Lanreotide ranbaxy

Package leaflet: Information for the user

Lanreotide Ranbaxy, 60 mg, solution for injection in pre-filled syringe
Lanreotide Ranbaxy, 90 mg, solution for injection in pre-filled syringe
Lanreotide Ranbaxy, 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. 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

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 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. Additionally, it affects certain advanced types of tumours (called neuroendocrine tumours) occurring in the intestine and pancreas by inhibiting or delaying their growth.

What Lanreotide Ranbaxy 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 hands and feet;
• Relief of symptoms such as flushing and diarrhoea, which may occur in patients with neuroendocrine tumours (NETs);
• Treatment and inhibition of growth of certain advanced tumours occurring in the intestine and pancreas, known as gastroenteropancreatic neuroendocrine tumours (GEP-NETs), when they 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 other medicines in 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 gallstone formation. 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 thyroid function;
• if the patient has heart function disorders, because sinus bradycardia (slow heart rate) may occur during treatment with lanreotide. Particular caution is required when initiating lanreotide treatment in patients with bradycardia (a heart rhythm disorder).

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

Consult a 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).

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 a doctor or pharmacist before using this medicine. Lanreotide Ranbaxy should only be administered if clearly necessary.

Driving and operating machinery

It is unlikely that Lanreotide Ranbaxy will affect 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 an adverse effect occurs, the patient should not drive or operate machinery.

3. How to use Lanreotide Ranbaxy

This medicine should always be used as directed 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 medicine to be injected will be selected by the doctor from among the three available strengths of Lanreotide Ranbaxy (60 mg, 90 mg or 120 mg).
If the desired response is achieved, the doctor may recommend changing the injection frequency of Lanreotide Ranbaxy 120 mg to once every 42 or 56 days.
The doctor will also decide on the duration of treatment.

Symptom relief (such as flushing and diarrhoea) associated with neuroendocrine tumours
The recommended dose is one injection every 28 days. The doctor will select the injection dose from among the three available strengths of Lanreotide Ranbaxy (60 mg, 90 mg or 120 mg).
If a satisfactory response to somatostatin analogue or Lanreotide Ranbaxy 60 mg or 90 mg is achieved, the doctor may recommend changing the injection frequency of Lanreotide Ranbaxy 120 mg to once every 42 or 56 days.
The doctor will also decide on the duration of treatment.

Treatment of advanced tumours of the gastrointestinal tract and pancreas called gastroenteropancreatic neuroendocrine tumours (GEP-NET). This 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 Ranbaxy to inhibit tumour growth.

Method of administration
Lanreotide Ranbaxy must 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 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, they should contact the doctor or healthcare professional for advice or further training.

When the injection is administered by a healthcare professional or a trained person (family member or friend), it should be given into the upper outer quadrant of the buttock or the upper outer part of the thigh (see Figures 5a and 5b below).
When self-administering the injection after appropriate training, it should be given into the upper outer part of the thigh (see Figure 5b below).

Instructions for use
Note: Read the entire instructions 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 Ranbaxy injection.
Lanreotide Ranbaxy is available as a ready-to-use pre-filled syringe equipped with an automatic safety system. The needle retracts automatically after the full dose has been injected, to prevent injury to the patient.

1. Remove the Lanreotide Ranb游戏副本y medicine from the refrigerator 30 minutes before administration. Injection of cold contents 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 expiry date of the medicine has passed; 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 prefilled syringe. The contents of the prefilled 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 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 part of the thigh.
or
5b. If the patient is
administering the
injection themselves:

 The injection site for Lanreotide Ranbaxy must 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. Prior to injection, remove the prefilled syringe from the tray. Discard the tray.

8. Pull off the needle cap and discard it.

9. Flatten the skin at the injection site by using the thumb and index finger of the hand not holding the pre-filled syringe, in order to stretch the skin. Do not create a skin fold. Insert the entire needle firmly and smoothly at a perpendicular angle (90º) to the skin surface. 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 pre-filled syringe is thicker and more difficult to inject than it appears.	Injection usually takes about 20 seconds. Inject the full dose and fully depress the plunger to ensure that no medication remains in the syringe. 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 shield and will be permanently locked inside.
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 instructions provided by your doctor or healthcare professional. Do not throw it into household waste.

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 higher than recommended dose of Lanreotide Ranbaxy has been administered, there is a risk of additional or more severe adverse reactions (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 who will provide advice on when the next dose should be given. Do not administer additional injections independently to make up for the missed dose without discussing it 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. Patients should consult their doctor before discontinuing the medication.

If you have any further doubts 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:

• increased thirst or fatigue and dry mouth – this may indicate high blood sugar levels or the development of 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 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 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 dysfunction, 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. These may cause 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 affect up to 1 in 10 people

• weight loss;
• lack of energy;
• slow heart rate;
• severe fatigue;
• decreased appetite;
• general weakness;
• fat in stools (steatorrhoea);
• 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;
• bile duct dilation (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 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, possibly with a sensation of fluid accumulation upon pressing, 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 (gallbladder inflammation);
• pain in the upper right abdomen, fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-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, 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, especially at the beginning of treatment.
Similarly, due to the potential for gallbladder disorders during treatment with Lanreotide Ranbaxy, the doctor may recommend monitoring the gallbladder at the start of treatment and at regular intervals thereafter.
Inform a doctor or pharmacist if the patient experiences any of the above adverse reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring 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 responsible entity.
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 outer carton and label after "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 in a closed bag, 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 injectable solution in a ready-to-use pre-filled syringe with an automatic safety system. The medicine is a semi-solid, white to pale yellow in colour.

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.
ul. Idzikowskiego 16
00-710 Warszawa
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 European Economic Area member states 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