Olanzapine 5 Mg Orodispersible Tablets
Package leaflet: Information for the patient
Olanzapine 5 mg orodispersible tablets Olanzapine 10 mg orodispersible tablets Olanzapine 15 mg orodispersible tablets Olanzapine 20 mg orodispersible tablets
olanzapine
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 further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Olanzapine is and what it is used for
2. What you need to know before you take Olanzapine
3. How to take Olanzapine
4. Possible side effects
5. How to store Olanzapine
6. Contents of the pack and other information
1. What OLANZAPINE is and what it is used for
Olanzapine contains the active substance olanzapine. Olanzapine belongs to a group of medicines called antipsychotics and Olanzapine 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.
Olanzapine has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
2. What you need to know before you take OLANZAPINE
Do not take Olanzapine if:
• You are allergic 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.
• You have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Olanzapine
• The use of Olanzapine 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 Olanzapine 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 Olanzapine. 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 Olanzapine. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine 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 formation of blood clots.
If you suffer from any of the following illnesses tell your doctor as soon as possible:
• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson’s disease
• Epilepsy (seizures)
• Prostate problems
• A blocked intestine (Paralytic ileus)
• Blood disorders
• Stroke or “mini” stroke (temporary symptoms of stroke)
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. Children and adolescents
Olanzapine is not for patients who are under 18 years.
Other medicines and Olanzapine
Only take other medicines while you are on Olanzapine if your doctor tells you that you can. You might feel drowsy if Olanzapine is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Olanzapine
Tell your doctor or pharmacist 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 Olanzapine dose.
Olanzapine with alcohol
Do not drink any alcohol if you have been given Olanzapine as Olanzapine together with alcohol it may make you feel drowsy.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take this medicine when pregnant, unless you have discussed this with your doctor.
You should not be given this medicine when breast-feeding, as small amounts of Olanzapine can pass into breast milk.
The following symptoms may occur in newborn babies, of mothers that have used Olanzapine 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.
Driving and using machines
There is a risk of feeling drowsy when you are given Olanzapine. If this happens do not drive or operate any tools or machines. Tell your doctor.
Olanzapine contains aspartame and lactose (a milk sugar)
Patients who cannot take phenylalanine should note that Olanzapine contains aspartame, which is a source of phenylalanine. May be harmful for people with phenylketonuria.
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.
3. How to take OLANZAPINE
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many orodispersible tablets to take and how long you should continue to take them. The daily dose of Olanzapine is between 5 and 20 mg. Consult your doctor if your symptoms return but do not stop taking Olanzapine unless your doctor tells you to.
You should take your Olanzapine 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. Olanzapine orodispersible tablets are for oral use.
Olanzapine orodispersible tablets break easily, so you should handle the tablets carefully. Do not handle the tablets with wet hands as the tablets may break up.
1. Carefully peel off the backing.
2. Gently push the tablet out.
3. Put the tablet in your mouth. It will dissolve directly in your mouth, so that it can be easily swallowed.
You can also place the tablet in a full glass or cup of water, orange juice, apple juice, milk or coffee, and stir. With some drinks, the mixture may change colour and possibly become cloudy. Drink it straight away.
Use in children and adolescents
Olanzapine is not for patients who are under 18 years.
If you take more Olanzapine than you should
Patients who have taken more Olanzapine 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.
If you forget to take Olanzapine
Take your tablets as soon as you remember. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Olanzapine
Do not stop taking your tablets just because you feel better. It is important that you carry on taking Olanzapine for as long as your doctor tells you.
If you suddenly stop taking Olanzapine, 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.
4. Possible side effects
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)
• Weight gain
• Sleepiness
• Increases in the 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)
• Changes in the levels of some blood cells and circulating fats
• Increases in the level of sugars in the blood and urine
• Feeling more hungry
• Dizziness
• Restlessness
• Tremor
• Constipation
• Dry mouth
• Rash
• Loss of strength
• Extreme tiredness
• Water retention leading to swelling of the hands, ankles or feet
• Sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
• Early in treatment, temporary increases in liver enzymes
• Increases in levels of uric acid and creatine phosphokinase in the blood
• Unusual movements (dyskinesia)
• Fever
• Joint pain
Uncommon side effects: (may affect up to 1 in 100 people)
• Slow heart rate
• Sensitivity to sunlight
• Urinary incontinence
• Lack of ability to urinate
• Hair loss
• Absence or decrease in menstrual periods
• Changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth
• Muscle stiffness or spasm (including eye movements)
• Problems with speech
• Allergic reaction (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)
• Bleeding from the nose
• Abdominal distension
• Memory loss or forgetfulness
Rare side effects: (may affect up to 1 in 1000 people).
• 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
• Prolonged and/or painful erection.
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 Olanzapine may worsen the symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store OLANZAPINE
Store in the original package in order to protect from moisture.
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 carton and on the blister after EXP. The expiry date refers to the last day of that month.
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.
6. Contents of the pack and other information What Olanzapine contains
• Olanzapine 5 mg orodispersible tablets: The active substance is olanzapine. Each tablet contains 5 mg olanzapine.
• Olanzapine 10 mg orodispersible tablets: The active substance is olanzapine. Each tablet contains 10 mg olanzapine.
• Olanzapine 15 mg orodispersible tablets: The active substance is olanzapine. Each tablet contains 15 mg olanzapine.
• Olanzapine 20 mg orodispersible tablets: The active substance is olanzapine. Each tablet contains 20 mg olanzapine.
• All strengths contain the following inactive ingredients: calcium carbonate DC CS90 (which consists of calcium carbonate, maize starch pregelatinised and maize starch), lactose monohydrate, crospovidone, aspartame (E951) and magnesium stearate.
What Olanzapine looks like and contents of the pack
5mg: Yellow to pale yellow, round, biconvex, tablet, embossed with ‘5’ on one side. The diameter is about
6.4 mm and the thickness is about 3.8 mm of the tablet.
10mg: Yellow to pale yellow, round, biconvex, tablet, embossed with ‘10’ on one side. The diameter is about
9.1 mm and the thickness is about 4.3 mm of the tablet.
15mg: Yellow to pale yellow, round, biconvex, tablet, embossed with ‘15’ on one side. The diameter is about
10.4 mm and the thickness is about 4.8 mm of the tablet.
20mg: Yellow to pale yellow, round, biconvex, tablet, embossed with ‘20’ on one side. The diameter is about
12.1 mm and the thickness is about 4.6 mm of the tablet.
All strengths are supplied in cartons containing 28, 30, 56, 60, 84 or 90 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Egis Pharmaceuticals PLC,
1106 Budapest, Kereszturi ut 30-38,
Hungary
Manufacturer:
Genepharm S.A., 18 Km Marathon Avenue, 15351 Pallini, Greece Egis Pharmaceuticals PLC, 1106 Budapest, Kereszturi ut 30-38, Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Olanzapine 5 mg, 10 mg, 15 mg, 20 mg orodispersible tablets
Bulgaria: Olanzapine EGIS 5 mg, 10 mg, 15 mg, 20 mg TabneTKH, gncneprapa^n ce b ycTara Czech Republic: Olanzapin EGIS 5 mg, 10 mg, 15 mg, 20 mg Hungary: Olanzapine EGIS 5mg, 10mg, 15mg & 20 mg szajban oldodo tabletta Poland: Olanzapine Egis
Latvia: Olanzapine Alvogen 5 mg, 10 mg, 15 mg, 20 mg mute disper ge jam as tabletes Lithuania: Olanzapine Alvogen 5 mg, 10 mg, 15 mg, 20 mg burnoje disperguojamosios tabletes Romania: Olanzapina Egis 5 mg, 10 mg, 15 mg, 20 mg comprimate orodispersabile Slovak Republic: Olanzapin Egis 5 mg, 10 mg, 15 mg, 20 mg
This leaflet was last revised in: 03/2015
PL 03525/0009-0001 PL 03525/0010-0001 PL 03525/0011-0001 PL 03525/0012-0001
POM