ZALASTA 2.5 MG Tablets

Зміст інструкції

1. Zalasta 2.5 mg tablets, 5 mg tablets, 7.5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets
   1. What is Zalasta and what is it used for
   2. What you need to know before taking Zalasta
   3. How to take Zalasta
   4. Possible side effects
   5. How to store Zalasta
   6. Contents of the pack and other information
2. Zalasta 5 mg orodispersible tablets, 7.5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets
   1. What is Zalasta and what is it used for
   2. What you need to know before taking Zalasta
   3. How to take Zalasta
   4. Possible side effects
   5. How to store Zalasta
   6. Package contents and other information

Zalasta 2.5 mg tablets, 5 mg tablets, 7.5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets

olanzapine

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to people even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Zalasta is and what it is used for
• 2. What you need to know before you take Zalasta
• 3. How to take Zalasta
• 4. Possible side effects
• 5. How to store Zalasta
• 6. Contents of the pack and other information

1. What is Zalasta and what is it used for

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

• Schizophrenia, an illness with symptoms such as hearing, seeing or feeling things that are not there, false beliefs, unjustified suspicion and social withdrawal. People with this illness may also feel depressed, anxious or tense.
• Moderate to severe manic episodes, a condition characterized by symptoms such as excitement or euphoria. Zalasta has also been shown to be able to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before taking Zalasta

Do not take Zalasta

• If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest with skin rash, itching, swelling of the face, swelling of the lips, shortness of breath. If this has happened to you, tell your doctor.
• If you have previously been diagnosed with an eye problem such as certain types of glaucoma (increased pressure inside the eye). Be careful with ZalastaTalk to your doctor or pharmacist before taking Zalasta.
• The use of Zalasta in elderly patients with dementia is not recommended as it may

cause serious side effects.

• Medicines of this type can cause unusual movements, especially of the face and tongue. If this happens after you have been given Zalasta, tell your doctor.
• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness and confusion or drowsiness. If this happens, see your doctor immediately.
• Weight gain has been observed in patients taking Zalasta. You and your doctor should check your weight regularly. If necessary, consider contacting a dietitian or getting help with a diet program.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Zalasta. The doctor must request blood tests to check the sugar and certain fat values ​​in the blood before you start taking Zalasta and, regularly, during treatment.
• Tell your doctor if you or someone in your family has had a history of blood clots, as medicines like these have been associated with the formation of blood clots. If you suffer from any of the following conditions, inform your doctor as soon as possible:
• Stroke or transient ischemic attack (symptoms of a stroke) (TIA)
• Parkinson's disease
• Problems with the prostate
• Bowel obstruction (paralytic ileus)
• Liver or kidney disease
• Blood diseases
• Heart disease
• Diabetes
• Convulsions
• If you know that you may have excessive salt loss due to severe and prolonged diarrhea and vomiting (being sick) or the use of diuretics (water pills) If you suffer from dementia, you or your caregiver must inform the doctor if you have had a stroke or transient ischemic attack in the past. As a routine precaution, if you are over 65 years of age, have your blood pressure checked periodically by your doctor. Children and adolescentsZalasta is not indicated in patients under the age of 18 years. Other medicines and ZalastaTake other medicines while taking Zalasta only if your doctor tells you that you can. You may feel sleepy if Zalasta is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquilizers). Tell your doctor if you are taking, have recently taken or may take any other medicine. In particular, tell your doctor if you are taking:
• medicines for Parkinson's disease,
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - it may be necessary to adjust your dose of Zalasta. Zalasta and alcoholDo not drink any type of alcohol during treatment with Zalasta as the simultaneous intake of Zalasta and alcohol can make you feel sleepy.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning to
become pregnant, ask your doctor for advice before taking this medicine. You should not
take this medicine during breastfeeding, as small amounts of Zalasta may
pass into breast milk.
The following symptoms may occur in newborns of mothers who have used Zalasta in the last
trimester (last three months of pregnancy): tremor, stiffness and/or muscle weakness, drowsiness,
agitation, breathing problems and difficulty feeding. If your baby presents any of these
symptoms, you may need to contact your doctor.

Driving and using machines
When you take Zalasta there is a risk that you may feel sleepy. If this happens, do not drive or
do not operate tools or machinery. Tell your doctor.

Zalasta contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

3. How to take Zalasta

Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will tell you how many Zalasta tablets you need to take and for how long you need to continue to
take them. The dose of Zalasta to be taken varies from 5 mg to 20 mg per day.
If your symptoms reappear, consult your doctor, but do not stop taking Zalasta unless
your doctor tells you to.
You should take Zalasta tablets once a day, following your doctor's instructions. Try to
take the tablets every day at the same time. It does not matter if you take them on a full or empty
stomach. Swallow them whole with a little water.

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

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

If you stop taking Zalasta
Do not stop taking the tablets as soon as you start to feel better. It is important that you continue
the treatment with Zalasta for as long as your doctor deems necessary.
If you suddenly stop taking Zalasta, symptoms such as
sweating, inability to sleep, tremor, anxiety, nausea and vomiting may occur. Your doctor may advise you to
gradually reduce the dose before stopping treatment.
If you have any further questions about the use of this medicine, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Report to your doctor immediately if you have:

• abnormal movements (a common side effect that can affect up to 1 in 10 people) mainly of the face or tongue
• blood clots in the veins (a rare side effect that can affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness of the leg), which can move to blood vessels in the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately
• a combination of fever, rapid breathing, sweating, muscle stiffness and drowsiness or dizziness (the frequency of these side effects cannot be estimated from available data). Very common side effects (may affect more than 1 in 10 patients) include weight gain; drowsiness; increased levels of prolactin in the blood. In the early stages of treatment, some people may experience a feeling of dizziness or fainting (with a slowing of the heartbeat), especially when getting up from a lying or sitting position. These effects usually subside spontaneously, but if this does not happen, inform your doctor. Common side effects (may affect up to 1 in 10 patients) include changes in the levels of some blood cells, circulating fats and in the early stages of treatment temporary increases in liver enzymes; increases in blood sugar and urine sugar levels; increases in uric acid and creatine phosphokinase levels in the blood; feeling of increased hunger; dizziness; restlessness; tremor unusual movements (dyskinesias); constipation; dry mouth; skin rash; loss of strength; extreme fatigue: water retention leading to swelling of the hands, ankles or feet; fever; joint pain and sexual dysfunction, such as decreased libido in men and women or erectile dysfunction in men. Uncommon side effects (may affect up to 1 in 100 patients) include hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slowing of the heartbeat; sensitivity to sunlight; nosebleeds; abdominal bloating; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and changes in the breasts in men and women, such as abnormal growth or abnormal milk secretion. Rare side effects (may affect up to 1 in 1,000 patients) include a decrease in body temperature; changes in heart rhythm; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and malaise; liver disease that manifests as yellowing of the skin and whites of the eyes; muscle disease that presents as tenderness and unexplained pain; and prolonged and/or painful erection. Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS is initially characterized by flu-like symptoms, such as a rash on the face and then spreading, high temperature, enlarged lymph nodes, high levels of liver enzymes in blood tests and an increase in a type of white blood cells (eosinophilia). During treatment with olanzapine, elderly patients with dementia may be subject to stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, skin flushing, gait disturbances. Some fatal cases have been reported in this particular group of patients.

In patients with Parkinson's disease Zalasta may worsen symptoms.

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

5. How to store Zalasta

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of the month.
Store in the original package to protect the medicine from light and moisture. This medicine does not require any particular storage temperature.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zalasta contains

• The active ingredient is olanzapine. Each tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, or 20 mg of olanzapine.
• The excipients are lactose monohydrate, powdered cellulose, pregelatinized starch (vegetable origin), corn starch, anhydrous colloidal silicon dioxide, magnesium stearate.
• See section 2 “Zalasta contains lactose”. Description of the appearance of Zalasta and contents of the packZalasta 2.5 mg tablets are round, slightly biconvex, light yellow in colour with possible single spots. Zalasta 5 mg tablets are round, slightly biconvex, light yellow in colour with possible single spots and marked with 5. Zalasta 7.5 mg tablets are round, slightly biconvex, light yellow in colour with possible single spots and marked with 7.5. Zalasta 10 mg tablets are round, slightly biconvex, light yellow in colour with possible single spots and marked with 10. Zalasta 15 mg tablets are round, slightly biconvex, light yellow in colour with possible single spots and marked with 15. Zalasta 20 mg tablets are round, slightly biconvex, light yellow in colour with possible single spots and marked with 20. Zalasta 2.5 mg tablets are available in packs containing 14, 28, 35, 56, 70 or 98 tablets in blisters. Zalasta 5 mg tablets are available in packs containing 14, 28, 35, 56, 70 or 98 tablets in blisters. Zalasta 7.5 mg tablets are available in packs containing 14, 28, 35, 56 or 70 tablets in blisters. Zalasta 10 mg tablets are available in packs containing 7, 14, 28, 35, 56, 70 or 98

tablets in blisters.
Zalasta 15 mg tablets are available in packs containing 14, 28, 35, 56 or 70 tablets
in blisters.
Zalasta 20 mg tablets are available in packs containing 14, 28, 35, 56 or 70 tablets
in blisters.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., ul. Ròwnoległa 5, 02-235 Warszawa, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta

• E. J. Busuttil Ltd. Tel: + 356 21 445 885 DeutschlandTAD Pharma GmbH Tel: + 49 (0) 4721 606-0 NederlandKRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) EestiKRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658 NorgeKRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) ΕλλάδαKRKA ΕΛΛΑΣ ΕΠΕ Τηλ: + 30 2100101613 ÖsterreichKRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300 EspañaKRKA Farmacéutica, S.L. Tel: + 34 911 61 03 80 PolskaKRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500 FranceKRKA France Eurl Tél: + 33 (0)1 57 40 82 25 PortugalKRKA Farmacêutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710
More detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu

Zalasta 5 mg orodispersible tablets, 7.5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets

olanzapine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful for people other than you, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Zalasta is and what it is used for
• 2. What you need to know before you take Zalasta
• 3. How to take Zalasta
• 4. Possible side effects
• 5. How to store Zalasta
• 6. Contents of the pack and other information

1. What is Zalasta and what is it used for

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

• Schizophrenia, an illness with symptoms such as hearing, seeing or feeling things that are not there, false beliefs, unjustified suspicion and social withdrawal. People with this illness may also feel depressed, anxious or tense.
• Moderate to severe manic episodes, a condition characterized by symptoms such as excitement or euphoria. Zalasta has also been shown to be able to prevent the recurrence of such symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before taking Zalasta

Do not take Zalasta

• 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 manifest with skin rash, itching, swelling of the face, swelling of the lips, shortness of breath. If this has happened to you, tell your doctor.
• If you have previously been diagnosed with an eye problem such as certain types of glaucoma (increased pressure inside the eye). Be careful with ZalastaTalk to your doctor or pharmacist before taking Zalasta.
• The use of Zalasta in elderly patients with dementia is not recommended as it may

cause serious side effects.

• Medicines of this type can cause unusual movements, especially of the face and tongue. If this happens after you have been given Zalasta, tell your doctor.
• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness and confusion or drowsiness. If this happens, consult your doctor immediately.
• Weight gain has been observed in patients taking Zalasta. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or getting help with a diet program.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Zalasta. Your doctor should request blood tests to check sugar and certain fat levels in the blood before you start taking Zalasta and, regularly, during treatment.
• Tell your doctor if you or someone in your family has a history of blood clot formation, as medicines like these have been associated with the formation of blood clots. If you suffer from any of the following conditions, tell your doctor as soon as possible:
• Stroke or transient ischemic attack (symptoms of a stroke) (TIA)
• Parkinson's disease
• Problems with the prostate
• Bowel obstruction (paralytic ileus)
• Liver or kidney disease
• Blood diseases
• Heart disease
• Diabetes
• Convulsions
• If you know that you may have excessive salt loss due to severe and prolonged diarrhea and vomiting (being ill) or the use of diuretics (water tablets) If you suffer from dementia, you or your caregiver should inform the doctor if you have had a stroke or transient ischemic attack in the past. As a routine precaution, if you are over 65 years of age, have your blood pressure checked periodically by your doctor. Children and adolescentsZalasta is not indicated in patients under the age of 18 years. Other medicines and ZalastaTake other medicines while taking Zalasta only if your doctor tells you that you can. You may feel sleepy if Zalasta is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquilizers). Tell your doctor if you are taking, have recently taken or may take any other medicine In particular, tell your doctor if you are taking:
• medicines for Parkinson's disease,
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), - it may be necessary to adjust your dose of Zalasta. Zalasta and alcoholDo not drink any alcohol while being treated with Zalasta as the simultaneous intake of Zalasta and alcohol can cause drowsiness. Pregnancy and breastfeeding

If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to
become pregnant, ask your doctor for advice before taking this medicine. You should not take
this medicine while breastfeeding, as small amounts of Zalasta may pass
into breast milk.
The following symptoms may occur in newborns of mothers who have used Zalasta in the last
trimester (last three months of pregnancy): tremor, stiffness and/or muscle weakness, drowsiness,
agitation, breathing problems and difficulty feeding. If your baby presents any of these
symptoms, you may need to contact your doctor.

Driving and using machines
When taking Zalasta there is a risk that you may feel sleepy. If this happens, do not drive or
operate tools or machinery. Tell your doctor.

Zalasta contains aspartame (a source of phenylalanine)
This medicine contains 0.50 mg of aspartame in each 5 mg orodispersible tablet.
This medicine contains 0.75 mg of aspartame in each 7.5 mg orodispersible tablet.
This medicine contains 1.00 mg of aspartame in each 10 mg orodispersible tablet.
This medicine contains 1.50 mg of aspartame in each 15 mg orodispersible tablet.
This medicine contains 2.00 mg of aspartame in each 20 mg orodispersible tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU),
a rare genetic disorder in which phenylalanine builds up because the body cannot remove it
properly.

3. How to take Zalasta

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your
doctor or pharmacist.
Your doctor will tell you how many Zalasta tablets you need to take and for how long you need to
continue taking them. The dose of Zalasta to be taken varies from 5 mg to 20 mg per day.
If your symptoms reappear, consult your doctor but do not stop taking Zalasta unless
your doctor tells you to.
You should take Zalasta tablets once a day, following your doctor's instructions. Try to
take the tablets every day at the same time. It does not matter if you take them on a full or
empty stomach.

How to take Zalasta
Zalasta tablets break easily, so be careful when taking the tablet
in your hand. Do not touch the tablets with wet hands as the tablets may break.
To remove the tablet from the packaging:

• 1. Hold the blister pack by the edges and separate one blister pocket from the rest of the blister pack by gently tearing along the perforated separation line.
• 2. Pull the edge of the foil and remove it completely.
• 3. Push the tablet out into your hand.
• 4. Place the tablet on your tongue immediately after removing it from the packaging.

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The tablet will dissolve directly in your mouth within a few seconds and can be swallowed with or without
water. Your mouth must be empty before placing the tablet on your tongue.
You can also put the tablet in a glass or cup of water. Drink it
immediately.

If you take more Zalasta than you should
Patients who have taken more Zalasta than they should have experienced the following
symptoms: increased heart rate, agitation/aggressiveness, speech problems,
unusual movements (especially of the face or tongue) and a reduced level of consciousness. Other
symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of
fever, rapid breathing, sweating, muscle stiffness, stupor or drowsiness, slowed
breathing rate, reduced cough reflex, high or low blood pressure, changes
in heart rhythm. Contact your doctor or hospital immediately if you experience any of the
above symptoms. Show your doctor your tablet pack.

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

If you stop taking Zalasta
Do not stop taking the tablets as soon as you start to feel better. It is important that you continue
treatment with Zalasta for as long as your doctor deems necessary.
If you suddenly stop taking Zalasta, symptoms such as
sweating, inability to sleep, tremor, anxiety, nausea and vomiting may occur. Your doctor may advise you to
gradually reduce the dose before stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Report to your doctor immediately if you have:

• abnormal movements (a common side effect that can affect up to 1 in 10 people) mainly of the face or tongue
• blood clots in the veins (a rare side effect that can affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness of the leg), which can move to blood vessels in the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately
• a combination of fever, fast breathing, sweating, muscle stiffness and drowsiness or dizziness (the frequency of these side effects 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 experience a feeling of dizziness or fainting (with a slowing of the

heartbeat), especially when getting up from a lying or sitting position. These effects usually subside spontaneously, but if this does not happen, inform your doctor.
Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and in the early stages of treatment temporary increases in liver enzymes; increases in blood sugar and urine sugar levels; increases in uric acid and creatine phosphokinase levels in the blood; feeling of increased hunger; dizziness; restlessness; tremor unusual movements (dyskinesias); constipation; dry mouth; skin rash; loss of strength; extreme fatigue: water retention leading to swelling of the hands, ankles or feet; fever; joint pain and sexual dysfunction, such as decreased libido in men and women or erectile dysfunction in men.
Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slowing of the heartbeat; sensitivity to sunlight; nosebleeds; abdominal bloating; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and changes in the breasts in men and women, such as abnormal growth or abnormal milk secretion.
Rare side effects (may affect up to 1 in 1,000 people) include a decrease in body temperature; changes in heart rhythm; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and malaise; liver disease that manifests as yellowing of the skin and whites of the eyes; muscle disease that presents as tenderness and unexplained pain; and prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS is initially characterized by flu-like symptoms, such as a rash on the face and then spreading, high temperature, enlarged lymph nodes, elevated liver enzyme levels in blood tests and an increase in a type of white blood cells (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may be subject to stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, skin flushing, gait disturbances. Some fatal cases have been reported in this particular group of patients.
In patients with Parkinson's disease Zalasta may worsen symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine
I

5. How to store Zalasta

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of the month.
Store in the original package to protect the medicine from light and moisture. This medicine does not require any particular storage temperature.
Medicines should not be disposed of 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 Zalasta contains

• The active ingredient is olanzapine. Each orally disintegrating tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg, or 20 mg of olanzapine.
• The excipients are mannitol, microcrystalline cellulose, crospovidone, low-substituted hydroxypropylcellulose, aspartame, calcium silicate, magnesium stearate.
• See section 2 “Zalasta contains aspartame”. Description of Zalasta and package contentsZalasta orally disintegrating tablets of 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg are round, slightly biconvex, mottled yellow in colour with possible single spots. Zalasta orally disintegrating tablets of 5 mg are available in packs containing 14, 28, 35, 56 or 70 tablets in blisters. Zalasta orally disintegrating tablets of 7.5 mg are available in packs containing 14, 28, 35, 56 or 70 tablets in blisters. Zalasta orally disintegrating tablets of 10 mg are available in packs containing 14, 28, 35, 56 or 70 tablets in blisters. Zalasta orally disintegrating tablets of 15 mg are available in packs containing 14, 28, 35, 56 or 70 tablets in blisters. Zalasta orally disintegrating tablets of 20 mg are available in packs containing 14, 28, 35, 56 or 70 tablets in blisters. Marketing authorisation holder and manufacturerKRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia ManufacturerKRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia KRKA-POLSKA Sp. z o.o., ul. Ròwnoległa 5, 02-235 Warszawa, Poland TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany For further information on this medicinal product, please contact the local representative of the marketing authorisation holder: België/Belgique/BelgienKRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 LietuvaUAB KRKA Lietuva Tel: + 370 5 236 27 40 БългарияКРКА България ЕООД Teл.: + 359 (02) 962 34 50 Luxembourg/LuxemburgKRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta

• E. J. Busuttil Ltd. Tel: + 356 21 445 885 DeutschlandTAD Pharma GmbH Tel: + 49 (0) 4721 606-0 NederlandKRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) EestiKRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658 NorgeKRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) ΕλλάδαKRKA ΕΛΛΑΣ ΕΠΕ Τηλ: + 30 2100101613 ÖsterreichKRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300 EspañaKRKA Farmacéutica, S.L. Tel: + 34 911 61 03 80 PolskaKRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500 FranceKRKA France Eurl Tél: + 33 (0)1 57 40 82 25 PortugalKRKA Farmacêutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650 HrvatskaKRKA - FARMA d.o.o. Tel: + 385 1 6312 100 RomâniaKRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05 IrelandKRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710 SlovenijaKRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100 ÍslandLYFIS ehf. Sími: + 354 534 3500 Slovenská republikaKRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 501 ItaliaKRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8841 Suomi/FinlandKRKA Finland Oy Puh/Tel: + 358 20 754 5330 ΚύπροςKI.PA. (PHARMACAL) LIMITED Τηλ: + 357 24 651 882 SverigeKRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) LatvijaKRKA Latvija SIA Tel: + 371 6 733 86 10 United Kingdom (Northern Ireland)KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710

More detailed information on this medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu