Active ingredient
- olanzapine
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL30306/0168, PL30306/0163, PL30306/0164, PL30306/0165, PL30306/0167, PL30306/0166.
Olanzapine 2.5mg, 5mg, 7.5mg,10mg, 15mg, 20mg Film-coated Tablets
PATIENT INFORMATION LEAFLET
Olanzapine 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1 What Olanzapine tablets are and what they are used for
2 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
6 Contents of the pack and other information
1 What Olanzapine tablets are and what they are used for
Olanzapine tablets 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 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 tablets
Do not take Olanzapine tablets if you
Warnings and precautions
Talk to your doctor or pharmacist before taking Olanzapine tablets
If you suffer from any of the following illnesses tell your doctor as soon as possible:
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 if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking:
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.
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.
You should not be given this medicine when breast-feeding, as small amounts of Olanzapine tablets can pass into breast milk.
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 lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Olanzapine tablets contains lecithin soya.
If you are allergic to peanut or soya, do not take this medicine.
3 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 is between 5 and 20 mg. 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. You should swallow the Olanzapine tablets whole with water.
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 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 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:
Very common side effects (may affect more than 1 in 10 people) include
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
Uncommon side effects (may affect up to 1 in 100 people) include
Rare side effects (may affect up to 1 in 1000 people) include
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, 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 at: 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 tablets
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.
Blister packs:
Store in the original package 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 protect the environment.
6 Contents of the pack and other information
What Olanzapine tablets contain
What Olanzapine tablets look like and contents of the pack
Film-coated tablet 2.5mg: Round, biconvex, white film-coated tablet 6mm in diameter, marked with “O” on one side.
Film-coated tablet 5mg: Round, biconvex, white film-coated tablet 8mm in diameter, marked with “O1” on one side.
Film-coated tablet 7.5mg: Round, biconvex, white film-coated tablet 9mm in diameter, marked with “O2” on one side.
Film-coated tablet 10mg: Round, biconvex, white film-coated tablet 10mm in diameter, marked with “O3” on one side.
Film-coated tablet 15mg: Oval, biconvex, light blue film-coated tablet 7.35 x 13.35mm in diameter, marked with “O” on one side.
Film-coated tablet 20mg: Oval, biconvex, light pink film-coated tablet 7.5 x 14.5mm in diameter, marked with “O” on one side.
Pack sizes
2.5mg, 5mg, 10mg, 15mg, 20mg:
In blisters: 28 film-coated tablets.
7.5mg:
In blisters: 28 and 56 film-coated tablets.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in January 2017
If you would like a leaflet with larger text, please contact 01271 385257.
BBBA0426
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 385 200
+44 (0)1271 385 257
+44 (0)1271 346 106