Zyprexa: detailed information

Package leaflet: Information for the user

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

olanzapine
Please read this leaflet carefully before 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 give it to others, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What ZYPREXA is and what it is used for
What you need to know before taking ZYPREXA
How to take ZYPREXA
Possible side effects
How to store ZYPREXA
Contents of the pack and other information

1. What ZYPREXA is and what it is used for

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

schizophrenia, an illness with symptoms such as hearing, seeing, or experiencing things that do not exist, false beliefs, unjustified suspicion, and social withdrawal. People with this illness may also feel depressed, anxious, or tense.
moderate to severe manic episodes, a condition characterised 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 has 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 present as skin rash, itching, facial swelling, swelling of the lips, or shortness of breath. If you have experienced this, inform 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 may cause unusual movements, especially of the face and tongue. If this occurs after you have started taking ZYPREXA, inform your doctor.
Very rarely, medicines of this type may cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, confusion, or drowsiness. If this occurs, contact 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 following a diet program.
Elevated blood levels of sugar and fats (triglycerides and cholesterol) have been observed in patients taking ZYPREXA. Your doctor should perform blood tests to monitor your blood sugar and certain fat levels before you start taking ZYPREXA and regularly during treatment.
Inform your doctor if you or someone in your family has a history of blood clots, as medicines like this have been associated with blood clot formation.

If you have any of the following conditions, inform your doctor as soon as possible:

Stroke or transient ischaemic attack (TIA) (temporary stroke-like symptoms)
Parkinson’s disease
Prostate problems
Intestinal blockage (paralytic ileus)
Liver or kidney disease
Blood disorders
Heart disease
Diabetes
Seizures
If you know you may experience excessive loss of salts due to severe and prolonged diarrhoea and vomiting (due to illness) or use of diuretics (water tablets)

If you have dementia, you or your caregiver should inform your doctor if you have previously had a stroke or transient ischaemic attack.
As a routine precaution, if you are over 65 years of age, have your blood pressure checked regularly by your doctor.

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

Other medicines and ZYPREXA
During treatment with ZYPREXA, take other medicines only after obtaining approval from your doctor.
You may feel drowsy if ZYPREXA is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquillisers).
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

medicines for Parkinson’s disease.
carbamazepine (an antiepileptic and mood stabiliser), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – your dose of ZYPREXA may need to be adjusted.

ZYPREXA and alcohol
Do not drink any alcoholic beverages during treatment with ZYPREXA, as taking ZYPREXA together with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine. You must not take this medicine while breastfeeding, as small amounts of ZYPREXA may pass into breast milk.
The following symptoms may occur in newborns whose mothers have taken ZYPREXA during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.

Driving and using machines
When taking ZYPREXA, there is a risk that you may become drowsy. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

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

3. How to take ZYPREXA

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many ZYPREXA tablets to take and for how long you should continue taking them. The daily dose of ZYPREXA ranges from 5 mg to 20 mg. If your symptoms return, talk to your doctor, but do not stop taking ZYPREXA unless your doctor tells you to do so.
You should take ZYPREXA tablets once daily, following your doctor's instructions.
Try to take the tablets at the same time every day. It does not matter whether you take them with or without food. ZYPREXA 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 prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face or tongue), and reduced level of consciousness. Other possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy, slowed breathing rate, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or hospital immediately if any of these symptoms occur. Show your doctor the pack of tablets.

If you forget to take ZYPREXA
Take the missed dose as soon as you remember. Do not take a double dose on the same day.

If you stop taking ZYPREXA
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue treatment with ZYPREXA for as long as your doctor considers necessary.
If you stop taking ZYPREXA suddenly, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.

If you have any questions about 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 everybody will experience them.
Immediately inform your doctor if you experience:

unusual movements (a common side effect which may affect up to 1 in 10 patients), especially of the face or tongue;
blood clots in the veins (an uncommon side effect which may affect up to 1 in 100 patients), particularly in the lower limbs (symptoms include swelling, pain and redness of the leg), which may travel through the blood vessels to the lungs and cause chest pain and breathing difficulties. If you experience any of these symptoms, seek medical advice immediately;
a combination of fever, rapid breathing, sweating, muscle stiffness and confusion or drowsiness (the frequency of this side effect cannot be estimated from the 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 dizziness or fainting (with a slowing of the heartbeat), especially when standing up from a lying or sitting position. These effects usually resolve spontaneously, but if they do not, inform your doctor.
Common side effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating fats, and temporary increases in liver enzymes during the early stages of treatment; increased levels of sugar in the blood and urine; increased levels of uric acid and creatine phosphokinase in the blood; increased feeling of hunger; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; 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.
Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in blood and urine) or coma; seizures, usually occurring in patients with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow heartbeat; sensitivity to sunlight; nosebleeds; abdominal swelling; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and breast changes 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; unexplained sudden 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 muscle 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 Syndrome). DRESS initially presents with influenza-like symptoms, a skin rash starting on the face and then spreading, high body temperature, swollen lymph nodes, increased liver enzyme levels observed in blood tests, and an increase in a type of white blood cell (eosinophilia).
In elderly patients with dementia treated with olanzapine, stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, increased body temperature, skin redness, and walking disturbances may occur. In this particular patient group, some fatal cases have been reported.
In patients with Parkinson’s disease, ZYPREXA may cause worsening of symptoms.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via 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 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 via wastewater 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 substance is olanzapine. Each ZYPREXA tablet contains either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, or 20 mg of active substance. The exact amount is indicated on the packaging of ZYPREXA tablets.
The other components are:
- (tablet core) lactose monohydrate, hydroxypropylcellulose, polyvinylpyrrolidone, microcrystalline cellulose, magnesium stearate, and
- (tablet coating) hypromellose, titanium dioxide (E171), carnauba wax. Additionally, the different strengths of ZYPREXA tablets contain the following excipients:

TABLET STRENGTH ADDITIONAL EXCIPIENTS
ZYPREXA 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets (coating) shellac, macrogol,
propylene glycol, polysorbate 80 and indigo carmine dye (E132), anhydrous ethanol,
isopropyl alcohol, butyl alcohol, ammonium hydroxide
ZYPREXA 15 mg tablets (coating) triacetin and indigo carmine dye (E132)
ZYPREXA 20 mg tablets (coating) macrogol and synthetic red iron oxide (E172)

Description of the appearance of ZYPREXA and contents of the pack
The 2.5 mg coated tablets of ZYPREXA are white, marked with the name “LILLY” and a numerical identification code "4112".
The 5 mg coated tablets of ZYPREXA are white, marked with the name “LILLY” and a numerical identification code "4115".
The 7.5 mg coated tablets of ZYPREXA are white, marked with the name “LILLY” and a numerical identification code "4116".
The 10 mg coated tablets of ZYPREXA are white, marked with the name “LILLY” and a numerical identification code "4117".
The 15 mg coated tablets of ZYPREXA are blue.
The 20 mg coated tablets of ZYPREXA 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.

Manufacturers:
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.

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

Package leaflet: Information for the user

ZYPREXA 10 mg powder for injectable solution

olanzapine
Please read this leaflet carefully before using 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.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

What ZYPREXA is and what it is used for
What you need to know before taking ZYPREXA
How to take ZYPREXA
Possible side effects
How to store ZYPREXA
Contents of the pack and other information

1. What ZYPREXA is and what it is used for

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

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

ZYPREXA Injectable is administered when rapid control of agitation and behavioral disturbance is required and treatment with ZYPREXA tablets is not appropriate. As soon as possible, your doctor will switch your therapy to 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 to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, facial swelling, lip swelling, or shortness of breath. If you have experienced this, inform 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 nurse before being given ZYPREXA Injection

Inform your doctor or nurse if, after the injection, you feel dizzy or faint. You may 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 unwanted effects.
Medicines of this type can cause unusual movements, especially of the face and tongue. If this occurs after you have been given ZYPREXA, speak to your doctor.
Very rarely, medicines of this type can cause a combination of fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness. If this occurs, contact your doctor immediately. You will not be given further injections.
Weight gain has been observed in patients taking ZYPREXA. You and your doctor should monitor your weight regularly. If necessary, consider seeking help from a dietitian or a diet program.
High levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking ZYPREXA. Your doctor should order blood tests to check your blood sugar and certain fat levels before you start taking ZYPREXA and regularly during treatment.
Inform your doctor if you or someone in your family has a history of blood clots, as medicines like this have been associated with blood clot formation.

If you have any of the following conditions, inform your doctor as soon as possible:

Stroke or transient ischaemic attack (temporary stroke symptoms) (TIA)
Parkinson’s disease
Prostate problems
Intestinal blockage (paralytic ileus)
Liver or kidney disease
Blood disorders
If you have recently had a heart attack, or have heart disease, including sick sinus syndrome, unstable angina, or low blood pressure
Diabetes
Seizures
If you know you may have excessive loss of salts due to severe and prolonged diarrhoea and vomiting (due to illness) or due to the use of diuretics (water tablets)

If you have dementia, you or your caregiver should inform your doctor if you have previously had a stroke or transient ischaemic attack.
As a routine precaution, if you are over 65 years old, have your blood pressure checked regularly by your doctor.

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

Other medicines and ZYPREXA
Taking ZYPREXA together with the following medicines may cause drowsiness: medicines used for anxiety or to help you sleep (tranquillisers, including benzodiazepines) and antidepressants.
During treatment with ZYPREXA, take other medicines only after approval by your doctor.
If you are being treated with ZYPREXA Injection, a simultaneous injection with a benzodiazepine is not recommended, as this may cause excessive drowsiness, serious effects on heart rate or breathing, and in very rare cases, may lead to death. If your doctor needs to administer a benzodiazepine by injection to treat your condition, at least one hour should pass after the ZYPREXA injection, and you must be closely monitored after the benzodiazepine injection.

Inform your doctor if you are taking or have recently taken any other medicines, including those without a prescription. In particular, inform your doctor if you are taking medicines for Parkinson’s disease.

ZYPREXA and alcohol
Do not drink any alcoholic beverages if you have been given ZYPREXA, as taking alcohol together with this medicine may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor 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 during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.

Driving and using machines
When taking ZYPREXA, 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 diagnosed you with an intolerance to certain sugars, contact your doctor 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 on a detachable section at the end of this leaflet.
Your doctor will decide how much ZYPREXA you need and for how long you should use it. The initial injection is generally 10 mg, but may be 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 as a powder. Your doctor or nurse will convert it into a solution.
ZYPREXA Injectable is for intramuscular use. The correct amount of solution will be injected into your muscle.
If you take more ZYPREXA than you should
Patients who have taken more ZYPREXA than prescribed have experienced the following symptoms: increased heart rate, agitation/aggression, speech difficulties, unusual movements (especially of the face or tongue), and reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, lethargy or drowsiness, slowed breathing, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Inform your doctor or nurse immediately.
Only a few doses of ZYPREXA Injectable are required. Your doctor will decide when you need a dose of ZYPREXA Injectable.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

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

unusual movements (a common side effect which may affect up to 1 in 10 patients), especially of the face or tongue;
blood clots in the veins (an uncommon side effect which may affect up to 1 in 100 patients), particularly in the lower limbs (symptoms include swelling, pain and redness of the leg), which may travel through the blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice 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 from the available data).

Common side effects (may affect up to 1 in 10 patients) with ZYPREXA Injectable
include slowed or faster heartbeat; drowsiness; decreased blood pressure; irritation at the injection site.
After injection, some people may feel dizzy or faint (with a slowed heartbeat), especially when standing up from a lying or sitting position. These symptoms usually resolve spontaneously, but if they do not, inform your doctor or nurse as soon as possible.
Uncommon side effects (may affect up to 1 in 100 patients) include slowed breathing; and changes in heart rhythm, which may be serious.
In addition, the following side effects have been observed after patients took ZYPREXA orally.
Further very common side effects (may affect more than 1 in 10 patients) include weight gain and increased levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with a slowed heartbeat), especially when standing up from a lying or sitting position. These effects usually resolve spontaneously, but if they do not, inform your doctor.
Further common side effects (may affect up to 1 in 10 patients) include increased levels of certain blood cells, increased circulating fats, and temporary increases in liver enzymes in the early stages of treatment; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; weakness; 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 patients) include hypersensitivity (e.g. swelling of the mouth and throat, itching, rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in blood and urine) or coma; epileptic seizures, usually occurring in patients with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slowed heartbeat; sensitivity to sunlight; nosebleeds; abdominal swelling; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduced menstrual cycles; and breast changes in males and females, such as abnormal growth or abnormal milk secretion.
Rare side effects (may affect up to 1 in 1,000 patients) include decreased body temperature; changes in heart rhythm; unexplained sudden 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 muscle pains; and prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS initially presents with flu-like symptoms, a rash on the face that subsequently becomes widespread, high body temperature, swollen lymph nodes, increased liver enzyme levels in blood tests, and increased levels of a type of white blood cell (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and walking disturbances. In this particular group of patients, some fatal cases have been reported.
In patients with Parkinson's disease, ZYPREXA may worsen symptoms.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via 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 stated on the carton.
Do not store above 25°C. Store in the original packaging to protect from light.
After ZYPREXA Injectable has been prepared in solution, use within one hour. Do not freeze after reconstitution.
Discard any unused portion.

6. OTHER INFORMATION

What ZYPREXA Injectable contains

The active substance is olanzapine. Each vial contains 10 mg of active substance.
The excipients are monohydrate lactose, 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. Your doctor or nurse will reconstitute it into a solution which will be administered to you by injection.
ZYPREXA Injectable is available in packs containing 1 or 10 vials. Not all pack sizes may be marketed.
Marketing Authorization Holder:
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 separation of information for healthcare professionals) INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS

Reconstitution and Administration of ZYPREXA
Reconstitute ZYPREXA Powder for Injectable Solution only with Water for Injections.
ZYPREXA Powder for Injectable Solution must not be mixed in the same syringe with any commercially available medicines due to incompatibility. Examples include the following.
Injectable olanzapine must not be added to a syringe containing injectable haloperidol, as the resulting low pH has been shown to degrade olanzapine over time.
Injectable olanzapine must not be added to a syringe nor used concomitantly with benzodiazepines.
Powder for Injectable Solution
Reconstitute ZYPREXA Powder for Injectable Solution using standard aseptic techniques for reconstitution of parenteral products.

Draw up 2.1 ml of Water for Injections into a sterile syringe. Inject it into a vial of ZYPREXA Powder for Injectable Solution.
Rotate the vial until the powder is completely dissolved, yielding a yellow solution. The vial contains 11.0 mg of olanzapine, equivalent to a 5 mg/ml solution. When 2.0 ml of solution are withdrawn, 1 mg of olanzapine remains in the vial and syringe, thus allowing administration of 10 mg of olanzapine.
The following table provides the volumes of solution to be injected to administer various doses of olanzapine:

Dose (mg)	Volume to be injected (ml)
10	2.0
7.5	1.5
5	1.0
2.5	0.5

Administer the solution by intramuscular route. Do not administer by intravenous or subcutaneous route.
Dispose of the syringe and any unused solution according to appropriate clinical procedures.
Use the solution immediately within 1 hour after reconstitution. Do not store above 25°C. Do not freeze.

Parenteral medicinal products should be inspected visually for particulate matter prior to administration.