN 60 mg, 90 mg, 120 mg oplossing voor injectie in een voorgevulde spuit
Ireland: Lanreotide SUN 60 mg, 90 mg, 120 mg solution for injection in a pre-filled syringe
Germany: Lanreotid SUN 60 mg, 90 mg, 120 mg Injektionslösung in einer Fertigspritze
Norway: Lanreotid SUN
Romania: Lanreotida Terapia 60 mg, 90 mg, 120 mg soluţie injectabilă în seringă preumplută
Slovakia: Lanreotid SUN 60 mg, 90 mg, 120 mg injekčný roztok v naplnenej injekčnej striekačke
Sweden: Lanreotid SUN 60 mg, 90 mg, 120 mg injektionsvätska, lösning i förfylld spruta
Hungary: Lanreotid SUN 60 mg, 90 mg, 120 mg oldatos injekció előretöltött fecskendőben
Italy: Lanreotide SUN