Patient leaflet - Olanzapine 15 mg film-coated tablets
1. What Olanzapine Film-coated Tablets are and what they are used for
2. What you need to know before you take Olanzapine Film-coated Tablets
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)
Store below 25°C.
3. How to take Olanzapine Film-coated Tablets
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
4. Possible side effects
5. How to store Olanzapine Film-coated Tablets
These measures will help to protect the environment.
Tell your doctor if any of the below side effects start bothering you.
6. Contents of the pack and other information
Very common side effects (may affect more than 1 in 10 people) include:
6.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
WHAT OLANZAPINE FILM-COATED
1.
CONTENTS OF THE PACK AND OTHER INFORMATION
- weight gain
TABLETS ARE AND WHAT THEY ARE USED FOR
- sleepiness
In particular, tell your doctor if you are taking:
What Olanzapine Film-coated Tablets contain
- increases in the levels of prolactin in the blood
- medicines for Parkinson’s disease
Olanzapine Film-coated Tablets belong to a group of medicines called antipsychotics and are used to treat the following conditions:
- The active substance is olanzapine. Each Olanzapine Film-coated Tablet contains either 2.5mg, 5mg, 10mg, 15mg or 20mg of the active substance. The exact amount is shown on your Olanzapine tablet pack.
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.
- carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine dose
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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.
- The other ingredients are (tablet core) lactose monohydrate, hyprolose (E463), crospovidone (E1202), microcrystalline cellulose (E460), magnesium stearate (E572) and (tablet coating) polyvinyl alcohol, talc (E553b), titanium dioxide (E171), lactose monohydrate and triacetin.
Olanzapine Film-coated Tablets with alcohol
Common side effects (may affect up to 1 in 10 people) include:
Do not drink any alcohol if you have been given Olanzapine Film-coated Tablets as Olanzapine and alcohol together may make you feel drowsy.
Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria
- changes in the levels of some blood cells and circulating fats and early in treatment, temporary increases in liver enzymes;
- increases in the level of sugars in the blood and urine
Pregnancy and breast-feeding
Olanzapine has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
What Olanzapine Film-coated Tablets look like and contents of the pack
- increases in levels of uric acid and creatine phosphokinase in the blood
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 Film-coated Tablets can pass into breast milk.
Olanzapine 2.5mg Film-coated Tablets are off-white to pale yellow and debossed with “2.5” on one side and blank on the other.
- feeling more hungry
- dizziness
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OLANZAPINE FILM-COATED TABLETS
Olanzapine 5mg Film-coated Tablets are off-white to pale yellow and debossed with “5” on one side and blank on the other.
2.
- restlessness
tremor
Olanzapine 10mg Film-coated Tablets are off-white to pale yellow and debossed with “10” on one side and blank on the other.
- unusual movements (dyskinesias)
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.
Do not take Olanzapine Film-coated Tablets:
- constipation
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.
Olanzapine 15mg Film-coated Tablets are off-white to pale yellow and debossed with “15” on one side and blank on the other.
- dry mouth
rash
Olanzapine 20mg Film-coated Tablets are off-white to pale yellow and debossed with “20” on one side and blank on the other.
- loss of strength
- extreme tiredness
- if you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
- 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
Driving and using machines
Olanzapine 2.5mg, 5mg, 10mg and 15mg Film-coated Tablets are available in 28, 50, 56, 60 and 70 tablet packs.
There is a risk of feeling drowsy when you are given Olanzapine Film-coated Tablets. If this happens do not drive or operate any tools or machines. Tell your doctor.
Warnings and precautions
Olanzapine 20mg Film-coated Tablets are available in 28 tablet packs. Not all pack sizes may be marketed.
Talk to your doctor or pharmacist before you take Olanzapine Film-coated Tablets.
Uncommon side effects (may affect up to 1 in 100 people) include:
Olanzapine Film-coated Tablets contain lactose
The use of Olanzapine Film-coated Tablets in elderly patients with dementia is not recommended as it may have serious side effects.
- hypersensitivity (e.g. swelling in the mouth and throat, itching, rash)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Marketing Authorisation Holder
- diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma
Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given Olanzapine Film-coated Tablets tell your doctor.
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.
- seizures, usually associated with a history of seizures (epilepsy)
3.
Manufacturer
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.
- muscle stiffness or spasms (including eye movements)
HOW TO TAKE OLANZAPINE FILM-COATED TABLETS
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K. Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.
- restless legs syndrome
- problems with speech
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Weight gain has been seen in patients taking Olanzapine Film-coated Tablets. You and your doctor should check your weight regularly. Consider referral to a dietician or help with a diet plan if necessary.
slow heart rate
PL 30464/0097-0102
- stuttering
Your doctor will tell you how many Olanzapine Film-coated Tablets to take and how long you should continue to take them. The daily dose of Olanzapine Film-coated Tablets is between 5 and 20mg.
sensitivity to sunlight
This leaflet was last revised in August 2021
- High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Film-coated Tablets. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Film-coated Tablets and regularly during treatment.
- bleeding from the nose
- abdominal distension
Consult your doctor if your symptoms return but do not stop taking Olanzapine Film-coated Tablets unless your doctor tells you to.
- drooling
- memory loss or forgetfulness
- 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.
- urinary incontinence; lack of ability to urinate
You should take your Olanzapine Film-coated 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.
- hair loss
- absence or decrease in menstrual periods
If you suffer from any of the following illnesses tell your doctor as soon as possible:
- changes in breasts in males and females such as abnormal production of breast milk or abnormal growth
Stroke or “mini” stroke (temporary symptoms of stroke)
Olanzapine Film-coated Tablets are for oral use. You should swallow the Olanzapine Film-coated Tablets whole with water.
- Parkinson’s disease
Prostate problems
Rare side effects (may affect up to 1 in 1000 people) include:
A blocked intestine (Paralytic ileus)
If you take more Olanzapine Film-coated Tablets than you should
- lowering of normal body temperature
Liver or kidney disease
Patients who have taken more Olanzapine Film-coated 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.
- abnormal rhythms of the heart
- Blood disorders
- sudden unexplained death
- Heart disease
- inflammation of the pancreas causing severe stomach pain, fever and sickness
- Diabetes
- liver disease appearing as yellowing of the skin and white parts of the eyes
- Seizures
- muscle disease presenting as unexplained aches and pains
- 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)
- 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).
See also section 4, “Possible side effects”.
Contact your doctor or hospital straight away if you experience any of the above symptoms. Show the doctor your pack of 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.
If you forget to take Olanzapine Film-coated Tablets
Take your tablets as soon as you remember. Do not take two doses in one day.
As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
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.
If you stop taking Olanzapine Film-coated Tablets
Do not stop taking your tablets just because you feel better. It is important that you carry on taking Olanzapine Film-coated Tablets for as long as your doctor tells you.
Children and adolescents
Olanzapine Film-coated Tablets are not suitable for patients who are under 18 years.
If you suddenly stop taking Olanzapine Film-coated 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.
In patients with Parkinson's disease Olanzapine Film-coated Tablets may worsen the symptoms.
Other medicines and Olanzapine Film-coated Tablets
Only take other medicines while you are on Olanzapine Film-coated Tablets if your doctor tells you that you can. You might feel drowsy if Olanzapine Film-coated Tablets are taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquilisers).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Colours Customer: Athlone Designer: DOB (AWG)
Product: Olanzapine Film-coated Tablets
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