OCTREOTIDE 0.05 MG/1 ML Injectable solution

Зміст інструкції

1. Octreotide SUN 0.05 mg/1 ml injectable solution, 0.1 mg/1 ml injectable solution, 0.5 mg/1 ml injectable solution, 1 mg/5 ml injectable solution
   1. What is Octreotide SUN and what is it used for
   2. What you need to know before using Octreotide SUN
   3. How to use Octreotide SUN
   4. Possible side effects
   5. How to store Octreotide SUN
   6. Contents of the pack and other information

Octreotide SUN 0.05 mg/1 ml injectable solution, 0.1 mg/1 ml injectable solution, 0.5 mg/1 ml injectable solution, 1 mg/5 ml injectable solution

octreotide

Generic medicine
Read this leaflet carefully before you start to use this medicine because 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 or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Octreotide SUN and what is it used for

Octreotide SUN is a synthetic compound derived from somatostatin, a substance normally present
in the human body, which inhibits the effects of certain hormones such as growth hormone. The advantages of
Octreotide SUN compared to somatostatin are greater potency and a longer duration of its
effects.

Octreotide SUN is used

• in acromegaly, a condition in which the body produces an excessive amount of growth hormone. Normally, growth hormone controls the growth of tissues, organs and bones. An excessive amount of growth hormone produces an increase in the size of the bones and tissues, particularly in the hands and feet. Octreotide SUN markedly reduces the symptoms of acromegaly, which include headache, excessive sweating, numbness of the hands and feet, fatigue and joint pain.
• to relieve the symptoms associated with some gastrointestinal tract tumors(e.g. carcinoid tumors, VIPomas, glucagonomas, gastrinomas, insulinomas). These diseases are characterized by the overproduction by the stomach, intestine or pancreas of certain specific hormones and other related substances. This overproduction disrupts the natural hormonal balance of the body and causes various symptoms, such as hot flashes, diarrhea, low blood pressure, rash and weight loss. Treatment with Octreotide SUN helps to control these symptoms.
• to prevent complications following pancreatic surgery. Treatment with Octreotide SUN helps to reduce the risk of complications (e.g. abdominal abscess, inflammation of the pancreas) after surgery.
• to stop bleeding and prevent the recurrence of bleeding due to ruptureof gastroesophageal varicesin patients suffering from cirrhosis (a chronic liver disease). Treatment with Octreotide SUN helps to control bleeding and reduces the need for transfusions.
• to treat pituitary tumors that produce an excess of thyroid-stimulating hormone (TSH). An excess of thyroid-stimulating hormone (TSH) causes hyperthyroidism. Octreotide SUN is used to treat people affected by pituitary tumors that produce an excess of thyroid-stimulating hormone (TSH):
• when other types of treatment (surgery or radiotherapy) are not suitable or have not been effective;
• after radiotherapy, to cover the period until the effectiveness of the radiotherapy manifests itself.

2. What you need to know before using Octreotide SUN

Do not use Octreotide SUN:

• if you are allergic to octreotide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using Octreotide SUN:

• if you know you have gallstones or have had them in the past; tell your doctor because prolonged use of Octreotide SUN may cause gallstones to form. Your doctor may perform periodic checks of the gallbladder.
• if you have problems with blood sugar levels, excessive (diabetes) or insufficient (hypoglycemia). When Octreotide SUN is used to treat bleeding from esophageal varices, it is mandatory to monitor blood sugar levels.
• if you have previously suffered from vitamin B12 deficiency, your doctor may want to periodically check your vitamin B12 levels.

Tests and checks
In case of prolonged treatment with Octreotide SUN, your doctor may want to check
periodically the thyroid function.
The doctor will check liver function.

Children
Experience with the use of Octreotide SUN in children is limited.

Other medicines and Octreotide SUN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Generally, you can continue to take other medicines during treatment with Octreotide SUN.
However, certain medicines, such as cimetidine, cyclosporine, bromocriptine, quinidine and
terfenadine, have been shown to be altered by Octreotide SUN.
If you are taking a medicine to control blood pressure (e.g. a beta blocker or a calcium channel
blocker) or a medicine to control fluid and electrolyte balance, your doctor may
need to adjust the dosage.
If you are diabetic, your doctor may need to adjust the dose of insulin.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Octreotide SUN should only be used in pregnancy if clearly necessary.
During treatment, women of childbearing potential must use effective contraception.
Do not breastfeed while using Octreotide SUN. It is not known whether Octreotide SUN passes into
breast milk.

Driving and using machines
Octreotide SUN does not alter or alters negligibly the ability to drive vehicles or use
machinery. However, some of the side effects that may occur during the use of
Octreotide SUN, such as headache and fatigue, may reduce the ability to drive vehicles and
use machinery safely.

Octreotide SUN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml of solution, i.e. it is practically
sodium-free.

3. How to use Octreotide SUN

Use this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
Depending on the disease to be treated, Octreotide SUN is administered by:

• subcutaneous injection (under the skin) or
• intravenous injection (into a vein). If you suffer from hepatic cirrhosis (a chronic liver disease), your doctor may need to adjust the maintenance dose.

Your doctor or nurse will explain how to inject Octreotide SUN under the skin, while the infusion
into a vein must always be performed by a healthcare professional.

Subcutaneous injection
The upper arms, thighs, and abdomen are suitable areas for subcutaneous injection.
Choose a new site for each subcutaneous injection so as not to irritate a particular area. Patients who self-administer the injection must receive precise instructions from the doctor or
nurse.
If you store the medicine in the refrigerator, it is recommended to let it reach room
temperature before using it. This precaution will reduce the risk of pain at the injection site. You
can warm it between your hands, but do not expose it to other sources of heat.
Some people experience pain at the subcutaneous injection site, which usually lasts only for a
short period. In this case, you can relieve the pain by gently rubbing the injection site for
a few seconds.
Before using a vial of Octreotide SUN, check that the solution does not contain particles or a
change in color. Do not use it if you notice anything abnormal.
To prevent contamination, do not puncture the cap of multi-dose vials more than 10 times.

If you use more Octreotide SUN than you should
No potentially life-threatening reactions have been reported after an overdose of Octreotide SUN.
The symptoms of an overdose are:

• irregular heartbeat
• low blood pressure
• cardiac arrest
• reduced oxygen supply to the brain
• severe pain in the upper abdomen
• yellowing of the skin and whites of the eyes
• nausea
• loss of appetite
• diarrhea
• weakness
• fatigue
• lack of energy
• weight loss
• abdominal swelling
• feeling of discomfort
• elevated lactic acid levels in the blood. If you believe that an overdose has occurred and you experience these symptoms, inform your doctor immediately.

If you forget to use Octreotide SUN
Administer a dose as soon as you remember, then continue as usual. Skipping a dose is not
harmful, however, symptoms may reappear temporarily until the normal administration schedule is resumed.
Do not inject a double dose of Octreotide SUN to make up for forgotten doses.

If you stop using Octreotide SUN
If you stop treatment with Octreotide SUN, the symptoms may reappear. Therefore, do not
stop Octreotide SUN unless instructed by your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Some side effects may be serious. Tell your doctor immediately if you experience:
Very common(may affect more than 1 in 10 people):

• gallstones, which cause a sudden back pain
• excessive level of sugars in the blood.

Common(may affect up to 1 in 10 people):

• hypothyroidism (underactive thyroid) which causes changes in heart rate, appetite or weight; fatigue, feeling cold or swelling in the front of the neck
• changes in thyroid function values
• inflammation of the gallbladder (cholecystitis); symptoms may include pain in the upper right of the abdomen, fever, nausea, yellowing of the skin and whites of the eyes (jaundice)
• insufficient level of sugars in the blood
• glucose intolerance
• slowed heart rate.

Uncommon(may affect up to 1 in 100 people):

• thirst, poor urine production, dark urine, dry and warm skin
• fast heart rate.

Other serious side effects

• hypersensitivity (allergic) reactions including skin rash
• a type of allergic reaction (anaphylaxis) that causes difficulty breathing or dizziness
• inflammation of the pancreas (pancreatitis); symptoms may include sudden pain in the upper part of the abdomen, nausea, vomiting, diarrhea
• inflammation of the liver (hepatitis); symptoms may include yellowing of the skin and whites of the eyes (jaundice), nausea, vomiting, loss of appetite, feeling generally unwell, itching, light-colored urine
• irregular heartbeat. Tell your doctor immediately if you notice any of the side effects listed above.

Other side effects:
Tell your doctor, pharmacist or nurse immediately if you notice any of the side effects
listed below. These effects are usually mild and tend to disappear with
continuation of treatment.

Very common(may affect more than 1 in 10 people):

• diarrhea
• abdominal pain
• nausea
• constipation
• flatulence (gas)
• headache
• localized pain at the injection site.

Common(may affect up to 1 in 10 people):

• indigestion (dyspepsia)
• vomiting
• feeling of fullness in the stomach
• fatty stools
• soft stools
• change in stool color
• dizziness
• loss of appetite
• changes in liver function values
• hair loss
• shortness of breath
• weakness. If you get any side effects, talk to your doctor, nurse or pharmacist.

Some people experience pain at the subcutaneous injection site, which usually lasts only for a
short period. In this case, you can relieve the pain by gently rubbing the injection site for
a few seconds.
If you administer Octreotide SUN by subcutaneous injection, it may be helpful to avoid
consuming meals around the time of the injection to help reduce the risk of gastrointestinal
side effects. It is therefore recommended to inject Octreotide SUN between meals or at bedtime.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Octreotide SUN

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 label. The expiry date refers to the last day of that month.
Store the vials and multi-dose vial in a refrigerator (2 °C - 8 °C). Do not freeze.
Store the vials and vial in the outer carton to protect them from light.
Unopened vials or multi-dose vials of Octreotide SUN can be stored for a maximum of 2
weeks at a temperature below 25 °C in the original packaging.
Once in use, a multi-dose vial can be stored for a maximum of 2 weeks in
a refrigerator (2 - 8 °C) in the original packaging. The multi-dose vial can be used up to 10
times; any remaining contents must be returned to the pharmacist if not used within two
weeks.
The chemical and physical stability during use of the diluted solution has been demonstrated for 8 hours at 25
°C. From a microbiological point of view, the product must be used immediately after
dilution. If the product is not used immediately, the storage times and conditions
before use are the responsibility of the user.
In case of discontinuation of treatment decided by the doctor, return the residual medicine to the pharmacist.
Store the medicine only if required by the doctor.
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 Octreotide SUN contains

• The active substance is octreotide, as octreotide acetate.

Each vial of 1 ml of injectable solution contains octreotide acetate equivalent to 0.05 milligrams, 0.1
milligrams, 0.5 milligrams of octreotide.
Each multi-dose vial of 5 ml of injectable solution contains octreotide acetate equivalent to 1
milligram of octreotide. 1 ml of solution contains 0.2 milligrams of octreotide

• The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections, phenol (only for the multi-dose vial)

Description of the appearance of Octreotide SUN and contents of the pack
This medicine is presented as a clear, colorless injectable solution.
Pack of 5, 10 or 30 vials of 1 ml solution
Pack of 1, 10 or 30 multi-dose vials of 5 ml solution
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Legal Representative for Italy:
Ranbaxy Italia S.p.A. - Viale Giulio Richard, 1 - 20143 Milano

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations
Denmark: Octreotid SUN 0.05, 0.1, 0.5 mg/1ml, 1 mg/5ml injektionsvæske, opløsning
Germany: Octreotid SUN 0.05, 0.1, 0.5 mg/1ml, 1 mg/5ml Injektionslösung
Italy: Octreotide SUN 0.05, 0.1, 0.5 mg/1ml, 1 mg/5 ml solution for injection
Norway: Oktreotid SUN 50, 100, 200, 500 micrograms/ml injeksjonsvæske, oppløsning
Netherlands: Octreotide SUN 0.05, 0.1, 0.2, 0.5 mg/ml solution for injection
Spain: Octreotida SUN 50, 100, 200, 500 micrograms/ml solution inyectable EFG
Sweden: Oktreotid SUN 50, 100, 200, 500 mikrogram/ml injektionsvätska, lösning
United Kingdom: Octreotide 50, 100, 200, 500 micrograms/ml Solution for Injection

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The following information is intended exclusively for healthcare professionals:
Intravenous infusion (for healthcare professionals)
Incompatibilities
Do not mix this medicine with other medicines, except for those listed in the paragraph
“Special precautions for disposal and handling”.
Special precautions for storage
Vials:
Store in a refrigerator (2 - 8 °C). Do not freeze. Store the vials in the carton to protect the
medicine from light.
The vials can also be stored at 25 °C for a maximum of two weeks.
Multi-dose vials:
Store in a refrigerator (2 - 8 °C). Do not freeze. Store the vial in the carton to protect
the medicine from light.
The vials can also be stored at 25 °C for a maximum of two weeks.

Special precautions for disposal and handling
Vials:
Open the vials immediately before use. Any unused solution must be
discarded.
To reduce discomfort at the injection site, allow the solution to warm to room temperature before
giving the injection. Avoid multiple injections in the same site at short intervals.
Subcutaneous administration:
Octreotide SUN must be administered undiluted by subcutaneous route.
Intravenous administration:
For i.v. use, dilute octreotide with physiological saline in a ratio of not less than 1 vol : 1 vol and not
more than 1 vol : 9 vol. Since octreotide can affect glucose homeostasis, it is recommended to
use saline solution rather than dextrose.
Do not dispose of any medicine in the water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Multi-dose vials:
Octreotide SUN 200 µg/ml must be administered only by subcutaneous route.
Octreotide SUN must be administered undiluted by subcutaneous route.
In order to avoid contamination, it is recommended not to puncture the vial cap more than 10 times.
To reduce discomfort at the injection site, bring the solution to room temperature before
proceeding with the injection. Avoid multiple injections at short intervals in the same site.

How much Octreotide SUN to use
The dose of Octreotide SUN depends on the disease to be treated.

Acromegaly
Treatment is usually started at 0.05 - 0.1 mg every 8 or 12 hours by subcutaneous injection.
It is then adjusted according to the effect and relief of symptoms (such as fatigue, sweating
and headache). For most patients, the optimal daily dose is 0.1 mg 3 times/day. The maximum dose of 1.5 mg/day should not
be exceeded.

Gastrointestinal tract tumors
Treatment is usually started at 0.05 mg once or twice a day by subcutaneous injection.
Depending on the response and tolerability, the dosage may be gradually increased to 0.1 mg - 0.2 mg 3 times/day. In carcinoid tumors, therapy should be discontinued if no improvement is observed after 1 week of treatment at the maximum tolerated dose.

Complications following pancreatic surgery
The usual dosage is 0.1 mg 3 times/day by subcutaneous injection for 1 week, starting
at least 1 hour before surgery.

Bleeding from gastroesophageal varices
The recommended dosage is 25 micrograms/hour for 5 days by continuous intravenous infusion.
Blood glucose monitoring is necessary during treatment.

TSH-secreting pituitary adenomas
The generally most effective dosage is 100 micrograms three times a day by subcutaneous injection. The dose may be adjusted based on TSH and thyroid hormone responses. At least 5 days of treatment are required to assess
effectiveness.