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, 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 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 the substance lanreotide in a long-acting formulation.
Lanreotide – the active substance – belongs to a group of medicines called growth hormone inhibitors. It is similar to another substance (hormone) called somatostatin.
Lanreotide reduces the activity in the body of certain hormones 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) occurring 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 (NETs);
• for the 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 any other 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 required 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 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 concomitantly administered medicines.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her 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 exactly as directed by your doctor. If you have any doubts,
you should consult your 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 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.
Symptom relief (such as flushing and diarrhoea) associated with neuroendocrine tumours
The recommended dose is one injection every 28 days. The dose of 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 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 known as
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 regarding self-administration or administration by another trained person
should be made by the doctor. If the patient has any doubts about the injection method,
they should contact their doctor or a healthcare professional for advice or further training.
When 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).
When self-injecting 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 an injection of Lanreotide Ranbaxy.
Lanreotide Ranbaxy is available 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
patient needlestick injury.

1. Remove the Lanreotide Ranbaxy from the refrigerator 30 minutes before administration. Injection of cold solution 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 medicinal product. Do not use the medicinal product if: The pre-filled syringe has been dropped or damaged, or if the pre-filled syringe or pouch appear in any way damaged. The expiry date has passed; the expiry date is printed on the carton and pouch. If any of the above situations occur, 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 immediate administration. These variations 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 performs self-injection:
 The injection site for Lanreotide Ranbaxy should 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 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 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 push the plunger completely to ensure 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 protective cap 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 waste.

Use of a higher than recommended dose of Lanreotide Ranbaxy
If a dose of Lanreotide Ranbaxy has been administered more frequently than recommended,
the physician 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 reactions (see section 4. "Possible side effects").

Missed administration of Lanreotide Ranbaxy
As soon as the patient realizes that a dose has been missed, they should contact
a healthcare professional, who will provide guidance on when the next dose should be given. The patient
must not administer additional doses independently to make up for the missed dose
without discussing this with a healthcare professional.

Discontinuation of Lanreotide Ranbaxy treatment
Missing more than one dose or stopping treatment with Lanreotide Ranbaxy prematurely
may affect the efficacy of therapy. The physician should be consulted before discontinuing the medication.

If there are any further doubts regarding the use of this medicinal product, consult the physician 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 affect up to 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 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. There may be 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;
• 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.

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 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 sign of pancreatitis;
• redness, pain, warmth, and swelling at the injection site, which may feel fluid-filled when pressed, accompanied by fever – these may be signs 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 signs 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 signs 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, 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 beginning 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 those not listed in this leaflet, inform 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,
Phone: 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 outer carton and label after "EXP". The expiry date refers to the last day of the stated month.
Lanreotide Ranbaxy should be stored in a refrigerator, at a temperature of 2°C to 8°C, in the original packaging to protect it from light.
After removal from the refrigerator, if kept below 30°C for a total of no longer than 72 hours, the medicine may be returned to the refrigerator (this temperature excursion may occur no more than three times) for continued storage and subsequent use.
Each pre-filled syringe is individually packaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will 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 components are:
water for injections
glacial acetic acid (for pH adjustment)

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 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).

Lanreotide Ranbaxy is available in packs containing 1 or 3 pre-filled syringes, or in multipacks 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 countries 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