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OLANZAPINE GENTIAN GENERICS 15 MG ORODISPERSIBLE TABLETS

Active substance(s): OLANZAPINE

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Package leaflet: Information for the user
/…/ 5 mg orodispersible tablet
/…/ 10 mg orodispersible tablet
/…/ 15 mg orodispersible tablet
/…/ 20 mg orodispersible tablet

Olanzapine
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
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Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects talk to your doctor, pharmacist or nurse .This includes any side effects not
listed in this leaflet. See section 4.

What is in this leaflet:
1.
What /…/ is and what it is used for
2.
What you need to know before you take /…/
3.
How to take /…/
4.
Possible side effects
5.
How to store /…/
6.
Contents of this pack and other information

1.

What /…/ is and what it is used for

/.../ contains the active substance olanzapine. /.../ belongs to a group of medicines called antipsychotics and is
used to treat the following conditions:
- Schizophrenia, 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mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.
- Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.

/.../ has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic
episode has responded to olanzapine treatment.
2.
What you need to know before you take /…/
Do not take /…/
if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6) 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).
Warnings and precautions
Talk to your doctor pharmacist or nurse before taking /…/
The use of /.../ in elderly patients with dementia is not recommended as it may have serious side
effects.
Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens
after you have been given /.../, tell your doctor.
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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.
Weight gain has been seen in patients taking /.../. You and your doctor should check your weight
regularly. Consider referral to a dietician or help with a diet plan if necessary.
High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients
taking /.../. Your doctor should do blood tests to check blood sugar and certain fat levels before you
start taking /.../ and regularly during treatment.
If you or someone else in your family has a history of blood clots, as medicines like these have been
associated with 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)
- Parkinson’s disease
- Prostate problems
- A blocked intestine (Paralytic ileus)
- Liver or kidney disease
- Blood disorders
- Heart disease
- Diabetes
- Seizures
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.
Children and adolescents
/…/ is not for patients who are under 18 years.
Other medicines and/…/
Only take other medicines while you are on /.../ if your doctor tells you that you can. You might feel drowsy
if /.../ is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep
(tranquillisers).
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) or ciprofloxacin
(an antibiotic) - it may be necessary to change your /…/ dose.
/…/ with alcohol
Do not drink any alcohol if you have been given /.../ as together with alcohol it may make you feel drowsy.
Pregnancy, breast-feeding and fertility
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 /…/ can pass into breast milk.
The following symptoms may occur in newborn babies, of mothers that have used /.../ 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.
Driving and using machines
There is a risk of feeling drowsy when you are given /.../. If this happens do not drive or operate any tools or
machines. Tell your doctor.
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/…/ contain aspartame
Patients who cannot take phenylalanine should note that /.../ contains aspartame, which is a source of
phenylalanine. May be harmful for people with phenylketonuria.

3.

How to take /…/

Always take /.../ 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 /.../ tablets to take and how long you should continue to take them. The
daily dose of /.../ is between 5 and 20 mg. Consult your doctor if your symptoms return but do not stop
taking /.../ unless your doctor tells you to.
You should take your /.../ 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. /.../ orodispersible
tablets are for oral use.
/…/ tablets break easily, so you should handle the tablets carefully. Do not handle the tablets with wet hands
as the tablets may break up.
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 or milk and stir. Drink it
straight away.
If you take more /…/ than you should
Patients who have taken more /.../ 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 if you experience any of the above symptoms. Show the
doctor your pack of tablets.
If you forget to take /…/
Take your tablets as soon as you remember. Do not take a double dose to make up for a forgotten tablet.
If you stop taking /…/
Do not stop taking your tablets just because you feel better. It is important that you carry on taking /…/ for as
long as your doctor tells you.
If you suddenly stop taking /…/, 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.

4.

Possible side effects

Like all medicines, /.../ 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

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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 (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; 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.
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; 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 dysfunctions 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 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; seizures, usually associated with a history of seizures (epilepsy);
muscle stiffness or spasms (including eye movements); spasms of the muscle of the eye causing rolling
movement of the eye; 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 or decrease 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 unexplained 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
in blood tests and an increase in a type of white blood cell (eosinophilia).
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 /.../ may worsen the symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store /…/

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 carton.
Store in the original package in order to protect from light and moisture.
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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What /…/ contains
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The active substance is olanzapine. Each /.../ orodispersible tablet contains either 5 mg, 10 mg, 15 mg
or 20 mg of the active substance. The exact amount is shown on your /.../ pack.
The other ingredients are magnesium stearate, L-Methionine, silica colloidal anhydrous,
hydroxypropyl cellulose (low substituted), crospovidone (Type B), aspartame, microcrystalline
cellulose, guar gum, magnesium carbonate heavy and orange flavour.

What /…/ looks like and contents of the pack
/…/ 5 mg orodispersible tablet is a round, biconvex, yellow tablet, 6 mm in diameter and marked with “O”
on one side.
/…/ 10 mg orodispersible tablet is a round biconvex, yellow tablet 8 mm in diameter and marked with “O1”
on one side.
/…/ 15 mg orodispersible tablet is a round, biconvex, yellow tablet, 9 mm in diameter and marked with “O2”
on one side.
/…/ 20 mg orodispersible tablet is a round, biconvex, yellow tablet, 10 mm in diameter and marked with
“O3” on one side.
Pack sizes:
Push-through blister packs: 28 orodispersible tablets.
Peel-to open blister packs: 28 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
<[To be completed nationally]>
{Name and address}
<{tel}>
<{fax}>
<{e-mail}>
Manufacturer
<[To be completed nationally]>
Actavis hf.
Reykjavíkurvegi 78
IS-220 Hafnarfjörður
Iceland
Actavis Ltd.
B16, Bulebel Industrial Estate
Zejtun ZTN 08
Malta

<{Name of the Member State}> <{Name of the medicinal product}>
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<{Name of the Member State}> <{Name of the medicinal product}>

This leaflet was last approved in {MM/YYYY}.
<[To be completed nationally]>



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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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