IPSTYL <120 мг Инъекционный раствор

Содержание инструкции

1. Ipstyl 30 mg/2 ml Powder and solvent, prolonged-release injectable suspension
   1. What is Ipstyl and what it is used for
   2. What you need to know before using Ipstyl
   3. How to use Ipstyl
   4. Possible side effects
   5. How to store Ipstyl
   6. Contents of the pack and other information
   7. What is Ipstyl 60mg, 90mg, 120mg and what it is used for
   8. What you need to know before using Ipstyl 60mg, 90mg, 120mg
   9. How to use Ipstyl
   10. Possible side effects
   11. How to store Ipstyl
   12. Package Contents and Other Information

Ipstyl 30 mg/2 ml Powder and solvent, prolonged-release injectable suspension

lanreotide
Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Ipstyl and what it is used for

Ipstyl 30mg/2ml is a prolonged-release formulation of lanreotide. Lanreotide, the active substance, belongs to the group of growth hormone inhibitors. It is similar to a natural hormone called somatostatin. Lanreotide decreases the levels of some hormones in the body such as growth hormone (GH) and insulin-like growth factor type I (IGF-I) and inhibits the release of some gastro-intestinal hormones and intestinal secretions.
This medicine is used in:

• Treatment of acromegaly (condition in which the body produces too much growth hormone), in patients awaiting surgical intervention or when growth hormone secretion is not normalized after surgery or radiotherapy
• Treatment of clinical symptoms of carcinoid tumors
• Treatment of primary thyroid tumors associated with hyperthyroidism (primary thyrotropinomas)

2. What you need to know before using Ipstyl

Do not use Ipstyl

• if you are allergic (hypersensitive) to lanreotide, somatostatin and medicines of the same class (somatostatin analogues) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Tell your doctor or pharmacist before using Ipstyl

• If you have gallstones, as lanreotide may lead to the formation of gallstones in the gallbladder. You may therefore require periodic monitoring. Your doctor may decide to stop treatment with lanreotide in case of complications resulting from gallstones;
• If you have been diagnosed with diabetesor suffer from hypoglycemia (low blood sugar) as lanreotide may alter blood glucose levels. Your doctor may periodically check your blood glucose levels and, in case of diabetes, adjust your antidiabetic treatment during therapy with lanreotide;
• If you suffer from thyroid dysfunction(the thyroid is a gland located in the front region of the neck) as lanreotide may slightly alter thyroid function;
• If you suffer from heart disorders, as a slowing of the heartbeat (sinus bradycardia) may occur during treatment;

If you have any of the conditions listed above, contact your doctor or pharmacist before
using Ipstyl.

Children
Ipstyl is not recommended in children.

Other medicines and Ipstyl
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Pay particular attention when administering lanreotide during therapy
with:

• Cyclosporine (a medicine that reduces the immune response, used for example after organ transplants or for autoimmune diseases);
• bromocriptine (dopamine agonist used in the treatment of pituitary tumors, in Parkinson's or to control abnormal increase of prolactin hormone);
• medicines that induce bradycardia (reduction of heart rate), for example beta-blockers;
• medicines that are known to be metabolized by cytochrome P450 enzymes and by CYP3A4 (example: quinidine, terfenadine);
• Insulin or other medicines for diabetes (medicines that reduce blood sugar levels)

Your doctor may consider a possible adjustment of the dosage of these medicines.

Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant, suspect or are
planning a pregnancy, or if you are breastfeeding with breast milk. In these cases Ipstyl
should only be administered if strictly necessary.

Driving and using machines
Although no effects on the ability to drive and operate machinery have been established,
dizziness has been reported with Ipstyl injectable suspension. If you suffer from it, you should not drive
or operate machinery.

Important information on the sodium content of Ipstyl 30 mg
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is
essentially ‘sodium-free’.

3. How to use Ipstyl

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor or pharmacist.

Dosage
Treatment must be adapted to each patient in a specialist setting. Taking into account the variability of tumor sensitivity to somatostatin analogs, it is recommended to start treatment with a test injection to assess the quality of the response (GH secretion, symptoms related to the carcinoid tumor, tumor secretion, etc.). A lack of response to this first injection requires reconsideration of the usefulness of the treatment.

Acromegaly

• In patients awaiting surgeryThe administration schedule of the prolonged-release formulation can be initially set at an intramuscular injection every 10 days.
• After surgery and/or radiotherapy The administration schedule of the prolonged-release formulation can be initially set at an intramuscular injection every 14 days: in case of insufficient response, assessed based on growth hormone and IGF-1 levels (measured before the next injection), the treatment schedule may involve an injection every 10 days.

Carcinoid tumors
The administration schedule of the prolonged-release formulation can be initially set at an intramuscular injection every 14 days. In case of insufficient response, assessed based on clinical symptoms (hot flashes, diarrhea), the interval can be reduced to an injection every 10 days.

Primary thyrotropic adenomas
The administration schedule of the prolonged-release formulation can be initially set at an intramuscular injection every 14 days. In case of insufficient response, assessed based on thyroid hormone and TSH levels, the interval can be reduced to an injection every 10 days.

Use in children and adolescents
The use of Ipstyl is not recommended in children and adolescents due to the lack of safety and efficacy data in this population.
If you suffer from impaired renal and/or hepatic function
If you suffer from impaired renal and/or hepatic function, no dosage adjustment is necessary.
Elderly patients
No dosage adjustment is necessary.
Method of administration
Ipstyl is administered by intramuscular injection into the upper outer quadrant of the gluteus.
It is necessary to alternate the injection site for intramuscular injection between the left and right sides.
The powder must be reconstituted with the solvent immediately before the injection, gently swirling the vial in a rotating motion, without inverting it, until a homogeneous, milky-looking suspension is obtained.
Any unused or spilled product must be disposed of in accordance with local regulations.
Do not use if the kit is damaged or opened.
The suspension must be prepared immediately before administration.

The box containing Ipstyl must be removed from the refrigerator 30 minutes before use.
Always use two needles: one to reconstitute the suspension and fill the syringe, and one for administering the product.

d 1 – PATIENT PREPARATION
	The patient must be in a prone position with the area of the gluteus intended for the injection disinfected.
2 – INJECTION PREPARATION
	n Screw one of the two needles onto the syringe (do not remove the needle protection yet!).
	i Break the neck of the solvent vial.
	l Remove the needle protection and draw all the solvent from the vial into the syringe. t I
	Remove the protective cap from the vial containing the powder. Insert the needle through the rubber stopper and slowly inject the solvent so that, if possible, it washes the entire upper part of the vial itself. i z
	Do not remove the syringe from the vial, but position the needle above the liquid level and while reconstituting the injectable suspension, homogeneous and milky, gently swirl the vial between your fingers and do not g invert it. Caution: do not mix the product by aspirating it into the syringe and then releasing it back into the vial repeatedly!

	o rare then all the suspension into the syringe. c a
u	m ove the first needle from the syringe and release the air from the syringe, if necessary. r a
	F it the second needle onto the syringe and immediately inject the suspension. Do not mix with other medicines. l
e 3 – INJECTION
	d ection must be performed intramuscularly into the gluteus muscle. Inject the contents of the syringe immediately and rapidly. The injection site must be alternated between the left and right sides.
a 4 – AFTER USE
	nare the needles and all the material used in special containers.
	n ouso. Any unused suspension must be discarded.

Dispose of the material used for the injection by placing it back in the packaging and do not reuse.

Important Note: It is important that the preparation of the injection is carried out strictly following the instructions. Any injection performed incorrectly that involves a loss of medication in an amount greater than what normally remains in the syringe used for the injection must be immediately reported to the treating physician.

If you use more Ipstyl than you should
In case of accidental ingestion of an excessive dose of Ipstyl, immediately inform your doctor or go to the nearest hospital.
In case of overdose, symptomatic treatment is indicated.

If you forget to use Ipstyl
As soon as you realize you have forgotten an injection, contact your doctor, who will give you instructions regarding the next injection. Do not take additional injections on your own to make up for the missed injection and do not worry if you have forgotten an injection once. In long-term treatments such as those with lanreotide, a forgotten injection does not dramatically compromise the success of the therapy.

If you stop the treatment with Ipstyl
Premature interruption or conclusion of treatment with Ipstyl may compromise the success of the therapy. Do not stop the therapy with Ipstyl on your own, but strictly follow the doctor's instructions. For any questions regarding the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately inform your doctor if you notice any of the following side effects:

• Unusual feeling of thirst or fatigue, dry mouth - these may be signs that you have high blood sugar levels or are developing diabetes
• Feeling of hunger, feeling of instability, abnormal sweating or feeling of confusion - these may be signs of low blood sugar levels. The frequency of these side effects is common, it may affect up to 1 in 10 people.

Immediately inform your doctor if you notice:

• that your face becomes red or swollen or develops spots or skin rashes
• that your chest becomes heavy and your breath becomes short or if you are wheezing
• a feeling of weakness, possibly due to a drop in blood pressure. These may be the effects of an allergic reaction. The frequency of these side effects is unknown: it cannot be estimated based on available data.

Other side effects
The most common expected side effects are gastrointestinal disorders, gallstones
(often without symptoms) and reactions at the injection site. The side effects that may occur with lanreotide are listed below according to their frequency:

Very common, occurring in 1 or more than 1 in 10 patients:

• Diarrhea, loss of stool, abdominal pain
• Gallstones and other biliary problems. You may experience symptoms such as severe and sudden abdominal pain, high fever, jaundice (yellowing of the skin and whites of the eyes), chills, loss of appetite, skin itching. Common, occurring in 1 or more than 1 in 100 patients:
• Weight loss
• Loss of energy
• Slowing of the heartbeat
• Feeling of profound fatigue
• Decreased appetite
• Generalized feeling of weakness
• Excessive fat in the stool
• Feeling of dizziness, headache
• Hair loss or decreased development of body hair
• Pain affecting muscles, ligaments, tendons and bones
• Reactions where the injection is given, such as pain, skin hardening or itching
• Abnormal liver and pancreas test results, changes in blood sugar levels
• Nausea, vomiting, constipation, flatulence, stomach bloating or discomfort, indigestion
• Bile duct dilation (widening of the bile ducts between the liver and the gallbladder and the intestine). You may have symptoms such as stomach pain, nausea, jaundice, and fever

Uncommon, occurring in 1 or more than 1 in 1000 patients:

• Hot flashes
• Difficulty sleeping
• Change in stool color
• Changes in sodium levels and alkaline phosphatase in blood tests

Not known,frequency cannot be defined based on available data

• Severe and sudden pain in the lower abdomen: this may be a sign of inflammation of the pancreas (pancreatitis)
• Redness, pain, warmth and swelling at the injection site that may feel fluid-filled when pressed, fever: this may be a sign of an abscess
• Sudden and severe pain in the upper right or center of the abdomen, which may spread to the shoulder or back, abdominal tenderness, nausea, vomiting and high fever: this may be a sign of inflammation of the gallbladder (cholecystitis)
• Pain in the upper right side of the abdomen, fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-colored stools, dark urine, fatigue: these may be signs of inflammation of the bile duct (cholangitis).

Because lanreotide can alter blood sugar levels, your doctor may want to
monitor your blood sugar levels, especially at the beginning of treatment.
Similarly, because gallbladder problems may occur with this medicine, your
doctor may want to check your gallbladder at the beginning of therapy with Ipstyl and from time to time during therapy.
Inform your doctor or pharmacist or nurse if you notice any of the side effects
described above.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please inform your doctor or pharmacist. You can also report side effects
directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store Ipstyl

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C- 8 °C) in the original packaging.
Do not use this medicine if you notice visible signs of deterioration.
Single-use. After reconstitution, the suspension must be used immediately.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ipstyl contains

• The active ingredient is lanreotide.
• The other components present in the powder vial are lactide-glycolide copolymer, lactic-glycolic copolymer, mannitol, sodium carboxymethylcellulose, polysorbate 80.
• The components of the solvent vial are mannitol, water for injections.

Description of the appearance of Ipstyl and contents of the pack
The powder vial contains 30 mg of lanreotide.
The powder is almost white and the presence of bubbles on the surface is normal.
The vial contains 2 ml of solvent suspension.
The pack contains 1 powder vial, in colored glass closed with an elastomer stopper
and an aluminum/plastic cap, 1 solvent vial of 2 ml and a sterile injection kit
containing 1 empty syringe and two needles.
The glass of the vial is slightly colored.
After reconstitution, the suspension has a milky appearance.

Marketing authorisation holder and manufacturer
IPSEN S.p.A. - Via del Bosco Rinnovato, 6 - Milanofiori Nord –Palazzo U7 - 20090 Assago (MI)

Manufacturer
Ipsen Pharma Biotech S.A.S, Parc d'Activités du Plateau de Signes - Chemin Départemental n.

• 402 - 83870 Signes (France)

Ipstyl 60 mg injectable solution Ipstyl 90 mg injectable solution Ipstyl 120 mg injectable
solution
Lanreotide

Read this leaflet carefully before you use this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Ipstyl 60mg, 90mg, 120mg is and what it is used for
• 2. What you need to know before you use Ipstyl 60mg, 90mg, 120mg
• 3. How to use Ipstyl 60mg, 90mg, 120mg
• 4. Possible side effects
• 5. How to store Ipstyl 60mg, 90mg, 120mg
• 6. Contents of the pack and other information

1. What is Ipstyl 60mg, 90mg, 120mg and what it is used for

The name of the medicine is Ipstyl. Ipstyl injectable solution is a prolonged-release formulation of lanreotide.
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 decreases the levels of some hormones in the body such as growth hormone (GH) and insulin-like growth factor type I (IGF-I) and inhibits the release of some hormones in the gastrointestinal tract and intestinal secretions. Furthermore, it has an effect on some types of tumors (called neuroendocrine tumors) in advanced stages of the intestine and pancreas, blocking or slowing down their growth.
Ipstyl is used in:

• Treatment of acromegaly (a condition in which the body produces too much growth hormone) and patients in whom growth hormone (GH) secretion is not normalized following surgery or radiotherapy
• Treatment of symptoms such as hot flashes and diarrhea that sometimes occur in patients with neuroendocrine tumors (very rare tumors that originate in glands or endocrine cells)
• Treatment and control of the growth of some advanced-stage tumors of the intestine and pancreas, called gastroenteropancreatic neuroendocrine tumors or GEP-NET. It is used when these tumors cannot be removed surgically.

2. What you need to know before using Ipstyl 60mg, 90mg, 120mg

Do not use Ipstyl

• If you are allergic (hypersensitive) to lanreotide, somatostatin or drugs of the same family (somatostatin analogues) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Take special care with treatment with Ipstyl
Talk to your doctor or pharmacist before using Ipstyl:

• If you have gallstones, as lanreotide may lead to the formation of gallstones in the gallbladder. You may therefore require periodic monitoring. Your doctor may decide to stop treatment with lanreotide in case of complications resulting from gallstones;
• If you have been diagnosed with diabetesor suffer from hypoglycemia (low blood sugar levels) as lanreotide may alter blood glucose levels. Your doctor may periodically check your blood glucose levels and, in case of diabetes, modify your anti-diabetic treatment during therapy with lanreotide;
• If you suffer from thyroid dysfunction(the thyroid is a gland located in the front region of the neck) as lanreotide may slightly alter thyroid function; If you suffer from heart disorders, as a slowing of the heartbeat (sinus bradycardia) may occur during treatment with lanreotide. If you suffer from any of the above conditions, consult your doctor or pharmacist before using Ipstyl. Use in children and adolescentsLanreotide is not recommended in children and adolescents.

Other medicines and Ipstyl
Some medicines can have an effect on other medicines. Tell your doctor or pharmacist if you are
taking, have recently taken or might take any other medicines.
Particular care should be taken when administering lanreotide during therapy with

• Cyclosporine (a drug that reduces the immune response, used for example after organ transplants or for autoimmune diseases);
• bromocriptine (dopamine agonist used in the treatment of some types of brain tumors and in Parkinson's disease or to control abnormal increase of the hormone prolactin);
• medicines that induce bradycardia (reduction of heart rate), for example beta-blockers;
• medicines that are known to be metabolized by cytochrome P450 enzymes and by CYP3A4 (example: quinidine, terfenadine);
• Insulin or other medicines for diabetes (drugs that reduce blood sugar levels). Your doctor may consider a possible modification of the dosage of these drugs.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy,
ask your doctor or pharmacist for advice before using this medicine. Lanreotide
should only be administered if strictly necessary.

Driving and using machines
Although effects on the ability to drive and operate machinery have not been established,
dizziness has been reported with Ipstyl injectable solution. If you suffer from it, do not drive or
operate machinery.

3. How to use Ipstyl

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor or pharmacist.

Recommended dose
Ipstyl injectable solution is available in a pre-filled syringe ready for use and containing 60 mg, 90 mg or 120 mg of lanreotide acetate.

Acromegaly
In patients with a new diagnosis, treatment may be started with Ipstyl injectable solution in a pre-filled syringe administered every 28 days at the most appropriate dosage established based on the clinical picture. Subsequently, the dosage must be individualized based on the response obtained. If the desired response is not obtained, the dosage may be modified by increasing the dose or reducing the intervals between administrations.
In patients undergoing therapy with Ipstyl 30 mg powder and solvent for injectable suspension, treatment may be continued with Ipstyl injectable solution according to the following scheme:

• from Ipstyl 30 mg powder and solvent for prolonged-release suspension every 14 days to Ipstyl 60 mg solution for injection in a pre-filled syringe every 28 days;
• from Ipstyl 30 mg powder and solvent for prolonged-release suspension every 10 days to Ipstyl 90 mg solution for injection in a pre-filled syringe every 28 days;
• from Ipstyl 30 mg powder and solvent for prolonged-release suspension every 7 days to Ipstyl 120 mg solution for injection in a pre-filled syringe every 28 days.

The dosage may also be adjusted by keeping the dose of Ipstyl injectable solution constant and varying the interval between administrations, for example according to the following scheme:

• from Ipstyl 30 mg every 14 days to Ipstyl 120 mg every 56 days;
• from Ipstyl 30 mg every 10 days to Ipstyl 120 mg every 42 days;
• from Ipstyl 30 mg every 7 days to Ipstyl 120 mg every 28 days.

Treatment of clinical symptoms of neuroendocrine tumors (such as hot flashes and diarrhea)
Treatment may be started with Ipstyl injectable solution in a pre-filled syringe administered every 28 days at the most appropriate dosage established based on the clinical picture. Subsequently, the dosage must be individualized by modifying the doses or the interval between administrations based on the degree of symptom reduction obtained, changes in plasma concentrations of tumor-derived markers, and the tolerability of the treatment.
In patients undergoing therapy with Ipstyl 30 mg powder and solvent for prolonged-release injectable suspension, treatment may be continued with Ipstyl solution in a pre-filled syringe according to the following scheme:

• from Ipstyl 30 mg every 14 days to Ipstyl 60 mg every 28 days;
• from Ipstyl 30 mg every 10 days to Ipstyl 90 mg every 28 days;
• from Ipstyl 30 mg every 7 days to Ipstyl 120 mg every 28 days.

Treatment of advanced-stage tumors of the intestine and pancreas, called gastroenteropancreatic neuroendocrine tumors or GEP-NETs. To be used when these tumors cannot be surgically removed
The recommended dose is 120 mg every 28 days.
The doctor will decide the duration of therapy with Ipstyl for tumor control.

Method of administration
Ipstyl must be administered by deep subcutaneous injection.
The injection must be performed by a healthcare professional or by a family member or friend or by yourself after appropriate training by a doctor.
The decision regarding self-administration or administration by a trained person must be made by your doctor.
If you have any doubts about how to administer Ipstyl, please contact your doctor or healthcare professional at any time for advice or further instructions.

If the injection is performed by a healthcare professional or another person who has been adequately trained (relative or friend), it must be performed in the upper outer quadrant of the buttock or in the upper outer part of the thigh (see below, fig. 5a and 5b).
In case of self-administration, after appropriate training, the injection must be performed in the upper outer part of the thigh (see below, fig. 5b).
Instructions for use
WARNING: Read the instructions carefully before performing the injection.
Administration is done by a deep subcutaneous injection that requires a specific technique different from normal subcutaneous injections.
The following instructions explain how to administer Ipstyl
Ipstyl is supplied in a pre-filled syringe ready for use, equipped with an automatic safety system. The needle retracts automatically after complete administration of the product to prevent needle-stick injuries.

• 1. Remove IPSTYL injectable solution from the refrigerator 30 minutes before administration.Injection with cold medicine can be painful. Keep the sealed laminate pouch sealed until just before the injection.

• 2. Caution: Before opening the pouch, check that it is intact and that the medicine has not expired.

Do not use the pre-filled syringe:

• If the pre-filled syringe is dropped or damaged or if the pre-filled syringe or pouch appears damaged in any way.
• If the product is expired; the expiration date is printed on the outer carton and on the pouch.

If any of the above conditions occur, contact your doctor or pharmacist.

• 3. Wash your hands with soap .
• 4. Open the pouch along the dotted line and remove the pre-filled syringe. The contents of the pre-filled syringe are a semi-solid solution with an appearance similar to a gel, with viscous characteristics and a color ranging from white to pale yellow. The supersaturated solution may also contain microbubbles that may disappear during the injection. These differences are normal and do not interfere with the quality of the product.

After opening the protective laminate pouch, the product must be administered immediately.

• 5. Choose an injection site:

5a: If the injection is performed by a healthcare professional or a trained family member or friend, inject into the upper outer quadrant of the buttock or the upper outer part of the thigh
or
5b: In case of self-administration, inject into the upper outer part of the thigh

• Perform the Ipstyl injection alternately to the right or left. Avoid areas with moles, scars, reddened skin, or skin that appears irregular.
• 6. Clean the injection site
• 7. Before performing the injection, remove the pre-filled syringe from its container. Dispose of the container.

• 8. Remove the needle cap by pulling it off and discard it.

• 9. Pinch the area of injection between the thumb and index finger of the hand that is not holding the pre-filled syringe to stretch the skin. Do not pinchthe skin. Use a firm, straight motion inserting the needle quicklyand perpendicularlyto the skin (90-degree angle), deep into the thickness of the skin. It is very important that the needle is inserted completely. No part of the needle should be visible once it is fully inserted.

Do not aspirate(do not pull back)

• 10. Release the skinat the injection site previously stretched by your hand. Push the plunger with a constant, firm pressure. The medicine is dense and more difficult to push than you might expect. It typically takes 20 seconds. Inject the full dose and give a final push, making sure you can’t push any further.

Note: maintain pressure on the plunger with your thumb to prevent activation of the automatic safety system.

• 11. Maintaining pressure on the plunger, remove the needle from the injection site.

• 12. At this point, release the pressure exerted on the plunger. The needle will automatically retract into its housing where it will remain locked permanently.

• 13. Apply light pressure to the injection site with a dry cotton ball or sterile gauze to prevent any bleeding. Do not rub or massagethe injection site after administration.
• 14. The syringe must be disposed of properly, according to the instructions of your doctor or other healthcare professional. Do not dispose of the device in household waste.

Use in children and adolescents
The use of Ipstyl is not recommended in children and adolescents due to the lack of safety and efficacy data.

If you have impaired kidney and/or liver function
If you have impaired kidney and/or liver function, no dosage adjustment is necessary.

Elderly patients
No dosage adjustment is necessary.

If you use more Ipstyl than you should
In case of accidental overdose of Ipstyl, immediately inform your doctor or go to the nearest hospital.
If you have any doubts about the use of Ipstyl, contact your doctor or pharmacist.

If you forget to use Ipstyl
As soon as you realize you have missed an injection, contact your doctor, who will give you instructions regarding the next injection. Do NOT take additional injections on your own to make up for the missed injection without first talking to your doctor.

If you stop treatment with Ipstyl
Interruption of more than one dose or premature termination of treatment with lanreotide may compromise the success of therapy. Do not stop treatment with Ipstyl on your own, but strictly follow your doctor's instructions. For any questions regarding the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of the following side effects:

• Feeling of unusual thirst or tiredness, dry mouth - these may be signs that you have high blood sugar levels or are developing diabetes
• feeling of hunger, feeling unstable, abnormal sweating or feeling confused - these may be signs of low blood sugar levels. The frequency of these side effects is common, it may affect up to 1 in 10 people.

Tell your doctor immediately if you notice:

• that your face becomes red or swollen or that spots or rashes develop
• that your chest becomes tight and your breath becomes short or if you wheeze
• a feeling of weakness, probably due to a drop in blood pressure.

These may be the effects of an allergic reaction.
The frequency of these side effects is not known: it cannot be estimated based on the available data.

Other side effects
Tell your doctor or pharmacist if you notice any of the following side effects.
The most common side effects expected related to the medicine are: gastrointestinal disorders,
gallstones and reactions at the injection site. The side effects that may occur with lanreotide are listed below according to their frequency:

Very common,may occur in more than 1 in 10 patients:

• Diarrhoea, loose stools, abdominal pain
• Gallstones and other bile problems. You may experience symptoms such as severe and sudden abdominal pain, high fever, jaundice (yellowing of the skin and the whites of the eyes), chills, loss of appetite, skin itching.

Common,may occur in up to 1 in 10 patients:

• Weight loss
• Loss of energy
• Slowing of the heartbeat
• Feeling of profound tiredness
• Decreased appetite
• Feeling of general weakness
• Excessive fat in the stool
• Feeling dizzy, headache
• Hair loss or decreased development of body hair
• Pain affecting muscles, ligaments, tendons and bones
• Reactions where the injection is given such as pain, skin hardening or itching
• Abnormal results of liver and pancreas tests, changes in blood sugar levels
• Nausea, vomiting, constipation, flatulence, stomach bloating or discomfort, indigestion.
• Bile duct dilation (widening of the bile ducts between the liver and the gallbladder and the intestine). You may have symptoms such as stomach pain, nausea, jaundice and fever Uncommon,may occur in up to 1 in 100 patients:
• Hot flushes
• Difficulty sleeping
• Change in stool color
• Change in sodium levels and alkaline phosphatase in blood tests

Not known,frequency cannot be estimated based on the available data:

• Severe and sudden pain in the lower abdomen: this may be a sign of inflammation of the pancreas (pancreatitis)
• Redness, pain, warmth and swelling at the injection site that may feel full of fluid when pressed, fever: this may be a sign of an abscess
• Sudden and severe pain in the upper right or center of the abdomen, which may spread to the shoulder or back, tenderness of the abdomen, nausea, vomiting and high fever: this may be a sign of inflammation of the gallbladder (cholecystitis)
• Pain in the upper right side of the abdomen, fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-colored stools, dark urine, fatigue: these may be signs of inflammation of the bile duct (cholangitis).

Because lanreotide can alter blood sugar levels, your doctor may want to
monitor your blood sugar levels, especially at the beginning of treatment.
Similarly, because gallbladder problems may occur with this medicine, your
doctor may want to check your gallbladder at the beginning of lanreotide therapy and from
time to time during therapy.
Tell your doctor or pharmacist if you notice any of the side effects described above.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Ipstyl

Store the medicine in a refrigerator between 2°C and 8 °C in the original packaging in order to
protect it from light. Once removed from the refrigerator, the medicine in the sealed bag can be
returned to the refrigerator (the number of temperature excursions must not exceed three)
and stored for subsequent use, provided that it has been kept in total for no
more than 24 hours below 40 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is printed on the box and on the bag
after the word EXP. The expiry date refers to the last day of that month.
Each syringe is individually packaged.
Do not use this medicine if the packaging or the bag is damaged or open.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ipstyl Contains

• The active ingredient is lanreotide. Each pre-filled syringe contains a supersaturated solution of lanreotide acetate corresponding to 0.246 mg of lanreotide base per mg of solution, which ensures the administration of 60 mg, 90 mg and 120 mg of lanreotide, respectively.
• The other ingredients are water for injections and glacial acetic acid (to adjust the pH).

Description of Ipstyl and Package Contents
Ipstyl is a dense injectable solution available in a pre-filled syringe ready for use and
containing 60 mg, 90 mg or 120 mg of lanreotide acetate.
The pre-filled syringe, equipped with an automatic safety system, contains injectable
solution for subcutaneous use.
Each pre-filled syringe is packaged in a laminated pouch and in a cardboard box.
The package contains a 0.5 ml syringe with an automatic safety system and a needle
(1.20mm x 20mm).

Marketing Authorisation Holder and Manufacturer
IPSEN S.p.A. – Via del Bosco Rinnovato, 6 - Milanofiori Nord – Palazzo U7
20057 Assago (MI)

MANUFACTURER AND FINAL CONTROL
Manufacturing stage: all stages of production, packaging and control
Ipsen Pharma Biotech S.A.S, Parc d'Activités du Plateau de Signes - Chemin Départemental n.

• 402 - 83870 Signes (France)

Detailed and updated information on this medicine is available by scanning the
QR code on the outer packaging with a smartphone. The same information is
also available at the following URL: http://qr-ipsen.it/t2vb12y/