Octreotide 50 Micrograms/Ml Solution For Injection
044BP1025D
Package leaflet: Information for the user
Octreotide 50 micrograms/ml Solution for Injection Octreotide 100 micrograms/ml Solution for Injection Octreotide 500 micrograms/ml Solution for Injection Octreotide 200 micrograms/ml Solution for Injection
Octreotide
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 further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Test and checks
If you receive treatment with Octreotide over a long period of time, your doctor may wish to check your thyroid function periodically.
Your doctor will check your liver function.
Children
There is little experience with the use of Octreotide in children.
Other medicines and Octreotide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You can generally continue taking other medicines while on Octreotide. However, certain medicines, such as cimetidine, ciclosporin, bromocriptine, quinidine and terfenadine have been reported to be affected by Octreotide.
If you are taking a medicine to control your blood pressure (e.g. a beta blocker or a calcium channel blocker) or an agent to control your 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 breast-feeding
What is in this leaflet
1. What Octreotide, is and what it is used for
2. What you need to know before you take Octreotide
3. How to use Octreotide
4. Possible side effects
5. How to store Octreotide
6. Contents of the pack and other information
1. What Octreotide is and what it is used for
Octreotide is a synthetic compound derived from somatostatin, a substance normally found in the
human body which inhibits the effects of certain hormones such as growth hormone. The
advantages of Octreotide over somatostatin are that it is stronger and its effects last longer.
Octreotide is used:
- in acromegaly, a condition where the body produces too much growth hormone. Normally, growth hormone controls growth of tissues, organs, and bones. Too much growth hormone leads to an increase in the size of bones and tissues, especially in the hands and feet. Octreotide markedly reduces the symptoms of acromegaly, which include headache, excessive perspiration, numbness of the hands and feet, tiredness, and joint pain.
- to relieve symptoms associated with some tumours of the gastrointestinal tract (e.g. carcinoid tumours, VIPomas, glucagonomas, gastrinomas, insulinomas). In these conditions, there is overproduction of some specific hormones and other related substances by the stomach, bowels, or pancreas. This overproduction upsets the natural hormonal balance of the body and results in a variety of symptoms, such as flushing, diarrhoea, low blood pressure, rash, and weight loss. Treatment with Octreotide helps to control these symptoms.
- to prevent complications following surgery of the pancreas gland. Treatment with Octreotide helps to lower the risk of complications (e.g. abscess in the abdomen, inflammation of the pancreas gland) after the surgery.
- to stop bleeding and to protect from re-bleeding from ruptured gastro-oesophageal varices
in patients suffering from cirrhosis (chronic liver disease). Treatment with Octreotide helps to control bleeding and reduce transfusion requirements.
- to treat pituitary tumours that produce too much thyroid-stimulating hormone (TSH). Too much thyroid-stimulating hormone (TSH) leads to hyperthyroidism.
Octreotide is used to treat people with pituitary tumours that produce too much thyroid-stimulating hormone (TSH):
- when other types of treatment (surgery or radiotherapy) are not suitable or have not worked;
- after radiotherapy, to cover the interim period until the radiotherapy becomes fully effective.
2. What you need to know before you use Octreotide
Do not use Octreotide:
- 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:
- if you know that you have gallstones now, or have had them in the past; tell your doctor, as prolonged use of Octreotide may result in gallstone formation. Your doctor may wish to check your gallbladder periodically.
- if you have problems with your blood sugar levels, either too high (diabetes) or too low (hypoglycaemia). When Octreotide is used to treat bleeding from gastro-oesophageal varices; monitoring of blood sugar level is mandatory.
- if you have a history of vitamin B12 deprivation your doctor may wish to check your vitamin B12 level periodically.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Octreotide should only be used during pregnancy if clearly needed.
Women of child-bearing age should use an effective contraceptive method during treatment.
Do not breast-feed while using Octreotide. It is not known whether Octreotide passes into breast milk.
Driving and using machines
Octreotide has no or negligible effects on the ability to drive and use machines. However, some of the side effects you may experience while using Octreotide, such as headache and tiredness, may reduce your ability to drive and use machines safely.
Octreotide contains sodium
This medicinal product contains less than 1 mmol (23mg) sodium per ml solution, i.e. essentially 'sodium-free'.
3. How to use Octreotide
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Depending on the condition being treated, Octreotide is given by:
- subcutaneous (under the skin) injection or
- intravenous (into a vein) infusion.
If you have liver cirrhosis (chronic liver disease), your doctor may need to adjust your maintenance dose.
Your doctor or nurse will explain to you how to inject Octreotide under the skin, but infusion into a vein must always be performed by a health care professional.
Subcutaneous injection
The upper arms, thighs, and abdomen are good areas for subcutaneous injection.
Choose a new site for each subcutaneous injection so that you do not irritate a particular area. Patients who will be injecting themselves must receive precise instructions from the doctor or nurse.
If you store the medicine in the refrigerator, it is recommended that you allow it to reach room temperature before using it. This will reduce the risk of pain at the site of injection. You can warm it up in your hand but do not heat it.
A few people experience pain at the site of the subcutaneous injection. This pain usually only lasts a short time. If this happens to you, you can relieve this by gently rubbing the site of injection for a few seconds afterwards.
Before using a Octreotide ampoule, check the solution for particles or a change of colour. Do not use it if you see anything unusual.
To prevent contamination the cap of the multidose vials should be punctured not more than 10 times.
If you use more Octreotide than you should
Contact your doctor or pharmacist immediately.
No life-threatening reactions have been reported after overdose of Octreotide.
The symptoms of overdose are:
- irregular heart beat
- low blood pressure
- cardiac arrest
- reduced supply of oxygen to the brain
- severe upper stomach pain
- yellow skin and eyes
- nausea
- loss of appetite
- diarrhoea
- weakness
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- tiredness
- lack of energy
- weight loss
- abdominal swelling
- discomfort
- high level of lactic acid in the blood.
If you think that an overdose has happened and you experience such symptoms, tell your doctor straight away.
If you forget to use Octreotide
Administer one dose as soon as you remember, and then continue as usual. It will not do any harm if you miss a dose, but you could get some temporary re-appearance of symptoms until you get back on schedule.
Do not inject a double dose of Octreotide to make up for forgotten individual doses.
If you stop using Octreotide
If you interrupt your treatment with Octreotide your symptoms may come back. Therefore, do not stop using Octreotide unless your doctor tells you to.
If you have any further questions on 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.
Some side effects could be serious. Tell your doctor straight away if you get any of the following:
Very common (may affect more than 1 in 10 people): - gallstones, leading to sudden back pain
- too much sugar in the blood.
Common (may affect up to 1 in 10 people):
- underactive thyroid gland (hypothyroidism) causing changes in heart rate, appetite or weight; tiredness, feeling cold, or swelling at the front of the neck
- changes in thyroid function tests
- inflammation of the gallbladder (cholecystitis); symptoms may include pain in the upper right abdomen, fever, nausea, yellowing of the skin and eyes (jaundice)
- too little sugar in the blood
- impaired glucose tolerance
- slow heart beat.
Uncommon (may affect up to 1 in 100 people):
- thirst, low urine output, dark urine, dry flushed skin
- fast heart beat.
Other serious side effects
- hypersensitivity (allergic) reactions including skin rash
- a type of an allergic reaction (anaphylaxis) which causes difficulty in breathing or dizziness
- an inflammation of the pancreas gland (pancreatitis); symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhoea
- liver inflammation (hepatitis); symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, generally feeling unwell, itching, light-coloured urine
- irregular heart beat.
Tell your doctor straight away if you notice any of the side effects above.
Other side effects:
Tell your doctor, pharmacist or nurse if you notice any of the side effects listed below. They are usually mild and tend to disappear as treatment progresses.
Very common (may affect more than 1 in 10 people):
- diarrhoea
- abdominal pain
- nausea
- constipation
- flatulence (wind)
- headache
- local pain at the injection site.
Common (may affect up to 1 in 10 people):
- stomach discomfort after meal (dyspepsia)
- vomiting
- feeling of fullness in the stomach
- fatty stools
- loose stools
- discolouration of faeces
- dizziness
- loss of appetite
- change in liver function tests
- hair loss
- shortness of breath
- weakness.
If you get any side effects, please tell your doctor, nurse or pharmacist.
A few people experience pain at the site of the subcutaneous injection. This pain usually only lasts a short time. If this happens to you, you can relieve this by gently rubbing the site of injection for a few seconds afterwards.
If you are administering Octreotide by subcutaneous injection, it may help to reduce the risk of gastrointestinal side effects if you avoid eating meals around the time of injection. It is therefore recommended that you inject Octreotide between meals or when you go to bed.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine
5. How to store Octreotide
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 ampoules and multidose vial in the refrigerator (between 2°C and 8°C). Do not freeze. Protect from light in the original packaging.
Unopened Octreotide ampoules or vials may be stored for a maximum of 2 weeks below 25°C and in the original pack.
Once in use, a multidose vial may be stored for a maximum of 2 weeks stored in a refrigerator (2 - 8 °C) and in the original pack. You can use your multidose vial up to 10 times and you must return any remainder to your pharmacist if you have not used it 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 not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
If your doctor decides to stop your treatment, return any leftover medicine to the pharmacist. Only keep it if your doctor tells you to.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Content of the pack and other information What Octreotide contains
The active substance is octreotide, as octreotide acetate.
One ampoule of 1 ml solution for injection contains octreotide acetate equivalent to 0.05 milligrams, 0.1 milligrams, 0.5 milligrams octreotide.
One multidose vial of 5 ml solution for injection contains octreotide acetate equivalent to 1milligram octreotide. 1 ml of solution contains 0.2 milligrams octreotide
The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections, (phenol for the multidose vial only).
What Octreotide Solution for Injection looks like and contents of the pack
This medicinal product is presented as a clear colourless solution for injection.
Pack size of 5, 10 or 30 ampoules of 1 ml solution Pack size of 1, 10 or 30 multidose vials of 5 ml solution.
Not all pack sizes may be marketed. q
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Marketing Authorization Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87 2132 JH Hoofddorp The Netherlands
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark: Octreotid SUN 0,05, 0,1,0,5 mg/1ml, 1 mg/5ml injektionsv^ske, opl0sning
Germany: Octreotid SUN 0,05, 0,1,0,5 mg/1ml, 1 mg/5ml Injektionslosung
Finland Oktreotid SUN 0,05, 0,1,0,5 mg/1ml, 1 mg/5ml injektioneste, liuos
France Octreotide SUN 50, 100, 200, 500 microgrammes/1 ml solution injectable
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 injeksjonsv^ske, oppl0sning
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 solucion inyectable EFG
Sweden: Oktreotid SUN 50, 100, 200, 500 mikrogram/ml injektionsvatska, losning
United Kingdom: Octreotide 50, 100, 200, 500 micrograms/ml Solution for Injection
This leaflet was last revised in October 2015.
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Octreotide Acetate Inj PI-248x375mm-EUUK-REV3-28-10-15
28 October 2015 15:14:45