Zalasta

Patient Information Leaflet: Information for the User

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

olanzapine
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform 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 taking 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 Zalasta is and what it is 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, a disorder characterized by symptoms such as hearing, seeing, or sensing things that do not exist, false beliefs, unjustified suspicion, and social withdrawal. People with this disorder may also feel depressed, anxious, or tense.
• Moderate to severe manic episodes, a condition characterized by symptoms such as excitement or euphoria. Zalasta has also been shown 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 excipients of this medicine (listed in section 6). An allergic reaction may manifest 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).

Be cautious with Zalasta
Talk 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 may cause unusual movements, especially of the face and tongue. If this occurs after you have been given Zalasta, inform your doctor.

• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness. If this occurs, consult your doctor immediately.

• Weight gain has been observed in patients taking Zalasta. 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 blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Zalasta. Your doctor should perform blood tests to check your blood sugar and certain fat levels before you start taking Zalasta 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 (transient stroke-like symptoms) (TIA)

• 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 diarrhea and vomiting (due to illness) or use of diuretics (water tablets)
  If you have dementia, you or your caregiver should inform the doctor if you have previously had a stroke or transient ischemic attack. As a routine precaution, if you are over 65 years old, have your blood pressure checked regularly by your doctor.

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

Other medicines and Zalasta
Take other medicines while on Zalasta only if your doctor tells you it is safe to do so. You may feel drowsy if Zalasta 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 stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – your dose of Zalasta may need to be adjusted.

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

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine. You must 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 during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby shows 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 drowsy. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

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

3. How to take Zalasta

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will tell you how many Zalasta tablets to take and for how long you should continue taking
them. The dose of Zalasta ranges from 5 mg to 20 mg per day.
If your symptoms return, consult your doctor, but do not stop taking Zalasta unless your doctor tells you
to do so.
You should take Zalasta 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. Swallow the
tablets whole with some water.
If you take more Zalasta than you should
Patients who have taken more Zalasta than recommended have experienced the following symptoms:
increased heart rate, 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,
lethargy or drowsiness, slowed breathing rate, reduced cough reflex, high or low blood pressure, and
changes in heart rhythm. Contact your doctor or hospital immediately if you experience any of the
symptoms listed above. Show your doctor the pack of tablets.
If you forget to take Zalasta
Take the missed dose as soon as you remember. Do not take a double dose on the same day.
If you stop taking Zalasta
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue
treatment with Zalasta for as long as your doctor considers necessary.
If you stop taking Zalasta 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 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 everybody gets them.

Tell your doctor immediately if you experience:

• abnormal movements (a common side effect that may affect up to 1 in 10 people), mainly of the face or tongue
• blood clots in the veins (a rare side effect that may affect up to 1 in 100 people), especially 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, seek medical advice immediately
• a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or mental confusion (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 dizziness or fainting (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 patients) include: changes in levels of certain blood cells, circulating fats, and temporary increases in liver enzymes during the early stages of treatment; increased levels of blood and urine sugar; 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 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 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; language problems; stuttering; slowed 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; and 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 patients) include: decreased body temperature; changes in heart rhythm; unexplained sudden death; inflammation of the pancreas causing severe stomach pain, fever, and malaise; liver disease manifesting as yellowing of the skin and whites of the eyes; muscle disease presenting as tenderness and unexplained muscle pain; 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 rash on the face later spreading to other areas, high fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cells (eosinophilia).

In elderly patients with dementia treated with olanzapine, stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, increased body temperature, skin redness, and gait disturbances may occur. In this particular group of patients, some fatal cases have been reported.

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

5. How to store Zalasta

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 the month.
Store in the original packaging to protect the medicine from light and moisture.
This medicine does not require any special storage temperature.
Medicines must 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 substance 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 monohydrate lactose, powdered cellulose, pregelatinized starch (of vegetable origin), maize starch, anhydrous colloidal silica, magnesium stearate.
• See section 2 “Zalasta contains lactose”.

Description of the appearance of Zalasta and contents of the pack

Zalasta 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 cartons containing 14, 28, 35, 56, 70 or 98 tablets in blisters.
Zalasta 5 mg tablets are available in cartons containing 14, 28, 35, 56, 70 or 98 tablets in blisters.
Zalasta 7.5 mg tablets are available in cartons containing 14, 28, 35, 56 or 70 tablets in blisters.
Zalasta 10 mg tablets are available in cartons containing 7, 14, 28, 35, 56, 70 or 98 tablets in blisters.
Zalasta 15 mg tablets are available in cartons containing 14, 28, 35, 56 or 70 tablets in blisters.
Zalasta 20 mg tablets are available in cartons 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. Równoległa 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/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

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

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

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

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

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

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

Ísland
LYFIS ehf.
Sími: + 354 534 3500

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

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

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

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

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

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

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

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

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

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

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

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

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

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

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

Package leaflet: information for the user

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

olanzapine
Please read this leaflet carefully before taking this medicine 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 personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform 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 taking 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 Zalasta is and what it is 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, a disorder with symptoms such as hearing, seeing or sensing 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 episodes, a condition characterized by symptoms such as excitement or euphoria. Zalasta has also been shown to prevent the recurrence of such symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you should know before taking Zalasta

Do not take Zalasta

• If you are allergic (hypersensitive) to olanzapine or to any of the excipients of this medicine (listed in section 6). An allergic reaction may manifest 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). Be cautious with Zalasta Talk 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 adverse effects.

• Medicines of this type may cause unusual movements, particularly of the face and tongue. If this occurs after you have been given Zalasta, inform your doctor.

• Very rarely, medicines of this type may 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 Zalasta. 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 blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Zalasta. Your doctor should request blood tests to monitor your blood sugar and certain blood fat levels before you start taking Zalasta and regularly during treatment.

• Inform your doctor if you or someone in your family has a history of blood clots, as such medicines have been associated with blood clot formation. If you have any of the following conditions, inform your doctor as soon as possible:

• Stroke or transient ischemic attack (temporary stroke-like symptoms) (TIA)

• 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 salts due to severe and prolonged diarrhea 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 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 Zalasta is not indicated for patients under 18 years of age. Other medicines and Zalasta Only take other medications while taking Zalasta if your doctor has instructed you to do so. You may feel drowsy if Zalasta 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 medicine. 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 Zalasta may need to be adjusted. Zalasta and alcohol Do not drink any alcoholic beverages during treatment with Zalasta, as taking Zalasta together with alcohol may cause drowsiness. Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine. You must not take this medicine while breastfeeding, as small amounts of Zalasta may pass into breast milk.
The following symptoms may occur in newborns whose mothers have taken Zalasta 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 Zalasta, there is a risk that you may feel drowsy. If this occurs, do not drive or operate tools or machinery. Inform 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 accumulates because the body cannot remove it properly.

3. How to take Zalasta

Always take this medicine exactly as instructed by your doctor. If you have any doubts, you must
consult your doctor or pharmacist.
Your doctor will tell you how many Zalasta tablets to take and for how long you should continue
taking them. The dose of Zalasta ranges from 5 mg to 20 mg daily.
If your symptoms return, consult your doctor, but do not stop taking Zalasta unless your doctor
tells you to do so.
You should take Zalasta 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.
How to take Zalasta
Zalasta tablets break easily, so handle them carefully when taking the tablet in your hand. Do not
touch the tablets with wet hands, as they may break.
To remove the tablet from the packaging:

1. Hold the blister by the edges and separate one blister cavity from the rest of the blister by gently tearing along the perforated line.
2. Pull and completely remove the foil.
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 the 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.
Alternatively, you may place the tablet in a glass or cup filled with water. Drink it
immediately.
If you take more Zalasta than you should
Patients who have taken more Zalasta than prescribed have experienced the following
symptoms: increased heart rate, agitation/aggression, speech difficulties, 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, drowsiness or lethargy, slowed breathing,
reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your
doctor or hospital immediately if you experience any of the symptoms listed above. Show your
doctor the tablet packaging.
If you forget to take Zalasta
Take the missed dose as soon as you remember. Do not take a double dose on the same day.
If you stop taking Zalasta
Do not stop taking the tablets as soon as you start feeling better. It is important that you
continue treatment with Zalasta for as long as your doctor considers necessary.
If you suddenly stop taking Zalasta, symptoms such as sweating, difficulty sleeping, 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, speak to 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:

• abnormal movements (a common side effect which may affect up to 1 in 10 people), mainly of the face or tongue
• blood clots in the veins (a rare side effect which may affect up to 1 in 100 people), especially 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, seek medical advice immediately
• a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or mental confusion (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 dizziness or fainting (with a slowing of the heart rate), especially when standing up from a lying or sitting position. These effects usually resolve spontaneously, but if they do not, inform your doctor.

Common side effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating fats; temporary increases in liver enzymes during the early stages of treatment; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased feeling of hunger; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles, or feet; fever; joint pain; and sexual dysfunction, such as decreased libido in males and females or erectile dysfunction in males.

Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in the 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 heart rate; sensitivity to sunlight; nosebleeds; abdominal swelling; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and breast-related changes in males and females, such as abnormal growth or abnormal milk secretion.

Rare side effects (may affect up to 1 in 1,000 people) include decreased body temperature; changes in heart rhythm; unexplained sudden death; inflammation of the pancreas causing severe stomach pain, fever, and malaise; liver disease manifesting as yellowing of the skin and whites of the eyes; muscle disease presenting as tenderness and unexplained muscle pain; and prolonged and/or painful erection.

Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS is initially characterized by flu-like symptoms such as rash on the face subsequently spreading to other areas, high temperature, enlarged lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cells (eosinophilia).

In elderly patients with dementia treated with olanzapine, stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and gait disturbances may occur. Fatal cases have been reported in this particular patient group.

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

5. How to store Zalasta

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 the month.
Store in the original packaging to protect the medicine from light and moisture.
This medicine does not require any special storage temperature conditions.
Medicines must 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 substance is olanzapine. Each orodispersible 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 the appearance of Zalasta and contents of the pack

Zalasta 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg orodispersible tablets are round, slightly biconvex, marbled yellow in colour with possible single spots.

Zalasta 5 mg orodispersible tablets are available in cartons containing 14, 28, 35, 56, or 70 tablets in blisters.
Zalasta 7.5 mg orodispersible tablets are available in cartons containing 14, 28, 35, 56, or 70 tablets in blisters.
Zalasta 10 mg orodispersible tablets are available in cartons containing 14, 28, 35, 56, or 70 tablets in blisters.
Zalasta 15 mg orodispersible tablets are available in cartons containing 14, 28, 35, 56, or 70 tablets in blisters.
Zalasta 20 mg orodispersible tablets are available in cartons containing 14, 28, 35, 56, or 70 tablets in blisters.

Marketing Authorisation Holder and Manufacturer

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

Manufacturers:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warszawa, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

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

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

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

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

Deutschland (Germany)
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Eesti (Estonia)
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Ελλάδα (Greece)
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

España (Spain)
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

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

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

Ísland (Iceland)
LYFIS ehf.
Sími: + 354 534 3500

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

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

Latvija (Latvia)
KRKA Latvija SIA
Tel: + 371 6 733 86 10

Lietuva (Lithuania)
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

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

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

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Nederland (Netherlands)
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

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

Österreich (Austria)
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

Polska (Poland)
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

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

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

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

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

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

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

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