OLANZAPINE ALTER 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Olanzapine Alter 5 mg orodispersible tablets EFG

Olanzapine Alter 10 mg orodispersible tablets EFG

Olanzapine Alter 15 mg orodispersible tablets EFG

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

• Keep this package 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 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 Alter and what is it used for
2. What you need to know before taking Olanzapine Alter
3. How to take Olanzapine Alter
4. Possible side effects
5. Storage of Olanzapine Alter
6. Contents of the pack and other information

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

Olanzapine Alter contains the active substance olanzapine. Olanzapine 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such as hearing, seeing, or feeling things that are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with these diseases may also feel depressed, anxious, or tense.
• Moderate to severe manic episodes, a disease with symptoms such as excitement or euphoria.

Olanzapine 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 taking Olanzapine Alter

Do not take Olanzapine Alter

• If you are allergic 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 pressure in the eye).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

• Olanzapine 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, tell your doctor.
• Very rarely, medicines of this type can cause 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. 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. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking this medicine and regularly during treatment.
• If you or a family member have 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, tell your doctor as soon as possible:

• Stroke or temporary lack of blood flow to the brain (transient symptoms of stroke).
• 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.

Taking Olanzapine Alter with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Only take other medicines at the same time as olanzapine if your doctor authorizes it. You may feel drowsy if you combine olanzapine with antidepressants or medicines for anxiety or to help you sleep (tranquilizers).

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 may need to be changed.

Taking Olanzapine Alter with alcohol

Do not drink alcohol while taking this medicine, as the combination with 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 taking this medicine. You should not take this medicine when you are breastfeeding, as small amounts of olanzapine may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with olanzapine in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

Driving and using machines

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

Olanzapine Alter contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Olanzapine Alter

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

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

The tablets of olanzapine should be taken once a day, following the instructions of your doctor. Try to take the tablets at the same time every day. You can take them with or without food. The orodispersible tablets of olanzapine are for oral administration.

The orodispersible tablets of olanzapine crumble easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may crumble. Carefully remove the tablet from the blister.

Place the tablet in the mouth. It will dissolve directly in the mouth, making it easy to swallow.

You can also put the tablet in a glass or cup filled with water, orange juice, apple juice, milk, or coffee, stirring. With some drinks, the mixture may change color and appear cloudy. It should be drunk immediately.

If you take more Olanzapine Alter than you should

Patients who have taken more olanzapine 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 experience any of the above symptoms. Show the doctor the package with the tablets.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Olanzapine Alter

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

If you stop taking Olanzapine Alter

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

If you stop taking olanzapine 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 can affect up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (a rare side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include swelling, 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 (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 a lying or sitting position. This feeling usually disappears on its own, but if it does not, consult your doctor.

Common side effects (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 (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); 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 urination ability; 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 (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 prolonged and/or painful erections.

Very rare side effects (may affect up to 1 in 10,000 people) include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS manifests with symptoms similar to the flu, with a rash on the face, and later with an extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell in the blood (eosinophilia).

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Alter

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

Store in the original package to protect from light and moisture.

Do not use this medicine after the expiration date stated on the package, after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Alter

• The active substance is olanzapine. Each orodispersible tablet contains 5 mg, 10 mg, or 15 mg of olanzapine. The exact amount is shown on the package of the medicine.
• The other ingredients are crospovidone, lactose monohydrate, colloidal silicon dioxide, hydroxypropylcellulose, flavoring, talc, magnesium stearate.

Appearance of the product and contents of the pack

Orodispersible tablet is the technical name for a tablet that dissolves directly in the mouth to make it easier to swallow.

Olanzapine Alter 5 mg: yellow, round, biconvex orodispersible tablets.

They are available in packs of 28 tablets.

Olanzapine Alter 10 mg: yellow, round, flat orodispersible tablets.

They are available in packs of 28 or 56 tablets.

Olanzapine Alter 15 mg: yellow, round, biconvex orodispersible tablets.

They are available in packs of 28 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Pharmathen International S.A.

Sapes Industrial Park, Block 5, 69300 Rodopi

Greece

or

Pharmaten S.A.

6 Dervenakion str.; Pallini 153 51; Attiki

Greece

Date of last revision of this package leaflet:May 2020.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/