Olanzapine 20mg Orodispersible Tablets
T00075-01 Malta Zejtun 190x380 PIL
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 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.
• The full name of this medicine is Olanzapine 5mg, 10mg, 15mg and 20mg Orodispersible Tablets but within the leaflet it will be referred to as Olanzapine tablets
What is in this leaflet:
j What Olanzapine tablets are and what they are used for
What you need to know before you take Olanzapine tablets _3 How to take Olanzapine tablets _4 Possible side effects _5| How to store Olanzapine tablets
Contents of the pack and other information
j What Olanzapine tablets are and what they are used for
Olanzapine tablets contain the active substance Olanzapine, belong 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.
Olanzapine tablets have been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
What you need to know before you take
Olanzapine tablets
Do not take Olanzapine tablets 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.
• 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 or pharmacist before you take Olanzapine tablets.
• The use of Olanzapine tablets 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 tablets 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 tablets. 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 tablets. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine tablets 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 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 tablets are not for patients who are under 18 years.
Other medicines and Olanzapine tablets
Only take other medicines while you are on Olanzapine tablets if your doctor tells you that you can. You might feel drowsy if Olanzapine tablets 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 Olanzapine tablets dose.
Olanzapine tablets with alcohol
Do not drink any alcohol if you have been given Olanzapine tablets as together with alcohol it may make you feel drowsy.
Pregnancy and breast-feeding
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 be given this medicine when breast-feeding, as small amounts of Olanzapine tablets can pass into breast milk.
The following symptoms may occur in newborn babies, of mothers that have used Olanzapine tablets 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 tablets. If this happens do not drive or operate any tools or machines. Tell your doctor.
Olanzapine tablets contains aspartame
Patients who cannot take phenylalanine should note that Olanzapine tablets contains aspartame, which is a source of phenylalanine. May be harmful for people with phenylketonuria.
Jl How to take Olanzapine tablets
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 Olanzapine tablets to take and how long you should continue to take them. The daily dose of Olanzapine tablets is between 5mg and 20mg. Consult your doctor if your symptoms return but do not stop taking Olanzapine tablets unless your doctor tells you to.
You should take your Olanzapine 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. Olanzapine tablets are for oral use.
Continued on next page
Continued top of next column AAAJ0954
Olanzapine 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. Keep your hands dry. Do not push the tablet out of the pocket
2. Separate one blister cell from the strip
3. Carefully peel off the backing
4. Take the tablet out of the pocket
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 or milk, and stir. With some drinks, the mixture may change colour and possibly become cloudy. Drink it straight away.
If you take more Olanzapine tablets than you should
Patients who have taken more Olanzapine tablets 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. Show the doctor your pack of tablets.
If you forget to take Olanzapine tablets
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 tablets
Do not stop taking your tablets just because you feel better. It is important that you carry on taking Olanzapine tablets for as long as your doctor tells you.
If you suddenly stop taking Olanzapine tablets, 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 product, ask your doctor or pharmacist.
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) 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); problems with speech; 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 spasm (including eye movements); spasms of the muscle of the eye causing rolling movement of the eye; problems with speech; slow heart rate; sensitivity to sunlight; bleeding from the nose: abdominal distension; 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.
Continued top of next column AAAJ0954
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 Olanzapine tablets may worsen the symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Olanzapine tablets
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton.
Olanzapine tablets should be stored in its original pack in order to protect from light and moisture.
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.
Contents of the pack and other information What Olanzapine tablets contain
• The active substance is olanzapine. Each Olanzapine Orodispersible Tablet contains either 5mg, 10mg, 15mg or 20mg of the active substance.
The other ingredients are
• magnesium stearate, L-Methionine, silica colloidal anhydrous, hydroxypropyl cellulose (low substituted), crospovidone (Type B), aspartame, microcrystalline cellulose, guar gum, magnesium carbonate heavy and orange flavour.
What Olanzapine tablets look like and contents of the pack
Olanzapine 5mg orodispersible tablet is a round, biconvex, yellow orodispersible tablet, 6mm in diameter and marked with "O" on one side. Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed.
Olanzapine 10mg orodispersible tablet is a round biconvex, yellow orodispersible tablet 8mm in diameter and marked with "O1" on one side. Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed.
Olanzapine 15mg orodispersible tablet is a round, biconvex, yellow orodispersible tablet, 9mm in diameter and marked with "O2" on one side. Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed.
Olanzapine 20mg orodispersible tablet is a round, biconvex, yellow orodispersible tablet, 10mm in diameter and marked with "O3" on one side. Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed.
Pack sizes:
28 orodispersible tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavikurvegur 76-78,220 HafnarfjorSur, Iceland
Manufacturer
Actavis Ltd., B16, Bulebel Industrial Estate, Zejtun ZTN 08, Malta
This leaflet was last revised in July 2016
If you would like a leaflet with larger % text, please contact 01271 385257.
Actavis, Barnstaple, EX32 8NS, UK