Zalasta
olanzapine
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What Zalasta is and what it is used for
What you need to know before you take Zalasta
How to take Zalasta
Possible side effects
How to store Zalasta
Contents of the pack and other information
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 disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense.
Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.
Zalasta has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as a rash, itching, a
swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor.
If you have been previously diagnosed with eye problems such as certain kinds of glaucoma
(increased pressure in the eye).
Talk to your doctor or pharmacist before you take Zalasta.
The use of Zalasta in elderly patients with dementia is not recommended as it may have serious side effects
Medicines of this type may cause unusual movements mainly of the face or tongue. If this
happens after you have been given Zalasta tell your doctor.
Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, contact your doctor at once.
Weight gain has been seen in patients taking Zalasta. You and your doctor should check your
weight regularly. Consider referral to a dietician or help with a diet plan if necessary.
High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Zalasta. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Zalasta and regularly during treatment.
Tell the doctor if you or someone else in your family has 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 illnesses tell your doctor as soon as possible:
Stroke or “mini” stroke (temporary symptoms of stroke)
Parkinson’s disease
Prostate problems
A blocked intestine (Paralytic ileus)
Liver or kidney disease
Blood disorders
Heart disease
Diabetes
Seizures
If you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)
If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.
As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
Zalasta is not for patients who are under 18 years.
Only take other medicines while you are on Zalasta if your doctor tells you that you can. You
might feel drowsy if Zalasta is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking:
medicines for Parkinson’s disease.
carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), - it may be necessary to change your Zalasta dose.
Do not drink any alcohol if you have been given Zalasta as together with alcohol it may make you
feel drowsy.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this medicine. You should not take this medicine when pregnant unless you have discussed this with your doctor.
The following symptoms may occur in newborn babies, of mothers that have used Zalasta in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
There is a risk of feeling drowsy when you are given Zalasta. If this happens do not drive or
operate any tools or machines. Tell your doctor.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacists if you are not sure.
Your doctor will tell you how many Zalasta tablets to take and how long you should continue to take them. The daily dose of Zalasta is between 5 mg and 20 mg. Consult your doctor if your symptoms return but do not stop taking Zalasta unless your doctor tells you to.
You should take your Zalasta tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food.
You should swallow the tablets whole with water.
Patients who have taken more Zalasta than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness. Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart. Contact your doctor or hospital straight away if you experience any of the above symptoms. Show the doctor your pack of tablets.
Take your tablets as soon as you remember. Do not take two doses in one day.
Do not stop taking your tablets just because you feel better. It is important that you carry on taking Zalasta for as long as your doctor tells you.
If you suddenly stop taking Zalasta, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur. Your doctor may suggest you to reduce the dose gradually before stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately if you have:
unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the
face or tongue;
blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may
travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately;
a combination of fever, faster 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; sleepiness and increases in levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell 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 early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; 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 dysfunctions 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 in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones 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; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; drooling; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.
Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia).
While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking. Some fatal cases have been reported in this particular group of patients.
In patients with Parkinson's disease Zalasta may worsen the symptoms.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreportingsystem
listedinAppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture. This medicine does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is olanzapine. Each tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg
or 20 mg olanzapine.
The other ingredients are lactose monohydrate, powdered cellulose, pregelatinised maize starch, maize starch, colloidal anhydrous silica, magnesium stearate.
See section 2 "Zalasta contains lactose".
Zalasta 2.5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible
individual yellow spots.
Zalasta 5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual
yellow spots and an inscription 5.
Zalasta 7.5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 7.5.
Zalasta 10 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual
yellow spots and an inscription 10.
Zalasta 15 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 15.
Zalasta 20 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 20.
Zalasta 2.5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister.
Zalasta 5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Zalasta 7.5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Zalasta 10 mg tablets: available in boxes of 7, 14, 28, 35, 56 and 70 tablets in blisters.
Zalasta 15 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Zalasta 20 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62
UAB KRKA Lietuva Tel: + 370 5 236 27 40
КРКА България ЕООД Teл.: + 359 (02) 962 34 50
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
E. J. Busuttil Ltd.
Tel: + 356 21 445 885
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300
KRKA Farmacéutica, S.L. Tel: + 34 911 61 03 80
KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100
LYFIS ehf.
Sími: + 354 534 3500
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330
KI.PA. (PHARMACAL) LIMITED Τηλ: + 357 24 651 882
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)
KRKA Latvija SIA
Tel: + 371 6 733 86 10
Consilient Health Limited
Tel: + 353 (0)1 2057760