Octreotide Sun

Package leaflet: Information for the user

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

octreotide
Generic medicine
Please read all of this leaflet carefully before you start taking 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What is in this leaflet

1. What Octreotide SUN is and what it is 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

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

Octreotide SUN is a synthetic compound derived from somatostatin, a substance naturally present
in the human body that 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 action.
Octreotide SUN is used

• in the treatment of acromegaly, a condition in which the body produces an excessive amount of growth hormone. Normally, growth hormone regulates the growth of tissues, organs and bones. Excess growth hormone leads to an increase in the size of bones and tissues, particularly in the hands and feet. Octreotide SUN significantly reduces the symptoms of acromegaly, including headache, excessive sweating, numbness in the hands and feet, fatigue and joint pain.
• to relieve symptoms associated with certain gastrointestinal tract tumours (e.g. carcinoid tumours, VIPomas, glucagonomas, gastrinomas, insulinomas). These conditions are characterized by the overproduction by the stomach, intestine or pancreas of specific hormones and other related substances. This overproduction disrupts the body's natural hormonal balance and causes various symptoms such as hot flushes, diarrhoea, low blood pressure, skin rash and weight loss. Treatment with Octreotide SUN helps control these symptoms.
• to prevent complications following pancreatic surgery. Treatment with Octreotide SUN helps reduce the risk of complications (e.g. abdominal abscess, inflammation of the pancreas) after surgery.
• to stop bleeding and prevent recurrence of bleeding due to rupture of gastro-oesophageal varices in patients with cirrhosis (a chronic liver disease). Treatment with Octreotide SUN helps control bleeding and reduces the need for blood transfusions.
• to treat pituitary tumours that produce excess thyroid-stimulating hormone (TSH). Excess thyroid-stimulating hormone (TSH) causes hyperthyroidism. Octreotide SUN is used to treat patients with pituitary tumours producing excess thyroid-stimulating hormone (TSH):
  • when other treatment options (surgery or radiotherapy) are not suitable or have not been effective;
  • after radiotherapy, to cover the period until the therapeutic effect of radiotherapy becomes evident.

2. What you need to know before using Octreotide SUN

Do not use Octreotide SUN:

• if you are allergic to octreotide or to 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 have gallstones or have previously suffered from them; inform your doctor, as long-term use of Octreotide SUN may cause gallstone formation. Your doctor may carry out periodic checks of your gallbladder.
• if you have problems with blood sugar levels, either too high (diabetes) or too low (hypoglycaemia). When Octreotide SUN is used to treat bleeding from gastroesophageal varices, monitoring of blood sugar levels is mandatory.
• if you have previously suffered from vitamin B12 deficiency, your doctor may wish to periodically monitor your vitamin B12 levels.

Examinations and monitoring
If you are receiving long-term treatment with Octreotide SUN, your doctor may wish to periodically monitor thyroid function.
Your doctor will monitor liver function.
Children
Experience with the use of Octreotide SUN in children is limited.
Other medicines and Octreotide SUN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Generally, you may continue taking other medicines during treatment with Octreotide SUN.
However, certain medicines such as cimetidine, cyclosporine, bromocriptine, quinidine, and terfenadine have been shown to be affected by Octreotide SUN.
If you are taking a medicine to control blood pressure (e.g. a beta-blocker or 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 your insulin dosage.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Octreotide SUN should be used during pregnancy only if clearly necessary.
Women of childbearing potential must use an effective method of contraception during treatment.
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 affect or affects to a negligible extent the ability to drive vehicles or operate machinery. However, some of the side effects that may occur during use of Octreotide SUN, such as headache and fatigue, could reduce the ability to drive or operate machinery safely.
Octreotide SUN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml of solution, i.e. essentially "sodium-free".

3. How to use Octreotide SUN

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Depending on the condition being treated, Octreotide SUN is administered either 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 your maintenance dose.

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

Subcutaneous injection
The upper arms, thighs, and abdomen are suitable areas for subcutaneous injection.
Choose a different injection site each time to avoid irritating any particular area. Patients who self-administer the injection must receive clear instructions from their doctor or nurse.

If you store the medicine in the refrigerator, it is recommended to allow it to reach room temperature before use. This will reduce the risk of injection-site pain. You may warm it gently between your hands, but do not expose it to other heat sources.

Some people may experience pain at the subcutaneous injection site, which usually lasts only briefly. In such cases, gently rubbing the injection site for a few seconds may help relieve the discomfort.

Before using a vial of Octreotide SUN, check that the solution does not contain particles or show any change in colour. Do not use it if anything abnormal is observed.

To prevent contamination, do not puncture the closure of multidose vials more than 10 times.

If you use more Octreotide SUN than you should
Potentially life-threatening reactions following overdose of Octreotide SUN have not been reported.
Symptoms of overdose may include:

• irregular heartbeat
• low blood pressure
• cardiac arrest
• reduced oxygen supply to the brain
• severe upper abdominal pain
• yellowing of the skin and whites of the eyes
• nausea
• loss of appetite
• diarrhoea
• weakness
• fatigue
• lack of energy
• weight loss
• abdominal swelling
• feeling of discomfort
• elevated blood lactate levels.

If you think an overdose has occurred and you experience any of these symptoms, inform your doctor immediately.

If you forget to use Octreotide SUN
Take the missed dose as soon as you remember, then continue with your regular dosing schedule. Missing a dose is not harmful, but symptoms may temporarily reappear until normal dosing is resumed.
Do not inject a double dose of Octreotide SUN to make up for a forgotten dose.

If you stop using Octreotide SUN
If you stop treatment with Octreotide SUN, your symptoms may return. Therefore, do not discontinue Octreotide SUN unless instructed by your doctor.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects could be serious. Inform your doctor immediately if you experience:

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

• gallstones, causing sudden back pain
• excessively high blood sugar levels.

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

• underactive thyroid gland (hypothyroidism), causing changes in heart rate, appetite, or weight; fatigue, feeling cold, or swelling in the front of the neck
• changes in thyroid function test values
• inflammation of the gallbladder (cholecystitis); symptoms may include pain in the upper right part of the abdomen, fever, nausea, yellowing of the skin and whites of the eyes (jaundice)
• low blood sugar levels
• disturbances in glucose tolerance
• slow heartbeat.

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

• thirst, low urine output, dark urine, dry and hot skin
• fast heartbeat.

Other serious side effects

• hypersensitivity (allergic) reactions, including skin rash
• a type of allergic reaction (anaphylaxis) causing difficulty in breathing or dizziness
• inflammation of the pancreas (pancreatitis); symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhoea
• 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, pale-coloured urine
• irregular heartbeat. Inform your doctor immediately if you notice any of the side effects listed above.

Other side effects:
Inform your doctor, pharmacist, or nurse immediately if you notice any of the following side effects. These are generally mild and tend to disappear with continued treatment.
Very common (may affect more than 1 in 10 people):

• diarrhoea
• abdominal pain
• nausea
• constipation
• flatulence (gas)
• headache
• injection site pain.

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

• stomach discomfort after meals (dyspepsia)
• vomiting
• feeling of stomach fullness
• fatty stools
• soft stools
• change in stool colour
• dizziness
• loss of appetite
• changes in liver function test values
• hair loss
• shortness of breath
• weakness. If you experience any side effect, contact your doctor, nurse, or pharmacist.

Some people experience pain at the subcutaneous injection site, which usually lasts only briefly. In such cases, the pain may be relieved by gently rubbing the injection site for a few seconds.
If you administer Octreotide SUN by subcutaneous injection, it may be helpful to avoid meals around the time of 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the label. The expiry date refers to the last day of that month.
Store the vials and the multidose vial in a refrigerator (2 °C - 8 °C). Do not freeze.
Keep the vials and the multidose vial in the outer packaging to protect them from light.
Unopened vials and multidose vials of Octreotide SUN may be stored for up to 2 weeks at a temperature not exceeding 25 °C in the original packaging.
Once in use, a multidose vial may be stored for up to 2 weeks in the refrigerator (2 °C - 8 °C) in the original packaging. The multidose vial may be used up to 10 times; any unused content must be returned to the pharmacist if not used within two weeks.
Chemical and physical in-use stability of the diluted solution has been demonstrated for 8 hours at 25 °C. From a microbiological point of view, the product should be used immediately after dilution. If the product is not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.
If treatment is discontinued by the physician, return any unused medicine to the pharmacist.
Only store the medicine if instructed to do so by your doctor.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Octreotide SUN contains

• The active substance is octreotide, as octreotide acetate.

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

• The other components are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injectable preparations, phenol (only in the multidose vial).

Description of the appearance of Octreotide SUN and contents of the pack
This medicinal product is a clear, colourless injectable solution.
Packs containing 5, 10 or 30 vials of 1 ml solution
Packs containing 1, 10 or 30 multidose 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
The Netherlands
Legal representative in Italy:
Ranbaxy Italia S.p.A. - Viale Giulio Richard, 1 - 20143 Milano

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
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 soluzione iniettabile
Norway: Oktreotid SUN 50, 100, 200, 500 mikrogram/ml injeksjonsvæske, oppløsning
The Netherlands: Octreotide SUN 0.05, 0.1, 0.2, 0.5 mg/ml oplossing voor injectie
Spain: Octreotida SUN 50, 100, 200, 500 microgramos/ml solución 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

This summary of product characteristics was last approved on

The following information is intended exclusively for healthcare professionals:

Intravenous infusion (for healthcare professionals)
Incompatibilities
Do not mix this medicinal product with other medicinal products except those listed in the section
“Special precautions for disposal and handling”.

Special precautions for storage
Vials:
Store in the refrigerator (2 - 8 °C). Do not freeze. Keep the vials in the original carton to protect from
light.
Vials may also be stored at 25 °C for up to two weeks.

Multiple-dose vials:
Store in the refrigerator (2 - 8 °C). Do not freeze. Keep the vial in the original carton to protect from
light.
Multiple-dose vials may also be stored at 25 °C for up to two weeks.

Special precautions for disposal and handling
Vials:
Open vials immediately before use. Any unused solution must be discarded.
To reduce injection site discomfort, allow the solution to reach room temperature before administration. Avoid repeated injections at the same site within short time intervals.

Subcutaneous administration:
Octreotide SUN must be administered subcutaneously without dilution.

Intravenous administration:
For intravenous use, dilute octreotide with physiological saline in a ratio not less than 1 volume of
octreotide to 1 volume of saline and not more than 1 volume of octreotide to 9 volumes of saline. Since
octreotide may affect glucose homeostasis, physiological saline should be used rather than dextrose-containing solutions.

Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Multiple-dose vials:
Octreotide SUN 200 µg/ml must be administered exclusively by subcutaneous route.
Octreotide SUN must be administered subcutaneously without dilution.
To avoid contamination, the vial stopper should not be punctured more than 10 times.
To reduce injection site discomfort, allow the solution to reach room temperature before administration. Avoid repeated injections at the same site within short time intervals.

Dosage of Octreotide SUN
The dose of Octreotide SUN depends on the disease being treated.

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

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

Postoperative complications following pancreatic surgery
The usual dosage is 0.1 mg three times daily by subcutaneous injection for 1 week, starting at least 1 hour before surgery.

Gastro-oesophageal variceal bleeding
The recommended dosage is 25 micrograms/hour for 5 days by continuous intravenous infusion.
Blood glucose monitoring is required during treatment.

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