Document: Octroflex solution for injection ENG PL change

• Octroflex solution for injection PL
• Octroflex solution for injection ENG PL

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Package leaflet: Information for the user

Octroflex 200 microgram/ml solution for injection

octreotide

Read all of this leaflet carefully before you start using 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, pharmacist or nurse

• This medicine has been prescribed for you only. Do not pass it on to others. It mayharm them, even if their signs of illness are the same as yours.

• If you get any side effect, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Octroflex is and what it is used for

2. What you need to know before you use Octroflex

3. How to use Octroflex

4. Possible side effects

6. Contents of the pack and other information

Octroflex 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 Octroflex over somatostatin are that it is stronger and its effects last longer.

Octroflex 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. Octrreoflex 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 Octroflex helps to control these symptoms.

• to prevent complications following surgery of the pancreas gland. Treatment with Octroflex helps to lower the risk of complications (e.g. abscess in the abdomen, inflammation of the pancreas gland) after the surgery.

• to treat pituitary tumours that produce too much thyroid-stimulating hormone (TSH). Too much thyroid-stimulating hormone (TSH) leads to hyperthyroidism.

Octroflex 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.

Do not use Octroflex:

- if you are allergic to octreotide or any of the ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Octroflex:

Test and checks

If you receive treatment with Octroflex 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 Octroflex in children.

Other medicines andOctroflex

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 Octroflex However, certain medicines, such as cimetidine, ciclosporin, bromocriptine, quinidine and terfenadine have been reported to be affected by Octroflex.

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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor before taking this medicine.

Octroflex 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 Octroflex. It is not known whether Octroflex passes into breast milk.

Driving and using machines

Octroflex has no or negligible effects on the ability to drive and use machines. However, some of the side effects you may experience while using Octroflex, such as headache and tiredness, may reduce your ability to drive and use machines safely.

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

A doctor or a nurse will usually give you this medicine.

Octroflex 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 Octroflex under the skin.

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 Octroflex 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 Octroflex than you should

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

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, tiredness, lack of energy, weight loss, abdominal swelling, discomfort and 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 Octroflex

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 Octroflex to make up for forgotten individual doses.

If you stop using Octroflex

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

If you have any further questions on the use of this medicine, ask your doctor, nurse 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):

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 Octroflex 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 Octroflex 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Octroflex

Keep the vials in the outer carton in order to protect from light.

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

The vials can be stored for two weeks below 25 °C.

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 and refers to the last day of that month.

If your doctor decides to stop your treatment, return any left over 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. Contents of the pack and other information

What Octroflex contains

What Octroflex looks like and contents of the pack

Octroflex 200 microgram/ml is a clear and colourless solution for injection available in clear vials.

Octroflex 200 microgram/ml is available in packs of 10 vials, each with 5 ml solution for injection.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

NordicInfu Care AB

Box 1225

SE-131 28 Nacka Strand, Sweden

Manufacturer

Bendalis GmbH

Keltenring 17

DE-82041 Oberhaching

Germany

This leaflet was last revised in 2015-09-11

The following information is aimed only for health care personal:

Octroflex 200 microgram/ml should only be administered by the subcutaneous route.

Before using an Octroflex vial, 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.

How much Octroflex to use

The dose of octreotide depends on the condition being treated.

Treatment is usually started at 0.05 to 0.1 mg every 8 or 12 hours by subcutaneous injection. It is then changed according to its effect and relief of symptoms (such as tiredness, sweating and headache). In most patients the optimal daily dose will be 0.1 mg 3 times/day. A maximum dose of 1.5 mg/day should not be exceeded.

Treatment is usually started at 0.05 mg once or twice a day by subcutaneous injection. Depending on response and tolerability, the dosage can be gradually increased to 0.1 mg to 0.2 mg 3 times/day. In carcinoid tumours, therapy should be discontinued if there is no improvement after 1 week of treatment at the maximum tolerated dose.

The usual dosage is 0.1 mg 3 times/day by subcutaneous injection for 1 week, starting at least 1 hour before surgery.

The dosage most generally effective is 100 micrograms three times a day by subcutaneous injection. The dose can be adjusted according to the responses of TSH and thyroid hormones. At least 5 days of treatment will be needed to judge the efficacy.