Olanzapine 15mg Orodispersible Tablets
Out of date information, search anotherOlanzapine-ratiopharm 5/7.5/10/15/20 mg orodispersible tablets ratiopharm GmbH, Germany DE/H/3079/007-011/DC
Package leaflet: Information for the user Olanzapine 5/7.5/10/15/20 mg orodispersible tablets
Olanzapine
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.
What is in this leaflet:
1. What Olanzapine orodispersible tablets is and what it is used for
2. What you need to know before you take Olanzapine orodispersible tablets
3. How to take Olanzapine orodispersible tablets
4. Possible side effects
5. How to store Olanzapine orodispersible tablets
6. Contents of the pack and other information
1. What Olanzapine orodispersible tablets is and what it is used for
Olanzapine orodispersible tablets contains the active substance olanzapine. Olanzapine orodispersible
tablets belongs 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 orodispersible 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 orodispersible tablets
Do not take Olanzapine orodispersible tablets
• if you are allergic 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.
• if you 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 orodispersible tablets.
• The use of Olanzapine orodispersible 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 orodispersible 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 orodispersible tablets. You and your doctor should check your weight regularly. Consider referral to a dietician 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 orodispersible tablets. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine orodispersible tablets and regularly during treatment.
• 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.
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
• Prostate problems
• A blocked intestine (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
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 orodispersible tablets is not for patients who are under 18 years.
Other medicines and Olanzapine orodispersible tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Only take other medicines while you are on Olanzapine orodispersible tablets if your doctor tells you that you can. You might feel drowsy if Olanzapine orodispersible tablets is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
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 orodispersible tablets dose.
Olanzapine orodispersible tablets with alcohol
Do not drink any alcohol if you have been given Olanzapine orodispersible 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. 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 orodispersible 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 orodispersible tablets. If this happens do not drive or operate any tools or machines. Tell your doctor.
Olanzapine orodispersible tablets contains aspartame
Contains a source of phenylalanine (aspartame). May be harmful for people with phenylketonuria.
|
Olanzapine orodispersible tablets |
5 mg |
7.5 mg |
10 mg |
15 mg |
20 mg |
|
Aspartame (amount per tablet) |
0.5 mg |
0.75 mg |
1 mg |
15 mg |
2 mg |
3. How to take Olanzapine orodispersible tablets
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 tablets to take and how long you should continue to take them. The daily dose of olanzapine is between 5 mg and 20 mg. Consult your doctor if your symptoms return but do not stop taking Olanzapine orodispersible tablets unless your doctor tells you to.
You should take your 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.
The orodispersible tablets are for oral use.
The tablets break easily, so you should handle the tablets carefully. Do not handle the tablets with wet hands as the tablets may break up. They must not be pushed through the packaging as this would damage them. To take a tablet out of the packaging, please proceed as follows:
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. Pull up the edge of the foil and peel foil off completely
3. Tip the tablet out onto your hand
4. Put the tablet on your tongue as soon as it is removed from the packaging. The tablet begins breaking up in the mouth within seconds and can then be swallowed with or without water. Your mouth should be empty before placing the tablet on the tongue.
You can also place the tablet in a full glass or cup of water, orange juice, apple juice, milk or coffee, and stir. Drink it straight away.
If you take more Olanzapine orodispersible tablets than you should
Patients who have taken more 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 orodispersible tablets
Take your tablets as soon as you remember. Do not take two doses in one day.
If you stop taking Olanzapine orodispersible tablets
Do not stop taking your tablets just because you feel better. It is important that you carry on taking Olanzapine orodispersible tablets for as long as your doctor tells you. If you suddenly stop taking Olanzapine orodispersible 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:
• 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 side effects (may affect more than 1 in 10 people)
• Weight gain.
• Sleepiness.
• 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)
• 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.
• 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)
• 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).
• Problems with speech.
• Slow heart rate.
• Sensitivity to sunlight.
• Bleeding from the nose.
• Abdominal distension.
• 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 1000 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.
• Prolonged and/or painful erection.
While taking Olanzapine orodispersible tablets, 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 orodispersible tablets 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Olanzapine orodispersible 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 or blister. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture and light.
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.
6. Contents of the pack and other information What Olanzapine orodispersible tablets contains
The active substance is olanzapine.
Each orodispersible tablet contains either 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine. The exact amount is shown on the carton.
The other ingredients are mannitol, microcrystalline cellulose, crospovidone, hyproxypropylcellulose, aspartame, calcium silicate and magnesium stearate.
What Olanzapine orodispersible tablets looks like and contents of the pack
Olanzapine orodispersible tablets 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg are orodispersible tablets. Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed.
All orodispersible tablets are round, slightly biconvex, yellow marbled with possible individual spots. The differences are:
Olanzapine 5 mg orodispersible tablets diameter of 5.5 mm
Olanzapine 7.5 mg orodispersible tablets diameter of 6.5 mm
Olanzapine 10 mg orodispersible tablets diameter of 7 mm
Olanzapine 15 mg orodispersible tablets diameter of 8 mm
Olanzapine 20 mg orodispersible tablets diameter of 10 mm
They are available in blister packs containing 7, 10, 14, 28, 30, 35, 56, 60, 70 and 98 orodispersible tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
<To be completed nationally>
Manufacturer
<To be completed nationally>
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria:
Finland:
France:
Germany:
Portugal:
United Kingdom:
Olanzapin-ratiopharm 5/7.5/10/15/20 mg Schmelztabletten Olanzapin ratiopharm 5/7.5/10/15/20 mg tabletti, suussa hajoava Olanzapine ratiopharm 5/10 mg, comprime orodispersible Olanzapin-ratiopharm 5/7.5/10/15/20 mg Schmelztabletten Olanzapina ratiopharm 5/10/15/20 mg Comprimido orodispersivel Olanzapin 5/10/15/20mg Orodispersible tablets
This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
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