Syngro is a synthetic compound derived from somatostatin. Somatostatin is normally found in the human body, where it inhibits the release of certain hormones such as growth hormone. The advantages of Syngro over somatostatin are that it is stronger and its effects last longer.

Syngro is used

• To treat acromegaly.

Acromegaly is 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. Syngro markedly reduces the symptoms of acromegaly, which include headache, excessive perspiration, numbness of the hands and feet, tiredness, and joint pain. In most cases, the overproduction of growth hormone is caused by an enlargement in the pituitary gland (a pituitary adenoma); Syngro treatment may reduce the size of the adenoma.

Syngro is used to treat people with acromegaly:

-     When other types of treatment for acromegaly (surgery or radiotherapy) are not suitable or haven’t worked;

-     After radiotherapy, to cover the interim period until the radiotherapy becomes fully effective.

• To relieve symptoms associated with overproduction of some specific hormones and other related substances by the stomach, bowels or pancreas.

Overproduction of specific hormones and other related natural substances can be caused by some rare conditions of the stomach, bowels or pancreas. This 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 Syngro helps to control these symptoms. 

• To treat neuroendocrine tumours located in the gut (e.g. appendix, small intestine or colon).

Neuroendocrine tumours are rare tumours which can be found in different parts of the body.

Syngro is also used to control the growth of these tumours, when they are located in the gut (e.g. appendix, small intestine or colon).

• To treat pituitary tumours that produce too much thyroid-stimulating hormone (TSH).

Too much thyroid-stimulating hormone (TSH) leads to hyperthyroidism. Syngro 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.

Follow all instructions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Read the following explanations before you use Syngro.

Do not use Syngro

• 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 Syngro:

• If you know that you have gallstones now, or have had them in the past or experience any complications like fever, chills, abdominal pain, or yellowing of your skin or eyes; tell your doctor, as prolonged use of Syngro may result in gallstone formation. Your doctor may wish to check your gallbladder periodically.
• If you know that you have diabetes, as Syngro can affect blood sugar levels. If you are diabetic, your sugar levels should be checked regularly.
• If you have a history of vitamin B12 deprivation your doctor may wish to check your vitamin B12 level periodically.

Test and checks

If you receive treatment with Syngro 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 Syngro

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 Syngro. 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 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 for advice before taking this medicine.

Syngro 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 Syngro. It is not known whether octreotide passes into breast milk.

Driving and using machines

Syngro 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.

Syngro contains sodium

Syngro contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Syngro must always be administered as an injection into the muscle of the buttocks. With repeated administration, the left and right buttock should be used alternately.

If you use more Syngro than you should

No life-threatening reactions have been reported after overdose of octreotide.

The symptoms of overdose are: hot flushes, frequent urination, tiredness, depression, anxiety and lack of concentration.

If you think that an overdose has happened and you experience such symptoms, tell your doctor straight away.

If you forget to use Syngro

If your injection is forgotten, it is recommended that you are given it as soon as it is remembered, and then continue as usual. It will not do any harm if a dose is a few days late, but you could get some temporary re-appearance of symptoms until you get back on schedule.

If you stop using Syngro

If you interrupt your treatment with Syngro your symptoms may come back. Therefore, do not stop using Syngro unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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, causing 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 can cause difficulty in swallowing or breathing, swelling and tingling, possibly with a drop in blood pressure with dizziness or loss of consciousness.
• 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.
• Low level of platelet count in blood; this could result in increased bleeding or bruising.

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.

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2-8°C). Do not freeze.

Store in the original package in order to protect from light.

Syngro may be stored below 25°C on the day of injection.

After reconstitution, use immediately.

Do not use this medicine after the expiry date which is stated on the package after “EXP”.  The expiry date refers to the last day of that month.

Do not use this medicine if you notice particles or a change of colour.

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 protect the environment.