Octreotide Mayne

Octreotide Mayne 50 micrograms/1ml solution for injection

Octreotide Mayne 100 micrograms/1ml solution for injection

Octreotide Mayne 200 micrograms/ml solution for injection

Octreotide Mayne 500 micrograms/1 ml solution for injection

Octreotide acetate

Read all of this leaflet carefully before you start using this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

• 1. What Octreotide Mayne is and what it is used for


• 2. Before you use Octreotide Mayne


• 3. How to use Octreotide Mayne


• 4. Possible side effects


• 5. How to store Octreotide Mayne


• 6. Further information

What Octreotide Mayne is and what it is used for

Octreotide Mayne is a synthetic version of a hormone that occurs naturally in the body, called somatostatin. Octreotide inhibits the release of growth hormone and some gut hormones and secretions.

Octreotide Mayne is used:

• To treat the symptoms that occurs with hormone producing gastrointestinal tumours. These symptoms are associated with the over-production of some of the body's natural substances which may result in an imbalance of your natural hormone levels. This imbalance may cause a variety of symptoms in the stomach, pancreas or intestines (gut).


• To reduce the levels of growth hormone and Insulin-like growth factor number 1 (IGF-1) if you have acromegaly and to improve symptoms that you may have due to over-production of these hormones.


• Prior to having an operation on the pancreas, to prevent further complications.

Before you use Octreotide Mayne

Octreotide Mayne should not be used if you are:

• allergic to octreotide or any of the ingredients in Octreotide Mayne (see Section 6).

Special care will be taken:

• as Octreotide may affect your blood sugar levels. You or your doctor should closely monitor your blood sugar levels.


• if you have a tumour (growth) that produces insulin (insulinoma). You or your doctor should closely monitor your blood sugar levels.


• if you have any thyroid problems


• if you have gallstones


• if you have liver disease


• if you are pregnant or planning to become pregnant. If you do become pregnant, tell your doctor immediately.


• if you are breast-feeding

Taking other medicines:

Please tell your doctor if you are taking any of the following medicines;

• ciclosporin (a drug used after a transplant)


• cimetidine (a drug used to reduce stomach acid)


• bromocriptine (a drug used in Parkinson's disease or in acromegaly or to suppress breast milk)


• terfenadine (to relieve allergic symptoms)


• carbamazepine (a drug used in psychiatric disorders, epilepsy, trigeminal neuralgia and neuropathy)


• digoxin (medicine for certain heart problems)


• warfarin (a drug used to thin the blood)

Other medicines that are metabolised by the liver can also be affected, so tell your doctor or pharmacist about all the medicines you are taking.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine. You should not use Octreotide if you are pregnant, unless you have been told by your doctor that it is absolutely necessary for you to do so.

You should not breastfeed your infant whilst receiving treatment with Octreotide, unless you have been told to do so.

How to use Octreotide Mayne injection

Always use Octreotide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure of anything.

A doctor or nurse will usually give you this medicine.

The medicine will be given to your either as a subcutaneous injection (underneath the skin) or as a slow intravenous injection (via a drip into the vein).

The usual dosages are given below; however your doctor will decide what dosage to give to you, as this depends on the nature of your treatment, your age and your medical condition:

• To treat the symptoms that occur with hormone producing gastrointestinal tumours: 50 micrograms each 24 hours or each 12 hours, depending on your response, the dose may be increased to 100 to 200 micrograms every 8 hours. The usual recommended maximum daily dosage is 600 micrograms.


• If you have acromegaly: initial doses of 50 to 100 micrograms, every 8 hours. For most patients the dosage is 200 to 300 micrograms per day and the maximum daily dosage is 1500 micrograms.


• Prior to having an operation on the pancreas: 100 micrograms every 8 hours for 7 days, starting on the day of the operation.

Your injection should be given between meals or at bedtime in order to reduce stomach and intestinal (gut) side effects.

To reduce discomfort, Octreotide Mayne solution for injection should reach room temperature before administration. Multiple subcutaneous injections at short intervals at the same administration site should be avoided.

If you use more Octreotide Mayne than advised: if you think you have had too much Octreotide, tell your doctor or nurse immediately.

Octreotide Mayne Side Effects

As other medicinal products, Octreotide Mayne injection can cause side effects although not everybody gets them.

If any of the following happen, tell your doctor immediately:

• severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing).


• pancreatitis - this may give you sudden severe pains in your abdomen. It may occur in the first few hours or days of treatment.


• intestinal obstruction - you may feel constipation and pains.

These are very serious side effects. You may need urgent medical attention. These side effects are rare (occur in less than 1 in 1000 patients but more than 1 in 10,000).

Tell your doctor as soon as possible if you notice any of the following side effects:

Common (occurs in less than 1 in 10 patients but more than 1 in 100):

• changes in blood sugar levels (both high or low levels may occur)


• diarrhoea


• vomiting


• steatorrhea (fatty material in the faeces)


• flatulence - excessive gas in your stomach or bowels


• feeling sick


• stomach pain


• gallstones that could gives gallbladder pain


• pain where the injection has been given

Uncommon (occurs in less than 1 in 100 patients but more than 1 in 1000):

• severe loss of appetite (anorexia)


• being sick


• epigastric pain (pain in upper part of stomach)

Rare (occurs in less than 1 in 1000 patients but more than 1 in 10,000):

• ileus-like conditions (your gut may not work properly)


• loss of hair


• rashes


• heart beating slower than normal

Your doctor will take blood tests to check for changes in liver function, which is a side effect of treatment with Octreotide.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Octreotide Mayne

Store in a refrigerator (2°C - 8°C). Do not freeze. Store the vial in the outer carton in order to protect the product from light.

The multidose vials of Octreotide 200 micrograms/ml solution for injection for daily use may be stored for two weeks below 25°C.

Octreotide Mayne, diluted in 0.9% sodium chloride would not normally be stored for longer than 24 hours in a refrigerator.

Keep out of the reach and sight of children.

Do not use Octreotide after the expiry date stated on the carton and label.

The injection should only be used if it is clear and free of particles.

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

Other information

Octreotide Mayne is available as vials containing a clear, colourless solution for injection. It contains octreotide as the active ingredient.

The vials also contain Glacial Acetic Acid, Sodium Acetate Trihydrate, Sodium Chloride and Water for Injections. The multi-dose vials additionally contain Phenol (a preservative).

This medicinal product contains less than 1 mmol (23 mg) of sodium (i.e., essentially sodium free) per ml of solution.

Octreotide Mayne is available in the following pack sizes:

• Octreotida Mayne solution for injection 50 micrograms/1 ml (packs of 5, or 30 vials)


• Octreotida Mayne solution for injection 100 micrograms/1 ml (packs of 5, or 30 vials)


• Octreotida Mayne solution for injection 500 micrograms/1 ml (packs of 5, or 30 vials)


• Octreotida Mayne solution for injection 200 micrograms/ ml (packs of 1 or 10 multidose vials)

The vials may be overwrapped with a protective plastic to minimise the risk of spillage if the vials break; these vials are referred to as ONCO-TAIN.

Marketing authorisation holder and manufacturer:

Mayne Pharma Plc

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

United Kingdom

This leaflet was last approved in June 2007