Patient leaflet - OLANZAPINE 20 MG ORODISPERSIBLE TABLETS
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Package leaflet: Information for the patient
Olanzapine 5mg, 10mg, 15mg and 20mg Orodispersible Tablets
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:
jH What Olanzapine tablets are and what they are used for
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What you need to know before you take Olanzapine tablets
How to take Olanzapine tablets
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Possible side effects
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How to store Olanzapine tablets Contents of the pack and other information
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2] What Olanzapine tablets are and what they are used for
Olanzapine tablets belong to a group of medicines called antipsychotics and are 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 taking 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 dietitian 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 your 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
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- 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.
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 are taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
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 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 or pharmacist for advice before taking this medicine. 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 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 contain aspartame
This medicine contains up to 2.8mg (5mg strength), 5.6mg (10mg strength), 8.4mg (15mg strength) and 11.2mg (20mg strength) aspartame in each 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.
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How to take Olanzapine tablets
Always take this medicine exactly as your doctor or pharmacist 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.
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 if you experience any of the above symptoms. 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 two doses in one day.
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, inability 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.
Very rare (may affect up to 1 in 10,000 people):
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Olanzapine tablets should be stored in its original pack in order to protect from light and moisture.
Olanzapine tablets do 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 protect the environment.
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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 (may affect more than 1 in 10 people): 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 (may affect up to 1 in 10 people):
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 (may affect up to 1 in 100 people):
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); 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 (may affect up to 1 in 1,000 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; and prolonged and/or painful erection.
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 exact amount is shown on your Olanzapine tablets pack.
The other ingredients are:
- magnesium stearate, L-Methionine, colloidal anhydrous silica, 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.
Olanzapine 10mg orodispersible tablet is a round, biconvex, yellow orodispersible tablet 8mm in diameter and marked with “O1” on one side.
Olanzapine 15mg orodispersible tablet is a round, biconvex, yellow orodispersible tablet, 9mm in diameter and marked with “O2” on one side.
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
Accord, Barnstaple, EX32 8NS, UK
Manufacturer
Actavis Ltd.
B16, Bulebel Industrial Estate
Zejtun ZTN 08
Malta
This leaflet was last revised in May 2021.
If you would like a leaflet with larger text, please contact 01271 385257.
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