OLANZAPINE APOTEX 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine Apotex 5 mg orodispersible tablets EFG

Olanzapine Apotex 10 mg orodispersible tablets EFG

Olanzapine Apotex 15 mg orodispersible tablets EFG

Olanzapine Apotex 20 mg orodispersible tablets EFG

Olanzapine

Read the entire package leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Olanzapine Apotex and what is it used for
2. What you need to know before you take Olanzapine Apotex
3. How to take Olanzapine Apotex
4. Possible side effects
5. Storage of Olanzapine Apotex
6. Package contents and further information

1. What is Olanzapine Apotex and what is it used for

Olanzapine Apotex contains the active substance olanzapine. Olanzapine Apotex belongs to a group of medicines called antipsychotics and is used to treat the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also be depressed, anxious, or tense.

• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Olanzapine Apotex has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before you take Olanzapine Apotex

Do not take Olanzapine Apotex

• If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). The allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor.
• If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Olanzapine Apotex.

• Olanzapine Apotex is not recommended for use in elderly patients with dementia, as it may have serious side effects.
• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine Apotex, tell your doctor.
• In very rare cases, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens to you, contact your doctor immediately.
• A weight gain has been observed in patients taking Olanzapine Apotex. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapine Apotex. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Olanzapine Apotex and regularly during treatment.
• If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with the formation of blood clots.

If you suffer from any of the following diseases, inform your doctor as soon as possible:

• Stroke or transient lack of blood flow to the brain (temporary stroke symptoms).
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you think you may have loss of salts due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medicines (urination tablets).

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or a lack of blood flow to the brain.

As a routine precaution, if you are over 65 years old, it would be advisable for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years of age should not take Olanzapine Apotex.

Using Olanzapine Apotex with other medicines

Use other medicines at the same time as Olanzapine Apotex only if your doctor authorizes it. You may feel drowsy if you combine Olanzapine Apotex with antidepressants or medicines for anxiety or that help you sleep (tranquilizers).

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

In particular, tell your doctor if you are taking:

• medication for Parkinson's disease
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of Olanzapine Apotex may need to be changed.

Using Olanzapine Apotex with alcohol

Do not drink alcohol if you have been given Olanzapine Apotex, as the combination of Olanzapine Apotex and alcohol can cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

You should not take this medicine when you are breastfeeding, as small amounts of Olanzapine Apotex may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used Olanzapine Apotex in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby has any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of drowsiness when taking Olanzapine Apotex. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

3. How to take Olanzapine Apotex

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Consult your doctor or pharmacist if you have doubts.

Your doctor will tell you how many Olanzapine Apotex tablets you should take and for how long. The daily dose of Olanzapine Apotex ranges from 5 mg to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Olanzapine Apotex unless your doctor tells you to.

You should take your Olanzapine Apotex tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. You can take them with or without food. Olanzapine Apotex orodispersible tablets are for oral administration.

Olanzapine Apotex tablets break easily, so you should handle them carefully. Do not handle them with wet hands, as they may disintegrate.

You can also put the tablet in a glass or cup filled with water, orange juice, apple juice, milk, or coffee and stir. With some drinks, the mixture may change color and possibly become cloudy. Drink it immediately.

If you take more Olanzapine Apotex than you should

Patients who have taken more Olanzapine Apotex than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the above symptoms. Show the doctor the package with the tablets.

If you forget to take Olanzapine Apotex

Take your tablets as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Olanzapine Apotex

Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapine Apotex while your doctor tells you to.

If you stop taking Olanzapine Apotex suddenly, you may experience symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

If you have any further questions about 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.

Contact your doctor immediately if you have:

• unusual movements (a frequent side effect that may affect up to 1 in 10 people), especially 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 sweating, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to the doctor immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (the frequency cannot be estimated from the available data).

Very common side effects (which may affect more than 1 in 10 people) include weight gain, drowsiness, and increased prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from lying down or sitting. This feeling usually goes away on its own, but if it does not, consult your doctor.

Common side effects (which may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment, increased blood sugar and urine levels, increased uric acid and creatine phosphokinase levels in the blood, increased appetite, dizziness, agitation, tremors, unusual movements (dyskinesia), constipation, dry mouth, skin rash, loss of strength, excessive fatigue, fluid retention that causes swelling of the hands, ankles, or feet, fever, joint pain, and sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects (which may affect up to 1 in 100 people) include hypersensitivity (e.g., inflammation of the mouth and throat, itching, skin rash), diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma, seizures, in most cases related to a history of seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech problems, stuttering, slow pulse, sensitivity to sunlight, nosebleeds, abdominal distension, excessive salivation, memory loss or forgetfulness, urinary incontinence, loss of ability to urinate, hair loss, absence or decrease of menstrual periods, and changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.

Rare side effects (which may affect up to 1 in 1,000 people) include a drop in normal body temperature, abnormal heart rhythm, sudden unexplained death, pancreatitis, which causes severe stomach pain, fever, and malaise, liver disease, with yellowing of the skin and the white parts of the eyes, muscle disorder that presents as unexplained pain and weakness, and prolonged and/or painful erections.

Very rare side effects include a severe allergic reaction such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS is initially manifested by flu-like symptoms with a rash on the face and then a generalized rash, fever, lymph node enlargement, elevated liver enzyme levels in blood tests, and an increase in the number of a type of white blood cell (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking problems. Some deaths have been reported in this particular group of patients.

Olanzapine Apotex may worsen symptoms in patients with Parkinson's disease.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Apotex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the package and blister after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Olanzapine Apotex

The active ingredient is olanzapine.

• Each 5 mg Olanzapine Apotex orodispersible tablet contains 5 mg of olanzapine.
• Each 10 mg Olanzapine Apotex orodispersible tablet contains 10 mg of olanzapine.
• Each 15 mg Olanzapine Apotex orodispersible tablet contains 15 mg of olanzapine.
• Each 20 mg Olanzapine Apotex orodispersible tablet contains 20 mg of olanzapine.

The other ingredients are mannitol (E421), microcrystalline cellulose, calcium carbonate, sucralose, magnesium stearate, and anhydrous colloidal silica.

Product Appearance and Package Contents

"Orodispersible tablet" is the technical name for a tablet that dissolves directly in the mouth so it can be easily swallowed.

• Olanzapine Apotex 5 mg orodispersible tablets are round, yellow, flat-surfaced, and beveled-edged tablets, engraved with "APO" on one side and "OL" over "5" on the other.
• Olanzapine Apotex 10 mg orodispersible tablets are round, yellow, flat-surfaced, and beveled-edged tablets, engraved with "APO" on one side and "OL" over "10" on the other.
• Olanzapine Apotex 15 mg orodispersible tablets are round, yellow, flat-surfaced, and beveled-edged tablets, engraved with "APO" on one side and "OL" over "15" on the other.
• Olanzapine Apotex 20 mg orodispersible tablets are round, yellow, flat-surfaced, and beveled-edged tablets, engraved with "APO" on one side and "OL" over "20" on the other.

• Olanzapine Apotex 5 mg and 10 mg orodispersible tablets are available in blister packs of 28, 56, and 98 tablets.

• Olanzapine Apotex 20 mg orodispersible tablets are available in blister packs of 28 and 56 tablets.

• Olanzapine Apotex 15 mg orodispersible tablets are available in blister packs of 28 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Apotex Europe B.V.

Archimedesweg 2,

2333 CN, Leiden,

Netherlands

Manufacturer:

APL Swift Services (Malta) Ltd.

HF26 Hal Far Industrial Estate,

Hal Far, Birzebbugia,

BBG 3000, Malta

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.