Olanzapine Cheplapharm

Package leaflet: Information for the user

OLANZAPINE CHEPLAPHARM 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
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 they have the same symptoms as yours, as it may 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 CHEPLAPHARM is and what it is used for
2. What you need to know before taking OLANZAPINE CHEPLAPHARM
3. How to take OLANZAPINE CHEPLAPHARM
4. Possible side effects
5. How to store OLANZAPINE CHEPLAPHARM
6. Contents of the pack and other information

1. What OLANZAPINA CHEPLAPHARM is and what it is used for

OLANZAPINA CHEPLAPHARM contains the active substance olanzapine. OLANZAPINA CHEPLAPHARM 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 experiencing things that do not exist, false beliefs, unjustified suspicion, and social withdrawal. People affected by this illness may also feel depressed, anxious, or tense.
• moderate to severe manic episode, a condition characterised by symptoms of excitement or euphoria.

OLANZAPINA CHEPLAPHARM 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 CHEPLAPHARM

Do not take OLANZAPINE CHEPLAPHARM

• if you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may present as 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 CHEPLAPHARM.

• The use of OLANZAPINE CHEPLAPHARM in elderly patients with dementia is not recommended, as it may cause serious adverse effects.
• Medicines of this type can cause unusual movements, especially of the face and tongue. If this occurs after you have been given OLANZAPINE CHEPLAPHARM, 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 OLANZAPINE CHEPLAPHARM. You and your doctor should monitor your weight regularly. If necessary, consider seeking advice from a dietitian or starting a dietary program.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking OLANZAPINE CHEPLAPHARM. Your doctor should request blood tests to monitor your blood sugar and certain blood fat levels before you start taking OLANZAPINE CHEPLAPHARM 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 transient ischaemic attack (temporary stroke-like 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 experience excessive loss of body salts due to severe and prolonged diarrhoea and vomiting (due to illness) 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 transient ischaemic 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 CHEPLAPHARM is not indicated for patients under 18 years of age.

Other medicines and OLANZAPINE CHEPLAPHARM
During treatment with OLANZAPINE CHEPLAPHARM, take other medicines only after consulting your doctor. You may feel drowsy if OLANZAPINE CHEPLAPHARM is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquillisers).
Inform your doctor 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) – your dose of OLANZAPINE CHEPLAPHARM may need to be adjusted.

OLANZAPINE CHEPLAPHARM and alcohol
Do not drink any alcoholic beverages during treatment with OLANZAPINE CHEPLAPHARM, as taking it together with alcohol may cause drowsiness.

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

OLANZAPINE CHEPLAPHARM contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take OLANZAPINE CHEPLAPHARM

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

If you take more OLANZAPINE CHEPLAPHARM than you should
Patients who have taken more OLANZAPINE CHEPLAPHARM than prescribed have experienced the following symptoms: increased heart rate, agitation/aggression, difficulty speaking, 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, drowsiness or somnolence, slowed breathing, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or go to hospital immediately if any of these symptoms occur. Show your doctor the tablet pack.

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

If you stop taking OLANZAPINE CHEPLAPHARM
Do not stop taking the tablets just because you start feeling better. It is important that you continue treatment with OLANZAPINE CHEPLAPHARM for as long as your doctor considers necessary.
If you suddenly stop taking OLANZAPINE CHEPLAPHARM, 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 questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 breathing. If you experience any of these symptoms, consult a doctor immediately;
• a combination of fever, rapid breathing, sweating, muscle stiffness and drowsiness or lethargy (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (may affect more than 1 in 10 people) include weight gain; drowsiness; increased levels of prolactin in the blood. In the initial stages of treatment, some people may feel dizzy or faint (with a slowed 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 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; 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, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in blood and urine) or coma; epileptic seizures, usually in patients with a history of seizures (epilepsy); muscle rigidity or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slowed 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; breast 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; prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS Syndrome). DRESS initially presents with flu-like symptoms, a facial rash that subsequently becomes widespread, high body temperature, swollen lymph nodes, increased levels of liver enzymes observed in blood tests, and an increase in a type of white blood cell (increased eosinophils).
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 group of patients, some fatal cases have been reported.
In patients with Parkinson's disease, OLANZAPINE CHEPLAPHARM 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 nurse. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OLANZAPINE CHEPLAPHARM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
OLANZAPINE CHEPLAPHARM must be stored in its original packaging to protect it from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What OLANZAPINA CHEPLAPHARM contains

• The active substance is olanzapine. Each OLANZAPINA CHEPLAPHARM tablet contains either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, or 20 mg of active substance. The exact amount is indicated on the packaging of OLANZAPINA CHEPLAPHARM tablets.
• The excipients are:
  • (tablet core) lactose monohydrate, hydroxypropylcellulose, polyvinylpyrrolidone, microcrystalline cellulose, magnesium stearate, and
  • (tablet coating) hypromellose, titanium dioxide (E171), carnauba wax.
• Additionally, the different strengths of OLANZAPINA CHEPLAPHARM tablets contain the following excipients:

TABLET STRENGTH ADDITIONAL EXCIPIENTS
OLANZAPINA CHEPLAPHARM 2.5 mg, 5 mg, 7.5 mg (coating) macrogol,
and 10 mg tablets polysorbate 80
OLANZAPINA CHEPLAPHARM 15 mg tablets (coating)
triacetin and indigo carmine dye (E132)
OLANZAPINA CHEPLAPHARM 20 mg tablets (coating)
macrogol and synthetic red iron oxide
(E172)

Description of the appearance of OLANZAPINA CHEPLAPHARM and contents of the pack
The OLANZAPINA CHEPLAPHARM 2.5 mg coated tablets are white, marked with the letters “ZYP” and a numerical identification code "2.5".
The OLANZAPINA CHEPLAPHARM 5 mg coated tablets are white, marked with the letters “ZYP” and a numerical identification code "5".
The OLANZAPINA CHEPLAPHARM 7.5 mg coated tablets are white, marked with the letters “ZYP” and a numerical identification code "7.5".
The OLANZAPINA CHEPLAPHARM 10 mg coated tablets are white, marked with the letters “ZYP” and a numerical identification code "10".
The OLANZAPINA CHEPLAPHARM 15 mg coated tablets are blue, engraved with “ZYP” and a numerical identification code "15".
The OLANZAPINA CHEPLAPHARM 20 mg coated tablets are pink, engraved with “ZYP” and a numerical identification code "20".
OLANZAPINA CHEPLAPHARM is available in packs containing 28, 35, 56, and 70 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
CHEPLAPHARM Registration GmbH
Weiler Straße 5e
79540 Lörrach
Germany

Manufacturer
Fidelio Healthcare Limburg GmbH, Mundipharmastraße 2, 65549 Limburg an der Lahn, Germany.
CHEPLAPHARM Registration GmbH, Weiler Straße 5e, 79540 Lörrach, Germany.

This medicinal product is authorised in the European Economic Area countries under the following names:
Greece: Olansek
Italy: Olanzapina CHEPLAPHARM

Package leaflet: information for the user

OLANZAPINE CHEPLAPHARM 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets

Olanzapine
Generic medicinal product
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OLANZAPINA CHEPLAPHARM orodispersible tablet is and what it is used for

OLANZAPINA CHEPLAPHARM contains the active substance olanzapine. OLANZAPINA CHEPLAPHARM orodispersible tablet 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 illness may also feel depressed, anxious, or tense.
• Moderate to severe manic episode, a condition characterized by symptoms of excitement or euphoria.

OLANZAPINA CHEPLAPHARM orodispersible tablet 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 CHEPLAPHARM orodispersible tablet

orodispersible
Do not take OLANZAPINE CHEPLAPHARM orodispersible tablet

• If you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may present as skin rash, itching, facial swelling, swelling of the lips or shortness of breath. If this has happened to you, 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 CHEPLAPHARM
orodispersible tablet

• The use of OLANZAPINE CHEPLAPHARM orodispersible tablet 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 been given OLANZAPINE CHEPLAPHARM orodispersible tablet, 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 OLANZAPINE CHEPLAPHARM orodispersible tablet. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or implementing a dietary program.
• Elevated blood levels of sugar and fats (triglycerides and cholesterol) have been observed in patients taking OLANZAPINE CHEPLAPHARM orodispersible tablet. Your doctor should order blood tests to monitor your blood sugar and certain blood fat levels before you start taking OLANZAPINE CHEPLAPHARM orodispersible tablet 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 transient ischemic attack (temporary stroke-like 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 experience excessive loss of salt due to severe and prolonged diarrhoea and vomiting (due to illness) or due to the 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 CHEPLAPHARM orodispersible tablet is not indicated for patients under 18 years of age.
Other medicines and OLANZAPINE CHEPLAPHARM orodispersible tablet
During treatment with OLANZAPINE CHEPLAPHARM orodispersible tablet, take other medicines only after obtaining approval from your doctor. You may feel drowsy if OLANZAPINE CHEPLAPHARM orodispersible tablet is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquilizers).
Inform your doctor 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) – your dose of OLANZAPINE CHEPLAPHARM orodispersible tablet may need to be adjusted.

OLANZAPINE CHEPLAPHARM orodispersible tablet and alcohol
Do not drink any alcoholic beverages during treatment with OLANZAPINE CHEPLAPHARM orodispersible tablet, as taking alcohol together with this medicine may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine. You must not take this medicine while breastfeeding, as small amounts of OLANZAPINE CHEPLAPHARM orodispersible tablet may pass into breast milk.
The following symptoms may occur in newborns of mothers who have used OLANZAPINE CHEPLAPHARM orodispersible tablet 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 CHEPLAPHARM orodispersible tablet, there is a risk of drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.
OLANZAPINE CHEPLAPHARM orodispersible tablet contains aspartame,
sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate
This medicine contains up to 1.6 mg of aspartame per 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.
This medicine contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions). An allergic reaction may be recognized by the appearance of a skin rash, itching, or shortness of breath. This reaction may occur immediately or some time after taking OLANZAPINE CHEPLAPHARM orodispersible tablet.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take OLANZAPINE CHEPLAPHARM orodispersible tablet

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 CHEPLAPHARM orodispersible tablets to take and for how long you should continue taking them. The dose of OLANZAPINE CHEPLAPHARM orodispersible tablet ranges from 5 mg to 20 mg daily. If your symptoms return, discuss this with your doctor, but do not stop taking OLANZAPINE CHEPLAPHARM orodispersible tablet unless your doctor tells you to do so.
You should take OLANZAPINE CHEPLAPHARM orodispersible 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 CHEPLAPHARM orodispersible tablets are for oral use.
OLANZAPINE CHEPLAPHARM orodispersible tablets break easily, so handle them carefully. Avoid touching the tablets with wet hands, as they may disintegrate.

1. Hold the blister strip by the edges and gently separate one blister cavity from the rest of the strip by pulling along the perforated line.
2. Carefully peel back the backing.
3. Gently push the tablet out.
4. Place the tablet in your mouth. It will dissolve rapidly in the mouth, allowing it to be swallowed easily.

You may also 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 immediately.

If you take more OLANZAPINE CHEPLAPHARM orodispersible tablet than you should
Patients who have taken more OLANZAPINE CHEPLAPHARM 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 rigidity, lethargy or drowsiness, slowed breathing, suppressed 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 the doctor your tablet package.
If you forget to take OLANZAPINE CHEPLAPHARM orodispersible tablet
Take the missed dose as soon as you remember. Do not take a double dose on the same day.
If you stop taking OLANZAPINE CHEPLAPHARM orodispersible tablet
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue treatment with OLANZAPINE CHEPLAPHARM for as long as your doctor recommends.
If you stop taking OLANZAPINE CHEPLAPHARM suddenly, 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.
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 breathing. If you notice any of these symptoms, consult a doctor immediately;
• a combination of fever, rapid breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (may affect more than 1 in 10 people) include
weight gain; drowsiness; increased levels of prolactin in the blood. In the early stages
of treatment, some people may feel dizzy or faint
(with 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, 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 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 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, skin rash); diabetes
or worsening of diabetes, occasionally associated with ketoacidosis (presence of
ketone bodies in blood and urine) or coma; epileptic seizures, usually occurring 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; drooling; memory loss or forgetfulness; urinary
incontinence; inability to urinate; hair loss; absence or reduction of menstrual
cycles; changes in the breasts 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 feeling unwell; liver disease presenting 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 syndrome). DRESS initially presents with flu-like symptoms, a rash on the face which subsequently spreads, high body temperature, swollen lymph nodes, increased liver enzyme levels observed in blood tests, and increased levels of a type of white blood cell (increased eosinophils).
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. Fatal cases have been reported in this particular group of patients.
In patients with Parkinson's disease, OLANZAPINA CHEPLAPHARM orodispersible tablet
may worsen symptoms.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects via
https://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 CHEPLAPHARM orodispersible tablet

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
OLANZAPINE CHEPLAPHARM orodispersible tablet must be stored in its original packaging to protect it from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What OLANZAPINA CHEPLAPHARM orodispersible tablet contains

• The active substance is olanzapine. Each orodispersible tablet of OLANZAPINA CHEPLAPHARM contains either 5 mg, 10 mg, 15 mg, or 20 mg of active substance. The exact amount is indicated on the OLANZAPINA CHEPLAPHARM packaging.
• The excipients are
  • gelatin, mannitol (E421), aspartame (E951), sodium methylparahydroxybenzoate (E219) and sodium propylparahydroxybenzoate (E217).

Description of the appearance of OLANZAPINA CHEPLAPHARM orodispersible tablet
and contents of the pack
OLANZAPINA CHEPLAPHARM 5 mg, 10 mg, 15 mg and 20 mg are yellow orodispersible tablets.
Orodispersible tablet is a technical term indicating a tablet that dissolves directly in the mouth, allowing it to be swallowed easily.
OLANZAPINA CHEPLAPHARM orodispersible tablets are available in packs containing 28, 35, 56 or 70 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder
CHEPLAPHARM Registration GmbH
Weiler Straße 5e
79540 Lörrach
Germany

Manufacturer
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Fidelio Healthcare Limburg GmbH, Mundipharmastraße 2, 65549 Limburg an der Lahn, Germany.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Greece: Olansek
Italy: Olanzapina CHEPLAPHARM