OLANZAPINE TEVA

Italy

This medicine is part of a group of antipsychotics and is used to treat schizophrenia and moderate to severe manic episodes. It can also be used to prevent the recurrence of these symptoms in patients with bipolar disorder.

Brand name OLANZAPINE TEVA

Dosage form tablets, film-coated

Active substance / Dosage

olanzapine

Prescription type Prescription only

ATC code

N05AH03

Registration number 040470

Manufacturer TEVA B.V.

Frequently asked questions

When should you not take Olanzapina Teva?

You must not take this medicine if you are allergic to olanzapine or any of its other ingredients, or if you suffer from certain types of glaucoma (increased pressure inside the eye).

How should the drug be taken?

Tablets should be taken once daily, always at the same time, following the doctor's instructions. Coated tablets should be swallowed whole with water, while orodispersible tablets can be placed in the mouth to dissolve or dissolved in a glass of water, juice, milk, or coffee and drunk immediately.

What are the common side effects of Olanzapina Teva?

Very common side effects include weight gain, drowsiness, and increased prolactin levels in the blood. Other common side effects may include increased appetite, dizziness, tremor, constipation, dry mouth, skin rashes, or changes in blood sugar and fat levels.

Are there any special warnings regarding other medicines or substances?

It is important to inform your doctor if you are taking antidepressants, tranquilizers, drugs for Parkinson's disease, or certain antibiotics and antiepileptics. Additionally, you should not consume alcohol during treatment as it may increase drowsiness.

What should you do in case of forgetting or interrupting treatment?

If you forget a dose, take it as soon as you remember, but do not take a double dose on the same day. Do not stop treatment suddenly without consulting your doctor, as symptoms such as anxiety, tremor, nausea, or inability to sleep may occur.

Who should pay particular attention during administration?

People with liver, kidney, or heart problems, diabetes, epilepsy, or prostate problems must inform their doctor. Use is not recommended in elderly patients with dementia, and the drug is not indicated for patients under 18 years of age.

Can the drug affect pregnancy or breastfeeding?

If you are pregnant, planning a pregnancy, or breastfeeding, you must consult your doctor. The medicine should not be taken during breastfeeding because it can pass into breast milk.

Instructions for use

Table of contents

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

Package leaflet: Information for the user

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

olanzapine
Please read all of 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

Schizophrenia, a disorder with symptoms such as hearing, seeing, or experiencing things that do not exist, false beliefs, unjustified suspiciousness, and social withdrawal. People with this disorder may also feel depressed, anxious, or tense.
Moderate to severe manic episodes, 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 whose manic episode has responded to treatment with olanzapine.

2. What you need to know before taking Olanzapine Teva

Do not take Olanzapine Teva

if you are allergic 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 pharmacist before taking Olanzapine Teva.

The use of Olanzapine 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 occurs after you have been given Olanzapine Teva, inform your doctor.
Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness. If this occurs, consult your doctor immediately.
Weight gain has been observed in patients taking Olanzapine Teva. Therefore, your doctor, with your cooperation, will regularly monitor your body weight. If necessary, consider seeking advice from a dietitian or support with a diet program.
Elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have been reported in patients taking Olanzapine Teva. Your doctor will therefore arrange for blood tests to monitor your blood sugar levels and certain blood fats before you start taking Olanzapine Teva and regularly during treatment.
Inform your doctor if you or a family member 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 "mini" strokes (transient ischemic attack symptoms)
Parkinson's disease
Prostate problems
Intestinal blockage (paralytic ileus)
Liver or kidney disease
Blood disorders
Heart disease
Diabetes
Epileptic seizures
If you know you may experience excessive loss of salt due to severe and prolonged diarrhea and vomiting (due to illness) or use of diuretics (water tablets)

If you have dementia, you or your caregiver should inform the doctor if you have previously had a stroke or transient ischemic attack.
As a routine precaution, if you are over 65 years old, have your blood pressure checked regularly by your doctor.
Children and adolescents
Olanzapine Teva is not indicated for patients under 18 years of age.
Other medicines and Olanzapine Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
During treatment with Olanzapine Teva, take other medicines only after approval from your doctor. You may feel drowsy if Olanzapine Teva is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquilizers).
In particular, inform your doctor if you are taking:

medicines for Parkinson's disease.
carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – as your dose of Olanzapine Teva may need to be adjusted.

Olanzapine Teva and alcohol
Do not drink any alcoholic beverages during treatment with Olanzapine Teva, as taking alcohol together with this medicine may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take this medicine while breastfeeding, as small amounts of Olanzapine Teva can pass into breast milk.
The following symptoms may occur in newborns whose mothers have used Olanzapine Teva 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 Olanzapine Teva, there is a risk of drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.
Olanzapine Teva contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Olanzapina Teva

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many Olanzapina Teva tablets to take and for how long you should continue taking them. The daily dose of Olanzapina Teva ranges from 5 mg to 20 mg. If your symptoms return, discuss this with your doctor, but do not stop taking Olanzapina Teva unless your doctor tells you to do so.
You should take Olanzapina Teva tablets once daily, following your doctor’s instructions. Try to take the tablets at the same time each day. It does not matter whether you take them with or without food. Olanzapina Teva coated tablets are for oral use.
Swallow the Olanzapina Teva tablets whole with water.

If you take more Olanzapina Teva than you should
Patients who have taken more Olanzapina Teva than recommended have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech difficulties, 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 rigidity, lethargy or drowsiness, slowed breathing rate, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or hospital immediately if you experience any of the symptoms described above. Show your doctor the package of tablets.

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

If you stop taking Olanzapina Teva
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue treatment with Olanzapina Teva for as long as your doctor considers necessary.
If you suddenly stop taking Olanzapina Teva, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, 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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately inform your doctor if any of the following occur:

unusual movements (a common side effect which may affect up to 1 in 10 people), mainly of the face or tongue;
blood clots in the veins (an uncommon side effect which 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 the blood vessels to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, seek immediate medical attention;
a combination of fever, rapid breathing, sweating, muscle stiffness and drowsiness or lethargy (the frequency of this side effect cannot be determined from the available data).

Very common side effects (may affect more than 1 in 10 people) include
weight gain; drowsiness; and 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 in the early stages of treatment temporary increases in liver enzymes; increased levels of sugar in the blood and urine; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite;
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 ketones in blood and urine) or coma; epileptic seizures, usually occurring in patients with a history of seizures (epilepsy); muscle rigidity or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow heartbeat; sensitivity to sunlight; nosebleeds; abdominal distension; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and breast-related 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). DRESS is initially characterised by influenza-like symptoms such as rash on the face subsequently spreading, high temperature, enlarged lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may be at risk of stroke, pneumonia, urinary incontinence, falls, extreme tiredness, 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, Olanzapina Teva 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 pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olanzapine Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "EXP.". The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the product in the original packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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.
The other components are: Tablet core: lactose monohydrate, hydroxypropylcellulose, crospovidone (type A), colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate. Tablet coating: hypromellose, polydextrose, glycerol triacetate, macrogol 8000, titanium dioxide (E171). Additionally, 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 white, round, biconvex film-coated tablet, marked with “OL 2.5” on one side and smooth on the other.
Olanzapina Teva 5 mg film-coated tablet is a white, round, biconvex film-coated tablet, marked with “OL 5” on one side and smooth on the other.
Olanzapina Teva 7.5 mg film-coated tablet is a white, round, biconvex film-coated tablet, marked with “OL 7.5” on one side and smooth on the other.
Olanzapina Teva 10 mg film-coated tablet is a white, round, biconvex film-coated tablet, marked with “OL 10” on one side and smooth on the other.
Olanzapina Teva 15 mg film-coated tablet is a blue, oval, biconvex film-coated tablet, marked with “OL 15” on one side and smooth on the other.
Olanzapina Teva 20 mg film-coated tablet is a pink, oval, biconvex film-coated tablet, marked with “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 Authorization Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturer
Teva Pharmaceutical Works Co. Ltd
Pallagi út 13
4042 Debrecen
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder in your country:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Тел: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
SanoSwiss UAB Teva Pharmaceuticals Ireland
Litauen L-Irlanda
Tlf: +370 70001320 Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
Specifar A.B.E.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 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.

Package leaflet: Information for the user

Olanzapine Teva 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets

olanzapine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

Schizophrenia, a disorder characterized by symptoms such as hearing, seeing, or sensing things that do not exist, false beliefs, unjustified suspicion, and social withdrawal. People with this disorder may also feel depressed, anxious, or tense.
Moderate to severe manic episodes, a condition characterized by symptoms of excitement or euphoria.

Olanzapina Teva 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 Olanzapine Teva

Do not take Olanzapine Teva

if you are allergic 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 pharmacist before taking Olanzapine Teva.

The use of Olanzapine Teva in elderly patients with dementia is not recommended, as it may cause serious side effects.
Medicines of this type may cause unusual movements, particularly of the face and tongue. If this occurs after you have started taking Olanzapine Teva, inform your doctor.
Very rarely, medicines like this 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 Olanzapine Teva. Your doctor will therefore regularly monitor your body weight, with your cooperation. If necessary, consider consulting a dietitian or following a diet program.
Increased levels of sugar and fats (triglycerides and cholesterol) in the blood have been reported in patients taking Olanzapine Teva. Your doctor will therefore arrange for blood tests to monitor your blood sugar and fat levels before you start taking Olanzapine Teva and periodically during treatment.
Inform your doctor if you or a family member has a history of blood clots, as such medicines have been associated with blood clot formation.

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

Stroke or "mini" strokes (transient ischemic attacks)
Parkinson's disease
Prostate problems
Intestinal blockage (paralytic ileus)
Liver or kidney disease
Blood disorders
Heart disease
Diabetes
Epileptic seizures
If you know you may experience excessive loss of salt due to severe and prolonged diarrhea and vomiting (due to illness) or use of diuretics (water tablets)

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

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

medicines for Parkinson's disease.
carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – as your dose of Olanzapine Teva may need to be adjusted.

Olanzapine Teva and alcohol
Do not drink any alcoholic beverages during treatment with Olanzapine Teva, as drinking alcohol together with this medicine may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should not take this medicine during breastfeeding, as small amounts of Olanzapine Teva may pass into breast milk.
The following symptoms may occur in newborns of mothers who have taken Olanzapine Teva 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
Olanzapine Teva may cause drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

Olanzapine Teva contains lactose, sucrose, and aspartame
This medicine contains lactose and sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains 2.25 mg/4.5 mg/6.75 mg/9 mg of aspartame in each 5 mg/10 mg/15 mg/20 mg orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take Olanzapine Teva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor will tell you how many Olanzapine Teva tablets to take and for how long you should continue taking them. The daily dose of Olanzapine Teva ranges from 5 mg to 20 mg. If your symptoms return, speak to your doctor, but do not stop taking Olanzapine Teva unless your doctor tells you to do so.
You should take Olanzapine Teva tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. It does not matter whether you take them with or without food. Olanzapine Teva orodispersible tablets are for oral use.
Olanzapine Teva tablets are easily broken, so handle them with care. Avoid touching the tablets with wet hands, as they may disintegrate. Place the tablet in your mouth. It will dissolve rapidly and can be easily swallowed.
Alternatively, you may place the tablet in a glass or cup containing water, orange juice, apple juice, milk, or coffee, and stir. With some beverages, the mixture may change colour and become slightly cloudy. Drink the mixture immediately.
If you take more Olanzapine Teva than you should
Patients who have taken more Olanzapine Teva than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech difficulties, 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 sleepiness, slowed breathing, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or hospital immediately if you experience any of the symptoms described above. Show your doctor the medicine's packaging.
If you forget to take Olanzapine Teva
Take the missed dose as soon as you remember. Do not take a double dose on the same day.
If you stop taking Olanzapine Teva
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue treatment with Olanzapine Teva for as long as your doctor considers necessary.
If you stop taking Olanzapine Teva 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediately inform your doctor if any of the following occur:

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

Very common side effects (may occur in more than 1 in 10 people) include weight gain; drowsiness; and increased levels of prolactin in the blood. In the initial stages of treatment, some people may experience dizziness or fainting (with a slowed heart rate), 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 occur in 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 initial stages of treatment; increased blood and urine sugar levels; 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 occur in 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 ketones in blood and urine) or coma; seizures, usually in patients with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slowed heart rate; 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 occur in 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 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 rash on the face later spreading to other areas, high temperature, swollen lymph nodes, elevated liver enzyme levels 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, Olanzapina Teva 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 pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Olanzapine Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Olanzapine Teva contains:

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

Description of the appearance of Olanzapine Teva and contents of the pack
Orodispersible tablet is a technical term used to describe a tablet that dissolves directly in the mouth, allowing it to be swallowed easily.
Olanzapine Teva 5 mg orodispersible tablet is a round, yellow, biconvex tablet with a diameter of 8 mm.
Olanzapine Teva 10 mg orodispersible tablet is a round, yellow, biconvex tablet with a diameter of 10 mm.
Olanzapine Teva 15 mg orodispersible tablet is a round, yellow, biconvex tablet with a diameter of 11 mm.
Olanzapine Teva 20 mg orodispersible tablet is a round, yellow, biconvex tablet with a diameter of 12 mm.
Olanzapine Teva 5 mg, 10 mg and 15 mg orodispersible tablets are available in packs of 28, 30, 35, 50, 56, 70 or 98 tablets.
Olanzapine 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 Authorization Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The 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
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder: