Active ingredient
- octreotide acetate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 31750/0083.
Octreotide 50, 100, 200 and 500 micrograms/ml Solution for Injection
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.
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:
Octreotide is used to treat people with pituitary tumours that produce too much thyroid-stimulating hormone (TSH):
2. What you need to know before you use Octreotide
Do not use Octreotide:
Warnings and precautions
Talk to your doctor before using Octreotide:
Octreotide may lower your heart rate and at very high doses may cause abnormal heart rhythm. Your doctor may monitor your heart rate during treatment.
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.
Your doctor may wish to check your pancreatic enzyme 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
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 (23 mg) 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:
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.
The symptoms of overdose are:
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):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Other serious side effects
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):
Common (may affect up to 1 in 10 people):
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 a refrigerator (2°C - 8°C). Do not freeze. Keep the ampoules and vials in the outer carton in order to protect from light.
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 1 milligram octreotide. 1 ml of solution contains 0.2 milligrams octreotide
The other ingredients are: sodium acetate trihydrate, acetic acid, glacial, sodium chloride, water for injection, (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.
Marketing Authorization Holder and Manufacturer
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) 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
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 (Northern Ireland): Octreotide 50, 100, 200, 500 micrograms/ml Solution for Injection
This leaflet was last revised in September 2021.
V023
6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, UK
+44 (0) 208 848 8688
+44 (0) 208 848 5052