Thursday, October 6, 2016

ZYPREXA 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg coated tablets






ZYPREXA 2.5 mg coated tablets



ZYPREXA 5 mg coated tablets



ZYPREXA 7.5 mg coated tablets



ZYPREXA 10 mg coated tablets



ZYPREXA 15 mg coated tablets



ZYPREXA 20 mg coated tablets


olanzapine



Read all of this leaflet carefully before you start taking this medicine.


  • 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. Do not pass it on to others. It may harm them, even if their symptoms are 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 ZYPREXA is and what it is used for

  • 2. Before you take ZYPREXA

  • 3. How to take ZYPREXA

  • 4. Possible side effects

  • 5. How to store ZYPREXA

  • 6. Further information




What Zyprexa Is And What It Is Used For


ZYPREXA belongs to a group of medicines called antipsychotics.


ZYPREXA is used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense.


ZYPREXA is used to treat a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. It is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with this condition.




Before You Take Zyprexa



Do not take ZYPREXA


  • if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of ZYPREXA. An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor.

  • if you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).



Take special care with ZYPREXA


  • Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given ZYPREXA tell your doctor.

  • Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, contact your doctor at once.

  • The use of ZYPREXA in elderly patients with dementia is not recommended as it may have serious side effects.

If you suffer from any of the following illnesses tell your doctor as soon as possible:


  • Diabetes

  • Heart disease

  • Liver or kidney disease

  • Parkinson’s disease

  • Epilepsy

  • Prostate problems

  • A blocked intestine (Paralytic ileus)

  • Blood disorders

  • Stroke or “mini” stroke (temporary symptoms of stroke)

If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.


As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.


ZYPREXA is not for patients who are under 18 years.




Taking other medicines


Only take other medicines while you are on ZYPREXA if your doctor tells you that you can. You might feel drowsy if ZYPREXA is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).


You should tell your doctor if you are taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as it may be necessary to change your ZYPREXA dose.


Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially tell your doctor if you are taking medicines for Parkinson’s disease.




Taking ZYPREXA with food and drink


Do not drink any alcohol if you have been given ZYPREXA as ZYPREXA and alcohol together may make you feel drowsy.




Pregnancy and breast-feeding


Tell your doctor as soon as possible if you are pregnant or think you may be pregnant. You should not take this medicine when pregnant, unless you have discussed this with your doctor. You should not be given this medicine when breast-feeding, as small amounts of ZYPREXA can pass into breast milk.




Driving and using machines


There is a risk of feeling drowsy when you are given ZYPREXA. If this happens do not drive or operate any tools or machines. Tell your doctor.




Important information about some of the ingredients of ZYPREXA


ZYPREXA contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.





How To Take Zyprexa


Always take ZYPREXA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.


Your doctor will tell you how many ZYPREXA tablets to take and how long you should continue to take them. The daily dose of ZYPREXA is between 5 and 20 mg. Consult your doctor if your symptoms return but do not stop taking ZYPREXA unless your doctor tells you to.


You should take your ZYPREXA tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food. ZYPREXA coated tablets are for oral use. You should swallow the ZYPREXA tablets whole with water.



If you take more ZYPREXA than you should


Patients who have taken more ZYPREXA than they should, have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness. Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart. Contact your doctor or hospital straight away. Show the doctor your pack of tablets.




If you forget to take ZYPREXA


Take your tablets as soon as you remember. Do not take two doses in one day.




If you stop taking ZYPREXA


Do not stop taking your tablets just because you feel better. It is important that you carry on taking ZYPREXA for as long as your doctor tells you.


If you suddenly stop taking ZYPREXA, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur. Your doctor may suggest you to reduce the dose gradually before stopping treatment.



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




Possible Side Effects


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


Very common side effects: affect 1 user in 10


  • Weight gain.

  • Sleepiness.

  • Increases in the levels of prolactin in the blood.

Common side effects: affect 1 to 10 users in 100


  • Changes in the levels of some blood cells and circulating fats.

  • Increases in the level of sugars in the blood and urine.

  • Feeling more hungry.

  • Dizziness.

  • Restlessness.

  • Tremor.

  • Muscle stiffness or spasm (including eye movements).

  • Problems with speech.

  • Unusual movement (especially of the face or tongue).

  • Constipation.

  • Dry mouth.

  • Rash.

  • Loss of strength.

  • Extreme tiredness.

  • Water retention leading to swelling of the hands, ankles or feet.

  • In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor.

  • Sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.

Uncommon side effects: affect 1 to 10 users in 1,000


  • Slow heart rate.

  • Make you sensitive to sunlight.

  • Urinary incontinence.

  • Hair loss.

  • Absence or decrease in menstrual periods.

  • Changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.

Other possible side effects: frequency cannot be estimated from the available data.


  • Allergic reaction (e.g. swelling in the mouth and throat, itching, rash).

  • Diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma.

  • Lowering of normal body temperature.

  • Seizures, usually associated with a history of seizures (epilepsy).

  • Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.

  • Spasms of the muscle of the eye causing rolling movement of the eye.

  • Abnormal rhythms of the heart.

  • Sudden unexplained death.

  • Blood clots such as deep venous thrombosis of the leg or blood clot on the lung.

  • Inflammation of the pancreas causing severe stomach pain, fever and sickness.

  • Liver disease appearing as yellowing of the skin and white parts of the eyes.

  • Muscle disease presenting as unexplained aches and pains.

  • Difficulty in passing urine.

  • Prolonged and/or painful erection.

While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking. Some fatal cases have been reported in this particular group of patients.


In patients with Parkinson's disease ZYPREXA may worsen the symptoms.


Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods. If this persists tell your doctor. Very rarely babies born to mothers who have taken ZYPREXA in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.


If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.




How To Store Zyprexa


Keep out of the reach and sight of children.


Do not use ZYPREXA after the expiry date, which is stated on the carton.


ZYPREXA should be stored in its original pack in order to protect from light and moisture.


Please return left over medicine to your pharmacist. 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.




Further Information



What ZYPREXA contains


  • The active substance is olanzapine. Each ZYPREXA tablet contains either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg of the active substance. The exact amount is shown on your ZYPREXA tablet pack.

  • The other ingredients are

    • (tablet core) lactose monohydrate, hyprolose, crospovidone, microcrystalline cellulose, magnesium stearate and
    • (tablet coating) hypromellose, titanium dioxide (E171), carnauba wax.

  • In addition the different ZYPREXA tablet strengths also contain the following ingredients:


TABLET STRENGTH : OTHER INGREDIENTS


ZYPREXA 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets : (tablet coating) shellac, macrogol, propylene glycol, polysorbate 80 and indigo carmine colour (E132)


ZYPREXA 15 mg tablets : (tablet coating) triacetin and indigo carmine colour (E132)


ZYPREXA 20 mg tablets : (tablet coating) macrogol and synthetic red iron oxide (E172)





What ZYPREXA looks like and contents of the pack


ZYPREXA 2.5 mg, 5 mg, 7.5 mg and 10 mg coated tablets are white.


ZYPREXA 15 mg coated tablets are light blue.


ZYPREXA 20 mg coated tablets are pink.


ZYPREXA tablets are available in 28, 35, 56 and 70 tablet packs. Not all pack sizes may be marketed.




Marketing Authorisation Holder and Manufacturer


Marketing Authorisation Holder:



Eli Lilly Nederland BV

Grootslag 1 – 5

NL-3991 RA

Houten

The Netherlands


Manufacturer:



Lilly S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

Spain



For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
































United Kingdom

Eli Lilly and Company Limited

Tel: + 44 (0) 1256 315999




This leaflet was last approved in December 2009.






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