List PLR Article Directory Pakistan: Sandostatin Ampoules and Multidose vial

SANDOSTATIN Ampoules 50, 100 and 500 micrograms in 1 ml, SANDOSTATIN

Multidose Vial 1 mg in 5 ml, solution for injection or concentrate for solution for infusion

(octreotide)

This medicine will be referred to as Sandostatin in this leaflet.

What you need to know about Sandostatin

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to have your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don't understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be 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 Sandostatin is and what it's used for

2. Things to consider before you start to take Sandostatin

3. How to take Sandostatin

4. Possible side effects

5. How to store Sandostatin

6. Further information

What Sandostatin is and what it's used for

Sandostatin is an injection. Sandostatin injections contain the active ingredient octreotide (as the acetate). Octreotide is a synthetic form of a hormone called somatostatin which occurs naturally in the body. It helps stop the release of some hormones, including growth hormone, in the body.

Sandostatin can be used:

1. To treat acromegaly

Acromegaly is a condition where the body produces too much growth hormone. The level of growth hormone controls the growth of tissues, organs and bones. Too much hormone means the size of bones and tissues, especially in the hands and feet, is larger than normal. The symptoms of acromegaly include headache, excessive perspiration, numb 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).

Sandostatin 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;

before surgery on the pituitary gland

2. To relieve stomach or bowel symptoms associated with certain tumours known as 'gastroenteropancreatic' tumours (rare tumours of 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 Sandostatin helps to control these symptoms.

3. To prevent complications following pancreatic surgery

Sandostatin can be used in some patients when they have an operation on the pancreas. It may help reduce some of the problems which can occur in the abdomen after the operation, such as inflammation (swelling) and infection.

Things to consider before you start to have Sandostatin

Some people MUST NOT be given Sandostatin. Talk to your doctor if:

you think you may be allergic to octreotide or to any of the other ingredients of the Sandostatin preparations. (These are listed at the end of the leaflet.)

you are breastfeeding.

You should also ask yourself these questions before having Sandostatin:

Are you pregnant?

Do you have diabetes?

Do you have any thyroid problems, or have you had a disease which may have affected your thyroid?

Do you have any problems with your liver, or have you had a disease which may have affected your liver?

Have you ever suffered from gallstones or other stomach problems?

Do you have a history of Vitamin B12 deficiency?

If the answer to any of these questions is YES, tell your doctor or nurse because Sandostatin might not be the right medicine for you.

Are you taking other medicines?

Sandostatin interacts with a large number of other medicines. Tell your doctor or nurse if you are taking any of the following:

Insulin, or other drugs for diabetes

Ciclosporin

Cimetidine

Bromocriptine

Medicines to control blood pressure (beta-blockers or calcium channel blockers) or agents to control fluid and electrolyte balance (diuretics)

Medicines metabolised by the liver for example carbamazepine, digoxin and warfarin and terfenadine.

Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Will there be any problems with driving or using machinery?

No problems have been reported.

Other special warnings

Your doctor may want to give you a check up from time to time while you are being treated with Sandostatin.

Growth hormone secreting pituitary tumours may sometimes expand and cause problems. Tell your doctor if you experience any problems with your eyes or sight.

Tell your doctor if your stomach or bowel problems get worse.

There is very little experience of using Sandostatin in children.

Sandostatin should only be used during pregnancy if clearly needed. Tell your doctor if you are pregnant or want to become pregnant.

Women of child bearing potential must use an effective contraceptive method during treatment with Sandostatin

How to take Sandostatin

Follow the instructions given you by your doctor. He/she will tell you the correct dose and how often to inject your medicine. Follow your doctor's instructions exactly and never change the dose yourself. Ask your doctor or pharmacist if you are unsure about how much medicine to have or when to have it.

Your medicine must be injected subcutaneously i.e. into the tissue under the skin. Your doctor or nurse will show you how to do this. If you are unsure, go back and ask for advice. You must use a clean, sterile syringe and needle every time.

The upper arms, thighs and stomach are good areas for subcutaneous injection. Choose a different place each time so that you don't irritate a particular area. Keep changing the injection site. Don't inject into the same place too frequently.

To avoid side effects like stomach ache, wind, diarrhoea and constipation do not inject at mealtimes. Inject between meals or before going to bed.

In rare cases Sandostatin will have to be injected intravenously (into a vein). If this is necessary the doctor or nurse will do it and monitor you closely. You must NOT inject Sandostatin into your veins yourself.

How to open the ampoule

The ampoules have a small etched mark at the breaking point, and a blue spot on the top. To snap open an ampoule, push carefully with the thumb of one hand on the blue spot at the top of the ampoule while holding the lower half of the ampoule with your other hand. The ampoule should snap open at the break point without shattering. If you have any problems opening the ampoules, ask your doctor or pharmacist.

Do not open the ampoule until it is time to have your injection. If you keep the injection in the fridge, warm it up to room temperature in your hand before using it. This will reduce any pain at the site of injection. Do not heat the ampoules or vials any other way.

Doses

For the treatment of acromegaly

The usual dose is 0.1 to 0.2 mg three times a day by subcutaneous injection. Depending on how you respond, your doctor will adjust the dose until he/she finds the right dose.

To relieve symptoms caused by over-production of some hormones

Your doctor will usually start your treatment with 0.05 mg once or twice daily by subcutaneous injection. Depending on how you respond, your doctor may gradually increase the dose until he/she finds your ideal dose.

To prevent complications following pancreatic surgery

0.1 mg three times a day for seven days starting on the day of the operation.

People with liver problems may be given a smaller dose.

What if you forget to take a dose?

If you forget to take a dose have the injection as soon as you remember unless it is almost time for your next dose, then go on as before. DO NOT take a double dose.

What if you take too much?

If you accidentally take too much, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine with you.

Possible side effects

Most people who are prescribed Sandostatin benefit from taking it, but a few can be upset by it. If you are receiving this medicine on a long term basis then you will go to hospital from time to time to have regular check-ups.

There is no need to worry if you suffer from any of the following common reactions at the site of injection:

Pain, stinging, tingling, burning, redness and swelling.

These rarely last more than 15 minutes and will be less if you let your medicine reach room temperature before injection.

Some side effects can be serious

Stop taking Sandostatin and tell your doctor straight away if you notice that:

Your face becomes flushed or swollen or you develop spots or a rash

Your chest feels tight, you become short of breath or wheezy

You feel faint, possibly as a result of a fall in blood pressure.

These might be the result of an allergic reaction.

If you develop any of the following see your doctor immediately:

Prolonged/troublesome bloating of the stomach with pain

Nausea/vomiting associated with drowsiness

Feeling restless or giddy

Yellowing of skin or the whites of your eyes

Acute pancreatitis (sudden, severe, burning pains in the stomach). This may happen within the first few hours or days of treatment and resolves itself upon drug withdrawal.

These other side effects have been reported in clinical trials:

Up to 1 in 10 people have experienced:

Stomach ache, nausea, wind, diarrhoea or constipation. (These will be less if you inject between meals or before going to bed.)

Changes in blood sugar levels (hyperglycaemia)

Headache

Gallstones

Local pain at the site of injection

Up to 1 in 100 people have experienced:

Slow heart beat

Hair loss

Itching

Rash

Shortness of breath

Dizziness

Loss of appetite

Changes in blood sugar levels (hypoglycaemia)

Impaired glucose tolerance

Stomach discomfort after a meal

Vomiting

Bloated stomach

Loose faeces (stools)

Discolouration of faeces

Fat in your faeces (pale and fatty loose stools)

Inflammation of the gallbladder

Biliary sludge

Yellow skin and eyes

Abnormal liver function test results

Changes in activity of the thyroid gland (hypothyroidism) causing changes in heart rate, appetite or weight, tiredness, feeling cold or sweating too much, anxiety or swelling at the front of the neck.

Up to 1 in 1,000 people have experienced:

Dehydration

Fast heart beat

Patients taking Sandostatin have reported experiencing the following additional side effects:

Anaphylaxis (a type of allergic reaction which causes difficulty in breathing or dizziness), allergy/hypersensitivity reactions

Itchy rash

Inflammation of the pancreas

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

Liver dysfunction.

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.

How to store Sandostatin

Keep all medicines out of the reach and sight of children.

In the long term the ampoules and multidose vials should be kept in the fridge (between 2°C and 8°C). Keep in the original packaging to protect them from light.

You can keep a few ampoules at room temperature away from direct heat for up to two weeks. If you do not use a whole ampoule return what is left to your pharmacist.

Once you have started a multidose vial you can store it at room temperature away from direct heat for up to two weeks. You can use your multidose vial up to 10 times. Return any remaining to your pharmacist if you have not used it within two weeks.

Do not take Sandostatin after the expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking Sandostatin, please take any which is left back to your pharmacist to be destroyed. Only keep it if the doctor tells you to. Do not throw it away with your normal household water or waste. This will help to protect the environment.

Further information

Sandostatin contains octreotide acetate. It is a clear, colourless solution, and is available in ampoules containing either 50, 100 or 500 micrograms in 1 ml.

It is also available in a multidose vial containing 1mg octreotide in 5ml (provides 0.2 mg octreotide in 1 ml).

The ampoules and vials also contain the inactive ingredients lactic acid, mannitol, sodium hydrogen carbonate and water for injection. In addition, multidose vials also contain the preservative, phenol.

Sandostatin contains less than 1mmol (23mg) sodium per dose i.e essentially sodium free.

Sandostatin Ampoules come in packs containing 5 ampoules. The multidose vials are available in packs containing 1 vial.

The product licence holder is

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

England

Sandostatin is made by

Novartis Pharmaceuticals UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB