Olanzapine Zentiva

Package leaflet: information for the patient

Olanzapine Zentiva 2.5 mg film-coated tablets, 5 mg film-coated tablets, 10 mg film-coated tablets

Generic medicine
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 their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Olanzapine Zentiva is and what it is used for
2. What you need to know before taking Olanzapine Zentiva
3. How to take Olanzapine Zentiva
4. Possible side effects
5. How to store Olanzapine Zentiva
6. Contents of the pack and other information

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

Olanzapina Zentiva contains the active substance olanzapine. Olanzapina Zentiva 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 episode, a condition characterized by symptoms of excitement or euphoria.

Olanzapina Zentiva 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 should know before taking Olanzapine Zentiva

Do not take Olanzapine Zentiva

• If you are allergic to olanzapine, peanuts, soya, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, facial swelling, swelling of the lips, or shortness of breath. If you have experienced this, inform your doctor.

• If you have previously been diagnosed with an eye problem such as certain types of glaucoma (increased pressure inside the eye).

Warnings and precautions
Talk to your doctor or pharmacist before taking Olanzapine Zentiva

• The use of Olanzapine Zentiva in elderly patients with dementia is not recommended, as it may cause serious side effects.
• Medicines of this type can cause unusual movements, particularly of the face and tongue. If this occurs after you have started taking Olanzapine Zentiva, inform your doctor.
• Very rarely, medicines of this type can 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 Zentiva. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or starting a diet program.
• High levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Olanzapine Zentiva. Your doctor should order blood tests to monitor your blood sugar and certain blood fat levels before you start taking Olanzapine Zentiva and regularly during treatment.
• Inform your doctor if you or someone in your family has a history of blood clots, as medicines like this have been associated with blood clot formation.

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

• Stroke or "mini" strokes (transient ischaemic attacks).
• Parkinson's disease.
• Prostate problems.
• Intestinal blockage (paralytic ileus).
• Liver or kidney disease.
• Blood disorders.
• Heart disease.
• Diabetes.
• Seizures.
  • If you know you may lose salts due to prolonged and severe diarrhoea or vomiting, or due to the use of diuretics (water tablets).

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

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

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

• Medicines for Parkinson's disease;
• Carbamazepine (an antiepileptic and mood stabiliser), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – a dose adjustment of Olanzapine Zentiva may be necessary.

Olanzapine Zentiva and alcohol
Do not drink any alcoholic beverages while taking Olanzapine Zentiva, as taking Olanzapine Zentiva together with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. You should not take this medicine while breastfeeding, as small amounts of Olanzapine Zentiva may pass into breast milk.
The following symptoms may occur in newborns whose mothers took Olanzapine Zentiva 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 Zentiva, you may experience drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

Olanzapine Zentiva contains lactose, lecithin (soya), and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
If you are allergic to peanuts or soya, do not use this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Olanzapine Zentiva

Take this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Your doctor will tell you how many Olanzapine Zentiva tablets to take and for how long you should
continue taking them.
The daily dose of Olanzapine Zentiva ranges between 5 and 20 mg.
If your symptoms return, discuss this with your doctor, but do not stop taking Olanzapine Zentiva
unless your doctor tells you to do so.
You should take Olanzapine Zentiva 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 Zentiva film-coated tablets are for oral use.
Swallow the Olanzapine Zentiva tablets whole with water.

If you take more Olanzapine Zentiva than you should
Patients who have taken more Olanzapine Zentiva than prescribed have experienced the following
symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially
of the face or tongue), and reduced level of consciousness. Other symptoms may include: acute
confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle
rigidity, stupor or drowsiness, slowed breathing, reduced cough reflex, high or low blood pressure,
and changes in heart rhythm. Contact your doctor or hospital immediately if any of these symptoms
occur. Show your doctor the pack of tablets.

If you forget to take Olanzapine Zentiva
Take the missed dose as soon as you remember.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Olanzapine Zentiva
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue
treatment with Olanzapine Zentiva for as long as your doctor considers necessary.
If you stop taking Olanzapine Zentiva 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.

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.
Tell your doctor immediately if you experience:

• unusual movements (a common side effect which may affect up to 1 in 10 patients), especially of the face or tongue;
• blood clots in the veins (an uncommon side effect which may affect up to 1 in 100 patients), particularly in the legs (symptoms include swelling, pain and redness of the leg), which may travel through the blood vessels to the lungs causing chest pain and difficulty in breathing. If you experience any of these symptoms, consult a doctor immediately;
• a combination of fever, rapid breathing, sweating, muscle stiffness and mental confusion or drowsiness (a rare side effect which may affect up to 1 in 1,000 patients).

Very common side effects (may affect more than 1 in 10 people):

• weight gain.
• drowsiness.
• increased levels of prolactin in the blood.
• In the early stages of treatment, some people may feel dizzy or faint (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):

• changes in levels of certain blood cells, circulating fats, and temporary increases in liver enzymes during the initial stages of treatment.
• increased levels of sugar in the blood and urine.
• increased levels of uric acid and creatine phosphokinase in the blood.
• increased feeling of hunger.
• dizziness.
• restlessness.
• tremor.
• unusual movements (dyskinesias).
• constipation.
• dry mouth.
• skin rash.
• loss of strength.
• extreme tiredness.
• fluid retention leading to swelling of the hands, ankles or feet.
• fever.
• joint pain.
• 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):

• 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 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.
• slowing of the heartbeat.
• sensitivity to sunlight.
• nosebleeds.
• abdominal swelling.
• memory loss or forgetfulness.
• urinary incontinence.
• inability to urinate.
• hair loss.
• absence or reduction of menstrual cycles.
• breast changes in males and females, such as abnormal milk secretion or abnormal growth.

Rare side effects (may affect up to 1 in 1,000 people):

• decreased body temperature.
• changes in heart rhythm.
• unexplained sudden death.
• inflammation of the pancreas causing severe stomach pain, fever and malaise.
• liver disease manifesting as yellowing of the skin and whites of the eyes.
• muscle disease presenting as tenderness and unexplained muscle pains.
• prolonged and/or painful erection.

Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially appears as flu-like symptoms, with a rash on the face followed by a widespread rash, high fever, swollen lymph nodes, increased levels of liver enzymes observed in blood tests, and an increase in a type of white blood cells (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may be at risk of stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, elevated body temperature, skin redness and walking disorders. In this particular group of patients, some fatal cases have been reported.
In patients with Parkinson's disease, Olanzapina Zentiva may cause worsening of 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 at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olanzapine Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in the original container to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Olanzapina Zentiva contains
The active substance is olanzapine. Each film-coated tablet contains 2.5 mg, 5 mg or 10 mg of
olanzapine.
The other components are:
Tablet core: mannitol, anhydrous lactose, sodium starch glycolate (type A),
hydroxypropylcellulose, magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), talc, soybean lecithin
(E322), xanthan gum.
Description of the appearance of Olanzapina Zentiva and pack contents

• Olanzapina Zentiva 2.5 mg: white, round, smooth, biconvex film-coated tablet.
• Olanzapina Zentiva 5 mg and 10 mg: white, round, biconvex film-coated tablet, with a score line on one side and smooth on the other side. The tablet can be divided into two equal doses.

Olanzapina Zentiva is available in packs of 14, 28, 35 or 70 tablets in blisters.
In Germany, Olanzapina Zentiva 2.5 mg and 5 mg may also be available in packs of 56 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale Luigi Bodio, 37/b
20158 Milano
Italy
Manufacturer:
S.C. Zentiva S.A.
B-dul Theodor Pallady n. 50, Sector 3
032266 Bucharest
Romania
This medicinal product is authorized in the Member States of the European Economic Area under the
following names:

Patient Information Leaflet

Olanzapine Zentiva 5 mg orodispersible tablets, 10 mg orodispersible tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Olanzapine Zentiva is and what it is used for
2. What you need to know before taking Olanzapine Zentiva
3. How to take Olanzapine Zentiva
4. Possible side effects
5. How to store Olanzapine Zentiva
6. Package contents and other information

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

Olanzapina Zentiva contains the active substance olanzapine. Olanzapina Zentiva 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 experiencing 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 episode, a condition characterized by symptoms of excitement or euphoria.

Olanzapina Zentiva 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 Olanzapina Zentiva

Do not take Olanzapina Zentiva

• 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, swelling of the lips, or shortness of breath. If you have experienced this, inform your doctor.
• If you have previously been diagnosed with an eye problem such as certain types of glaucoma (increased pressure inside the eye).

Warnings and precautions
Talk to your doctor or pharmacist before taking Olanzapina Zentiva

• The use of Olanzapina Zentiva in elderly patients with dementia is not recommended, as it may cause serious side effects.
• Medicines of this type may cause unusual movements, especially of the face and tongue. If this occurs after you have been given Olanzapina Zentiva, inform your doctor.
• Very rarely, medicines of this type cause a combination of symptoms including 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 Olanzapina Zentiva. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or following a dietary program.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina Zentiva. Your doctor should perform blood tests to monitor your blood sugar and certain fat levels before you start taking Olanzapina Zentiva and regularly during treatment.
• Inform your doctor if you or someone in your family has a history of blood clots, as medicines like this have been associated with blood clot formation.

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

• Stroke or "mini" stroke (transient stroke symptoms).
• Parkinson's disease.
• Prostate problems.
• Intestinal blockage (paralytic ileus).
• Liver or kidney disease.
• Blood disorders.
• Heart disease.
• Diabetes.
• Seizures.
• If you know you may lose salts due to prolonged severe diarrhea and vomiting, or due to the use of diuretics (water tablets).

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

• Medicines for Parkinson's disease;
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – a dose adjustment of Olanzapina Zentiva may be necessary.

Olanzapina Zentiva and alcohol
Do not drink any alcoholic beverages while taking Olanzapina Zentiva, as taking Olanzapina Zentiva together with alcohol may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine. You should not take this medicine while breastfeeding, as small amounts of Olanzapina Zentiva may pass into breast milk.
The following symptoms may occur in newborns whose mothers have taken Olanzapina Zentiva 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 Olanzapina Zentiva, there is a risk that you may experience drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.
Olanzapina Zentiva contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; i.e., essentially "sodium-free".

3. How to take Olanzapine Zentiva

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will tell you how many Olanzapine Zentiva tablets to take and for how long you should continue taking them.
The daily dose of Olanzapine Zentiva ranges between 5 and 20 mg.
If your symptoms return, speak to your doctor, but do not stop taking Olanzapine Zentiva unless your doctor tells you to.
You should take Olanzapine Zentiva tablets once daily, as instructed 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 Zentiva orodispersible tablets are for oral use.
Olanzapine Zentiva tablets break easily and therefore must be handled with care. Do not handle the tablets with wet hands as they may break.

• Place the tablet in your mouth. It will dissolve directly in the mouth, allowing it to be swallowed easily.
• Alternatively, you may place the tablet in a glass or cup of water and stir. Drink the solution immediately.

If you take more Olanzapine Zentiva than you should
Patients who have taken more Olanzapine Zentiva than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, difficulty speaking, unusual movements (especially of the face or tongue), and reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, stupor or drowsiness, slowed breathing, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or go to a hospital immediately if any of these symptoms occur. Show your doctor the medicine package.

If you forget to take Olanzapine Zentiva
Take the missed dose as soon as you remember.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Olanzapine Zentiva
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue treatment with Olanzapine Zentiva for as long as your doctor considers necessary.
If you suddenly stop taking Olanzapine Zentiva, 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 everybody gets them.
Inform your doctor immediately if you experience:

• unusual movements (a common side effect which may affect up to 1 in 10 patients), especially of the face or tongue.
• blood clots in the veins (an uncommon side effect which may affect up to 1 in 100 patients), particularly in the lower limbs (symptoms include swelling, pain and redness of the leg), which may travel through the blood vessels to the lungs causing chest pain and breathing difficulties. If you experience any of these symptoms, consult a doctor immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness and lethargy or drowsiness (a rare side effect which may affect up to 1 in 1,000 patients).

Very common side effects (may affect more than 1 in 10 people):

• weight gain.
• drowsiness.
• increased levels of prolactin in the blood.
• in the initial stages of treatment, some people may experience dizziness or fainting (with a slowing of the heart rate), particularly 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):

• changes in levels of certain blood cells, circulating fats, and temporary increases in liver enzymes during the initial stages of treatment.
• increased levels of sugar in the blood and urine.
• increased levels of uric acid and creatine phosphokinase in the blood.
• increased feeling of hunger.
• dizziness.
• restlessness.
• tremor.
• unusual movements (dyskinesias).
• constipation.
• dry mouth.
• skin rash.
• loss of strength.
• extreme tiredness.
• water retention leading to swelling of the hands, ankles or feet.
• fever.
• joint pain.
• 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):

• hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash).
• diabetes or worsening of existing 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.
• slowing of the heart rate.
• sensitivity to sunlight.
• nosebleeds.
• abdominal swelling.
• memory loss or forgetfulness.
• urinary incontinence.
• inability to urinate.
• hair loss.
• absence or reduction of menstrual cycles.
• breast changes in males and females, such as abnormal milk secretion or abnormal growth.

Rare side effects (may affect up to 1 in 1,000 people):

• 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 (jaundice).
• muscle disease presenting as tenderness and unexplained muscle pain.
• prolonged and/or painful erection (priapism).

Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially appears as flu-like symptoms, with a rash on the face followed by a widespread rash, high fever, swollen lymph nodes, increased 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 at risk of stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness and walking disturbances. In this particular group of patients, some fatal cases have been reported.

In patients with Parkinson's disease, Olanzapina Zentiva 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 at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olanzapina Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Olanzapina Zentiva contains
The active substance is olanzapine. Each orodispersible tablet contains 5 mg or 10 mg of
olanzapine.
The other ingredients are: monohydrate lactose, hydroxypropylcellulose, sodium starch glycolate (type
A), sodium saccharin, magnesium stearate.
Description of the appearance of Olanzapina Zentiva and the pack contents
Olanzapina Zentiva 5 mg: yellow, round, smooth, biconvex orodispersible tablet.
Olanzapina Zentiva 10 mg: yellow, round, smooth, biconvex orodispersible tablet with a break line on one side and smooth on the other. The tablet can be divided into equal doses.
Olanzapina Zentiva tablets are available in packs of 14, 28, 35, 56, 70, 98 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale Luigi Bodio, 37/b
20158 Milano
Italy
Manufacturer:
S.C. Zentiva S.A.
B-dul Theodor Pallady no. 50, Sector 3
032266 Bucharest
Romania
This medicinal product is authorized in the European Economic Area countries with the
following names: