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OLANZAPINE REGEUROPE 7.5MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
olanzapine RegEurope 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg 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. What olanzapine is and what it is used for.
2. Before you take olanzapine.
3. How to take olanzapine.
4. Possible side effects.
5. How to store olanzapine.
6. Further information
1. WHAT OLANZAPINE IS AND WHAT IT IS USED FOR
Olanzapine belongs to a group of medicines called antipsychotics.
Olanzapine 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which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 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
Do not take olanzapine:

If you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of
olanzapine tablets. An allergic reaction can be recognised as rash, itching, a swollen o
face, swollen lips, or shortness of breath. If this 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:

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.

Medicines of this type may cause unusual movements mainly of the face or tongue. If this
happens after you have been given olanzapine 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.
The use of olanzapine 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 is not for patients who are under 18 years.
Taking other medicines:

Only take other medicines while you are on olanzapine if your doctor tells you that your
can. You may feel drowsy if olanzapine 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 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 with food and drink:
Do not drink any alcohol while you have been given olanzapine as olanzapine 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. 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.
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.
Important information about some of the ingredients of olanzapine:
This medicine contains lactose. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE olanzapine





Always take olanzapine 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 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 unless your doctor tells you to.
You should take your olanzapine 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. Olanzapinetablets are for oral use. You should swallow the olanzapine
tablets whole with water.

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. Show the doctor your pack of tablets.
If you forget to take olanzapine:
Take your tablet as soon as you remember it. Do not take two doses in one day.
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, olanzapine 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.
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.
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.
Blood clots such as deep venous thrombosis of the leg or blood clot on the
lung.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, 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.
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 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 or pharmacist.
5. HOW TO STORE OLANZAPINE
Keep out of the reach and sight of children.
Do not use olanzapine after the expiry date which is stated on the carton.
Store in the original package.
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 contains
The active substance is olanzapine. Each olanzapine tablet contains either 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg or 20 mg of the active substance.
The other ingredients are: Microcrystalline cellulose, anhydrous lactose, crospovidone, magnesium
stearate.
What olanzapine looks like and contents of the pack
Olanzapine is supplied in the form of tablets.
Description: Olanzapine 2,5 mg,, 5 mg, 7.5 mg, 10 mg, 15 mg tablets are yellow, cylindrical and
biconvex tablets.
Olanzapine 20 mg tablets are yellow, oblong and biconvex.
Olanzapine tablets are available in 28 and 56 tablets packs.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
RegEurope SARL
23 cité de l´union, 59290 Wasquehal, France
Manufacturer:
Laboratorios Cinfa, S.A.
C/ Olaz-Chipi, 10 – Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) – Spain
This leaflet was last approved in March/2012
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence
holder at the address (or telephone, fax, email) above.

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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