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OLANZAPINE MEDANA 20 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Olanzapine Medana 5 mg
Olanzapine Medana 10 mg
Olanzapine Medana 15 mg
Olanzapine Medana 20 mg
film-coated tablets
Olanzapine

Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Olanzapine Medana is and what it is used for
Before you take Olanzapine Medana
How to take Olanzapine Medana
Possible side effects
How to store Olanzapine Medana
Further information

1.

WHAT OLANZAPINE MEDANA IS AND WHAT IT IS USED FOR

Olanzapine Medana belongs to a group of medicines called antipsychotics.
Olanzapine Medana is used to treat 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which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.
Olanzapine Medana is used to treat a condition with symptoms such as feeling "high", having
excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing
ideas and sometimes severe irritability. It is also a mood stabiliser that prevents further occurrences of
the disabling high and low (depressed) extremes of mood associated with this condition.
2.

BEFORE YOU TAKE OLANZAPINE MEDANA

Do not take Olanzapine Medana
- if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of
Olanzapine Medana. 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).
Take special care with Olanzapine Medana
- Medicines of this type may cause unusual movements mainly of the face or tongue. If
this happens after you have been given Olanzapine Medana 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.

-

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If you or someone else in your family has a history of blood clots, as medicines like these
have been associated with formation of blood clots.
Weight gain has been seen in patients taking Olanzapine Medana. You and your doctor
should check your weight regularly.
High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in
patients taking Olanzapine Medana. Your doctor should do blood tests to check blood sugar
and certain fat levels before you start taking Olanzapine Medana and regularly during
treatment.
The use of Olanzapine Medana in elderly patients with dementia is not recommended
as it may have serious side effects.

If you suffer from any of the following illnesses tell your doctor as soon as possible:

Diabetes

Heart disease

Liver or kidney disease

Parkinson's disease

Epilepsy

Prostate problems

A blocked intestine (Paralytic ileus)

Blood disorders

Stroke or "mini" stroke (temporary symptoms of stroke).
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 Medana is not for patients who are under 18 years.
Taking other medicines
Only take other medicines while you are on Olanzapine Medana if your doctor tells you that you can.
You might feel drowsy if Olanzapine Medana is taken in combination with antidepressants or
medicines taken for anxiety or to help you sleep (tranquillisers).
You should tell your doctor if you are taking fluvoxamine (an antidepressant or ciprofloxacin (an
antibiotic), as it may be necessary to change your Olanzapine Medana dose.
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. Especially tell your doctor if you are taking medicines for
Parkinson's disease.
Taking Olanzapine Medana with food and drink
Do not drink any alcohol if you have been given Olanzapine Medana as Olanzapine Medana and
alcohol together may make you feel drowsy.
Pregnancy and breast-feeding
Tell your doctor as soon as possible if you are pregnant or think you may be pregnant. You should
not take this medicine when pregnant, unless you have discussed this with your doctor.
The following symptoms may occur in newborn babies, of mothers that have used Olanzapine
Medana 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 Medana
can pass into breast milk.

2

Driving and using machines
There is a risk of feeling drowsy when you are given Olanzapine Medana. If this happens do not drive
or operate any tools or machines. Tell your doctor.
Important information about some of the ingredients of Olanzapine Medana
Olanzapine Medana 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.
Tablets 20 mg also contain sunset yellow FCF (E110), which may cause allergic reactions.
3.

HOW TO TAKE OLANZAPINE MEDANA

Always take Olanzapine Medana exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Your doctor will tell you how many Olanzapine Medana tablets to take and how long you should
continue to take them. The daily dose of Olanzapine Medana is between 5 and 20 mg. Consult your
doctor if your symptoms return but do not stop taking Olanzapine Medana unless your doctor tells you
to.
You should take your Olanzapine Medana 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 Medana coated tablets are for oral use. You should swallow the Olanzapine
Medana tablets whole with water.
If you take more Olanzapine Medana than you should
Patients who have taken more Olanzapine Medana 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. Show the doctor your pack of tablets.
If you forget to take Olanzapine Medana
Take your tablets as soon as you remember. Do not take two doses in one day.
If you stop taking Olanzapine Medana
Do not stop taking your tablets just because you feel better. It is important that you carry on taking
Olanzapine Medana for as long as your doctor tells you.
If you suddenly stop taking Olanzapine Medana, 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Olanzapine Medana can cause side effects, although not everybody gets them.
Very common side effects: affect 1 user in 10
• Weight gain.
• Sleepiness.
• Increases in the levels of prolactin in the blood.
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Common side effects: affect 1 to 10 users in 100
• Changes in the levels of some blood cells and circulating fats.
• Increases in the level of sugars in the blood and urine.
• Feeling more hungry.
• Dizziness.
• Restlessness.
• Tremor.
• Muscle stiffness or spasm (including eye movements).
• Problems with speech.
• Unusual movement (especially of the face or tongue).
• Constipation.
• Dry mouth.
• Rash.
• Loss of strength.
• Extreme tiredness.
• Water retention leading to swelling of the hands, ankles or feet.
• 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.
• Sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in
males.
Uncommon side effects: affect 1 to 10 users in 1,000
• Slow heart rate.
• Make you sensitive to sunlight.
• Urinary incontinence.
• 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.
• Blood clots in the veins 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.
Other possible side effects: frequency cannot be estimated from the available data.
• Allergic reaction (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.
• Lowering of normal body temperature.
• Seizures, usually associated with a history of seizures (epilepsy).
• Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or
sleepiness.
• Spasms of the muscle of the eye causing rolling movement of the eye.
• 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.
• Difficulty in passing urine.
• Prolonged and/or painful erection.
While taking Olanzapine Medana, 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.
4

In patients with Parkinson's disease Olanzapine Medana may worsen the symptoms.
Rarely women taking medicines of this type for a long time have started to secrete milk and have
missed periods or had irregular periods. If this persists tell your doctor. Very rarely babies born to
mothers who have taken Olanzapine Medana in the last stage of pregnancy (3rd trimester) may have
tremors, be sleepy or drowsy.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor.
5.

HOW TO STORE OLANZAPINE MEDANA

Keep out of the reach and sight of children.
Do not use Olanzapine Medana after the expiry date, which is stated on the carton.
Store in the original package to protect from light.
Please return left over medicine to your pharmacist. Medicines should not be disposed of via
wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6.

FURTHER INFORMATION

What Olanzapine Medana contains
The active substance is olanzapine. Each Olanzapine Medana tablet contains either 5 mg, 10
mg, 15 mg or 20 mg of the active substance. The exact amount is shown on your Olanzapine
Medana tablet pack.
The other ingredients are:
(tablet core): lactose monohydrate, povidone 30, crospovidone A, magnesium stearate, sodium
starch glycolate (type A), silica colloidal anhydrous.
(tablet coating): polyvinyl alcohol, titanium dioxide (E171), talc, macrogol (type 3350).
In addition Olanzapine Medana tablets 15 mg and 20 mg also contain the following
ingredients:
Tablet strength
Olanzapine Medana 15 mg tablets
Olanzapine Medana 20 mg tablets

Other ingredients
(tablet coating) quinoline yellow aluminium lake
(E104), iron oxide yellow (E172)
(tablet coating) lecithin, sunset yellow FCF
aluminium lake (E110), quinoline yellow
aluminium lake (E104).

What Olanzapine Medana looks like and contents of the pack
Olanzapine Medana 5 mg and 10 mg film-coated tablets are white or almost white.
Olanzapine Medana 15 mg film-coated tablets are yellow.
Olanzapine Medana 20 mg film-coated tablets are orange.
Olanzapine Medana tablets are available in 30 tablet packs.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medana Pharma SA
10, Władysława Łokietka Street, 98-200 Sieradz, Poland

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Manufacturer
Pharmaceutical Works POLPHARMA SA
19, Pelplińska Street, 83-200 Starogard Gdański, Poland
This medicinal product is authorised in the Member States of the EEA under the following
names:
United Kingdom, Czech Republic, Hungary, Latvia, Bulgaria, Estonia: Olanzapine Medana 5 mg,
Olanzapine Medana 10 mg, Olanzapine Medana 15 mg, Olanzapine Medana 20 mg
Lithuania: Olanzapine Medana 5 mg plėvele dengtos tabletės, Olanzapine Medana 10 mg plėvele
dengtos tabletės, Olanzapine Medana 15 mg plėvele dengtos tabletės, Olanzapine Medana 20 mg
plėvele dengtos tabletės
Romania: Olanzapină Medana 5 mg comprimate filmate, Olanzapină Medana 10 mg comprimate
filmate, Olanzapină Medana 15 mg comprimate filmate, Olanzapină Medana 20 mg comprimate
filmate
For any information about this medicine, please contact the local representative of the
Marketing Authorisation Holder:

<[To be completed nationally]>

This leaflet was last approved in 04/2012.

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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