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Octreotide 100 Micrograms/Ml Solution For Injection

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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

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 or pharmacist.

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

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1. What Octreotide is and what it is used for

2. What you need to know before you use 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 hormone-containing medicinal product that inhibits the secretion of other hormones, in a similar way to somatostatin, a hormone that occurs naturally in the body. As a result, the symptoms of diseases in which hormones play a role can be reduced or resolved.

Octreotide is used:

A. To treat excessive growth of bones and soft tissues, particularly of the nose, lower jaw and ears, once puberty has passed. This condition is known as acromegaly. Excessive release of specific hormones cause acromegaly and in most cases, the excessive hormone production is due to an enlargement of the pituitary gland (adenoma of the pituitary gland). Symptoms include: an excessive increase in height, tiredness, pigmented spots on the skin, joint pain and sweating.

Octreotide can be helpful to treat patients with acromegaly who:

• have no benefit from surgery or radiotherapy (radiation);

• cannot or do not want to undergo an operation or await surgery, or

• have just started radiotherapy

B. To relieve symptoms related to specific, rare tumours located in the stomach, intestines (gut) and pancreas caused by overproduction of specific hormones or other natural substances, such as flushes, diarrhoea, low blood pressure.

C. To prevent complications after an operation of the pancreas (a gland secreting digestive enzymes and hormones), such as inflammation or infection.

2. What you need to know before you use Octreotide

Do not use Octreotide:

• 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 or pharmacist before using Octreotide if any of the following conditions apply to you or have applied to you in the past:

• If you experience problems with your eyesight. This might be due to growth of a tumour of the pituitary gland (a gland that is located in the brain, next to the optic nerves). Your doctor must examine you regularly and may decide to start another treatment.

• If you are a woman at childbearing age you must seek advice for appropriate contraception. This is because fertility might be restored during treatment of acromegaly.

• If octreotide is used as part of a long-term treatment, thyroid function should be monitored by your doctor.

• If you experience bradycardia (slowed heartbeat), it may be necessary to adjust the dose of certain heart medicines (for instance, beta-blockers or calcium channel blockers).

• If you are treated for symptoms of bowel, gut or pancreas tumours and if severe symptoms of these tumours reoccur suddenly and rapidly or get worse, see your doctor.

• If you have a tumour that produces insulin (insulinoma), or if you have a type I or type II diabetes mellitus or if you have low or high blood sugar levels, your blood sugar levels must be closely monitored.

• If you have or have had gallstones, tell your doctor, because gallstones can occur or re-occur after longterm use of octreotide.

• If you have a vitamin B12 deficiency, your vitamin B12 level should be monitored.

Children

Experience with Octreotide use in children is limited. Ask your doctor about use in children.

Other medicines and Octreotide

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

It is especially important to tell your doctor if you take the following medicines, because they may interact with Octreotide:

• Cidosporin: used to prevent and treat rejection reactions after a transplantation and to treat severe skin diseases and severe inflammation of the eyes and joints;

• Cimetidine: used to reduce acid in your stomach;

• Bromocriptine: used to treat Parkinson's disease;

• Terfenadine: used to treat allergies;

• Quinine: used to treat pain and fever;

• Carbamazepine: used to treat epilepsy and neuropathy;

• Digoxin: used to treat certain heart problems;

• Phenprocoumon: used for the prophylaxis of thrombosis.

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.

Fertility

Fertility may be restored during octreotide therapy of acromegaly. Seek advice for appropriate contraception.

Do not use Octreotide during pregnancy or if you are breast-feeding, unless you have been told explicitly by your doctor that it is necessary. There is only insufficient knowledge about the use of Octreotide during pregnancy and breast-feeding.

Driving and using machines

It is not known whether Octreotide affects the ability to drive or use machines.

Do not drive or use machines unless your doctor has allowed you to do so.

Octreotide contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per ml, which means it is essentially "sodium-free".

3. How to use Octreotide

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

Below are the usual doses used in different types of therapy with octreotide.

When used to treat acromegaly in adults (as

mentioned above in section 1, point A):

• Initial dose: 50-100 micrograms, twice or three times daily, by injection under the skin

• Your doctor will adapt the dose depending on how you respond to treatment

• Maximum dose: 1500 micrograms daily

• The treatment must be stopped if no improvement has occurred after 3 months.

When used to treat symptoms of tumours located in the stomach, intestine (gut) and pancreas (as

mentioned above in section 1, point B):

• Initial dose: 50 micrograms, once or twice daily, by injection under the skin

• Your doctor will adapt the dose depending on how you respond to treatment

• Rarely, higher doses than 200 micrograms three times daily may be necessary

• Maintenance dose: is to be determined individually.

• The treatment should be stopped if no effect is observed after 1 week.

When used to prevent complications after operation of the pancreas (as mentioned above in section 1, point C):

• Begin the treatment at least 1 hour before the operation

• Usual dose: 100 micrograms, three times daily for 7 days, by injection under the skin

In all cases, a regular check of your blood sugar levels is required.

Patients with liver problems

Your doctor may adapt your maintenance dose if you have a chronic liver disease (cirrhosis).

Use in children

Experience with Octreotide in children is limited. If the doctor determines treatment with this medicine is necessary, he/she will determine the dose.

Duration of administration

This is determined by your doctor. You may have to use Octreotide as a lifelong therapy.

Method of administration

• The solution for injection must not be mixed with other liquids.

• The solution must be checked before administration for the absence of suspended particles.

• Do not heat the solution. When the solution is taken out of the refrigerator, allow it to gradually reach room temperature before it is injected. By allowing the solution to reach room temperature, this reduces the risk of local side effects.

• Administer Octreotide between meals or shortly before going to bed to prevent stomach and intestinal (gut) side effects.

• Octreotide can be injected under the skin or into a vein. Injections into the vein must be administered by specifically trained medical staff only. Administration into a vein should always be given in a hospital.

• Your doctor or nurse will explain to you how to self-inject Octreotide under the skin. Suitable injections sites are:

- the upper arm

- the thigh

- the abdomen

• Do not always inject at the same site if several injections are necessary at short intervals.

• This reduces the risk of local side effects.

If you use more Octreotide than you should

Contact your doctor or pharmacist immediately.

Symptoms of an overdose can be:

• brief drop in heart rate;

• flushing of the face;

• abdominal cramps;

• diarrhoea;

• an empty feeling in the stomach;

• feeling sick.

These symptoms usually disappear within 24 hours of administration. The management of an overdose involves controlling the symptoms.

If you forget to use Octreotide

You can still administer it unless it is almost time for your next dose. In that case, take only your currently scheduled dose.

Do not take a double dose to make up for a forgotten dose.

If you stop using Octreotide

Do not stop using Octreotide without your doctor's

consent, since otherwise your condition may recur.

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

The following information is intended for healthcare professionals only:

Special precautions for handling

Vials should be opened immediately prior to use. Any unused solution should be discarded.

Prior to administration the solution should be inspected visually for discolouration or particulate matters.

To reduce local discomfort, it is recommended to let the solution reach room temperature before injection.

Avoid multiple injections at short intervals at the same site.

Subcutaneous administration:

For subcutaneous use Octreotide should not be diluted.

Intravenous administration:

For intravenous use octreotide should be diluted with 9 mg/ml sodium chloride solution to a ratio of not less than 1 vol: 1 vol and not more than 1 vol: 9 vol. Dilution of octreotide with glucose solution is not recommended.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Octreotide and tell your doctor immediately if you experience:

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

• sudden severe pain in your abdomen that can be a symptom of an acute constipation or an inflammation of the pancreas. This may occur in the first few hours or days of treatment.

Side effects are classified in the following categories of frequency:

Very common (may affect more than 1 in 10 people):

• excessively high sugar levels;

• headache;

• watery stools (diarrhoea), stomach/belly pain, nausea, extreme constipation, wind;

• development of gallstones (from long-term use);

• symptoms at the injection site (rarely last longer than 15 minutes) including local pain, irritation, tingling or heat, redness and/or swelling.

Common (may affect up to 1 in 10 people):

• reduced function of the thyroid gland (resulting in low levels of thyroid hormones);

• low blood-sugar levels, reduced glucose tolerance, loss of appetite;

• dizziness;

• slowed heartbeat;

• breathlessness;

• indigestion, vomiting, bloated feeling in the abdomen;

• fatty, loose and/or discoloured stools;

• inflammation of the gall bladder, particular matters in the bile;

• increased levels of bilirubin (degradation product of red blood cells) in the blood;

• itching, rash, hair loss;

• increased liver enzyme levels (transaminases).

Uncommon (may affect up to 1 in 100 people):

• dehydration;

• fast heartbeat.

Rare (may affect up to 1 in 1000 people):

• stomach and intestinal (gut) disorders can resemble acute and extreme constipation accompanied by severe pain in the upper abdomen, tenderness of the abdomen and/or defence reactions;

• acute inflammation of the pancreas;

• inflammation of the pancreas caused by gallstones (transaminases, especially during long-term treatment).

The following side effects have been reported spontaneously. Their frequencies are not known:

• severe allergic reactions;

• irregular heartbeat;

• acute inflammation of the pancreas, acute inflammation of the liver, accompanied by yellow discolouration of the skin or eyes (with or without bile flow blockage);

• hives;

• increase in liver enzyme levels (alkaline phosphatise, gamma-glutamyl transferase).

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. By reporting side effects you can help provide more information on the safety of this medicine.

For UK - You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For Ireland - Reports may be made by following the links to the online reporting option accessible from the IMB homepage, or by completing the downloadable report form also accessible from the IMB website, which may be completed manually and submitted to the IMB via freepost, to the following address: FREEPOST

Pharmacovigilance Section Irish Medicines Board Kevin O'Malley House Earlsfort Centre Earlsfort Terrace Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.imb.ie(http://www.imb.ie) e-mail: imbpharmacovigilance@imb.ie

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 after "EXP". The expiry date refers to the last day of that month.

Store the vial in a refrigerator (2 °C to 8 °C).

For day-to-day use unopened vials may be stored at room temperature for up to two weeks.

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

For single use only.

Diluted solution: Chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at room temperature. From a microbiological point of view, the product should be used immediately after it is diluted. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

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.

6. Contents of the pack and other information

What Octreotide contains

• The active substance is octreotide as octreotide acetate.

• Octreotide is available in three different strenghts:

50 micrograms/ml: One vial of 1 ml solution for injection contains octreotide acetate equivalent to 50 micrograms octreotide.

100 micrograms/ml: One vial of 1 ml solution for injection contains octreotide acetate equivalent to 100 micrograms octreotide.

500 micrograms/ml: One vial of 1 ml solution for injection contains octreotide acetate equivalent to 500 micrograms octreotide.

• The other ingredients are: (S)-lactic acid, sodium hydrogen carbonate (for pH adjustment), mannitol, water for injections.

What Octreotide solution for injection looks like and contents of the pack

Octreotide solution for injection is a clear, colourless to slightly brownish solution.

Pack sizes:

1 vial.

5 vials.

30 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire,

WA7 1NT UK

Manufacturer

Fresenius Kabi Deutschland GmbH Else-Kroner-StraGe 1 61352 Bad Homburg v.d.H.

Germany Tel.: 06172-686 0

This medicinal product is authorised in the Member States of the EEA under the following names:

Octreotide 0.05 mg/ml
Belgium	Octreotide Fresenius Kabi 0,05 mg/ml
Cyprus	Octreotide Kabi
Czech Republic	Octreotide Kabi 0,05 mg/ml
Denmark	Octreotide Fresenius Kabi
France	Octreotide Kabi 50 microgrammes/1 ml, solution injectable
Germany	Octreotid Kabi 0,05 mg/ml Injektionslosung
Greece	Octreotide Kabi
Ireland	Octreotide 50 micrograms/ml solution for injection
Italy	Octreotide Kabi 0,05 mg/ml soluzione iniettabile
Luxembourg	Octreotid Kabi 0,05 mg/ml Injektionslosung
Malta	Octreotide 50 micrograms/ml solution for injection
Netherlands	Octreotide Fresenius Kabi 0,05 mg/ml
Norway	Octreotide Fresenius Kabi
Poland	Octreotide Kabi
Portugal	OCTREOTIDO KABI
Slovenia	Oktreotid Kabi 0,05 mg/ml raztopina za injiciranje
Spain	Octreotida 50 microgramos/ml solucion inyectable EFG
Sweden	Octreotide Fresenius Kabi
United Kingdom	Octreotide 50 micrograms/ml solution for injection
Octreotide 0.1 mg/ml
Belgium	Octreotide Fresenius Kabi 0,1 mg/ml
Bulgaria	Octreotide Kabi 0,1 mg/ml MHWeK^OHeH pa3TBop
Cyprus	Octreotide Kabi
Czech Republic	Octreotide Kabi 0,1 mg/ml
Denmark	Octreotide Fresenius Kabi
France	Octreotide Kabi 100 microgrammes/1 ml, solution injectable
Germany	Octreotid Kabi 0,1 mg/ml Injektionslosung
Greece	Octreotide Kabi
Ireland	Octreotide 100 micrograms/ml solution for injection
Italy	Octreotide Kabi 0,1 mg/ml soluzione iniettabile
Luxembourg	Octreotid Kabi 0,1 mg/ml Injektionslosung
Malta	Octreotide 100 micrograms/ml solution for injection
Netherlands	Octreotide Fresenius Kabi 0,1 mg/ml
Norway	Octreotide Fresenius Kabi
Poland	Octreotide Kabi
Portugal	OCTREOTIDO KABI
Romania	Octreotid Kabi 0,1 mg/ml solutie injectabila
Slovak Republic	Octreotide Kabi 0,1 mg/ml
Slovenia	Oktreotid Kabi 0,1 mg/ml raztopina za injiciranje
Spain	Octreotida 100 microgramos/ml solucion inyectable EFG
Sweden	Octreotide Fresenius Kabi
United Kingdom	Octreotide 100 micrograms/ml solution for injection
Octreotide 0.5 mg/ml
Belgium	Octreotide Fresenius Kabi 0,5 mg/ml
Cyprus	Octreotide Kabi
Czech Republic	Octreotide Kabi 0,5 mg/ml
Denmark	Octreotide Fresenius Kabi
France	Octreotide Kabi 500 microgrammes/1 ml, solution injectable
Germany	Octreotid Kabi 0,5 mg/ml Injektionslosung
Greece	Octreotide Kabi
Ireland	Octreotide 500 micrograms/ml solution for injection
Italy	Octreotide Kabi 0,5 mg/ml soluzione iniettabile
Luxembourg	Octreotid Kabi 0,5 mg/ml Injektionslosung
Malta	Octreotide 500 micrograms/ml solution for injection
Netherlands	Octreotide Fresenius Kabi 0,5 mg/ml
Norway	Octreotide Fresenius Kabi
Poland	Octreotide Kabi
Portugal	OCTREOTIDO KABI
Slovak Republic	Octreotide Kabi 0,5 mg/ml
Slovenia	Oktreotid Kabi 0,5 mg/ml raztopina za injiciranje
Spain	Octreotida 500 microgramos/ml solucion inyectable EFG
Sweden	Octreotide Fresenius Kabi
United Kingdom	Octreotide 500 micrograms/ml solution for injection

This leaflet was last revised in 08/2013

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