Patient Leaflet Updated 06-Jul-2020 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company
Olanzapine 2.5/5/7.5/10/15/20mg tablets
Olanzapine 2.5 mg tablets
Olanzapine 5 mg tablets
Olanzapine 7.5 mg tablets
Olanzapine 10 mg tablets
Olanzapine 15 mg tablets
Olanzapine 20 mg tablets
Olanzapine 5 mg orodispersible tablets
Olanzapine 10 mg orodispersible tablets
Olanzapine 15 mg orodispersible tablets
Olanzapine 20 mg orodispersible tablets
olanzapine
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
Olanzapine contains the active substance olanzapine. Olanzapine belongs to a group of medicines called antipsychotics and is used to treat the following conditions:
Olanzapine has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Talk to your doctor or pharmacist before taking Olanzapine.
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.
Olanzapine is not for patients who are under 18 years.
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).
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:
Do not drink any alcohol if you have been given Olanzapine as together with alcohol it may make you feel drowsy.
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 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.
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 tablets contain 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.
Patients who cannot take phenylalanine should note that Olanzapine orodispersible tablets contain aspartame, which is a source of phenylalanine. May be harmful for people with phenylketonuria.
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 recommended daily dose of Olanzapine is between 5 mg 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 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:
You should swallow the Olanzapine tablets whole with water.
Olanzapine orodispersible tablets:
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. Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.
2. Carefully peel off the backing.
3. Gently push the tablet out.
4. 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.
Patients who have taken more Olanzapine than they should have experienced the following symptoms:
Other symptoms may be:
Contact your doctor or hospital straight away if you experience any of the above symptoms. Show the doctor your pack of tablets.
Take your tablets as soon as you remember. Do not take a double dose to make up for a forgotten dose.
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.
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 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); 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 spasms (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 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.
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.
Very rare side effects (may affect up to 1 in 10000 people) 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).
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 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.
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 blister, bottle or carton after EXP.
The expiry date refers to the last day of that month.
Olanzapine tablet:
Do not store above 30°C.
Olanzapine orodispersible tablet:
This medicinal product does not require any special 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 to protect the environment.
Olanzapine tablet:
Olanzapine orodispersible tablet:
Olanzapine tablet:
Olanzapine 2.5 mg tablets are yellow, round uncoated tablets with ’2.5’ debossed on one side and plain on the other.
Olanzapine 5 mg tablets are yellow, oval uncoated tablets with ’5’ debossed on one side and plain on the other.
Olanzapine 7.5 mg tablets are yellow, round uncoated tablets with ’7.5’ debossed on one side and plain on the other.
Olanzapine 10 mg tablets are yellow, oval uncoated tablets with ’10’ debossed on one side and plain on the other.
Olanzapine 15 mg tablets are yellow, oval uncoated tablets with ’15’ debossed on one side and plain on the other.
Olanzapine 20 mg tablets are yellow, oval uncoated tablets with ’20’ debossed on one side and plain on the other.
Olanzapine 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg tablets are available in blister packs containing 28, 35, 56 or 70 tablets and HDPE bottles containing 30 or 100 tablets.
Olanzapine orodispersible tablet:
Olanzapine 5 mg orodispersible tablets are yellow, round, uncoated tablets with ‘O5’ debossed on one side and plain on the other.
Olanzapine 10 mg orodispersible tablets are yellow, round, uncoated tablets with ‘O10’ debossed on one side and plain on the other.
Olanzapine 15 mg orodispersible tablets are yellow, round, uncoated tablets with ‘O15’ debossed on one side and a plain on the other.
Olanzapine 20 mg orodispersible tablets are yellow, round, uncoated tablets with ‘O20’ debossed on one side and a plain on the other.
28 x 1, 35 x 1, 56 x 1 or 70 x 1 Olanzapine 5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
This medicinal product is authorised in the Member States of the EEA under the following names
Italy Olanzapina SUN 2,5/5/7,5/10/15/20 mg compresse;
Olanzapina SUN 5/10/15/20 mg compresse orodispersibili
The Netherlands Olanzapine SUN 2,5/5/7,5/10/15/20 mg tabletten;
Olanzapine SUN 5/10/15/20 mg orodispergeerbare tabletten
Sweden Olanzapin SUN, 2,5/5/7,5/10/15/20 mg tablett;
Olanzapin SUN, 5/10/15/20 mg munsönderfallande tablett
United Kingdom Olanzapine 2.5/5/7.5/10/15/20 mg tablets;
Olanzapine 5/10/15/20 mg orodispersible tablets
This leaflet was last revised in 05/2020.
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