Patient leaflet - Olanzapine Sandoz 15 mg film-coated tablets
What Olanzapine is and what it is used for
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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 dose.
Olanzapine with alcohol
Do not drink any alcohol if you have been given Olanzapine 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 can pass into breast milk.
The following symptoms may occur in newborn babies, of mothers who 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.
Driving and using machines
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 contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Olanzapine 15 mg film coated tablets contain less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially “sodium-free”.
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 is between 5mg 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 film-coated tablets are for oral use. You should swallow the Olanzapine tablets with water.
Olanzapine 5 mg, 10 mg, 15 mg and 20 mg film-coated tablets can be divided into equal doses.
If you take more Olanzapine than you should
Patients who have taken more Olanzapine 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
Take your tablets as soon as you remember. Do not take two doses in one day.
Continued on the next page >> What is in this leaflet:
What you need to know before you take Olanzapine
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How to take Olanzapine
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In patients with Parkinson’s disease Olanzapine 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 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 carton and on the blister/ label of the HDPE-bottle after “EXP”. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.
Storage conditions after first opening of the bottle:
Do not store above 25°C.
Shelf life after first opening of the bottle: 6 months
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.
What Olanzapine contains
The active substance is olanzapine. Each film-coated tablet contains either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg of olanzapine.
Olanzapine Sandoz 2.5 mg, 5 mg, 7.5 mg and 10 mg film-coated tablets also contain: Tablet core: lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate. Tablet coat: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171) and talc.
Olanzapine Sandoz 15 mg film-coated tablets also contain:
Tablet core: lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate. Tablet coat: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc and indigo carmine (E 132) (contains sodium).
Olanzapine Sandoz 20 mg film-coated tablets also contain:
Tablet core: The other ingredients are lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate.
Tablet coat: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc and iron oxide red (E 172).
What Olanzapine looks like and contents of the pack
Olanzapine Sandoz 2.5 mg Film-coated Tablets:
White and round, approximately 6.5 mm in diameter.
Olanzapine Sandoz 5 mg Film-coated Tablets:
White and round, approximately 8 mm in diameter, with a score line on one side.
Olanzapine Sandoz 7.5 mg Film-coated Tablets:
White and round, approximately 9 mm in diameter.
Olanzapine Sandoz 10 mg Film-coated Tablets:
White and round, approximately 10 mm in diameter, with a score line on one side.
Olanzapine Sandoz 15 mg Film-coated Tablets:
Light blue and oval, approximately 12 mm in length, with a score line on both sides.
Olanzapine Sandoz 20 mg Film-coated Tablets:
Pink and oval, approximately 13 mm in length, with a score line on both sides.
The film-coated tablets are packed in aluminium/aluminium blisters and inserted in a carton, or are packed in a HDPE bottle with a desiccant in the cap.
Pack sizes:
Blister: 7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 70, 98, 100, 500 film-coated tablets HDPE bottle: 50, 100, 250, 500 film-coated tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke Allee 1, 39179 Barleben, Germany or
LEK S.A., 16 Podlipie Str., 95-010 Strykow, Poland
or
LEK S.A., 50 Domaniewska Str., 02-672 Warsaw, Poland
or
Lek Pharmaceuticals d.d., Verovskova 57, SI-1526 Ljubljana, Slovenia
This leaflet was last revised in 06/2020.
SZ00000LT000 If you stop taking Olanzapine
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:
- 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 (a rare side effect that may affect up to 1 in 1,000 people).
Very common side effects (may affect more than 1 in 10 people) include:
- Weight gain
- Sleepiness
- Increases in the 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 and circulating fats
- Temporary increases in liver enzymes, especially early in treatment
- 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
- 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)
- 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
- 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 1,000 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
- 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 on blood tests and an increase in a type of white blood cells (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.
Possible side effects
4 How to store Olanzapine
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Contents of the pack and other information
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