Zyprexa

Main information

  • Trade name:
  • Zyprexa Tablet/ Zyprexa Zydis Orodispersible Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Zyprexa Tablet/ Zyprexa Zydis Orodispersible Tablet
    Malaysia
  • Language:
  • English

Other information

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL08061564, MAL08061565, MAL04125490, MAL04125491
  • Last update:
  • 28-05-2018

Patient Information leaflet

ZYPREXA TABLET /ZYPREXA ZYDIS

ORODISPERSIBLE TABLET

Olanzapine (5 mg, 10 mg)

1

Consumer Medication Information Leaflet (RiMUP)

What is in this leaflet

What Zyprexa is used for

How Zyprexa works

Before you use Zyprexa

How to use Zyprexa

While you are using it

Side effects

Storage and Disposal of Zyprexa

Product Description

Manufacturer and Product

Registration Holder

Date of revision

What Zyprexa

is used for

Zyprexa is used to treat the following

conditions:

Schizophrenia, a mental 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withdrawn.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.

Short-term treatment of acute manic

episode associated with Bipolar

Disorder.

Zyprexa has been shown to prevent

recurrence of manic, depressive or

mixed episodes in Bipolar Disorder.

How Zyprexa works

Zyprexa is an antipsychotic, antimanic

and mood stabilising agent. Zyprexa

contains the active ingredient

olanzapine. Zyprexa belongs to a

group of medicines called

antipsychotics. It helps to correct

chemical imbalances in the brain

which may cause mental illness.

Before you use Zyprexa

- When you must not use it

If you are allergic (hypersensitive)

to olanzapine or any of the other

ingredients of this medicine (see

section

Product description

). 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 Parkinson’s disease.

If you have been previously

diagnosed with eye problems

such as certain kinds of

glaucoma (increased pressure in

the eye).

The use if Zyprexa in elderly

with dementia (symptoms that

may include memory loss and

difficulties with thinking,

problem-solving or language) is

not recommended as it may have

serious side effects.

- Before you start to use it

Talk to your doctor or pharmacist

before you take Zyprexa.

High blood sugar and high levels of

fat (triglycerides and cholesterol)

have been seen in individuals taking

Zyprexa. Your doctor should do

blood tests to check blood sugar and

certain fat levels before you start

taking Zyprexa and regularly during

treatment.

Tell the doctor if you or someone

else in your family has 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

illnesses tell your doctor as soon as

possible:

Stroke or “mini” stroke (temporary

symptoms of stroke)

Prostate enlargement

A blocked intestine (Paralytic ileus)

Liver or kidney disease

Blood disorders

Heart disease

Diabetes

Seizures

Pregnancy and lactation

If you are pregnant or breast-feeding,

think you may be pregnant or are

planning to have a baby, ask your

doctor for advice before taking this

medicine. You should not be given

this medicine when breast-feeding, as

small amounts of Zyprexa can pass

into breast milk.

The following symptoms may occur in

newborn babies, of mothers that have

used Zyprexa in the last trimester (last

three months of their pregnancy):

shaking, muscle stiffness and/or

weakness, sleepiness, agitation,

breathing problems, and difficulty in

feeding. If your baby develops any of

these symptoms you may need to

contact your doctor.

Taking other medicines

Only take other medicines while you

are on Zyprexa if your doctor tells you

that you can.

Tell your doctor if you are taking,

have recently taken or might take any

other medicines.

In particular, tell your doctor if you

are taking:

medicines for Parkinson’s disease

carbamazepine (an anti-epileptic

and mood stabiliser), fluvoxamine

(an antidepressant), charcoal or

ciprofloxacin (an antibiotic) - it may

be necessary to change your

Zyprexa dose.

Do not drink any alcohol if you have

been given ZYPREXA as together

with alcohol it may make you feel

drowsy.

Other medicines not listed above may

also interact with Zyprexa. Your

doctor and pharmacist have more

information on medicines to be careful

with or avoid while taking Zyprexa.

How to use Zyprexa

How much to use

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 mg

and 20 mg. Consult your doctor if

your symptoms return but do not stop

taking Zyprexa unless your doctor tells

you to.

Children and adolescents

: Zyprexa is

not for children and adolescents under

18 years.

When to use it

You should take your Zyprexa tablets

normally once a day following the

advice of your doctor or pharmacist.

Try to take your tablets at the same

time each day. It does not matter

2

Consumer Medication Information Leaflet (RiMUP)

whether you take them with or without

food. Zyprexa tablets and Zyprexa

Zydis orodispersible tablets are for

oral use.

Zyprexa Tablet:

Zyprexa tablets should be swallowed

whole with a glass of water.

Zyprexa Zydis Orodispersible Tablet:

Zyprexa Zydis orodispersible tablets

break easily, so you should handle the

tablets carefully. Do not handle the

tablets with wet hands as the tablets

may break up.

Hold the blister strip at the edges

and separate one blister cell from

the rest of the strip by gently

tearing along the perforations

around it.

Carefully peel off the backing.

Gently push the tablet out.

Put the tablet in your mouth. It

will dissolve directly in your

mouth, so that it can be easily

swallowed.

You can also place the tablet in a full

glass or cup of water, orange juice,

apple juice, milk or coffee, and stir.

With some drinks, the mixture may

change colour and possibly become

cloudy. Drink it straight away.

How long to use it

Continue taking Zyprexa

for as long as

your doctor recommends.

If you forget to use it

Take your tablets as soon as you

remember. Do not take two doses in

one day.

If you use too much (overdose)

Individuals 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, high fever,

faster breathing, sweating, muscle

stiffness, 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 if you experience any of

the above symptoms. Show the doctor

your pack of tablets.

While you are using it

Things you must do

Take your medicine exactly as your

doctor has told you.

Tell all the doctors, dentists and

pharmacists treating you that you are

taking Zyprexa.

Tell your doctor immediately if you

become pregnant while taking this

medication

.

Things you must not do

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 medicine, ask your

doctor or pharmacist.

Things to be careful of

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.

Zyprexa tablet contains lactose

If you have been told by your doctor

that you have an intolerance to some

sugar, contact your doctor before

taking this medicinal product.

Zyprexa Zydis orodispersible tablet

contains aspartame, mannitol and

sodium methyl parahydroxybenzoate

and sodium propyl

parahydroxybenzoate

People who cannot take phenylalanine

should note that Zyprexa Zydis

contains aspartame, which is a source

of phenylalanine. May be harmful for

people with phenylketonuria.

People who cannot take mannitol

should note that Zyprexa Zydis

contains mannitol.

Zyprexa Zydis contains methyl

parahydroxybenzoate and sodium

propyl parahydroxybenzoate, which

may cause an allergic reaction in some

people. An allergic reaction may be

recognized as a rash, itching or

shortness or breath. This may occur

immediately or some time after you

take Zyprexa Zydis.

Side effects

Weight gain

Weight gain has been seen in

individuals taking Zyprexa. You and

your doctor should check your weight

regularly. Consider referral to a

dietician or help with a diet plan if

necessary.

Elderly

As a routine precaution, if you are

over 65 years your blood pressure may

be monitored by your doctor.

Like all medicines, this medicine can

cause side effects, although not

everybody gets them.

Tell your doctor immediately if you

have:

unusual movement (a common

side effect that may affect up to 1

in 10 people) mainly of the face

or tongue;

blood clots in the veins (an

uncommon side effect that may

affect up to 1 in 100 people)

especially in the legs (symptoms

include swelling, pain, and redness

in the leg), which may travel

through blood vessels to the lungs

causing chest pain and difficulty in

breathing. If you notice any of these

symptoms seek medical advice

immediately;

a combination of fever, faster

breathing, sweating, muscle

stiffness and drowsiness or

sleepiness (rare side effects [may

affect up to 1 in 1000 people]).

Very common side effects (may affect

more than 1 in 10 people) include

weight gain; sleepiness; and increases

in levels of prolactin in the blood. 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.

3

Consumer Medication Information Leaflet (RiMUP)

Common side effects (may affect up to 1

in 10 people) include changes in the

levels of some blood cells, circulating

fats and early in treatment, temporary

increases in liver enzymes; increases in

the level of sugars in the blood and

urine; increases in levels of uric acid and

creatine phosphokinase in the blood;

feeling more hungry; dizziness;

restlessness; tremor; 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

dysfunctions such as decreased libido

(sexual desire) in males and females or

erectile dysfunction (inability to get and

maintain an erection) in males.

Uncommon side effects (may affect up

to 1 in 100 people) include

hypersensitivity (e.g. swelling in the

mouth and throat, itching, rash);

diabetes or the worsening of diabetes,

occasionally associated with

ketoacidosis (build up of acid in the

blood) or coma; seizures, usually

associated with a history of seizures

(epilepsy); muscle stiffness or spasms

(including eye movements); restless legs

syndrome; problems with speech; slow

heart rate; sensitivity to sunlight;

bleeding from the nose; abdominal

distension; memory loss or

forgetfulness; urinary incontinence; lack

of ability to urinate; hair loss; absence in

menstrual periods; and changes in

breasts in males and females such as an

abnormal production of breast milk or

abnormal growth.

Rare side effects (may affect up to 1 in

1000 people) include lowering of

normal body temperature; abnormal

rhythms of the heart; sudden death;

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; and

prolonged and/or painful erection.

Very rare side effects include serious

allergic reactions such as Drug Reaction

with Eosinophilia and Systemic

Symptoms (DRESS). DRESS appears

initially as flu-like symptoms with a

rash on the face and then with an

extended rash, high temperature,

enlarged lymph nodes, increased levels

of liver enzymes seen on blood tests and

an increase in a type of white blood cells

(eosinophilia).

While taking olanzapine, elderly with

dementia may suffer from stroke,

pneumonia (infection that leads to

inflammation of the lungs), urinary

incontinence, falls, extreme tiredness,

visual hallucinations (seeing things

that are not real), a rise in body

temperature, redness of the skin and

have trouble walking. Some fatal cases

have been reported in this particular

group of individuals.

In people with Parkinson's disease

Zyprexa may worsen the symptoms.

Other side effects not listed above may

occur in some people. Tell your doctor

or pharmacist if you notice anything

else that is making you feel unwell,

even if it is not on this list.

You may report any side effects or

adverse drug reactions directly to the

National Centre for Adverse Drug

Reaction Monitoring by calling Tel:

03-78835550, or visiting the website

npra.moh.gov.my (Public

Reporting Medicinal Problems / Side

Effects / AEFI / Vaccine Safety).

Storage and disposal of

Zyprexa

Storage

Keep out of the reach and sight of

children.

Do not use this medicine after the

expiry date, which is stated on the

carton.

Zyprexa Tablet

Do not store above 30

Zyprexa Zydis Orodispersible Tablet

Store below 30

C in the original

package in order to protect from light

and moisture.

Disposal

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.

Product Description

What it looks like

Zyprexa Tablet

Zyprexa 5 mg Tablets

are round,

white, coated tablets imprinted with

"LILLY" and a numeric identicode

“4115”.

ZYPREXA 10mg Tablets

are round,

white, coated tablets imprinted with

"LILLY" and a numeric identicode

“4117”.

Zyprexa Zydis Orodispersible

Tablet

Zyprexa Zydis 5mg and 10mg

Orodispersible Tablet

is a yellow,

round, freeze dried, rapid-

dispersing preparation to be

placed in the mouth or

alternatively to be dispersed in

water or other suitable beverages

for use.

Not all formulations are marketed.

Ingredients

Active ingredient

Olanzapine

Inactive ingredients

Zyprexa Tablet

Tablet core

Lactose monohydrate

Hydroxypropylcellulose

Crospovidone

Microcrystalline cellulose

Magnesium stearate

Tablet coat

Hypromellose

Color mixture white (hypromellose,

titanium dioxide)

Carnauba wax

Edible blue ink (shellac, macrogol,

indigo carmine E132)

Zyprexa Zydis Orodispersible Tablet

Gelatin

Mannitol

Aspartame

Sodium methyl

parahydroxybenzoate

Sodium propyl

parahydroxybenzoate

MAL number(s)

Zyprexa Tablet 5 mg

MAL08061564AZ

Zyprexa Tablet 10 mg

MAL08061565AZ

Zyprexa Zydis 5mg Orodispersible

Tablet

MAL04125490ACRZ

4

Consumer Medication Information Leaflet (RiMUP)

Zyprexa Zydis 10mg Orodispersible

Tablet

MAL04125491ACRZ

Manufacturer

Zyprexa Tablet 5mg

Zyprexa Tablet 10mg

Lilly Spain S.A

Avda Industria 30

28108 Alcobendas

Madrid, Spain

Zyprexa

Zydis

5mg

Orodispersible

Tablet

Zyprexa

Zydis

10mg

Orodispersible

Tablet

Catalent UK Swindon Zydis Limited

Frankland Road, Blagrove, Swindon

Wiltshire SN5 8RU, United Kingdom

Product Registration Holder

Elil Lilly (Malaysia) Sdn Bhd

Level 7, Menara OBYU,

No 4, Jalan PJU 8/8A,

Damansara Perdana,

47820, Petaling Jaya,

Selangor, Malaysia.

Date of revision

01/11/2017

Serial Number

NPRA(R4/1)311017/00300