10 mg, 20 mg, and 30 mg powder and solvent for solution for injection, prolonged-release suspension
octreotide
What Octreotide Teva is and what it is used for
Octreotide Teva is a synthetic version of somatostatin. Somatostatin occurs naturally in the body where it inhibits the release of one of the certain hormones such as. growth hormone. The advantages of Octreotide Teva compared to somatostatin are that it is stronger and that the effect lasts longer.
Octreotide Teva is used
- To treat acromegaly ,
acromegaly is a condition in which the body produces too much growth hormone . Normally, growth hormone controls the growth of tissues , organs and bones. Too much growth hormone causes the size of your bones and tissues to increase, especially in your hands and feet. Octreotide Teva significantly reduces the symptoms of acromegaly , which include headaches, excessive sweating, numbness in the hands and feet, fatigue and joint pain. In most cases, overproduction of growth hormone is caused by an enlargement of the pituitary glandone (a pituitary adenoma); treatment with Octreotide Teva may reduce the size of the adenoma.
Octreotide Teva is used to treat people with acromegaly:- when other types of acromegaly treatment (surgery or radiation therapy) are not appropriate or have not worked;
- after radiation treatment, to cover the transition period until the radiation treatment becomes fully effective.
- to relieve symptoms associated with overproduction of certain hormones and other similar substances in the stomach, intestines or pancreas,
Overproduction of certain hormones and other natural substances can be caused by rare conditions in the stomach, intestines or pancreas. This upsets the natural hormone balance in the body and results in a variety of symptoms, such as redness , diarrhea, low blood pressure , rash, and weight loss. Treatment with Octreotide Teva helps control these symptoms. - to treat neuroendocrine tumors located in the intestine (eg, appendix, small intestine or colon ),
neuroendocrine tumors are rare tumors that can be found in different parts of the body. Octreotide Teva is also used to control the growth of these tumors , when they are located in the gut (eg appendix, small intestine or colon). - to treat pituitary tumors that produce too much thyroid- stimulating hormone ( TSH ).
Too much thyroid- stimulating hormone ( TSH ) leads to hyperthyroidism . Octreotide Teva is used to treat people with pituitary tumors that produce too much thyroid- stimulating hormone ( TSH ):- when other types of treatments ( surgery or radiation therapy) are not appropriate or have not worked;
- after radiation treatment to cover the transition period until the radiation treatment becomes fully effective.
Octreotide contained in Octreotide Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Octreotide Teva
Carefully follow all instructions given to you by your doctor. They may differ from the information in this leaflet.
Read the following explanations before using Octreotide Teva.
Do not use Octreotide Teva
- if you are allergic to octreotide or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before using Octreotide Teva:
- If you know you have or have had gallstones before or if you experience other complications such as fever, chills, abdominal pain or yellow skin or yellow eyes, tell your doctor as long-term use of Octreotide Teva may lead to gallstone formation. Your doctor may want to check your gallbladder at regular intervals.
- if you know you have diabetes because Octreotide Teva can affect your blood sugar levels. If you are diabetic, your sugar levels should be checked regularly.
- If you have a B 12 deficiency in the past, your doctor may want to check your B 12 levels at regular intervals.
Sampling and inspections
If you have been treated with Octreotide Teva for a long time, your doctor may want to check your thyroid function at regular intervals.
Your doctor will check your liver function.
Your doctor may want to check your pancreatic enzyme function.
Octreotide can lower the heart rate and in very high doses can cause abnormal heart rhythms. Your doctor may monitor your heart rate during treatment.
Children
Experience with Octreotide Teva in children is limited.
Other medicines and Octreotide Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You can usually continue to take other medicines while you are being treated with Octreotide Teva. However, certain drugs such as cimetidine, ciclosporin, bromocriptine, quinidine, and terfenadine have been reported to be affected by Octreotide Teva.
If you are being treated with medicine to control your blood pressure (such as a beta-blocker or a calcium channel blocker) or medicine to regulate your fluid and electrolyte balance, your doctor may need to adjust your dose.
If you are diabetic, your doctor may need to adjust your insulin dose.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Octreotide Teva should only be used during pregnancy if clearly necessary.
Female patients who may become pregnant should use a safe method of contraception during treatment. Do not breastfeed during treatment with Octreotide Teva. It is not known if Octreotide Teva passes into breast milk.
Driving and using machines
Octreotide Teva has no or negligible effect on the ability to drive and use machines. However, some of the side effects that you may get from treatment with Octreotide Teva, such as headaches and fatigue, may impair your ability to drive and use machines safely.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Octreotide Teva contains sodium
Octreotide Teva contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially ‘sodium-free’.
How to use Octreotide Teva
Octreotide Teva should always be given as an injection into the gluteal muscle. With repeated administration, alternate between the left and right gluteal muscles.
If you use more Octreotide Teva than you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor or hospital immediately for assessment of the risk and advice.
The symptoms of overdose are hot flashes, frequent urination, fatigue, depression, anxiety, difficulty concentrating, and abnormal heart rhythm.
If you think you have had an overdose and are experiencing such symptoms, talk to your doctor immediately.
If you forget to use Octreotide Teva
If you have missed your injection, it is recommended that you receive it as soon as possible and that treatment then continues as usual. It does not hurt if you receive a dose a few days late, but you can temporarily get symptoms back before you are back on the dosing schedule.
If you stop using Octreotide Teva
If you stop taking Octreotide Teva, your symptoms may return. Therefore, you should not stop taking Octreotide Teva unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious. Talk to your doctor immediately if you get any of the following:
Very common (may affect more than 1 in 10 people):
- Gallstones that cause sudden back pain.
- High blood sugar.
Common (may affect up to 1 in 10 people):
- Underactive thyroid gland (hypothyroidism) which causes changes in heart rate, appetite or weight; fatigue, coldness or swelling on the front of the neck.
- Changes in thyroid function tests.
- Inflammation of the gallbladder (cholecystitis); Symptoms may include pain in the upper right part of the abdomen, fever, nausea, yellowing of the skin and eyes (jaundice).
- Low blood sugar.
- Impaired glucose tolerance.
- Slow heartbeat.
Uncommon ( may affect up to 1 in 100 people):
- Thirst, low urine production, dark urine, dry reddened skin.
- Fast heartbeat.
Other serious side effects are
- Hypersensitivity reaction (allergic) including skin rash.
- A type of allergic reaction ( anaphylaxis ) that can cause difficulty swallowing or breathing, swelling and tingling and even drops in blood pressure that can lead to dizziness or unconsciousness.
- Inflammation of the pancreas ( pancreatitis ); Symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhea
- Inflammation of the liver ( hepatitis ); symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, general malaise, itching , light-colored urine.
- Irregular heartbeats.
- Low platelet count , which may lead to an increased tendency for bleeding or bruising.
Talk to your doctor immediately if you experience any of the above side effects.
Other side effects:
Tell your doctor, pharmacist, or nurse if you notice any of the side effects below. They are usually mild and tend to disappear during the course of treatment.
Very common (may affect more than 1 in 10 people):
- Diarrhea.
- Stomach pain.
- Nausea.
- Constipation.
- Gas formation.
- Headache
- Pain at the injection site.
Common (may affect up to 1 in 10 people):
- Stomach upset after a meal ( dyspepsia ).
- Vomiting.
- Feeling full.
- Fatty stools.
- Loose stools.
- Discolored stools.
- Dizziness.
- Loss of appetite.
- Changes in liver function tests.
- Hair loss.
- Respiratory distress.
- Faintness.
If you get any side effects, talk to your doctor, nurse, or pharmacist.
How to store Octreotide Teva
Keep this medicine out of the sight and reach of children.
Store in the original package. Sensitive to light.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Octreotide Teva can be stored at a maximum of 25 ° C during the day of injection.
Octreotide Teva should be used immediately after reconstitution and not saved for later use.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if you notice particles or discoloration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is octreotide.One vial contains 10 mg, 20 mg or 30 mg octreotide (as octreotide acetate).
- Other ingredients are:in powder ( vial ): poly (DL-lactide-co-glycolide) and mannitol (E421).in diluent (pre-filled syringe ): caramel sodium, mannitol (E421), poloxamer, water for injections.
What the medicine looks like and contents of the pack
Octreotide 10 mg: Each pack contains 1 glass vial with 10 mg octreotide with rubber stopper sealed with a dark blue aluminum cap, 1 pre-filled glass syringe with 2 ml diluent, 1 safety needle for injection, and 1 vial or 3 vials with 10 mg octreotide, 3 vials syringes with 2 ml of diluent, 3 safety needles for injection and 3 bottle adapters.
Octreotide 20 mg: Each pack contains 1 glass vial of 20 mg octreotide with rubber stopper sealed with an orange aluminum cap, 1 pre-filled glass syringe with 2 ml diluent, 1 safety needle for injection, and 1 bottle adapter or 3 vials with 20 mg octreotide, 3 pre-filled syringes with 2 ml of diluent, 3 safety needles for injection and 3 bottle adapters.
Octreotide 30 mg: Each pack contains 1 glass vial of 30 mg octreotide with rubber stopper sealed with a dark red aluminum cap, 1 pre-filled syringe with 2 ml diluent, 1 safety needle for injection and 1 vial or 3 vials with 30 mg octreotide, 3 vials syringes with 2 ml of diluent, 3 safety needles for injection and 3 bottle adapters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Teva BV
Swensen 5
2031 GA Haarlem
Netherlands
Manufacturer
Teva Pharmaceuticals Europe BV
Swensen 5
2031 GA Haarlem
Netherlands
Merckle GmbH
Ludwig-Merckle-Str. 3,
Blueberries
89143
Germany
Actavis Group PTC EHF.
Reykjavíkurvegur 76-78.
Hafnarfjörður,
IS-220
Iceland
PLIVA HRVATSKA doo (PLIVA CROATIA Ltd.)
Prilaz baruna Filipovicá 25,
Zagreb
10000
Croatia