OLANZAPINA 2.5 mg Film-coated tablets

Зміст інструкції

1. Olanzapina Teva 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
   1. What is Olanzapina Teva and what is it used for
   2. What you need to know before taking Olanzapina Teva
   3. How to take Olanzapina Teva
   4. Possible side effects
   5. How to store Olanzapina Teva
   6. Contents of the pack and other information
2. Olanzapina Teva 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets
   1. What is Olanzapina Teva and what is it used for
   2. What you need to know before you take Olanzapina Teva
   3. How to take Olanzapina Teva
   4. Possible side effects
   5. How to store Olanzapina Teva
   6. Package contents and other information

Olanzapina Teva 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

olanzapina

Read this leaflet carefully before you start taking 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 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 Olanzapina Teva is and what it is used for
• 2. What you need to know before you take Olanzapina Teva
• 3. How to take Olanzapina Teva
• 4. Possible side effects
• 5. How to store Olanzapina Teva
• 6. Contents of the pack and other information

1. What is Olanzapina Teva and what is it used for

Olanzapina Teva contains the active ingredient olanzapine. Olanzapina Teva 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 experiencing things that do not exist, false beliefs, unjustified suspicion and social withdrawal. People with this disease may also feel depressed, anxious or tense.
• Moderate to severe episodes of mania, a condition characterized by symptoms of excitement or euphoria.

Olanzapina Teva has been shown to be able to prevent the recurrence of these symptoms in
patients with bipolar disorder in whom the manic episode responded to treatment with olanzapine.

2. What you need to know before taking Olanzapina Teva

Do not take Olanzapina Teva

• if you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest with skin rash, itching, facial swelling, 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
Talk to your doctor or pharmacist before taking Olanzapina Teva.

• The use of Olanzapina Teva 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 Olanzapina Teva, 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, see your doctor immediately.
• An increase in weight has been observed in patients taking Olanzapina Teva. Your doctor will therefore, with your collaboration, regularly check your body weight. If necessary, consider consulting a dietitian or getting help with a diet program.
• High levels of sugars and fats have been reported in patients taking Olanzapina Teva (triglycerides and cholesterol). Your doctor will therefore arrange for you to have blood tests to check your sugar and fat levels before you start taking Olanzapina Teva and then regularly during treatment.
• Tell your doctor if you or a family member 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 conditions, tell your doctor as soon as possible:

• Stroke or “mini” stroke (transient stroke symptoms)
• Parkinson's disease
• Prostate problems
• Bowel obstruction (paralytic ileus)
• Liver or kidney disease
• Blood diseases
• Heart disease
• Diabetes
• Epileptic seizures
• If you know you may have excessive salt loss 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
Olanzapina Teva is not indicated in patients under the age of 18 years.

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

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

Olanzapina Teva with alcohol
Do not drink any alcohol while being treated with Olanzapina Teva as the simultaneous
consumption of alcohol can cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
You should not take this medicine during breastfeeding, as small amounts of
Olanzapina Teva can pass into breast milk.
The following symptoms may occur in newborns of mothers who have used Olanzapina Teva
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 Olanzapina Teva there is a risk that you may experience drowsiness. If this
happens, do not drive or operate tools or machinery. Tell your doctor.

Olanzapina Teva 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 Olanzapina Teva

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 Olanzapina Teva tablets you need to take and for how long you need to
continue taking them. The dose of Olanzapina Teva 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 Olanzapina Teva unless your doctor tells you to.
You should take Olanzapina Teva 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. Olanzapina Teva
film-coated tablets are for oral use.
Swallow Olanzapina Teva tablets whole with water.

If you take more Olanzapina Teva than you should
Patients who have taken more Olanzapina Teva than they should have, have experienced 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, slowed breathing rate, reduced cough reflex, high or low blood pressure, changes in heart rhythm.
Contact your doctor or hospital immediately if you experience any of the symptoms described above. Show
your doctor your pack of tablets.

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

If you stop taking Olanzapina Teva
Do not stop taking the tablets as soon as you start to feel better. It is important that you continue
treatment with Olanzapina Teva for as long as your doctor deems necessary.
If you suddenly stop taking Olanzapina Teva, 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 doubts 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 gets them.
Inform your doctor immediately if any of the following occur:

• unusual movements (a common side effect that may occur in up to 1 in
• 10 people), mainly of the face or tongue;
• blood clots in the veins (an uncommon side effect that may occur in up to 1 in 100 people), especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention;
• a combination of fever, rapid breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be determined based on available data).

Very common side effects (may affect more than 1 in 10 people) include
weight gain; drowsiness; and increases in prolactin levels in the blood. In the early stages of
treatment, some people may experience a feeling of dizziness or fainting (with a
slowing of the heartbeat), 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 and urine sugar levels; increases
in uric acid and creatine phosphokinase levels in the blood; feeling 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; problems with speech; 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 men and women, such as abnormal growth or abnormal milk secretion.
Rare side effects (may affect up to 1 in 1,000 people) include: decrease
in body temperature; changes in heart rhythm; unexplained sudden 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 is initially characterized by flu-like symptoms,
such as a rash on the face and then spreading, high temperature, enlarged lymph nodes, high levels of liver enzymes in blood tests and an increase in a type of white blood cells (eosinophilia).
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, gait disturbances. Some fatal cases have been reported in this particular
group of patients.
In patients with Parkinson's disease Olanzapina Teva may lead to a worsening of symptoms.

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

5. How to store Olanzapina Teva

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 after “EXP.”. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Keep the product in the original packaging to
protect it from light.
Do not dispose of any medicine in 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 Olanzapina Teva contains::

• The active substance is olanzapine. Each film-coated tablet of Olanzapina Teva 2.5 mg contains 2.5 mg of active substance. Each film-coated tablet of Olanzapina Teva 5 mg contains 5 mg of active substance. Each film-coated tablet of Olanzapina Teva 7.5 mg contains 7.5 mg of active substance. Each film-coated tablet of Olanzapina Teva 10 mg contains 10 mg of active substance. Each film-coated tablet of Olanzapina Teva 15 mg contains 15 mg of active substance. Each film-coated tablet of Olanzapina Teva 20 mg contains 20 mg of active substance.
• Other components are: Tablet core:lactose monohydrate, hydroxypropylcellulose, crospovidone (type A), anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate. Tablet coating:hypromellose, polydextrose, glycerol triacetate, macrogol 8000, titanium dioxide (E171). In addition, the 15 mg tablets contain indigo carmine (E132) and the 20 mg tablets contain red iron oxide (E172).

Description of the appearance of Olanzapina Teva and contents of the pack
Olanzapina Teva 2.5 mg film-coated tablet is a film-coated tablet, round, of
white color, biconvex, with imprinted “OL 2.5” on one side and smooth on the other.
Olanzapina Teva 5 mg film-coated tablet is a film-coated tablet, round, of
white color, biconvex, with imprinted “OL 5” on one side and smooth on the other.
Olanzapina Teva 7.5 mg film-coated tablet is a film-coated tablet, round, of
white color, biconvex, with imprinted “OL 7.5” on one side and smooth on the other.
Olanzapina Teva 10 mg film-coated tablet is a film-coated tablet, round, of
white color, biconvex, with imprinted “OL 10” on one side and smooth on the other.
Olanzapina Teva 15 mg film-coated tablet is a film-coated tablet, oval, of
blue color, biconvex, with imprinted “OL 15” on one side and smooth on the other.
Olanzapina Teva 20 mg film-coated tablet is a film-coated tablet, oval, of
pink color, biconvex, with imprinted “OL 20” on one side and smooth on the other.
Olanzapina Teva 2.5 mg film-coated tablets are available in packs of 28, 30, 35, 56,
70 or 98 film-coated tablets.
Olanzapina Teva 5 mg film-coated tablets are available in packs of 28, 28 x 1, 30,
30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 or 98 x 1 film-coated tablets.
Olanzapina Teva 7.5 mg film-coated tablets are available in packs of 28, 28 x 1, 30,
30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x 1 film-coated tablets.
Olanzapina Teva 10 mg film-coated tablets are available in packs of 7, 7 x 1, 28,
28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x 1 film-coated
tablets.
Olanzapina Teva 15 mg film-coated tablets are available in packs of 28, 30, 35, 50,
56, 70 or 98 film-coated tablets.
Olanzapina Teva 20 mg film-coated tablets are available in packs of 28, 30, 35, 56,
70 or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands

Manufacturer
Teva Pharmaceutical Works Co. Ltd
Pallagi út 13
4042 Debrecen
Hungary
For further information on this medicine, contact the local representative of the Marketing Authorisation
Holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Тел: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
SanoSwiss UAB
Litauen
Tlf: +370 70001320

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Specifar A.B.E.E.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

EspañaPolska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800
Teva Pharma, S.L.U.
Tel: +34 913873280

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu.

Olanzapina Teva 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible 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 Olanzapina Teva is and what it is used for
• 2. What you need to know before you take Olanzapina Teva
• 3. How to take Olanzapina Teva
• 4. Possible side effects
• 5. How to store Olanzapina Teva
• 6. Contents of the pack and other information

1. What is Olanzapina Teva and what is it used for

Olanzapina Teva contains the active ingredient olanzapine. Olanzapina Teva 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 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.

Olanzapina Teva has been shown to be able to prevent the recurrence of these symptoms in
patients with bipolar disorder in whom the manic episode responded to treatment with olanzapine.

2. What you need to know before you take Olanzapina Teva

Do not take Olanzapina Teva

• if you are allergic to olanzapine or to 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
Talk to your doctor or pharmacist before taking Olanzapina Teva.

• The use of Olanzapina Teva 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 Olanzapina Teva, 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.
• An increase in weight has been observed in patients taking Olanzapina Teva. Your doctor will therefore, with your cooperation, regularly check your body weight. If necessary, consider consulting a dietitian or getting help with a diet program.
• Elevated levels of sugars and fats in the blood (triglycerides and cholesterol) have been reported in patients taking Olanzapina Teva. Your doctor will therefore arrange for you to have blood tests to check your sugar and some fat levels in the blood before you start taking Olanzapina Teva and then regularly during treatment.
• Tell your doctor if you or a family member 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 conditions, tell your doctor as soon as possible:

• Stroke or “mini” stroke (transient symptoms of stroke)
• Parkinson’s disease
• Prostate problems
• Bowel obstruction (paralytic ileus)
• Liver or kidney disease
• Blood diseases
• Heart disease
• Diabetes
• Epileptic seizures
• If you know you may have excessive salt loss 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 a transient ischemic attack in the past.
As a routine precaution, if you are over 65 years old, have your
blood pressure checked periodically by your doctor.

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

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

• medicines for Parkinson’s disease.
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - because it may be necessary to change your dose of Olanzapina Teva.

Olanzapina Teva with alcohol
Do not drink any alcohol during treatment with Olanzapina Teva as the simultaneous
consumption of alcohol may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
You should not take this medicine during breastfeeding, as small amounts of
Olanzapina Teva can pass into breast milk.
The following symptoms may occur in newborns of mothers who have used Olanzapina Teva
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 Olanzapina Teva there is a risk that you may experience drowsiness. If this
happens, do not drive or operate tools or machinery. Tell your doctor.

Olanzapina Teva contains lactose, sucrose and aspartame
This medicine also contains lactose and sucrose. If your doctor has told you that you
have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains 2.25 mg/4.5 mg/6.75 mg/9 mg of aspartame in each dispersible tablet
of 5 mg/10 mg/15 mg/20 mg. Aspartame is a source of phenylalanine. It may be
harmful to you if you suffer from phenylketonuria, a rare genetic disorder that causes a buildup of phenylalanine
because the body cannot dispose of it properly.

3. How to take Olanzapina Teva

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 Olanzapina Teva tablets you need to take and for how long you need to
continue taking them. The dose of Olanzapina Teva 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 Olanzapina Teva unless your doctor tells you to.
You must take Olanzapina Teva 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. Olanzapina Teva
orodispersible tablets are for oral use.
Olanzapina Teva tablets break easily, so be careful when taking the tablet in your hand. Do not touch the
tablets with wet hands as the tablets may break. Place the tablet in your mouth. It will dissolve directly in your
mouth, so that it can be easily swallowed.
You can also put the tablet in a glass or cup filled with water, orange juice, apple juice, milk or coffee,
stirring everything. With some drinks, the mixture may change color and become somewhat opaque. Drink it
immediately.

If you take more Olanzapina Teva than you should
Patients who have taken more Olanzapina Teva than they should have, have experienced 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, slowed breathing rate, reduced cough reflex, high or low blood pressure, changes in heart rhythm.
Contact your doctor or hospital immediately if you experience any of the symptoms described above. Show your
doctor your pack of tablets.

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

If you stop taking Olanzapina Teva
Do not stop taking the tablets as soon as you start to feel better. It is important that you continue
treatment with Olanzapina Teva for as long as your doctor deems necessary.
If you suddenly stop taking Olanzapina Teva, symptoms such as sweating, inability to sleep, tremors, 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.
Inform your doctor immediately if any of the following occur:

• unusual movements (a common side effect that can occur in up to 1 in 10 people)
• primarily of the face or tongue;
• blood clots in the veins (an uncommon side effect that can occur in up to 1 in 100 people), especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention;
• a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this side effect cannot be determined based on available data).

Very common side effects (may affect more than 1 in 10 people) include weight gain; drowsiness; and increased prolactin levels in the blood. In the early stages of treatment, some people may experience a feeling of dizziness or fainting (with a slowing of the heartbeat), especially when getting up from a lying or sitting position.
These effects usually resolve 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 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; 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 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; slowing of the heartbeat; sensitivity to sunlight; nosebleeds; abdominal bloating; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or cessation of menstrual cycles; and changes affecting 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 patients) 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; prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS is initially characterized by flu-like symptoms, such as a rash on the face and then spreading, high temperature, enlarged lymph nodes, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cells (eosinophilia).
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, gait disturbances. Some fatal cases have been reported in this particular group of patients.
In patients with Parkinson's disease Olanzapina Teva may lead to a worsening of symptoms.

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

5. How to store Olanzapina Teva

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 after “EXP.”. The
expiry date refers to the last day of that month.
Store the product in the original packaging to protect it from light.
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. Package contents and other information

What Olanzapina Teva contains:

• The active ingredient is olanzapine. Each Olanzapina Teva 5 mg orodispersible tablet contains 5 mg of active ingredient. Each Olanzapina Teva 10 mg orodispersible tablet contains 10 mg of active ingredient. Each Olanzapina Teva 15 mg orodispersible tablet contains 15 mg of active ingredient. Each Olanzapina Teva 20 mg orodispersible tablet contains 20 mg of active ingredient.
• The other ingredients are mannitol, aspartame (E951), magnesium stearate, crospovidone type B, lactose monohydrate, hydroxypropylcellulose, lemon flavour [aromatic preparation, maltodextrin, sucrose, gum arabic (E414), glycerol triacetate (E1518) and alpha-tocopherol (E307)].

Description of the appearance of Olanzapina Teva and package contents
Orodispersible tablet is a technical term to indicate a tablet that dissolves
directly in the mouth, so that it can be swallowed easily.
Olanzapina Teva 5 mg orodispersible tablet is a round tablet, yellow in colour,
biconvex, with a diameter of 8 mm.
Olanzapina Teva 10 mg orodispersible tablet is a round tablet, yellow in colour,
biconvex, with a diameter of 10 mm.
Olanzapina Teva 15 mg orodispersible tablet is a round tablet, yellow in colour,
biconvex, with a diameter of 11 mm.
Olanzapina Teva 20 mg orodispersible tablet is a round tablet, yellow in colour,
biconvex, with a diameter of 12 mm.
Olanzapina Teva 5 mg, 10 mg and 15 mg orodispersible tablets are available in packs of 28,
30, 35, 50, 56, 70 or 98 tablets.
Olanzapina Teva 20 mg orodispersible tablets are available in packs of 28, 30, 35, 56, 70
or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands

Manufacturer
Teva Pharmaceutical Works Co. Ltd
Pallagi út 13
4042, Debrecen
Hungary
TEVA PHARMA S.L.U.
Poligono Industrial Malpica, c/C, no. 4

• 50.016 Zaragoza Spain

Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Тел: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
SanoSwiss UAB
Lithuania
Tlf: +370 70001320

Malta
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Specifar A.B.E.E.
Tel: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

EspañaPolska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800
Teva Pharma, S.L.U.
Tel: +34 913873280

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
Specifar A.B.E.E.
Greece
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .