ZYPREXA 2.5 мг Коированные таблетки

Содержание инструкции

1. ZYPREXA 2.5 mg coated tablets, 5 mg coated tablets, 7.5 mg coated tablets, 10 mg coated tablets, 15 mg coated tablets, 20 mg coated tablets
   1. What is ZYPREXA and what is it used for
   2. What you need to know before taking ZYPREXA
   3. How to take ZYPREXA
   4. Possible side effects
   5. How to store ZYPREXA
   6. Contents of the pack and other information
2. ZYPREXA 20 mg tablets (tablet coating) macrogol and synthetic red iron oxide (E172)
3. ZYPREXA 10 mg powder for injectable solution
   1. What is ZYPREXA and what is it used for
   2. What you need to know before you are given ZYPREXA
   3. How to take ZYPREXA
   4. Possible side effects
   5. How to store ZYPREXA
   6. OTHER INFORMATION

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

olanzapine

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What ZYPREXA is and what it is used for
• 2. What you need to know before you take ZYPREXA
• 3. How to take ZYPREXA
• 4. Possible side effects
• 5. How to store ZYPREXA
• 6. Contents of the pack and other information

1. What is ZYPREXA and what is it used for

ZYPREXA contains the active ingredient olanzapine. ZYPREXA belongs to a group of drugs called
antipsychotics and is used to treat the following conditions:

• schizophrenia, an illness with symptoms such as hearing, seeing or feeling things that are not there, false beliefs, unjustified suspicion and social withdrawal. People with this illness may also feel depressed, anxious or tense.
• moderate to severe episodes of mania, a condition characterized by symptoms of excitement or euphoria

ZYPREXA has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose
manic episode responded to treatment with olanzapine.

2. What you need to know before taking ZYPREXA

Do not take ZYPREXA

• if you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest with skin rash, itching, swelling of the face, swelling of the lips, shortness of breath. If this has happened to you, report it to your doctor.
• if you have previously been diagnosed with an eye problem such as certain types of glaucoma (increased pressure inside the eye).

Warnings and precautions
Talk to your doctor or pharmacist before taking ZYPREXA

• The use of ZYPREXA in elderly patients with dementia is not recommended as it may cause serious side effects.
• Medicines of this type can cause unusual movements, especially of the face and tongue. If this happens after you have been given ZYPREXA, report it to your doctor.
• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness and confusion or drowsiness. If this happens, consult your doctor immediately.
• Weight gain has been observed in patients taking ZYPREXA. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or getting help with a diet program.
• High levels of sugar and fat (triglycerides and cholesterol) in the blood have been observed in patients taking ZYPREXA. The doctor must request blood tests to check sugar and certain fat levels in the blood before you start taking ZYPREXA and, regularly, during treatment.
• Report to your doctor if you or someone in your family has had a history of blood clots, as medicines like these have been associated with the formation of blood clots.

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

• Stroke or transient ischemic attack (TIA) (temporary symptoms of stroke)
• Parkinson's disease
• Prostate problems
• Bowel obstruction (paralytic ileus)
• Liver or kidney disease
• Blood diseases
• Heart disease
• Diabetes
• Convulsions
• If you know that you may have excessive loss of salts due to severe and prolonged diarrhea and vomiting (being ill) or the use of diuretics (water pills)

If you suffer from dementia, you or your caregiver must inform the doctor if you have
previously had a stroke or a transient ischemic attack.
As a routine precaution, if you are over 65 years of age, have your
blood pressure checked periodically by your doctor.

Children and adolescents
ZYPREXA is not indicated in patients under the age of 18 years.

Other medicines and ZYPREXA
During treatment with ZYPREXA, take other medicines only with your doctor's authorization.
You may feel sleepy if ZYPREXA is taken in combination with antidepressants or
medicines taken for anxiety or to help you sleep (tranquilizers).
Tell your doctor if you are taking, have recently taken or may take any other
medicine.
In particular, tell your doctor if you are taking:

• medicines for Parkinson's disease.
• carbamazepine (an anti-epileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - it may be necessary to adjust your dose of ZYPREXA.

ZYPREXA with alcohol
Do not drink any type of alcohol during treatment with ZYPREXA as the simultaneous
administration of ZYPREXA and alcohol can cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant or if you are breastfeeding with breast
milk, ask your doctor for advice before taking this medicine. You should not take this
medicine while breastfeeding, as small amounts of ZYPREXA can pass into
breast milk.
The following symptoms may occur in newborns of mothers who have used ZYPREXA in the last
trimester (last three months of pregnancy): tremor, stiffness and/or muscle weakness, drowsiness,
agitation, breathing problems and difficulty feeding. If your baby presents any of these
symptoms, you may need to contact your doctor.

Driving and operating machinery
When taking ZYPREXA there is a risk that you may experience drowsiness. If this occurs
do not drive or operate tools or machinery. Inform your doctor.

ZYPREXA contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact him before taking
this medicine.

3. How to take ZYPREXA

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will tell you how many ZYPREXA tablets you need to take and for how long you need to continue to
take them. The dose of ZYPREXA to be taken varies from 5 mg to 20 mg per day. If your symptoms
reappear, talk to your doctor, but do not stop taking ZYPREXA unless your
doctor tells you to.
You should take ZYPREXA tablets once a day, following your doctor's instructions.
Try to take the tablets every day at the same time. It does not matter if you take them on a
full or empty stomach. ZYPREXA film-coated tablets are for oral use. 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, have shown the
following symptoms: increased heart rate, agitation/aggression, speech problems,
unusual movements (especially of the face or tongue) and a reduced level of consciousness. Other
symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever,
accelerated breathing, sweating, muscle rigidity, stupor or drowsiness, slowing of the respiratory rate,
reduced cough reflex, high or low blood pressure, changes in heart rhythm. Contact your doctor or hospital immediately if any of the above
symptoms occur. Show your doctor your pack of tablets.

If you forget to take ZYPREXA
Take the tablets as soon as you remember. Do not take a double dose in one day.

If you stop taking ZYPREXA
Do not stop taking the tablets just because you start to feel better. It is important that you continue
the treatment with ZYPREXA for as long as your doctor deems necessary.
If you suddenly stop taking ZYPREXA, symptoms such as
sweating, inability to sleep, tremor, anxiety or nausea and vomiting may occur. Your doctor may advise you to
gradually reduce the dose before stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Report to your doctor immediately if you experience:

• unusual movements (a common side effect that can affect up to 1 in 10 patients), especially of the face or tongue;
• blood clots in the veins (an uncommon side effect that can affect up to 1 in 100 patients), especially in the lower limbs (symptoms include swelling, pain and redness of the leg), which can circulate through blood vessels to the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, consult a doctor immediately;
• a combination of fever, rapid breathing, sweating, muscle stiffness and confusion or drowsiness (the frequency of this side effect cannot be estimated based on available data).

Very common side effects (may affect more than 1 in 10 people) include weight gain; drowsiness; increased levels of prolactin in the blood. In the early stages of treatment, some people may experience a feeling of dizziness or fainting (with a slowing of the heart rate), especially when getting up from a lying or sitting position. These effects usually subside spontaneously, but if this does not happen, inform your doctor.
Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and, in the early stages of treatment, temporary increases in liver enzymes; increases in blood sugar and urine sugar levels; increases in uric acid and creatine phosphokinase levels in the blood; a feeling of increased hunger; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; skin rash; loss of strength; extreme fatigue; water retention leading to swelling of the hands, ankles or feet; fever; joint pain and sexual dysfunction, such as decreased libido in men and women or erectile dysfunction in men.
Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash); diabetes or a worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slowing of the heart rate; sensitivity to sunlight; nosebleeds; abdominal bloating; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and changes in the breasts in men and women, such as abnormal growth or abnormal milk secretion.
Rare side effects (may affect up to 1 in 1,000 people) include a decrease in body temperature; changes in heart rhythm; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and malaise; liver disease that manifests as yellowing of the skin and whites of the eyes; muscle disease that presents as tenderness and unexplained pain; and prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially manifests with flu-like symptoms, with a rash on the face that subsequently becomes widespread, high body temperature, enlarged lymph nodes, increased levels of liver enzymes observed in blood tests and an increase in a type of white blood cells (increased eosinophils).
During treatment with olanzapine, elderly patients with dementia may be subject to stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, skin flushing, and gait disturbances. Some fatal cases have been reported in this particular group of patients.
In patients with Parkinson's disease ZYPREXA may worsen symptoms.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or nurse. You can also report side effects directly through the national reporting system as detailed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ZYPREXA

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 pack.
ZYPREXA should be stored in its original packaging to protect it from light and
moisture.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ZYPREXA contains

• The active ingredient is olanzapine. Each ZYPREXA tablet contains either 2.5 mg, or 5 mg, or 7.5 mg, or 10 mg, or 15 mg, or 20 mg of the active ingredient. The exact amount is reported on the ZYPREXA tablet packaging.
• The other ingredients are
• (tablet core) lactose monohydrate, hydroxypropylcellulose, polyvinylpyrrolidone, microcrystalline cellulose, magnesium stearate and
• (tablet coating) hypromellose, titanium dioxide (E171), carnauba wax. In addition, the different concentrations of ZYPREXA tablets also contain the following excipients:

TABLET DOSAGEOTHER EXCIPIENTS
ZYPREXA 2.5 mg, 5 mg, 7.5 mg and 10 mg (tablet coating) shellac, macrogol,
tablets propylene glycol, polysorbate 80 and coloring
indigo carmine (E132), anhydrous ethanol, isopropyl alcohol, butyl alcohol, ammonium hydroxide
ZYPREXA 15 mg tablets (tablet coating) triacetin and
coloring indigo carmine (E132)

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

of iron red synthetic (E172)

Description of the appearance of ZYPREXA and contents of the pack
ZYPREXA 2.5 mg coated tablets are white with the name “LILLY” and a
numeric identification code "4112" imprinted on them.
ZYPREXA 5 mg coated tablets are white with the name “LILLY” and a
numeric identification code "4115" imprinted on them.
ZYPREXA 7.5 mg coated tablets are white with the name “LILLY” and a
numeric identification code "4116" imprinted on them.
ZYPREXA 10 mg coated tablets are white with the name “LILLY” and a
numeric identification code "4117" imprinted on them.
ZYPREXA 15 mg coated tablets are blue.
ZYPREXA 20 mg coated tablets are pink.
ZYPREXA is available in packs containing 28, 35, 56, 70 or 98 tablets. Not all
pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
CHEPLAPHARM Registration GmbH, Weiler Straße 5e, 79540 Lörrach, Germany.

Manufacturer:
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Fidelio Healthcare Limburg GmbH, Mundipharmastraße 2, 65549 Limburg an der Lahn,
Germany .
CHEPLAPHARM Registration GmbH, Weiler Straße 5e, 79540 Lörrach, Germany .
Further detailed information on this medicine is available on the website of the European
Medicines Agency http://www.ema.europa.eu

ZYPREXA 10 mg powder for injectable solution

olanzapine

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What ZYPREXA is and what it is used for
• 2. What you need to know before you take ZYPREXA
• 3. How to take ZYPREXA
• 4. Possible side effects
• 5. How to store ZYPREXA
• 6. Contents of the pack and other information

1. What is ZYPREXA and what is it used for

ZYPREXA contains the active ingredient olanzapine. ZYPREXA Injectable belongs to a group of
drugs called antipsychotics and is used to treat symptoms such as agitation and behavioral disturbance
that can occur in the following conditions:

• Schizophrenia, a disease with symptoms such as hearing, seeing or experiencing things that do not exist, false beliefs, unjustified suspicion and social withdrawal. People with this disease may also feel depressed, anxious or tense;
• Mania, a condition with symptoms of excitement or euphoria.

ZYPREXA Injectable is administered when rapid control of agitation and
behavioral disturbance is necessary and treatment with ZYPREXA tablets is not appropriate. As
soon as possible, the doctor will switch the therapy to a treatment with ZYPREXA tablets.

2. What you need to know before you are given ZYPREXA

Do not take ZYPREXA

• if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest with skin rash, itching, swelling of the face, swelling of the lips, shortness of breath. If this has happened to you, tell your doctor.
• if you have previously been diagnosed with an eye problem such as certain types of glaucoma (increased pressure inside the eye).

Warnings and precautions
Consult your doctor or nurse before taking ZYPREXA Injectable

• Tell your doctor or nurse if you feel dizzy or faint after the injection. You will probably need to lie down until you feel better. Your doctor or nurse may also need to check your blood pressure and pulse.
• The use of ZYPREXA in elderly patients with dementia is not recommended as it may cause serious side effects.
• Medicines of this type can cause unusual movements, especially of the face and tongue. If this happens after you have been given ZYPREXA, tell your doctor.
• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness and confusion or drowsiness. If this happens, consult your doctor immediately. You will not be given any further injections.
• Weight gain has been observed in patients taking ZYPREXA. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or getting help with a diet program.
• High levels of sugar and fat (triglycerides and cholesterol) in the blood have been observed in patients taking ZYPREXA. Your doctor should request blood tests to check sugar and certain fat levels in the blood before you start taking ZYPREXA and, regularly, during treatment.
• Tell your doctor if you or someone in your family has had a history of blood clots, as medicines like these have been associated with the formation of blood clots.

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

• Stroke or transient ischemic attack (TIA) (transient symptoms of stroke)
• Parkinson's disease
• Prostate problems
• Bowel obstruction (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• If you have recently had a heart attack, or have heart disease, including atrial fibrillation, unstable angina or suffer from low blood pressure
• Diabetes
• Convulsions
• If you know that you may have excessive loss of salts due to severe and prolonged diarrhea and vomiting (being ill) or the use of diuretics (water tablets)

If you suffer from dementia, you or your caregiver must inform the doctor if you have
had a stroke or transient ischemic attack in the past.
As a routine precaution, if you are over 65 years of age, have your
blood pressure checked periodically by your doctor.

Children and adolescents
ZYPREXA is not indicated for patients under the age of 18 years.

Other medicines and ZYPREXA
The combination of ZYPREXA with the following medicines may cause you to feel drowsy: medicines
taken for anxiety or to help you sleep (tranquilizers, including benzodiazepines) and antidepressants.
During treatment with ZYPREXA, take other medicines only with your doctor's authorization.
If you are being treated with ZYPREXA Injectable, a simultaneous injection with
a benzodiazepine is not recommended as this can cause excessive drowsiness, can have serious effects on
heartbeat or breathing and, in very rare cases, can cause death. If the doctor needs
to administer a benzodiazepine by injection to treat your health condition, they must allow a
period of at least one hour after the ZYPREXA injection and you must be closely
monitored after the benzodiazepine is administered by injection.
Tell your doctor if you are taking or have recently taken any other medicines, even
those without a prescription. In particular, tell your doctor if you are taking medicines for
Parkinson's disease.

ZYPREXAwith alcohol
Do not drink any type of alcohol if you have been given ZYPREXA as the simultaneous
intake with alcohol can cause you to feel drowsy.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor for advice before taking this medicine. You should not take this
medicine during breastfeeding, as small amounts of ZYPREXA can pass into
breast milk.
The following symptoms may occur in newborns of mothers who have used ZYPREXA in the last
trimester (last three months of pregnancy): tremor, stiffness and/or muscle weakness, drowsiness,
agitation, breathing problems and difficulty feeding. If your baby presents any of these
symptoms, you may need to contact your doctor.

Driving and using machines
When you take ZYPREXA there is a risk that you may experience drowsiness. If this happens
do not drive or operate tools or machinery. Tell your doctor.

ZYPREXA contains Lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking
this medicine.

ZYPREXA contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is essentially
‘sodium-free’.

3. How to take ZYPREXA

Information on reconstitution and administration is provided in a detachable section at the
end of this leaflet.
The doctor will decide how much ZYPREXA you need and for how long you should take it. For the first
injection, the dose is generally 10 mg, but it may also be quantitatively lower. Up to
20 mg may be administered within 24 hours. In patients over 65 years of age, the dose is
2.5 mg or 5 mg.
ZYPREXA is supplied in powder form. The doctor or nurse will transform it into a solution.
ZYPREXA Injectable is for intramuscular use. The correct amount of solution will be injected
intramuscularly.

If you take more ZYPREXA than you should
Patients who have taken more ZYPREXA than they should have, have manifested the
following symptoms: increased heart rate, agitation/aggression, speech problems,
unusual movements (especially of the face or tongue) and a reduced level of consciousness. Other
symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of
fever, rapid breathing, sweating, muscle rigidity, stupor or drowsiness, slowing of the
respiratory rate, reduced cough reflex, high or low blood pressure, changes
in heart rhythm. Inform your doctor or nurse about this.
Only a few doses of ZYPREXA Injectable are necessary. The doctor will decide when you need a
dose of ZYPREXA Injectable.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, ZYPREXA Injectable can cause side effects, although not everybody gets them.
Report to your doctor immediately if you experience:

• unusual movements (a common side effect that can affect up to 1 in 10 patients) especially of the face or tongue;
• blood clots in the veins (an uncommon side effect that can affect up to 1 in 100 patients), especially in the lower legs (symptoms include swelling, pain and redness of the leg), which can travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, consult a doctor immediately;
• a combination of fever, fast breathing, sweating, muscle stiffness and confusion or drowsiness (the frequency of this side effect cannot be estimated based on available data).

Common side effects (may affect up to 1 in 10 people) with ZYPREXA Injectable
include slowed or accelerated heartbeat; drowsiness; decreased blood pressure; irritation at the injection site.
After the injection, some people may feel dizzy or faint (with a decrease in heart rate), especially when getting up from a lying or sitting position. These symptoms usually resolve spontaneously but if this does not happen, inform your doctor or nurse as soon as possible.
Uncommon side effects (may affect up to 1 in 100 people) include slowing of breathing; and changes in heart rhythm, which can be serious.
In addition, the following side effects have been observed after patients had taken ZYPREXA orally.
Further very common side effects (may affect more than 1 in 10 people) include weight gain and increases in prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (with a slowing of the heart rate), especially when getting up from a lying or sitting position. These effects usually resolve spontaneously, but if this does not happen inform your doctor.
Further common side effects (may affect up to 1 in 10 people) include increases in levels of certain blood cells, circulating fats and in the early stages of treatment temporary increases in liver enzymes; increases in blood sugar and urine sugar levels; increases in uric acid and creatine phosphokinase levels in the blood; feeling of increased hunger; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; skin rash; loss of strength; water retention leading to swelling of the hands, ankles or feet; fever; joint pain and sexual dysfunction, such as decreased libido in males and females or erectile dysfunction in males.
Further uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slowing of the heartbeat; sensitivity to sunlight; nosebleeds; abdominal bloating; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles and changes in the breasts in males and females, such as abnormal growth or abnormal milk secretion.
Rare side effects (may affect up to 1 in 1,000 people) include decreased body temperature; changes in heart rhythm; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and malaise; liver disease manifesting as yellowing of the skin and whites of the eyes; muscle disease presenting as tenderness and unexplained pain; and prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially manifests with flu-like symptoms, with a rash on the face that subsequently becomes widespread, high fever, enlarged lymph nodes, increased levels of liver enzymes observed in blood tests and an increase in a type of white blood cells (increased eosinophils).
During treatment with olanzapine, elderly patients with dementia may be subject to stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, skin flushing and gait disturbances. Some fatal cases have been reported in this particular group of patients.
In patients with Parkinson's disease ZYPREXA may worsen symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ZYPREXA

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 pack.
Do not store at a temperature above 25°C. Store in the original package to protect it from
light.
After ZYPREXA Injectable has been prepared in solution, use within one hour. Do not freeze
after reconstitution.
Dispose of any unused content.

6. OTHER INFORMATION

What ZYPREXA Injectable contains

• The active ingredient is olanzapine. Each vial contains 10 mg of the active ingredient.
• The excipients are lactose monohydrate, tartaric acid, hydrochloric acid and sodium hydroxide.

Description of the appearance of ZYPREXA Injectable and contents of the pack
ZYPREXA is a yellow powder contained in a vial. One vial of ZYPREXA contains
10 mg of olanzapine. The doctor or nurse will transform it into a solution which will be
administered to you by injection.
ZYPREXA Injectable is available in a pack containing 1 or 10 vials. Not all pack sizes may be
marketed.

Marketing Authorisation Holder and Manufacturer:
CHEPLAPHARM Registration GmbH, Weiler Straße 5e, 79540 Lörrach, Germany.

Manufacturer:
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Prestige Promotion Verkaufsfoerderung & Werbeservice GmbH, Borsigstrasse 2, 63755 Alzenau,
Germany.
CHEPLAPHARM Registration GmbH, Weiler Straße 5e, 79540 Lörrach, Germany.
More detailed information on this medicine is available on the website of the European
Medicines Agency http://www.ema.europa.eu

• - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - (Perforated line allowing the information to be detached for healthcare professionals)INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS

Reconstitution and administration of ZYPREXA
Reconstitute ZYPREXA Powder for Solution for Injection only with water for injections.
ZYPREXA Powder for Solution for Injection must not be mixed in the syringe with any of the
commercially available medicines due to incompatibility. Some examples are given below.
Olanzapine injectable must not be added in a syringe to haloperidol injectable because it has been
shown that the resulting low pH degrades olanzapine over time.
Olanzapine injectable cannot be added in a syringe nor must it be used in association with
benzodiazepines.

Powder for Solution for Injection
Reconstitute ZYPREXA Powder for Solution for Injection using standard aseptic techniques for the
reconstitution of products for parenteral use.

• 1. Withdraw 2.1 ml of water for injections with a sterile syringe. Inject it into a vial of ZYPREXA Powder for Solution for Injection.
• 2. Rotate the vial until the powder is completely dissolved, giving a yellow solution. The vial contains 11.0 mg of olanzapine equivalent to a 5 mg/ml solution. If 2.0 ml of solution are withdrawn, 1 mg of olanzapine remains in the vial and in the syringe, thus allowing the administration of 10 mg of olanzapine.
• 3. The following table provides the volumes of solution to be injected to administer various dosages of olanzapine:
• 4. Administer the solution by intramuscular injection. Do not administer by intravenous or subcutaneous route.
• 5. Discard the syringe and any unused solution in accordance with appropriate clinical procedures.
• 6. Use the solution immediately within 1 hour of reconstitution. Do not store at temperatures above 25°C. Do not freeze.

Before being administered, medicinal products for parenteral use must be checked for the presence of
particles.